| Domain | Subdomain | Application field | English | Definition | Definition Source | Use | Posology | Possible side effects | Source of information | Variant (Brands) | Term Note | Author | Campo de utilización | Subcampo de utilización | Ámbito de aplicación | Español | Definición | Fuente de la definción | Uso | Posología | Posibles efectos adversos | Fuente de la información | Variante (marcas) | Nota | Autor |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Amphotericin B | «Amphotericin B belongs to a group of medicines called anti-fungal antibiotics». |
Bristol-Myers Squibb Pharmaceuticals limited (2017) Package leaflet: Information for the patient Fungizone 50mg Powder for Sterile Concentrate. Disponible en: https://www.medicines.org.uk/emc/files/pil.3775.pdf [Consultado: 25-05-2018] | «It is used to treat serious infections such as blood infection with candida, aspergillus, cryptococcus, fusarium, zygomycetes, blastomycetes or coccidiodes, or cryptococcal meningitis caused by certain fungi». |
«Treatment is normally started at 1 mg per kg of body weight, every day over 2 to 4 weeks. Your doctor may decide to increase the amount you receive to as high as 3 mg per kg of body weight. For mucormycosis the starting dose is normally 5 mg per kg of body weight per day. The duration of therapy will be determined on an individual basis by your Doctor». |
«Very common side effects These can affect more than 1 in every 10 people: Low blood potassium levels, leading to feeling tired, confused, having muscle weakness or cramps Feeling sick or being sick Fever, chills or shivering. Common side effects These can affect up to 1 in every 10 people: Low magnesium, calcium or sodium blood levels, leading to feeling tired, confused, muscle weakness or cramps High blood sugar levels Headache A faster heart rate than normal Widening of the blood vessels, causing low blood pressure and flushing Breathlessness Diarrhoea Stomach (abdominal) pain Rash Chest pain Back pain Abnormal results for liver or kidney function showing up in blood tests or urine tests». |
Gilead Sciences Ltd (2017) Package leaflet: Information for the user AmBisome 50 mg Powder for solution for infusion Liposomal amphotericin B. Disponible en: https://www.medicines.org.uk/emc/files/pil.1022.pdf [Consultado: 25-05-2018] | «AmBisome; Amphotericin B Lipid Complex_Abelcet 5mg/mL Concentrate for Suspension for Infusion; Fungizone 50mg Powder for Sterile Concentrate». | Precautions: «You should not be given this medicine if you: – are allergic (hypersensitive) to amphotericin, If you have previously experienced a severe allergic reaction (anaphylactic or anaphylactoid)». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Amfotericina B | «Antimicótico, fungicida o fungistático según la dosis; actúa uniéndose al ergosterol de la membrana celular». | Vademecum (2016) Amfotericina B. Disponible en: https://www.vademecum.es/principios-activos-amfotericina+b-j02aa01 [Consultado: 28:05:2018] | «Presentación complejo sulfato sódico de colesterilo: tto. de aspergillosis invasiva en pacientes con I.R. o toxicidad inaceptable lo que impide el uso de anfotericina B en dosis efectivas y en pacientes donde el anterior tto. sistémico antifúngico ha fallado». - Liposomal: micosis sistémica grave, micosis con neutropenia grave por patología hematológica maligna o por citotóxicos o inmunosupresores, leishmaniosis visceral inmunocompetentes e inmunocomprometidos cuando no hay respuesta a antimoniales o amfotericina B convencional. - Complejo lipídico: candidiasis invasiva grave, micosis sistémicas graves (aspergilosis, criptococosis, fusariosis, zigomicosis, blastomicosis y coccidioidomicosis) en pacientes que no responden al tto. con amfotericina B deoxicolato o a otros agentes antifúngicos sistémicos, I.R. u otras contraindicaciones a su uso, o nefrotoxicidad causada por amfotericina B deoxicolato. Leishmaniasis visceral y su profilaxis 2 aria en infectados por VIH con recuento linfocitos T CD4+ < 200 células/µl. |
«Ads.: a) Complejo sulfato sódico de colesterilo: infus. IV (1-2 mg/kg/h); comenzar con 1 mg/kg/día hasta alcanzar 3-4 mg/kg/día; máx. 6 mg/kg/día. Dosis acumulada media 3,5 g. Duración media: 16 días. Administrar dosis de prueba previa. b) Liposomal: infus. IV (30-60 min), concentración recomendada: 0,2-2 mg/ml. Inicialmente: 1 mg/kg/día, aumentar gradualmente a 3 mg/kg/día. - Infección extremadamente severa: máx. 5 mg/kg/día. - Leishmaniasis visceral: 1-1,5 mg/kg/día, 21 días (preferible en inmunocomprometidos) o 3 mg/kg/día alternativamente, 10 días. c) Complejo lipídico: perfus. IV (2,5 mg/kg/h). Concentración final tras dilución: 1 mg/ml; niños y enf. cardiovascular: 2 mg/ml. Dosis de prueba: 1 mg durante 15 min. - Micosis sistémicas: 5 mg/kg/día, mín. 14 días. - Leishmaniasis visceral. Tto.: 3 mg/kg/día, 5 días consecutivos o bien alternos durante 9 días (dosis total 15 mg/kg); en inmunodeprimidos con infección VIH: 3 mg/kg/día, 5-10 días consecutivos, (dosis total 15-30 mg/kg). Profilaxis 2 aria en infectados por VIH: 3 mg/kg cada 21 días (interrumpir según recomendaciones nacionales)». |
«Aumento de creatinina sérica, de fosfatasa alcalina y de urea; taquicardia, arritmias incluida taquicardia supraventricular, bradicardia, fibrilación auricular, bloqueo auriculoventricular de 2º grado, extrasístoles ventriculares; anemia, leucopenia, trombocitopenia; cefalea, temblores, somnolencia, confusión; asma, disnea, hiperventilación, alteración respiratoria, hipoxia; diarrea, náuseas, vómitos, hemorragia gastrointestinal incluida hemorragia rectal y gingival, dolor abdominal; I.R. incluido fallo renal, hematuria, oliguria; rash; acidosis, alteraciones del equilibrio hídrico, hiperbilirrubinemia, alteraciones del equilibrio electrolítico incluidos hiperpotasemia, hipomagnesemia, anorexia; infección, sepsis; hipertensión, hipotensión; escalofríos, pirexia, astenia, edema generalizado, reacción en el lugar de iny., dolor torácico; anomalías en PFH». | Vademecum (2016) Amfotericina B. Disponible en: https://www.vademecum.es/principios-activos-amfotericina+b-j02aa01 [Consultado: 28:05:2018] | «ABELCET Concentrado para suspensión para perfusión 5 mg/ml AMBISOME Polvo para concentrado para disperión 50 mg» |
«No puede tomar amfotericina B en caso de hipersensibilidad, a menos que en la opinión del médico las ventajas del tto. sean mayores que los riesgos. Precauciones: I.H./I.R.; reducir velocidad infus. (durante 2 h) o administrar rutinariamente difenhidramina, paracetamol, petidina o hidrocortisona para evitar reacción aguda por infus.; prever posible reacción anafiláctica; riesgo: de nefrotoxicidad, monitorizar función renal, hepática, hematopoyética y nivel sérico de K y Mg, especialmente en tto. prolongado, concomitancia con otros nefrotóxicos e I.R. preexistente o que hayan experimentado fallo renal (en hemodializados administrar tras diálisis); de hipopotasemia (puede requerirse suplemento de K); de toxicidad pulmonar aguda con transfusión de leucocitos (espaciar administración y vigilar función pulmonar). Además en complejo lipídico: no usar en micosis no grave o superficial; niños y adolescentes, ancianos. En caso de insuficiencia renal monitorizar función renal, disminuir dosis si es necesario». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Amikacin | «Amikacin is one of a group of antibiotic medicines called ‘aminoglycosides’». |
Hospira UK Ltd (2017) PACKAGE LEAFLET: INFORMATION FOR THE USER Amikacin 250 mg/ml Injection. Disponible en: https://www.medicines.org.uk/emc/files/pil.3784.pdf [Consultado: 25-05-2018] | «Amikacin is used in the treatment of serious infections caused by bacteria sensitive to amikacin». |
«It will usually be given to you two or three times a day, for up to 10 days. Page 3 of 6 Adults and children over 12 years: The usual dose is 15 mg per kg per day which is administered as a single dose or divided into two equal doses of 7.5 mg per kg administered every 12 hours. The total dose should not exceed 1.5 g. When treatment is given in to a vein it is usually administered over a 30 to 60 minute period. Children up to 12 years: The usual dose is 15 – 20 mg per kg of body weight once a day or divided into two equal doses of 7.5 mg per kg which is administered every 12 hours. Neonates: The initial dose is 10 mg per kg of body weight followed by 7.5 mg per kg every 12 hours. Premature infants: The recommended dosing in premature babies is 7.5 mg per kg every 12 hours». |
«Rare side-effects which may affect less than 1 person in 1000 are listed below: ringing in your ears or loss of hearing decrease in the amount of urine you produce Not known; numbers of sufferers cannot be estimated from available data are listed below: severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint paralysis deafness sudden loss of breathing severe kidney failure Uncommon side-effects which may affect more than 1 person in 1000 are listed below: skin rash nausea and vomiting an excessive build up of bacteria or yeast which are resistant to amikacin Rare side-effects which may affect less than 1 person in 1000 are listed below: dizziness or vertigo (spinning sensation) headache fever unusually low amount of red blood cells in the blood (anaemia) or excessive amounts of the white blood cells known as eosinophils in the blood (eosinophilia) low levels of magnesium in the blood abnormal tingling or ‘pins and needles’ sensation muscle tremors joint pain low blood pressure itching or hives». |
Hospira UK Ltd (2017) PACKAGE LEAFLET: INFORMATION FOR THE USER Amikacin 250 mg/ml Injection. Disponible en: https://www.medicines.org.uk/emc/files/pil.3784.pdf [Consultado: 25-05-2018] | «Amikacin 250 mg/ml Injection; Amikin Injection 100 mg / 2 ml (amikacin sulphate)». | Precautions: «Do not use Amikacin Injection if you have shown signs of hypersensitivity (severe allergy) to amikacin, or any of the other ingredients listed in section 6, in the past if you suffer from a disorder called myasthenia gravis (severe weakness of certain muscles of the body). Take special care with Amikacin Injection if you have kidney problems if you have hearing difficulties or tinnitus (ringing or buzzing in the ears) if you have shown signs of allergy to any of the antibiotics related to amikacin (aminoglycosides) in the past If you have a known allergy to sulphites Amikacin should be used with caution in premature and neonatal infants». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Amikacina | «Bactericida, inhibe la síntesis proteica bacteriana. | Vademecum (2016) Amikacina. Disponible en: https://www.vademecum.es/principios-activos-amikacina-J01GB06 [Consultado: 28-05-2018] | «Tto. a corto plazo de infecciones graves producidas por gram - sensibles: Pseudomonas, E. coli, Proteus (indolpositivo e indolnegativo), Providencia, Klebsiella, Enterobacter, Serratia y Acinetobacter (Mima-Herellea). Tto. de corta duración de infecciones graves causadas por cepas de microorganismo sensibles como: septicemias (incluyendo sepsis neonatal); infecciones severas del tracto respiratorio; infecciones del SNC (meningitis); infecciones intra-abdominales (incluyendo peritonitis); infecciones complicadas y recidivantes del aparato urinario, cuyo tto. no sea posible con otros antibióticos de menor toxicidad; infecciones de la piel, huesos, tejidos blandos y articulaciones; infecciones en quemaduras; infecciones post quirúrgicas (incluyendo cirugía post-vascular)». | «IM o perfus. IV (en 30-60 min). Ads. y niños: 15 mg/kg/24 h o 7,5 mg/kg/12 h o 5 mg/kg/8 h. En pacientes con gran masa corporal, máx. 1,5 g/día. Prematuros: 7,5 mg/kg/12 h. Recién nacidos: dosis de carga 10 mg/kg seguido de 7,5 mg/kg/12 h. Niños > 2 sem: 7,5 mg/kg/12 h o 5 mg/kg/8 h. - Bacteriemia, septicemia, infección respiratoria, complicada del tracto urinario, intraabdominal y neutropenia febril, con Clcr ≥ 50 ml/min. Ads.: 15 mg/kg/24 h. Niños ≥ 4 sem: 20 mg/kg/día. - Infección urinaria no complicada: 500 mg/24 h o 250 mg/12 h. Duración del tto.: 7-10 días. En I.R. disminuir dosis o prolongar intervalo de administración. En pacientes obesos: dosis inicial debe calcularse en el peso ideal más un 40 % de exceso de peso. Pacientes con quemaduras y pacientes con infecciones graves pueden ser necesario administrar cada 4-6 h». |
«Nefrotoxicidad: elevaciones de creatinina sérica, albuminuria, presencia en orina de cilindros, leucocitos o eritrocitos, azotemia, oliguria; neurotoxicidad-ototoxicidad: toxicidad del VIII par craneal (pérdida de la audición, vértigo, daño coclear incluyendo pérdida de la audición en frecuencias altas), mareos, ataxia, vértigo, tinnitus, zumbido de oídos; neurotoxicidad-bloqueo neuromuscular: parálisis muscular aguda y apnea, entumecimiento, hormigueo, espasmos musculares y convulsiones». | Vademecum (2016) Amikacina. Disponible en: https://www.vademecum.es/principios-activos-amikacina-J01GB06 [Consultado: 28-05-2018] | «AMICACINA BRAUN Sol. iny. 500 mg/2 ml AMICACINA BRAUN Sol. para perfusión 10 mg/ml AMICACINA BRAUN Sol. para perfusión 5 mg/ml AMIKACINA NORMON EFG Sol. iny. 500 mg/2 ml AMIKACINA SALA EFG Sol. iny. 125 mg/2 ml» |
«No puede tomar amikacina en caso de hipersensibilidad a aminoglucósidos. No debe administrarse simultáneamente con productos neuro o nefrotóxicos ni con potentes diuréticos. Precauciones en caso de: Historial de miastenia gravis o parkinson; riesgo de oto y nefrotoxicidad en: tto. prolongado, dosis elevadas, concomitancia con medicamentos nefro o neurotóxicos e I.R.; riesgo de bloqueo neuromuscular en concomitancia con anestésicos o curarizantes; puede darse sobrecrecimiento de microorganismos no sensibles; no exceder de 10 días de tto.; vigilar hidratación; ajustar dosis en I.R.; precaución en ancianos, prematuros y neonatos (por la I.R. asociada); no recomendada dosis única diaria en inmunocomprometidos, I.R., embarazo. En caso de insuficiencia renal monitorizar concentración sérica y reducir dosis o prolongar intervalo de administración». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Amoxicillin | «Amoxicillin is a semisynthetic penicillin (beta-lactam antibiotic) that inhibits one or more enzymes (often referred to as penicillin-binding proteins, PBPs) in the biosynthetic pathway of bacterial peptidoglycan, which is an integral structural component of the bacterial cell wall. Inhibition of peptidoglycan synthesis leads to weakening of the cell wall, which is usually followed by cell lysis and death. Amoxicillin is susceptible to degradation by beta-lactamases produced by resistant bacteria and therefore the spectrum of activity of amoxicillin alone does not include organisms which produce these enzymes». |
Bowmed Ibisqus Limited (2017) Amoxicillin 1g powder for solution for injection vials. Disponible en: https://www.medicines.org.uk/emc/product/8740/smpc [Consultado: 25-05-2018] | «Amoxicillin is indicated for the treatment of the following infections in adults and children. Severe infections of the ear, nose and throat (such as mastoiditis, peritonsillar infections, epiglottitis, and sinusitis when accompanied by severe systemic signs and symptoms) • Acute exacerbations of chronic bronchitis • Community acquired pneumonia • Acute cystitis • Acute pyelonephritis • Severe dental abscess with spreading cellulitis • Prosthetic joint infections • Lyme disease • Bacterial meningitis • Bacteremia that occurs in association with, or is suspected to be associated with, any of the infections listed above Amoxicillin is also indicated for the treatment and prophylaxis of endocarditis». |
«Children weighing less than 40kg who are able to swallow capsules All doses are worked out depending on the child’s body weight in kilograms. • Your doctor will advise you how much Amoxicillin capsules you should give to your baby or child. • Usual dose - 40mg to 90mg for each kilogram of body weight a day, given in two or three divided doses. • The maximum recommended dose is 100mg for each kilogram of body weight a day. Adults, elderly patients and children weighing 40 kg or more The usual dose of Amoxicillin is 250 mg to 500 mg three times a day or 750 mg to 1 g every 12 hours, depending on the severity and type of infection. • Severe infections: 750 mg to 1 g three times a day • Urinary tract infection: 3 g twice daily for one day. • Lyme disease (an infection spread by parasites called ticks): Isolated erythema migrans (early stage - red or pink circular rash): 4 g a day, Systemic manifestations (late stage - for more serious symptoms or when the disease spreads around yur body): up to 6 g a day. • Stomach ulcers: one 750 mg or one 1 g dose twice a day for 7 days with other antibiotics and medicines to treat stomach ulcers. To prevent heart infection during surgery: the dose will vary according to the type of surgery. Other medicines may also be given at the same time. Your doctor, pharmacist or nurse can give you more details. • The maximum recommended dose is 6 g per day. Kidney problems If you have kidney problems the dose might be lower than the usual dose». |
«Stop taking Amoxicillin capsules and see a doctor straight away, if you notice any of the following serious side effects - you may need urgent medical treatment: The following are very rare (may affect up to 1 in 10,000 people) • allergic reactions, the signs may include: skin itching or rash, swelling of the face, lips tongue, body or breathing difficulties. These can be serious and occasionally deaths have occurred • Rash or pinpoint flat red round spots under the skin surface or bruising of the skin. This is due to an inflammation of blood vessel walls due to an allergic reaction. It can be associated with joint pain (arthritis) and kidney problems. • A delayed allergic reaction can occur usually 7 to 12 days after having amoxicillin, some signs include: rashes, fever, joint pain and enlargement of lymph nodes especially under the arms • A skin reaction known as ‘erythema multiforme’ where you may develop: itchy reddish purple patches on the skin especially on the palms of the hands or soles of the feet, ‘hive-like’ raised swollen areas on the skin, tender areas on the surfaces of the mouth, eyes and genitals. You may have a fever and be very tired. • Other severe skin reactions can include: changes in skin colour, bumps under the skin, blistering, pustules, peeling, redness, pain, itching, scaling. These may be associated with fever, headaches and body aches. • fever, chills, a sore throat or other signs of an infection, or if you bruise easily. These may be signs of a problem with your blood cells • flu-like symptoms with a rash, fever, swollen glands, and abnormal blood test results (including increased white blood cells (eosinophilia) and liver enzymes) (Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS)). • the Jarisch-Herxheimer reaction which occurs during treatment with Amoxicillin for Lyme disease and cause fever, chills, headache, muscle pain and skin rash. • inflammation of the large bowel (colon) with diarrhoea (sometimes containing blood), pain and fever • serious liver side effects may occur. They are mainly associated with people having treatment over a long period, males and the elderly. You must tell your doctor urgently if you get: • severe diarrhoea with bleeding • blisters, redness or bruising of the skin • darker urine or paler stools • yellowing of the skin or the whites of the eyes (jaundice). See also anaemia below which might result in jaundice. These can happen when having the medicine or for up to several weeks after. Sometimes you may get less severe skin reactions such as: • a mildly itchy rash (round, pink-red patches), ‘hive-like’ swollen areas on forearms, legs, palms, hands or feet. This is uncommon (may affect up to 1 in 100 people)». |
Bowmed Ibisqus Limited (2017) Amoxicillin 1g powder for solution for injection vials. Disponible en: https://www.medicines.org.uk/emc/product/8740/smpc [Consultado: 25-05-2018] | «Amoxicillin 125mg/5ml Oral Suspension BP; Amoxicillin 125mg/5ml Oral Suspension Sugar Free BP; Amoxicillin 1g powder for solution for injection vials; Amoxicillin 120 mg Capsules BP; Amoxicillin 250mg Capsules; Amoxicillin 250mg Capsules BP (PL06453/0017); Amoxicillin 250mg powder for solution for injection vials; Amoxicillin 250mg/5ml Oral Suspension BP; Amoxicillin 250mg/5ml Oral Suspension Sugar Free BP; Amoxicillin 3g Sachet Sugar Free; Amoxicillin 500 mg Capsules BP; Amoxicillin 500 mg Capsules BP (PL06453/0018); Amoxicillin 500mg Capsules; Amoxicillin 500mg powder for sulution for injection vials; Amoxicillin Sodium for injection; Amoxil Capsules 250mg; Amoxil Capsules 500mg; Amoxil Paedriatic Suspension; Amoxil Vials for injection 1g; Amoxil Vials for injection 500mg; Augmentin 125/31 Suspension; Augmentin 250/62 Suspension; Augmentin 375mg Tablets; Augmentin 400/57; Augmentin 625mg Tablets; Augmentin Intravenous; Co-Amoxiclav 1000 mg/200 mg powder for Solution for injection/infusion; Co-amoxiclav 1000mg/200mg powder for solution for injection vials; Co-amoxiclav 125 mg/31.25 mg/5 ml Powder for Oral Suspension; Co-amoxiclav 125/31.25 mg/5 ml Powder for Oral Suspension; Co-amoxiclav 250 mg/125 mg film-coated tablets; Co-amoxiclav 250 mg/62.5 mg/5 ml Powder for Oral Suspension; Co-Amoxiclav 250mg/125mg film-coated tablets; Co-amoxiclav 400/57mg/5ml Powder for Oral Suspension; Co-amoxiclav 500 mg/125 mg film-coated tablets; Co-amoxiclav 500 mg/125 mg film-coated tablets; Co-amoxiclav 500 mg_125 mg Film-coated Tablets; Co-amoxiclav 500/100 mg Powder for Solution for Injection/Infusion; Co-amoxiclav 500/125 mg Tablets; Co-amoxiclav 500/125mg, Film-coated Tablets; Co-amoxiclav 500mg /125 mg film-coated Tablets; Co-amoxiclav 500mg/100mg powder for solution for injection vials; Co-Amoxiclav 500mg/125mg film-coated tablets ; Co-amoxiclav for Injection 1000/200mg; Co-amoxiclav for Injection 500/100mg; Co-amoxiclav Tablets BP 250/125mg». |
Precautions: «do not take Amoxicillin Capsules • if you are allergic to amoxicillin, penicillin or any of the other ingredients of this medicine (listed in section 6) • if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat Do not take Amoxicillin if any of the above apply. If you are not sure, talk to your doctor or pharmacist before taking amoxicillin. Precautions: Talk to your doctor or pharmacist before taking Amoxicillin Capsules if you: • suffer from kidney problems, since you may need a lower dose. • have glandular fever (fever, sore throat, swollen glands and extreme tiredness), lymphatic leukemia or HIV infection, since you may be more prone to developing a skin rash. • are not urinating regularly If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Amoxicillin. Having urine or blood tests If you are having: • Urine tests (glucose) or blood tests for liver function • Oestriol tests (used during pregnancy to check the baby is developing normally) Tell your doctor or pharmacist that you are taking Amoxicillin. This is because Amoxicillin can affect the results of these tests. If you have kidney problems the dose might be lower than the usual dose». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Amoxicilina | «Bactericida. Inhibe la acción de peptidasas y carboxipeptidasas impidiendo la síntesis de la pared celular bacteriana | Vademecum (2018) Amoxicilina. Disponible en: https://www.vademecum.es/principios-activos-amoxicilina-J01CA04 [Consultado: 28-05-2018] | «Infecciones causadas por cepas sensibles como: infecciones de garganta, nariz y oídos (amigdalitis, otitis media, sinusitis); infecciones del tracto respiratorio inferior (bronquitis aguda y crónica, neumonías bacterianas); infecciones del tracto genito-urinario sin complicaciones urológicas (cistitis y uretritis); infecciones de la piel y tejidos blandos (incluyendo infecciones de la herida quirúrgica); infecciones en odonto-estomatología; infecciones del tracto biliar; enf. o borreliosis de Lyme: en el tto. de la infección precoz localizada (primer estadío o eritema migratorio localizado) y de la infección diseminada o segundo estadío; fiebres tifoidea y paratifoidea (especialmente indicado para el tto. de los portadores biliares crónicos); tto. de erradicación de Helicobacter pylori en asociación con IBP y en su caso a otros antibióticos: úlcera péptica y linfoma gástrico de tejido linfoide asociado a mucosa, de bajo grado; profilaxis de endocarditis producida por bacteriemia post-manipulación/extracción dental; tto.. y profilaxis de septicemia, endocarditis, meningitis, pielonefritis y ciertas neuropatías». | «Ads.: 50-200 mg/kg/día; máx. 12 g/día. Infección pulmonar, postquirúrgica, genitourinaria y pielonefritis: 1 g/6-8 h. Septicemia, endocarditis: 1 g/4 h o 2 g/8 h, en perfus. I.R.: Clcr 30-60 ml/min: 2-4 g/día; Clcr 10-30 ml/min: 1 g inicial, seguido de 0,5 g/12 h; Clcr < 10 ml/min: 1 g inicial, seguido de 0,5 g/24 h. Niños: 25 mg/kg/6 h. Infección grave: 50 mg/kg/6 h, perfus. - Oral. Ads. y niños > 40 kg: 1,5-3 g/día en dosis equivalentes; máx. 6 g/día. Enf. de Lyme, estadio 1: 4 g/día, 10-21 días; estadio 2: 6 g/día, 10-30 días. Infección por H. pylori: 750 mg-1 g, 2 veces/día, asociado a otros antibióticos y a inhibidor de bomba de protones, 7 días. Cistitis simple en mujer: 3 g dosis única. I.R.: Clcr 10-30 ml/min: máx. 500 mg 2 veces/día; Clcr < 10 ml/min: máx. 500 mg/día; hemodiálisis: 15 mg/kg/día dosis única + dosis adicional; diálisis peritoneal: máx. 500 mg/día. Niños < 40 kg: 20-40 mg/kg/día en dosis equivalentes, máx. 150 mg/kg/día. Enf. de Lyme: 25-50 mg/kg/día en etapa temprana (10-21 días) y 100 mg/kg/día en etapa tardía (10-30 días); mín. 12 días. I.R.: Clcr 10-30 ml/min: 15 mg/kg 2 veces/día (máx. 500 mg 2 veces/día); Clcr < 10 ml/min: 15 mg/kg/día dosis única (máx. 500 mg/día). Profilaxis de endocarditis: ads. 3 g 1 h antes de manipulación dental y 2ª dosis a las 6-8 h si es necesario; niños < 10 años: ½ dosis ads.; niños < 5 años: ¼ dosis ads». |
«Diarrea, náuseas; erupciones cutáneas. Reacción a medicamentos con eosinofilia y síntomas sistémicos». | Vademecum (2018) Amoxicilina. Disponible en: https://www.vademecum.es/principios-activos-amoxicilina-J01CA04 [Consultado: 28-05-2018] | «AMITRON Cáps. dura 500 mg AMITRON Polvo o liofilizado + amp. de disolvente 250 mg AMITRON Polvo o liofilizado + amp. de disolvente 500 mg AMITRON Polvo para suspensión oral 250 mg/5 ml AMITRON Sol. iny. 1 g AMOXICILINA ALMUS Comp. dispersable 1000 mg AMOXICILINA ALMUS Comp. dispersable 500 mg AMOXICILINA ALMUS Comp. dispersable 750 mg AMOXICILINA ARDINE Cáps. dura 500 mg AMOXICILINA ARDINE Comp. 1000 mg AMOXICILINA ARDINE Comp. 500 mg AMOXICILINA ARDINE Comp. 750 mg AMOXICILINA ARDINE Polvo para susp. oral 1000 mg AMOXICILINA ARDINE Polvo para susp. oral 125 mg/5 ml AMOXICILINA ARDINE Polvo para susp. oral 250 mg AMOXICILINA ARDINE Polvo para susp. oral 500 mg AMOXICILINA ARISTO Cáps. 500 mg AMOXICILINA ARISTO Polvo para susp. oral 250 mg/5ml AMOXICILINA BENEL Cáps. 500 mg AMOXICILINA BENEL Comp. 1000 mg AMOXICILINA BENEL Polvo para susp. oral 1000 mg AMOXICILINA CINFA EFG Cáps. 500 mg AMOXICILINA CINFA EFG Comp. 1000 mg AMOXICILINA CINFA EFG Polvo para susp. oral 1000 mg AMOXICILINA CINFA EFG Polvo para susp. oral 500 mg AMOXICILINA DESGEN Cáps. dura 500 mg AMOXICILINA KERN PHARMA Cáps. dura 500 mg AMOXICILINA MUNDOGEN EFG Polvo para suspensión oral 250 mg/5 ml AMOXICILINA NORMON EFG Cáps. 500 mg AMOXICILINA NORMON EFG Comp. 1000 mg AMOXICILINA NORMON EFG Comp. 500 mg AMOXICILINA NORMON EFG Comp. 750 mg AMOXICILINA NORMON EFG Polvo para sol. extemporánea 1000 mg/sobre AMOXICILINA NORMON EFG Polvo para sol. extemporánea 250 mg/sobre AMOXICILINA NORMON EFG Polvo para sol. extemporánea 500 mg AMOXICILINA NORMON EFG Susp. extemporánea 250 mg/5 ml AMOXICILINA PENSA EFG Cáps. dura 500 mg AMOXICILINA PENSA EFG Comp. recub. 1 g AMOXICILINA PENSA EFG Comp. recub. 750 mg AMOXICILINA RATIOPHARM EFG Comp. recub. 1000 mg AMOXICILINA RATIOPHARM EFG Comp. recub. 500 mg AMOXICILINA RATIOPHARM EFG Comp. recub. 750 mg AMOXICILINA SANDOZ Cáps. dura 500 mg AMOXICILINA SANDOZ Comp. dispersable 1000 mg AMOXICILINA SANDOZ Comp. dispersable 750 mg AMOXICILINA SANDOZ Comp. recub. con película 1 g AMOXICILINA SANDOZ Comp. recub. con película 750 mg AMOXICILINA SANDOZ Polvo para suspensión oral 500 mg AMOXICILINA SANDOZ Susp. oral 250 mg/5ml AMOXICILINA TEVA Cáps. 500 mg AMOXICILINA TEVA Comp. 1000 mg AMOXICILINA TEVA Polvo para susp. oral 1000 mg/sobre AMOXICILINA TEVA Polvo para susp. oral 500 mg/sobre CLAMOXYL Cáps. 500 mg CLAMOXYL Comp. 1 g CLAMOXYL Comp. dispersable 750 mg CLAMOXYL Polvo para susp. oral en sobre 250 mg CLAMOXYL INY. IM Sol. iny. 1 g/vial» |
«No puede tomar amoxicilina si presenta hipersensibilidad a ß-lactámicos, si tiene antecedentes de una reacción de hipersensibilidad inmediata grave (ej. anafilaxis) a otro agente ß-lactámico (p. ej. cefalosporina, carbapenem o monobactam). Tenga especial precaución si presenta insuficiencia hepática, pues puede monitorizar la función hepática en pacientes con disfunción hepática. Tenga especial precaución si presenta insuficiencia renal. Deberá recibir una adaptación de la dosis». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Ampicillin | «Ampicillin is a broad-spectrum penicillin». | Chemidex Pharma Ltd (2015) Penbritin 250 mg Capsules. Disponible en: https://www.medicines.org.uk/emc/product/6341/smpc [Consultado: 25-05-2018] | «It is indicated for the treatment of a wide range of bacterial infections caused by ampicillin-sensitive organisms. Typical indications include: ear, nose and throat infections, bronchitis, pneumonia, urinary tract infections, gonorrhoea, gynaecological infections, septicaemia, peritonitis, endocarditis, meningitis, enteric fever, gastro-intestinal infections». | «Usual adult dosage (including elderly patients): Ear, nose and throat infections: 250mg four times a day. Bronchitis: Routine therapy: 250mg four times a day. High-dosage therapy: 1 g four times a day. Pneumonia: 500 mg four times a day. Urinary tract infections: 500 mg three times a day. Gonorrhoea: 2 g orally with 1 g probenecid as a single dose. Repeated doses are recommended for the treatment of females. Gastro-intestinal infections: 500-750 mg three to four times daily. Enteric: Acute: 1-2 g four times a day for two weeks. Carriers: 1-2 g four times a day for four to twelve weeks Usual children's dosage (under 10 years): Half adult routine dosage. All recommended dosages are a guide only. In severe infections the above dosages may be increased, or ampicillin given by injection. Oral doses of ampicillin should be taken half to one hour before meals. Renal Impairment In the presence of severe renal impairment (creatinine clearance <10ml/min) a reduction in dose or extension of dose interval should be considered. In cases of dialysis, an additional dose should be administered after the procedure». |
«If any hypersensitivity reaction occurs, the treatment should be discontinued. Skin rash, pruritis and urticaria have been reported occasionally. The incidence is higher in patients suffering from infectious mononucleosis and acute or chronic leukaemia of lymphoid origin. Purpura has also been reported. Rarely, skin reactions such as erythema multiforme and Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported. As with other antibiotics, anaphylaxis (see Item 4.4 – Warnings) has been reported rarely. Renal effects: Interstitial nephritis can occur rarely. Gastrointestinal reactions: Effects include nausea, vomiting and diarrhoea. Pseudomembraneous colitis and haemorrhagic colitis have been reported rarely. Hepatic effects: As with other beta-lactam antibiotics, hepatitis and cholestatic jaundice have been reported rarely. As with most other antibiotics, a moderate and transient increase in transaminases has been reported. Haematological effects: As with other beta-lactams, haematological effects including transient leucopenia, transient thrombocytopenia and haemolytic anaemia have been reported rarely. Prolongation of bleeding time and prothrombin have also been reported rarely». |
Chemidex Pharma Ltd (2015) Penbritin 250 mg Capsules. Disponible en: https://www.medicines.org.uk/emc/product/6341/smpc [Consultado: 25-05-2018] | «Co-fluampicil 125mg/125mg/5ml Powder for Oral Suspension; Co-Fluampicil 250/250 mg Capsules, hard; Co-fluampicil 250mg/250mg Hard Capsules; Magnapen 250mg/250mg Powder for Solution for Injection or Infusion; Penbritin 250 mg Capsules; Penbritin 500 mg Capsules». | Precautions: «Ampicillin is a penicillin and should not be given to patients with a history of hypersensitivity to beta-lactam antibiotics (e.g. ampicillin, penicillins, cephalosporins) or excipients. Precautions: Before initiating therapy with ampicillin, careful enquiry should be made concerning previous hypersensitivity reactions to beta-lactam antibiotics. Serious and occasionally fatal hypersensitivity reactions (anaphylaxis) have been reported in patients receiving beta-lactam antibiotics. Although anaphylaxis is more frequent following parenteral therapy, it has occurred in patients on oral penicillins. These reactions are more likely to occur in individuals with a history of beta-lactam hypersensitivity. Ampicillin should be avoided if infectious mononucleosis and/or acute or chronic leukaemia of lymphoid origin are suspected. The occurrence of a skin rash has been associated with these conditions following the administration of ampicillin. Prolonged use may occasionally result in overgrowth of non-susceptible organisms». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Ampicilina | «Bactericida. Inhibe la síntesis y la reparación de la pared bacteriana, amplio espectro. | Vademecum (2016) Ampicilina. Disponible en: https://www.vademecum.es/principios-activos-ampicilina-J01CA01 [Consultado: 28-05-2018] | «Infección ORL, respiratoria, odontoestomatológica, gastrointestinal, genitourinaria, de piel y tejido blando, neurológica, cirugía, traumatología, meningitis bacteriana y septicemia». | «Ads. 500 mg/6-8, oral/parenteral o 1.000 mg/8 h, oral. Lactantes: 50-100 mg/kg/día; niños < 12 años: 125-500 mg/6-8 h, según edad, oral/parenteral. Aumentar dosis según gravedad. Administrar las formas orales ½-1 h antes de la comida. Infección por estreptococo ß-hemolítico, duración mín. 10 días». | «Náuseas, vómitos, diarrea, erupción eritematosa maculopapular (> incidencia con mononucleosis infecciosa), urticaria, leucopenia, neutropenia, eosinofilia reversible, elevación moderada de transaminasas en niños, sobreinfección». | Vademecum (2016) Ampicilina. Disponible en: https://www.vademecum.es/principios-activos-ampicilina-J01CA01 [Consultado: 28-05-2018] | «BRITAPEN Cáps. 500 mg BRITAPEN Comp. 1 g BRITAPEN Jarabe 250 mg/5 ml BRITAPEN Polvo y disolv. para sol. iny. 1 g BRITAPEN Polvo y disolv. para sol. iny. 500 mg/2 ml GOBEMICINA Polvo y disolv. para sol. iny. 1 g GOBEMICINA Polvo y disolv. para sol. iny. 250 mg GOBEMICINA Polvo y disolv. para sol. iny. 500 mg» |
«No puede tomar ampicilina si es alérgico a penicilinas o si presenta mononucleosis infecciosa, si es alérgico a las cefalosporinas, si tiene un historial alérgico medicamentoso. Riesgo de alteración de la flora gastrointestinal y colitis pseudomembranosa. Ajustar dosis en I.R. Tenga especial precaución si presenta insuficiencia rena. En ese caso, ajustar la dosis». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Azithromycin | «Azithromycin is one of a group of antibiotics known as macrolides». | Generics UK T/A Mylan (2017) Package leaflet: Information for the patient Azithromycin 250 mg Film-coated Tablets Azithromycin 500 mg Film-coated Tablets (azithromycin). Disponible en: https://www.medicines.org.uk/emc/files/pil.8426.pdf [Consultado: 25-05-2018] | «It is used to treat bacterial infections caused by micro organisms such as bacteria. These infections include: chest infections such as bronchitis and pneumonia infections in your sinuses, throat, tonsils or ears mild to moderate skin and soft tissue infections, e.g. infection of the hair follicles (folliculitis), bacterial infection of the skin and its deeper layers (cellulitis), skin infection with shiny red swelling (erysipelas) infections caused by a bacterium called Chlamydia trachomatis. They can cause inflammation of the tube that carries urine from your bladder (urethra) or where your womb joins your vagina (cervix)». |
«The recommended dose is: Adults (including older patients), children and adolescents with a body weight of over 45 kg: The recommended dose is 1500 mg divided over either 3 or 5 days as follows: when taken over 3 days, 500 mg once daily when taken over 5 days, 500 mg as a single dose on the first day and then 250 mg once daily on days 2 through to 5. Inflammation of the urethra or cervix caused by Chlamydia: 1000 mg taken as a single dose, for one day only. Children and adolescents with a body weight of 45 kg and under: Tablets are not indicated for these patients. Other pharmaceutical forms of azithromycin-containing products (e.g. suspensions) may be used. Patients with kidney or liver problems: You should tell your doctor if you have kidney or liver problems as your doctor may need to alter the normal dose». |
«Uncommon (may affect up to 1 in 100 people): an allergic reaction (causing swelling of the lips, face or neck leading to severe difficulty in breathing; skin rash or hives) yellowing of the skin and whites of the eyes, tiredness and loss of appetite which may be caused by inflammation of the liver (hepatitis). Rare (may affect up to 1 in 1,000 people): yellowing of the skin or eyes (jaundice). Very rare (may affect up to 1 in 10,000 people): skin rash accompanied by other symptoms such as fever, swollen glands and an increase of eosinophils (a type of white blood cell). Very common (may affect more than 1 in 10 people): diarrhoea. Common (may affect up to 1 in 10 people): headache being or feeling sick abdominal pain changes in white blood cell count in blood tests low blood bicarbonate». |
Generics UK T/A Mylan (2017) Package leaflet: Information for the patient Azithromycin 250 mg Film-coated Tablets Azithromycin 500 mg Film-coated Tablets (azithromycin). Disponible en: https://www.medicines.org.uk/emc/files/pil.8426.pdf [Consultado: 25-05-2018] | «Azithromycin 200mg/5ml Powder for Oral Suspension; Azithromycin 250 mg Capsules; Azithromycin 250 mg film-coated tablet; Azithromycin 500 mg Film-coated Tablets; Azithromycin 500mg Tablets; Azithromycin film coated Tablets 250mg; Azyter; Zedbac 500mg powder for solution for infusion; Zithromax 250 Capsules (PIL); Zithromax 250 Capsules (SPC); Zithromax Powder for Oral Suspension (PIL); Zithromax Powder for Oral Suspension (SPC)». | Precautions: «Do not take Azithromycin: if you are allergic to azithromycin, any other macrolide (such as erythromycin or clarithromycin) or ketolide antibiotic or any of the ingredients of this medicine. Talk to your doctor or pharmacist before taking Azithromycin if you: have ever had a serious allergic reaction causing swelling of the face and throat, possibly with breathing problems, rash, fever, swollen glands or increase in eosinophils (certain type of white blood cells) have severe kidney problems: your doctor may alter the dose have liver problems: your doctor may need to monitor your liver function or stop the treatment have myasthenia gravis (localised muscle weakness) Page 33 of 39 have been diagnosed with a neurological disease, which is a disease of the brain or nervous system have mental, emotional or behavioural problems are taking medicines known as ergot alkaloids (such as ergotamine), which are used to treat migraine: azithromycin is not recommended (see 'Other medicines and Azithromycin' below). Since azithromycin may increase the risk of abnormal heart rhythm please tell your doctor if you have any of the following problems before taking this medicine (especially you are female or elderly): you are aware of ever being diagnosed to have prolonged QT interval (a heart condition, shown on an electro-cardiogram or ECG machine): azithromycin is not recommended are aware that you have a slow or irregular heart beat, or reduced heart function (heart failure): azithromycin is not recommended know that you have low levels of potassium or magnesium in your blood: azithromycin is not recommended are taking medicines known as antiarrhythmics (e.g. quinidine, procainamide, dofetilide, amiodarone, sotalol: used to treat abnormal heart rhythms), cisapride (used to treat stomach problems) or terfenadine (an antihistamine that is used to treat allergies), or antipsychotic agents (e.g. pimozide), antidepressants (e.g. citalopram), some antibiotics (e.g. moxifloxacin, levofloxacin) that can affect the heart rhythm: azithromycin is not recommended (see ‘Other medicines and Azithromycin’ below)». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Azitromicina | Macrólido. Inhibe la síntesis de proteínas bacterianas por unión a la subunidad 50s del ribosoma e inhibiendo la translocación de los péptidos. | Vademecum (2018) Azitromicina. Disponible en: https://www.vademecum.es/principios-activos-azitromicina-J01FA10 [Consultado: 28-05-2018] | «Oral. Infección por germen sensible: sinusitis bacteriana aguda y otitis media bacteriana aguda (diagnosticadas adecuadamente); faringitis, amigdalitis; exacerbación aguda de bronquitis crónica (diagnosticada adecuadamente); neumonía adquirida en la comunidad de leve a moderadamente grave; infecciones de piel y tejidos blandos de gravedad de leve a moderada (p.ej. foliculitis, celulitis, erisipelas); uretritis y cervicitis no complicadas producidas por Chlamydia trachomatis; chancroide; eritema migratorio (1ª fase de la enf. de Lyme), si los antibióticos de 1ª y 2ª línea (doxiciclina, amoxicilina y cefuroxima axetil) están contraindicados. - IV, ads. inmunocompetentes: neumonía adquirida en la comunidad». |
«Oral. Dosis única diaria. Ads., ancianos, adolescentes y niños con p.c. > 45 kg: 500 mg/día, 3 días o 500 mg el 1 er día, seguido de 250 mg/día 4 días; enf. de transnmisión sexual (uretritis, cervicitis, cancroide): 1.000 mg, dosis única; eritema migratorio: 1 g el 1 er día, seguido de 500 mg/día 4 días (dosis total: 3 g).Niños < 15 kg: 10 mg/kg/día, 3 días o 10 mg/kg el 1 er día, seguido de 5 mg/kg/día 4 días; 15-25 kg: 200 mg/día, 3 días o 200 mg el 1 er día, seguido de 100 mg/día 4 días; 26-35 kg: 300 mg/día, 3 días o 300 mg el 1 er día, seguido de 150 mg/día 4 días; 36-45 kg: 400 mg/día, 3 días o 400 mg el 1 er día, seguido 200 mg/día 4 días; faringitis estreptocócica (niños ≥ 2 años): 10 o 20 mg/kg/día 3 días, máx. 500 mg/día. Máx. total en niños: 1.500 mg. Perfus. IV tras reconstitución y dilución, no en bolus ni como iny. IM (velocidad 1 mg/ml durante 3 h o 2 mg/ml durante 1 h). Ads.: 500 mg, dosis única diaria, mín. 2 días, continuando con tto. oral: 500 mg/día hasta completar 7-10 días». |
«Anorexia; mareo, cefalea, parestesia, disgeusia; alteración visual; sordera; diarrea, dolor abdominal, náuseas, flatulencia, vómitos, dispepsia; erupción, prurito; artralgia; fatiga; recuento disminuido de linfocitos y del bicarbonato sanguíneo, recuento elevado de eosinófilos, basófilos, monocitos y neutrófilos». | Vademecum (2018) Azitromicina. Disponible en: https://www.vademecum.es/principios-activos-azitromicina-J01FA10 [Consultado: 28-05-2018] | «ARATRO Comp. recub. 500 mg ARATRO Polvo para susp. oral 200 mg/5 ml ARATRO Polvo para susp. oral 500 mg/sobre AZITROMICINA G.E.S. Polvo para sol. para perfusión 500 mg AZITROMICINA ADVENTIA EFG Polvo para susp. oral en frasco 200 mg/5 ml AZITROMICINA ALMUS Comp. recub. con película 500 mg AZITROMICINA ALTER EFG Comp. recub. con película 500 mg AZITROMICINA ALTER EFG Granulado para susp. oral 500 mg AZITROMICINA APOTEX Comp. recub. con película 500 mg AZITROMICINA ARISTO Comp. recub. con película 500 mg AZITROMICINA AUROVITAS Comp. recub. con película 500 mg AZITROMICINA AUROVITAS SPAIN Comp. recub. con película 500 mg AZITROMICINA BENEL Comp. recub. 500 mg AZITROMICINA BENEL Polvo para susp. oral 200 mg/5 ml AZITROMICINA BENEL Polvo para susp. oral 250 mg/sobre AZITROMICINA BENEL Polvo para susp. oral 500 mg/sobre AZITROMICINA BLUEPHARMA Comp. recub. con película 500 mg AZITROMICINA CINFA EFG Comp. recub. 500 mg AZITROMICINA CINFA EFG Polvo para susp. oral 500 mg/sobre AZITROMICINA COMBIX Comp. recub. con película 500 mg AZITROMICINA KERN PHARMA EFG Comp. recub. 500 mg AZITROMICINA KERN PHARMA EFG Polvo para susp. oral 200 mg/5 ml AZITROMICINA KERN PHARMA EFG Polvo para susp. oral 250 mg/sobre AZITROMICINA KERN PHARMA EFG Polvo para susp. oral 500 mg/sobre AZITROMICINA KORHISPANA EFG Comp. recub. 500 mg AZITROMICINA KRKA Comp. recub. con película 250 mg AZITROMICINA KRKA Comp. recub. con película 500 mg AZITROMICINA MABO EFG Comp. recub. 500 mg AZITROMICINA MABO EFG Polvo para susp. oral 500 mg/sobre AZITROMICINA MYLAN EFG Comp. recub. con película 500 mg AZITROMICINA MYLAN EFG Polvo para susp. oral 200 mg/5 ml AZITROMICINA MYLAN EFG Polvo para susp. oral 500 mg/sobre AZITROMICINA NORMON EFG Comp. recub. 500 mg AZITROMICINA NORMON EFG Polvo para susp. oral 500 mg/sobre AZITROMICINA PENSA EFG Comp. recub. 500 mg AZITROMICINA PENSA EFG Granulado para suspensión oral 500 mg AZITROMICINA PHARMAGENUS EFG Comp. recub. con película 500 mg AZITROMICINA PLACASOD Comp. recub. 500 mg AZITROMICINA QUALIGEN Comp. recub. con película 500 mg AZITROMICINA QUALIGEN Polvo para susp. oral 200 mg/5 ml AZITROMICINA RANBAXY Comp. recub. con película 500 mg AZITROMICINA RATIO Comp. recub. con película 500 mg AZITROMICINA RATIO Polvo para susp. oral 200 mg/5 ml AZITROMICINA RATIOPHARM Comp. dispersable 500 mg AZITROMICINA RATIOPHARM Comp. dispersables 250 mg AZITROMICINA RATIOPHARM EFG Comp. recub. con película 500 mg AZITROMICINA RATIOPHARM EFG Polvo para susp. oral en sobre 250 mg/sobre AZITROMICINA RATIOPHARM EFG Polvo para susp. oral en sobre 500 mg/sobre AZITROMICINA SANDOZ Comp. recub. 500 mg AZITROMICINA SANDOZ Polvo para susp. oral 200mg/5 ml AZITROMICINA SANDOZ Polvo para susp. oral 250 mg/sobre AZITROMICINA SANDOZ Polvo para susp. oral 500 mg/sobre AZITROMICINA STADA Polvo para susp. oral 200 mg/5 ml AZITROMICINA STADA EFG Comp. recub. 500 mg AZITROMICINA TARBIS Comp. recub. 500 mg AZITROMICINA TARBIS EFG Polvo para susp. oral 250 mg/sobre AZITROMICINA TARBIS EFG Polvo para susp. oral 40 mg/ml AZITROMICINA TARBIS EFG Polvo para susp. oral 500 mg/sobre AZITROMICINA TECNIGEN Comp. recub. con película 500 mg AZITROMICINA TEVA Comp. dispersable 500 mg AZITROMICINA TEVA Comp. dispersables 250 mg AZITROMICINA TEVA EFG Comp. 250 mg AZITROMICINA TEVA EFG Comp. recub. 500 mg AZITROMICINA TEVA EFG Polvo para susp. oral 200 mg/5 ml AZITROMICINA TEVA EFG Polvo para susp. oral 250 mg/sobre AZITROMICINA TEVA EFG Polvo para susp. oral 500 mg/sobre AZITROMICINA UR EFG Comp. recub. 500 mg AZITROMICINA ZENTIVA Comp. recub. con película 500 mg AZITROMICINA ZENTIVA Granulado pra susp. oral 500 mg ZITROMAX Cáps. 250 mg ZITROMAX Comp. recub. 500 mg ZITROMAX Polvo para sol. para perfusión 500 mg ZITROMAX Polvo para susp. oral 1000 mg ZITROMAX Polvo para susp. oral 200 mg/5 ml ZITROMAX Polvo para susp. oral 250 mg ZITROMAX Polvo para susp. oral 500 mg» |
«No puede tomar azitromicina en los siguientes casos: hipersensibilidad a azitromicina, eritromicina o a cualquier otro antibiótico macrólido o ketólido. I.R. grave; enf. hepática significativa, vigilar PFH si aparecen signos/síntomas de disfunción y suspender en caso de I.H. grave; vigilar aparición de reacciones alérgicas graves (ej. pustulosis exantemática generalizada aguda (PEGA), síndrome de Stevens Johnson (SSJ), necrólisis epidérmica tóxica (NET) (mortal en raras ocasiones) y una reacción medicamentosa con eosinofilia y síntomas sistémicos (DRESS); suspender el tto. si aparecen); riesgo de diarrea asociada a Clostridium difficile y sobreinfección por microorganismos no sensibles de tipo fúngico; precaución en pacientes con enf. arritmogénicas en curso (sobre todo mujeres y ancianos) tales como pacientes con: prolongación del intervalo QT congénito o confirmado, conmcomitancia con fármacos prolongadores del intervalo QT: antiarrítmicos clase IA (quinidina y procainamida) y III (dofetilida, amiodarona y sotalol), cisaprida, terfenadina, antipsicóticos como pimozida, antidepresivos como citalopram y fluoroquinolonas como moxifloxacino y levofloxacino, alteración electrolítica (en particular hipopotasemia o hipomagnesemia), bradicardia clínicamente relevante, arritmia, insuf. cardiaca grave; riesgo de exacerbación o de aparición de miastenia gravis; no recomendado en tto. concomitante con alcaloides ergóticos por riesgo de erogtismo; no es de 1ª elección para tto. de faringitis/amigdalitis causadas por Streptococcus pyogenes (para estas afecciones y para la profilaxis de fiebre reumática aguda, la penicilina es el tto. de elección); con frecuencia tampoco lo es para el tto. de sinusitis ni de otitis media agua; no indicada para tto. de quemaduras infectadas; análisis de sensibilidad previo para tto. infección tejido blando; en el caso de ETS, excluir la existencia de una infección concomitante por T. palladium; enf. neurológicas o psiquiátricas; seguridad-eficacia no establecida para prevención y tto. por Mycobacterium avium complex en niños; datos limitados de uso para tto. de sinusitis en sujetos < 16 años; niños < 6 meses, seguridad limitada; monitorizar en caso de eritema migratorio. Vía IV, además, seguridad y eficacia no establecida en niños y adolescentes, evitar perfus. de concentración > 2 mg/ml tras dilución. En caso de enf. hepática significativa, vigilar PFH si aparecen signos/síntomas de disfunción y suspender en caso de I.H. grave. Especial precaución si presencia insuficiencia renal grave». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Aztreonam | «Aztreonam is an antibiotic and a member of the family of medicines called monobactams». |
Bristol-Myers Squibb Pharmaceuticals limited (2017) Package leaflet: Information for the patient Azactam™ 1g or 2g Powder for Solution for Injection or Infusion Aztreonam. https://www.medicines.org.uk/emc/files/pil.7866.pdf [Consultado: 25-05-2018] | «Aztreonam is for the treatment of serious infections caused by bacteria which require an antibiotic injection». |
«Adults: The adult dose range is 1 to 8g daily. This dose can be split equally over the day meaning you may be given between one to four doses a day. Maximum recommended dose is 8 g per day. Children: The usual daily dose in children older than one week is 30mg per kg of body weight given every 6 to 8 hours, but in severe infections in patients two years of age or older this will be increased to 50mg per kg of body weight». |
«Tell your doctor immediately if you get any of the following symptoms: • swelling of the face, lips, tongue and/or throat with difficulty in swallowing or breathing. These may be signs of an allergic reaction. • severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is rare side effect which may occur after treatment with antibiotics and can be a sign of serious bowel inflammation». |
Bristol-Myers Squibb Pharmaceuticals limited (2017) Package leaflet: Information for the patient Azactam™ 1g or 2g Powder for Solution for Injection or Infusion Aztreonam. https://www.medicines.org.uk/emc/files/pil.7866.pdf [Consultado: 25-05-2018] | «Azactam 1g Powder for Solution for Injection or Infusion, vial; Azactam 2 g Powder for Solution for Injection or Infusion, vial; Cayston 75 mg powder and solvent for nebuliser solution». | Precautions: «You must tell your doctor if: • You have ever had an allergic reaction to any antibiotics • You have diarrhoea or usually get diarrhoea when you take antibiotics or have ever suffered from problems with your stomach or intestines. If you develop severe or prolonged or bloody diarrhoea during or after using Azactam tell your doctor as soon as possible since it may be necessary to interrupt the treatment. • You have any Liver problems • You have any Kidney problems • You are taking a medicine against blood clots (anticoagulants) • You have any blood disorders, e.g. severe reduction in blood cells which can cause weakness, bruising or make infections more likely (pancytopenia) ________________________________________________________________________ • You have skin disorders, including serious illness with blistering of the skin (toxic epidermal necrolysis) • You have fits (convulsions or seizures)». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Aztreonam | «Bactericida. Inhibe la síntesis de pared celular bacteriana. Activo frente a un amplio espectro de patógenos aerobios Gram- incluyendo P. aeruginosa. | Vademecum (2016) Aztreonam. Disponible en: https://www.vademecum.es/principios-activos-aztreonam-J01DF01 [Consultado: 28-05-2018] | «Infecciones del tracto urinario, complicadas y no complicadas, incluyendo pielonefritis, cistitis inicial y recurrente, y bacteriuria asintomática; del tracto respiratorio inferior incluyendo neumonía y bronquitis (también mejoría clínica en exacerbación pulmonar aguda de fibrosis quística); septicemia/bacteriemia; de piel y tejidos blandos incluyendo heridas post-operatorias, úlceras y quemaduras; de huesos y articulaciones; intraabdominales incluida peritonitis; ginecológicas incluyendo EPI, endometritis y celulitis pélvica; urogenitales o anorrectales no complicadas por cepas de N. gonorrhoeae que produzcan o no betalactamasas. Terapia adyuvante en cirugía en infección por microorganismo sensible. Por vía inhalatoria: tto. infección pulmonar crónica por P. aeruginosa en pacientes ≥ 6 años con fibrosis quística». | «IM/IV. Ads. Infecciones del tracto urinario: 500 mg-1 g/ 8-12 h. Infecciones sistémicas moderadamente graves: 1-2 g/8-12 h. Infecciones sistémicas graves o que comprometen la vida: 2 g/6-8 h. Tto. de gonorrea aguda no complicada y cistitis aguda no complicada: 1 g IM en dosis única. Niños > 1 sem: 30 mg/kg/6-8 h. Infecciones graves en niños ≥ 2 años o infecciones por P. aeruginosa en pacientes pediátricos: 50 mg/kg/6-8 h, la dosis máx. diaria no debe exceder dosis máx. en ads. I.R.: dosis inicial normal; mantenimiento: Clcr 10-30 ml/min: reducir a ½; Clcr < 10 ml/min: reducir a ¼ de la dosis inicial, a intervalos fijos de 6, 8 ó 12 h; en infecciones graves además administrar un octavo de la dosis inicial tras la hemodiálisis. I.H.: reducir dosis 20-25 % para el tto. a largo plazo de pacientes con enf.hepática crónica con cirrosis (sobre todo en cirrosis alcohólica y cuando también la función renal se encuentre alterada). - Vía inhalatoria. Ads. y niños ≥ 6 años:: 75 mg, 3 veces/día con intervalo mín. de 4 h, 28 días. Puede administrarse en ciclos repetidos de 28 días de terapia + 28 días sin terapia». |
«Erupción cutánea, diarrea, fiebre, aumento de eosinófilos, plaquetas, AST, ALT, creatinina sérica, neutropenia; reacciones locales: dolor, eritema, induración, flebitis. Por vía inhalatoria: tos, congestión nasal, sibilancias, dolor faringolaríngeo, disnea, pirexia, broncoespasmo, molestias torácicas, rinorrea, hemoptisis, exantema, artralgias, descenso en pruebas de función pulmonar». | Vademecum (2016) Aztreonam. Disponible en: https://www.vademecum.es/principios-activos-aztreonam-J01DF01 [Consultado: 28-05-2018] | «AZACTAM Polvo y disolv. para sol. inyec. IM/IV 1 g/4 ml CAYSTON Polvo y disolv. para sol. para inhal. nebul. 75 mg» |
«No puede tomar aztreonam en caso de hipersensibilidad. Precauciones: antecedente de alergia a ß-lactámicos y carbapenémicos; riesgo de sobreinfección por otros patógenos y de aparición de P. aeruginosa resistente a antibióticos. Vía IM/IV: prever posible reacción anafiláctica; I.H./I.R. (observación clínica); suspender tto. ante cambios graves del hemograma o la piel; riesgo de convulsiones; notificados casos de diarrea asociada a C. difficile (no administrar inhibidores del peristaltismo); prolonga TP y la acción de anticoagulantes orales; sobrecrecimiento de microorganismos no sensibles; falta información de uso en neonatos < 1 sem; en tto. concomitante con aminoglucósidos (sobre todo dosis altas o tto. prolongado) vigilar la función renal debido a la potencial nefrotoxicidad y ototoxicidad; suspender lactancia durante tto. parenteral. Vía inhalatoria: no recomendado en pacientes < 6 años; I.R. con creatinina sérica > 2 x LSN precaución, no preciso ajustar dosis; sin datos en I.H. grave; ante el riesgo de broncoespasmo paradójico, usar un broncodilatador antes de cada dosis (de acción corta entre 15 min y 4 h antes, de acción larga entre 30 min y 12 h antes); riesgo de hemoptisis (valorar tto. en pacientes con hemoptisis activa); no se ha establecido la eficacia en los pacientes con un VEF1 esperado > 75%; lactancia compatible en tto. inhalado (escasa absorción). En caso de insuficiencia hepática IM/IV: observación clínica. En caso de insuficiencia renal, IM/IV, ajustar dosis según Clcr: dosis inicial normal; mantenimiento: Clcr 10-30 ml/min, reducir a ½; Clcr < 10 ml/min, reducir a ¼ de la dosis inicial, a intervalos fijos de 6, 8 ó 12 h; en infecciones graves además administrar un octavo de la dosis inicial tras la hemodiálisis. Vía inhalatoria: precaución, no es preciso ajustar dosis». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Benzylpenicillin | «Benzylpenicillin sodium is one of a group of medicines known as penicillins, which are antibiotics. Antibiotics are used to kill the bacteria (germs) which cause infections». |
Genus Pharmaceuticals Benzylpenicillin sodium 600mg and 1200mg Powder for Injection Technical Leaflet. Disponible en: https://www.medicines.org.uk/emc/files/pil.7381.pdf [Consultado: 25-05-2018] | «Benzylpenicillin is indicated for most wound infections, pyogenic infections of the skin, soft tissue infections and infections of the nose, throat, nasal sinuses, respiratory tract and middle ear, etc. It is also indicated for the following infections caused by penicillin-sensitive microorganisms: Generalised infections, septicaemia and pyaemia from susceptible bacteria. Acute and chronic osteomyelitis, sub-acute bacterial endocarditis and meningitis caused by susceptible organisms. Suspected meningococcal disease. Gas gangrene, tetanus, actinomycosis, anthrax, leptospirosis, rat-bite fever, listeriosis, severe Lyme disease, and prevention of neonatal group B streptococcal infections. Complications secondary to gonorrhoea and syphilis (e.g. gonococcal arthritis or endocarditis, congenital syphilis and neurosyphilis). Diphtheria, brain abscesses and pasteurellosis». |
«The following dosages apply to both intramuscular and intravenous injection. Alternate sites should be used for repeated injections. Adults 600 to 3,600 mg (1 to 6 mega units) daily, divided into 4 to 6 doses, depending on the indication. Higher doses (up to 14.4 g/day (24 mega units) in divided doses) may be given in serious infections such as adult meningitis by the intravenous route. In bacterial endocarditis, 7.2 to 12 g (12 to 20 mega units) or more may be given daily in divided doses by the intravenous route, often by infusion. Doses up to 43.2 g (72 mega units) per day may be necessary for patients with rapidly spreading gas gangrene. High doses should be administered by intravenous injection or infusion, with intravenous doses in excess of 1.2g (2 mega units) being given slowly, taking at least one minute for each 300 mg (0.5 mega unit) to avoid high levels causing irritation of the central nervous system and/or electrolyte imbalance. High dosage of benzylpenicillin sodium may result in hypernatraemia and hypokalaemia unless the sodium content is taken into account. For the prevention of Group B Streptococcal disease of the newborn, a 3 g (5 mega units) loading dose should be given to the mother initially, followed by 1.5 g (2.5 mega units) every 4 hours until delivery. Children aged 1 month to 12 years 100 mg/kg/day in 4 divided doses; not exceeding 4 g/day. Infants 1-4 weeks 75 mg/kg/day in 3 divided doses. Newborn Infants 50 mg/kg/day in 2 divided doses. Meningococcal disease Children 1 month to 12 years: 180-300 mg/kg/day in 4-6 divided doses, not exceeding 12 g/day. Infants 1-4 weeks: 150 mg/kg/day in 3 divided doses. Newborn infants: 100 mg/kg/day in 2 divided doses. Adults and children over 12 years: 2.4 g every 4 hours. Suspected meningococcal disease If meningococcal disease is suspected general practitioners should give a single dose of benzylpenicillin sodium, before transferring the patient to hospital, as follows: Adults and children over 10 years: 1,200 mg IV (or IM) Children 1-9 years: 600 mg IV (or IM) Children under 1 year: 300 mg IV (or IM) Premature babies and neonates Dosing should not be more frequent than every 8 or 12 hours in this age group, since renal clearance is reduced at this age and the mean half-life of benzylpenicillin may be as long as 3 hours. Since infants have been found to develop severe local reactions to intramuscular injections, intravenous treatment should preferably be used. Patients with renal insufficiency For doses of 0.6-1.2 g (1-2 mega units) the dosing interval should be no more frequent than every 8-10 hours. Elderly Patients: Elimination may be delayed in elderly patients and dose reduction may be necessary». |
«Haemolytic anaemia and granulocytopenia (neutropenia), agranulocytosis, leucopenia and thrombocytopenia, have been reported in patients receiving prolonged high doses of benzylpenicillin sodium (eg. Subacute bacterial endocarditis). Immune System Disorders Very Common (>10%) Patients undergoing treatment for syphilis or neurosyphilis with benzylpenicillin may develop a Jarisch-Herxheimer reaction. Common (1-10%) Hypersensitivity to penicillin in the form of rashes (all types), fever, and serum sickness may occur (1-10% treated patients). These may be treated with antihistamine drugs. Rare (0.01%-0.1%) More rarely, anaphylactic reactions have been reported (<0.05% treated patients). Nervous System Disorders Rare (0.01%-.01%) Central nervous system toxicity, including convulsions, has been reported with massive doses over 60 g per day and in patients with severe renal impairment. Renal and Urinary Disorders Rare (0.01%-0.1%) Interstitial nephritis has been reported after intravenous benzylpenicillin sodium at doses of more than 12 g per day». |
Genus Pharmaceuticals Benzylpenicillin sodium 1200mg Powder for Injection. Disponible en: https://www.medicines.org.uk/emc/product/7381/smpc [Consultado: 25-05-2018] | «Benzylpenicillin sodium 1200mg Powder for Injection; Benzylpenicillin sodium 600mg Powder for Injection». | Precautions: «Allergy to penicillins. Hypersensitivity to any ingredient of the preparation. Cross allergy to other beta-lactams such as cephalosporins should be taken into account. 600 mg benzylpenicillin contains 1.68 mmol of sodium. Massive doses of Benzylpenicillin Sodium can cause hypokalaemia and sometimes hypernatraemia. Use of a potassium-sparing diuretic may be helpful. In patients undergoing high-dose treatment for more than 5 days, electrolyte balance, blood counts and renal functions should be monitored. In the presence of impaired renal function, large doses of penicillin can cause cerebral irritation, convulsions and coma. Skin sensitisation may occur in persons handling the antibiotic and care should be taken to avoid contact with the substance. It should be recognised that any patient with a history of allergy, especially to drugs, is more likely to develop a hypersensitivity reaction to penicillin. Patients should be observed for 30 minutes after administration and if an allergic reaction occurs the drug should be withdrawn and appropriate treatment given. Delayed absorption from the intramuscular depot may occur in diabetics. Prolonged use of benzylpenicillin may occasionally result in an overgrowth of non-susceptible organisms or yeast and patients should be observed carefully for superinfections. Pseudomembranous colitis should be considered in patients who develop severe and persistent diarrhoea during or after receiving benzylpenicillin. In this situation, even if Clostridium difficile is only suspected, administration of benzylpenicillin should be discontinued and appropriate treatment given». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Bencilpenicilina | «Bactericida. Bloquea la reparación y la síntesis de la pared celular bacteriana. | Vademecum (2016) Bencilpenicilina. Disponible en: https://www.vademecum.es/principios-activos-bencilpenicilina-J01CE01 [Consultado: 28-05-2018] | «Neumonía, pleuritis y meningitis, por neumococos. Amigdalitis, faringitis, otitis media, sinusitis aguda, escarlatina, absceso pulmonar, fiebre puerperal, septicemia y endocarditis, por estreptococos. Bronconeumonía, osteomielitis, septicemia, empiema, enterocolitis aguda, aborto séptico, endocarditis subaguda y meningitis, por estafilococo no productor de penicilinasa. Gonorrea y complicación genitourinaria, por gonococo. Meningitis meningocócica, gangrena gaseosa, difteria y tétanos. Estomatitis y angina de Vicent, por espiroquetas. Actinomicosis. Sífilis por T. pallidum. Profilaxis de gérmenes sensibles antes de intervención quirúrgica». | «Ads. IM: 1.000.000 UI/6 h; IV: 1.000.000 UI/4 h; infus. IV: 10-100 MUI/día. Niños: según edad y peso, considerando dosis de ads. (60 kg)». | «Urticaria, edema angioneurótico, ataque asmático, shock anafiláctico, erupción, fiebre, leucopenia, púrpura, neutropenia, sobreinfección, anemia hemolítica, nefrotoxicidad con I.R.». | Vademecum (2016) Bencilpenicilina. Disponible en: https://www.vademecum.es/principios-activos-bencilpenicilina-J01CE01 [Consultado: 28-05-2018] | «PENIBIOT "1" Iny. 1.000.000 UI PENIBIOT "2" Iny. 2.000.000 UI/vial PENIBIOT "5" Iny. 5.000.000 UI PENILEVEL Polvo disolv. sol. iny. 5000000 UI PENILEVEL Polvo disolv. sol. iny. 600000 UI PENILEVEL Polvo y disolv. para sol. iny. 1000000 UI PENILEVEL Polvo y disolv. para sol. iny. 10000000 UI PENILEVEL Polvo y disolv. para sol. iny. 2000000 UI SODIOPEN Iny. 2.000.000 UI SODIOPEN Iny. 5.000.000» |
«No puede tomar bencilpenicilina si es alérgico a penicilinas, si es alérgico a cefalosporinas, si presenta un historial alérgico medicamentoso, de colitis ulcerosa, pseudomembranosa, enf. de Crohn o desequilibrio electrolítico. Asmáticos e ICC. En I.R. grave ajustar dosis. Tenga especial precacución si presenta insuficiencia renal. En ese caso, ajustar la dosis al grado de insuf.». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Cefazolin | «Cefazolin is an antibiotic which belongs to a group of medicines called cephalosporins». | MIP Pharma GmbH (2015) Package leaflet: Information for the user Cefazolin 2 g powder for solution for injection / infusion. Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1452145930102.pdf [Consultado: 25-05-2018] | «Cefazolin is indicated for the treatment of the following infections caused by cefazolin-susceptible micro-organisms • Skin and soft tissue infections • Bone and joint infections Perioperative prophylaxis. For surgical operations with increased risk of infections with anaerobic pathogens, e.g. colorectal surgery, a combination with an appropriate drug with activity against anaerobes is recommended. The use of cefazolin should be limited to cases where parenteral treatment is needed». |
«The dosage as well as the method of administration are dependent on the location and severity of the infection and on the clinical and bacteriological progress. Adults and adolescents (above 12 years of age and ≥ 40 kg bodyweight) • Infections caused by sensitive micro-organisms: 1 g - 2 g cefazolin per day divided into 2-3 equal doses. • Infections caused by moderately sensitive micro-organisms : 3 g - 4 g cefazolin per day divided into 3-4 equal doses. In severe infections, doses of up to 6 g per day can be administered in three or four equal doses (one dose every 6 or 8 hours). Special dosage recommendations Peri-operative prophylaxis • To prevent postoperative infection in contaminated or potentially contaminated surgery, recommended doses are: 1 g cefazolin 30 - 60 minutes before surgery • In case of long surgical interventions (2 hours or more) additional 0.5 - 1 g cefazolin during the intervention. • Prolonged continuation of administration beyond the surgical intervention should be supported by national official guidance. It is important that (1) the preoperative dose be given just (30 min to 1 hour) prior to the start of surgery so that adequate antibiotic levels are present in the serum and tissues at the time of initial surgical incision; and (2) cefazolin be administered, if necessary, at appropriate intervals during surgery to provide sufficient levels of the antibiotic at the anticipated moments of greatest exposure to infective organisms. Adults with renal impairment may need a lower dose to avoid overlapping. Infections caused by sensitive microorganisms A dose of 25-50 mg / kg body weight divided into two to four equal doses per day is recommended (one dose every 6, 8 or 12 hours). Infections caused by moderately sensitive microorganisms A dose of up to 100 mg / kg body weight divided in three or four equal doses is recommended (one dose every 6 or 8 hours). Prematures and infants below the age of 1 month Since safety of use in prematures and infants below the age of one month has not been determined, the use of Cefazolin in these patients is not recommended. Elderly patients: In elderly patients with normal renal function no dosage adjustment is necessary». |
«Uncommon side effects (occurring in 1 to 10 out of 1,000 treated patients) are: • redness of the skin (erythema), widespread skin rash (erythema multiforme or exanthema), hives (red, itchy, bumpy skin rash) on the surface of the skin (urticaria), fever, swelling beneath the skin (angioedema) and/or swelling of the lung tissue possibly with a cough and breathing difficulties (interstitial pneumonia or pneumonitis), as these side effects may indicate an allergic reaction to this medicine. Rare (occurring in 1 to 10 out of 10,000 treated patients) • jaundice (yellow colour in the skin and whites of the eyes) • severe skin rash with flushing, fever, blisters or ulcers (Stevens Johnson syndrome) or a severe rash with reddening, peeling and swelling of the skin that looks like a burn (toxic epidermal necrolysis). Very rare (occurring in less than 1 out of 10,000 treated patients) • a severe allergic reaction (anaphylactic shock) with breathing difficulty , swelling of the throat, face, eyelids or lips, increased heart rate and falling blood pressure. This reaction may start soon after you first take the medicine, or it might start later». |
MIP Pharma GmbH (2015) SUMMARY OF PRODUCT CHARACTERISTICS. Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1452145930461.pdf [Consultado: 25-05-2018] | «Cefazolin 2 g, powder for solution for injection / infusion». | Precautions: «Do not take cefazolin if: Hypersensitivity to cefazolin. Patients with known hypersensitivity to cephalosporin antibiotics. History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems). In case of a renal insufficiency with a glomerular filtration rate under 55 ml/min, an accumulation of cefazolin must be taken into consideration. Therefore, the dosage has to be reduced accordingly or the dosage interval has to be prolonged. In patients with renal impairment the use of cefazolin may be associated with seizures». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Cefazolina | «Antibacteriano betalactámico del grupo de las cefalosporinas de primera generación. Interfiere en la fase final de síntesis de pared celular bacteriana. | Vademecum (2016) Cefazolina. Disponible en: https://www.vademecum.es/principios-activos-cefazolina-J01DB04 [Consultado: 28-05-2018] | «Infección respiratoria inferior, exacerbación bacteriana de bronquitis crónica y neumonía, urinaria, pielonefritis, de piel y tejido blando, biliar, osteoarticular, septicemia, endocarditis; profilaxis en cirugía contaminada o infección de herida quirúrgica con riesgo importante». | «IM/IV. - Ads. Neumonía neumocócica: 500 mg/12 h. Infección leve por cocos gram+: 500 mg/8 h. Infección urinaria no complicada: 1 g/12 h. Infección moderada-grave por gram--: 0,5-1 g/6-8 h. Infección grave con riesgo vital, endocarditis y septicemia: 1-1,5 g/6 h, en ocasiones se han utilizado 12 g/día. Profilaxis de infección perioperatoria: 1-2 g, ½-1 h antes de cirugía; 0,5-1 g durante y 0,5-1 g/6-8 h, en las 24 h postoperatorias. Cirugía de corazón y artroplastia protésica: continuar 3-5 días tras cirugía. I.R. Clcr 35-54 ml/min: dosis estándar/8 h; Clcr 11-34 ml/min: 50% de dosis estándar/12 h; Clcr < 10 ml/min: 50% de dosis estándar/18-24 h. - Niños > 1 año, infección leve-moderada: 25-50 mg/kg dividida en 3-4 dosis. Máx. 100 mg/kg, incluso en infección grave. I.R. Clcr 40-70 ml/min: 60% de dosis estándar/12 h; Clcr 20-40 ml/min: 25% de dosis estándar/12 h; Clcr 5-20 ml/min: 10% de dosis estándar/24 h». |
«Vaginitis, moniliasis genital, fiebre medicamentosa, erupción cutánea, prurito vulvar, eosinofilia, shock anafiláctico; neutro, leuco y trombocitopenia; elevación de enzimas hepáticas, BUN y creatinina sérica, I.R., diarrea, náuseas, vómitos, anorexia, aftas bucales, trastorno hepatobiliar y urinario, prurito genital, dolor y flebitis en zona de iny.». | Vademecum (2016) Cefazolina. Disponible en: https://www.vademecum.es/principios-activos-cefazolina-J01DB04 [Consultado: 28-05-2018] | «CEFAZOLINA NORMON EFG Polvo para sol. iny. 2 g IV CEFAZOLINA NORMON EFG Polvo y disolv. para sol. iny. IM 1 g/vial CEFAZOLINA NORMON EFG Polvo y disolv. para sol. iny. IV 1 g/vial CEFAZOLINA REIG JOFRE Iny. 1 g/10 ml CEFAZOLINA REIG JOFRE Sol. iny. 2 g CEFAZOLINA SALA Polvo para sol. iny. 2 g/vial CEFAZOLINA SALA Polvo y disolv. para sol. iny. IM 1 g/vial CEFAZOLINA SALA Polvo y disolv. para sol. iny. IV 1 g/vial INTRAZOLINA Polvo y disolv. sol. iny. y perfusión 1.000 mg INTRAZOLINA Polvo y disolv. sol. iny. y perfusión 500 mg» |
«No puede tomar cefazolina si tiene hipersensibilidad a cefalosporinas, hipersensibilidad a penicilinas, alergias medicamentosas; en I.R. Ajustar dosis; riesgo de colitis pseudomembranosa y sobrecrecimiento de microorganismos no sensibles, en tto. prolongado; máx. 100 mg/kg en niños con p.c. < 60 kg y 6 g/día en niños con p.c. > 60 kg; no recomendado en prematuros y < 1 mes; no administrar vía intratecal: toxicidad severa del SNC. En caso de insuficiencia renal, ajustar la dosis. Ads.: Clcr 35-54 ml/min: dosis estándar/8 h; Clcr 11-34 ml/min: 50% de dosis estándar/12 h; Clcr < 10 ml/min: 50% de dosis estándar/18-24 h. Niños: Clcr 40-70 ml/min: 60% de dosis estándar/12 h; Clcr 20-40 ml/min: 25% de dosis estándar/12 h; Clcr 5-20 ml/min: 10% de dosis estándar/24 h». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Cefepime | «It belongs to a group of antibiotics called cephalosporins». | Renascience Pharma Limited (2017) Package leaflet: Information for the user Renapime 1g & 2g powder for solution for injection/infusion Cefepime. Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1513314209905.pdf [Consultado: 25-05-2018] | «It is indicated in the treatment of infections caused by bacteria susceptible to cefepime, namely: - lower respiratory tract infections, including nosocomial pneumonia and community acquired pneumonia, acute bacterial exacerbation of chronic bronchitis and secondary bacterial infection of acute bronchitis; - uncomplicated and complicated urinary tract infections, including pyelonephritis; - skin and subcutaneous tissue infection; - intrabdominal infection, including peritonitis, and biliary tract infections; - gynecological infections; - bacterial meningitis in infants and children; - in combination with other antibacterial agents in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection; - treatment of patients with bacteraemia that occurs in association with, or is suspected to be associated with, any of the infections listed above». |
«Cefepime can be administered via intravenous use or intramuscular use. The usual dose and the route of administration vary in accordance with the severity of the infection, the renal function and the general conditions of the patient. For adult patients and children with a body weight > 40 kg, with normal renal function: Mild to moderate urinary tract infections (UTI) - 500 mg to 1 g IV or IM - every 12 h; Other mild to moderate infections (non UTI) - 1 g IV or IM - every 12 h; Severe infections - 2 g IV - every 12 h; Very severe infection or lifethreatening infections - 2 g IV - every 8 h. The usual duration of treatment is 7 to 10 days; more serious infections may require a longer treatment. In the empiric treatment of febrile neutropenia, the usual treatment duration should not be less than 7 days or until the resolution of the neutropenia. In patients with a body weight ≤ 40 kg, the recommended dosage for children applies. Use in children For children with normal renal function: In children the recommended dose is: – Pneumonia, urinary tract infections, skin and subcutaneous tissue infection: • Children aged more than 2 months and weighing ≤ 40 kg: 50 mg/kg every 12 hours for 10 days; in more severe infections, the 8 hours interval between the intakes should be done. – Bacteraemia that occurs in association with, or is suspected to be associated with infections, bacterial meningitis and empirical treatment of febrile neutropenia: • Children aged more than 2 months and weighing ≤ 40 kg: 50 mg/kg every 8 hours during 7 to 10 days. Experience in children under 2 months of age is limited. Children of this age should be monitored carefully during administration of Renapime. In children with body weight > 40 kg, the adult dosage is recommended. Do not exceed the maximum recommended adult dose (2 g every 8 hours). Experience with the intramuscular route in children is limited. Elderly, patients with renal dysfunction, dialysis patients and children with renal dysfunction: The doctor will determine the dose to be administered. |
«Very common (can affect more than 1 user in 10): - Positive Coombs test without hemolysis (method of determining antibody levels); Common (can affect up to 1 user in 10): - Increased blood coagulation time (increased prothrombin or thromboplastin time); - anaemia; - an elevated level of certain blood cells (eosinophilia); - infusion site phlebitis; - diarrhoea; - rashes; - infusion site reaction; - pain and inflammation on the injection site; - an elevated level in certain blood counts (alanine aminotransferase, aspartate aminotransferase, bilirubin, alkaline phosphatase). Uncommon (can affect up to 1 user in 100) - fungal infections of the mouth with white coating (oral candidiasis); - vaginal infection; - reduced levels of certain blood cells (thrombocytopenia, leukopenia, neutropenia) - headaches; - colitis (inflammation of the large intestine); - pseudomembranous colitis; - nausea; - vomiting; - erythema (reddening of the skin); - urticaria; - itching; - elevated blood urea; - elevated serum creatinine; - fever; - inflammation on the infusion site». |
Renascience Pharma Limited (2017) Package leaflet: Information for the user Renapime 1g & 2g powder for solution for injection/infusion Cefepime. Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1513314209905.pdf [Consultado: 25-05-2018] | «Renapime 1g & 2g powder for solution for injection/infusion». | Precautions: «Do not use Renapime: - if you are allergic to cefepime, any other cephalosporin antibiotics; if you have history of severe allergic reaction any other type of beta-lactam antibiotics (penicillins, monobactams and carbapenems). – Cefepime is not adequate for the treatment of certain types of infections. Your doctor has prescribed you this antibiotic because it is the best option for your illness. – if you have kidney problems (such as reduced renal function) as the elimination of this medicine may be affected. – if you suffer from persistent diarrhoea during or after using this medicine. Tell your doctor immediately so he can investigate whether the diarrhoea is the result of an intestinal inflammation caused by the use of the antibiotic; treatment with this medicine may need to be discontinued. – If you suffer from allergies (such as hay fever, nettle rash) or have had an allergic reaction to medicines in the past. Cefepime must be discontinued on the appearance of any kind of hypersensitivity reaction and appropriate therapeutic measures initiated. – Dosages for elderly patients should be chosen carefully and should take renal function into account, as there is a greater possibility to develop kidney disease». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Cefepima | «Antibacteriano; inhibe la síntesis de pared bacteriana. | Vademecum (2016) Cefepima. Disponible en: https://www.vademecum.es/principios-activos-cefepima-J01DE01 [Consultado: 28-05-2018] | «Ads., adolescentes y niños (2 meses-12 años): neumonía; infecciones graves del tracto urinario, de la piel y de tejidos blandos; tto. empírico de pacientes con neutropenia febril. Además en ads. y adolescentes: infecciones intra-abdominales graves/complicadas (incluidas peritonitis e infección de la vesícula biliar); profilaxis en la cirugía intra-abdominal. Además en niños (2 meses-12 años): meningitis bacteriana». | «Ads. y adolescentes con p.c. > 40 kg. IV/IM. Infecciones leves-moderadas: 1 g/12 h. IV. Infecciones moderadas-graves de piel y tejidos blandos, infecciones graves: 2 g/12 h. Infecciones extremadamente graves/potencialmente mortales: 2 g/8 h. Profilaxis en cirugía intra-abdominal: 2 g mediante perfus. IV 30 min, 60 min antes de la intervención + 500 mg d metronidazol. Niños de 2 meses-12 años, ≤ 40 kg. Neumonía, infecciones del tracto urinario, de la piel y tejidos blandos: 50 mg/kg/12 h. Infecciones graves, meningitis bacteriana, fiebre en neutropénicos: 50 mg/kg/8 h. Niños < 1-2 meses: 30 mg/kg/8-12 h y monitorización. Duración habitual: 7-10 días. Máx.: 2 g/8 h. I.R. leve-moderada, ads.: inicialmente dosis habitual. Mantenimiento. DPCA: 0,5-2 g/48 h, según gravedad. I.R., niños: dosis pediátrica comparable a 2 g en ads. Mantenimiento en niños > 2 meses-12 años con I.R.». |
«Test de Coombs +, aumento del TP y del TTPA, anemia, eosinofilia; flebitis/tromboflebitis en el lugar de iny.; diarrea; aumento de ALT, AST y bilirrubina total; exantema; reacciones en lugar de perfus., dolor e inflamación en lugar de iny.; aumento de fosfatasa alcalina». | Vademecum (2016) Cefepima. Disponible en: https://www.vademecum.es/principios-activos-cefepima-J01DE01 [Consultado: 28-05-2018] | «CEFEPIMA ACCORD Polvo para sol. iny. y para perfusión 1 g CEFEPIMA ACCORD Polvo para sol. iny. y para perfusión 2 g CEFEPIMA KABI Polvo para sol. iny. y para perfusión 1 g CEFEPIMA KABI Polvo para sol. iny. y para perfusión 2 g CEFEPIMA MIP Polvo para sol. iny. 1 g CEFEPIMA MIP Polvo para sol. iny. 2 g CEFEPIMA NORMON Polvo y disolv. para sol. iny. y perfusión 1 g CEFEPIMA NORMON Polvo y disolv. para sol. iny. y perfusión 2 g CEFEPIMA SALA Polvo para sol. iny. 1 g CEFEPIMA SALA Polvo para sol. iny. 2 g» |
«No puede tomar cefepima en caso de hipersensibilidad a ß-lactámicos. Precauciones: historia de hipersensibilidad, asma o diátesis alérgica (interrumpir el tto. si aparece); riesgo de sobrecrecimiento de organismos no sensibles y diarrea o colitis pseudomembranosa por C. difficile; I.R.: ajustar dosis; valorar función renal en concomitancia con nefrotóxicos; con dosis mayor a la recomendada e I.R. se ha descrito: encefalopatía reversible, mioclonía, crisis epiléptica y/o fallo renal; ancianos. En caso de insuficiencia renal, ajustar dosis con Clcr < 50/min». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Cefixime | «Cefixime belongs to a group of antibiotics called ‘cephalosporins’». |
Sanofi (2017) Package leaflet: information for the user Suprax 200mg Tablets Cefixime. Disponible en: https://www.medicines.org.uk/emc/files/pil.5534.pdf [Consultado: 25-05-2018] | «It is used to treat infections caused by bacteria. These include infections of the: • Ear • Nose, sinuses (such as sinusitis) • Throat (such as tonsillitis, pharyngitis) • Chest and lungs (such as bronchitis, pneumonia) • Urinary system (such as cystitis and kidney infections)». |
«The usual dose is: Adults, Elderly and Children over 10 years or weighing more than 50kg • 1-2 tablets each day given as a single or divided dose People with kidney problems • Your doctor may prescribe a lower dose Children under 10 years old • Suprax Paediatric should be used instead». |
«The majority of adverse reactions observed in clinical trials were mild and self-limiting in nature. The following adverse reaction (Preferred term# or equivalent) will be considered listed: Blood and lymphatic system disorders: Eosinophilia Hypereosinophilia Agranulocytosis Leucopenia Neutropenia Granulocytopenia Haemolytic anaemia Thrombocytopenia Thrombocytosis Gastrointestinal: Abdominal pain Diarrhoea* Dyspepsia Nausea Vomiting Flatulance Hepatobiliary disorders: Jaundice Infections and infestations: Pseudomembranous colitis Investigations: Aspartate aminotransferase increased Alanine aminotransferase increased Blood bilirubin increased Blood urea increased Blood creatinine increased Nervous system disorders: Dizziness Headache Cases of convulsions have been reported with cephalosporins including cefixime (frequency not known)** Beta-lactams, including cefixime, predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment (frequency not known)** Respiratory, thoracic and mediastinal disorders: Dyspnoea Renal and urinary disorders: Renal failure acute including tubulointerstitial nephritis as an underlying pathological condition Immune System disorders, administrative site conditions, skin and subcutaneous tissue disorders: Anaphylactic reaction Serum sickness-like reaction Drug rash with eaosinophilia and systemic symptoms (DRESS) Pruritus Rash Drug Fever Arthralgia Erythema multiforme Stevens-Johnson syndrome Toxic epidermal necrolysis Angio-oedema Urticaria Pyrexia Face oedema Genital pruritus Vaginitis The above mentioned listed adverse reactions have been observed during clinical studies and/or during marketed use. *Diarrhoea has been more commonly associated with higher doses. Some cases of moderate to severe diarrhoea have been reported; this has occasionally warranted cessation of therapy». |
Sanofi (2017) Suprax Tablets 200 mg. Disponible en: https://www.medicines.org.uk/emc/product/5534 [Consultado: 25-05-2018] | «Suprax Tablets 200mg». | Precautions: «Patients with known hypersensitivity to cephalosporin antibiotics or any of the other components of the product. Encephalopathy Beta-lactams, including cefixime, predispose the patient to encephalopathy risk (which may include convulsions, confusion, impairment of consciousness, movement disorders), particularly in case of overdose or renal impairment. Severe cutaneous adverse reactions Severe cutaneous adverse reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome and drug rash with eosinophilia and systemic symptoms (DRESS) have been reported in some patients on cefixime. When severe cutaneous adverse reactions occur, cefixime should be discontinued and appropriate therapy and/or measures should be taken. Suprax should be given with caution to patients who have shown hypersensitivity to other drugs. Hypersensitivity to penicillins As with other cephalosporins, cefixime should be given with caution to patients with a history of hypersensitivity to penicillin, as there is some evidence of partial cross-allergenicity between the penicillins and cephalosporins. Patients have had severe reactions (including anaphylaxis) to both classes of drugs. Haemolytic anaemia Drug-induced haemolytic anaemia, including severe cases with a fatal outcome, has been described for cephalosporins (as a class). The recurrence of haemolytic anaemia after re-administration of cephalosporins in a patient with a history of cephalosporin (including cefixime) –associated haemolytic anaemia has also been reported. Renal failure acute As with other cephalosporins, cefixime may cause acute renal failure including tubulointerstitial nephritis as an underlying pathological condition. When acute renal failure occurs, cefixime should be discontinued and appropriate therapy and/or measures should be taken. Paediatric use Safety of cefixime in premature or newborn infant has not been established. Treatment with broad spectrum antibiotics alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridium difficile is a primary cause of antibiotic-associated diarrhoea. Pseudomembranous colitis is associated with the use of broad-spectrum antibiotics (including macrolides, semi-synthetic penicillins, lincosamides and cephalosporins); it is therefore important to consider its diagnosis in patients who develop diarrhoea in association with the use of antibiotics. Symptoms of pseudomembranous colitis may occur during or after antibiotic treatment. Management of pseudomembranous colitis should include sigmoidoscopy, appropriate bacteriologic studies, fluids, electrolytes and protein supplementation. If the colitis does not improve after the drug has been discontinued, or if the symptoms are severe, oral vancomycin is the drug of choice for antibiotic-associated pseudomembranous colitis produced by C. difficile. Other causes of colitis should be excluded. Renal impairment Cefixime should be administered with caution in patients with markedly impaired renal function». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Cefixima | «Bactericida. Inhibe la síntesis de pared bacteriana. | Vademecum (2016) Cefixima. Disponible en: https://www.vademecum.es/principios-activos-cefixima-J01DD08 [Consultado: 28-05-2018] | «Faringitis y amigdalitis por S. pyogenes. Bronquitis aguda, reagudización de bronquitis crónica y neumonías por B. catarrhalis, S. pneumoniae y H. influenzae. Otitis media y sinusitis aguda por H. influenzae, B. catarrhalis, S. pyogenes y S. pneumoniae. Infección urinaria no complicada por E. coli y P. mirabilis». | «Oral. Ads. y niños > 12 años (> 50 kg): 400 mg/24 h o 200 mg/12 h, 7-14 días. Máx.: 12 mg/kg/24 h. Cistitis aguda no complicada en mujer: 400 mg/24 h, 1-3 días. Niños: 8 mg/kg/24 h o 4 mg/kg/12 h. Máx.: 12 mg/kg/día. I.R.: Clcr < 20 ml/min y hemodializados: máx. 200 mg/24 h». | «Diarrea, heces blandas». | Vademecum (2016) Cefixima. Disponible en: https://www.vademecum.es/principios-activos-cefixima-J01DD08 [Consultado: 28-05-2018] | «CEFIXIMA NORMON EFG Cáps. dura 200 mg CEFIXIMA NORMON EFG Cáps. dura 400 mg CEFIXIMA SANDOZ EFG Cáps. dura 400 mg DENVAR Cáps. 200 mg DENVAR Cáps. 400 mg DENVAR Susp. 100 mg/5 ml XIFIA Comp. recub. con película 400 mg» |
«No puede tomar cefixima si tiene hipersensibilidad a cefalosporinas o en los siguientes casos: reacción de hipersensibilidad previa, inmediata o intensa a la penicilina o a cualquier antibiótico betalactámico. Si aparece reacción de hipersensibilidad suspender el tto.; I.R. con Clcr < 20 ml/min; no recomendado en niños y adolescentes con I.R.; vigilar función renal en tto. concomitante con aminoglucósidos, polimixina B, colistina u otros diuréticos del asa en dosis elevadas; riesgo de sobreinfección por microorganismos no sensibles, colitis pseudomembranosa y de reacciones cutáneas intensas como síndrome de hipersensibilidad inducido por fármacos (síndrome DRESS) o reacciones cutáneas ampollosas (necrólisis epidérmica tóxica, síndrome de Stevens-Johnson) (suspender el tto. si aparece); asma y diátesis alérgica; no recomendado en niños < 12 años (formas sólidas) o prematuros, recién nacidos y < 6 meses (formas líquidas); no recomendado con alteración gastrointestinal severa que incluya náuseas y vómitos. Si presenta insuficiencia renal, ajustar la dosis con Clcr < 20 ml/min y hemodializados: máx. 200 mg/24 h, monitorizar». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Cefotaxime | «Cefotaxime belongs to a group of medicines called cephalosporins which are antibiotics. These medicines work by killing bacteria that cause infections». | Bowmed Ibisqus Limited (2017) Cefotaxime 1g powder for solution for injection vials. Disponible en: https://www.medicines.org.uk/emc/product/8750/smpc [Consultado: 25-05-2018] | «Cefotaxime for injection is used for the treatment of a range of serious bacterial infections including infections of the blood stream (septicaemia), bones (osteomyelitis), the heart valves (endocartitis), the membranes covering the brain (meningitis) and the lining of the abdomen (peritonitis), and to prevent and treat infections following surgical operations». |
«The dosage, route and frequency of administration should be determined by the severity of infection, the sensitivity of causative organisms and condition of the patient. As a general rule Cefotaxime is administered for a further 3 to 4 days after improvement/regression of the symptoms. Adults and children over 12 years in general receive 1 g Cefotaxime every 12 hours. In severe cases, the daily dose can be increased up to 12 g. Daily doses up to 6 g can be divided into at least two individual administrations at 12 hourly intervals. Higher daily doses must be divided into at least 3 to 4 individual administrations at 8 or 6 hour intervals respectively. In most cases due to less sensitive infective bacteria, an increase may be necessary, i.e. 1 g Cefotaxime. Examination for syphilis needs to be carried out before commencing therapy. Lyme borrelisosis: A daily dose of 6 g Cefotaxime (14 to 21 days duration). The daily dose was generally administered divided into 3 parts (2 g Cefotaxime 3 times daily). Infants and children up to 12 years receive 50 to 100 mg Cefotaxime according to the severity of the infection (up to 150 mg) per kilogram of body weight per day, divided into equal doses, administered at 12 (up to 6) hour intervals. In individual cases – particularly in life threatening situations – it may be necessary to increase the daily dose to 200 mg Cefotaxime per kilogram of body weight. In neonates and infants doses of 50 mg Cefotaxime per kilogram of body weight per day should not be exceeded in view of not fully matured kidney clearance. In case of life-threatening situations it may be necessary to increase the daily dose. With patients with a creatinine clearance of 20ml/minute or less, the maintenance dose is reduced to half the normal dose. With patients with a creatinine clearance of 5 ml/minute or less, a reduction of the maintenance dose to 1 g Cefotaxime (divided into 2 individual administrations at 12 hour intervals), seems to be appropriate. The stated recommendations are based on experiences with adults. Since Cefotaxime is to a large extent eliminated by haemodialysis, an additional dose should be administered to patients who are dialysed, after the dialysis procedure». |
«There is no common undesirable effects. Uncommon: leucopoenia, eosinophilia, thrombocytopenia, Jarisch-Herxheimer reaction, convulsions, diarrhoea, increase in liver enzymes and/or bilirubin, Rash, pruritis, urticaria, decrease in renal function/increase of creatinine, Fever inflammatory reactions at the injection site including phlebitis, thrombophlebitis». |
Bowmed Ibisqus Limited (2017) Cefotaxime 1g powder for solution for injection vials. Disponible en: https://www.medicines.org.uk/emc/product/8750/smpc [Consultado: 25-05-2018] | «Cefotaxime 1g powder for solution for injection vials; Cefotaxime 2g Powder for solution for injection or infusion; Cefotaxime 500mg powder for solution for injection vials; Cefotaxime 500mg/1g Powder for solution for injection or infusion». | Precautions: «Known or suspected hypersensitivity to Cefotaxime or other cephalosporins. Allergic cross-reactions can exist between penicillins and cephalosporins. Cefotaxime must never be used: - by the intravenous route - in infants under 30 months of age - in subjects with a previous history of hypersensitivity to Lidocaine or other local anaesthetics of the amide type - in patients who have a non-paced heart block - in patients with severe heart failure. As with other antibiotics, the use of cefotaxime, especially if prolonged, may result in overgrowth of non-susceptible organisms. Repeated evaluation of the patients condition is essential. If superinfection occurs during treatment, appropriate measures should be taken. Cefotaxime should be used with caution in persons with a history of allergies or asthma. The use of cefotaxime is strictly contraindicated in subjects with a history of immediate-type hypersensitivity to cephalosporins. Cases of serious bullous skin reactions such as Stevens-Johnson syndrome or toxic epidermal necrolysis have been reported with cefotaxime. Patients should be advised to contact their doctor immediately prior to continuing treatment if skin and/or mucosal reactions occur. Diarrhoea, particularly if severe and/or persistent, occurring during treatment or in the initial weeks following treatment, may be symptomatic of Clostridium difficile associated disease may range in severity from mild to life threatening, the most severe form of which is pseudomembranous colitis. Leucopenia, neutropenia and more rarely, agranulocytosis, may develop during treatment with cefotaxime, particularly if given over long periods». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Cefotaxima | «Bactericida. Inhibe síntesis de pared celular bacteriana. | Vademecum (2016) Cefotaxima. Disponible en: https://www.vademecum.es/principios-activos-cefotaxima-J01DD01 [Consultado: 28-05-2018] | «Infecciones por gérmenes sensibles: ORL; tracto respiratorio inferior (exacerbación aguda de bronquitis crónica incluida), neumonía nosocomial; urinarias complicadas (pielonefritis); ETS (EPI, prostatitis, gonocócica); bacteriemia y endocarditis bacteriana; meningitis (salvo causada por listeria) y otras infecciones del SNC; osteoarticulares; complicadas de piel y tejidos blandos; abdominales (peritonitis, tracto biliar)». | «IV (lenta 3-5 min o perfus.) o IM (con lidocaína). Ads. y niños > 12 años, infección no complicada: 1 g/12 h; infección grave: máx. 12 g/día; gonocócica, IM: dosis única 500 mg, 1 g si la cepa es muy resistente. Lactantes y niños < 12 años, prematuros de 0-1 sem, IV: 50-100 mg/kg/día, fraccionada/12 h; prematuros 1-4 sem, IV: 75-150 mg/kg/día, fraccionada/8 h; niños < 12 años con p.c. < 50 kg, IV (o IM sólo si son > 30 meses): 50-100 mg/kg/día, fraccionada/6-8 h (se puede doblar con infección grave, meningitis), máx. 2 g/24 h; con p.c. ≥ 50 kg misma dosis ads. I.R. (Clcr < 5 ml/min): ½ dosis habitual. Hemodiálisis: según gravedad, 1-2 g/día». |
«Exantema, prurito, urticaria, náuseas, vómitos, dolor abdominal, diarrea. En administración IM: dolor en lugar de iny.». | Vademecum (2016) Cefotaxima. Disponible en: https://www.vademecum.es/principios-activos-cefotaxima-J01DD01 [Consultado: 28-05-2018] | «CEFOTAXIMA FRESENIUS KABI EFG Polvo y disolv. para sol. iny. IM 1 g/vial CEFOTAXIMA FRESENIUS KABI EFG Sol. iny. IV Polvo y disolv 500 mg/vial CEFOTAXIMA FRESENIUS KABI EFG Sol. iny. IV Polvo y disolv. 1 g/vial CEFOTAXIMA FRESENIUS KABI ESPAÑA EFG Sol. iny. IV Polvo y disolv. 2 g/vial CEFOTAXIMA NORMON EFG Polvo y disolv. para sol. iny. 1 g IM/vial CEFOTAXIMA NORMON EFG Polvo y disolv. para sol. iny. 1 g IV/vial CEFOTAXIMA NORMON EFG Polvo y disolv. para sol. iny. 2 g/vial CEFOTAXIMA NORMON EFG Polvo y disolv. para sol. iny. 250 mg/vial CEFOTAXIMA NORMON EFG Polvo y disolv. para sol. iny. 500 mg/vial CEFOTAXIMA SALA EFG Polvo y disolv. para sol. iny. IV 1 g/vial CEFOTAXIMA SALA EFG Polvo y disolv. para sol. iny. IV 2 g/vial CEFOTAXIMA TORLAN EFG Polvo 2 g IV/vial CEFOTAXIMA TORLAN EFG Polvo para inyección en vial 0,5 g/vial CEFOTAXIMA TORLAN EFG Polvo para inyección en vial 1 g IM/vial CEFOTAXIMA TORLAN EFG Polvo para inyección en vial 1 g/vial» |
«No puede tomar cefotaxima en los siguientes casos: Hipersensibilidad a cefalosporinas, antecedente de hipersensibilidad inmediata a cefalosporinas. Antecedente de hipersensibilidad a penicilinas por riesgo de reacción alérgica cruzada (vigilancia estrecha en 1ª administración). I.R. grave, ajustar dosis. Vigilar función renal en ancianos, I.R. y asociado con aminoglucósidos, diuréticos potentes (furosemida) u otros nefrotóxicos (puede potenciar nefrotoxicidad). Suspender si aparece diarrea intensa, por posible colitis pseudomembranosa. Tto. prolongado: riesgo de sobreinfección por organismos resistentes, y de leucopenia, neutropenia y raramente de agranulocitosis (monitorizar leucocitos si tto. > 7-10 días, suspender en caso de neutropenia). Riesgo de encefalopatía (con dosis elevadas e I.R.). Notificadas reacciones cutáneas graves de tipo vesiculoso. En caso de insuficiencia renal ajustar la dosis si Clcr < 5 ml/min: ½ dosis habitual. Hemodiálisis: según gravedad, 1-2 g/día. Riesgo de encefalopatía si dosis altas». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Ceftaroline | «Ceftaroline belongs to a group of medicines called ‘cephalosporin antibiotics’». |
Pfizer Limited (2017) Package leaflet: Information for the user Zinforo ® 600 mg powder for concentrate for solution for infusion Ceftaroline fosamil. Disponible en: https://www.medicines.org.uk/emc/files/pil.4297.pdf [Consultado: 25-05-2018] | «It is used to treat children from the age of 2 months and adults with: infections of the skin and the tissues below the skin an infection of the lungs called ‘pneumonia’». |
«The usual recommended dose for adults is 600 mg every 12 hours. Your doctor may increase your dose to 600 mg every 8 hours for some infections. The usual recommended dose for children depends on the age and weight of the child and is given every 8 or 12 hours. It is given as a drip into a vein lasting 60 or 120 minutes. A course of treatment usually lasts for 5 to 14 days for skin infections and 5 to 7 days for pneumonia. If you have kidney problems your doctor may lower your dose». |
«Tell your doctor straight away if you get these symptoms as you may need urgent medical treatment: Sudden swelling of your lips, face, throat or tongue; a severe rash; and, swallowing or breathing problems. These may be signs of a severe allergic reaction (anaphylaxis) and may be lifethreatening; Diarrhoea that becomes severe or does not go away or stool that contains blood or mucus during or after treatment with Zinforo. In this situation, you should not take medicines that stop or slow bowel movement. Very common (may affect more than 1 in 10 people) Changes in a blood test called a ‘Coombs test’ commonly seen in patients receiving this type of antibiotic. This test looks for certain antibodies which may act against your red blood cells. Common (may affect up to 1 in 10 people) Fever Headache Feeling dizzy Itching, skin rash Diarrhoea, stomach pain Feeling sick (nausea) or being sick (vomiting) More enzymes produced by your liver (as shown in blood tests) Pain and irritation of the veins Redness, pain or swelling where the injection was given». |
Pfizer Limited (2017) Package leaflet: Information for the user Zinforo ® 600 mg powder for concentrate for solution for infusion Ceftaroline fosamil. Disponible en: https://www.medicines.org.uk/emc/files/pil.4297.pdf [Consultado: 25-05-2018] | «Zinforo 600 mg powder for concentrate for solution for infusion». | Precautions: If you are allergic to ceftaroline fosamil; If you are allergic to other cephalosporin antibiotics If you have had previous severe allergic reactions to other antibiotics like penicillin or carbapenem; Talk to your doctor or nurse: If you have kidney problems (your doctor may have to prescribe a lower dose) If you have ever had fits (seizures or convulsions) If you have ever had any non-severe allergic reactions to other antibiotics like penicillin or carbapenem If you have had severe diarrhoea whilst taking antibiotics in the past». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Ceftarolina fosamilo | «Antibacteriano betalactámico del grupo de las cefalosporinas y penemes. | Vacemecum (2016) Ceftarolina fosamilo. Disponible en: https://www.vademecum.es/principios-activos-ceftarolina+fosamilo-J01DI02 [Consultado: 28-05-2018] | «En ads. y niños > 2 meses para el tto. de infecciones complicadas de piel y tejidos blandos (IPTBc) y neumonía adquirida en la comunidad (NAC)». | «Perfus. IV de 60 min: ads. y adolescentes ≥ 12 -< 18 años y p.c. ≥ 33 kg: 600 mg/12 h, duración del tto.: 5-14 días para IPTBc y 5-7 días para NAC; adolescentes ≥ 12 -< 18 años y p.c. < 33 kg: 12 mg/kg/8 h (máx. 400 mg/8 h); niños ≥2-<12 años: 12 mg/kg/8 h (máx. 400 mg/8 h); niños < 2años-≥ 2 meses: 8 mg/kg/8 h. I.R.: en ads. y adolescentes ≥ 12-< 18 años y p.c. ≥ 33 kg: si Clcr > 30-≤ 50 ml/min: 400 mg/12 h; si Clcr ≥ 15-≤ 30 ml/min: 300 mg/12 h; si enf. renal terminal (incluyendo hemodiálisis): 200 mg/12 h. I.R en ≥ 12-< 18 años y p.c. < 33 kg y niños ≥2-<12 años: si Clcr > 30-≤ 50 ml/min: 8 mg/kg/8 h (máx. 300 mg/8 h); si Clcr ≥ 15-≤ 30 ml/min: 6 mg/kg/8 h (máx. 200 mg/8 h)». |
«Rash, prurito; cefalea, mareo; flebitis; diarrea, náuseas, vómitos, dolor abdominal; transaminasas aumentadas; pirexia, reacciones en el lugar de la perfus. (eritema, flebitis, dolor); test de Coombs directo positivo». | Vacemecum (2016) Ceftarolina fosamilo. Disponible en: https://www.vademecum.es/principios-activos-ceftarolina+fosamilo-J01DI02 [Consultado: 28-05-2018] | «ZINFORO Polvo para concentrado para sol. para perf. 600 mg» | «No puede tomar ceftarolina fosamilo en los siguientes casos: hipersensibilidad al principio activo, a otras cefalosporinas o hipersensibilidad inmediata y grave a cualquier otro tipo de betalactámico. Precauciones: posibles reacciones de hipersensibilidad graves (a veces mortales); diarrea asociada a Clostridium difficile (interrumpir el tto. de ceftarolina y emplear medidas específicas); pueden darse sobreinfecciones de organismos no sensibles; pacientes con enf. epiléptica preexistente; puede darse seroconversión del test de antiglobulina (test de Coombs) directo y riesgo potencial de anemia hemolítica durante el tto.; para el tto. de NAC precaución en: inmunocomprometidos, sepsis grave/shock séptico, enf. pulmonar subyacente grave, riesgo PORT Clase V, y/o NAC que requiera ventilación en el comienzo, NAC debida a S. aureus resistente a meticilina o pacientes que requieran cuidados intensivos; para el tto. de IPTBc precaución en: inmunocomprometidos, sepsis grave/shock séptico, fascitis necrotizante, absceso perirrectal, quemaduras de tercer grado y extensas, infecciones de pie diabético; sin datos de seguridad ni eficacia en niños < 2 meses, enf. renal terminal en adolescentes de 12-< 18 años con p.c. < 33 kg o niños 2-12 años ni niños de 2 meses-< 2 años con I.R. moderada-grave o enf. renal terminal. En caso de insuficiencia renal en ads. y adolescentes ≥ 12-< 18 años y p.c. ≥ 33 kg: si Clcr > 30-≤ 50 ml/min: 400 mg/12 h; si Clcr ≥ 15-≤ 30 ml/min: 300 mg/12 h; si enf. renal terminal (incluyendo hemodiálisis): 200 mg/12 h. I.R en ≥ 12-< 18 años y p.c. < 33 kg y niños < 12-≥ 2 años: si Clcr > 30-≤ 50 ml/min: 8 mg/kg/8 h (máx. 300 mg/8 h); si Clcr ≥ 15-≤ 30 ml/min: 6 mg/kg/8 h (máx. 200 mg/8 h)». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Ceftazidime | «Ceftazidime is an antibiotic used in adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporin». |
Consilient Health Ltd (2015) Package leaflet: information for the user Ceftazidime 1 g powder for solution for injection/infusion Ceftazidime 2 g powder for solution for injection/infusion ceftazidime. Disponible en: https://www.medicines.org.uk/emc/files/pil.754.pdf [Consultado: 25-05-2018] | «Ceftazidime is used to treat severe bacterial infections of: • the lungs or chest • the lungs and bronchi in patients suffering from cystic fibrosis • the brain (meningitis) • the ear • the urinary tract • the skin and soft tissues • the abdomen and abdominal wall (peritonitis) • the bones and joints. Ceftazidime can also be used: • to prevent infections during prostate surgery in men • to treat patients with low white blood cell counts (neutropenia) who have a fever due to a bacterial infection». |
«Ceftazidime is made up by the doctor, pharmacist or nurse using water for injections or a suitable infusion fluid. The recommended dose is: The correct dose of Ceftazidime for you will be decided by your doctor and depends on: the severity and type of infection; whether you are on any other antibiotics; your weight and age; how well your kidneys are working. Use in children: Newborn babies (0-2 months) For every 1 kg the baby weighs, they’ll be given 25 to 60 mg Ceftazidime per day divided in two doses. Babies (over 2 months) and children who weigh less than 40 kg For every 1 kg the baby or child weighs, they’ll be given 100 to 150 mg of Ceftazidime per day divided in three doses. Maximum 6 g per day. Adults and adolescents who weigh 40 kg or more 1 to 2 g of Ceftazidime three times daily. Maximum of 9 g per day. Patients over 65 The daily dose should not normally exceed 3 g per day, especially if you are over 80 years of age. Patients with kidney problems You may be given a different dose to the usual dose. The doctor or nurse will decide how much Ceftazidime you will need, depending on the severity of the kidney disease. Your doctor will check you closely and you may have more regular kidney function tests». |
«Common side effects (up to 1 in 10 people are affected) • Diarrhoea • Swelling and redness along a vein • Red raised skin rash which may be itchiness • Pain, burning, swelling or inflammation at the injection site. Tell your doctor if any of these are troubling you. Common side effects that may show up in blood tests: • An increase in a type of white blood cell (eosinophilia) • An increase in the number of cells that help the blood to clot • An increase in liver enzymes. Uncommon side effects (up to 1 in 100 people are affected) • Inflammation of the gut which can cause pain or diarrhoea which may contain blood • Thrush -fungal infections in the mouth or vagina • Headache • Dizziness • Stomach ache • Feeling sick or being sick • Fever and chills. Tell your doctor if you get any of these. Uncommon side effects that may show up in blood tests: • A decrease in the number of white blood cells • A decrease in the number of blood platelets (cells that help the blood to clot) • An increase in the level of urea, urea nitrogen or serum creatinine in the blood». |
Consilient Health Ltd (2015) Package leaflet: information for the user Ceftazidime 1 g powder for solution for injection/infusion Ceftazidime 2 g powder for solution for injection/infusion ceftazidime. Disponible en: https://www.medicines.org.uk/emc/files/pil.754.pdf [Consultado: 25-05-2018] | «Ceftazidime 1 g powder for solution for injection/infusion; Ceftazidime 1g Powder for solution for injection; Ceftazidime 1g powder for solution for injection vials; Ceftazidime 2g Powder for solution for injection or infusion; Ceftazidime 2g powder for solution for injection vials; Ceftazidime 500mg powder for solution for injection vials; Fortum 1g Injection; Fortum 3g Injection; Fortum 500 Injection; Fortum for Injection 2 g; Zavicefta 2g/0.5g powder for concentration for solution for infusion». | Precautions: «• if you are allergic (hypersensitive) to ceftazidime or any of the other ingredients of this medicine; • if you have had a severe allergic reaction to any other antibiotic (penicillins, monobactams and carbapenems) as you may also be allergic to Ceftazidime. Talk to your doctor or nurse before using Ceftazidime. You must look out for certain symptoms such as allergic reactions, nervous system disorders and gastrointestinal disorders such as diarrhoea while you are being given Ceftazidime. This will reduce the risk of possible problems (see Section 4). If you have had an allergic reaction to other antibiotics you may also be allergic to Ceftazidime. If you need a blood or urine test Ceftazidime can affect the results of urine tests for sugar and a blood test known as the Coombs test. If you are having tests: • tell the person taking the sample that you have been given Ceftazidime». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Ceftazidima | «Bactericida. Inhibe la síntesis de pared bacteriana. Altamente estable a la mayoría de ß-lactamasas clínicamente importantes. | Vademecum (2016) Ceftazidima. Disponible en: https://www.vademecum.es/principios-activos-ceftazidima-J01DD02 [Consultado: 28-05-2018] | «Tto. de las infecciones que se enumeran a continuación en ads. y niños incluyendo recién nacidos (desde el nacimiento): neumonía nosocomial, infecciones broncopulmonares en fibrosis quística, meningitis bacteriana, otitis media supurativa crónica y externa maligna; infecciones del tracto urinario complicadas, infecciones de la piel y tejidos blandos complicadas, infecciones intraabdominales complicadas, infecciones de los huesos y de las articulaciones, peritonitis asociada a diálisis en pacientes con DPCA (Diálisis Peritoneal Continua Ambulatoria); tto. de pacientes con bacteriemia que ocurre en asociación con, o se sospecha que está asociada con, cualquiera de las infecciones mencionadas anteriormente; tto. de pacientes neutropénicos con fiebre que se cree que es debida a una infección bacteriana; profilaxis perioperatoria de infecciones del tracto urinario en pacientes sometidos a resección transuretral de la próstata (RTUP). Debe ser coadministrado con otros agentes antibacterianos». | «IM profunda/IV (iny. o perfus.). Ads. y niños con p.c. ≥ 40 kg. Infecciones broncopulmonares en fibrosis quística: 100-150 mg/kg/día cada 8 h, máx. 9 g/día; neutropenia febril, neumonía nosocomial, meningitis bacteriana, bacteriemia: 2 g/8 h; otitis media supurativa crónica y externa maligna, infecciones de la piel y tejidos blandos complicadas, infecciones intraabdominales complicadas, infecciones de huesos y articulaciones, peritonitis asociada a diálisis en pacientes con DPCA: 1-2 g/8 h; infecciones del tracto urinario complicadas: 1-2 g/8-12 h; profilaxis perioperatoria de infecciones del tracto urinario en pacientes sometidos a RTUP: 1 g en la inducción a la anestesia y 2ª dosis al retirar el catéter. Ancianos: máx. 3 g/día. Lactantes > 2 meses y p.c. < 40 kg: 100-150 mg/kg/día en 3 dosis, máx. 6 g/día. Nenonatos y lactantes < 2 meses: 25-60 mg/kg/día en 2 dosis. I.R. Ads., inicial: 1 g. Mantenimiento, Clcr 31-50 ml/min: 1 g/12 h; Clcr 16-30: 1 g/24 h; Clcr 6-15: 0,5 g/24 h; Clcr < 5: 0,5 g/48 h. Infección grave, aumentar 50% dosis indicadas para I.R. o la frecuencia de administración. Niños: ajustar Clcr a superficie o a masa corporal magra, Clcr 31-50 ml/min: 25 mg/kg/12 h; Clcr 16-30: 25 mg/kg/24 h; Clcr 6-15: 12,5 mg/kg/24 h; Clcr < 5: 12,5 mg/kg/48 h. Diálisis peritoneal y DPCA: además del uso IV se puede añadir al fluido de diálisis (125-250 mg ceftazidima/2 l fluido). Hemodiálisis: repetir tras cada periodo de hemodiálisis la dosis de mantenimiento adecuada según las tablas de abajo; hemodiálisis arterio-venosa continua o hemofiltración de alto flujo en UCI: 1 g/día como dosis única o en dosis divididas; hemofiltración de bajo flujo, seguir la recomendación de dosis para I.R.; hemofiltración veno-venosa y hemodiálisis veno-venosa, ver a continuación». |
«Eosinofilia, trombocitosis; flebitis o tromboflebitis con la administración IV; diarrea; elevaciones transitorias en una o más enzimas hepáticas; erupción maculopapular o urticaria; dolor y/o inflamación después de la iny. IM; test de Coombs positivo». | Vademecum (2016) Ceftazidima. Disponible en: https://www.vademecum.es/principios-activos-ceftazidima-J01DD02 [Consultado: 28-05-2018] | «CEFTAZIDIMA ACCORD Polvo para perfusión 1 g/vial CEFTAZIDIMA ACCORD Polvo para perfusión 2 g/vial CEFTAZIDIMA KABI Polvo para sol. iny. y para perfusión 1 g CEFTAZIDIMA KABI Polvo para sol. iny. y para perfusión 2000 mg CEFTAZIDIMA LDP TORLAN EFG Polvo para sol. para perfusión 1 g/vial CEFTAZIDIMA LDP TORLAN EFG Polvo para sol. para perfusión 2 g/vial CEFTAZIDIMA LDP TORLAN EFG Polvo y disolv. para sol. iny. 1000 mg/vial CEFTAZIDIMA LDP TORLAN EFG Polvo y disolv. para sol. iny. 500 mg/vial CEFTAZIDIMA NORMON EFG Polvo para perfusión 2 g/vial CEFTAZIDIMA NORMON EFG Polvo y disolv. 1 g/vial CEFTAZIDIMA NORMON EFG Polvo y disolv. 500 mg/vial CEFTAZIDIMA SALA Polvo para sol. para perfusión 1000 mg/vial CEFTAZIDIMA SALA Polvo para sol. para perfusión 2000 mg/vial CEFTAZIDIMA SALA Polvo y disolv. para sol. iny. 1000 mg/vial» |
«No tomar ceftazidima en los siguientes casos: hipersensibilidad a ceftazidima, cefalosporinas; antecedentes de hipersensibilidad grave a cualquier otro tipo de antibiótico ß-lactámicos. Precauciones: en caso de insuficiencia hepática o insuficiencia renal monitorizar; antecedentes de hipersensibilidad no grave a otros agentes ß-lactámicos; si aparece reacción de hipersensibilidad suspender el tto.; I.R., ajustar dosis y monitorizar; riesgo de nefrotoxicidad en concomitancia con fármacos nefrotóxicos: aminoglucósidos, diuréticos potentes; en tto. prolongado: riesgo de sobreinfección por organismos no susceptibles; riesgo de colitis peudomembranosa (suspender el tto. si aparece)». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Ceftriaxone | «Ceftriaxone is an antibiotic given to adults and children (including newborn babies). It works by killing bacteria that cause infections. It belongs to a group of medicines called cephalosporins». |
Wockhardt UK Ltd (2018) Package leaflet: Information for the user Ceftriaxone 1g powder for solution for injection Ceftriaxone 2g powder for solution for injection or infusion. Disponible en: https://www.medicines.org.uk/emc/files/pil.1361.pdf [Consultado: 25-05-2018] | «Ceftriaxone is used to treat infections of • the brain (meningitis). • the lungs. • the middle ear. • the abdomen and abdominal wall (peritonitis). • the urinary tract and kidneys. • bones and joints. • the skin or soft tissues. • the blood. • the heart. It can be given: • to treat specific sexually transmitted infections (gonorrhoea and syphilis). • to treat patients with low white blood cell counts (neutropenia) who have fever due to bacterial infection. • to treat infections of the chest in adults with chronic bronchitis. • to treat Lyme disease (caused by tick bites) in adults and children including newborn babies from 15 days of age. • to prevent infections during surgery». |
«The dose depends on the severity, susceptibility, site and type of infection and on the age and hepato-renal function of the patient. 1-2 g - Once a daily - Community acquired pneumonia, acute exacerbations of chronic obstructive pulmonary disease, intra-abdominal infections, complicated urinary tract infections (including pyelonephritis). 2g - Once a daily - Hospital acquired pneumonia, complicated skin and soft tissue infections, infections of bones and joints. 2-4g - Once a daily - management of neutropenic patients with fever that is suspected to be due to a bacterial infection, bacterial endocarditis, bacterial meningitis. Indications for adults and children over 12 years of age (≥ 50 kg) that require specific dosage schedules: Acute otitis media A single intramuscular dose of Ceftriaxone 1-2 g can be given. Limited data suggest that in cases where the patient is severely ill or previous therapy has failed, Ceftriaxone may be effective when given as an intramuscular dose of 1-2 g daily for 3 days. Pre-operative prophylaxis of surgical site infections 2 g as a single pre-operative dose. Gonorrhoea 500 mg as a single intramuscular dose. Syphilis The generally recommended doses are 500 mg-1 g once daily increased to 2 g once daily for neurosyphilis for 10-14 days. The dose recommendations in syphilis, including neurosyphilis, are based on limited data. National or local guidance should be taken into consideration». |
«The most frequently reported adverse reactions for ceftriaxone are eosinophilia, leucopenia, thrombocytopenia, diarrhoea, rash, and hepatic enzymes increased». | Wockhardt UK Ltd (2018) Ceftriaxone 1g Powder for solution for injection. Disponible en: https://www.medicines.org.uk/emc/product/1361/smpc [Consultado: 25-05-2018] | «Ceftriaxone 1g Powder for solution for injection; Ceftriaxone 1g powder for solution for injection vials; Ceftriaxone 250mg powder for solution for injection vials; Ceftriaxone 2g powder for solution for injection vials; Ceftriaxone 2g Powder for solution for injection/infusion; Rocephin 1g Powder for Solution for Injection or Infusion; Rocephin 250mg Powder for Solution for Injection; Rocephin 2g Powder for Solution for Injection or Infusion». | Precautions: «hypersensitivity to the active substance, to any other cephalosporin or to any of the excipients. History of severe hypersensitivity (e.g. anaphylactic reaction) to any other type of beta-lactam antibacterial agent (penicillins, monobactams and carbapenems). Ceftriaxone is contraindicated in: • Premature neonates up to a postmenstrual age of 41 weeks (gestational age + chronological age)* • Full-term neonates (up to 28 days of age): - with hyperbilirubinaemia, jaundice, or who are hypoalbuminaemic or acidotic because these are conditions in which bilirubin binding is likely to be impaired* - if they require (or are expected to require) intravenous calcium treatment, or calcium-containing infusions due to the risk of precipitation of a ceftriaxone-calcium salt. In vitro studies have shown that ceftriaxone can displace bilirubin from its serum albumin binding sites leading to a possible risk of bilirubin encephalopathy in these patients». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Ceftriaxona | «Bactericida de amplio espectro y acción prolongada. Inhibe la síntesis de pared celular bacteriana. | Vademecum (2016) Ceftriaxona. Disponible en: https://www.vademecum.es/principios-activos-ceftriaxona-J01DD04 [Consultado: 20-05-2018] | «Sepsis, meningitis, peritonitis, infección biliar; gastrointestinal; ósea; articular; de piel y tejido blando, de heridas, renal, urinaria, respiratoria, neumonía, de garganta, nariz y oídos, genital, gonocócica, borreliosis de Lyme, infección con mecanismo defensivo disminuido. Profilaxis perioperatoria». | «IM/IV. Ads. y niños > 12 años: 1-2 g/24 h. Caso grave o por bacteria moderadamente sensible: máx. 4 g, una sola vez/día. Gonorrea, IM: 250 mg, dosis única. Recién nacidos (0-14 días): 20-50 mg/kg/24 h. Niños de 15 días-12 años: 20-80 mg/kg/día. Dosis IV ≥ 50 mg/kg, administrar en infus., mín. 30 min. Meningitis bacteriana (lactantes y niños): inicial 100 mg/kg/día, máx. 4 g, 4 días por N. meningitidis, 6 días por H. influenzae, 7 días por S. pneumoniae. Profilaxis preoperatoria: 1-2 g 30-90 min antes de la intervención, dosis única. I.R.: Clcr < 10 ml/min: máx. 2 g/día». | «Diarrea, náuseas, vómitos, estomatitis, glositis; eosinofilia, leucopenia, granulocitopenia, anemia hemolítica, trombocitopenia; exantema, dermatitis alérgica, prurito, urticaria, edema y edema multiforme». | Vademecum (2016) Ceftriaxona. Disponible en: https://www.vademecum.es/principios-activos-ceftriaxona-J01DD04 [Consultado: 20-05-2018] | «CEFTRIAXONA ACCORD EFG Polvo y disolv. para sol. iny. IV 1000 mg /10 ml CEFTRIAXONA FRESENIUS KABI EFG Polvo para sol. para perfusión 2 g/vial CEFTRIAXONA FRESENIUS KABI EFG Polvo y disolv. para sol. iny. IM 1 g/vial CEFTRIAXONA FRESENIUS KABI EFG Polvo y disolv. para sol. iny. IV 1 g/10 ml CEFTRIAXONA LDP TORLAN Polvo para sol. para perfusión 2 g/vial CEFTRIAXONA LDP TORLAN Polvo y disolv. para sol. iny. 250 mg IV CEFTRIAXONA LDP TORLAN Polvo y disolv. para sol. iny. IM 1 g/vial CEFTRIAXONA LDP TORLAN Polvo y disolv. para sol. iny. IM 500 mg/vial CEFTRIAXONA LDP TORLAN Polvo y disolv. para sol. iny. IV 1 g/vial CEFTRIAXONA LDP TORLAN Polvo y disolv. para sol. iny. IV 500 mg/vial CEFTRIAXONA NORMON EFG Polvo para sol. para perfusión 2000 mg/vial CEFTRIAXONA NORMON EFG Polvo y disolv. para sol. iny. 1000 mg IM CEFTRIAXONA NORMON EFG Polvo y disolv. para sol. iny. IM 250 mg/2 ml CEFTRIAXONA NORMON EFG Polvo y disolv. para sol. iny. IM 500 mg/2 ml CEFTRIAXONA NORMON EFG Polvo y disolv. para sol. iny. IV 1000 mg/10 ml CEFTRIAXONA NORMON EFG Polvo y disolv. para sol. iny. IV 500 mg/5 ml CEFTRIAXONA REIG JOFRE Polvo y disolv. para solución iny. 1 g/vial CEFTRIAXONA SALA EFG Polvo para sol. iny. IV 2 g/vial CEFTRIAXONA SALA EFG Polvo y disolv. para sol. iny. IV 1 g/vial» |
«No puede tomar ceftriaxona en los siguientes casos: Hipersensibilidad a cefalosporinas o a penicilinas; recién nacidos prematuros hasta la edad corregida de 41 sem (semanas de gestación + semanas de vida); recién nacidos a término (hasta 28 días) con: ictericia, hipoalbuminemia o acidosis o si se necesita (o se considera que se va a necesitar) tto. con Ca IV o infusiones que contengan Ca debido al riesgo de precipitación de la ceftriaxona con Ca. Precauciones: riesgo de: colitis pseudomembranosa, sobreinfección por microorganismo no susceptible; hiperbilirrubinémicos (puede desplazar bilirrubina de la albúmina sérica), controlar perfil hemático en tto. prolongado; I.R. grave: ajustar dosis; descritos casos de reacciones mortales en prematuros y recién nacidos a término < 1 mes por precipitados de calcio-ceftriaxona en pulmones y riñones. En caso de insuficiencia renal ajustar dosis con I.R. grave. Clcr < 10 ml/min: máx. 2 g/día». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Ciprofloxacin | «Ciproxin contains the active substance ciprofloxacin. Ciprofloxacin is an antibiotic belonging to the fluoroquinolone family. Ciprofloxacin works by killing bacteria that cause infections. It only works with specific strains of bacteria». |
Bayer plc (2017) Package leaflet: Information for the patient Ciproxin 750mg film-coated tablets Ciprofloxacin. Disponible en: https://www.medicines.org.uk/emc/files/pil.6151.pdf [Consultado: 25-05-2018] | «Ciproxin is used in adults to treat the following bacterial infections: 029_0 Page 2 of 10 respiratory tract infections long lasting or recurring ear or sinus infections urinary tract infections genital tract infections in men and women gastro-intestinal tract infections and intra-abdominal infections skin and soft tissue infections bone and joint infections to prevent infections due to the bacterium Neisseria meningitidis anthrax inhalation exposure Ciprofloxacin may be used in the management of patients with low white blood cell counts (neutropenia) who have a fever that is suspected to be due to a bacterial infection. Ciproxin is used in children and adolescents, under specialist medical supervision, to treat the following bacterial infections: lung and bronchial infections in children and adolescents suffering from cystic fibrosis complicated urinary tract infections, including infections that have reached the kidneys (pyelonephritis) anthrax inhalation exposure Ciproxin may also be used to treat other specific severe infections in children and adolescents when your doctor considered this necessary». |
«Adults: Infections of the lower respiratory tract - 500 mg twice daily to 750 mg twice daily/10 mL twice daily to 15 mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) - 7 to 14 days; Acute exacerbation of chronic sinusitis - 500 mg twice daily to 750 mg twice daily/10 mL twice daily to 15 mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) - 7 to 14 days; Chronic suppurative otitis media - 500 mg twice daily to 750 mg twice daily/10 mL twice daily to 15 mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) - 7 to 14 days; Malignant external otitis - 750 mg twice daily/15 mL twice daily (three 5-mL measuring spoonfuls twice daily) - 28 days up to 3 months; Uncomplicated cystitis - 250 mg twice daily to 500 mg twice daily/5-mL twice daily to 10 mL twice daily (one 5-mL measuring spoonful twice daily up to two 5-mL measuring spoonfuls twice daily) - 3 days (In pre-menopausal women, 500 mg single dose may be used corresponding to 10 mL single dose = two 5-mL measuring spoonfuls as a single dose); Complicated cystitis, Uncomplicated pyelonephritis - 500 mg twice daily/10 mL twice daily (two 5-mL measuring spoonfuls twice daily) - 7 days; Complicated pyelonephritis - 500 mg twice daily to 750 mg twice daily/10 mL twice daily to 15-mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) - at least 10 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses); Prostatitis - 500 mg twice daily to 750 mg twice daily/10 mL twice daily to 15-mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) - 2 to 4 weeks (acute) to 4 to 6 weeks (chronic); Gonococcal uretritis and cervicitis - 500 mg as a single dose/10 mL as a single dose corresponding to two 5-mL measuring spoonfuls as a single dose - 1 day (single dose); Epididymo-orchitis and pelvic inflammatory diseases - 500 mg twice daily to 750 mg twice daily/10 mL twice daily to 15-mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) - at least 14 days; Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers' diarrhoea - 500 mg twice daily/10 mL twice daily (two 5-mL measuring spoonfuls twice daily) - 1 day; Diarrhoea caused by Vibrio cholerae - 500 mg twice daily/10 mL twice daily (two 5-mL measuring spoonfuls twice daily) - 3 days; Typhoid fever - 500 mg twice daily/10 mL twice daily (two 5-mL measuring spoonfuls twice daily) - 7 days; Intra-abdominal infections due to Gram-negative bacteria - 500 mg twice daily to 750 mg twice daily/10 mL twice daily to 15-mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) - 5 to 14 days; Indications Daily dose in mg Daily dose in mL (Number of 5-mL measuring spoonfuls) Total duration of treatment (potentially including initial parenteral treatment with ciprofloxacin) Infections of the lower respiratory tract 500 mg twice daily to 750 mg twice daily 10 mL twice daily to 15 mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) 7 to 14 days Infections of the upper respiratory tract Acute exacerbation of chronic sinusitis 500 mg twice daily to 750 mg twice daily 10 mL twice daily to 15 mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) 7 to 14 days Chronic suppurative otitis media 500 mg twice daily to 750 mg twice daily 10 mL twice daily to 15 mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) 7 to 14 days Malignant external otitis 750 mg twice daily 15 mL twice daily (three 5-mL measuring spoonfuls twice daily) 28 days up to 3 months Urinary tract infections (see section 4.4) Uncomplicated cystitis 250 mg twice daily to 500 mg twice daily 5-mL twice daily to 10 mL twice daily (one 5-mL measuring spoonful twice daily up to two 5-mL measuring spoonfuls twice daily) 3 days In pre-menopausal women, 500 mg single dose may be used corresponding to 10 mL single dose = two 5-mL measuring spoonfuls as a single dose Complicated cystitis, Uncomplicated pyelonephritis 500 mg twice daily 10 mL twice daily (two 5-mL measuring spoonfuls twice daily) 7 days Complicated pyelonephritis 500 mg twice daily to 750 mg twice daily 10 mL twice daily to 15-mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) at least 10 days, it can be continued for longer than 21 days in some specific circumstances (such as abscesses) Prostatitis 500 mg twice daily to 750 mg twice daily 10 mL twice daily to 15-mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) 2 to 4 weeks (acute) to 4 to 6 weeks (chronic) Genital tract infections Gonococcal uretritis and cervicitis 500 mg as a single dose 10 mL as a single dose corresponding to two 5-mL measuring spoonfuls as a single dose 1 day (single dose) Epididymo-orchitis and pelvic inflammatory diseases 500 mg twice daily to 750 mg twice daily 10 mL twice daily to 15-mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) at least 14 days Infections of the gastro-intestinal tract and intra-abdominal infections Diarrhoea caused by bacterial pathogens including Shigella spp. other than Shigella dysenteriae type 1 and empirical treatment of severe travellers' diarrhoea 500 mg twice daily 10 mL twice daily (two 5-mL measuring spoonfuls twice daily) 1 day Diarrhoea caused by Shigella dysenteriae type 1 500 mg twice daily 10 mL twice daily (two 5-mL measuring spoonfuls twice daily) 5 days Diarrhoea caused by Vibrio cholerae 500 mg twice daily 10 mL twice daily (two 5-mL measuring spoonfuls twice daily) 3 days Typhoid fever 500 mg twice daily 10 mL twice daily (two 5-mL measuring spoonfuls twice daily) 7 days Intra-abdominal infections due to Gram-negative bacteria 500 mg twice daily to 750 mg twice daily 10 mL twice daily to 15-mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) 5 to 14 days Infections of the skin and soft tissue - 500 mg twice daily to 750 mg twice daily - 10 mL twice daily to 15-mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) - 7 to 14 days; Bone and joint infections - 500 mg twice daily to 750 mg twice daily - 10 mL twice daily to 15-mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) - max. of 3 months; Neutropenic patients with fever that is suspected to be due to a bacterial infection. Ciprofloxacin should be co-administered with appropriate antibacterial agent(s) in accordance to official guidance - 500 mg twice daily to 750 mg twice daily/10 mL twice daily to 15-mL twice daily (two 5-mL measuring spoonfuls twice daily up to three 5-mL measuring spoonfuls twice daily) - Therapy should be continued over the entire period of neutropenia; Prophylaxis of invasive infections due to Neisseria meningitidis - 500 mg as a single dose/10 mL as a single dose corresponding to two 5-mL measuring spoonfuls as a single dose - 1 day (single dose); Inhalation anthrax post-exposure prophylaxis and curative treatment for persons able to receive treatment by oral route when clinically appropriate - 500 mg twice daily/10 mL twice daily (two 5-mL measuring spoonfuls twice daily) - 60 days from the confirmation of Bacillus anthracis exposure. In patients with impaired liver function no dose adjustment is required. Patients with renal impairment: Creatinine Clearance [mL/min/ 1.73 m²]: > 60 - Serum Creatinine [µmol/L]: < 124 - Oral Dose [mg]: See Usual Dosage; Creatinine Clearance [mL/min/ 1.73 m²]: 30-60 - Serum Creatinine [µmol/L]: 124 to 168 - Oral Dose [mg]: 250-500 mg every 12 h; Creatinine Clearance [mL/min/ 1.73 m²]: < 30 - Serum Creatinine [µmol/L]: > 169 - Oral Dose [mg]: 250-500 mg every 24 h». |
«Stop taking Ciproxin and contact your doctor immediately in order to consider another antibiotic treatment if you notice any of the following serious side effects: Rare (may affect up to 1 in 1,000 people) - Seizure (see Section 2: Warnings and precautions) Very rare (may affect up to 1 in 10,000 people) - Severe, sudden allergic reaction with symptoms such as tightness in the chest, feeling dizzy, sick or faint, or experience dizziness when standing up (anaphylactic reaction/shock) (see Section 2: Warnings and precautions) 029_0 Page 7 of 10 - Muscle weakness, inflammation of the tendons which could lead to rupture of the tendon, particularly affecting the large tendon at the back of the ankle (Achilles tendon) (see Section 2: Warnings and precautions) - A serious life-threatening skin rash, usually in the form of blisters or ulcers in the mouth, throat, nose, eyes and other mucous membranes such as genitals which may progress to widespread blistering or peeling of the skin (Stevens-Johnson syndrome, toxic epidermal necrolysis). Common (may affect up to 1 in 10 people) - nausea, diarrhoea - joint pain and joint inflammation in children». |
Bayer plc (2017) Package leaflet: Information for the patient Ciproxin 750mg film-coated tablets Ciprofloxacin. Disponible en: https://www.medicines.org.uk/emc/files/pil.6151.pdf [Consultado: 25-05-2018] | «Cetraxal 2mg/ml ear drops, solution single-dose container; CILODEX 3 mg/ml / 1 mg/ml ear drops, suspension; Ciloxan 0.3% w/v eye drops, solution; Ciprofloxacin 250mg film-coated tablets; Ciprofloxacin 500mg film coated tablets; Ciprofloxacin 100 mg film-coated tablets; Ciprofloxacin 2 mg/ml solution for infusion; Ciprofloxacin 250 mg film-coated tablets; Ciprofloxacin 2mg/ml solution for infusion; Ciprofloxacin 500 mg film-coated tablets; Ciprofloxacin 750 mg film-coated tablets; Ciprofloxacin 750mg Film-Coated Tablets (Accord); Ciprofloxacin 750mg tablets; Ciproxin solution for infusion; Ciproxin Suspension; Ciproxin Tablets 500mg; Ciproxin Tablets 750mg» | Precautions: «Do not take Ciproxin: if you are allergic to the active substance, to other quinolone drugs or to any of the other ingredients of this medicine (listed in Section 6) if you are taking tizanidine (see Section 2: Other medicines and Ciproxin) Warnings and precautions Talk to your doctor before taking Ciproxin if you have ever had kidney problems because your treatment may need to be adjusted. if you suffer from epilepsy or other neurological conditions. if you have a history of tendon problems during previous treatment with antibiotics such as Ciproxin. if you are diabetic because you may experience a risk of hypoglycaemia with ciprofloxacin. if you have myasthenia gravis (a type of muscle weakness) because symptoms can be exacerbated. if you have heart problems. Caution should be taken when using Ciprofloxacin, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording 029_0 Page 3 of 10 of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section 2. Other medicines and Ciproxin). If you or a member of your family is known to have a deficiency in glucose-6-phosphate dehydrogenase (G6PD), since you may experience a risk of anaemia with ciprofloxacin. For the treatment of some genital tract infections, your doctor can prescribe another antibiotic in addition to ciprofloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor.» |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Ciprofloxacino | «Bactericida. Interfiere en la replicación de ADN bacteriano por inhibición de la ADN-girasa y topoisomerasa IV bacterianas. | Vademecum (2017) Ciprofloxacino. Disponible en: https://www.vademecum.es/principios-activos-ciprofloxacino-J01MA02 [Consultado: 28-05-2018] | «Infección de vías respiratorias bajas por gram- (exacerbación de EPOC, infección broncopulmonar en fibrosis quística o en bronquiectasia, neumonía). Exacerbación aguda de sinusitis crónica por gram- y otitis media supurativa crónica. Otitis maligna externa. Cistitis no complicada. Cistitis complicada, pielonefritis no complicada. Cistitis complicada, pielonefritis no complicada. Cistitis complicada, pielonefritis no complicada. Cistitis complicada, pielonefritis no complicada. Pielonefritis complicada. Prostatitis. Uretritis y cervicitis gonocócicas sensibles a fluoroquinolonas. Epididimorquitis y EPI. Infección gastrointestinal. Infección intraabdominal por gram-. Infección de piel y tejidos blandos. Infección de huesos y articulaciones. Neutropenia. Profilaxis de infección invasiva por N. meningitidis. Profilaxis post-exposición y tto. curativo de carbunco por inhalación. Infección broncopulmonar en fibrosis quística por P. aeruginosa. Infección complicada de vías urinarias, pielonefritis. Otras infecciones graves. Profilaxis post-exposición y tto. curativo de carbunco por inhalación. Algunas infecciones pueden requerir la asociación de otro antibacteriano adecuado, como las causadas por bacterias Pseudomonas aeruginosa, Acinetobacter o Staphylococcus, e infecciones intraabdominales, de piel y tejidos blandos, en sujetos con neutropenia o en EPI». | «IV, infus. lenta 60 min: 400 mg, 2-3 veces/día. Oral. La duración de los ttos. incluye el posible inicio por vía IV. Ads.: - Infección de vías respiratorias bajas por gram- (exacerbación de EPOC, infección broncopulmonar en fibrosis quística o en bronquiectasia, neumonía): 500-750 mg, 2 veces/día, 7-14 días. - Exacerbación aguda de sinusitis crónica por gram- y otitis media supurativa crónica: 500-750 mg, 2 veces/día, 7-14 días. - Otitis maligna externa: 750 mg, 2 veces/día, 28 días-3 meses. - Cistitis no complicada: 250-500 mg, 2 veces/día, 3 días. En pre-menopausia puede administrarse dosis única 500 mg. - Cistitis complicada, pielonefritis no complicada: 500 mg, 2 veces/día, 7 días. - Pielonefritis complicada: 500-750 mg, 2 veces/día, mín. 10 días (más de 21 días en casos específicos como abscesos). - Prostatitis: 500-750 mg, 2 veces/día, 2-4 sem (aguda) y 4-6 sem crónica. - Uretritis y cervicitis gonocócicas sensibles a fluoroquinolonas: dosis única 500 mg. - Epididimorquitis y EPI: 500-750 mg, 2 veces/día, mín. 14 días. - Infección gastrointestinal: 500 mg, 2 veces/día. Duración tto.: 1 día en diarrea bacteriana, incluyendo Shigella spp. distintas de Shigella dysenteriae tipo 1 y tto. empírico de diarrea del viajero grave; 5 días en diarrea causada por Shigella dysenteriae tipo 1; 3 días en la causada por Vibrio cholerae; 7 días en fiebre tifoidea. - Infección intraabdominal por gram-: 500-750 mg, 2 veces/día, 5-14 días. - Infección de piel y tejidos blandos: 500-750 mg, 2 veces/día, 7-14 días. - Infección de huesos y articulaciones: 500-750 mg, 2 veces/día, máx. 3 meses. - Tto. y profilaxis de infecc. en pacientes con neutropenia (coadministrado con antibacteriano adecuado según recomendaciones oficiales): 500-750 mg, 2 veces/día, durante la neutropenia. - Profilaxis de infección invasiva por N. meningitidis: dosis única 500 mg. - Profilaxis post-exposición y tto. curativo de carbunco por inhalación. Oral: dosis única 500 mg o 500 mg 2 veces/día; IV: 400 mg, 2 veces/día, pasar a vía oral en cuanto sea posible. Administrar tan pronto se sospeche o confirme, 60 días desde confirmación. Niños y adolescentes. - Infección broncopulmonar en fibrosis quística por P. aeruginosa: 20 mg/kg, 2 veces/día (máx. 750 mg/dosis), 10-14 días. IV (infus. 60 min): 10 mg/kg/8 h, máx. 400 mg/dosis. Puede utilizarse terapia secuencial. - Infección complicada de vías urinarias, pielonefritis: 10-20 mg/kg, 2 veces/día (máx. 750 mg/dosis), 10-21 días. IV: 6-10 mg/kg/8 h, máx. 400 mg/dosis. - Otras infecciones graves: 20 mg/kg, 2 veces/día (máx. 750 mg/dosis), duración tto. según tipo de infección. IV. 10 mg/kg/8 h, máx. 400 mg/dosis. - Profilaxis post-exposición y tto. curativo de carbunco por inhalación. Oral: 10-15 mg/kg, 2 veces/día (máx. 500 mg/dosis); IV misma dosis (máx. 400 mg/dosis), pasar a vía oral en cuanto sea posible. Administrar tan pronto se sospeche o confirme, 60 días desde confirmación. I.R., ads.: - Oral. Clcr 30-60 ml/min: 250-500 mg/12 h; Clcr < 30 y diálisis peritoneal: 250-500 mg/24 h; hemodializados: 250-500 mg/24 h tras diálisis. - IV. Clcr 31-60 ml/min: máx. 800 mg/día; Clcr ≤ 30: máx. 400 mg/día; hemodializados: 400 mg/día los días de diálisis y tras ésta; DPAC: 50 mg/l dializado/6 h». |
«Náuseas, diarrea. Además IV: vómitos, reacciones en el lugar de perfus., aumento transitorio transaminasas, erupción cutánea. En niños además la artropatía se produce con frecuencia». | Vademecum (2017) Ciprofloxacino. Disponible en: https://www.vademecum.es/principios-activos-ciprofloxacino-J01MA02 [Consultado: 28-05-2018] | «ARAXACINA Comp. recub. con película 250 mg ARAXACINA Comp. recub. con película 500 mg ARAXACINA Comp. recub. con película 750 mg BAYCIP Comp. recub. con película 500 mg CETRAXAL Comp. recub. con película 500 mg CETRAXAL Comp. recub. con película 750 mg CETRAXAL Susp. oral 100 mg/ml CIPROFLOXACINO ALTER EFG Comp. recub. con película 250 mg CIPROFLOXACINO ALTER EFG Comp. recub. con película 500 mg CIPROFLOXACINO ALTER EFG Comp. recub. con película 750 mg CIPROFLOXACINO ANAGES Sol. para perfusión 2 mg/ml CIPROFLOXACINO ARISTO Comp. recub. con película 250 mg CIPROFLOXACINO ARISTO Comp. recub. con película 750 mg CIPROFLOXACINO ARISTO EFG Comp. recub. con película 500 mg CIPROFLOXACINO AUROBINDO Comp. recub. con película 250 mg CIPROFLOXACINO AUROBINDO Comp. recub. con película 500 mg CIPROFLOXACINO AUROBINDO Comp. recub. con película 750 mg CIPROFLOXACINO BLUEPHARMA Comp. recub. con película 250 mg CIPROFLOXACINO BLUEPHARMA Comp. recub. con película 500 mg CIPROFLOXACINO CINFA EFG Comp. recub. 250 mg CIPROFLOXACINO CINFA EFG Comp. recub. 500 mg CIPROFLOXACINO CINFA EFG Comp. recub. 750 mg CIPROFLOXACINO COMBIX Comp. recub. con película 500 mg CIPROFLOXACINO FRESENIUS KABI EFG Sol. para perfusión 2 mg/ml CIPROFLOXACINO G.E.S. EFG Sol. para perfusión 2 mg/ml CIPROFLOXACINO KABI Sol. para perfusión 2 mg/ml CIPROFLOXACINO KERN PHARMA Sol. para infusión 2 mg/ml CIPROFLOXACINO KORHISPANA EFG Comp. recub. 250 mg CIPROFLOXACINO KORHISPANA EFG Comp. recub. 750 mg CIPROFLOXACINO MABO EFG Comp. recub. con película 500 mg CIPROFLOXACINO MABO EFG Comp. recub. con película 750 mg CIPROFLOXACINO NORMON Solución para perfusión 2 mg/ml CIPROFLOXACINO NORMON EFG Comp. recub. con película 250 mg CIPROFLOXACINO NORMON EFG Comp. recub. con película 500 mg CIPROFLOXACINO NORMON EFG Comp. recub. con película 750 mg CIPROFLOXACINO PENSA EFG Comp. recub. con película 250 mg CIPROFLOXACINO PENSA EFG Comp. recub. con película 500 mg CIPROFLOXACINO RANBAXY Comp. 500 mg CIPROFLOXACINO RATIO Comp. 250 mg CIPROFLOXACINO RATIO Comp. 500 mg CIPROFLOXACINO RATIO Comp. 750 mg CIPROFLOXACINO SANDOZ Comp. recub. con película 500 mg CIPROFLOXACINO STADA EFG Comp. recub. 500 mg CIPROFLOXACINO TARBIS Comp. 250 mg CIPROFLOXACINO TARBIS Comp. 500 mg CIPROFLOXACINO TARBIS Comp. 750 mg CIPROFLOXACINO TEVAGEN Comp. recub. con película 250 mg CIPROFLOXACINO TEVAGEN Comp. recub. con película 500 mg CIPROFLOXACINO TEVAGEN Comp. recub. con película 750 mg CIPROFLOXACINO VIR EFG Comp. recub. 250 mg CIPROFLOXACINO VIR EFG Comp. recub. 500 mg DORIMAN Comp. recub. 250 mg DORIMAN Comp. recub. 500 mg RIGORAN Comp. 500 mg» |
«No puede tomar ciprofloxacino en caso de hipersensibilidad a quinolonas. No administrar con tizanidina. Precauciones en los siguientes casos: I.R. ajustar dosis, miastenia gravis, pacientes con factores de riesgo conocidos de prolongación del intervalo QT (sínd. congénito de QT largo, uso concomitante de medicamentos que prolongan el intervalo QT: antiarrítmicos de clase IA y III, antidepresivos tricíclicos, macrólidos, antipsicóticos, desequilibrio electrolítico no corregido: hipocalemia, hipomagnesemia, edad avanzada , alteraciones cardíacas: fallo cardiaco, infarto de miocardio, bradicardia, arritmia del tipo de Torsades de Pointes. Epilepsia, trastornos SNC que predispongan a convulsiones (bajo umbral convulsivo, antecedente de convulsiones, riego sanguíneo cerebral reducido, alteración orgánica cerebral o ACV). Evitar con historia familiar o déficit G6PDH por riesgo de hemólisis (valorar beneficio/riesgo y vigilar). Riesgo de resistencias en tto. prolongado. Vigilar hidratación y evitar exceso de alcalinidad de orina, descrita cristaluria. Suspender tto. en caso de: hipersensibilidad (posible reacción anafiláctica de alto riesgo); colitis pseudomembranosa; signos de hepatopatía (descritas necrosis hepática e I.H. de alto riesgo); signos de tendinopatía, mayor riesgo en ancianos o en tratados con corticoesteroides, y posible hasta varios meses tras suspensión del tto.; convulsiones; síntomas de neuropatía; ideas suicidas (vigilar reacciones psiquiátricas y suspender tto. ante ideación suicida). Asociar a antibacteriano adecuado en tto. de: infecciones graves, causadas por gram+, anaerobios o N. gonorrhoeae (informarse de prevalencia local de resistencia y confirmar sensibilidad, reevaluar si no hay mejoría en 3 días). En infecc. urinarias, considerar la prevalencia local de resistencia de E. coli (patógeno más común involucrado) a las fluoroquinolonas. No recomendado en infecciones estreptocócicas (eficacia insuficiente), datos limitados de eficacia en infección intraabdominal posquirúrgica. Carbunco por inhalación, consultar documentos de consenso nacionales y/o internacionales sobre su tto. Diarrea del viajero: consultar información de resistencia a ciprofloxacino de los patógenos pertinentes en los países visitados. En niños/adolescentes evaluar beneficio/riesgo por posibles efectos adversos en articulaciones y/o tejidos circundantes. Infección broncopulmonar en fibrosis quística en niños 1-5 años, experiencia limitada. Según recomendaciones oficiales su uso para tratar otras infecciones graves, puede justificarse tras valorar beneficio/riesgo, si no pueden usarse otros ttos. o si fracasa el convencional, siempre tras comprobación microbiológica; aconsejable precaución. Concomitancia con: teofilina, clozapina, ropinirol, tizanidina, agomelatina (vigilancia clínica por aumento de sus concentraciones, controlar la de teofilina y ajustar dosis); metotrexato (no recomendado). Evitar exposición solar. Consultar al oculista si se deteriora la visión. En caso de insuficiencia renal a justar dosis (no estudiada en niños con I.R.). Ads. Oral: Clcr 30-60 ml/min, 250-500 mg/12 h; Clcr < 30 y diálisis peritoneal, 250-500 mg/24 h; hemodializados, 250-500 mg/24 h tras diálisis. I.V.: Clcr 31-60 ml/min, máx. 800 mg/día; Clcr ≤ 30, máx. 400 mg/día; hemodializados, 400 mg/día los días de diálisis y tras ésta; DPAC, 50 mg/l dializado/6 h». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Clarithromycin | «Clarithromycin belongs to a group of medicine called macrolide antibiotics. Antibiotics stop the growth of bacteria (bugs) which cause infections». |
Accord Healthcare Limited (2018) Package leaflet – information for the user Clarithromycin 250mg Film-coated Tablets Clarithromycin 500mg Film-coated Tablets (Clarithromycin). Disponible en: https://www.medicines.org.uk/emc/files/pil.6094.pdf [Consultado: 25-05-2018] | «Clarithromycin tablets are used to treat following infections: Chest infections such as bronchitis and pneumonia, Throat and sinus infections, Skin and soft tissue infections, Helicobacter pylori infections associated with duodenal ulcers. Clarithromycin tablets are indicated in adults and children 12 years and older». |
«Patients with respiratory tract/skin and soft tissue infections Adults: The usual dose is 250 mg twice daily although this may be increased to 500mg twice daily in severe infections. The usual duration of treatment is 6 to 14 days. (Adult only formulation) Children older than 12 years: As for adults. Children younger than 12 years: Use of clarithromycin tablets are not recommended for children younger than 12 years. Clinical trials have been conducted using clarithromycin paediatric suspension in children 6 months to 12 years of age. Therefore, children under 12 years of age should use clarithromycin paediatric suspension (granules for oral suspension). Clarithromycin may be given without regard to meals as food does not affect the extent of bioavailability». |
«If you suffer from any of the following at any time during your treatment STOP TAKING your tablets and contact your doctor immediately: severe or prolonged diarrhoea, which may have blood or mucus in it. Diarrhoea may occur over two months after treatment with clarithromycin, in which case you should still contact your doctor. a rash, difficulty breathing, fainting or swelling of the face and throat. This is a sign that you may have developed an allergic reaction. severe skin reactions such as blistering of the skin, mouth, lips, eyes and genitals (symptoms of a rare allergic reaction called Stevens-Johnson syndrome/toxic epidermal necrolysis). yellowing of the skin (jaundice), skin irritation, pale stools, dark urine, tender abdomen or loss of appetite. These may be signs that your liver may not be working properly. Henoch-Schonlein purpura (a rash which appears as purple spots on the skin). Muscle pain or weakness known as rhabdomyolysis (a condition which causes the breakdown of muscle tissue which can result in kidney damage). Drug reaction with eosinophilia and systemic symptoms (DRESS). This can include symptoms such as rash, fever abnormal blood count and inflammation of internal organs. Common side effects (may affect up to 1 in 10 people) include; headache difficulty sleeping changes in sense of taste widening of blood vessels stomach problems such as feeling sick, vomiting, stomach pain, indigestion, diarrhoea a change in the way the liver works skin rash increased sweating». |
Accord Healthcare Limited (2018) Package leaflet – information for the user Clarithromycin 250mg Film-coated Tablets Clarithromycin 500mg Film-coated Tablets (Clarithromycin). Disponible en: https://www.medicines.org.uk/emc/files/pil.6094.pdf [Consultado: 25-05-2018] | «Clarithromycin 250 mg film-coated tablets; Clarithromycin 500 mg film-coated tablets; Clarithromycin 125 mg/5ml suspension; Clarithromycin 250 mg/5ml suspension; Clarithromycin 250mg Tablets; Clarithromycin 500 mg Film-coated Tablets; Clarithromycin 500 mg powder for concentrate for solution for infusion; Clarithromycin 500mg Film-coated Tablets; Clarithromycin 500mg powder for solution for infusion vials; Klaricid Adult Sachet 250 mg; Klaricid IV 500mg; Klaricid IV 500mg (SmPC); Klaricid Paediatric Suspension 125mg/5ml; Klaricid Paediatric Suspension 250mg/5ml; Klaricid XL 500mg tablets; Mycifor XL 500mg Prolonged Release Tablets» | Precautions: «Take special care with Clarithromycin tablets If you have abnormally low levels of magnesium in your blood (hypomagnesaemia) consult your doctor before taking these tablets. Talk to your doctor or pharmacist before taking Clarithromycin tablets; If you have heart problems (e.g. heart disease, heart failure, an unusually slow heart rate, or low levels of magnesium in the blood) you are pregnant or breast-feeding if you have, or are prone to, fungal infections (e.g. thrush) if you have any liver or kidney problems». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Claritromicina | «Macrólido. Interfiere la síntesis de proteínas en las bacterias sensibles ligándose a la subunidad 50S ribosomal. | Vademecum (2018) Claritromicina. Disponible en: https://www.vademecum.es/principios-activos-claritromicina-J01FA09 [Consultado: 28-05-2018] | «Oral, en formas de liberación normal y de liberación modificada: ads. y niños ≥12 años: faringitis, amigdalitis, sinusitis (diagnosticada), bronquitis aguda, exacerbación aguda de bronquitis crónica, neumonía bacteriana (adquirida en la comunidad), infección de piel y tejidos blandos leve-moderada, foliculitis, celulitis, erisipela. - Oral, en formas de liberación normal: ads. y niños ≥12 años: infección localizada o diseminada por M. avium o M. intracellulare, infección localizada por M. chelonae, M. fortuitum y M. kansaii. Úlcera gástrica o duodenal asociada a H. pylori (junto con antiulceroso adecuado). Prevención de infección diseminada por M. avium complex en pacientes con VIH de alto riesgo (linfocitos CD4 ≤ 50/mm 3 ). Niños > 12 meses a 11 años: faringitis estreptocócica, bronquitis y neumonía bacteriana, otitis media aguda, impétigo, foliculitis, celulitis, abscesos. - IV: ads.: tto. parenteral de faringitis o amigdalitis estreptocócica si no es posible tto. de 1ª línea con betalactámicos o hay sensibilidad demostrada a S. pyogenes; sinusitis bacteriana aguda diagnosticada; exacerbación aguda de bronquitis crónica; infec. de piel y partes blandas, leves-moderadas si los betalactámicos no son apropiados». |
«IV. Ads.: 1 g/día dividido en 2 dosis iguales, perfus. IV de 60 min, 2-5 días (puede extenderse según gravedad). - Oral. Ads. y niños ≥12 años: 250 mg/12 h; infección severa: 500 mg/12 h, 6-14 días. Niños 1-12 años: 7,5 mg/kg/12 h, 5-10 días; máx. 500 mg/12 h. Infección por M. avium complex (asociado a otros antimicobacterianos), ads. y adolescentes de 12-18 años: 500 mg/12 h; niños: 7,5 mg/kg/12 h hasta beneficio clínico; profilaxis: 500 mg/12 h. Úlcera péptica asociada a H. pylori, terapia triple: 500 mg/12 h + 1 g amoxicilina/12 h + 20 mg omeprazol/24 h, 10 días o 500 mg + 1 g amoxicilina + 20 mg omeprazol/12 h, 7 días; terapia doble: 500 mg/8 h + 40 mg omeprazol/24 h, 2 sem (en pacientes con mala respuesta terapéutica, prolongar el tto. con 40 mg de omeprazol hasta 4 sem). I.R., Clcr < 30 ml/min: ½ dosis. Comp. de liberación modificada. Ads. y niños ≥ 12 años: 500 mg/24 h, con alimento, máx. 1 g/día, 6-14 días». |
«Cefalea, perversión del sabor, disgeusia; insomnio; pérdida de audición (reversible con la interrupción del tto.), tinnitus; dispepsia, náuseas, dolor abdominal; cambios en PFH erupciones leves de la piel, hiperhidrolisis. Vía IV, además: vasodilatación, flebitis, dolor e inflamación en el lugar de iny. Además: arritmia, infarto de miocardio y mortalidad cardiovascular». | Vademecum (2018) Claritromicina. Disponible en: https://www.vademecum.es/principios-activos-claritromicina-J01FA09 [Consultado: 28-05-2018] | «CLARITROMICINA UNIDIA RATIOPHARM Comp. de liberación prolongada 500 mg CLARITROMICINA ALMUS Comp. recub. con película 500 mg CLARITROMICINA ALTER Comp. recub. 250 mg CLARITROMICINA ALTER EFG Comp. recub. 500 mg CLARITROMICINA AMNEAL Comp. recub. con película 500 mg CLARITROMICINA ARAFARMA GROUP EFG Comp. recub. 250 mg CLARITROMICINA ARAFARMA GROUP EFG Comp. recub. 500 mg CLARITROMICINA ARISTO Comp. recub. 250 mg CLARITROMICINA ARISTO Comp. recub. 500 mg CLARITROMICINA AUROBINDO Comp. recub. con película 250 mg CLARITROMICINA AUROBINDO Comp. recub. con película 500 mg CLARITROMICINA BLUEPHARMA Comp. recub. con película 250 mg CLARITROMICINA BLUEPHARMA Comp. recub. con película 500 mg CLARITROMICINA CINFA Comp. recub. con película 250 mg CLARITROMICINA CINFA EFG Comp. 500 mg CLARITROMICINA DERMOGEN Comp. recub. 250 mg CLARITROMICINA DERMOGEN Comp. recub. 500 mg CLARITROMICINA FARMALIDER Comp. recub. 250 mg CLARITROMICINA FARMALIDER Comp. recub. 500 mg CLARITROMICINA G.E.S. Liofilizado para solución para perfusión 500 mg CLARITROMICINA KERN PHARMA Comp. recub. 250 mg CLARITROMICINA KERN PHARMA EFG Comp. recub. 500 mg CLARITROMICINA KRKA Comp. recub. con película 250 mg CLARITROMICINA KRKA Comp. recub. con película 500 mg CLARITROMICINA MYLAN Comp. recub. 250 mg CLARITROMICINA MYLAN EFG Comp. recub. 500 mg CLARITROMICINA NORMON EFG Comp. recub. 250 mg CLARITROMICINA NORMON EFG Comp. recub. 500 mg CLARITROMICINA PHARMAGENUS EFG Comp. recub. 500 mg CLARITROMICINA RAMBAXY Comp. recub. con película 500 mg CLARITROMICINA RATIO Comp. recub. con película 250 mg CLARITROMICINA RATIO Comp. recub. con película 500 mg CLARITROMICINA SANDOZ Comp. recub. con película 250 mg CLARITROMICINA SANDOZ Comp. recub. con película 500 mg CLARITROMICINA SANDOZ Granulado 125 mg/5 ml CLARITROMICINA SANDOZ Granulado 50 mg/ml CLARITROMICINA TARBIS EFG Comp. recub. 500 mg CLARITROMICINA TECNIGEN Comp. recub. con película 250 mg CLARITROMICINA TECNIGEN Comp. recub. con película 500 mg CLARITROMICINA TEVAGEN Comp. recub. con película 250 mg CLARITROMICINA TEVAGEN Comp. recub. con película 500 mg CLARITROMICINA UNIDIA KERN PHARMA Comp. de liberación modificada 500 mg CLARITROMICINA UNIDIA TECNIGEN Comp. de liberación modificada 500 mg CLARITROMICINA UNIDIA TEVA Comp. de liberación prolongada 500 mg CLARITROMICINA VIR Comp. recub. 250 mg CLARITROMICINA VIR Comp. recub. 500 mg KLACID Comp. recub. 500 mg KLACID Granulado para sol. oral monodosis 500 mg KLACID IV Liofilizado para sol. para perfusión 500 mg/vial KLACID UNIDIA Comp. liberación modificada 500 mg» |
«No puede tomar claritromicina en los siguientes casos: hipersensibilidad a macrólidos; concomitancia con: astemizol, cisaprida, pimozida, terfenadina, disopiramida y quinidina por aumentar el riesgo de prolongación de intervalo QT y arritmias cardíacas graves (ECG y monitorizar nivel sérico), ticagrelor o ranolazina, colchicina, ergotamina y dihidroergotamina por toxicidad aguda del cornezuelo del centeno y con inhibidores de la HMG-CoA reductasa (estatinas), que se metabolizan de forma extensa por CYP3A4 (lovastatina o simvastatina), debido al riesgo de rabdomiólisis; hipopotasemia; I.H. grave combinada con I.R.; prolongación congénita o adquirida del intervalo QT; comp. de liberación modificada contraindicadas con Clcr < 30 ml/min. Evaluar riesgo/beneficio en embarazo; ancianos; I.R. moderada-grave; I.H.; interrumpir el tto. si aparecen signos o síntomas de enf. hepática (anorexia, ictericia, orina oscura, prurito o sensibilidad abdominal); riesgo de: colitis pseudomembranosa por C. difficile, de exacerbación de miastenia gravis, de sobreinfección por organismos no sensibles en tto. prolongado, de uveítis (monitorizar); precaución en tto. concomitante con: triazolobenzodiacepinas (triazolam y midazolam), medicamentos ototóxicos como aminoglucósidos (monitorizar la función vestibular y auditiva durante y después del tto.), medicamentos que prolongan el intervalo QT, insulina y/o agentes hipoglucemiantes (riesgo de hipoglucemia, control de glucosa), anticoagulantes orales (riesgo de hemorragia grave y niveles de INR y protrombina elevados, monitorizar), inductores del citocromo CYP3A4; precaución en arteriopatía coronaria, insuf. cardiaca grave, alteraciones de la conducción auricoloventricular o bradicardia clínicamente relevante, hipomagnesemia; realizar prueba de sensibilidad en: neumonía adquirida en la comunidad; interrumpir el tto. en caso de reacciones de hipersensibilidad (anafilaxia, síndrome de Steve-Johnson, necrólisis epidérmica tóxica); realizar control periódico de: capacidad auditiva en tto. de infección por M. avium, recuento de leucocitos y plaquetas; posible resistencia cruzada con otros macrólidos, lincomicina y clindamicina; riesgo de rabdomiolosis incrementado en tto. concomitante con HMG-CoA reductasa». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Clindamycin | «Clindamycin belongs to a group of medicines called antibiotics. Antibiotics are used to treat infections». |
Accord-UK Ltd (2016) Package leaflet: information for the user Clindamycin 300 mg capsules, hard clindamycin. Disponible en: https://www.medicines.org.uk/emc/files/pil.2485.pdf [Consultado: 25-05-2018] | «Clindamycin capsules are used to kill certain serious bacterial infections». |
«Adults The usual dose is 150-450 mg every six hours, depending on the severity of the infection. Elderly patients Dosage requirements in elderly patients should not be influenced by age alone Pediatric population The usual dose is 3-6 mg/kg every six hours depending on the severity of the infection (not to exceed the adult dose). Clindamycin capsules are not suitable for children who are unable to swallow them whole. The capsules do not provide exact mg/kg doses therefore it may be necessary to use an alternative formulation in some cases. Renal impairment No dose adjustment is necessary in patients with mild to moderate impairment of renal function. In patients with severe renal impairment or anuria, plasma concentration should be monitored. Depending on the results, this measure can make a reduction in dosage or an increase in the dose interval of 8 or even 12 hours necessary. Hepatic impairment In patients with moderate to severe hepatic impairment, elimination half-life of clindamycin is prolonged. A reduction in dosage is generally not necessary if clindamycin is administered every 8 hours. However, the plasma concentration of clindamycin should be monitored in patients with severe hepatic impairment. Depending on the results, this measure can make a reduction in dosage or an increase in the dose intervals necessary». |
«Tell your doctor immediately if you have any of the following side effects: severe, persistent or bloody diarrhoea (which may be associated with stomach pain or fever). This is an uncommon side effect which may occur after treatment with antibiotics and can be a sign of serious bowel inflammation. signs of a severe allergic reaction such as sudden wheeziness, difficulty in breathing, swelling of eyelids, face or lips, rash or itching (especially affecting the whole body). blistering and peeling of large areas of skin, fever, cough, feeling unwell and swelling of the gums, tongue or lips. yellowing of the skin and whites of the eyes (jaundice). Other possible side effects may include effects on your: Nervous system: impaired sense of taste Skin: reddening of the skin, skin rash, itching (hives) Stomach and intestines: throat ulcers, sore throat, feeling sick, being sick, stomach pain and diarrhoea Blood system: reduced numbers of blood cells (shown on blood tests) which may cause bruising or bleeding or weaken the immune system Liver function: shown by blood tests Genital area: inflammation of the vagina». |
Accord-UK Ltd (2016) Package leaflet: information for the user Clindamycin 300 mg capsules, hard clindamycin. Disponible en: https://www.medicines.org.uk/emc/files/pil.2485.pdf [Consultado: 25-05-2018] | «Clindamycin 150 mg Capsules; Clindamycin 150mg Hard Capsules; Clindamycin 150mg/ml Solution for Injection or Infusion; Clindamycin 300 mg Capsules; Clindamycin 300mg Hard Capsules; Clindamycin 300mg/2ml solution for injection ampoules (150mg/ml in 2ml ampoules); Clindamycin 600mg/4ml solution for injection ampoules (150mg/ml in 4 ml ampoules); Dalacin C Capsules 150 mg; Dalacin C Capsules 75mg; Dalacin C Phosphate Sterile Solution; Dalacin Cream 2%; Dalacin T Topical Lotion or Clindamycin Phosphate Topical Lotion; Dalacin T Topical Solution; Duac Once Daily 10 mg/g + 30 mg/g Gel; Duac Once Daily 10mg/g + 50mg/g Gel; Treclin 30g». | Precautions: «If you have been told you are allergic (hypersensitive) to clindamycin (the active ingredient in Clindamycin capsules), lincomycin (another antibiotic) or to any of the ingredients of Clindamycin capsules. Talk to your doctor or pharmacist before taking Clindamycin capsules – If you have diarrhoea or usually get diarrhoea when you take antibiotics or have ever suffered from problems with your stomach or intestines. If you develop severe or prolonged or bloody diarrhoea during or after using Clindamycin capsules tell your doctor immediately since it may be necessary to interrupt the treatment. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics. – If you suffer from problems with your kidneys or liver. – If you suffer from asthma, eczema or hayfever. 2 – If you have been told by your doctor that you have an intolerance to some sugars». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Clindamicina | «Antibiótico bactericida. Inhibe la síntesis proteica bacteriana a nivel de la subunidad 50S ribosomal y evita formación de uniones peptídicas. | Vademecum (2018) Clindamicina. Disponible en: https://www.vademecum.es/principios-activos-clindamicina-J01FF01 [Consultado: 28-05-2018] | «Tto. de las siguientes infecciones graves causadas por microorganismos sensibles: en ads.: neumonía adquirida en la comunidad causada por Staphylococcus aureus, neumonía por aspiración, empiema (adquirido en la comunidad), absceso pulmonar, faringoamigdalitis aguda causada por estreptococo del gupo A (S. pyogenes), infecciones odontógenas, infecciones de la piel y tejidos blandos (complicadas y no complicadas), osteomielitis, neumonía causada por Pneumocystis jiroveci (Pneumocystis carinii) en pacientes con infección por VIH, encefalitis toxoplásmica en pacientes con infección por VIH. En niños > 1 mes y < 18 años: sinusitis aguda». | «1 ) Oral. Ads.: 600-1.800 mg/día en 2, 3 o 4 dosis iguales en función de la gravedad, lugar de infección y sensibilidad del microorganismo. Duración: 7 a 14 días. - Infecciones por estreptococo ß-hemolítico y faringoamigdalitis aguda causada por S. pyogenes: 300 mg 2 veces/día, 10 días. - Enf. inflamatoria pélvica en hospitalizados: inicial, 900 mg/8 h IV, 4 días; a las 48 h de mejoría del paciente: 450-600 mg/6 h oral. Duración total: 10-14 días. - Neumonía causada por Pneumocystis jiroveci (Pneumocystis carinii) en pacientes con VIH: 300-450 mg/6 h oral + 15-30 mg/día de primaquina, 21 días. - Encefalitis toxoplásmica con SIDA: inicial, 600-1.200 mg/6 h oral o IV, 2 sem; seguido de 300-600 mg/6 h oral, 8-10 sem + 25-75 mg/día de pirimetamina, 8-10 sem + 10-20 mg/día de ác. folínico. Niños > 1 mes: 8-25 mg/kg/día en 3-4 dosis iguales. 2 ) IM/IV. Ads. y adolescentes > 12 años: - Infección moderadamente grave: 1,8-2,7 g/día, fraccionado en 3-4 dosis iguales. - Infección grave: 2,4-2,7 g/día, fraccionado en 2-4 dosis iguales. - Infección muy grave, con riesgo vital: se han administrado hasta 4,8 g/día IV. Máx. recomendado: 2,7 g/día. Lactantes y niños (> 1 mes y ≤ 12 años). Infecciones graves: 15-25 mg/kg/día en 3-4 dosis iguales; infecciones más graves: 25-40 mg/kg/día en 3-4 dosis iguales (administrar mín. 300 mg/día)». |
«Colitis pseudomembranosa, diarrea, dolor abdominal, alteraciones en PFH; vía IM: irritación local, dolor, induraciones, abscesos estériles; vía IV: dolor, tromboflebitis». | Vademecum (2018) Clindamicina. Disponible en: https://www.vademecum.es/principios-activos-clindamicina-J01FF01 [Consultado: 28-05-2018] | «CLINDAMICINA KABI Sol. iny. 150 mg/ml CLINDAMICINA ACCORD Sol. iny. 150 mg/ml CLINDAMICINA NORMON EFG Sol. iny. 300 mg/2 ml CLINDAMICINA NORMON EFG Sol. iny. 600 mg/4 ml CLINDAMICINA QUALIGEN Cáps. dura 150 mg CLINDAMICINA QUALIGEN Cáps. dura 300 mg DALACIN Cáps. 150 mg DALACIN Cáps. 300 mg» |
«Debe tener especial precacuión en las siguientes causas: insuficiencia hepática, insuficiencia renal; Precauciones: I.H.; I.R.; riesgo de: reacciones de hipersensibilidad graves como reacción a fármaco con eosinofilia y síntomas sistémicos (DRESS), síndrome de Stevens-Johnson (SJS), necrolisis epidérmica tóxica (NET) y pustulosis exantémica generalizada aguda (AGEP) (suspender el tto. si aparecen); riesgo de sobrecrecimiento de Clostridium difficile (puede causar diarrea o colititis asociada a antibióticos (suspender el tto. si aparece) y de microorganismos no sensibles, incluyendo hongos; contraindicados medicamentos que inhiben el peristaltismo; precaución en: enf. intestinal inflamatoria (p. ej. enf. de Crohn o colitis ulcerosa) y en tto. concomitante con bloqueantes neuromusculares; monitorizar función renal, hepática y recuentos sanguíneos; no usar en el tto. de meningitis. IV: evitar iny. rápida (puede causar efectos graves sobre el corazón)». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Chloramphenicol | «Chloramphenicol belongs to a group caused by bacteria». |
Martindale Pharma (2001) Package leaflet: information for the user Chloramphenicol Ear Drops 10% w/v BP Chloramphenicol. Disponible en: https://www.medicines.org.uk/emc/files/pil.3530.pdf [Consultado: 25-05-2018] | «It is used for the treatment of a variety of infections caused by bacteria normally in eyes or ears». | «Three to four drops should be applied into the affected ear up to two to three times daily for up to one week. Do not use Chloramphenicol Ear Drops for more than a one week period unless your doctor has told you otherwise. Always use Chloramphenicol Ear Drops exactly as your doctor has told you. You should check with your doctor or pharmacist if you are not sure. Chloramphenicol Ear Drops are for external use only. If you suspect someone has swallowed any Chloramphenicol Ear Drops, contact your doctor or go to the accident and emergency department of your local hospital at once. Always take the container with you, if possible, even if empty». |
«Possible side effects include: • mild stinging • irritation • burning • itching • inflammation of the skin (dermatitis). Rare side effects include: • bone marrow depression (a condition where the marrow is unable to produce blood cells) • a reduced production and death of red blood cells (anaemia) • in very young children, grey baby syndrome». |
Martindale Pharma (2001) Package leaflet: information for the user Chloramphenicol Ear Drops 10% w/v BP Chloramphenicol. Disponible en: https://www.medicines.org.uk/emc/files/pil.3530.pdf [Consultado: 25-05-2018] | «Boots Infected Eyes 1%w/w Eye Ointment; Boots Pharmacy Antibiotic Eye Drops; Brolene Antibiotic 0.5% w/v Eye Drops; Chloramphenicol 0.5% Eye Drops; Chloramphenicol 0.5% Eye Drops - FARMIGEA; Chloramphenicol 1% w/w Eye Ointment; Chloramphenicol 1% w/w Eye Ointment; Chloramphenicol Ear Drops BP 10% w/v;Chloramphenicol Ear Drops BP 5% w/v; Clorogen Eye Drops 0.5% w/v; Eykappo (Chloramphenicol) 5mg/ml Eye Drops; Minims Chloramphenicol 0.5%, Eye drops solution; Optrex Bacterial Conjunctivitis 1% w/w Eye ointment; Optrex Infected Eye Drops; Tubilux Infected Eyes Eye Drops Golden Eye Antibiotic 0.5% w/v Chloramphenicol Eye Drops; Vistaphenicol Eye Drops». |
Precautions: «Do not use Chloramphenicol Ear Drops if: • you are allergic (hypersensitive) to Chloramphenicol, Propylene Glycol or to any of the other ingredients in this medicine (see section 6) • you have a hole in your ear drum. Take special care with Chloramphenicol Ear Drops Tell your doctor if : • you are pregnant, trying for a baby or are breast-feeding». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Cloranfenicol | «Antibiótico bacteriostático de amplio espectro, interfiere en la síntesis proteica bacteriana. | Vademecum (2015) Cloranfenicol. Disponible en: https://www.vademecum.es/principios-activos-cloranfenicol-J01BA01 [Consultado: 28-05-2018] | «Infección aguda por Salmonella typhi (no indicado para tto. de portadores). Infección grave por cepas de salmonellas, H. influenzae (específicamente en meníngeas), bacterias gram- causantes de meningitis o bacteriemia, Rickettsias del grupo linfogranuloma, psitacosis y otros microorganismos sensibles, resistentes a todos los demás antimicrobianos». | «Oral. Ads., dosis media: 500 mg/6-8 h; conseguida apirexia, continuar tto. de mantenimiento. Niños: 25-50 mg/kg/día, en 4 tomas. Fiebre tifoidea y brucelosis: puede acompañarse de vacunas específicas. Dosis máx. ads.: 2 g/día. Duración máx.: 10 días». | «Leucopenia, agranulocitosis, anemia, reacción neurológica, de intolerancia o hiperergínica». | Vademecum (2015) Cloranfenicol. Disponible en: https://www.vademecum.es/principios-activos-cloranfenicol-J01BA01 [Consultado: 28-05-2018] | «CHEMICETINA Jarabe 125 mg/5 ml» | «No puede tomar cloranfenicol en los siguientes casos: antecedente de sensibilidad, porfiria, I.R., embarazo (1 er trimestre). En recién nacidos y prematuros no administrar más de 25-15 mg/kg/día, respectivamente. En caso de insuficiencia hepática reajustar la dosis. Totalmente contraidicado en caso de insuficiencia renal». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Cloxacillin | «It belongs to a group of antibiotics called ‘penicillins’». |
Beecham Group plc (2014) Package Leaflet: Information for the User Ampiclox Injection 250mg ampicillin & 250mg cloxacillin. Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1506055590107.pdf [Consultado: 25-05-2018] | «It is indicated for the treatment of infections in which susceptible organisms have been detected or are suspected: Surgery: post-operative wound infections, post-operative pulmonary infections - Respiratory infections: bronchopneumonia, acute exacerbations of chronic bronchitis - Obstetrics: puerperal fever - Bacteraemia». |
«Injection or an infusion into a vein (intravenously) or muscle (intramuscularly): Adults, elderly patients and children over 10 years of age One to two vials every four to six hours Children 2 – 10 years Half adult dose. Dosage may be further increased where necessary. Children up to 2 years Quarter adult dose. Kidney and liver problems If you have kidney or liver problems the dose might be lower than the usual dose./Oral: – Child over 10 years: 50 mg/kg/day in 3 divided doses for 7 days (max. 3 g/day) – Adult: 3 g/day in 3 divided doses for 7 days». |
«Common (may affect up to 1 in 10 people) skin rash feeling sick (nausea) diarrhoea. Uncommon (may affect up to 1 in 100 people) being sick (vomiting). Very rare (may affect up to 1 in 10,000 people) kidney problems fits (convulsions), seen in patients on high doses or with kidney problems sudden, involuntary jerking or a muscle or group of muscles hyperactivity an excessive breakdown of red blood cells causing a form of anaemia. Signs include: tiredness, headaches, shortness of breath, dizziness, looking pale and yellowing of the skin and the whites of the eyes». |
Beecham Group plc (2014) Package Leaflet: Information for the User Ampiclox Injection 250mg ampicillin & 250mg cloxacillin. Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1506055590107.pdf [Consultado: 25-05-2018] Médecins Sans Frontières (Ed. 2º edición) (2017) Essential drugs practical guide intended for physicians, pharmacists, nurses and medical auxiliars. Disponible en: https://medicalguidelines.msf.org/viewport/EssDr/english/cloxacillin-oral-16683395.html [Consultado: 25-05-2018] | «Ampiclox Injection 500mg; Cloxacillin Oral 250/500mg». | Precautions: «do not take cloxacillin if: you are allergic (hypersensitive) to amoxicillin, cloxacillin or penicillin have ever had an allergic (hypersensitive) reaction to any antibiotic. This can include a skin rash or swelling of the face or neck. Check with your doctor, pharmacist or nurse before having this medicine if you: have ever had any reactions to antibiotics, including a skin rash or swelling of the face or neck when taking any antibiotic are being treated for kidney or liver problems have glandular fever and/or leukaemia as you may develop a rash if you have these conditions and take ampicillin are on a diet that restricts the amount of sodium you can eat. If this medicine is being given to your baby, tell your doctor: if you (mother) are allergic to penicillin if your baby has jaundice (yellowing of the skin and/or eyes). |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Cloxacilina | «Bactericida. Inhibe transpeptidasas y carboxipeptidasas impidiendo la síntesis de la pared celular bacteriana. Resistente a penicilinasa estafilocócica». | Vademecum (2016) Cloxacilina. Disponible en: https://www.vademecum.es/principios-activos-cloxacilina-J01CF02 [Consultado: 20-05-2018] | «Infección sistémica o localizada por estafilococos penicilín-resistentes: septicemia, sinusitis, otitis, forunculosis, heridas y quemaduras infectadas, celulitis, piomiositis, mastitis, artritis séptica, osteomielitis, osteítis, empiema pleural, absceso pulmonar, sepsis, endocarditis, meningitis». | «IM/IV. Ads.: 0,5-1 g/6-8 h. Niños > 2 años: 12,5-25 mg/kg/6-8 h. Niños < 2 años: 6,25-12,5 mg/kg/6 h. En I.R. e I.H. puede ser necesario ajustar dosis. - Oral. Ads.: 0,5-1 g/4-6 h. Niños de 2-10 años: ½ dosis ads. Niños < 2 años: ¼ dosis ads. Aumentar si la gravedad lo requiere». |
«Prurito, rash cutáneo, urticaria, nefritis intersticial, diarrea, náuseas, vómitos. Vía IV a dosis elevadas: convulsiones, toxicidad en SNC (especialmente en pacientes con fallo renal), flebitis, candidiasis oral». | Vademecum (2016) Cloxacilina. Disponible en: https://www.vademecum.es/principios-activos-cloxacilina-J01CF02 [Consultado: 20-05-2018] | «ANACLOSIL Cáps. 500 mg ANACLOSIL Polvo para sol. iny. y para perfus. 1 g/vial ANACLOSIL Polvo para sol. iny. y para perfus. 500 mg/vial CLOXACILINA NORMON EFG Polvo para sol. iny. 1 g/vial CLOXACILINA NORMON EFG Polvo y disolv. para sol. iny. 500 mg/vial ORBENIN Cáps. 500 mg ORBENIN Suspensión oral 125 mg/5 ml» |
«No puede tomar cloxacilina si tiene hipersensibilidad a ß-lactámicos. Precauciones: Neonatos con ictericia. Antecedente de hipersensibilidad a penicilinas o cefalosporinas. Se ha observado reacción de hipersensibilidad grave. Riesgo de neurotoxicidad, especialmente a dosis elevada con deterioro de la función renal. Alteración de la flora intestinal, con sobrecrecimiento de C. difficile y colitis pseudomembranosa. En caso de insuficiencia hepática puede requerir ajuste de dosis. En caso de insuficiencia renal puede requerir ajuste de dosis». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Colistin/Colistimethate sodium | «Colistimethate sodium is an antibiotic. It belongs to a group of antibiotics that are called polymyxins». | Teva UK Limited (2016) Packaged leaftlet: information for the user Colomycin injection 1 million or 2 million International Unts Powder for solution for injection for infusion or inhalation. Disponible en: https://www.medicines.org.uk/emc/files/pil.1094.pdf [Consultado: 25-05-2018] | «Colistimethate is given by injection to treat some types of serious infections caused by certain bacteria. Colistimethate is used when other antibiotics are not suitable». |
«Colistimethate Sodium is administered intravenously as a slow infusion over 30 – 60 minutes. Dilution/flush solution: For bolus injection: Reconstitute the contents of the vial with not more than 10ml water for injection or 0.9% sodium chloride. For infusion: The contents of the reconstituted vial may be diluted, usually with 50ml 0.9% sodium chloride. During reconstitution swirl gently to avoid frothing. Reconstituted Colistimethate Sodium is a clear solution. Dosage (adjustment required in renal impairment): Adults and adolescents Maintenance dose 9MIU/day in 2-3 divided doses In patients who are critically ill, a loading dose of 9 MIU should be administered. The most appropriate time interval to the first maintenance dose has not been established. Loading and maintenance doses of up to 12 MIU may be required in patients with good renal function in some cases. The loading dose applies to patients with normal and impaired renal functions including those on renal replacement therapy. Renal impairment Dose adjustments in renal impairment are necessary. The following dose adjustments are suggested as guidance. Dose reductions are recommended for patients with creatinine clearance < 50 ml/min: Twice daily dosing is recommended. Paediatric population The data supporting the dose regimen in paediatric patients are very limited. Renal maturity should be taken into consideration when selecting the dose. The dose should be based on lean body weight. Children ≤ 40kg 75,000-150,000 IU/kg/day divided into 3 doses. For children with a body weight above 40 kg, use of the dosing recommendation for adults should be considered. The use of doses >150,000 IU/kg/day has been reported in children with cystic fibrosis». |
«Tell the doctor or nurse immediately if you notice any of the following symptoms: Wheezing or breathing difficulties which can lead to collapse, a rash, itching or hives on the skin, or sudden swelling of the face, throat or lips. These can be signs of a severe allergic reaction. The following side effects have also been reported: Reactions, such as irritation, at the injection site. Kidney problems. These are more likely in patients who already have poor kidneys, or who are given Colistimethate at the same time as other medicines that can affect the kidneys, or who are given a dose that is too high. These problems will normally get better if treatment is stopped, or the dose of Colistimethate is reduced. Neurological problems such as inability to breathe because of paralysis of the chest muscles, numbness or tingling (especially around the face), dizziness or loss of balance, rapid changes in blood pressure or blood flow (including faintness and flushing), slurred speech, problems with vision, confusion and mental problems (including loss of sense of reality). Side effects that affect the nervous system are more likely to occur when the dose of Colistimethate is too high, in people who have poor kidneys or in those who are also receiving muscle relaxants or other medicines with a similar effect on how the nerves work». |
Beacon Pharmaceuticals (2018) Patient information leaflet colistimethate sodium 1 million I.U. powder for solution for injection. Disponible en: https://www.medicines.org.uk/emc/files/pil.5648.pdf [Consultado: 25-05-2018] | «ColiFin 1 MIU Powder for Nebuliser Solution; Colistimethate Sodium 1 Million I.U. Powder for Solution for Injection; Colobreathe; Colomycin Injection; Promixin 1 million International Units (IU) Powder for Nebuliser Solution; Promixin, 1 million International Units (IU), Powder for Solution for Infusion». | Precautions: «Colistimethate is not suitable for everyone. Some people must not have this injection. Do not have the injection: If you are allergic (hypersensitive) to colistimethate, colistin or to other polymyxins. If you are unsure about anything, ask your doctor before you have the injection- Talk to your doctor, pharmacist or nurse before using Colistimethate - If you have or have had kidney problems. - If you suffer from myasthenia gravis - If you suffer from porphyria In premature and new-born babies, special care should be taken when using Colistimethate as the kidneys are not yet fully developed». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Colistina | «Polipéptido activo frente a diversas bacterias aeróbicas Gram- Agente tensioactivo que altera la permeabilidad de la membrana celular bacteriana produciendo muerte celular. El colistimetato de sodio es un profármaco de la colistina». | Vademecum (2017) Colistina. Disponible en: https://www.vademecum.es/principios-activos-colistina-J01XB01 [Consultado: 29-05-2018] | «IV, intratecal, intraventricular: en ads. y niños, incluidos los neonatos, para el tto. de infecciones graves causadas por determinados patógenos aerobios Gram - en pacientes con opciones de tto. limitadas». Inhalatoria: en ads. y pacientes pediátricos para el tto. de infecciones pulmonares crónicas causadas P. aeruginosa, en pacientes con fibrosis quística |
«Colistimetato de sodio (80 mg = 1 MUI). - perfus. IV lenta (30-60 min). Ads. y adolescentes: 9 MUI/día en 2-3 dosis; pacientes en estado crítico: dosis de carga de 9 MUI. I.R.: Clcr < 50-30 ml/min: 5,5-7,5 MUI/día; Clcr < 30-10 ml/min: 4,5-5,5 MUI/día; Clcr < 10 ml/min: 3,5 MUI/día; hemodiálisis: se recomienda administrar 2 veces/día, en días sin hemodiálisis: 2,25 MUI/día; en días con hemodiálisis: 3 MUI/día administrado después de cada sesión; hemo(dia)filtración continua: 9 MUI/día en 3 tomas. Niños ≤ 40 kg: 75.000-150.000 UI/kg/día en 3 dosis. - intratecal, intraventricular. Ads.: 125.000 UI/día. - inhalatoria. Ajustar en función de la gravedad y de la respuesta clínica, dosis recomendadas: ads., adolescentes y niños ≥ 2 años: 1-2 MUI 2-3 veces/día (máx. 6 MUI/día); niños < 2 años: 0,5-1 MUI 2 veces/día (máx. 2 MUI/día). Según el tipo de nebulizador utilizado, ajustar tiempo y velocidad de administración». |
«Mareos, parestesias faciales transitoria, lenguaje farfullante, inestabilidad vasomotora, alteraciones visuales, confusión, psicosis, apnea, neuro y nefrotoxicidad, erupción cutánea. Vía inhalatoria además: tos, broncoespasmo, opresión en el pecho». | Vademecum (2017) Colistina. Disponible en: https://www.vademecum.es/principios-activos-colistina-J01XB01 [Consultado: 29-05-2018] | «COLFINAIR Polvo para sol. inhalación nebul 1 millón UI COLFINAIR Polvo para sol. inhalación nebul 2 millones UI COLISTIMETATO DE SODIO ACCORD Polvo para sol. iny. y para perfusión 1 millón de COLISTIMETATO DE SODIO ACCORD Polvo para sol. iny. y para perfusión 2 millones d COLISTIMETATO DE SODIO G.E.S. Polvo para sol. iny. 2000000 UI COLISTIMETATO DE SODIO GES Polvo para sol. iny./nebulización inhalador 1 MI COLISTIMETATO DE SODIO XELLIA Polvo para sol. iny. y para perfusión 1000000 UI COLIXIN 1 MUI Polvo sol. iny. o sol. inhalac. por nebulizador COLOBREATHE Polvo para inhal. 1.662.500 UI» |
«No puede tomar colistina en caso de hipersensibilidad al producto u a otras polimixinas. Precauciones: considerar la administración IV concomitante con otros agentes antibacterianos; sólo se debe administrar cuando los antibióticos comúnmente prescritos no sean eficaces o apropiados; I.H.; I.R.: ajustar dosis vía IV, vía inhalatoria controlar concentraciones en suero; evaluar la función renal antes y durante el tto.; riesgo de: nefro o neurotoxicidad a dosis superior a recomendadas, de colitis asociada a antibióticos y colitis pseudomembranosa y de paro respiratorio; no administrar medicamentos que inhiben el peristaltismo; niños < 1 año; interrumpir el tto. en caso de reacción alérgica; máx. precaución en miastenia gravis y porfiria; precaución en hipovolémicos y tto. de meningitis si se emplea por vía intratecal o intraventricular. Vía inhalatoria: riesgo de broncoespasmo (administrar 1ª dosis bajo supervisión, aconsejable administración previa rutinaria de broncodilatador; si persiste broncoespasmo suspender tto.) e hiperreactividad bronquial (con uso continuado); se da resistencia adquirida a colistimetato de sodio en P. aeruginosa mucoide: realizar tests de sensibilidad en tto. prolongado y en caso de exacerbación de la enf. Precaución en caso de insuficiencia hepática. En caso de insuficiencia renal, ajustar dosis. Ads., IV, Clcr < 50-30 ml/min: 5,5-7,5 MUI/día; Clcr < 30-10 ml/min: 4,5-5,5 MUI/día; Clcr < 10 ml/min: 3,5 MUI/día; hemodiálisis: se recomienda administrar 2 veces/día, en días sin hemodiálisis: 2,25 MUI/día; en días con hemodiálisis: 3 MUI/día administrado después de cada sesión; hemo(dia)filtración continua: 9 MUI/día en 3 tomas. Inhalatoria: aunque es improbable alcanzar concentraciones elevadas en suero por esta vía, es aconsejable controlar concentración es suero, especialmente en pacientes con insuf. renal». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Daptomycin | «Daptomycin is an antibacterial that can stop the growth of certain bacteria». | Accord Healthcare Limited (2017) Package leaflet: Information for the patient Daptomycin 500 mg powder for solution for injection/infusion daptomycin. Disponible en: https://www.medicines.org.uk/emc/files/pil.8767.pdf [Consultado: 25-05-2018] | «Daptomycin is used in adults and in children and adolescents (age from 2 to 17 years) to treat infections of the skin and the tissues below the skin. It is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a bacterium called Staphylococcus aureus and to treat infections in the blood caused by the same bacterium when associated with skin or heart infection». |
«The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection. In adult patients, this dose is given directly into your blood stream (into a vein), either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes. The same dose is recommended in people aged over 65 years provided their kidneys are working well. Children and adolescents (2 to 17 years of age) The dose for children and adolescents (2 to 17 years of age) being treated for skin infection will depend on the age of patient. 12 to 17 years - 5 mg/kg once every 24 hours infused over 30 minutes - Up to 14 days; 7 to 11 years - 7 mg/kg once every 24 hours infused over 30 minutes - Up to 14 days; 2 to 6 years - 9 mg/kg once every 24 hours infused over 60 minutes - Up to 14 days. If your kidneys do not work well, you may receive Daptomycin less often, e.g. once every other day. If you are receiving dialysis, and your next dose of Daptomycin is due on a dialysis day, you will be usually given Daptomycin after the dialysis session. A course of treatment usually lasts for 1 to 2 weeks for skin infections. For blood or heart infections and skin infections your doctor will decide how long you should be treated». |
«Common side effects (may affect up to 1 in 10 people) - Fungal infections such as thrush, - Urinary tract infection, - Decreased number of red blood cells (anaemia), - Dizziness, anxiety, difficulty in sleeping, - Headache, - Fever, weakness (asthenia), - High or low blood pressure, - Constipation, abdominal pain, - Diarrhoea, feeling sick (nausea) or being sick (vomiting), - Flatulence, - Abdominal swelling or bloating, - Skin rash or itching, - Pain, itchiness or redness at the site of infusion, - Pain in arms or legs, - Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK). Uncommon side effects (may affect up to 1 in 100 people) - Blood disorders (e.g. increased number of small blood particles called platelets, which may increase the tendency for blood clotting, or higher levels of certain types of white blood cells), - Decreased appetite, - Tingling or numbness of the hands or feet, taste disturbance, - Trembling, - Changes in heart rhythm, flushes, - Indigestion (dyspepsia), inflammation of the tongue, - Itchy rash of skin, - Muscle pain or weakness, inflammation of the muscles (myositis), joint pain, - Kidney problems, - Inflammation and irritation of the vagina, - General pain or weakness, tiredness (fatigue), - Blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or lactate dehydrogenase (LDH), prolonged blood clotting time or imbalance of salts». |
Accord Healthcare Limited (2017) Package leaflet: Information for the patient Daptomycin 500 mg powder for solution for injection/infusion daptomycin. Disponible en: https://www.medicines.org.uk/emc/files/pil.8767.pdf [Consultado: 25-05-2018] | «Cubicin 350 mg powder for solution for injection or infusion; Cubicin 500 mg powder for solution for injection or infusion; Daptomycin 350 mg powder for solution for injection/infusion; Daptomycin 500 mg powder for solution for injection/infusion». | Precautions: You should not be given Daptomycin If you are allergic to daptomycin. Talk to your doctor or nurse before you are given Daptomycin. - If you have, or have previously had kidney problems. Your doctor may need to change the dose of Daptomycin (see section 3 of this leaflet). - Occasionally, patients receiving daptomycin may develop tender or aching muscles or muscle weakness (see section 4 of this leaflet for more information). If this happens tell your doctor. Your doctor will make sure you have a blood test and will advise whether or not to continue with Daptomycin. The symptoms generally go away within a few days of stopping Daptomycin. - If you are very overweight. There is a possibility that your blood levels of daptomycin could be higher than those found in persons of average weight and you may need careful monitoring in case of side effects. Tell your doctor straight away if you develop any of the following symptoms: - Serious, acute allergic reactions have been observed in patients treated with nearly all antibacterial agents, including daptomycin. Tell a doctor or a nurse straight away if you experience symptoms suggestive of allergic reaction, such as wheezing, difficulty breathing, swelling of the face, neck and throat, rashes and hives, fever (see section 4 of this leaflet for more information). - Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements. If this happens, tell your doctor who will decide whether you should continue the treatment. - Diarrhoea, especially if you notice blood or mucus, or if diarrhoea becomes severe or persistent. - New or worsening fever, cough or difficulty breathing. These may be signs of a rare but serious lung disorder called eosinophilic pneumonia. Your doctor will check the condition of your lungs and decide whether or not you should continue Daptomycin treatment. Children and adolescents Daptomycin should not be administered to children below one year of age as studies in animals have indicated that this age group may experience severe side effects. Use in elderly People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well. |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Daptomicina | «La daptomicina es un lipopéptido cíclico natural, activo únicamente contra las bacterias gram-positivas. El mecanismo de acción consiste en la unión (en presencia de iones de calcio) a las membranas bacterianas de las células tanto en fase de crecimiento como estacionaria, causando una despolarización y conduciendo a una rápida inhibición de la síntesis de proteínas, de ADN y de ARN. El resultado es la muerte de la célula bacteriana con una lisis celular insignificante». | Vademecum (2017) Daptomicina. Disponible en: https://www.vademecum.es/principios-activos-daptomicina-J01XX09 [Consultado: 29-05-2018] | «Tto. de infecciones complicadas de piel y partes blandas (IPPBc) en ads. y pacientes pediátricos (1-17 años); ads. con endocarditis infecciosa del lado dcho. (EID) por Staphylococcus aureus; ads. con bacteriemia por S. aureus (BSA) cuando está asociada con EID o IPPBc y en pacientes pediátricos (1-17 años) con bacteriemia por S. aureus (BSA) cuando está asociada con IPPBc. Activa sólo frente a Gram+». | Ads.: perfus. IV (30 min) o iny. I.V. (2 min): - Infecciones complicadas de piel y partes blandas sin bacteriemia por S. aureus concurrente: 4 mg/kg, 1 vez/24 h, 7-14 días o hasta desaparición de infección. - Infecciones complicadas de piel y partes blandas con bacteriemia por S. aureus concurrente: 6 mg/kg, 1 vez/24 h. Puede requerirse duración tto. > 14 días. - Endocarditis infecciosa del lado dcho. conocida o sospechada por S. aureus: 6 mg/kg, 1 vez/24 h. I.R. Infecciones complicadas de piel y partes blandas sin bacteriemia por S. aureus, Clcr < 30 ml/min, hemodializados y DPCA: 4 mg/kg/48 h. Infecciones complicadas de piel y partes blandas o endocarditis infecciosa del lado dcho. asociadas con bacteriemia por S. aureus, Clcr < 30 ml/min, hemodializados y DPCA: 6 mg/kg/48 h. Niños: perfus. IV (30 min niños 7-17 años, 60 min en niños 1-6 años): - IPPBc sin BSA: 12-17 años: 5 mg/kg, 1 vez/24 h; 7-11 años: 7 mg/kg, 1 vez/24 h; 2-6 años: 9 mg/kg, 1 vez/24 h; 1-< 2 años: 10 mg/kg, 1 vez/24 h. Máx. 14 días de tto. - IPPBc asociada a BSA: 12-17 años: 7 mg/kg, 1 vez/24 h; 7-11 años: 9 mg/kg, 1 vez/24 h; 2-6 años: 12 mg/kg, 1 vez/24 h; 1-< 2 años: 12 mg/kg, 1 vez/24 h. |
«Infecciones fúngicas y del tracto urinario, candidiasis; anemia; ansiedad, insomnio; mareos, cefalea; hipertensión, hipotensión; dolor gastrointestinal y abdominal, náuseas, vómitos, estreñimiento, diarrea, flatulencia, hinchazón, distensión; ALT, CPK, AST y fosfatasa alcalina elevadas; exantema, prurito; dolor en una extremidad; reacciones en la zona de perfus., pirexia, astenia». | Vademecum (2017) Daptomicina. Disponible en: https://www.vademecum.es/principios-activos-daptomicina-J01XX09 [Consultado: 29-05-2018] | «CUBICIN Polvo para sol. iny. y para perfusión 350 mg CUBICIN Polvo para sol. iny. y para perfusión 500 mg DAPTOMICINA ACCORD Polvo para sol. iny. y para perfusión 350 mg DAPTOMICINA ACCORD Polvo para sol. iny. y para perfusión 500 mg» |
«No puede tomar daptomicina en caso de hipersensibilidad. Precauciones: eExperiencia clínica limitada con I.R. (Clcr < 80 ml/min), precaución y monitorización periódica. Con Clcr < 30 ml/min ajustar dosis y administrar sólo si beneficio > riesgo; I.H. grave, no hay datos; vigilar función renal asociado con agentes nefrotóxicos. Riesgo de miopatía: vigilar signos y CPK al iniciar tto. y mín. 1 vez/sem; con mayor frecuencia si CPK inicial > 5 x LSN (valorar inicio de tto.) y en mayor riesgo de miopatía (I.R., hemodiálisis y DPCA, y asociación con fármacos causantes de miopatía como inhibidores HMG-CoA reductasa, fibratos y ciclosporina, evitar coadministración salvo beneficio > riesgo); monitorizar CPK cada 2 días si hay dolor muscular de origen desconocido, hipersensibilidad, debilidad o calambres; suspender en caso de dolor muscular de origen desconocido con CPK > 5 x LSN; riesgo de sobrecrecimiento de microorganismos no sensibles, de diarrea asociada a Clostridium difficile (suspender e instaurar tto. adecuado) y de neuropatía periférica (vigilar síntomas y valorar suspensión). Notificados casos de neumonía eosinofílica, suspender y si es preciso, iniciar tto. esteroideo; información limitada en obesos con IMC > 40 kg/m 2 ; no eficaz en tto. de neumonía; eficacia no demostrada con infección en válvula protésica o con endocarditis infecciosa del lado izdo. debida a S. aureus; eficacia sin determinar en infecciones por enterococos, incluidos E. faecalis y E. faecium; suspender si aparece reacción alérgica; ancianos; niños < 1 año no deben recibir daptomicina debido al riesgo de efectos potenciales sobre el sistema muscular, neuromuscular, y/o nervioso (ya sea periférico y/o central); no se ha establecido la seguridad y eficacia en niños y adolescentes < 18 años con endocarditis infecciosa del lado derecho debida a Staphylococcus aureus; no establecida la pauta posológica en niños con I.R. En caso de experiencia clínica limitada con I.R. (Clcr < 80 ml/min), monitorizar función periódicamente y vigilar CPK por mayor riesgo de miopatía. Ajustar dosis y administrar sólo si beneficio > riesgo con Clcr < 30 ml/min: en infecciones complicadas de piel y partes blandas sin bacteriemia por S. aureus, Clcr ≤ 30 ml/min, hemodializados y DPCA, 4 mg/kg/48 h; infecciones complicadas de piel y partes blandas o endocarditis infecciosa del lado dcho. asociadas con bacteriemia por S. aureus, Clcr < 30 ml/min, hemodializados y DPCA, 6 mg/kg/48 h». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Doxycycline | «It belongs to a group of medicines called tetracycline antibiotics». |
Kent Pharmaceuticals Ltd (2017) Patient information leaflet Doxycycline 100mg capsules. Disponible en: https://www.medicines.org.uk/emc/files/pil.4063.pdf [Consultado: 25-05-2018] | «It may be used to treat a wide range of infections caused by bacteria, these include: • Chest, lung or nasal infections e.g. bronchitis, pneumonia, sinusitis • Infections of the kidneys and bladder e.g. cystitis, urethritis • Infections of the skin such as acne • Eye infections • Sexually transmitted diseases e.g. gonorrhoea, syphilis, chlamydia • Rickettsial infections such as Q fever or fevers associated with louse or tick bites • Malaria, when chloroquine is not effective • Other infections such as cholera, brucellosis, leptospirosis and psittacosis Doxycycline capsules are also used to prevent certain infections developing such as scrub typhus, traveller’s diarrhoea, malaria and leptospirosis». |
«Adults and the elderly: Respiratory, urinary tract, ophthalmic and other infections The usual dose is 200mg on the first day as a single dose or two 100mg doses, followed by 100mg daily. For severe infections your doctor may increase the dose to 200mg a day. The duration of treatment is dependent on the infection being treated. Acne 50mg daily for 6-12 weeks, with food or fluid. Sexually transmitted diseases 100mg twice daily for 7-10 days. Primary and secondary syphilis 300mg daily in divided doses for at least 10 days. Fevers associated with louse or tick bites Single dose of 100mg or 200mg depending on severity. Treatment of malaria, when chloroquine is not effective 200mg daily for at least 7 days. Prevention of malaria 100mg daily for 1-2 days before travelling until 4 weeks after returning. Prevention of scrub typhus Single dose of 200mg. Prevention of travellers’ diarrhoea 100mg twice daily on the first day of travel, followed by 100mg daily throughout the stay in the area. If you are planning to take these capsules for more than 21 days, please consult your doctor. Prevention of leptospirosis 200mg once each week during the stay in the area; 200mg on completion of the trip. If you are planning to take these capsules for more than 21 days, please consult your doctor. Doctors may prescribe different doses to these depending on the infection being treated. Check with your doctor if you are not sure why you have been prescribed the medicine. The label on the pack will tell you what dose YOU should take, how often and for how long to take it. If you are still not sure, ask your doctor or pharmacist. Children over 12 years of age The recommended dosage schedule for children over 12 years of age, weighing 50 kg or less is 4 mg/kg of body weight on the first day of treatment (given as a single dose or divided into two equal doses with a 12 hour interval), followed by 2 mg/kg of body weight on subsequent days. For more severe infections up to 4 mg/kg of body weight may be used daily. For children over 50 kg the usual adult dose should be used». |
«Stop taking your medicine and tell your doctor immediately, or go to accident and emergency if you notice any of the following symptoms. Although the symptoms are very rare, they may be severe. • Symptoms of an allergic reaction - sudden wheeziness, difficulty in breathing, chest pain, fever, sudden swellings of the face, lips, tongue, throat, hands or feet, rash or itching (especially affecting the whole body), pericarditis (inflammation of the membrane surrounding the heart), worsening of systemic lupus erythematosus (autoimmune disease) If you experience any of the side effects listed below, tell your doctor as soon as possible: • Severe skin reactions such as erythema multiforme (circular, irregular red patches), Stevens-Johnson syndrome (rash with flushing, fever, blisters or ulcers), toxic epidermal necrolysis (reddening, peeling and swelling that resembles burns) • Sensitivity to sunlight - you may get a skin rash, itching, redness or severe sunburn when out in sunlight or after using a sun bed • Increased pressure in the skull (severe headaches, blurred and/or double vision, blind spots, permanent loss of vision) • Bulging fontanelles (soft spot on head) of infants • Swollen tongue, severe watery or bloody diarrhoea, fever and cramps (pseudomembranous colitis) • Low blood pressure • Aches in the joints or muscles • Unusual rapid heart beats (palpitations), fainting • Blood disorders (symptoms may include tiredness, weakness, easy bruising or susceptibility to infection) • Porphyria (sensitivity of the skin to sunlight, inflammation of nerves and stomach pains) • Discolouration of thyroid tissue (does not affect thyroid function) • Changes in liver function tests • Hepatitis (inflammation of the liver) • Liver failure • An increase in urea in the blood • Jaundice (yellowing of the skin or white of the eyes) has rarely been reported • Pancreatitis (manifested by severe upper abdominal pain) has rarely been reported • Discolouration or underdevelopment of teeth • Loosening of the nail from the nail bed after exposure to the sun • The Jarisch-Herxheimer reaction which causes fever, chills, headache, muscle pain and skin rash that is usually self-limiting. This occurs shortly after starting doxycycline treatment for infections with spirochete such as Lyme disease». |
Kent Pharmaceuticals Ltd (2017) Patient information leaflet Doxycycline 100mg capsules. Disponible en: https://www.medicines.org.uk/emc/files/pil.4063.pdf [Consultado: 25-05-2018] | «Doxycycline 100 mg Capsules, Hard; Doxycycline 100mg Capsules; Doxycycline 50mg Capsules; Doxycycline Capsules BP 100mg; Doxycycline Capsules BP 50mg; Efracea 40mg Modified Release Hard Capsules; Periostat 20mg film-coated tablets; Vibramycin-D Dispersible Tablets 100mg». | Precautions: «Do not take your medicine and tell your doctor, if you: • have taken Doxycycline or any other antibiotic before and suffered an allergic reaction (e.g. rash, itching, swelling of the face, fainting and breathing problems) • are allergic to any of the other ingredients in Doxycycline Capsules (see section 6 Contents of the pack and other information) • are pregnant or trying to become pregnant • are breast-feeding • are giving it to a child under 12 years of age. Take special care with your medicine You should let your doctor know and ask their advice, if you: • are likely to be exposed to strong sunlight or ultraviolet light (e.g. on a sunbed) • have liver problems or are taking medicines which affect your liver • have severe kidney problems • have myasthenia gravis (a disease which causes unusual tiredness and weakness of certain muscles, particularly in the eyelid, difficulty chewing and swallowing and slurred speech) • have porphyria (a rare genetic disease of blood pigments) • have systemic lupus erythematosus (SLE) a condition characterised by a rash (especially on the face), hair loss, fever, malaise and joint pain. This condition may be worsened by taking Doxycycline». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Doxiciclina | «Bacteriostático. Inhibidor de la síntesis proteica bacteriana por unión a la subunidad ribosomal 30S». | Vademecum (2017) Doxiciclina. Disponible en: https://www.vademecum.es/principios-activos-doxiciclina-J01AA02 [Consultado: 29-05-2018] | «Tto. de las siguientes infecciones causadas por microorganismos sensibles: neumonía atípica causada por Mycoplasma pneumoniae y por Chlamydia pneumoniae; psitacosis; uretritis, cervicitis y proctitis no gonocócicas no complicadas; linfogranuloma venéreo; granuloma inguinal (donovanosis); enf. inflamatoria pélvica; estadíos 1 ario y 2 ario de la sífilis, así como sífilis tardía y latente, en pacientes alérgicos a la penicilina; orquiepididimitis aguda; tracoma; conjuntivitis de inclusión; infecciones causadas por rickettsias tales como la fiebre manchada de las Montañas Rocosas, la fiebre mediterránea, el tifus (endémico y tifus de la maleza) y fiebre Q; brucelosis (en combinación con estreptomicina); cólera; enf. de Lyme (estadíos iniciales 1 y 2); fiebres recurrentes transmitidas por piojos y garrapatas; malaria causada por Plasmodium falciparum resistente a cloroquina. - Tto. alternativo en: carbunco (cutáneo, intestinal o pulmonar), tularemia, listeriosis, bartonelosis y actinomicosis. - Coadyuvante en el tto. del acné vulgar grave. - Profilaxis de: malaria causada por Plasmodium falciparum en áreas con resistencia a mefloquina o cuando no se puedan utilizar otros antipalúdicos en áreas con resistencia a cloroquina y profilaxis post-exposición a Bacillus anthracis, como tto. alternativo a quinolonas. Formas de liberación modificada: reducir lesiones papulopustulares en ads. con rosácea facial». |
«1) Ads. y niños > 8 años con p.c. > 45 kg. 1 er día: 200 mg en dosis única o 100 mg/12 h; mantenimiento: 100 mg/24 h, infección severa: 100 mg/12 h. - IV. Uretritis, cervicitis y proctitis no gonocócicas no complicadas y orquiepididimitis: administrar junto con ceftriaxona. Brucelosis: administrar con estreptomicina.EPI: en pacientes que requieren hospitalización administrar 100 mg/12 h, junto con una cefalosporina (cefoxitina) IV al menos 4 días y por lo menos hasta 24-48 h después de observar la mejoría del paciente; continuar con 100 m/12 h por vía oral. Duración del tto.: 14 días. Cólera: 300 mg como dosis única. Carbunco cutáneo, intestinal o pulmonar: inicial, 100 mg/12 h IV seguid de la misma dosis vía oral cuando se considere apropiado; duración del tto.: 60 días, excepto en carbunco cutáneo sin compromiso sistémico, que será 7-10 días. - Oral. Formas de liberación modificada. Ads., incluyendo pacientes de edad avanzada: 40 mg/día. 2) Niños > 8 años con p.c. ≤ 45 kg. 1 er día: 4,4 mg/kg en dosis única o 2,2 mg/kg/12 h; mantenimiento: 2,2 mg/kg/24 h; infección severa: 4,4 mg/kg/24 h. Tto. del carbunco cutáneo, intestinal o pulmonar: 2,2 mg/kg/12 h IV seguida de la misma dosis por vía oral 2 veces/día, 60 días (reducir duración a 7-10 días en carbunco cutáneo sin compromiso sistémico y considerar el uso de 2 antibióticos en asociación en carbunco pulmonar). Profilaxis de la malaria: 2 mg/kg en dosis única/día (sin superar la de ads.), 1-2 días antes del viaje, durante y 4 sem después». |
«Reacción anafiláctica (incluyendo angioedema, exacerbación del lupus eritematoso sistémico, pericarditis, hipersensibilidad, enf. del suero; púrpura Schönlein-Henoch, hipotensión, disnea, taquicardia, edema periférico y urticaria); cefalea; náuseas, vómitos; reacción de fotosensibilidad, erupción incluyendo erupción eritematosa y maculopapular. Formas de liberación modificada: nasofaringitis, sinusitis, infección fúngica; ansiedad; cefalea sinusoidal; hipertensión; diarrea, dolor abdominal superior, boca seca; dolor de espalda; dolor en el lugar de iny.; ASAT, presión sanguínea, LDH en sangre y glucosa en sangre elevadas. Además: la reacción Jarisch- Herxheimer». | Vademecum (2017) Doxiciclina. Disponible en: https://www.vademecum.es/principios-activos-doxiciclina-J01AA02 [Consultado: 29-05-2018] | «DOSIL Cáps. 100 mg DOXICILINA NORMON Gragea 100 mg DOXICLAT Comp. recub. con película 100 mg DOXIPIL Cáps. dura 100 mg DOXITEN BIO Cáps. 100 mg ORACEA Cáps. dura de liberación modificada 40 mg PRODERMA Cáps. dura 100 mg PRODERMA Cáps. dura 200 mg PRODERMA Cáps. dura 50 mg REXILEN Cáps. 100 mg VIBRACINA Cáps. dura 100 mg VIBRACINA Susp. oral 10 mg/ml VIBRAVENOSA Sol. iny. IV 100 mg» |
«No puede tomar doxiciclina en los siguientes casos: Hipersensibilidad a doxiciclina u otras tetraciclinas, tto. concomitante con metoxiflurano (notificados casos de toxicidad renal con resultado mortal). Además en formas inyectables: pacientes con miastenia gravis. Además para formas de liberación modificada: bebes y niños ≤ 12 años; 2º er y 3 er trimestre de embarazo; tto. concomitante con retinoides orales; pacientes con aclorhidria o que han sido sometidos a cirugía que evite (by-pass) o extirpe el duodeno. Precauciones: no usar, salvo excepciones en niños < 8 años, 2ª mitad de embarazo y lactancia (posible coloración dental permanente, hipoplasia del esmalte y alteración reversible de crecimiento óseo); vigilar sobreinfección por microorganismos resistentes; precaución en pacientes con: historia de predisposición a desarrollar candidiasis, miastenia gravis, alteraciones hepáticas o en tto. concomitante con medicamentos hepatotóxicos, realizar control hematológico y de funciones hepática y renal (posible aumento de BUN); riesgo de: diarrea asociada a Clostridium difficile, colitis pseudomembranosa, fotosensibilidad (suspender tto. si eritema cutáneo); puede causar hipertensión intracraneal benigna (pseudotumor cerebri) transitoria; realizar evaluaciones oftálmicas; evitar el tto. concomitante con isotretinoína; puede causar en niños abombamiento de fontanelas, reversible; evitar en lupus eritematoso sistémico; en infección por estreptococo ß-hemolítico grupo A, administrar mín. 10 días; formas orales sólidas: administrar con alimento y no tumbarse en mín. 1 h, riesgo de daño esofágico; no usar en manifestaciones oculares de rosácea (como rosácea ocular y/o blefaritis/meibomianitis)». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Erythromycin | «Erythromycin is an antibiotic for the treatment and prevention of infections». |
Aurobindo Pharma - Milpharm Ltd. (2017) Package leaflet: information for the user Erythromycin Tablets 250 mg (erythromycin). Disponible en: https://www.medicines.org.uk/emc/files/pil.528.pdf | «Erythromycin is an antibiotic for the treatment and prevention of infections caused by erythromycin-sensitive organisms, such as: • Upper and lower respiratory tract infections • Eye, ear infections • Oral infections • Skin and soft tissue infections • Gastrointestinal infections. • Prophylaxis pre- and post- operative trauma, burns, rheumatic fever • Other infections: osteomyelitis, urethritis, gonorrhoea, syphilis, lymphogranuloma venereum, diphtheria, prostatitis, scarlet fever». |
«Adults and children over 12 years old or weighing > 40 kg The usual dose is 1 to 2 g per day equivalent to 25 mg/kg/day in divided doses (generally 3-4 single doses). This may be increased to 4 g per day if your infection is very severe. It is important that you complete your full course of antibiotics; do not stop receiving your infusion treatment early, even if you feel better. Children over 1 month to 12 years old or weighing ≤ 40 kg The usual dose is 15-20 mg/kg of body weight divided over 3-4 single doses. Your doctor will calculate the exact dose your child will receive taking into account his/her body weight. Term newborn infants (birth to 1 month) The usual dose is 10-15 mg/kg divided over 3 single doses. Your doctor will calculate the exact dose your child will receive taking into account his/her body weight. Use in patients with severe kidney problems Your doctor will calculate your exact dose according to the way your kidney work. Use in elderly patients Your doctor will carefully decide your dose and take into account the way your kidneys and liver work because you have a greater risk of developing kidney disease». |
«The most frequently side effects are anorexia (lack of appetite), retching, vomiting, abdominal pains, nausea, flatulence, discomfort, cramps, soft stools or diarrhoea. The following side effects have been reported: Uncommon (may affect up to 1 in 100 people): – Fungal infections (candidiasis) of the mouth with white coating – Vaginal inflammation – Itching of the vulva in women – Allergic reactions – Widespread skin rash (urticarial exanthema) – Skin itchiness – Redness of the skin with increase of blood flow (hyperaemia) – Abnormal liver and gallbladder function detected by blood tests – Pain or irritation at the site of injection – Swelling and redness along a vein which is extremely tender when touched Rare (may affect up to 1 in 1,000 people): – Swelling of certain part of your body including face and neck (allergic oedema/angioedema, anaphylaxis) – Symptom of poor appetite (anorexia) – Epigastric pain radiating to the back with nausea, vomiting, diarrhoea and loss of appetite (pancreatitis) – Itchiness with jaundice, pale stool and dark urine (cholestasis and cholestatic jaundice) – Swollen joints – Fever – Hives – Skin eruptions – Inflammation of the colon with severe diarrhoea». |
Panpharma UK Ltd (2017) Package leaflet: information for the patient powder for solution for infusion Erythromycin 1g Erythromycin (as erythromycin lactobionate). Disponible en: https://www.medicines.org.uk/emc/files/pil.7311.pdf [Consultado: 25-05-2018] | «Aknemycin Plus; Erythrocin 250 Tablets; Erythrocin 500 Tablets; Erythromycin 125 mg/5 ml Sugar Free Granules for Oral Suspension; Erythromycin 1g Powder for Solution for Infusion; Erythromycin 250 mg/5 ml Sugar Free Granules for Oral Suspension; Erythromycin 500mg/5ml Sugar Free Granules for Oral suspension; Erythromycin ethyl succinate 125mg/5ml Granules for Oral Suspension; Erythromycin ethyl succinate 250 mg/5 ml Granules for Oral Suspension; Erythromycin ethyl succinnate 500 mg/5 ml Granules for Oral Suspension; Erythromycin Ethylsuccinate granules for oral suspension 125mg/5ml; Erythromycin Ethylsuccinate Granules for Oral Suspension 250mg/5ml; Erythromycin Ethylsuccinate Granules for Oral Suspension 500mg/5ml; Erythromycin Lactobionate 1g Powder for Solution for Infusion; Erythromycin Suspension 125mg/5ml SF; Erythromycin Tablets BP 250 mg; Erythroped A 500 mg Tablets; Erythroped SF 250mg/5ml; Erythroped SF 500mg/5ml; Isotrexin Gel; Zineryt». | Precautions: DO NOT take Erythromycin Tablets if you are: • Allergic (hypersensitive) to erythromycin or any of the other ingredients in the product (see Section 6 ‘What Erythromycin Tablets contain’s) • are currently taking a medicine called - ergotamine or dihydroergotamine (used to treat migraines) while taking erythromycin as this may cause serious side effects. - terfenadine or astemizole or mizolastine (widely taken for hayfever or allergies), domperidone (for nausea (feeling sick) and vomiting (being sick)), cisapride (for stomach disorders) or pimozide or amisulpride (for psychiatric conditions) while receiving erythromycin, as combining these drugs can sometimes cause serious disturbances in heart rhythm. Consult your doctor for advice on alternative medicines you can take instead. - simvastatin (used to lower cholesterol and triglycerides (types of fat) in the blood). - tolterodine (used for treating overactive bladder with symptoms of urinary frequency, urgency and leakage). Talk to your doctor or pharmacist before taking Erythromycin tablets if you: • are taking colchicine (used for treatment of gout and arthritis) whilst taking erythromycin as this may cause serious side effects. • have any liver problems or have been told that any drugs you are taking can cause liver problems. Suffer from a condition called myasthenia gravis, which causes muscle weakness, consult your doctor before receiving erythromycin • irregular heart rhythm • a condition called porphyria • have previously experienced diarrhoea following the use of antibiotics • are treating a young child with antibiotics and they are irritable or vomit when fed, you should contact your physician immediately. • are pregnant and have been told that your have a sexually transmitted disease called syphilis. In this case erythromycin may not be effective for preventing the transfer of this infection to your body. Consult your doctor before receiving erythromycin. Alternatively if you were treated for early stages of syphilis during your pregnancy, and child is under 1 year and is prescribed erythromycin, consult your doctor before giving erythromycin to your child. • are taking erythromycin with ‘statins’ such as simvastatin or lovastatin (used to lower cholesterol) as serious side effects can occur». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Eritromicina | «Antibiótico macrólido. Interfiere en la síntesis proteica bacteriana a nivel de subunidad 50S ribosomal». |
Vademecum (2015) Eritromicina. Disponible en: https://www.vademecum.es/principios-activos-eritromicina-J01FA01 [Consultado: 29-05-2018] | «Infección por S. pyogenes: respiratoria, de piel y tejido blando, alternativa en faringitis estreptocócica. Infección por S. alfahemolítico, viridans: profilaxis de endocarditis bacteriana antes de intervención odontológica, quirúrgica de vías aéreas superiores, en pacientes con valvulopatía adquirida o cardiopatía congénita. Infección por S. aureus: aguda, leve o moderada de piel y tejido blando. Por S. pneumoniae: otitis media, faringitis, neumonía, leve-moderada. Por M. pneumoniae: respiratoria. Por U. urealyticum: uretritis en ads. varones. Por C. jejuni: enterocolitis, diarrea grave o prolongada. Por H. influenzae: respiratoria superior, con sulfonamida. Por C. trachomatis: conjuntivitis del recién nacido, neumonía en la infancia, infección urogenital en embarazo, uretral, endocervical y rectal cuando las tetraciclinas están contraindicadas. Por T. pallidum: sífilis 1 aria en alérgicos a penicilina. Por C. diphtheriae: coadyuvante de antitoxina, para prevenir portadores. Por E. histolytica: amebiasis intestinal. Por L. monocytogenes. Por N. gonorrhoeae: mujeres con historia de sensibilidad a penicilina, alternativa a penicilina en EPI. Por B. pertussis: eliminación de la nasofaringe, profilaxis en expuestos. Puede ser efectiva en enf. del legionario». | «Oral, IV. Ads.: 1 ó 2 g/día en 3-4 tomas, puede aumentarse hasta 4 g/día. Prevención de endocarditis por estreptococo alfa hemolítico, viridans: 1 g antes de la intervención y 500 mg/6 h, en 8 dosis. Sífilis 1 aria : 30-40 g fraccionados durante 10-15 días. Disentería amebiana: 250 mg/6 h, 10-14 días. Enf. legionario: 1-4 g/día, fraccionados, 14-21 días. Niños: 30-50 mg/kg/día en 3-4 tomas. Disentería amebiana: 30-50 mg/kg/día fraccionados, 14-21 días. Infección por estreptococo con antecedente de cardiopatía reumática: mín. 10 días». |
«Dolor abdominal, náuseas, vómitos, diarrea, anorexia, sobrecrecimiento de microorganismos no susceptibles, urticaria, erupción cutánea, fenómenos anafilácticos, pérdida reversible de audición». | Vademecum (2015) Eritromicina. Disponible en: https://www.vademecum.es/principios-activos-eritromicina-J01FA01 [Consultado: 29-05-2018] | «ERITROMICINA ESTEDI Cáps. 250 mg ERITROMICINA NORMON Comp. recub. 500 mg PANTOMICINA Comp. recub. con película 500 mg PANTOMICINA Granulado para susp. oral 100 mg/ml PANTOMICINA Granulado para susp. oral 1.000 mg PANTOMICINA Granulado para susp. oral 250 mg PANTOMICINA Granulado para susp. oral 500 mg PANTOMICINA Polvo y disolv. para sol. inyec. 1 g» |
«No tomar eritromicina en los siguientes casos: hipersensibilidad a macrólidos, antecedente de ictericia. Vigilar función hepática por riesgo de disfunción; embarazo y lactancia». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Phenoxymethylpenicillin | «Phenoxymethylpenicillin, the active ingredient, is an antibiotich, which belongs to a group of medicines called penicillins, which are used to kill bacteria that cause infections in your body». | Kent Pharmaceuticals Ltd (2017) Package leaflet information for the patient- spoon Phenoxymethylpenicillin 125mg/5ml oral solution sugar free. Disponible en: https://www.medicines.org.uk/emc/files/pil.8153.pdf [Consulta: 25-05-2018] | «It is used to: treat bacterial infections of the ear, throat, respiratory tract, ski and soft tissues; prevent infections such as rheumatic fever or chorea recurring; prevent pneumococcal infection (e.g. in asplenia and in patients with sickle cell disease)». | «Adults: The dosage is 250-500 mg every six hours. Elderly: The dosage is as for adults. The dosage should be reduced if renal function is markedly impaired. Prophylactic Use: The dosage is 250 mg daily for long term prophylaxis of rheumatic fever. Paediatric population Children 1-5 years: 125 mg every six hours 6-12 years: 250 mg every six hours To avoid late complications (rheumatic fever), infections with β-haemolytic streptococci should be treated for 10 days. The treatment of acute otitis media should be limited to 5 days. However, 5-10 days treatment may be recommended in patients with potential for complications». |
«Potential allergic reactions include urticaria, angioneurotic oedema, erythema multiforme, exfoliative dermatitis, fever, joint pain, serum sickness-like reactions, haemolytic anaemia, interstitial nephritis or anaphylactic shock (which could be fatal) with collapse and anaphylactoid reactions (asthma, purpura, gastrointestinal symptoms). Although these are less common, and take a milder course, in oral treatment than during parenteral penicillin treatment, it should be remembered that all degrees of hypersensitivity, including fatal anaphylaxis, have been observed with oral penicillin. Gastro-intestinal tract Phenoxymethylpenicillin potassium is generally well tolerated. Occasionally soft stools occur and they do not require the interruption of the treatment. Nausea, diarrhoea, vomiting, stomatitis and glossitis are sometimes seen. Sustained severe diarrhoea should prompt suspicion of pseudomembranous colitis. As this condition may be life-threatening phenoxymethylpenicillin should be withdrawn immediately and treatment guided by bacteriologic studies with appropriate antibiotherapy (i.e. vancomycin).. Blood Eosinophilia, haemolytic anaemia, leukopenia, thrombocytopenia and agranulocytosis are extremely rare. Other possible effects on the blood composition include: neutropenia, haemolytic anaemia and coagulation disorders. Central nervous system Central nervous system toxicity, including convulsions, has been reported, especially following high doses or in severe renal impairment. Paraesthesia has been reported with prolonged use. As with other broad-spectrum antibiotics prolonged use may result in the overgrowth of non-susceptible organisms, e.g. candida. This may present a vulvo-vaginitis». |
Sandoz Limited (2017) Penicillin VK Tablets 250 mg. Disponible en: https://www.medicines.org.uk/emc/product/1754/smpc [Consultado: 25-05-2018] | «Penicillin VK Tablets 250 mg; Phenoxymethyl Penicillin 125mg/5ml Oral Solution Sugar Free (spoon); Phenoxymethyl Penicillin 125mg/5ml Oral Solution Sugar Free (syringe); Penicillin VK Tablets 250 mg; Phenoxymethyl Penicillin 125mg/5ml Oral Solution Sugar Free (spoon); Phenoxymethyl Penicillin 125mg/5ml Oral Solution Sugar Free (syringe); Phenoxymethyl Penicillin 250mg/5ml Oral Solution Sugar Free (spoon); Phenoxymethyl Penicillin 250mg/5ml Oral Solution Sugar Free (syringe); Phenoxymethylpenicillin 125 mg/5ml Oral Solution; Phenoxymethylpenicillin 250 mg/5ml Oral Solution». | Precautions: «Phenoxymethylpenicillin is contraindicated in patients with known penicillin hypersensitivity. Phenoxymethylpenicillin should be given with caution to patients with a history of allergy, especially to other drugs. Phenoxymethylpenicillin should also be given cautiously to cephalosporin-sensitive patients, as there is some evidence of partial cross-allergenicity between the cephalosporins and penicillins. Patients have had severe reactions (including anaphylaxis) to both drugs. If the patient experiences an allergic reaction phenoxymethylpenicillin should be discontinued and treatment with the appropriate agents initiated (e.g. adrenaline and other pressor amines, antihistamines and other corticosteroids). Particular caution should be exercised in prescribing phenoxymethylpenicillin to patients with an allergic diathesis or with bronchial asthma Oral penicillins are not indicated in patients with severe illness or with a gastrointestinal disease that causes persistent nausea, vomiting gastric dilation, cardiospasm, intestinal hypermotility or diarrhoea because absorption may be reduced. Occasionally, patients do not absorb therapeutic amounts of orally administered penicillin. Streptococcal infections should be treated for a minimum of 10 days and post-therapy cultures should be performed to confirm the eradication of the organisms. In patients undergoing long-term phenoxymethylpenicillin treatment the complete and differential blood count, as well as the liver and kidney function, should be monitored. During long-term treatment attention should also be paid to the potential overgrowth of resistant organisms including Pseudomonas or Candida. If super-infection occurs, appropriate measures should be taken. Caution should be used when treating patients with a history of antibiotic-associated colitis. Attention should be paid to possible cross-sensitivity with other beta-lactam antibiotics e.g. cephalosporins. Severe acute infections should not be treated with phenoxymethylpenicillin». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Fenoximetilpenicilina | «Bactericida. Inhibe la biosíntesis de la pared celular durante la multiplicación bacteriana». | Vademecum (2016) Fenoximetilpenicilina. Disponible en: https://www.vademecum.es/principios-activos-fenoximetilpenicilina-J01CE02 [Consultado: 29-05-2018] | «Amigdalitis, faringitis séptica, otitis, bronquitis, bronconeumonía, escarlatina, erisipela, forúnculo, absceso, profilaxis de fiebre reumática y endocarditis bacteriana; flemón, estomatitis, gingivitis, profilaxis en extracción dental, tto. y profilaxis de infección estreptocócica». | «Oral. Ads. y niños > 12 años, infección estreptocócica: 800 mg/8 h o 500 mg/6-8 h, 10 días; gingivitis necrótica: 800 mg/8 h o 500 mg/6-8 h; profilaxis de fiebre reumática y endocarditis bacteriana: 250-500 mg/12 h. Niños: general, 50 mg/kg/día, repartido en 2-3 tomas. Infección estreptocócica, niños de 1-5 años: 250 mg/8 h o 500 mg/12 h, 10 días; niños de 6-12 años: 500 mg/8 h, 10 días. Profilaxis de fiebre reumática y endocarditis bacteriana: 250 mg/12 h. Infección por estreptococo hemolítico: mín. 10 días». | «Urticaria, erupción eritematosa, náuseas, vómitos, diarrea, alteración hemática reversible: anemia, trombocitopenia, leucopenia y trastorno de coagulación». |
Vademecum (2016) Fenoximetilpenicilina. Disponible en: https://www.vademecum.es/principios-activos-fenoximetilpenicilina-J01CE02 [Consultado: 29-05-2018] | «PENILEVEL Cáps. 400 mg PENILEVEL Polvo sobre 250 mg» |
«No puede tomar fenoximetilpenicilina en los siguientes casos: historial de hipersensibilidad a penicilinas o en los siguientes casos: Alergia a cefalosporinas. Historial alérgico medicamentoso. Si se presenta manifestación alérgica, suspender tto.». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Fluconazole | «Fluconazole, the active ingredient, belongs to a group of medicines called anti-fungal agents and it is used to treat infections caused by fungi and may also be used to stop you from getting a candidal infection. The most common cause of fungal infections is yeast called Candida». |
FDC International Ltd (2016) Fluconazole capsules 50 mg Fluconazole capsules 200mg. Disponible en: https://www.medicines.org.uk/emc/files/pil.4959.pdf [Consultado: 25-05-2018] | «Adults You might be given this medicine by your doctor to treat the following types of fungal infections: - Cryptococcal meningitis – a fungal infection in the brain - Coccidioidomycosis – a disease of the bronchopulmonary system - Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract - Mucosal thrush - infection affecting the lining of the mouth, throat and denture sore mouth - Genital thrush – infection of the vagina or penis - Skin infections - e.g. athlete's foot, ringworm, jock itch, nail infection You might also be given Fluconazole to: - stop cryptococcal meningitis from coming back - stop mucosal thrush from coming back - reduce recurrence of vaginal thrush - stop you from getting an infection caused by Candida (if your immune system is weak and not working properly) Children and adolescents (0 to 17 years old) You might be given this medicine by your doctor to treat the following types of fungal infections: - Mucosal thrush - infection affecting the lining of the mouth, throat - Infections caused by Candida and found in the blood stream, body organs (e.g. heart, lungs) or urinary tract - Cryptococcal meningitis – a fungal infection in the brain You might also be given Fluconazole to: - stop you from getting an infection caused by Candida (if your immune system is weak and not working properly) - stop cryptococcal meningitis from coming back». |
«Adults: To treat cryptococcal meningitis: 400 mg on the first day then 200 mg to 400 mg once daily for 6 to 8 weeks or longer if needed. Sometimes doses are increased up to 800 mg; To treat internal fungal infections caused by Candida: 800 mg on the first day then 400 mg once daily until you are told to stop; To treat mucosal infections affecting the lining of mouth, throat and denture sore mouth: 200 mg to 400 mg on the first day then 100 mg to 200 mg until you are told to stop; To stop mucosal infections affecting the lining of mouth, throat: 100 mg to 200 mg once daily, or 200 mg 3 times a week, while you are at risk of getting an infection; To treat fungal skin and nail infections: depending on the site of the infection 50 mg once daily, 150 mg once weekly, 300 to 400 mg once weekly for 1 to 4 weeks (Athlete’s foot may be up to 6 weeks, for nail infection treatment until infected nail is replaced);To stop you from getting an infection caused by Candida (if your immune system is weak and not working properly): 200 mg to 400 mg once daily while you are at risk of getting an infection. Children to 11 years old: the maximum dose for children is 400 mg daily. Mucosal thrush and throat infections caused by Candida – dose and duration depends on the severity of the infection and on where the infection is located: 3 mg per kg of body weight (6 mg per kg of body weight might be given on the first day); Cryptococcal meningitis or internal fungal infections caused by Candida: 6 mg to 12 mg per kg of body weight; To stop children from getting an infection caused by Candida (if their immune system is not working properly) 3 mg to 12 mg per kg of body weight». |
«If you getany of the following symptoms, tell your doctor immediately. sudden wheeziness, difficulty breathing or tightness in the chest swelling of the eyelids, face or lips itching all over the body, reddening of the skin or itchy red spots skin rash severe skin reactions such as a rash that causes blistering (this can affect the mouth and tongue) Fluconazole may affect your liver. The signs of liver problems include: tiredness loss of appetite vomiting yellowing of your skin or the whites of your eyes (jaundice) Fluconazole may affect your adrenal glands and the levels of steroid hormones produced. The signs of adrenal problems include: tiredness muscle weakness loss of appetite weight loss abdominal pain. Common side effects (may affect up to 1 in 10 people) are: headache stomach discomfort, diarrhoea, feeling sick, vomiting increases in blood tests of liver function rash». |
FDC International Ltd (2016) Fluconazole capsules 50 mg Fluconazole capsules 200mg. Disponible en: https://www.medicines.org.uk/emc/files/pil.4959.pdf [Consultado: 25-05-2018] | «Azocan-P Capsules 150mg; Boots Thrush 150mg Capsule; Boots Thrush Oral Capsule and Cream Duo; Boots Thrush Oral Capsule and Cream Duo - Fluconazole 150mg Capsule; Canesten Thrush Duo Oral Capsule & External Cream 150mg / 2% w/w capsule and cream (GSL); Canesten Thrush Oral Capsule 150mg capsule; Diflucan 10 mg/ml powder for oral suspension; Diflucan 150 Capsules; Diflucan 2 mg/ml solution for infusion; Diflucan 200 mg hard capsules; Diflucan 40 mg/ml powder for oral suspension; Diflucan 50mg hard capsules; Fluconazole 150 mg capsules; Fluconazole 200 mg capsules; Fluconazole 50 mg capsules; Fluconazole 100mg Capsule; Fluconazole 150 mg Capsules; Fluconazole 150 mg Hard Capsules; Fluconazole 2 mg/ml solution for infusion; Fluconazole 200 mg Capsules; Fluconazole 200mg Capsules Athlone Pharma; Fluconazole 200mg/100ml infusion bags (2mg/ml in 200ml infusion bags); Fluconazole 2mg/ml Solution for Infusion; Patient Leaflet Fluconazole 400mg/200ml infusion bags (2mg/ml in 200ml infusion bags); Fluconazole 50 mg Capsules; Fluconazole 50mg Hard Capsules; Fluconazole 50mg/5ml Powder for Oral Suspension; Fluconazole/Azocan 150mg Capsules; Fluconazole/Azocan 200mg Capsules; Fluconazole/Azocan 50mg Capsules». |
Precautions: «Do not take Fluconazole if: You have ever had an allergic reaction to fluconazole, to other medicines you may have to treat fungal infections; if you are taking terfenadine or astemizole (antihistamine medicines for allergies), cisapride (used for stomach upsets), pimozide (used for treating mental illness), quinidine (used for treating heart arrhythmia) or erythromycin (an antibiotic for treating infections). Talk to your doctor or pharmacist before taking Fluconazole if you have any disease or illness affecting your liver or kidneys suffer from heart disease, including heart rhythm problems if you have abnormal levels of potassium, calcium or magnesium in your blood if you develop severe skin reactions (itching, reddening of the skin or difficulty in breathing) if you develop signs of ‘adrenal insufficiency’ where the adrenal glands do not produce adequate amounts of certain steroid hormones such as cortisol (chronic, or long lasting fatigue, muscle weakness, loss of appetite, weight loss, abdominal pain)». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Fluconazol | «Antifúngico. Inhibe la síntesis fúngica de esteroles. Antimicótico». | Vademecum (2017) Fluconazol. Disponible en: https://www.vademecum.es/principios-activos-fluconazol-J02AC01 [Consultado: 29-05-2018] | «IV/oral: - Meningitis criptocóccica. - Coccidioidomicosis. - Candidiasis invasiva. - Candidiasis de las mucosas incluyendo las candidiasis orofaríngea y esofágica, candiduria y candidiasis mucocutánea crónica. - Candidiasis oral atrófica crónica (asociada al uso de prótesis dentales) cuando la higiene dental o el tto. tópico sean insuficientes. - Recaídas de meningitis criptocóccica en pacientes con alto riesgo de recidivas. - Recaídas de Candidiasis orofaríngea y esofágica en pacientes con infección por VIH quienes tienen gran riesgo de experimentar recaídas. - Profilaxis de infecciones por Candida en pacientes con neutropenia prolongada (tales como pacientes con neoplasias hematológicas que reciben quimioterapia o pacientes receptores de un Trasplante Hematopoyético de Células Madre). Oral: - Candidiasis vaginal aguda o recurrente cuando la terapia local no sea adecuada. - Balanitis por Candida cuando la terapia local no sea adecuada. - Reducir la incidencia de candidiasis vaginal recurrente (4 o más episodios al año). - Dermatomicosis, incluidas las producidas por Tinea pedis, Tinea corporis, Tinea cruris, Tinea versicolor e infecciones dérmicas por Candida cuando la terapia sistémica esté indicada. - Tto. de la infección por Tinea unguinum (onicomicosis) cuando los tratamientos de elección no se consideren apropiados». |
«Oral/infus. IV: - Criptococosis: tto. de la meningitis criptocóccica. Ads.: 400 mg el 1 er día, seguido de 200-400 mg, 6-8 días (en casos graves aumentar a 800 mg/día). Niños de 28 días a 11 años: 6-12 mg/kg/día; máx. 400 mg/día. Recaídas de meningitis criptocóccica en pacientes con alto riesgo de recidivas. Ads: 200 mg/día. Niños de 28 días a 11 años: 6 mg/kg/día; máx. 400 mg/día. - Coccidioidomicosis: 200 mg-400 mg, 11-24 meses. Algunas infecciones y enf. meníngea: 800 mg/día. - Candidiasis invasiva. Ads.: 800 mg el 1 er día, seguido de 400 mg, 2 sem. Niños de 28 días a 11 años: 6-12 mg/kg/día; máx. 400 mg/día. - Candidiasis de las mucosas. Ads.: candidiasis orofaríngea: 200-400 mg el 1 er día, seguido de 100-200 mg/día, 7-21 días; candidiasis esofágica: 200-400 mg el 1 er día, seguido de 100-200 mg/día, 14-30 días; candiduria: 200-400 mg/día, 7-21 días; candidiasis atrófica crónica. Ads.: 50 mg/día, 14 días; candidiasis mucocutánea crónica.: 50-100 mg/día, hasta 28 días. Niños de 28 días a 11 años: 6 mg/kg/día seguido de 3 mg/kg/día; máx. 400 mg/día. - Prevención de recaídas de candidiasis orofaríngea y esofágica en pacientes con VIH. Ads.: 100-200 mg/día o 200 mg 3 veces/sem, indefinidamente. - Profilaxis de infecciones por Candida en pacientes con neutropenia prolongada. Ads.: 200-400 mg, 7 días. Niños: 3-12 mg/kg/día. Oral: - Candidiasis vaginal aguda y recurrente, balanitis por Candida. Ads.: 150 mg, dosis única. - Prevención de candidiasis vaginal recurrente (más de 4 episodios recurrentes). Ads.: 150 mg cada 3 días seguido de 150 mg/sem, 6 meses. - Dermatomicosis por T. pedis, corporis, cruris y Candida. Ads.: 50 mg/24 h o 150 mg/sem, 2-4 sem. T. pedis hasta 6 sem. T. versicolor: 50 mg/24 h, 2-4 sem o 300-400 mg/sem, 1-3 sem. T. unguium (onicomicosis): 150 mg/sem, 3-6 meses (manos) o 6-12 meses (pies). Neonatos 1ª y 2ª sem de vida: misma dosis que lactantes y niños/72 h, máx. 12 mg/kg/72 h; 3ª y 4ª sem de vida: misma dosis que lactantes y niños/48 h, máx. 12 mg/kg/48 h. I.R. (si se administran dosis múltiples): inicial de choque 50-400 mg y continuar con 50% de dosis habitual si Clcr ≤ 50 ml/min. Dializados: dosis habitual tras diálisis». |
«Cefalea; dolor abdominal, vómitos, diarrea, náuseas; aumento de ALT, AST y fosfatasa alcalina; erupción». |
Vademecum (2017) Fluconazol. Disponible en: https://www.vademecum.es/principios-activos-fluconazol-J02AC01 [Consultado: 29-05-2018] | «CANDIFIX Cáps. 100 mg CANDIFIX Cáps. 150 mg CANDIFIX Cáps. 200 mg CITIGES Sol. para perfusión IV 2 mg/ml DIFLUCAN Cáps. dura 100 mg DIFLUCAN Cáps. dura 150 mg DIFLUCAN Cáps. dura 200 mg DIFLUCAN Cáps. dura 50 mg DIFLUCAN Polvo para susp. oral 10 mg/ml DIFLUCAN Polvo para susp. oral 40 mg/ml DIFLUCAN Sol. para perfusión 2 mg/ml FLUCONAZOL APOTEX Cáps. dura 100 mg FLUCONAZOL APOTEX Cáps. dura 150 mg FLUCONAZOL APOTEX Cáps. dura 200 mg FLUCONAZOL APOTEX Cáps. dura 50 mg FLUCONAZOL ARISTO EFG Cáps. 100 mg FLUCONAZOL ARISTO EFG Cáps. 150 mg FLUCONAZOL ARISTO EFG Cáps. 200 mg FLUCONAZOL ARISTO EFG Cáps. 50 mg FLUCONAZOL AUROBINDO Cáps. dura 100 mg FLUCONAZOL AUROBINDO Cáps. dura 150 mg FLUCONAZOL AUROBINDO Cáps. dura 200 mg FLUCONAZOL AUROBINDO Cáps. dura 50 mg FLUCONAZOL B.BRAUN Sol. para perfusión 2 mg/ml FLUCONAZOL CANTABRIA EFG Cáps. 100 mg FLUCONAZOL CANTABRIA EFG Cáps. 150 mg FLUCONAZOL CANTABRIA EFG Cáps. 200 mg FLUCONAZOL CANTABRIA EFG Cáps. 50 mg FLUCONAZOL CINFA EFG Cáps. dura 100 mg FLUCONAZOL CINFA EFG Cáps. dura 150 mg FLUCONAZOL CINFA EFG Cáps. dura 200 mg FLUCONAZOL CINFA EFG Cáps. dura 50 mg FLUCONAZOL COMBIX Cáps. dura 100 mg FLUCONAZOL COMBIX Cáps. dura 150 mg FLUCONAZOL COMBIX Cáps. dura 200 mg FLUCONAZOL COMBIX Cáps. dura 50 mg FLUCONAZOL FARMAGES EFG Sol. para perfusión 2 mg/ml FLUCONAZOL GENFARMA EFG Sol. para perfusión 2 mg/ml FLUCONAZOL KABI Sol. para perfusión 2 mg/ml FLUCONAZOL KERN PHARMA Sol. para perfusión 2 mg/ml FLUCONAZOL MABO EFG Cáps. 100 mg FLUCONAZOL MABO EFG Cáps. 150 mg FLUCONAZOL MABO EFG Cáps. 200 mg FLUCONAZOL MABO EFG Cáps. 50 mg FLUCONAZOL MYLAN EFG Cáps. dura 100 mg FLUCONAZOL MYLAN EFG Cáps. dura 150 mg FLUCONAZOL MYLAN EFG Cáps. dura 200 mg FLUCONAZOL MYLAN EFG Cáps. dura 50 mg FLUCONAZOL NORMON EFG Cáps. 100 mg FLUCONAZOL NORMON EFG Cáps. 150 mg FLUCONAZOL NORMON EFG Cáps. 200 mg FLUCONAZOL NORMON EFG Cáps. 50 mg FLUCONAZOL NORMON EFG Sol. para perfusión 2 mg/ml FLUCONAZOL QUALIGEN EFG Cáps. dura 100 mg FLUCONAZOL QUALIGEN EFG Cáps. dura 150 mg FLUCONAZOL QUALIGEN EFG Cáps. dura 200 mg FLUCONAZOL QUALIGEN EFG Cáps. dura 50 mg FLUCONAZOL SALA EFG Sol. para perfusión 2 mg/ml FLUCONAZOL SANDOZ EFG Cáps. 100 mg FLUCONAZOL SANDOZ EFG Cáps. 150 mg FLUCONAZOL SANDOZ EFG Cáps. 200 mg FLUCONAZOL SANDOZ EFG Cáps. 50 mg FLUCONAZOL STADA Cáps. 100 mg FLUCONAZOL STADA Cáps. dura 150 mg FLUCONAZOL STADA Cáps. dura 200 mg FLUCONAZOL TARBIS EFG Cáps. 100 mg FLUCONAZOL TARBIS EFG Cáps. 150 mg FLUCONAZOL TARBIS EFG Cáps. 200 mg FLUCONAZOL TARBIS EFG Cáps. 50 mg FLUCONAZOL TECNIGEN EFG Cáps. dura 150 mg FLUCONAZOL TECNIGEN EFG Cáps. dura 200 mg FLUCONAZOL TECNIGEN EFG Cáps. dura 50 mg FLUCONAZOL TEVA Cáps. dura 100 mg FLUCONAZOL TEVA Cáps. dura 150 mg FLUCONAZOL TEVA Cáps. dura 200 mg FLUCONAZOL TEVA Cáps. dura 50 mg LAVISA Cáps. 150 mg LIDFEX Cáps. dura 100 mg LIDFEX Cáps. dura 150 mg LIDFEX Cáps. dura 200 mg LIDFEX Cáps. dura 50 mg LOITIN Cáps. dura 100 mg LOITIN Cáps. dura 150 mg LOITIN Cáps. dura 200 mg LOITIN Cáps. dura 50 mg LOITIN Polvo para susp. oral 10 mg/ ml LOITIN Polvo para susp. oral 40 mg/ml» |
«No puede tomar fluconazol en los siguientes casos: hipersensibilidad a compuestos azólicos; concomitancia con fármacos que prolongan intervalo QT y metabolizados por el CYP3A4: cisaprida, astemizol, pimozida, quinidina, eritromicina y terfenadina si dosis múltiples fluconazol ≥ 400 mg. Precauciones: no recomendado en Tinea capitis, criptococosis en otros lugares (p.ej.: pulmonar y cutánea) ni en otras formas de micosis endémicas (paracoccidioidomicosis, esporotricosis linfocutánea e histoplasmosis); I.R./I.H.; vigilar PFH en caso de alteración, se ha asociado con hepatotoxicidad, suspender si aparecen signos/síntomas; riesgo de reacción cutánea exfoliativa (mayor con SIDA), si aparece exantema en infección fúngica superficial, suspender administración; en infección fúngica invasiva o sistémica, controlar, e interrumpir en caso de lesión bullosa o eritema multiforme; pacientes con riesgo de prolongación QT (alteración anatómica del corazón, anormalidad electrolítica, medicación concomitante); monitorizar asociado con fármacos de estrecho margen terapéutico metabolizados por CYP2C9, CYP2C19 y CYP3A4, y con terfenadina si dosis fluconazol < 400 mg; no recomendado en tto. concomitante con halofantrina. Precaución con I.H. Vigilar PFH en caso de alteración, se ha asociado con hepatotoxicidad, suspender si aparecen signos/síntomas. En caso de insuficiencia renal ajustar si se administran dosis múltiples: inicial 50-400 mg y continuar con 50% de dosis habitual si Clcr ≤ 50 ml/min. Dializados: dosis habitual tras diálisis». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Fosfomycin | «Fosfomycin belongs to a group of medicines known as antibiotics. It works by killing bacteria, which can cause infections». |
Concordia International - formerly AMCo (2015) Package leaflet: Information for the user Fosfomycin 3 g, granules for oral solution Fosfomycine Trometamol. Disponible en: https://www.medicines.org.uk/emc/files/pil.7219.pdf [Consultado: 25-05-2018] | «Fosfomycin is used to treat or prevent infections of the bladder. Fosfomycin is not suitable for the treatment of children younger than 12 years of age». |
«Adults including older people The recommended dose is 3g of Fosfomycin as a single dose. Fosfomycin should be taken orally, on an empty stomach, preferably before bedtime, after emptying the bladder. The contents if its a sachet should be dissolved in half a glass of water. ». |
«While taking Fosfomycin if you develop any of the following symptoms you should contact your doctor immediately: anaphylactic shock: a life threatening type of allergic reaction (its frequency cannot be estimated from the available data). The signs may include a sudden onset of rash, itching or hives on the skin and or shortness of breath, wheezing or trouble breathing. serious allergic reaction which causes swelling of the face, lips, tongue or throat with breathing difficulties (angioedema) (its frequency cannot be estimated from the available data); faster heart beat (tachycardia) (its frequency is rare, may affect up to 1 in 1,000 people) mild to severe abdominal crumps, bloody stools and /or fever may mean that you have an infection of the large intestine (pseudomembranous colitis). Common (may affect up to 1 in 10 people): Headache; Dizziness; Indigestion; Infection of the female genital organs with symptoms like inflamation, irritation, itching (vulvovaginitis). Uncommon (may affect up to 1 in 100 people): Tingling or numbness; Diarrhoea; Nausea; Vomiting; Stomachache; Rash; Tiredness». |
Concordia International - formerly AMCo (2015) Package leaflet: Information for the user Fosfomycin 3 g, granules for oral solution Fosfomycine Trometamol. Disponible en: https://www.medicines.org.uk/emc/files/pil.7219.pdf [Consultado: 25-05-2018] | «Fomicyt 40mg/ml Powder for Solution for Infusion; Fosfomycin 3 g granules for oral solution; Monuril 3g granules for oral solution». | Precautions: «Do not take Fosfomycin: if you are allergic to fosfomycin or any of the other ingredients of this medicine; if you suffer from severe kidney problems; if you are undergoing haemodialysis (a procedure used to clean the blood by filtering out wastes and extra fluids, when the kidneys are not functioning). Talk to your doctor, pharmacist or nurse before taking Fosfomycin, especially: - if you have an intolerance to some sugars (see below); - if you have previously experienced diarrhoea upon administration of any other antibiotics». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Fosfomicina | «Bactericida. Inhibe la síntesis de pared bacteriana por bloqueo irreversible de UDP-N-acetil-glucosamina». | Vademecum (2016) Fosfomicina. Disponible en: https://www.vademecum.es/principios-activos-fosfomicina-J01XX01 [Consultado: 29-05-2018] | «Infección urinaria no complicada, gastrointestinal, dermatológica. Infección urinaria recurrente en ancianos. Profilaxis de infección urinaria antes de intervención quirúrgica o maniobra transuretral diagnóstica. Infección genitourinaria, respiratoria, de tejido blando. Infección urinaria complicada o grave, dermatológica, ginecológica, respiratoria, del aparato locomotor, quirúrgica, septicemia, endocarditis, meningitis (asociada a otros antibióticos), infección hospitalaria grave, meningitis estafilocócica meticilín resistente». | «Oral: - Infección urinaria no complicada, gastrointestinal, dermatológica. Ads.: 0,5-1 g/8 h o 3 g en una sola dosis. Niños > 1 año: 250-500 mg/8 h. 6-12 años: 2 g en una sola dosis. Prematuros y lactantes: 150-300 mg/8 h. - Infección urinaria recurrente en ancianos: 2-3 g/24 h, 2 días. - Profilaxis de infección urinaria antes de intervención quirúrgica o maniobra transuretral diagnóstica: 3 g, 3 h antes y 24 h después. IM: - Infección genitourinaria, respiratoria, de tejido blando. Ads.: 1-2 g/8 h. Infección grave: máx. 8 g/día. Niños > 2,5 años: 0,5-1 g/8 h. IV (en goteo, 1 h): - Infección urinaria complicada o grave, dermatológica, ginecológica, respiratoria, del aparato locomotor, quirúrgica, septicemia, endocarditis, meningitis (asociada a otros antibióticos), infección hospitalaria grave, meningitis estafilocócica meticilín resistente. Ads.: 4 g/6-8 h. Niños: 200-400 mg/kg/día en 2-3 administraciones. - I.R.: Clcr 20-40 ml/min: 4 g/12 h. Clcr 11-20: 4 g/24 h. Clcr ≤ 10: 4 g/48 h. - Hemodializados: 2-4 g tras hemodiálisis». |
«Exantema, urticaria, angioedema, reacción de hipersensibilidad grave, aumento de transaminasas y fosfatasa alcalina, alteración visual, inapetencia, disnea, broncoespasmo, cefalea, náuseas, pirosis, diarrea, vómitos, dispepsia, sobreinfección». | Vademecum (2016) Fosfomicina. Disponible en: https://www.vademecum.es/principios-activos-fosfomicina-J01XX01 [Consultado: 29-05-2018] | «FOSFOCINA Cáps. 500 mg FOSFOCINA Polvo para susp. oral 250 mg/5 ml FOSFOCINA INTRAMUSCULAR Polvo y disolv. para sol. iny. 1 g FOSFOCINA INTRAVENOSA Polvo para sol. iny. 4 g FOSFOCINA INTRAVENOSA Polvo y disolv. para sol. iny. 1 g FOSFOMICINA KERN PHARMA Granulado para sol. oral 3 g FOSFOMICINA ABAMED Granulado para sol. oral en sobres 2 g FOSFOMICINA ABAMED Granulado para sol. oral en sobres 3 g FOSFOMICINA CALCICA SOLUFOS Cáps. 500 mg FOSFOMICINA FARMALIDER Granulado para sol. oral 3 g FOSFOMICINA LABIANA Granulado para sol. oral en sobres 2 g FOSFOMICINA LABIANA Granulado para sol. oral en sobres 3 g FOSFOMICINA LABIANA PHARMA Granulado para sol. oral en sobres 2 g FOSFOMICINA LABIANA PHARMA Granulado para sol. oral en sobres 3 g FOSFOMICINA LEVEL INTRAMUSCULAR Polvo y disolv. para sol. iny. 1 g FOSFOMICINA LEVEL INTRAVENOSA Polvo para sol. iny. 4 g FOSFOMICINA LEVEL INTRAVENOSA Polvo y disolv. para sol. iny. 1 g FOSFOMICINA PENSA Granulado para sol. oral 3 g FOSFOMICINA QUALIGEN Granulado para sol. oral 3 g FOSFOMICINA STADA Granulado para sol. oral 3 g FOSFOMICINA TARBIS Granulado para sol. oral 2 g FOSFOMICINA TARBIS Granulado para sol. oral 3 g UROSEPTIC Granulado para sol. oral 2000 mg UROSEPTIC Granulado para sol. oral 3 g» |
«No puede tomar fosfomicina en caso de hipersensibilidad; I.R. grave con Clcr < 10 ml/min; hemodializados; niños < 2,5 años (iny.); niños < 6 años (granulado para sol. oral). Precauciones: hipersensibilidad previa. Asociar en infección hospitalaria grave. I.R.: ajustar intervalo entre dosis. Absorción disminuida por alimento. Riesgo de colitis asociada al antibiótico (incluyendo colitis pseudomembranosa), iniciar medidas terapéuticas adecuadas en pacientes que desarrollen diarrea grave durante o después del uso de fosfomicina trometamol». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Gentamicin | «Gentamicin belongs to a group of antibiotics called ‘aminoglycosides’». |
Sanofi (2015) Package leaflet: information for the user Cidomicyn 80mg/2ml solution for injection Gentamicin. Disponible en: https://www.medicines.org.uk/emc/files/pil.1264.pdf [Consultado: 25-05-2018] | «Cidomycin is used to treat infections caused by bacteria. This includes infections of the: Ŧ 6SJOBSZ USBDU JODMVEJOH ZPVS LJEOFZT PS bladder) Ŧ $IFTU JODMVEJOH ZPVS MVOHT Ŧ #MPPE Ŝ UIJT JT TPNFUJNFT DBMMFE ‘bacteraemia’ or ‘septicaemia’». |
«ADULTS: serious infections: If renal function is not impaired, 5mg/kg/daily in divided doses at six or eight hourly intervals. The total daily dose may be subsequently increased or decreased as clinically indicated. Systemic infections: If renal function is not impaired, 3-5mg/kg/day in divided doses according to severity of infection, adjusting according to clinical response and body weight. Urinary tract infections: As “Systemic infections”. Or, if renal function is not impaired, 160mg once daily may be used. PAEDIATRIC PATIENTS: The daily dose recommended in children aged 1 year and above and adolescents with normal renal function, is 3-6 mg/kg body weight per day as 1 (preferred) up to 2 single doses. The daily dose in infants after the first month of life is 4.5-7.5 mg/kg body weight per day as 1 (preferred) up to 2 single doses. The daily dose in neonates and pre-term infants (aged 0-4 weeks old) is 4-7 mg/kg body weight per day. Due to the longer half-life, newborns are given the required daily dose in 1 single dose. THE ELDERLY: There is some evidence that elderly patients may be more susceptible to aminoglycoside toxicity whether secondary to previous eighth nerve impairment or borderline renal dysfunction. Accordingly, therapy should be closely monitored by frequent determination of gentamicin serum levels, assessment of renal function and signs of ototoxicity. In impaired renal function, the recommended daily dose has to be decreased and adjusted to the renal function. The recommended dose and precautions for intramuscular and intravenous administration are identical. Gentamicin when given intravenously should be injected directly into a vein or into the drip set tubing over no less than three minutes. If administered by infusion, this should be over no longer than 20 minutes and in no greater volume of fluid than 100ml». |
«Tell your doctor or nurse as soon as possible if any of the following side effects happen: Ear problems: these may happen because Cidomycin can sometimes damage the ear, especially if your kidneys do not work very well. The side effects are: Difficulty keeping your balance, feeling dizzy, poor hearing. Kidney problems: if you notice anything unusual when you pass water, such as: If your see any sign of blood in your water (urine), if you find you are passing less water than is normal for you. is normal for you. Nerve or muscle problems: If you have unusual difficulty in moving which has not happened before, if you have a feeling of weakness or unusual tiredness, if you have any breathing difficulties that have not happened before, numbness, weakness and pain in the arms and legs (peripheral neuropathy). If you are not sure if you have any of the above, talk to your doctor or nurse as soon as possible. Tell your doctor or nurse if any of the following side effects get serious or last longer than a few days: allergic (also called hypersensitivity) reactions, such as nettle rash or difficulty breathing, headache, feeling tired, purplish or reddish-brown skin colouring, mouth ulcers, feeling or being sick (nausea or vomiting), rash, bloody diarrhoea, fits or convulsions, depression, strange visions or sounds (hallucinations) and memory loss». |
Sanofi (2015) Package leaflet: information for the user Cidomicyn 80mg/2ml solution for injection Gentamicin. Disponible en: https://www.medicines.org.uk/emc/files/pil.1264.pdf [Consultado: 25-05-2018] | «Cidomycin 80mg/2ml Solution for Injection; Gentamicin 10mg/ml Solution for Injection or Infusion; Gentamicin 40 mg/ml Injection; Gentamicin 40mg/ml Solution for Injection or Infusion; Gentamicin Eye/Ear Drops 0.3%; Gentamicin Intrathecal 5mg/ml; Gentamicin Paediatric 20mg/2ml; Genticin (Gentamicin) 40mg/ml Injectable; Genticin Eye/Ear Drops/Gentamicin 0.3% w/v eye/ear drops; Gentisone HC Ear Drops/ Gentamicin 0.3% w/v and Hydrocortisone acetate 1% w/v Ear Drops». | Precautions: «Do not have this medicine if: you have Myasthenia Gravis. this is a disease that causes muscle weakness. You are allergic (hypersensitive) to gentamicin, any other antibiotics or to any of the other ingredients of this medicine». Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat and tongue. |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Gentamicina | «Bactericida. Penetra en la bacteria y se une a las subunidades ribosomales 30S y 50S inhibiendo la síntesis proteica». | Vademecum (2018) Gentamicina. Disponible en: https://www.vademecum.es/principios-activos-gentamicina-J01GB03 [Consultado: 29-05-2018] | «Septicemia (incluyendo bacteriemia y sepsis neonatal); infecciones de la piel y tejidos blandos (incluyendo quemaduras); infecciones de las vías respiratorias incluyendo pacientes con fibrosis quística; infecciones del SNC (incluyendo meningitis y ventriculitis); infecciones complicadas y recurrentes de las vías urinarias; infecciones óseas, incluyendo articulaciones; infecciones intra-abdominales, incluyendo peritonitis; endocarditis bacteriana». | «IM/IV. Ads., infección grave: 1 mg/kg/8 h o bien 3 mg/kg/24 h en perfus. IV (30-60 min), 7-10 días; en riesgo vital: máx. 5 mg/kg/día, repartido en 3-4 dosis; infección respiratoria, fibrosis quística: 8-10 mg/kg/día; infección urinaria: 2 mg/kg/día. Niños: 2-2,5 mg/kg/8 h. Lactantes y recién nacidos > 1 sem: 2,5 mg/kg/8 h. Prematuros o recién nacidos a término de hasta 1 sem: 2,5 mg/kg/12 h. Duración habitual: 7-10 días. En pacientes obesos: dosis inicial debe calcularse en el peso ideal más un 40 % de exceso de peso. Pacientes con quemaduras y pacientes con infecciones graves pueden ser necesario administrar cada 4-6 h. I.R.: inicial, 1 mg/kg; mantenimiento: disminuir dosis en función del Clcr o prolongar intervalo de dosificación. Hemodializados: 1-1,7 mg/kg tras la diálisis». |
«Nefrotoxicidad: elevaciones de creatinina sérica, albuminuria, presencia en orina de cilindros, leucocitos o eritrocitos, azotemia, oliguria; neurotoxicidad-ototoxicidad: toxicidad del VIII par craneal (pérdida de la audición, vértigo, daño coclear incluyendo pérdida de la audición en frecuencias altas), mareos, ataxia, vértigo, tinnitus, zumbido de oídos; neurotoxicidad-bloqueo neuromuscular: parálisis muscular aguda y apnea, entumecimiento, hormigueo, espasmos musculares y convulsiones. Además: lesión renal aguda, pérdida de audición irreversible y sordera. En tto. prolongado y dosis altas: síndrome adquirido de Fanconi». | Vademecum (2018) Gentamicina. Disponible en: https://www.vademecum.es/principios-activos-gentamicina-J01GB03 [Consultado: 29-05-2018] | «GENTA GOBENS Sol. iny. 40 mg/2 ml GENTA GOBENS Sol. iny. 80 mg/2 ml GENTA-GOBENS Sol. iny. 240 mg/3 ml GENTAMICINA BRAUN Sol. iny. 20 mg/2 ml GENTAMICINA BRAUN Sol. iny. 40 mg/2 ml GENTAMICINA BRAUN Sol. iny. 80 mg/2 ml GENTAMICINA BRAUN Sol. para perfusión IV 3 mg/ml GENTAMICINA IV BRAUN Sol. para perfusión 1 mg/1 ml» |
«No puede tomar gentamicina si presenta hipersensibilidad a aminoglucósidos. No debe administrarse simultáneamente con productos neuro o nefrotóxicos ni con potentes diuréticos. Precauciones: en caso de insuficiencia renal, ajustar la dosis y monitorizar: inicial, 1 mg/kg; mantenimiento: disminuir dosis en función del Clcr o prolongar intervalo de dosificación. Hemodializados: 1-1,7 mg/kg tras la diálisis. Prematuros, recién nacidos y ancianos; monitorizar; evitar nivel plasmático pico > 12 mcg/ml y valle > 2 mcg/ml; riesgo de sobreinfección por microorganismos resistentes, de bloqueo neuromuscular con anestesia, y de nefrotoxicidad y ototoxicidad (monitorizar funciones auditiva y renal, ajustar dosis o suspender tto.); trastorno neurológico o muscular como miastenia gravis y párkinson; mantener buena hidratación; no emplear dosis única diaria en inmunocomprometidos, I.R. y embarazo». | Irene Abellán Serrano |
| Pharmacology | Antifungical for systemic use | Infectious diseases | Griseofulvin | «Griseofulvin is an antifungal antibiotic. It works by helping the newly formed skin, hair and nails to resist attack by fungi. As the new tissue grows, the old and infected is cast off». |
Brown and Burk UK Ltd (2011) Griseofulvin 125 mg and 500 mg Tablets Griseofulvin. Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1430459732990.pdf [Consultado: 26-05-2018] | «Griseofulvin kills the fungi that cause infections of: the skin, scalp, hair or nails». |
«Adults: the usual dose is 500 mg to 1000 mg once daily. Your doctor may ask you to take a smaller dose several times a day. Children: follow your doctor's instructions. Keep taking the tablets for at least two weeks after all signs of infection have disappeared. You may need to take Griseofulvin every day for many weeks or months while new skin, hair or nails grow. This depends upon the thickness of keratin (hair, nails) at the site of infection. For toe or finger nails you may need 6 to 12 months treatment. For hair or skin at least 4 weeks treatment is required». |
«STOP taking the tablets and seek medical help immediately if you have any of the following allergic reactions: difficulty breathing or swallowing, swelling of the face, lips, tongue or throat severe itching of the skin, with a red rash or raised lumps. Seek immediate medical attention if you have any of the following symptoms: yellowing of the skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness fever, sore throat, mouth ulcers, repeated infections or infections that will not go away butterfly-shaped skin rash over the nose and cheeks made worse by exposure to the sun. Tiredness and joint pains. Tell your doctor if you get any of the following side effects: reactions to the sun. Your skin may become red, painful and swollen - do not sunbathe, use a sun bed, or expose your skin to artificial UV light feeling confused, dizzy or unsteady feeling tired, drowsy or sleepy feeling of numbness and tingling in hands and feet griseofulvin may upset normal sperm production. Men wishing to father children within six months of treatment should discuss the possible side effects with their doctor. The following side effects usually settle without changing the dose: diarrhoea and stomach problems nausea and vomiting headache». |
Brown and Burk UK Ltd (2011) Griseofulvin 125 mg and 500 mg Tablets Griseofulvin. Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1430459732990.pdf [Consultado: 26-05-2018] | «Griseofulvin 125 mg tablets; Griseofulvin 500 mg tablets; Grisol 1% Spray solution; Grisol 1% AF Spray solution». | Precautions: «Do NOT take Griseofulvin tablets if you: are allergic to griseofulvin are pregnant or intending to become pregnant within 1 month of stopping treatment are planning to father children within 6 months of treatment with these tablets have severe liver disease have porphyria (a metabolism disorder which causes abdominal pains and mental disorder) have systemic lupus erythematosus (a disorder which causes the immune system to attack the body). Griseofulvin tablets must not be taken if your skin, hair or nails are healthy, as a precaution to prevent a long-past infection returning. Griseofulvin may increase the effect of alcohol». |
Irene Abellán Serrano | Farmacología | Antifúngicos para uso sistémico | Enfermedades infecciosas | Griseofulvina | «Antifúngico Inhibe la mitosis celular fúngica por destrucción de la estructura del uso mitótico, interrumpiéndose la metafase de la división celular». | Vademecum (2015) Griseofulvina. Disponible en: https://www.vademecum.es/principios-activos-griseofulvina-D01BA01 [Consultado: 29-05-2018] | «Infecciones fúngicas de la piel, cabello y uñas». | «Oral, ads.: 500-1.000 mg/día, niños: 10 mg/kg/día; en dosis única o divididas (después de las comidas)». | «Erupción cutánea, urticaria, cefaleas, molestias gastrointestinales, mareos, fatiga, granulocitopenia, leucopenia». | Vademecum (2015) Griseofulvina. Disponible en: https://www.vademecum.es/principios-activos-griseofulvina-D01BA01 [Consultado: 29-05-2018] | «Fulvicin P/G; Fulvicin-U/F; Grifulvin V; Gris-PEG; Grisactin; Grisactin Ultra; Griseofulvina Ultra». | «No puede tomar griseofulvina en los siguientes casos: porfiria, I.H., lupus eritematoso, embarazo. Precauciones: lactancia. Puede dañar las células espermáticas. Puede elevar falsamente los niveles renales del ác. vanililmándelico. Con anticonceptivos orales riesgo de hemorragia, amenorrea y fracaso del anticonceptivo, tomar medidas contraceptivas adicionales durante y hasta 1 mes después del tto.». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Imipenem + cilastatin | «Imipenem/Cilastatin belongs to a group of medicines called carbapenem antibiotics. It kills a wide range of bacteria (germs) that cause infections in various parts of the body in adults and children one year of age and above». |
Hospira UK Ltd (2018) Package leaflet: Information for the user Imipenem/Cilastatin 500 mg/500 mg Powder for Solution for Infusion. Disponible en: https://www.medicines.org.uk/emc/files/pil.4593.pdf [Consultado: 26-05-2018] | «Your doctor has prescribed Imipenem/Cilastatin because you have one (or more) of the following types of infection: Complicated infections in the abdomen Infection affecting the lungs (pneumonia) Infections that you can catch during or after the delivery of your baby Complicated urinary tract infections Complicated skin and soft tissue infections Imipenem/Cilastatin may be used in the management of patients with low white blood cell counts, who have fever that is suspected to be due to a bacterial infection. Imipenem/Cilastatin may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above». |
«Use in adults and adolescents The recommended dose of Imipenem/Cilastatin for adults and adolescents is 500 mg/500 mg every 6 hours or 1,000 mg/1,000 mg every 6 or 8 hours. If you have kidney problems your doctor may lower your dose. Use in children The recommended dose for children one year of age or older is 15/15 or 25/25 mg/kg/dose every 6 hours. Imipenem/Cilastatin is not recommended in children under one year of age and children with kidney problems. Method of administration Imipenem/Cilastatin is given intravenously (into a vein) over 20-30 minutes for a dose of ≤500 mg/500 mg or 40-60 minutes for a dose of >500 mg/500 mg. The rate of infusion may be slowed if you feel sick». |
«Common (may affect up to 1 in 10 people): Nausea, vomiting, diarrhoea. Nausea and vomiting appear to occur more frequently in patients with low number of white blood cells Swelling and redness along a vein which is extremely tender when touched Rash Abnormal liver function detected by blood tests Increase in some white blood cells Uncommon (may affect up to 1 in 100 people): Local skin redness Local pain and formation of a firm lump at the injection site Skin itchiness Hives Fever Blood disorders affecting the cell components of the blood and usually detected by blood tests (symptoms may be tiredness, paleness of skin, and prolonged bruising after injury) Abnormal kidney, liver and blood function detected by blood tests Tremors and uncontrolled twitching of muscles Seizures (fits) Psychic disturbances (such as mood swings and impaired judgment) Seeing, hearing or feeling something that is not there (hallucinations) Confusion Dizziness, sleepiness Low blood pressure». |
Hospira UK Ltd (2018) Package leaflet: Information for the user Imipenem/Cilastatin 500 mg/500 mg Powder for Solution for Infusion. Disponible en: https://www.medicines.org.uk/emc/files/pil.4593.pdf [Consultado: 26-05-2018] | «Imipenem/Cilastatin 500 mg/500 mg Powder for Solution for Infusion». | Precautions: «Do not use Imipenem/Cilastatin - if you are allergic to imipenem, cilastatin or any of the other ingredients of this medicine; if you are allergic to other antibiotics such as penicillins, cephalosporins, or carbapenems. Talk to your doctor or nurse before using Imipenem/Cilastatin about any medical condition you have or have had including: - allergies to any medicines including antibiotics (sudden life-threatening allergic reactions require immediate medical treatment) - colitis or any other gastrointestinal disease - kidney or urinary problems, including reduced kidney function (Imipenem/Cilastatin blood levels increase in patients with reduced kidney function. Central nervous system adverse reactions may occur if the dose is not adjusted to the kidney function) - any central nervous system disorders such as localized tremors or epileptic seizures (fits) - liver problems You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells. Your doctor will discuss this with you. Children Imipenem/Cilastatin is not recommended in children less than one year of age or children with kidney problems». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Imipenem + cilastatina | «Antibiótico ß-lactámico de amplio espectro, asociado a un inhibidor del metabolismo renal que aumenta su concentración». | Vademecum (2015) Imipenem + Cilastatina. Disponible en: https://www.vademecum.es/principios-activos-imipenem+%2B+cilastatina-J01DH51+P1 [Consultado: 20-05-2018] | «Ads. y niños > 1 año: infecciones complicadas intraabdominales, del tracto urinario, y de piel y tejidos blandos; infección intraparto y postparto; neumonía grave, incluidas nosocomial y asociada a ventilación; sospecha de infección bacteriana en pacientes neutropénicos con fiebre, tto. de bacteriemia asociada o se sospecha asociada a infecciones anteriores». | «Mg imipenem/mg cilastatina. Perfus. IV (reconstitución y dilución previa): 20-30 min para dosis ≤ 500/500 mg; 40-60 min para dosis > 500/500 mg. Si se producen náuseas puede reducirse la velocidad de perfus. - Ads. y adolescentes. Con p.c. ≥ 70 kg: 500/500 mg/6 h o 1.000/1.000 mg/8 ó 6 h; dosis recomendada si se sospecha o demuestra infección por patógeno menos sensible (por ej. P. aeruginosa ), o la infección es muy grave (p. ej. neutropenia con fiebre): 1.000/1.000 mg/6 h. Ajustar y calcular dosis con p.c. < 70 kg según fórmula: p.c. (kg) x dosis estándar/70 (kg). Dosis máx./día: 4.000/4.000 mg. - Niños ≥ 1 año: 15/15 mg ó 25/25 mg/kg/6 h; dosis recomendada si se sospecha o demuestra infección por patógeno menos sensible (por ej. P. aeruginosa ), o la infección es muy grave (p. ej. neutropenia con fiebre): 25/25 mg/6 h. I.R. Ads..: seleccionar dosis/día con función renal normal y administrar la dosis según Clcr. Hemodializados: al terminar sesión y cada 12 h a partir de ese momento». |
«Náuseas y vómitos (más frecuentes con granulocitopenia), diarrea, erupción (p. ej. exantematosa), eosinofilia, trombocitosis, fiebre, hipotensión, convulsiones, mareos, prurito, urticaria, somnolencia, aumento de transaminasas, bilirrubina y/o de fosfatasa alcalina séricas; flebitis/tromboflebitis, induración de vena, dolor y eritema en lugar de iny.». | Vademecum (2015) Imipenem + Cilastatina. Disponible en: https://www.vademecum.es/principios-activos-imipenem+%2B+cilastatina-J01DH51+P1 [Consultado: 20-05-2018] | «IMIPENEM/CILASTATINA AUROVITAS Polvo para sol. para perfusión 500/500 mg IMIPENEM/CILASTATINA KABI Polvo para sol. para perfusión 250/250 mg IMIPENEM/CILASTATINA KABI Polvo para sol. para perfusión 500/500 mg» |
«No puede tomar imipenem + cilastatina en los siguientes casos: hipersensibilidad a componentes y a carbapenémicos. Antecedente de hipersensibilidad grave a ß- lactámicos, antes de iniciar tto. investigar reacciones de hipersensibilidad previa a ß- lactámicos u otros alérgenos. Precauciones: suspender tto. en caso de reacción alérgica y prever tto. urgente ante posible anafilaxis. Vigilar función hepática, riesgo de hepatotoxicidad. I.R., ajustar dosis; mayor riesgo de convulsiones en especial con Clcr 6-30 ml/min y en hemodializados (valorar beneficio riesgo); no usar con Clcr ≤ 5 ml/min salvo que se instituya hemodiálisis en 48 h; vigilar a dializados, en especial con antecedente de enf. del SNC. Mayor riesgo de efectos adversos en SNC (mioclonías, confusión, convulsiones) con trastornos del SNC (lesión cerebral o antecedente de convulsiones) y/o I.R por riesgo de sobredosificación; evaluar y establecer/mantener tto. anticonvulsivo, y suspender tto. o ajustar dosis en caso de persistencia. Vigilancia estrecha de síntomas neurológicos o convulsiones en niños con factores de riesgo o tto. reductor del umbral convulsivo. Datos clínicos insuficientes para recomendar dosis en niños < 1 año y en niños con I.R. No recomendado en tto. de meningitis. No es de elección en tto. de infecciones por patógenos de sensibilidad limitada salvo que esté documentado y se conozca sensibilidad, o se sospeche de alta sensibilidad al tto. de los patógenos probables. Podría asociarse con: un agente anti-S. aureus cuando se sospeche o demuestre infección por este patógeno; con un aminoglucósido cuando se sospeche o demuestre infección por P. aeruginosa. Riesgo de colitis asociada a antibióticos y de colitis pseudomembranosa, valorar suspensión del tto. en caso de aparición. Concomitancia no recomendada con ác. valproico. En caso de insuficiencia renal con antecedente de trastorno hepático asociado al tto., vigilar función hepática. En caso de insuficiencia renal, precaución, mayor riesgo de efectos adversos en SNC. Sin datos clínicos en niños. Ajustar dosis en ads. según Clcr (ml/min/1,73 m 2 ) y dosis/día con función renal normal según gravedad: - Si 2.000/2.000 mg/día con función renal normal. Con Clcr 41-70: 500/500 mg/8 h; con Clcr 21-40: 250/250 mg/6 h; con Clcr 6-20 y dializados con Clcr ≤ 5: 250/250 mg/12 h. - Si 3.000/3.000 mg/día con función renal normal. Con Clcr 41-70: 500/500 mg/6 h; con Clcr 21-40: 500/500 mg/8 h; con Clcr 6-20 y dializados con Clcr ≤ 5: 500/500 mg/12 h. - Si 4.000/4.000 mg/día con función renal normal. Con Clcr 41-70: 750/750 mg/8 h; con Clcr 21-40: 500/500 mg/6 h; con Clcr 6-20 y dializados con Clcr ≤ 5: 500/500 mg/12 h». |
Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Itraconazole | «Itraconazole, a member of the following pharmacotherapeutic class of drugs: Antimycotic for systemic use, triazole derivatives». |
Accord-UK Ltd (2017) Package leaflet: information for the user Itraconazole 100mg Capsules, Hard. Disponible en: https://www.medicines.org.uk/emc/files/pil.5914.pdf [Consultado: 26-05-2018] | «Itraconazole is very effective against a variety of infections caused by yeasts and fungi. It has great affinity for highly keratinized tissues such as skin and nails, as well as for the vaginal wall lining». |
«Vaginal infections: 2 capsules (200mg itraconazole) twice a day (1 day)/2 capsules (200mg itraconazole) once a day (3 days); Skin infections: 2 capsules (200mg itraconazole) once a day (7 days)/1 capsule (100mg itraconazole) once a day (15 days) (If there is a thin layer of callus on the palms of the hands or soles of the feet, it may be necessary to take 2 capsules (200mg itraconazole) twice a day for 7 days or 1 capsule (100mg itraconazole) once a day for one month.); Infections of the mouth: 1 capsule (100mg itraconazole) once a day (15 days); Infections of the internal organs: higher doses (longer periods); For nail infections, depending on your specific requirements, your doctor may opt for continuous or pulse treatment: Continuous nail treatment: 2 capsules (200mg itraconazole) once a day (3 months)/Pulse nail treatment: Toenails with or without fingernail involvement: Take 2 capsules (200mg itraconazole) twice a day (week 1) - Take 2 Capsules (200mg itraconazole) twice a day (week 5) - Take 2 capsules (200mg itraconazole) twice a day (week 9); Finger nails only: Take 2 capsules (200mg itraconazole) twice a day (week 1) - Take 2 capsules (200 mg itraconazole) twice a day (week 5)». |
«Stop using itraconazole and tell your doctor straight away if you notice or suspect any of the following. You may need urgent medical treatment. • Sudden signs of allergy such as rash, hives (also known as nettle rash or urticaria), severe irritation of your skin, swelling of the face, lips, tongue or other parts of the body. These may be signs of a severe allergic reaction. This only happens in a small number of people. • Severe skin disorders with peeling and/ or rashes with small pustules (with a fever) or blistering of the skin, mouth, eyes and genitals, with fever, chills, aching muscles and generally feeling unwell. (the precise frequency of how often these may occur is not known) • A tingling sensation, numbness or weakness in your limbs (the precise frequency of how often this may occur is not known) • Severe lack of appetite, feeling sick (nausea), being sick (vomiting), unusual tiredness, stomach pain, muscle weakness, yellowing of your skin or whites of your eyes (jaundice), unusually dark urine, pale stools or hair loss. These may be signs of a liver problem. This only happens in a small number of people • Shortness of breath, unexpected weight gain, swelling of your legs or abdomen, feeling unusually tired or waking up short of breath at night. These may be signs of heart failure. Shortness of breath can also be a sign of fluid on the lungs (this only happens in a small number of people). Tell your doctor or pharmacist if you notice any of the following side effects: Common (may affect up to 1 in 10 people) • Stomach ache, feeling sick (nausea). Uncommon (may affect up to 1 in 100 people) • Problems with periods • Headache, dizziness • Constipation, diarrhoea, wind, being sick (vomiting), indigestion, change in taste • Swelling due to fluid under the skin • Unusual hair loss or thinning (alopecia) • Red, itchy, flaking or peeling skin». |
Accord-UK Ltd (2017) Package leaflet: information for the user Itraconazole 100mg Capsules, Hard. Disponible en: https://www.medicines.org.uk/emc/files/pil.5914.pdf [Consultado: 26-05-2018] | «Itraconazole 10 mg/ml Oral Solution; Itraconazole 100 mg Capsules; Itraconazole 100 mg Capsules, hard; Sporanox 10 mg/ml Oral Solution; Patient Leaflet Sporanox Capsules; Sporanox I.V. 10 mg/ml concentrate and solvent for solution for infusion; Sporanox-Pulse». |
Precautions: «Do not take Itraconazole capsules if: • you are allergic to itraconazole, • you are pregnant or could become pregnant unless your doctor has told you to. Talk to your doctor or pharmacist before taking Itraconazole capsules if: • you have ever had kidney problems. Your dose of itraconazole capsules may have to be changed • you have ever had liver problems such as yellow skin (jaundice). Your dose of itraconazole capsules may have to be changed. If after taking this medicine you have a severe lack of appetite, feel sick (nausea), are sick (vomiting), feel unusually tired, get stomach pain, muscle weakness, yellowing of the skin or whites of the eyes, unusually dark urine, pale stools or hair loss. Stop taking itraconazole capsules and tell your doctor straight away • you have ever had a heart problem including heart failure (also called congestive heart failure or CHF). Itraconazole capsules could make it worse. If after taking this medicine you get any of the following: - shortness of breath - unexpected weight gain - swelling of your legs or tummy - feel unusually tired - wake up short of breath at night stop taking itraconazole capsules and tell your doctor straight away. These may be signs of heart failure». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Itraconazol | «Antifúngico. Interfiere en la síntesis proteica de ergosterol en células micóticas». | Vademecum (2016) Itraconazol. Disponible en: https://www.vademecum.es/principios-activos-itraconazol-J02AC02 [Consultado: 29-05-2018] | «Histoplasmosis, infección fúngica sistémica resistente a antifúngico de 1ª elección, aspergilosis, candidiasis, criptococosis (incluyendo meningitis criptocócica) en inmunodeprimidos con criptococosis y en pacientes con criptococosis del SNC. Candidiasis oral y/o esofágica en VIH u otras inmunodeficiencias. Profilaxis de infección fúngica sistémica, si el tto. estándar no es adecuado, con neoplasia hematológica maligna o trasplantados de médula ósea, en los que cabe esperar neutropenia. Candidiasis vulvovaginal. Pitriasis versicolor. Dermatofitosis en zonas altamente queratinizadas (Tinea pedis, Tinea manus). Queratitis fúngica. Candidiasis oral. Onicomicosis por dermatofitos y candidas. Aspergilosis sistémica. Criptococosis no meníngea. Meningitis criptocócica. Histoplasmosis. Esporotricosis. Paracoccidioidomicosis. Cromomicosis. Blastomicosis. Pitiriasis versicolor. Dermatomicosis. Aspergilosis sistémica. Candidiasis sistémica. Histoplasmosis». | «Perfus. IV (1 h). Ads.: - Histoplasmosis, infección fúngica sistémica resistente a antifúngico de 1ª elección, aspergilosis, candidiasis, criptococosis (incluyendo meningitis criptocócica) en inmunodeprimidos con criptococosis y en pacientes con criptococosis del SNC: 200 mg/12 h, 2 días, seguido de 200 mg/24 h, máx. 14 días. Oral. Ads.: Itraconazol 100 mg (convencional): - Candidiasis oral y/o esofágica en VIH u otras inmunodeficiencias: 200 mg/24 h en 1-2 tomas, 1-2 sem; resistente a fluconazol: 100-200 mg/12 h, 2-4 sem; máx. 400 mg/24 h, 14 días. - Profilaxis de infección fúngica sistémica, si el tto. estándar no es adecuado, con neoplasia hematológica maligna o trasplantados de médula ósea, en los que cabe esperar neutropenia: 5 mg/kg/día en 2 tomas, inmediatamente antes del tto. con citostáticos y 1 sem antes de trasplante. - Candidiasis vulvovaginal: 200 mg/12 h, 1 día o 200 mg/24 h, 3 días. - Pitiriasis versicolor: 200 mg/24 h, 7 días. - Dermatofitosis: 200 mg/24 h, 7 días o 100 mg/24 h, 15 días. En zonas altamente queratinizadas (Tinea pedis, Tinea manus): 200 mg/12 h, 7 días o 100 mg/24 h, 30 días. - Queratitis fúngica: 200 mg/24 h, 21 días. - Candidiasis oral: 100 mg/24 h, 15 días. - Onicomicosis por dermatofitos y candidas: tto. pulsátil o tto. continuo. Pulsátil: 1 ciclo = 200 mg/12 h, 1 sem + 3 sem sin tto. Pies o pies + manos: 3 ciclos. Manos: 2 ciclos. Continuo: 200 mg/24 h, 3 meses. - Aspergilosis sistémica: 200 mg/24 h, 2-5 meses. Candidiasis sistémica: 100-200 mg/24 h, 3 sem-7 meses. Invasiva o diseminada: 200 mg/12 h. - Criptococosis no meníngea: 200 mg/24 h, 2-12 meses. Meningitis criptocócica: 200 mg/12 h, 2-12 meses. - Histoplasmosis: 200 mg/12-24 h, 8 meses. - Esporotricosis: 100 mg/24 h, 3 meses. - Paracoccidioidomicosis: 100 mg/24 h, 6 meses. - Cromomicosis: 100-200 mg/24 h, 6 meses. - Blastomicosis: 100 mg/24 h o 200 mg/12 h, 6 meses. Itraconazol 50 mg: - Pitiriasis versicolor: 100 mg/24 h, 7 días. - Dermatomicosis: tiña corporal, tiña crural: 50 mg/24 h, 2 sem; tiña de la mano, tiña del pie: 50 mg/24 h, 4 sem; tiña ungueal: 100 mg/24 h, 12 sem. - Aspergilosis sistémica: 100 mg/24 h, 2-5 meses. Candidiasis sistémica: 50-100 mg/24 h, 3 sem-7 meses. Invasiva o diseminada: 100 mg/12 h. - Histoplasmosis: 100 mg/12-24 h, 8 meses». |
«Dolor abdominal, náuseas; exantema. Además IV: hipopotasemia; dolor de cabeza, mareos; disnea; vómitos, diarrea, estreñimiento; hepatitis, ictericia, hiperbilirrubinemia, incremento de enzimas hepáticas; prurito; edema, pirexia». | Vademecum (2016) Itraconazol. Disponible en: https://www.vademecum.es/principios-activos-itraconazol-J02AC02 [Consultado: 29-05-2018] | «CANADIOL Cáps. 100 mg CANADIOL Sol. oral 10 mg/ml HONGOSERIL Cáps. 100 mg ITRACONAZOL ALTER EFG Cáps. 100 mg ITRACONAZOL CINFA Cáps. 100 mg ITRACONAZOL GENFARMA Concentrado para sol. para perfusión 10 mg/ml ITRACONAZOL MYLAN Cáps. dura 100 mg ITRACONAZOL NORMON Cáps. dura 100 mg ITRACONAZOL SANDOZ Cáps. 100 mg ITRACONAZOL STADA Cáps. dura 100 mg ITRACONAZOL TARBIS Cáps. dura 100 mg ITRACONAZOL TECNIGEN EFG Cáps. 100 mg ITRAGERM Cáps. dura 50 mg SPORANOX Cáps. 100 mg» |
«No puede tomar itraconazol en los siguientes casos: hipersensibilidad. Concomitancia con: terfenadina, astemizol, bepridil, mizolastina, cisaprida, triazolam y midazolam oral, dofetilida, levacetilmetadol, sertindol, quinidina, pimozida, simvastatina, lovastatina, atorvastatina, dronedarona, dabigatrán, alcaloides del cornezuelo del centeno (dihidroergotamina, ergometrina, ergotamina y metilergometrina), eletriptán, nisoldipino, disopiramida o halofantrina (salvo en indicaciones que sean potencialmente mortales). Embarazo, lactancia o pacientes con evidencia de disfunción ventricular como ICC o historial de ICC (salvo en tto. de infecciones en las que peligra la vida del paciente o en otras infecciones graves). Precauciones: hipersensibilidad a azoles, ancianos, niños, I.R., I.H. monitorizar. Valorar riesgo beneficio en ICC o con historia de la misma, monitorizar e interrumpir el tto. si aparecen signos/síntomas de ICC. Riesgo de hepatotoxicidad, monitorizar; suspender tto. y realizar PFH si aparece hepatitis (instruir al paciente de los signos). Suspender tto. si aparece neuropatía. Notificada pérdida transitoria o permanente de audición. Observado descenso transitorio asintomático de la fracción de eyección del ventrículo izdo. Concomitancia con: bloqueadores canales Ca por aumento del riesgo de ICC; inductores CYP3A4 (rifampicina, rifabutina, fenobarbital, fenitoína, carbamazepina, hipérico, isoniazida) por riesgo de reducir biodisponibilidad, no usar hasta pasadas 2 sem de suspender tto. con inductor. Se recomienda tomar itraconazol oral convencional con refresco de cola en caso de aclorhidria o tto. supresor de secreción gástrica (antagonistas H2 o inhibidores de bomba de protones por ej.). Antes de iniciar tto. de candidiasis sistémica comprobar sensibilidad a itraconazol ante sospecha de cepas de Candida resistentes a fluconazol. No recomendado vía oral como tto. inicial de micosis sistémicas potencialmente mortales. Precaución en: inmunodeprimidos o pacientes con SIDA. En caso de insuficiencia hepática, riesgo de hepatotoxicidad, monitorizar e interrumpir tto. y realizar PFH si aparece hepatitis (instruir al paciente de los signos). En caso de insuficiencia renal, evaluar por riesgo de ICC». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Levofloxacin | «Levofloxacin belongs to a group of medicines called antibiotics. Levo oxacin is a ’quinolone’ antibiotic. It works by killing the bacteria that cause infections in your body». |
Accord Healthcare Limited (2014) Package leaflet: information for the user Levofloxacin 250 mg Film-coated Tablets Levofloxacin 500 mg Film-coated Tablets. Disponible en: https://www.medicines.org.uk/emc/files/pil.6129.pdf [Consultado: 26-05-2018] | «Levofloxacin is an antibiotic which is used to treat bacterial infections of the sinuses lungs, in people with long-term breathing problems or Pneumonia urinary tract, including your kidneys or bladder prostate gland, where you have a long lasting infection skin and underneath the skin, including muscles. This is sometimes called ‘soft tissue’ In some special situations, Levofloxacin Tablets may be used to lessen the chances of getting a pulmonary disease named anthrax or worsening of the disease after you are exposed to the bacteria causing anthrax». |
«Adults and the elderly Sinuses infection • Two tablets of Levofloxacin Tablets 250 mg, once each day • Or, one tablet of Levofloxacin Tablets 500 mg, once each day Lungs infection, in people with long-term breathing problems • Two tablets of Levofloxacin Tablets 250 mg, once each day • Or, one tablet of Levofloxacin Tablets 500 mg, once each day Pneumonia • Two tablets of Levofloxacin Tablets 250 mg, once or twice each day • Or, one tablet of Levofloxacin Tablets 500 mg, once or twice each day Infection of urinary tract, including your kidneys or bladder • One or two tablets of Levofloxacin Tablets 250 mg, each day • Or, 1/2 or one tablet of Levofloxacin Tablets 500 mg, each day Prostate gland infection • Two tablets of Levofloxacin Tablets 250 mg, once each day • Or, one tablet of Levofloxacin Tablets 500 mg, once each day Infection of skin and underneath the skin, including muscles • Two tablets of Levofloxacin Tablets 250 mg, once or twice each day • Or, one tablet of Levofloxacin Tablets 500 mg, once or twice each day. Adults and the elderly with kidney problems Your doctor may need to give you a lower dose. Children and adolescents This medicine must not be given to children or teenagers. |
«Tell your doctor if any of the following side effects gets serious or lasts longer than a few days: Common (may affect up to 1 in 10 people) • Sleeping problems • Headache, feeling dizzy • Feeling sick (nausea, vomiting) and diarrhoea • Increase in the level of some liver enzymes in your blood Uncommon (may affect up to 1 in 100 people) • Changes in the number of other bacteria or fungi, infection by fungi named Candida, which may need to be treated • Changes in the number of white blood cells shown up in the results of some blood tests (leukopenia, eosinophilia) • Feeling stressed (anxiety), feeling confused, feeling nervous, feeling sleepy, trembling, a spinning feeling (vertigo) • Shortness of breath (dyspnoea) • Changes in the way things taste, loss of appetite, stomach upset or indigestion (dyspepsia), pain in your stomach area, feeling bloated (flatulence) or constipation • Itching and skin rash, severe itching or hives (urticaria), sweating too much (hyperhidrosis) • Joint pain or muscle pain • Blood tests may show unusual results due to liver (bilirubin increased) or kidney (creatinine increased) problems • General weakness. Rare (may affect up to 1 in 1,000 people) • Bruising and bleeding easily due to a lowering in the number of blood platelets (thrombocytopenia) • Low number of white blood cells (neutropenia) • Exaggerated immune response (hypersensitivity) • Lowering of your blood sugar levels (hypoglycaemia). This is important for people that have diabetes. • Seeing or hearing things that are not there (hallucinations, paranoia), change in your opinion and thoughts (psychotic reactions) with a risk of having suicidal thoughts or actions • Feeling depressed, mental problems, feeling restless (agitation), abnormal dreams or nightmares • Tingly feeling in your hands and feet (paraesthesia) • Problems with your hearing (tinnitus) or eyesight (blurred vision) • Unusual fast beating of your heart (tachycardia) or low blood pressure (hypotension) • Muscle weakness. This is important in people with myasthenia gravis (a rare disease of the nervous system). • Changes in the way your kidney works and occasional kidney failure which may be due to an allergic kidney reaction called interstitial nephritis. • Fever». |
Accord Healthcare Limited (2014) Package leaflet: information for the user Levofloxacin 250 mg Film-coated Tablets Levofloxacin 500 mg Film-coated Tablets. Disponible en: https://www.medicines.org.uk/emc/files/pil.6129.pdf [Consultado: 26-05-2018] | «Levofloxacin 250 mg Film-coated Tablets; Levofloxacin 5 mg/ml Solution for Infusion; Levofloxacin 500 mg Film-coated Tablets; Levofloxacin 500mg/100ml solution for infusion vials (5mg/ml in 100ml vials); Levofloxacin 5mg/ml Eye Drops Solution; Oftaquix 5 mg/ml eye drops, solution; Oftaquix Unit Dose 5 mg/ml eye drops, solution in single dose container; Quinsair 240 mg nebuliser solution». | Precautions: «Do not take Levofloxacin Tablets and tell your doctor if: You are allergic to levofloxacin, any other quinolone antibiotic such as moxifloxacin, ciprofloxacin or ofloxacin or to any of the other ingredients of this medicine (listed in section 6). Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue. If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately. You have ever had epilepsy You have ever had a problem with your tendons such as tendonitis that was related to treatment with a ‘quinolone antibiotic'. A tendon is the cord that joins your muscle to your skeleton. You are a child or a growing teenager You are pregnant, trying to become pregnant or are breast-feeding. Do not take this medicine if any of the above applies to you. If you are not sure, talk to your doctor or pharmacist before taking Levofloxacin Tablets. Talk to your doctor or pharmacist before taking Levofloxacin Tablets if: You are 60 years of age or older. You are using corticosteroids, sometimes called steroids (see section “Other medicines and Levofloxacin Tablets”). You have ever had a fit (seizure). You have had damage to your brain due to a stroke or other brain injury. You have kidney problems. You have something known as ‘glucose – 6 – phosphate dehydrogenase deficiency’. You are more likely to have serious problems with your blood when taking this medicine. You have ever had mental health problems. You have ever had Heart problems : Caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes (see section Other medicines and Levofloxacin Tablets). You are diabetic You have ever had liver problems You have myasthenia gravis. Other warnings Levofloxacin may rarely cause pain and inflammation in tendons. Particularly if you are elderly or are taking steroid medicines (such as cortisone or hydrocortisone). If you have any problems with your tendons whilst or shortly after taking levofloxacin, seek medical advice at once and rest the affected limb (leg or arm). Do not take the next dose of levofloxacin unless your doctor tells you to. In such as cases, you experience swelling or pain in the area of affected tendon. It may be necessary to stop treatment If you start having severe, persistent and/or bloody diarrhoea during or after treatment with levofloxacin, tell your doctor immediately. This could mean you have serious inflammation of your bowel (pseudomembranous colitis), which can sometimes occur after antibiotic treatment. You may need to stop taking levofloxacin and for your doctor to give you another medicine. Whilst taking Levofloxacin Tablets you are advised to stay out of strong sunlight and not to use a sun lamp. This is because some patients may become more sensitive to light whilst taking the tablets and get a sun-burn like reaction. Levofloxacin should be discontinued if the patient experiences symptoms Burning, tingling, pain or numbness. These may be signs of something called ‘neuropathy’. Levofloxacin is not an optimal therapy for most severe cases of Pneumococcal pneumonia. Infections got from a hospital during treatment due to P.aeruginosa may require combination therapy. Levofloxacin is not effective against infections caused by MRSA. In infections suspicious for MRSA levofloxacin should be combined with an agent approved to treat MRSA infections». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Levofloxacino | «Antibacteriano. Actúa sobre el complejo ADN-ADN girasa y sobre la topoisomerasa IV». | Vademecum (2016) Levofloxacino. Disponible en: https://www.vademecum.es/principios-activos-levofloxacino-J01MA12 [Consultado: 29-05-2016] | «Ads., tto. de: pielonefritis e infección urinaria complicada, prostatitis bacteriana crónica, cistitis no complicada, ántrax por inhalación (tto. y profilaxis tras exposición). Tto., cuando los antibacterianos recomendados sean inapropiados, de: sinusitis bacteriana aguda, exacerbación aguda de bronquitis crónica, neumonía adquirida en comunidad, infección complicada de piel y tejido blando». |
«Ads. Sinusitis bacteriana aguda: 500 mg, 1 vez/día oral, 10-14 días. Exacerbación aguda de bronquitis crónica: 500 mg, 1 vez/día oral, 7-10 días. Neumonía adquirida en la comunidad: 500 mg 1 ó 2 veces/día, 7-14 días oral o perfus. IV lenta. Pielonefritis: 500 mg, 1 vez/día oral o perfus. IV lenta, 7-10 días. Infección urinaria complicada: 500 mg 1 vez/día, 7-14 días oral o perfus. IV lenta. Infecciones urinarias no complicadas, cistitis: 250 mg 1vez/día oral, 3 días. Prostatitis bacteriana crónica: 500 mg 1 vez/día, 28 días oral o perfus. IV lenta. Infecciones complicadas de piel y tejido blando: 500 mg 1 vez/día oral o 500 mg 2 veces/día oral o perfus. IV lenta, 7-14 días. Ántrax por inhalación: 500 mg 1vez/día oral o perfus. IV lenta, 8 sem. La perfus. es lenta de mín. 30 min para 250 mg y 60 min para 500 mg. La duración del tto. deberá continuarse mín. 48-72 h después de que el paciente permanezca sin fiebre o se haya demostrado la erradicación bacteriana. I.R.: oral/IV». |
«Insomnio; cefalea, mareos; náuseas, diarrea, vómitos; elevación de enzimas hepáticas. I.V.: flebitis, reacción en el sitio de perfus». | Vademecum (2016) Levofloxacino. Disponible en: https://www.vademecum.es/principios-activos-levofloxacino-J01MA12 [Consultado: 29-05-2016] | «ASEY Comp. recub. con película 500 mg LEVOFLOXACINO ACCORD Comp. recub. con película 500 mg LEVOFLOXACINO ACCORDPHARMA Sol. para perfusión 5 mg/ml LEVOFLOXACINO ALMUS Comp. recub. con película 500 mg LEVOFLOXACINO ALTER Comp. recub. con película 500 mg LEVOFLOXACINO AMNEAL Comp. recub. con película 500 mg LEVOFLOXACINO APOTEX Comp. recub. con película 500 mg LEVOFLOXACINO APOTEX AG Comp. recub. con película 500 mg LEVOFLOXACINO AUROBINDO Comp. recub. con película 500 mg LEVOFLOXACINO AUROVITAS Comp. recub. con película 500 mg LEVOFLOXACINO AUROVITAS SPAIN Sol. para perfusión 5 mg/ml LEVOFLOXACINO AUROVITAS SPAIN SPAIN Comp. recub. con película 500 mg LEVOFLOXACINO BLUEFISH Comp. recub. con película 500 mg LEVOFLOXACINO BLUEPHARMA Comp. recub. con película 500 mg LEVOFLOXACINO CINFA Comp. recub. con película 500 mg LEVOFLOXACINO CIPLA Comp. recub. con película 500 mg LEVOFLOXACINO COMBIX Comp. recub. con película 500 mg LEVOFLOXACINO G.E.S. Sol. para perfusión 5 mg/ml LEVOFLOXACINO HOSPIRA Sol. para perfusión 5 mg/ml LEVOFLOXACINO KABI Sol. para perfusión 5 mg/ml LEVOFLOXACINO KERN PHARMA Comp. recub. con película 500 mg LEVOFLOXACINO KERN PHARMA Sol. para perfusión 5 mg/ml LEVOFLOXACINO KRKA Comp. recub. con película 500 mg LEVOFLOXACINO MABO Comp. recub. con película 500 mg LEVOFLOXACINO MYLAN Comp. recub. con película 500 mg LEVOFLOXACINO NORMON Comp. recub. con película 500 mg LEVOFLOXACINO NORMON Sol. para perfusión 5 mg/ml LEVOFLOXACINO PENSA Comp. recub. con película 500 mg LEVOFLOXACINO PHARMA COMBIX Comp. recub. con película 500 mg LEVOFLOXACINO PHARMATHEN Comp. recub. con película 500 mg LEVOFLOXACINO PREMIUM PHARMA Comp. recub. con película 500 mg LEVOFLOXACINO QUALIGEN Comp. recub. con película 500 mg LEVOFLOXACINO RATIOPHARM Comp. recub. con película 500 mg LEVOFLOXACINO SANDOZ Comp. recub. con película 500 mg LEVOFLOXACINO SANOVEL Comp. recub. con película 500 mg LEVOFLOXACINO SERRACLINICS Sol. para perfusión 5 mg/ml LEVOFLOXACINO STADA Comp. recub. con película 500 mg LEVOFLOXACINO TARBIS Comp. recub. con película 500 mg LEVOFLOXACINO TEVA Comp. recub. con película 500 mg LEVOFLOXACINO VEGAL Comp. recub. con película 500 mg LEVOFLOXACINO VIR Comp. recub. con película 500 mg TAVANIC Comp. recub. con película 500 mg TAVANIC Sol. para perfusión 500 mg/100 ml» |
«No tomar levofloxacino en los siguientes casos: hipersensibilidad a levofloxacino u otras quinolonas. Epilepsia. Antecedente de trastorno del tendón relacionado con fluoroquinolonas. Niños/adolescentes en desarrollo. Embarazo y lactancia. Precauciones: en caso de insuficiencia renal, ajustar dosis. S. aureus resistente a meticilina probablemente es resistente a levofloxacino. Considerar la resistencia local a E. coli. Advertencias y precauciones en predisposición a convulsiones o tto. con fármacos que disminuyen umbral convulsivo (teofilina, fenbufeno, AINE). Riesgo de: colitis pseudomembranosa (suspender tto); tendinitis o rotura de tendones (mayor en > 60 años, los que reciben dosis > 1000 mg/día y en tratados con corticosteroides); reacciones hipersensibilidad graves sin exposición previa (ej. angioedema, shock anafiláctico); reacciones graves cutáneas (s. de Stevens- Johnson o necrólisis epidérmica tóxica); hemorragia e incremento de pruebas de coagulación en tratados con antagonistas de vit. K (controlar); reacciones hemolíticas en pacientes con deficiencia de G6PDH; hiper o hipoglucemia en diabéticos (vigilar glucosa); reacciones psicóticas (Advertencias y precauciones, en psicosis o historial de enf. psiquiátrica); sobreinfección por microorganismos no sensibles. Advertencias y precauciones en pacientes con riesgo de prolongación intervalo QT: s. congénito de intervalo QT largo, desequilibrio electrolítico no corregido, ancianos, mujeres, enf.cardiaca (p.ej. insuf. cardiaca, infarto de miocardio, bradicardia), concomitancia con prolongadores intervalo QT (antiarrítmicos clase IA y III, antidepresivos tricíclicos, macrólidos, antipsicóticos). Descritos casos de necrosis hepática hasta insuficiencia hepática fulminante y de neuropatía periférica sensorial o sensitivomotora. No recomendado con miastenia gravis. Vigilar posible trastorno ocular. Evitar exposición UV/solar. Respetar tiempo de perfus. recomendado e interrumpir ante caída brusca de presión sanguínea». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Meropenem | «Meronem contains the active substance meropenem and belongs to a group of medicines called carbapenem antibiotics. It works by killing bacteria, which can cause serious infections». |
Pfizer Limited (2017) Package leaflet: information for the user Meronem IV 500 mg and 1 g Powder for solution for injection or infusion. Disponible en: https://www.medicines.org.uk/emc/files/pil.6731.pdf [Consultado: 26-05-2018] | «Meronem is used to treat the following in adults and children aged 3 months and older: Infection affecting the lungs (pneumonia) Lung and bronchial infections in patients suffering from cystic fibrosis Complicated urinary tract infections Complicated infections in the abdomen Infections that you can catch during or after the delivery Complicated skin and soft tissues infections Acute bacterial infection of the brain (meningitis) Meronem may be used in the management of neutropenic patients with fever that is suspected to be due to a bacterial infection. Meronem may be used to treat bacterial infection of the blood which might be associated with a type of infection mentioned above». |
«Use in adults: The dose depends on the type of infection that you have, where the infection is in the body and how serious the infection is. Your doctor will decide on the dose that you need. The dose for adults is usually between 500 mg (milligrams) and 2 g (gram). You will usually receive a dose every 8 hours. However you may receive a dose less often if your kidneys do not work very well. Use in children and adolescents: The dose for children over 3 months old and up to 12 years of age is decided using the age and weight of the child. The usual dose is between 10 mg and 40 mg of Meronem for each kilogram (kg) that the child weighs. A dose is usually given every 8 hours. Children who weigh over 50 kg will be given an adult dose». |
«If you have a severe allergic reaction, stop using Meronem and see a doctor straight away. You may need urgent medical treatment. The signs may include a sudden onset of: Severe rash, itching or hives on the skin. Swelling of the face, lips, tongue or other parts of the body. Shortness of breath, wheezing or trouble breathing. Damage to red blood cells (not known) The signs include: Being breathless when you do not expect it. Red or brown urine. Other possible side effects: Common (may affect up to 1 in 10 people) Abdominal (stomach) pain. Feeling sick (nausea). Being sick (vomiting). Diarrhoea. Headache. Skin rash, itchy skin. Pain and inflammation. Increased numbers of platelets in your blood (shown in a blood test). Changes in blood tests, including tests that show how well your liver is working». |
Pfizer Limited (2017) Package leaflet: information for the user Meronem IV 500 mg and 1 g Powder for solution for injection or infusion. Disponible en: https://www.medicines.org.uk/emc/files/pil.6731.pdf [Consultado: 26-05-2018] | «Meronem IV 500mg & 1g; Meropenem 1 g powder for solution for injection or infusion; Meropenem 1 g Powder for Solution for Injection or Infusion; Meropenem 1 g, powder for solution for injection; Meropenem 1g powder for solution for injection/infusion; Meropenem 500 mg powder for solution for injection or infusion; Meropenem 500 mg Powder for Solution for Injection or Infusion; Meropenem 500 mg, powder for solution for injection; Meropenem 500mg powder for solution for injection/ infusion». | Precautions: «Do not use Meronem if: you are allergic (hypersensitive) to meropenem or any of the other ingredients of Meronem (listed in Section 6 Contents of the pack and other information). you are allergic (hypersensitive) to other antibiotics such as penicillins, cephalosporins, or carbapenems as you may also be allergic to meropenem. Talk to your doctor, pharmacist or nurse before using Meronem if: you have health problems, such as liver or kidney problems. you have had severe diarrhoea after taking other antibiotics. You may develop a positive test (Coombs test) which indicates the presence of antibodies that may destroy red blood cells». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Meropenem | «Bactericida. Inhibe síntesis de pared celular bacteriana en bacterias Gram+ y Gram-, ligándose a proteínas de unión a penicilina. | Vademecum (2017) Meropenem. Disponible en: https://www.vademecum.es/principios-activos-meropenem-J01DH02 [Consultado: 29-05-2018] | «Neumonía grave (incluyendo la adquirida en el hospital y asociada a ventilacion), infección complicada del tracto urinario, complicada intra-abdominal, complicada de piel y tejidos blandos. Infección intra- y post-parto. Infección broncopulmonar en fibrosis quística y meningitis bacteriana aguda. Neutropenia febril que se sospecha por infección bacteriana. Infecciones por Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. o infecciones muy graves». | «Perfus. IV durante 15-30 min (o bolus IV de 5 min para dosis ≤ 1 g en ads., adolescentes y niños con p.c. > 50 kg o para dosis 20 mg/kg en niños 3 meses-11 años con p.c. ≤ 50 kg). Dosis recomendadas: - Neumonía grave (incluyendo la adquirida en el hospital y asociada a ventilacion), infección complicada del tracto urinario, complicada intra-abdominal, complicada de piel y tejidos blandos. Ads., adolescentes y niños con p.c. > 50 kg: 500 mg o 1 g/8 h; niños 3 meses-11 años con p.c. ≤ 50 kg: 10 o 20 mg/kg/8 h. - Infección intra- y post-parto. Ads. y adolescentes: 500 mg o 1 g/8 h. - Infección broncopulmonar en fibrosis quística y meningitis bacteriana aguda. Ads., adolescentes y niños con p.c. > 50 kg: 2 g/8 h; niños 3 meses-11 años y p.c. ≤ 50 kg: 40 mg/kg/8 h. - Tto. de pacientes con neutropenia febril que se sospecha por infección bacteriana. Ads., adolescentes y niños con p.c. > 50 kg: 1 g/8 h; niños 3 meses-11 años y p.c. ≤ 50 kg: 20 mg/kg/8 h. Infecciones por Enterobacteriaceae, Pseudomonas aeruginosa, Acinetobacter spp. o infecciones muy graves pueden requerir hasta 2 g/8 h en ads. y adolescentes, y hasta 40 mg/kg/8 h en niños. Niños < 3 meses: seguridad/eficacia no establecidas, datos limitados sugieren 20 mg/kg/8 h. I.R. Ads. y adolescentes: Clcr 26-50 ml/min: 1 unidad de dosis/12 h; Clcr 10-25: ½ unidad de dosis/12 h; Clcr < 10: ½ unidad de dosis/24 h. (Unidad de dosis = 500 mg o 1 g o 2 g). Administrar tras hemodiálisis; no hay recomendación de dosis con diálisis peritoneal. En niños no hay experiencia». |
«Trombocitemia; cefalea; diarrea, vómitos, náuseas, dolor abdominal; aumento de transaminasas, fosfatasa alcalina sanguínea y deshidrogenasa láctica sanguínea, rash, prurito; en lugar iny.: inflamación, dolor». | Vademecum (2017) Meropenem. Disponible en: https://www.vademecum.es/principios-activos-meropenem-J01DH02 [Consultado: 29-05-2018] | «MERONEM IV Polvo para sol. iny. y para perfusión 1 g MERONEM IV Polvo para sol. iny. y para perfusión 500 mg MEROPENEM ACCORDPHARMA Polvo para sol. iny. y perfusión 1 g MEROPENEM ACCORDPHARMA Polvo para sol. iny. y perfusión 500 mg MEROPENEM ACIC Polvo para sol. iny. y para perfusión 1000 mg MEROPENEM ACIC Polvo para sol. iny. y para perfusión 500 mg MEROPENEM AUROVIT Polvo para sol. iny. y para perfusión 1000 mg MEROPENEM AUROVIT Polvo para sol. iny. y para perfusión 500 mg MEROPENEM FARMALIDER Polvo para sol. iny. y para perfusión 1000 mg MEROPENEM FARMALIDER Polvo para sol. iny. y para perfusión 500 mg MEROPENEM KABI Polvo para sol. iny. y para perfusión 1000 mg MEROPENEM KABI Polvo para sol. iny. y para perfusión 500 mg MEROPENEM KERN PHARMA Polvo para sol. iny. o para perfusión 500 mg MEROPENEM NORIDEM Polvo para sol. iny. y para perfusión 1000 mg MEROPENEM RANBAXY Polvo para sol. iny. y para perfusión 1000 mg MEROPENEM RANBAXY Polvo para sol. iny. y para perfusión 500 mg MEROPENEM SALA Polvo para sol. iny. y para perfusión 1000 mg MEROPENEM SALA Polvo para sol. iny. y para perfusión 500 mg» |
«No puede tomar meropenem en caso de hipersensibilidad a carbapenémicos e hipersensibilidad grave a ß-lactámicos. Precauciones en los siguientes casos: antecedente de hipersensibilidad a carbapenémicos y ß-lactámicos, suspender en caso de reacción alérgica grave; I.R., ajustar dosis con Clcr < 51 ml/min; I.H., monitorizar; riesgo de: colitis asociada a antibióticos, colitis pseudomembranosa, convulsiones y de toxicidad hepática; evitar concomitancia con ác. valproico/valproato de sodio/valpromida o medicamentos que inhiban el peristaltismo; niños < 3 meses. En caso de insuficiencia hepática monitorizar función hepática. En caso de insuficiencia renal: ajustar dosis, ads. y adolescentes, Clcr 26-50 ml/min: 1 unidad de dosis/12 h; Clcr 10-25: ½ unidad de dosis/12 h; Clcr < 10: ½ unidad de dosis/24 h. (Unidad de dosis = 500 mg o 1 g o 2 g). Administrar tras hemodiálisis; no hay recomendación de dosis con diálisis peritoneal. En niños no hay experiencia». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Metronidazole | «Metronidazole tablets belong to a group of medicines called anti-infective agents». |
Accord-UK Ltd (2017) Metronidazole tablets 500mg. Disponible en: https://www.medicines.org.uk/emc/files/pil.5882.pdf [Consutado: 26-05-2018] | «They may be used to treat: • infections, caused by bacteria of the blood, brain, bone, lung, stomach lining and pelvic area, following childbirth or in a wound following an operation • urinary or genital infections caused by a parasite, Trichomonas • genital infection in women caused by bacteria • the parasitic diseases amoebiasis • the disease giardiasis • gum and teeth infections • infected leg ulcers or pressure sores • stomach ulcers caused by Helicobacter pylori. • or prevent infections occurring after operations». |
«The recommended dose is: for doses less than 500mg (one tablet) an alternative dosage form should be used. To treat bacterial infections • Adults and children over 10 years: 800mg followed by 400mg at eight hourly intervals. Treatment is usually for 7 days but will depend upon your condition. To treat anaerobic infections • Children 8 weeks-12 years: 20-30mg/kg/day as a single dose or divided into 7.5mg/kg every 8 hours for 7 days. The daily dose may be increased to 40mg/kg, depending on the severity of the infection. • Children under 8 weeks: 15mg/kg/day as a single dose or divided into 7.5mg/kg every 12 hours. • Children under 10 years: A more suitable dosage form should be used for this age group. To treat infection caused by Trichomonas • Adults and adolescents: 2g as a single dose, or 200mg three times a day for 7 days, or 400mg twice a day for 5-7 days. Your partner should also be treated. • Children under 10 years: 40mg/kg as a single dose or 15- 30mg/kg/day two to three times daily for 7 days. Doses should not to exceed 2000mg/dose. • Children under 10 years: A more suitable dosage form should be used for this age group. To treat non-specific genital infection in women • Women: 400mg twice a day for 7 days, or 2g as a single dose for 1 day only. • Adolescent girls: 400mg twice daily for 5 to 7 days or 2g as a single dose. To treat amoebiasis • Adults and children over 10 years: 400mg-800mg three times a day for 5 to 10 days. • Children 7-10 years: 200mg-400mg three times a day for 5 to 10 days. • Children 3-7 years: 100mg-200mg four times daily for 5 to 10 days. • Children 1-3 years: 100mg-200mg three times daily for 5 to 10 days. Or 35-50mg/kg/day in 3 divided doses for 5 to 10 days. • Children under 7 years: A more suitable dosage form should be used for this age group. To treat giardiasis • Adults and children over 10 years: 2g once a day for 3 days, or 400mg three times a day for 5 days or 500mg twice daily for 7 to 10 days. • Children 7-10 years: 1 g once a day for 3 days. • Children 3-7 years: 600mg-800mg once daily for 3 days. • Children 1-3 years: 500mg once daily for 3 days. Or 15-40mg/ kg/day divided in two to three doses. • Children under 7 years: A more suitable dosage form should be used for this age group. To treat infections of the gums (for 3 days) or teeth (for 3-7days) • Adults and children over 10 years: 200mg three times a day. To treat infected leg ulcers or pressure sores (for 7 days) • Adults and children over 10 years: 400mg three times a day. To treat stomach ulcers caused by Helicobacter pylori To be taken as directed by your doctor as part of a course with two other medicines. To prevent infections after surgery • Adults: 1g as a single dose 24 hours before surgery then, 400mg at 8 hourly intervals during the 24 hours before the operation. • Children under 12 years: 20-30mg/kg as a single dose 1-2 hours before the operation. • Newborns with a gestation age less than 40 weeks: 10 mg/kg body weight as a single dose before operation. • Children under 10 years: A more suitable dosage form should be used for this age group. If you are elderly or have liver disease, it is particularly important to take this medicine exactly as directed by the doctor». |
«• Allergic reactions: skin rash, which may be itchy, swelling of the face, lips, tongue or throat, fever or difficulty in breathing. Tell your doctor if you notice any of the following side effects or notice any other effects not listed: Very rare (less than 1 in 10,000 users): • increased bruising, nosebleeds, sore throats or infections, this medicine may alter the numbers and types of your blood cells. You should tell your doctor who might want you to have a blood test • mental health problems including hallucinations (seeing or hearing things that are not there), drowsiness, dizziness, fits, tingling, pain or a feeling of weakness in the arms or legs, numbness • Encephalopathy (headaches, light sensitivity, confusion, fever, paralysis, stiff neck) • Cerebellar syndrome (poor co-ordination or muscle control, involuntary shakiness, uncontrolled eye movements, speech disorders, walking abnormally) • double vision, short sightedness • changes in liver function tests, jaundice (yellowing of the skin or whites of the eyes), inflammation of the pancreas (pancreatitis causing very severe abdominal pain), flushing • skin rashes, itching, small pus-containing blisters, muscle and joint pain, darkening of the urine». |
Accord-UK Ltd (2017) Metronidazole tablets 500mg. Disponible en: https://www.medicines.org.uk/emc/files/pil.5882.pdf [Consutado: 26-05-2018] | «Acea 0.75% w/w Gel; Flagyl 1g Suppositories; Flagyl 200mg Tablets; Flagyl 400mg Tablets; Flagyl 500mg Suppositories; Metrogel; Metronidazole 200mg Tablets; Metronidazole 400 mg Tablets; Metronidazole 500 mg / 100 ml Intravenous Infusion; Metronidazole Oral Suspension 200mg/5ml; Metronidazole Tablets 500 mg; Metronidazole Tablets BP 200mg; Metronidazole Tablets BP 400mg; ROSICED 7.5mg/g cream; Rozex Cream; Rozex Gel; Zidoval; Zyomet Gel». | Precautions: «Do not take Metronidazole tablets: • if you are allergic to Metronidazole tablets or any of the other ingredients of this medicine (listed in section 6). • if you are in the first 3 months of pregnancy or are breastfeeding. Talk to your doctor, pharmacist or nurse before taking Metronidazole tablets: • if you have kidney disease, particularly if you require dialysis treatments • if you have ever suffered from any liver disease • if you are in the 4th-9th month of pregnancy • if you have epilepsy or have ever had fits • if you have porphyria (a genetic disease that can cause skin blisters, abdominal pain and brain/nervous system disorders) • if you have any disorder of the blood and/or blood cells • if you have any nervous system disorders • if you have been exposed to any sexually transmitted disease. Cases of severe liver toxicity/acute liver failure, including cases with a fatal outcome, in patients with Cockayne syndrome have been reported with product containing metronidazole. If you are affected by Cockayne syndrome, your doctor should also monitor your liver function frequently while you are being treated with metronidazole and afterwards». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Metronidazol | «Antiinfeccioso antibacteriano y antiparasitario, posiblemente por interacción con el ADN». | Vademecum (2016) Metronidazol. Disponible en: https://www.vademecum.es/principios-activos-metronidazol-J01XD01 [Consultado: 29-05-2018] | «Lambliasis (Giardiasis). Amebiasis intestinal y hepática. Infección por anaerobios. Tricomoniasis urogenital. Vaginosis bacteriana. Infección por bacterias anaerobias: Bacterioides, Fusobacterias, Eubacterias, Clostridium y Estreptococos anaerobios. Prevención de infección postoperatoria por bacterias anaerobias, especialmente Bacteroides y Estreptococos anaerobios. Prevención de infección postoperatoria por bacterias anaerobias, especialmente Bacteroides y Estreptococos anaerobios. Prevención de infección postoperatoria por bacterias anaerobias, especialmente Bacteroides y Estreptococos anaerobios. Prevención de infección postoperatoria por bacterias anaerobias, especialmente Bacteroides y Estreptococos anaerobios. Cirugía colorrectal. Recién nacidos antes de la operació». | «Oral (durante la comida): - Lambliasis (Giardiasis). Pacientes > 10 años: 2 g/día, 3 días ó 400 mg 3 veces/día, 5 días ó 500 mg 2 veces/día, 7-10 días; de 7-10 años: 1 g/día, 3 días; de 3-7 años: 600-800 mg/día, 3 días; de 1-3 años: 500 mg/día, 3 días. Expresado en p.c.: 15-40 mg/kg/día en 2-3 dosis. - Amebiasis intestinal y hepática. Pacientes > 10 años: 400-800 mg 3 veces/día; de 7-10 años: 200-400 mg 3 veces/día; de 3-7 años: 100-200 mg 4 veces/día; de 1-3 años: 100-200 mg 3 veces/día. Duración del tto. : 5-10 días. Expresado en p.c.: 35-50 mg/kg/día en 3 dosis, sin exceder 2,4 g/día. - Infección por anaerobios. Ads.: 500 mg/8 h. Niños > 8 sem - 12 años: 20-30 mg/kg/día como dosis única ó 7,5 mg/kg/8 h, 7 días. Niños < 8 sem: 15 mg/kg/día como dosis única ó 7,5 mg/kg/12 h. - Tricomoniasis urogenital. Ads. y adolescentes: 2 g como dosis única ó 200 mg 3 veces/día, 7 días ó 400 mg 2 veces/día, 5-7 días. Niños < 10 años: 40 mg/kg como dosis única ó 15-30 mg/kg/día en 2-3 tomas durante 7 días. Máx. 2 g/día. - Vaginosis bacteriana. Adolescentes: 400 mg 2 veces/día durante 5-7 días o 2 g como dosis única. Perfus. IV (30-60 min): - Infección por bacterias anaerobias: Bacterioides, Fusobacterias, Eubacterias, Clostridium y Estreptococos anaerobios. Ads. y niños > 12 años: 500 mg/8 h, máx. 7 días. Niños > 8 sem-12 años: 20-30 mg/kg/día como dosis única ó 7,5 mg/kg/8 h, 7 días. Niños < 8 sem: 15 mg/kg/día como dosis única ó 7,5 mg/kg/12 h. - Prevención de infección postoperatoria por bacterias anaerobias, especialmente Bacteroides y Estreptococos anaerobios. Ads. y niños > 12 años: 500 mg preoperatoriamente o 1,5 g en una dosis antes, durante o después de la intervención quirúrgica. Cirugía colorrectal: 500 mg/8 h durante 24 h, comenzando antes de intervención, prorrogar 3-5 días si hay perforación de víscera hueca o apendicitis gangrenosa. Niños > 8 sem- 12 años: 20-30 mg/kg como dosis única 1-2 h antes de la cirugía. Recién nacidos < 40 sem: 10 mg/kg como dosis única antes de la operación». |
«Dolor epigástrico, náuseas, vómitos, diarrea, mucositis oral, trastorno del sabor, anorexia, pancreatitis (reversible), decoloración de la lengua/ lengua pilosa; angioedema, shock anafiláctico; neuropatía sensorial periférica, cefaleas, convulsiones, vértigo, encefalopatía, síndrome cerebeloso agudo, meningitis aséptica; trastorno psicótico, confusión, alucinación, comportamiento depresivo; trastornos transitorios de la visión, neuropatía óptica, neuritis; agranulocitosis, neutropenia, trombocitopenia; aumento de enzimas hepáticas (AST, ALT, fosfatasa alcalina), hepatitis colestásica o mixta y daño hepatocelular, fallo hepático; rash, prurito, sofocos, urticaria, erupciones pustulares, síndrome de Stevens-Johnson, necrólisis epidérmica tóxica; fiebre». | Vademecum (2016) Metronidazol. Disponible en: https://www.vademecum.es/principios-activos-metronidazol-J01XD01 [Consultado: 29-05-2018] | «FLAGYL Comp. 250 mg FLAGYL Sol. para perfusión 1500 mg/300 ml FLAGYL Sol. para perfusión 500 mg/100 ml FLAGYL Susp. oral 125 mg/5 ml METRONIDAZOL G.E.S. EFG Sol. para perfusión 5 mg/ml METRONIDAZOL IV BRAUN Sol. iny. 5 mg/ml METRONIDAZOL NORMON Sol. para perfusión 5 mg/ml METRONIDAZOL NORMON EFG Comp. 250 mg METRONIDAZOL SERRACLINICS Sol. para perfusión 5 mg/ml» |
«No puede tomar metronidazol si presenta hipersensibilidad a imidazoles. Precauciones: insuficiencia hepática I.R. reducir dosis, cuando no estén sometidos a diálisis, y monitorizar nivel sérico de metabolitos; encefalopatía hepática; enf. aguda o crónica grave del SNC o SNP, riesgo de empeoramiento neurológico; si es preciso alargar el tto., valorar beneficio/riesgo, realizar determinaciones hematológicas, en especial recuento leucocitario, y vigilar por riesgo de neuropatías central o periférica; oscurece la orina; efecto antabús con alcohol, evitar; evaluar uso en tto. prolongado; fallo hepático en combinación con otros antibióticos; riesgo de tromboflebitis (vía IV) y sobreinfecciones por microorganismos no susceptibles; notificados casos de hepatotoxicidad grave e insuficiencia renal (incluyendo un paciente con desenlace mortal), en pacientes con síndrome de Cockayne: no administrar a menos que no exista alternativa terapéutica disponible (si finalmente se administra, realizar una estrecha monitorización de la función hepática y si se detecta alguna alteración hepática, suspender el tto.). Precaución en caso de encefalopatía hepática y en caso de insuficiencia renal, recomendable reducir dosis, cuando no estén sometidos a diálisis, y monitorizar nivel sérico de metabolitos». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Moxifloxacin | «Moxifloxacin contains the active substance moxifloxacin which belongs to a group of antibiotics called fluoroquinolones. Moxifloxacin works by killing bacteria that cause infections». |
Accord-UK Ltd (2017) Package leaflet: information for the user Moxifloxacin 400mg Film-coated Tablets. Disponible en: https://www.medicines.org.uk/emc/files/pil.3273.pdf [Consultado: 26-05-2018] | «Moxifloxacin is used in patients 18 years of age and older for treating the following bacterial infections when caused by bacteria against which Moxifloxacin is active. Moxifloxacin should only be used to treat these infections when usual antibiotics cannot be used or have not worked: • Infection of the sinuses • Sudden worsening of long term inflammation of the airways • Infection of the lungs (pneumonia) acquired outside the hospital (except severe cases) • Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infections of the fallopian tubes and infections of the uterus mucous membrane. Moxifloxacin is not sufficient on it’s own for treating this kind of infection. Therefore, another antibiotic in addition to Moxifloxacin should be prescribed by your doctor for the treatment of infections of the female upper genital tract. Moxifloxacin tablets may also be prescribed by your doctor to complete the course of therapy: • Infection of the lungs (pneumonia) acquired outside the hospital, • Infections of the skin and soft tissue». |
«The recommended dose for adults is one 400mg film-coated tablet once daily. Moxifloxacin tablets are for oral use. Swallow the tablet whole (to mask the bitter taste) and with plenty of liquid. You can take Moxifloxacin with or without food. Try to take the tablet at approximately the same time each day. The same dose can be taken by elderly patients, patients with a low bodyweight or in patients with kidney problems. The length of time you will take Moxifloxacin for depends on your infection. Unless your doctor tells you otherwise, your treatment will be as follows: • for sudden worsening (acute exacerbation) of chronic bronchitis 5 - 10 days • for infection of the lungs (pneumonia) acquired outside the hospital except severe cases 10 days • for acute infection of the sinuses (acute bacterial sinusitis) 7 days • Mild to moderate infections of the female upper genital tract (pelvic inflammatory disease), including infection of the fallopian tubes and infection of the uterus mucous membrane 14 days. When Moxifloxacin film-coated tablets are used to complete a course of therapy started with Moxifloxacin solution for infusion, the recommended durations of use are: - Infection of the lungs (pneumonia) acquired outside the hospital 7 - 14 days Most patients with pneumonia were switched to oral treatment with (Moxifloxacin) film-coated tablets within 4 days. - Infections of the skin and soft tissue 7 - 21 days Most patients with infections of the skin and soft tissue were switched to oral treatment with Moxifloxacin film-coated tablets within 6 days». |
«Stop taking Moxifloxacin and tell your doctor immediately if you notice the following (as you may need urgent medical advice): • Alterations of the skin and mucous membranes like painful blisters in the mouth/nose or at the penis/vagina (Stevens-Johnson syndrome or toxic epidermal necrolysis) (very rare side effects, potentially life threatening) • Inflammation of blood vessels (signs could be red spots on your skin, usually on your lower legs or effects like joint pain) (very rare side effect) • Abnormal fast heart rhythm (rare side effect) • Pain and swelling of the tendons (tendonitis) (rare side effect) • Rupture of tendons (very rare side effect) • Severe diarrhoea containing blood and/or mucus (antibiotic associated colitis including pseudomembranous colitis), which very rarely, may develop into complications that are lifethreatening (rare side effects) • That you suddenly start feeling unwell or notice yellowing of the whites of the eyes, dark urine, itching of the skin, a tendency to bleed or disturbances of thought or wakefulness (these can be signs and symptoms of fulminant inflammation of the liver potentially leading to life-threatening liver failure (including fatal cases) (very rare side effect) • Severe, sudden allergic reaction including very rarely life-threatening shock (e.g. difficulty in breathing, drop of blood pressure, fast pulse) (rare side effect) • Swelling (including potentially life-threatening swelling of the airway) (rare side effect) • Convulsions (rare side effect) • Troubles associated with the nervous system such as pain, burning, tingling, numbness and/or weakness in extremities (rare side effect) • Depression (which in very rare cases may lead to self-harm, such as suicidal ideations/thoughts, or suicide attempts) (rare side effect) • Abnormal heart rhythms, life-threatening irregular heartbeat, stopping of heartbeat (very rare side effects). Worsening of the symptoms of myasthenia gravis (abnormal muscle fatigue leading to weakness and in serious cases paralysis) (very rare side effect) • If you are elderly with existing kidney problems and you notice a decrease in urine output, swelling in your legs, ankles or feet, fatigue, nausea, drowsiness, shortness of breath or confusion (these can be signs and symptoms of kidney failure) (rare side effect) • Feeling mentally unwell (potentially leading to self-harm, such as suicidal ideations/thoughts, or suicide attempts) (very rare side effect) • Your blood sugar is increased and you suffer from diabetes (rare side effect). Transient loss of vision. Other side effects: Common (may affect up to 1 in 10 people): • Infections caused by resistant bacteria or fungi, e.g. oral and vaginal infections caused by Candida (thrush) • Headache • Dizziness • Feeling sick (nausea) • Being sick (vomiting) • Stomach and abdominal ache • Diarrhoea • Increase of a special liver enzyme in the blood (transaminases) • Change of the heart rhythm (ECG) in patients with low blood potassium level». |
Accord-UK Ltd (2017) Package leaflet: information for the user Moxifloxacin 400mg Film-coated Tablets. Disponible en: https://www.medicines.org.uk/emc/files/pil.3273.pdf [Consultado: 26-05-2018] | «Avelox 400 mg film-coated tablets;Avelox 400 mg/250 ml solution for infusion; Moxifloxacin 400 mg Film-coated Tablets; MOXIVIG 0.5%w/v Eye Drops, Solution». | Precautions: «Do not take Moxifloxacin • If you are allergic to moxifloxacin, any other quinolone antibiotics or any of the other ingredients of this medicine (listed in section 6). • If you are pregnant or breast-feeding. • If you are younger than 18 years of age. • If you have previously had problems with your tendons related to treatment with quinolone antibiotics (see ‘Warnings and Precautions’ and section ‘4. Possible side effects’). • If you have a severe liver disease or increased liver enzymes (transaminases) higher than 5 times the upper normal limit. • If you were born with or have any condition with abnormal heart rhythm (seen on ECG, electrical recording of the heart). • If you have a salt imbalance in the blood (especially low levels of potassium or magnesium in the blood). • If you have a very slow heart rhythm (called ‘bradycardia’). • If you have a weak heart (heart failure). • If you have a history of abnormal heart rhythms. • If you are taking other medicines that result in abnormal ECG changes (see ‘Other medicines and Moxifloxacin’). This is because Moxifloxacin can cause changes on the ECG, that is a prolongation of the QT-interval, i.e., delayed conduction of electrical signals. Talk to your doctor, pharmacist or nurse before taking Moxifloxacin • Moxifloxacin can change your heart’s ECG, especially if you are female, or if you are elderly. If you are currently taking any medicine that decreases your blood potassium levels, consult your doctor before taking Moxifloxacin. • If you suffer from epilepsy or a condition which makes you likely to have convulsions, tell your doctor before taking Moxifloxacin. • If you have or have ever had any mental health problems, consult your doctor before taking Moxifloxacin. • If you suffer from myasthenia gravis (abnormal muscle fatigue leading to weakness and in serious cases paralysis), taking Moxifloxacin may worsen the symptoms of your disease. If you think you are affected consult your doctor immediately. • If you or any member of your family have glucose-6-phosphate dehydrogenase deficiency (a rare hereditary disease), tell your doctor, who will advise whether Moxifloxacin is suitable for you. • If you have a complicated infection of the female upper genital tract (e.g. associated with an abscess of the fallopian tubes and ovaries or of the pelvis), for which your doctor considers an intravenous treatment necessary, treatment with Moxifloxacin tablets is not appropriate. • For the treatment of mild to moderate infections of the female upper genital tract your doctor should prescribe another antibiotic in addition to Moxifloxacin. If there is no improvement in symptoms after 3 days of treatment, please consult your doctor». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Moxifloxacino | «Bactericida. Inhibe topoisomerasas II y IV esenciales para replicación, transcripción y reparación del ADN bacteriano». | Vademecum (2017) Moxifloxacino. Disponible en: https://www.vademecum.es/principios-activos-moxifloxacino-J01MA14 [Consultado: 29-05-2018] | «Pacientes ≥ 18 años, tto. infecciones bacterianas por microorganismos sensibles si no es apropiado el tto. inicial con antibacterianos comúnmente recomendados o éstos no resuelven la infección. Por vía IV, neumonía adquirida en la comunidad e infección complicada de piel y tejidos blandos. Por vía oral, sinusitis bacteriana aguda, exacerbación aguda de bronquitis crónica, neumonía adquirida en la comunidad (excepto grave), EPI leve o moderada (infección en tracto genital superior femenino, salpingitis y endometritis incluidas) sin absceso tubo-ovárico o pélvico asociado, y completar tto. de neumonía adquirida en la comunidad e infección complicada de piel y tejidos blandos tras mejoría inicial por vía IV». | «Ads.: - Oral: 400 mg, 1 vez/día. Duración tto.: sinusitis bacteriana aguda, 7 días; exacerbación aguda de bronquitis crónica, 5-10 días; neumonía adquirida en la comunidad, 10 días; EPI leve o moderada (combinar con antibacteriano adecuado, por ej. cefalosporina, por aumento de cepas N. gonorrhoeae resistentes, monoterapia sólo si se excluye resistencia), 14 días. Máx. 400 mg/día. - Perfus. IV (60 min). Ads.: 400 mg, 1 vez/día. Duración total recomendada: neumonía adquirida en la comunidad 7-14 días; infección complicada de piel y tejidos blandos 7-21 días». |
«Sobreinfecciones debidas a bacterias resistentes u hongos (candidiasis oral y vaginal); cefalea, mareo; prolongación QT en pacientes con hipopotasemia; náuseas, vómitos, diarrea, dolor gastrointestinal y abdominal; aumento de transaminasas; vasculitis y neuropatía periférica (poco frecuentes). Además IV: reacción el lugar de iny.». | Vademecum (2017) Moxifloxacino. Disponible en: https://www.vademecum.es/principios-activos-moxifloxacino-J01MA14 [Consultado: 29-05-2018] | «ACTIRA Comp. recub. con película 400 mg ACTIRA Sol. para perfusión 400 mg/250 ml MOXIFLOXACINO AUROBINDO Comp. recub. con película 400 mg MOXIFLOXACINO AUROVITAS SPAIN Comp. recub. con película 400 mg MOXIFLOXACINO BLUEPHARMA Comp. recub. con película 400 mg MOXIFLOXACINO CINFA Comp. recub. con película 400 mg MOXIFLOXACINO G.E.S. Sol. para perfusión 400 mg/250 ml MOXIFLOXACINO HETERO Comp. recub. con película 400 mg MOXIFLOXACINO KABI Sol. para perfusión 400 mg/250 ml MOXIFLOXACINO KERN PHARMA Comp. recub. con película 400 mg MOXIFLOXACINO KERN PHARMA Sol. para perfusión 400 mg/250 ml MOXIFLOXACINO KRKA Comp. recub. con película 400 mg MOXIFLOXACINO MACLEODS Comp. recub. con película 400 mg MOXIFLOXACINO MYLAN Comp. recub. con película 400 mg MOXIFLOXACINO NORMON Comp. recub. con película 400 mg MOXIFLOXACINO PHARMATHEN Comprimido recubierto con película 400 mg MOXIFLOXACINO PHARMATHEN Sol. para perfusión 400 mg/250 ml MOXIFLOXACINO QUALIGEN Comp. recub. con película 400 mg MOXIFLOXACINO RATIOPHARM Comp. recub. con película 400 mg MOXIFLOXACINO SANDOZ Comp. recub. con película 400 mg MOXIFLOXACINO STADA Comp. recub. con película 400 mg MOXIFLOXACINO TEVAGEN Comp. recub. con película 400 mg» |
«No tomar moxifloxacino en los siguientes casos: hipersensibilidad a moxifloxacino y otras quinolonas; embarazo, lactancia; pacientes < 18 años; pacientes con historia de enf./trastornos en los tendones asociados al tto. con quinolonas; prolongación QT congénita o adquirida y documentada; alteraciones electrolíticas (en particular hipopotasemia no corregida); bradicardia clínicamente relevante; insuf. cardíaca clínicamente relevante con reducción de fracción de eyección ventricular izda.; historial previo de arritmias sintomáticas; concomitancia con prolongadores QT; I.H. (Child Pugh C) y transaminasas 5 x LSN. Precauciones: valorar riesgo/beneficio; precaución en miastenia gravis y pacientes con afecciones proarrítmicas en curso (p. ej. isquemia aguda de miocardio, prolongación intervalo QT) por riesgo mayor de arritmia ventricular (torsades de pointes incluida) y parada cardiaca, en especial mujeres y ancianos (se debe interrumpir tto. y realizar ECG); concomitancia con fármacos reductores del nivel de K o asociados con bradicardia clínicamente significativa; descritas reacciones alérgicas/hipersensibilidad tras 1ª administración, suspender; precaución en pacientes con trastornos SNC u otros factores que predispongan a convulsiones o a reducción del umbral, suspender tto. en caso de aparición; ancianos con alteración renal e ingesta inadecuada de líquidos por mayor riesgo de I.R.; pacientes psicóticos o historia de enf. psiquiátrica; riesgo de tendinitis y ruptura tendinosa, en especial del tendón de Aquiles, (mayor en ancianos y en tratados con corticosteroides), de colitis pseudomembranosa, de diarrea asociada a C. difficile, y de reacciones hemolíticas con historia familiar o déficit real de G6PDH; vigilar aparición de reacciones cutáneas o de mucosas, de signos de hepatitis fulminante (realizar PFH) y de síntomas de neuropatía periférica y niveles de glucosa en diabéticos; evitar exposición UV/solar; puede causar alteración de visión; no recomendado en tto. de infecciones por S. aureus resistente a meticilina ni en enf. inflamatoria pélvica complicada; posible falso - en cultivo de Mycobacterium spp.; riesgo de neuropatía periférica; Además IV: eficacia no establecida en quemadura grave, fascitis, infección pie diabético con osteomielitis; evitar uso intraarterial». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Nystatin | «Nystatin belongs to a group of medicines called anti-fungal antibiotics». | Bristol-Myers Squibb Pharmaceuticals limited (2017) Package leaflet: Information for the patient Nystan 100,000 units/ml Oral Suspension. Disponible en: https://www.medicines.org.uk/emc/files/pil.408.pdf [Consultado: 26-05-2018] | «It is used to prevent and treat fungal infections (thrush) of the mouth, throat or gut. It also provides effective prevention against oral thrush in those born of mothers with vaginal thrush. This medicine works by killing the yeast or fungus that has caused your symptoms». |
«Oral Candidiasis Infants (1 month to 2 years) 1ml should be dropped into the mouth four times a day. Children (≥ 2 years) and adults For the treatment of denture sores, and oral infections in children (≥ 2 years) and adults caused by candidas albicans. 1ml of the suspension should be dropped into the mouth four times daily; it should be kept in contact with the affected areas as long as possible. Intestinal candidiasis Infants (1 month to 2 years) 1ml should be dropped into the mouth four times a day. Adults For the treatment of intestinal candidosis 5ml of the suspension should be dropped into the mouth four times daily. Paediatric population (≥ 2 years) 1ml should be dropped into the mouth four times a day. For prophylaxis a total daily dosage of 1 million units has been found to suppress the overgrowth of candidas albicans in patients receiving broad-spectrum antibiotic therapy. For prophylaxis in the newborn the suggested dose is 1ml once daily. The longer the suspension is kept in contact with the affected area in the mouth before swallowing, the greater will be its effect. Administration should be continued for 48 hours after clinical cure to prevent relapse. Older people No specific dosage recommendations or precautions». |
«Nystatin is generally well tolerated by all age groups, even during prolonged use. If irritation or sensitisation develops, treatment should be discontinued. Nausea has been reported occasionally during therapy. Large oral doses of Nystatin have occasionally produced diarrhoea, gastrointestinal distress,nausea and vomiting. Rash, including urticaria has been reported rarely. Steven-Johnson Syndrome has been reported very rarely. Hypersensitivity and angioedema, including facial oedema have been reported». |
Sandoz Limited (2017) Nystatin Oral Suspension BP. Disponible en: https://www.medicines.org.uk/emc/product/4463/smpc [Consultado: 26-05-2018] | «Nystaform HC Ointment; Nystan Oral Suspension (Ready -Mixed); Nystatin Oral Suspension BP; Nystatin/Chlorhexidine acetate/Hydrocortisone 100,000 units/g/1%/1% Ointment; Nystatin/Chlorhexidine hydrochloride 100,000 IU/g /1% Cream; Nystatin/Chlorhexidine hydrochloride/Hydrocortisone 100,000 units/g/1%/0.5% Cream; Timodine Cream; Trimovate; Trimovate Cream». | Precautions: «do not take nystatin: if you are allergic to nystatin. Talk to your doctor or pharmacist as Nystan should not be used if you have a fungal infection in the lungs or on the skin (systemic mycoses)». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Nistatina | «Antifúngico obtenido a partir de Streptomyces noursei. Nistatina posee propiedades fungistáticas y fungicidas in vitro frente a una amplia variedad de levaduras y hongos relacionados. Actúa uniéndose a los esteroles de la membrana celular de las especies sensibles de Candida (Candida albicans y otras especies) y formando canales iónicos en las mismas, provocando cambios en la permeabilidad de la membrana y la consiguiente salida de los elementos intracelulares». | Vademecum (2018) Nistatina. Disponible en: https://www.vademecum.es/principios-activos-nistatina-A07AA02 [Consultado: 29-05-2018] | «Tto. de las siguientes infecciones fúngicas: candidiasis oral y candidiasis intestinal». | «Oral. - Candidiasis oral. Lactantes > 1 año, niños, adolescentes y ads.: 250.000-500.000 UI/6-12 h; lactantes ≤ 1 año: 250.000 UI/6 h; recién nacidos y lactantes con bajo peso al nacer: 100.000 UI/6 h. - Candidiasis intestinal. Ads.:500.000-1.000.000 UI/6 h; niños y adolescentes: 250.000-750.000 UI/6 h; lactantes: 100.000-300.000 UI/6 h. Continuar durante mín. 48 h tras desaparición de síntomas para evitar recidivas. Si los síntomas empeoran/persisten tras 14 días, reevaluar». |
«Poco frecuentes: náuseas, vómitos, malestar gastrointestinal, diarrea». | Vademecum (2018) Nistatina. Disponible en: https://www.vademecum.es/principios-activos-nistatina-A07AA02 [Consultado: 29-05-2018] | «MYCOSTATIN Susp. oral 100.000 U/ml» | «No puede tomar nistatina en caso de hipersensibilidad. Precauciones: no utilizar en el tto. de infecciones fúngicas sistémicas; suspender si aparece irritación o sensibilización; se recomienda frotis KOH, cultivos u otros métodos de determinación para confirmar candidiasis y descartar a otros patógenos, en caso de no obtener respuesta, repetir método diagnóstico». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Nitrofurantoin | «Nitrofurantoin is an antibiotic». | Concordia International - formerly AMCo (2014) Package leaflet: information for the user Nitrofurantoin 50mg and 100mg Capsules, Hard. Disponible en: https://www.medicines.org.uk/emc/files/pil.428.pdf [Consultado: 26-05-2018] | «It is used to prevent and treat infections of the bladder, kidney and other parts of the urinary tract». | «Adults: The normal dosage depends on the type of infection you have and instructions should be written on the label provided by the pharmacist. Consult your pharmacist or doctor if these instructions are not clear. The usual doses are: • For treatment of infections: Either one 50mg capsule or one 100mg capsule four times a day for seven days • For prevention of further infections: Either one 50mg capsule or one 100mg capsule at bedtime • For prevention of infections during surgery: One 50mg capsule four times a day on the day of the operation and three days thereafter. Children and infants over three months of age: The dose depends on the weight of the child and will be provided by your doctor. Follow your doctor’s instructions exactly. Children below 3 months of age should not take Nitrofurantoin Capsules. Nitrofurantoin Capsules should be taken with food or milk». |
«If you notice any sudden wheeziness, difficulty in breathing, swelling of the eyelids, face or lips, rash or itching (especially affecting your whole body) STOP TAKING your medicine and go to a doctor immediately. If you experience any of the side effects detailed below stop taking Nitrofurantoin Capsules and consult your doctor. • Your lungs may react to Nitrofurantoin Capsules. This may develop quickly, within a week of starting treatment or very slowly, especially in elderly patients. This may produce fever, chills, cough and shortness of breath • Jaundice (inflammation of the liver causing yellowing of the skin or whites of the eyes) • The nerves outside the spinal cord may be affected causing changes to the sense of feeling and the use of muscles. In addition headache, extreme changes of mood or mental state, confusion, weakness, blurred vision may occur. These effects may be severe and in some instances permanent • Raised pressure in the skull (causing severe headaches). Please note that while taking Nitrofurantoin Capsules your urine may become dark yellow or brown coloured. This is quite normal and not a reason to stop taking the medicine. Other side effects include: • Feeling sick (nausea) and headache • Loose stools • Loss of appetite, stomach ache, and being sick (vomiting) • Dizziness, drowsiness • Blood cells have been affected in some patients. This may result in bruising, delayed clotting of the blood, sore throat, fever, anaemia, and a susceptibility to colds or persistent cold • A variety of skin rashes or reactions have occurred in some patients. These may appear as flaking skin, a red rash or fever accompanied by rapid heart rate and severe rash with blistering. Other reactions may include inflammation of salivary glands (causing facial pains), inflammation of the pancreas (causing severe abdominal pain) and joint pains • Short-term hair loss • Urinary infection by germs which are not sensitive to Nitrofurantoin Capsules». |
Concordia International - formerly AMCo (2014) Package leaflet: information for the user Nitrofurantoin 50mg and 100mg Capsules, Hard. Disponible en: https://www.medicines.org.uk/emc/files/pil.428.pdf [Consultado: 26-05-2018] | «Furadantin 25mg/5ml Oral Suspension; Macrobid Capsules 100mg B.P; Nitrofurantoin 100 mg Tablets; Nitrofurantoin 100mg Capsules; Nitrofurantoin 25mg/5ml Oral Suspension; Nitrofurantoin 50 mg Tablets; Nitrofurantoin 50mg Capsules». | Precautions: «DO NOT TAKE Nitrofurantoin Capsules and talk to your doctor if: • you are allergic (causing itching, reddening of the skin or difficulty in breathing) to nitrofurantoin or any of the ingredients of Nitrofurantoin Capsules (listed in Section 6 at the end of the leaflet) or other medicines containing nitrofurantoin • you have a disease of the kidneys which is severely affecting the way they work (ask your doctor if you are not sure) • you are in the final stages of pregnancy (labour or delivery) as there is a risk that it might affect the baby • you suffer from a blood disorder called porphyria • you are deficient in an enzyme called G6PD (glucose-6-phosphate dehydrogenase) • in infants under three months of age • you are breast feeding a baby with suspected or known deficiency in an enzyme called G6PD (glucose-6-phosphate dehydrogenase). Tell your doctor if you are not sure about any of the above. TAKE SPECIAL CARE with Nitrofurantoin Capsules and speak to your doctor or pharmacist before taking the capsules if: • you have diabetes • you are suffering from any illness causing severe weakness • you have anaemia (a decrease in red blood cells causing pale skin, weakness and breathlessness); or a lack of vitamin B or abnormal levels of salts in your blood (your doctor will be able to advise you) • you have a history of allergic reactions. The above conditions may increase the chance of developing a side effect which results in damage to the nerves, causes altered sense of feeling, pins and needles. • you lack an enzyme (body chemical) called glucose-6-phosphate dehydrogenase, which causes your red blood cells to be more easily damaged (this is more common in black people and people of Mediterranean, Middle Eastern or Asian origin. Your doctor will know) • you have any disease of the lungs, liver or nervous system. If you need to take Nitrofurantoin Capsules for a number of months, your doctor may want to regularly check how your lungs and liver are working». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Nitrofurantoína | «Bactericida. Interfiere en los procesos enzimáticos de respiración celular, metabolismo glucídico y síntesis de pared bacteriana». | Vademecum (2016) Nitrofurantoína. Disponible en: https://www.vademecum.es/principios-activos-nitrofurantoina-J01XE01 [Consultado: 29-05-2018] | «Cistitis aguda en niñas, adolescentes y mujeres adultas». | «Oral. Ads.: 50-100 mg/8 h; niñas > 6 años y adolescentes 12-<18 años: 5-7 mg/kg/día en 4 tomas (dosis máx. = dosis de ads.); niñas > 3 meses: 1-2 mg/kg/6 h (dosis máx. = dosis de ads.). Duración del tto.: 5-7 días». |
«Reacciones cutáneas alérgicas (prurito, urticaria), manifestaciones pseudo-lupus (fiebre, escalofríos, artralgia) a veces asociados con síntomas pulmonares, angioedema; mareos, neuropatías periféricas asociadas a sobredosificación o disminución de la eliminación renal (I.R.) o a un factor contribuyente (diabetes, alcoholismo, edad avanzada, tratamientos prolongados); náuseas, vómitos, dolor abdominal, diarrea». | Vademecum (2016) Nitrofurantoína. Disponible en: https://www.vademecum.es/principios-activos-nitrofurantoina-J01XE01 [Consultado: 29-05-2018] | «FURANTOINA Comp. 50 mg FURANTOINA Susp. oral 10 mg/ml» |
«No tomar nitrofurantoína en los siguientes casos: hipersensibilidad a nitrofurantoína y otros nitrofuranos; tratamientos prolongados, continuos (> 7 días) o intermitentes; I.R. con Clcr < 45 ml/min; porfiria aguda; deficiencias de G6PDH; 2 últimas semanas de embarazo por riego de anemia hemolítica fetal; niños < 3 meses. Precauciones: No indicado en tto. profiláctico de infecciones urinarias recidivantes, tto. de infecciones urinarias en varones, infecciones del tracto urinario de vías altas, bacteriemia o sepsis secundaria a la misma; valorar riesgo/beneficio en caso de antecedentes o sospecha de infección por microorganismos multirresistente; precaución en: I.R. con Clcr 30-44 ml/min, enf. pulmonar, alteración de la función hepática, predisposición a reacciones alérgicas, anemia, diabetes mellitus, desequilibrio electrolítico, debilidad o déficit de vit. B (en particular de ác. fólico); interrumpir el tto. si aparece alteraciones hepáticas, en la función pulmonar, síntomas de hipersensibilidad o neurológicos (parestesias); falsos + en pruebas con pruebas de glucosa en orina.Contraindicado en. I.R. con Clcr < 45 ml/min. Precaución en caso de insuficiencia renal con Clcr 30-44 ml/min». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Norfloxacin | «Norfloxacin belongs to a group of antibiotics called quinolones which work by killing bacteria that cause infections». |
Ratiopharm GmbH (2017) Package leaflet: information for the user Norfloxacin 400 mg Tablets. Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1514525819486.pdf [Consultado: 26-05-2018] | «This medicine is indicated for the treatment of bacterial infections of the urinary tract e. g. cystitis, pyelitis and chronic prostatitis». |
«The usual dose in adults is 1 film-coated tablet (400 mg norfloxacin) twice daily. Dosage in patients with kidney problems If you suffer from severe renal impairment, your doctor may adjust your dosage. The recommended dose is 1 film-coated tablet (400 mg norfloxacin) once daily. Preferably the tablets should be taken in the morning and evening. If you only take a single daily dose, always take this at the same time of day. The duration of treatment depends on the type and severity of infection. For women with acute, uncomplicated inflammation of the bladder, the usual duration of treatment is a 3 day course of this medicine with the recommended dose. In the treatment of urinary tract infections, adults will generally need to use this medicine for 7-10 days. In chronic inflammation of the prostate the usual duration of treatment is 4 weeks. The symptoms of urinary tract infection, such as a burning sensation experienced during passing water, pain, and fever, will generally disappear within 1-2 days. However, the treatment course with this medicine should be continued for up to 12 weeks in chronic relapsing urinary tract infections. If the infection is adequately controlled within the first 4 weeks of treatment, the dose may be reduced to 400 mg norfloxacin (1 film-coated tablet) daily». |
«If you experience any of the following rare symptoms or side effects, stop the treatment and seek medical advice immediately: • An allergic reaction soon after you start taking the tablets - including: swelling of the face, lips, tongue and/or throat (with difficulty in breathing or swallowing), itching, nettle rash, and severe skin reactions causing blisters and bleeding (exfoliative dermatitis, toxic epidermal necrolysis, Stevens-Johnson syndrome). Allergic reactions can, very rarely, be life-threatening. • Inflammation of the membrane that lines a joint capsule and very rarely rupture of the tendon e.g. Achilles tendon. If you experience tendon pain or signs of inflammation of the Achilles tendon, stop taking this medicine, seek medical advice immediately and rest the affected limb. Inflammation of the liver with jaundice (yellowing of the skin or whites of the eyes) commonly occurs. Stop treatment and contact your doctor if you experience signs and symptoms of liver problems such as loss of appetite, jaundice, dark urine, itching or sensitivity to pressure in the abdominal cavity. If you develop the rare side effect of severe and persistent diarrhoea whilst you are taking your tablets or after stopping your tablets you should consult your doctor. In rare cases seizures occur. If fits occur, stop taking this medicine. Common, (may affect upto 1 in 10 people): • Breakdown of the the muscle tissue with muscle pain, weakness (rhabdomyolysis) Uncommon , (may affect up to 1 in 100 people): • Reduced number of white blood cells “leucocytes“ [leucopenia] or “neutrophiles” [neutropenia], increased number of certain white blood cells “eosinophiles” [eosinophilia], which may cause sore throat and mouth, increased frequency of infections • Reduced number of blood platelets [thrombocytopenia], reduced volume of the red blood cells in the blood [hematocrit], reduced blood clotting ability, which may cause prolonged bleeding after injury • Headache, dizziness and drowsiness • Abdominal pain and cramps, heartburn, diarrhoea and sickness • Increased liver enzymes • Rash • Effects on the kidney which cause pain and discomfort when passing water (crystalluria)». |
Ratiopharm GmbH (2017) Package leaflet: information for the user Norfloxacin 400 mg Tablets. Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1514525819486.pdf [Consultado: 26-05-2018] | «Norfloxacin 400 mg Tablets; Norfloxacin-ratiopharm® 400 mg tablets». | Precautions: «Do not take this medicine • if you are allergic to norfloxacin, other quinolone antibiotics • if you are pregnant or think you could be pregnant • if you have had pain, inflammation or rupture of tendons after taking quinolone antibiotics • if you have not reached puberty or are a teenager who is still growing. Talk to your doctor or pharmacist or nurse: • if you have a history of convulsions (symptoms include body twitching, jerking limbs, fits), or a disorder that increases the risk of having convulsions • if you suffer from psychiatric disorders, hallucinations and/or confusion • if you suffer from a condition called myasthenia gravis (an auto-immune disease) which causes muscle weakness • if you or any member of your family suffers from a deficiency disorder where patients become anaemic after taking certain drugs (glucose-6-phosphate dehydrogenase, G-6-PD deficiency) (symptoms of anaemia include paleness and tiredness) • If your eyesight becomes impaired or if your eyes seem to be otherwise affected, consult an eye specialist immediately. If you suffer from severe renal impairment your doctor may prescribe you a lower dosage of this medicine. Caution should be taken when using this kind of medicine, if you were born with or have family history of prolonged QT interval (seen on ECG, electrical recording of the heart), have salt imbalance in the blood (especially low level of potassium or magnesium in the blood), have a very slow heart rhythm (called ‘bradycardia’), have a weak heart (heart failure), have a history of heart attack (myocardial infarction), you are female or elderly or you are taking other medicines that result in abnormal ECG changes. Pain, inflammation or rupture of tendons, particularly around the ankles may occur with this class of antibiotics, especially if you are older or if you are taking corticosteroids at the same time. If you experience tendon pain or signs of inflammation of the Achilles tendon stop taking your medicine and contact your doctor and rest the affected limb. Providing you do not have a problem with your heart or kidneys, you should drink plenty of liquid whilst taking this medicine. This medicine may cause a problem with your kidneys called “crystalluria” which results in tiny crystals forming in the urine. These crystals cannot be seen by the naked eye. Drinking plenty of liquid can help prevent this occurring. You should avoid excessive sunlight while taking this medicine as the drug may make your skin more sensitive to sunlight or UV light». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Norfloxacino | «Antibacteriano bactericida, inhibidor de la ADN-girasa bacteriana». | Vademecum (2015) Norfloxacino. Disponible en: https://www.vademecum.es/principios-activos-norfloxacino-J01MA06 [Consultado: 29-05-2018] | «Tto. infección tracto urinario superior e inferior, incluidas cistitis, pielitis, cistopielitis, pielonefritis, y gastroenteritis aguda bacteriana; causadas por germen sensible». | «Oral. Ads.: 400 mg/12 h. Infección urinaria: 7-10 días. Cistitis aguda no complicada: 3-7 días. Infección urinaria crónica recurrente: hasta 12 sem (reducir a 400 mg/día si remite en 4 1 as sem). Gastroenteritis aguda infecciosa: 5-7 días. I.R.: máx. 400 mg/día si Clcr < 30 ml/min». | «Náusea, elevación de ALT y AST». | Vademecum (2015) Norfloxacino. Disponible en: https://www.vademecum.es/principios-activos-norfloxacino-J01MA06 [Consultado: 29-05-2018] | «NORFLOXACINO CINFA Comp. recub. con película 400 mg NORFLOXACINO LESVI EFG Comp. recubierto con película 400 mg NORFLOXACINO NORMON EFG Comp. recub. 400 mg NORFLOXACINO PENSA EFG Comp. recub. con película 400 mg NORFLOXACINO QUALIGEN Comp. recub. con película 400 mg NORFLOXACINO SANDOZ EFG Comp. 400 mg NORFLOXACINO STADA EFG Comp. recub. 400 mg» |
«No tomar norfloxacino en caso de: hipersensibilidad a norfloxacino, quinolonas o estructuras relacionadas (ác. pipemídico). Precauciones: antecedentes de convulsiones o predisposición a las mismas. Miastenia grave. Riesgo de tendinitis y/o rotura de tendones (en especial asociado a corticoides) suspender tto. ante cualquier signo/dolor, de anemia hemolítica con déficit congénito de G6PDH, de colitis pseudomembranosa, y de artropatías en prepubescentes (uso no recomendado). Evitar exposición UV/solar. Posible prolongación QT y arritmia: evitar con hipopotasemia, bradicardia significativa y concomitancia con antiarrítmicos clase Ia o II; precaución con antecedente o historia familiar de prolongación QT, cisaprida, eritromicina, antipsicóticos, antidepresivos tricíclicos. En caso de insuficiencia renal, ajustar dosis con Clcr < 30 ml/min: máx. 400 mg/día. En I.R. muy avanzada, valorar conveniencia individualmente». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Piperacillin-tazobactam | «Piperacillin/Tazobactam contains piperacillin and tazobactam, which belong to the group of medicines known as penicillins, including beta-lactamase inhibitors. Piperacillin belongs to the group of medicines known as ‘broad-spectrum penicillin antibiotics’. It can kill many kinds of bacteria. Tazobactam can prevent some resistant bacteria from surviving the effects of piperacillin. This means that when piperacillin and tazobactam are given together, more types of bacteria are killed». |
Generics UK T/A Mylan (2017) Package leaflet: Information for the user Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion. Disponible en: https://www.medicines.org.uk/emc/files/pil.2589.pdf [Consultado: 26-05-2018] | «Piperacillin/Tazobactam is used in adults and adolescents to treat bacterial infections, such as those affecting the lower respiratory tract (lungs), urinary tract (kidneys and bladder), abdomen, skin or blood. Piperacillin/Tazobactam may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections). Piperacillin/Tazobactam is used in children aged 2-12 years to treat infections of the abdomen such as appendicitis, peritonitis (infection of the fluid and lining of the abdominal organs), and gallbladder (biliary) infections. Piperacillin/Tazobactam may be used to treat bacterial infections in patients with low white blood cell counts (reduced resistance to infections)». |
«Adults and adolescents aged 12 years or older The recommended dose is 4 g/0.5 g of piperacillin / tazobactam given every 6-8 hours, which is given into one of your veins (directly into the blood stream). Children aged 2 to 12 years The recommended dose for children with abdominal infections is 100 mg/12.5 mg/kg of body weight of piperacillin/tazobactam given every 8 hours into one of your veins (directly into the blood stream). The recommended dose for children with low white blood cell counts is 80 mg/10 mg/kg of body weight of piperacillin/tazobactam given every 6 hours into one of your veins (directly into the blood stream). Your doctor will calculate the dose depending on your child’s weight but each individual dose will not exceed 4 g/0.5 g of Piperacillin/Tazobactam. You will be given Piperacillin/Tazobactam until the sign of infection has gone completely (5 to 14 days). Patients with kidney problems Your doctor may need to reduce the dose of Piperacillin/Tazobactam or how often you are given it. Your doctor may also want to test your blood to make sure that your treatment is at the right dose, especially if you have to take this medicine for a long time». |
«If you notice any of the following side effects, stop taking this medicine and contact your doctor, or other healthcare professional, or go to the nearest hospital casualty department straight away: Common: may affect up to 1 in 10 people - reduction in one or more types of blood cells, which may be severe, such as red blood cells, white blood cells that help fight infection, or platelets that help the blood to clot (the signs include: a worsening or increase in infections e.g. sore throat, mouth ulcers, fever and chills, feeling tired, breathless or weak, unusual bruising or bleeding) (agranulocytosis, pancytopenia, leukopenia, neutropenia, thrombocytopenia). - bruising or bleeding for longer than normal, particularly if you are taking anticoagulants such as warfarin. Rare: may affect up to 1 in 1,000 people - serious skin rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis, dermatitis bullous, dermatitis exfoliative) appearing initially as reddish target-like spots or circular patches often with central blisters on the trunk. Additional signs include ulcers in the mouth, throat, nose, extremities, genitals and red and swollen eyes. The rash may progress to widespread blistering or peeling of the skin and potentially may be life-threatening. - severe or persistent diarrhoea accompanied by fever or weakness. This may be a sign of a certain form of infection of the colon (pseudomembranous colitis)». |
Generics UK T/A Mylan (2017) Package leaflet: Information for the user Piperacillin/Tazobactam 4 g/0.5 g powder for solution for infusion. Disponible en: https://www.medicines.org.uk/emc/files/pil.2589.pdf [Consultado: 26-05-2018] | «Piperacillin/Tazobactam 2 g / 0.25 g powder for solution for injection or infusion; Piperacillin/Tazobactam 2 g/0.25 g Powder for Solution for Infusion; Piperacillin/Tazobactam 4 g / 0.5 g Powder for Solution for Infusion; Piperacillin/Tazobactam 4 g / 0.5 g powder for solution for injection or infusion; Piperacillin/Tazobactam 4gm/0.5gm Injection». | Precautions: «Do not use Piperacillin/Tazobactam - if you are allergic to piperacillin or tazobactam. - if you are allergic to antibiotics known as penicillins, cephalosporins or other beta-lactamase inhibitors, as you may be allergic to Piperacillin/Tazobactam. Talk to your doctor, pharmacist or nurse before receiving Piperacillin/Tazobactam. - if you have allergies. If you have several allergies, make sure you tell your doctor or other healthcare professional before receiving this product. - if you are suffering from diarrhoea before, or if you develop diarrhoea during or after your treatment. In this case, make sure you tell your doctor or other healthcare professional immediately. Do not take any medicine for the diarrhoea without first checking with your doctor. - if you have low levels of potassium in your blood. Your doctor may want to check your kidneys before you take this medicine and may perform regular blood tests during treatment. - if you have kidney or liver problems, or are receiving haemodialysis. Your doctor may want to check your kidneys before you take this medicine, and may perform regular blood tests during treatment. - if you are taking certain medicines (called anticoagulants) to avoid an excess of blood clotting (see also ‘Other medicines and Piperacillin/Tazobactam’ in this leaflet) or any unexpected bleeding occurs during the treatment. In this case, you should inform your doctor or other healthcare professional immediately. Children below 2 years Piperacillin/Tazobactam is not recommended for use in children below the age of 2 years due to insufficient data on safety and effectiveness». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Piperacilina + tazobactam | «Piperacilina: bactericida; inhibe la síntesis de pared celular bacteriana. Tazobactam: inhibidor de ß-lactamasas». | Vademecum (2015) Piperacilina + tazobactam. Disponible en: https://www.vademecum.es/principios-activos-piperacilina+%2B+tazobactam-J01CR05+P1 [Consultado: 29-05-2018] | «Tto. infección bacteriana en pacientes neutropénicos > 2 años, además en ads., adolescentes y ancianos: tto. infección urinaria complicada (incluida pielonefritis) y no complicada, intra-abdominal, ginecológica, de piel y partes blandas, polimicrobianas causadas por microorganismos aerobios y anaerobios, septicemia bacteriana y neumonía nosocomial». | «Piperacilina/tazobactam. IV lenta (mín. 3-5 min) o perfus. IV lenta (20-30 min). Ads. y niños > 12 años: 2.000/250-4.000/500 mg/6-8 h; habitual: 4.000/500 mg/8 h; neutropenia: 4.000/500 mg/6 h combinado con aminoglucósido. Niños neutropénicos 2-12 años con p.c. < 40 kg: 80/10 mg/kg/6 h combinado con aminoglucósido, máx. 4.000/500 mg/6 h. Duración recomendada: mín. 5 días, máx. 14 días. I.R. Ads. ancianos y niños con p.c. > 40 kg que reciben = dosis ads.: Clcr < 20 ml/min, 4.000/500 mg/12 h; hemodializados máx./día: 8.000/1.000 mg y dosis adicional de 2.000/250 mg tras diálisis. Niños 2-12 años (o con p.c. < 40 kg): Clcr 20-39 ml/min: 80/10 mg/kg/8 h; Clcr < 20: 80/10 mg/kg/12 h; niños hemodializados y con p.c. < 50 kg, dosis recomendada: 45 mg/5 mg/kg/8h». |
«Diarrea, náuseas, vómitos, exantema (incluyendo el maculopapular)». | Vademecum (2015) Piperacilina + tazobactam. Disponible en: https://www.vademecum.es/principios-activos-piperacilina+%2B+tazobactam-J01CR05+P1 [Consultado: 29-05-2018] | «PIPERACILINA TAZOBACTAM MYLAN Polvo para solución para perfusión 2/0,25 g PIPERACILINA TAZOBACTAM MYLAN Polvo para solución para perfusión 4/0,5 g PIPERACILINA/TAZOBACTAM ACCORD EFG Polvo y disolv. para sol. para perfusión 2/0,25 g PIPERACILINA/TAZOBACTAM ACCORD EFG Polvo y disolv. para sol. para perfusión 4/0,5 g PIPERACILINA/TAZOBACTAM ACCORDPHARMA Polvo para solución para perfusión 4/0,5 g PIPERACILINA/TAZOBACTAM ACCORDPHARMA Polvo y disolv. para sol. para perfusión 2/0,25 g PIPERACILINA/TAZOBACTAM AUROVITAS Polvo para sol. para perfusión 2 g/0,25 g PIPERACILINA/TAZOBACTAM AUROVITAS Polvo para sol. para perfusión 4 g/0,5 g PIPERACILINA/TAZOBACTAM KABI Polvo para sol. para perfusión 2/0,25 g PIPERACILINA/TAZOBACTAM KABI Polvo para sol. para perfusión 4/0,5 g PIPERACILINA/TAZOBACTAM SALA Polvo para sol. para perfusión 4/0,5 g PIPERACILINA/TAZOBACTAM SALA Polvo y disolv. para sol. iny. 2/0,25 g PIPERACILINA/TAZOBACTAM SANDOZ Polvo para sol. para perfusión 2 g/0,25 g PIPERACILINA/TAZOBACTAM SANDOZ Polvo para sol. para perfusión 4 g/0,5 g PIPERACILINA/TAZOBACTAM VANCOMBEX Polvo para sol. perfusión 2 g/0,25 g PIPERACILINA/TAZOBACTAM VANCOMBEX Polvo para sol. perfusión 4 g/0,5 g» |
«No puede tomar pieracilina + tazobactam en los siguientes casos: hipersensibilidad a piperacilina u otro antibiótico ß-lactámico, tazobactam cualquier inhibidor de ß-lactamasas. Precauciones: riesgo de hipersensibilidad (antes de iniciar, investigar reacciones previas), de colitis pseudomembranosa, de sobreinfección y de manifestaciones hemorrágicas. Evaluación renal, hepática y hematopoyética periódica en tto. prolongado. Antes de tratar gonorrea descartar sífilis. Con dosis altas riesgo de excitabilidad neuromuscular o convulsiones (en especial si hay deterioro de función renal). Asociado con mayor incidencia de fiebre y exantema en sujetos con fibrosis quística. No se recomienda en niños < 2 años. En caso de insuficiencia renal ajustar la dosis: Ads. ancianos y niños con p.c. > 40 kg que reciben = dosis ads.: Clcr < 20 ml/min, 4.000/500 mg/12 h; hemodializados máx./día: 8.000/1.000 mg y dosis adicional de 2.000/250 mg tras diálisis. Niños 2-12 años (o con p.c. < 40 kg): Clcr 20-39 ml/min: 80/10 mg/kg/8 h; Clcr < 20: 80/10 mg/kg/12 h; niños hemodializados y con p.c. < 50 kg, dosis recomendada: 45 mg/5 mg/kg/8h». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Sulfamethoxazole + trimehoprim | «They both belong to a group of medicines called antibacterials. These medicines work by killing bacteria.» |
Chemidex Pharma Ltd. (2017) Package leaflet: information for the user Co-trimoxazole Tablets BP (400/80). Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1503033463788.pdf [Consultado: 26-05-2018] | «Together they work by stopping the growth of bacteria which cause infections such as: pneumonia, bronchitis, chest infections urinary tract infections ear infections skin infections brain infections». |
«For infusion: Standard dosage recommendations for acute infections: Adults (> 18 years old: 2 ampoules (10 mL) every 12 hours. The standard dosage for children is equivalent to approximately 6 mg trimethoprime and 30 mg sulfamethoxazole per kg body weight per day, given in two equally divided doses. Children over 12 years old (>12 to <18 years olld): 2 ampoules (10 mL) every 12 hours. Children aged 12 years and under (>6 weekds to <12 years old): 6 weeks to 5 months: 1.25 mL every 12 hours; 6 months to 5 years: 2.5 mL every 12 hours; 6 to 12 years: 5.0 mL every 12 hours. For severe infections in all age groups, dosage may be increased by 50%. Treatment should be continued until the patient has been symptom free for two days; the majority will require treatment for at least 5 days. Caution should be exercised when treating patients with severe hepatic impairment as there may be changes in the absorption and biotransformation of trimethoprim and sulfamethoxazole. Impaired renal function: Dosage recommendation: Adults (>18 years old) and Children over 12 years old (>12 to <18 years old): Creatinine Clearance (ml/min) > than 30: 2 ampoules (10 mL) every 12 hours; Creatinine Clearance (ml/min) 15-30: 1 ampoules (10 mL) every 12 hours; Creatinine Clearance (ml/min) < 15: not recommended./Oral (400mg/80mg): Children aged 6 to 12 years (OR body weight > 27 kg): One tablet every 12 hours; Children > 12 years (OR body weight > 53 kg): Two tablets every 12 hours. Adults: the usual dose is two tablets twice a day (every 12 hours). Children 6 to 12 years: one tablet twice a day (every 12 hours). Children under 6 years: this medicine is NOT suitable for children under 6 years. Treatment will normally be given for 1- 5 days. If no improvement is seen after 7 days the doctor will reassess you. Doses to treat Pneumocystis infections jirovecii lung infection (PCP) Your doctor may prescribe higher doses than usual for more than 7 days. Doses to prevent Pneumocystis infections Adults: two tablets once a day on each day of the week; or two tablets three times a week taken on alternate days; or two tablets twice daily three times a week taken on alternate days. Children 6 to 12 years: one tablet twice daily on each day of the week; or one tablet twice daily three times a week on alternate days; or one tablet twice daily three times a week on consecutive days; or two tablets once a day three times a week on consecutive days. Patients with kidney problems If your kidneys are not working very well, your doctor may change the dose and test your blood to see if the medicine is working properly. Elderly Care should be taken as the elderly may get more side effects, which could be serious if they have existing conditions or are taking other medicines». |
«STOP taking it and seek medical help immediately if you have any of the following allergic reactions: difficulty breathing or swallowing, swelling of the face, lips, tongue or throat severe itching of the skin, with a red rash or raised lumps blistering of the mouth, eyes, or genital region, patchy areas of rash, peeling skin. Seek immediate medical attention if you have any of the following symptoms: sudden headache, stiff neck, fever, sensitivity to bright light, drowsiness and muscle pain, with or without a rash pinpoint red spots on the skin, unusual purple bruise-like rash on the skin or in the mouth, unusual or heavy bleeding fever, sore throat, mouth ulcers, repeated infections or infections that will not go away cough, feeling breathless, chest pain swollen legs or joints, feeling tired pain behind the ribs radiating towards the back, often worse when lying down, nausea, vomiting, fever severe stomach cramps, watery and severe diarrhoea which may be bloody yellowing of the skin or eyes, pale faeces and dark urine, unexplained persistent nausea, stomach problems, loss of appetite or unusual tiredness seizures (fits). Very common side effects (in more than 1 in 10 people): increased amount of potassium in the blood. You cannot feel or see this but your doctor may test your blood for this. Common side effects (in less than 1 in 10 people): headache nausea diarrhoea skin rashes oral thrush (white, furry sore tongue and mouth) vaginal thrush (sore, itchy vagina with vaginal discharge) thrush affecting the penis. Uncommon side effects (in less than 1 in 100 people): vomiting.» |
Chemidex Pharma Ltd. (2017) Package leaflet: information for the user Co-trimoxazole Tablets BP (400/80). Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1503033463788.pdf [Consultado: 26-05-2018]; Aspen Pharma Trading Limited (2018) Co-Trimoxazole 16 mg/80 mg per mL for Infusion Trimethoprim/Sulfamethoxazole. Disponible en: http://www.mhra.gov.uk/home/groups/spcpil/documents/spcpil/con1522297511425.pdf [Consultado: 26-05-2018] | «CO-TRIMOXAZOLE 16 MG/80 MG PER ML FOR INFUSION CO-TRIMOXAZOLE 160 MG/800 MG FORTE TABLETS CO-TRIMOXAZOLE 160MG/800MG FORTE TABLETS CO-TRIMOXAZOLE 40 MG/200 MG PER 5 ML PAEDIATRIC SUSPENSION CO-TRIMOXAZOLE 40MG/200MG PER 5ML PAEDIATRIC SUSPENSION CO-TRIMOXAZOLE 80 MG/400 MG PER 5 ML ADULT SUSPENSION CO-TRIMOXAZOLE 80 MG/400 MG TABLETS CO-TRIMOXAZOLE 800MG/160MG FORTE TABLETS CO-TRIMOXAZOLE 80MG/400MG TABLETS CO-TRIMOXAZOLE 960MG TABLETS CO-TRIMOXAZOLE TABLETS BP CO-TRIMOXAZOLE TABLETS BP 80/400MG SEPTRIN 160 MG/800 MG FORTE TABLETS SEPTRIN 160MG/800MG FORTE TABLETS SEPTRIN 40 MG/200 MG PER 5 ML PAEDIATRIC SUSPENSION SEPTRIN 40MG/200MG PER 5ML PAEDIATRIC SUSPENSION SEPTRIN 80MG/400MG TABLETS SEPTRIN FORTE 160MG/800MG TABLETS». |
Precautions: «do not take sulfamethoxazole + trimethoprim if you are allergic to sulfamethoxazole, trimethoprim, or any other sulfonamide; if you have liver disease; if you have a blood disorder; if you have severe kidney problems. Take special care if you: have lung problems (e.g. asthma) have severe allergies (e.g. hayfever) are over 65 years of age, as the elderly may get more side effects have a folic acid deficiency could be suffering from malnutrition (e.g. due to dieting or bowel problems) have glucose-6-phosphate dehydrogenase (G6PD) deficiency suffer from phenylketonuria (an enzyme deficiency) and are not on a special diet have porphyria (a metabolism disorder which causes abdominal pains and mental disorder) have HIV (Human Immunodeficiency Virus) have a bacterial throat infection called streptococcal pharyngitis have ever had high blood potassium levels are taking pyrimethamine, a medicine for malaria». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Sulfametoxazol y trimetoprima | «Antibacteriano que pertenece al grupo de las sulfonamidas y trimetroprima». | Vademecum (2016) Sulfametoxazol y trimetoprima. Disponible en: https://www.vademecum.es/principios-activos-sulfametoxazol+y+trimetoprima-J01EE01 [Consultado: 29-05-2018] | «IV/IM. 1ª elección: en ads. y niños > 2 meses para: tto. de la neumonía por P. carinii; nocardiosis. 2ª elección para el tto. de: toxoplasmosis, listeriosis e infecciones por cepas de S. aureus resistentes a meticilina (MRSA) como osteomielitis y artritis séptica o infecciones de la piel y de los tejidos blandos». - Oral. 1ª elección en ads., adolescentes, lactantes y niños (> 6 sem) para: tto. y prevención de neumonía por P. carinii; profilaxis 1 ria de toxoplasmosis; nocardiosis; melioidosis. 2ª elección en: otitis media aguda; exacerbaciones agudas de bronquitis crónica en pacientes sin factores de riesgo; infecciones agudas no complicadas del tracto urinario (cistitis, pielonefritis); diarrea infecciosa; tto. de toxoplasmosis; granuloma inguinal (donovanosis); brucelosis. |
«IM profunda y lenta o perfus. IV tras dilución. Ads. y niños > 12 años: infección leve-moderada: 800/160 mg/12 h; infección grave: 1.600/320 mg/6-12 h. Niños 2 meses-12 años (dosis media 16/3,2 mg/kg/12 h): de 6-12 años: 400/80 mg/12 h; de 6 meses-5 años: 200/40 mg/12 h; de 2-5 meses: 100/20 mg/12 h. Oral. Ads. y niños >12 años: 800/160 mg/12 h. Lactantes y niños < 12 años (dosis media 30/6 mg/kg/día): de 6-12 años: 400/80 mg/12 h; de 6 meses-5 años: 200/40 mg/12 h; de 6 sem-5 meses: 100/20 mg/12 h. Tras 7 días de tto. reevaluar. - Neumonía por P. carinii. Tto. Ads. y niños: 75-100/15-20 mg/kg/día, en 2 o más dosis divididas, 2-4 sem (picos ≥ 5 mcg/ml). Profilaxis. Ads.: 800/160 mg/día, 7 días, o bien: 800/160 mg o 1.600/320 mg/día 3 veces/sem en días alternos. Niños 6-12 años: 400/80 mg/12 h, 7 días o 3 veces/sem en días alternos o consecutivos. Niños 6 meses-5 años: 200/40 mg/12 h, 7 días o 3 veces/sem en días alternos o consecutivos. Niños 6 sem-5 meses: 100/20 mg/12 h, 7 días o 3 veces/sem en días alternos o consecutivos. Aproximadamente se corresponde con: 750/150 mg/m 2 /día. Máx. 1.600/320 mg/día. - Toxoplasmosis. Profilaxis 1 ria . Ads. y niños > 12 años: 400/80 mg/día o 800/160 mg 3 veces/sem o 800/160 mg/día. Niños: 750/150 mg/m 2 /día. Máx. 1.600/320 mg/día. Tto. Ads.(sin datos en niños): 25/5 mg/kg/12 h, 6 sem. - Infección urinaria no complicada y diarrea infecciosa: 800/160 mg/12 h (en niños: 25/5 mg/kg/12 h), 3 días. - Granuloma inguinal (Donovanosis): 800/160 mg/12 h, 3 sem o hasta que desaparezcan las lesiones. - Nocardiosis: 50-75/10-15 mg/kg/día en 2 o más dosis divididas, 3-6 meses. En caso de infección del SNC, infección diseminada o existencia de inmunodepresión, duración del tto. > 1 año. - Listeriosis. Ads.: 50-100/10-20 mg/kg/día en 2-4 dosis, 2 sem en pacientes con bacteriemia y 2-4 sem en afectación del SNC. En inmunodeprimidos, de 3-6 sem en bacteriemia y de 4-8 sem en afección del SNC. Niños: 50-60/10-12 mg/kg/día en 4 dosis, 14-21 días. - Osteomielitis y artritis séptica. Ads.: 3,4-4 mg/kg/dosis/8-12 h. - Celulitis purulenta. Ads.: 800-1.600/160-320 mg/12 h; niños: 20-30/4-6 mg/kg/12 h. - Infecciones de la piel y de los tejidos blandos. Ads.: 800/160 mg/12 h. - Brucelosis. Ads. y niños > 8 años: 800/160 mg/12 h, 6 sem; niños < de 8 años (tto. de 1ª elección): 25/5 mg/kg/12 h, 6 sem. - Melioidosis: 40/8 mg/kg/12 h, 3-6 meses. I.R. Ads. y niños >12 años. Clcr 15-30 ml/min: ½ dosis habitual, Clcr < 15: no recomendado. Si concentración plasmática > 150 mcg/ml, suspender hasta que sea < 120 mcg/ml». |
«Candidiasis; hiperpotasemia; dolor de cabeza; náuseas, diarrea; erupciones cutáneas». | Vademecum (2016) Sulfametoxazol y trimetoprima. Disponible en: https://www.vademecum.es/principios-activos-sulfametoxazol+y+trimetoprima-J01EE01 [Consultado: 29-05-2018] | «SEPTRIN Comp. 400/80 mg SEPTRIN FORTE Comp. 800/160 mg SEPTRIN PEDIATRICO Comp. 100/20 mg SEPTRIN PEDIATRICO Susp. oral 8 mg/40 mg/ml SOLTRIM Sol. iny. 160 mg/800 mg» |
«No tomar sulfametoxazol y trimetoprima en los siguientes casos: antecedentes de hipersensibilidad a cualquiera de los principios activos o a sulfonamidas; niños prematuros y niños a término < 6 sem (vía oral) o niños < 2 meses (vía IV/IM); sospecha o diagnóstico confirmado de porfiria aguda; anemia megaloblástica por deficiencia de folato documentada; I.R. grave; I.H. grave; embarazo y lactancia; tto. concomitante con dofelitida. Precauciones: resistencia de microorganismos implicados en otitis media aguda y exacerbación aguda de la bronquitis crónica (S. pneumoniae) e infección no complicada del tracto urinario (E. coli) puede variar de un país a otro, el profesional sanitario debe tener en cuenta los datos de resistencia a nivel local; interrumpir el tto. si aparecen reacciones de hipersensibilidad (algunas mortales como síndrome de Steven Johnson y necrólisis epidérmica tóxica) o alteraciones hematológicas graves (agranulocitosis, anemia aplásica, discrasias sanguíneas); realizar recuentos sanguíneos mensualmente (sobre todo en tto. prolongado, ancianos y déficit de folato; mantener diuresis adecuada; riesgo de: diarrea y colitis pseudomembranosa por C. difficile; precaución en: I.R. (ajustar posología), lesión del parénquima hepático, ancianos, deficiencia de G6PDH (riesgo de hemólisis), alergias grave so asma bronquial, SIDA, fenilcetonúricos, pacientes con riesgo de hiperpotasemia e hipernatremia (monitorizar Na y K); no recomendado en tto. de faringitis por estreptococo beta-hemolítico del grupo A (S. pyogenes)». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Teicoplanin | «Targocid is an antibiotic. It contains a medicine called ‘teicoplanin’. It works by killing the bacteria that cause infections in your body». |
Sanofi (2017) Package leaflet: information for the user Targocid 200 mg powder for solution for injection/infusion or oral solution Targocid 400 mg powder for solution for injection/infusion or oral solution. Disponible en: https://www.medicines.org.uk/emc/files/pil.2927.pdf [Consultado: 26-05-2018] | «Targocid is used in adults and children (including newborn babies) to treat bacterial infections of: - the skin and underneath the skin - sometimes called ‘soft tissue’ - the bones and joints - the lung - the urinary tract - the heart - sometimes called ‘endocarditis’ - the abdominal wall - peritonitis - the blood, when caused by any of the conditions listed above Targocid can be used to treat some infections caused by ‘Clostridium difficile’ bacteria in the gut. For this, the solution is taken by mouth». |
«The recommended dose is Adults and children (12 years and over) with no kidney problems Skin and soft tissue, lung and urinary tract infections • Starting dose (for the first three doses): 6 mg for every kilogram of body weight, given every 12 hours, by injection into a vein or muscle. • Maintenance dose: 6 mg for every kilogram of body weight, given once a day, by injection into a vein or muscle Bone and joint infections, and heart infections • Starting dose (for the first three to five doses): 12 mg for every kilogram of body weight, given every 12 hours, by injection into a vein • Maintenance dose: 12 mg for every kilogram of body weight, given once a day, by injection into a vein or muscle Infection caused by ‘Clostridium difficile’ bacteria The recommended dose is 100 to 200 mg by mouth, twice a day for 7 to 14 days. Adults and elderly patients with kidney problems If you have kidney problems, your dose will usually need to be lowered after the fourth day of treatment: • For people with mild and moderate kidney problems - the maintenance dose will be given every two days, or half of the maintenance dose will be given once a day. • For people with severe kidney problems or on haemodialysis - the maintenance dose will be given every three days, or one-third of the maintenance dose will be given once a day. Peritonitis for patients on peritoneal dialysis The starting dose is 6 mg for every kilogram of body weight, as a single injection into a vein, followed by: • Week one: 20 mg/L in each dialysis bag • Week two: 20 mg/L in every other dialysis bag • Week three: 20 mg/L in the overnight dialysis bag. Babies (from birth to the age of 2 months) • Starting dose (on the first day): 16 mg for every kilogram of body weight, as an infusion through a drip into a vein. • Maintenance dose: 8 mg for every kilogram of body weight, given once a day, as an infusion through a drip into a vein. Children (from 2 months to 12 years) • Starting dose (for the first three doses): 10 mg for every kilogram of body weight, given every 12 hours, by injection into a vein. • Maintenance dose: 6 to 10 mg for every kilogram of body weight, given once a day, by injection into a vein». |
«Stop your treatment and tell your doctor or nurse straight away, if you notice any of the following serious side effects - you may need urgent medical treatment: Common (may affect up to 1 in 10 people) • Rash, erythema, pruritus • Pain • Fever Uncommon (may affect up to 1 in 100 people) • decrease in platelet count. • raised blood levels of liver enzymes • raised in blood levels of creatinine (to monitor your kidney) • hearing loss, ringing in the ears or a feeling that you, or things around you are moving • feeling or being sick (vomiting), diarrhoea • feeling dizzy or headache Rare (may affect up to 1 in 1,000 people) • infection (abscess)». |
Sanofi (2017) Package leaflet: information for the user Targocid 200 mg powder for solution for injection/infusion or oral solution Targocid 400 mg powder for solution for injection/infusion or oral solution. Disponible en: https://www.medicines.org.uk/emc/files/pil.2927.pdf [Consultado: 26-05-2018] | «Targocid 200mg; Targocid 400mg». | Precautions: «Do not use Targocid if: • you are allergic to teicoplanin or any of the other ingredients of this medicine. Talk to your doctor, pharmacist or nurse before you are given Targocid if: • you are allergic to an antibiotic called ‘vancomycin’ • you have had a flushing of your upper part of your body (red man syndrome) • you have a decrease in platelet count (thrombocytopenia) • you have kidney problems. you are taking other medicines which may cause hearing problems and/or kidney problems. You may have regular tests to check if your kidneys and/or liver are working properly (see ‘Other medicines and Targocid’). If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before you are given Targocid. Tests During treatment you may have tests to check your blood, your kidneys and/or your hearing. This is more likely if: • your treatment will last for a long time • you have a kidney problem • you are taking or may take other medicines that may affect your nervous system, kidneys or hearing. In people who are given Targocid for a long time, bacteria that are not affected by the antibiotic may grow more than normal - your doctor will check for this». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Teicoplanina | «Bactericida. Inhibe la biosíntesis de la pared celular bacteriana». | Vademecum (2015) Teicoplanina. Disponible en: https://www.vademecum.es/principios-activos-teicoplanina-J01XA02 [Consultado: 20-05-2018] | «Infección por gram+ resistente a meticilina y cefalosporinas: endocarditis, osteomielitis, infección respiratoria, de piel, tejido blando, renal, urinaria, gastrointestinal, sepsis, septicemia, peritonitis asociada a DPCA. Profilaxis de endocarditis tras cirugía dental en alérgicos a ß-lactámicos y asociado a aminoglucósidos en individuos con prótesis valvular cardiaca, infección en alérgicos a penicilinas o cefalosporinas, profilaxis antimicrobiana en cirugía cardiovascular y ortopédica con riesgo de infección por estafilococos meticilín resistentes. Oral: diarrea asociada a C. difficile». |
«Ads. - Infección leve-moderada: inicial 400 mg/24 h (6 mg/kg) IV, seguido de 200 mg/24 h (3 mg/kg) IV/IM en días siguientes. - Sepsis, endocarditis, osteomielitis, artritis séptica, infección en inmunodeprimidos: 400 mg/12 h (6 mg/kg), 1-4 días, seguido de 400 mg/24 h IM/IV en días siguientes. - Quemaduras infectadas o endocarditis por S. aureus: mantenimiento, hasta 12 mg/kg IV. - Diarrea por C. difficile asociada a antibióticos: 200 mg/12 h, oral. Niños > 2 meses: - Infección severa y neutropénicos: 10 mg/kg/12 h (3 dosis: 0, 12 y 24 h), seguido de 10 mg/kg/24 h IV/IM. - Infección moderada: 10 mg/kg/12 h (0, 12 y 24 h); seguido de 6 mg/kg/24 h IV o IM. Recién nacidos: - Infección por gram+: 16 mg/kg 1 er día, seguido de 8 mg/kg/día, infus. IV (30 min). I.R.: ajustar a partir de la 5ª dosis. Clcr 40-60 ml/min: ½ dosis habitual/24 h o dosis habitual/48 h. Clcr < 40 o hemodializados: 1/3 dosis habitual/24 h o dosis habitual/72 h. DPCA: 20 mg/l por bolsa la 1ª sem; 20 mg/l en bolsas alternas la 2ª sem; 20 mg/l en bolsa nocturna la 3ª sem y 400 mg IV en febriles. - Profilaxis de endocarditis por gram+ en cirugía dental y con enf. vascular: en inducción de anestesia 400 mg (6 mg/kg) IV». |
«Eritema, dolor local, tromboflebitis, absceso (IM), rash, prurito, fiebre, escalofríos, broncoespasmo, urticaria, angioedema, dermatitis exfoliativa, necrólisis epidérmica tóxica, eritema multiforme, náusea, vómito, diarrea, eosinofilia, leucopenia, neutropenia, trombocitopenia, elevación de transaminasas, fosfatasa alcalina y creatinina sérica, mareo, cefalea, pérdida auditiva, tinnitus, trastorno vestibular, sobreinfección». |
Vademecum (2015) Teicoplanina. Disponible en: https://www.vademecum.es/principios-activos-teicoplanina-J01XA02 [Consultado: 20-05-2018] | «TARGOCID Polvo y disolv. para sol. iny. 200 mg TARGOCID Polvo y disolv. para sol. iny. 400 mg TEICOPLANINA ACCORD Polvo y disolv. para sol. iny. 200 mg TEICOPLANINA ACCORD Polvo y disolv. para sol. iny. 400 mg TEICOPLANINA ACCORDPHARMA Polvo y disolv. para sol. iny. y perfusión 200 mg TEICOPLANINA ACCORDPHARMA Polvo y disolv. para sol. iny. y perfusión 400 mg TEICOPLANINA SALA Polvo y disolv. para sol. iny. y perfusión 200 mg TEICOPLANINA SALA Polvo y disolv. para sol. iny. y perfusión 400 mg» |
«No puede tomar teicoplanina en caso de hipersensibilidad, Precauciones: hipersensibilidad a vancomicina (reacción cruzada). Realizar control hematológico, auditivo, renal y hepático en: tto. prolongado, I.R. y concomitancia con fármacos oto y nefrotóxicos. En caso de insuficencia renal, ajustar dosis según Clcr». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Tigecycline | «Tigecycline is an antibiotic of the glycylcycline group that works by stopping the growth of bacteria that cause infections». |
Generics UK T/A Mylan (2017) Package leaflet: Information for the user Tigecycline 50 mg powder for solution for infusion Tigecycline. Disponible en: https://www.medicines.org.uk/emc/files/pil.9232.pdf [Consultado: 26-05-2018] | «Your doctor prescribed Tigecycline because you or your child at least 8 years old has one of the following types of serious infections: Complicated infection of the skin and soft tissues (the tissue below the skin), excluding diabetic foot infections. Complicated infection in the abdomen Tigecycline is only used when your doctor thinks other antibiotics are not suitable». |
«The recommended dose is 100 mg given initially, followed by 50 mg every 12 hours. This dose is given intravenously (directly into your blood stream) over a period of 30 to 60 minutes. The recommended dose in children aged 8 to <12 years is 1.2 mg/kg given every 12 hours intravenously to a maximum dose of 50 mg every 12 hours. The recommended dose in adolescents aged 12 to <18 years is 50 mg given every 12 hours. A course of treatment usually lasts for 5 to 14 days. Your doctor will decide how long you should be treated». |
«Pseudomembranous colitis may occur with most antibiotics including Tigecycline. This consists of severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation, which may occur during or after your treatment. Very common side effects (may affect more than 1 in 10 people): Nausea, vomiting, diarrhoea. Common side effects (may affect up to 1 in 10 people): Abscess (collection of pus), infections Laboratory measurements of decreased ability to form blood clots Dizziness Vein irritations from the injection, including pain, inflammation, swelling and clotting Abdominal pain, dyspepsia (stomach ache and indigestion), anorexia (loss of appetite) Increases in liver enzymes, hyperbilirubinaemia (excess of bile pigment in the blood) Pruritus (itching), rash Poor or slow wound healing Headache Increase in amylase, which is an enzyme found in the salivary glands and pancreas, increased blood urea nitrogen (BUN). Pneumonia Low blood sugar Sepsis (severe infection in the body and blood stream)/septic shock (serious medical condition which can lead to multiple organ failure and death as a result of sepsis) Injection site reaction (pain, redness, inflammation) Low protein levels in the blood». |
Generics UK T/A Mylan (2017) Package leaflet: Information for the user Tigecycline 50 mg powder for solution for infusion Tigecycline. Disponible en: https://www.medicines.org.uk/emc/files/pil.9232.pdf [Consultado: 26-05-2018] | «Tigecycline 50 mg powder for solution for infusion; Tygacil 50mg powder for solution for infusion». | Precautions: «Do not use Tigecycline: if you are allergic to tetracycline class antibiotics (e.g., minocycline, doxycycline, etc.), you may be allergic to tigecycline. Talk to your doctor or nurse before receiving Tigecycline: If you have poor or slow wound healing. If you are suffering from diarrhoea before you are given Tigecycline. If you develop diarrhoea during or after your treatment, tell your doctor at once. Do not take any diarrhoea medicine without first checking with your doctor. If you have or previously had any side effects due to antibiotics belonging to the tetracycline class (e.g., skin sensitization to sun light, staining on developing teeth, pancreas inflammation, and alteration of certain laboratory values aimed at measuring how well your blood clots). If you have, or previously had liver problems. Depending on the condition of your liver, your doctor may reduce the dose to avoid potential side effects. If you have blockage of the bile ducts (cholestasis)». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Tigeciclina | «Antibiótico bacteriostático del grupo de las glicilciclinas, inhibe la traducción de proteínas en las bacterias uniéndose a la subunidad ribosomal 30S». | Vademecum (2016) Tigeciclina. Disponible en: https://www.vademecum.es/principios-activos-tigeciclina-J01AA12 [Consultado: 29-05-2018] | «Infecciones complicadas de piel y tejidos blandos, excepto las de pie diabético e infecciones complicadas intraabdominales en ads. y niños ≥ 8 años». | «Ads.: perfus. IV (30-60 min), inicial 100 mg, seguida de 50 mg/12 h, 5 a 14 días. I.H. grave: reducir dosis a 25 mg/12h tras dosis inicial de 100 mg. Niños: perfus. IV (60 min), 8-< 12 años: 1,2 mg/kg/12 h, dosis máx.: 50 mg/12 h, 5 a 14 días; adolescentes 12-< 18 años: 50 mg/12 h, 5 a 14 días». | «Sepsis/shock séptico, neumonía, abscesos, infecciones; prolongación de TTPA y TP; hipoglucemia, hipoproteinemia; mareo; flebitis; náuseas, vómitos, diarrea, dolor abdominal, dispepsia, anorexia; aumento en suero de AST, ALT, hiperbilirrubinemia; prurito, erupción cutánea; problemas de cicatrización, reacción en el lugar de iny., cefalea; aumento de amilasa en suero y del BUN». | Vademecum (2016) Tigeciclina. Disponible en: https://www.vademecum.es/principios-activos-tigeciclina-J01AA12 [Consultado: 29-05-2018] | «TYGACIL Polvo para sol. para perfusión 50 mg» | «No puede tomar tigeciclina en caso de hipersensibilidad a tigeciclina o tetraciclinas. Precauciones: insuficiencia hepática grave; experiencia limitada en enf. subyacente grave o bacteriemia concurrente; considerar su uso asociado con otros antibióticos para tto. de pacientes graves con infección complicada intraabdominal grave 2 aria a perforación intestinal, o a sujetos con sepsis incipiente o shock séptico; monitorizar tests de coagulación si tto. con anticoagulantes y a sujetos con colestasis; notificados casos de pancreatitis aguda (considerar suspensión de tto.) y reacciones anafilácticas potencialmente letales; riesgo de: colitis pseudomembranosa, sobreinfección por microorganismos resistentes (vigilar), pseudotumor cerebrii, acción antianabólica que conduce a aumento del BUN, azotemia, acidosis e hipofosfatemia, y coloración permanente de dientes en desarrollo de dentición (no recomendado en sujetos < 8 años); no recomendado para tto. de infección de pie diabético; riesgo de hipofibrinogenemia. Precaución en I.H. grave: reducir dosis a 25 mg/12 h tras dosis inicial de 100 mg y vigilar la respuesta al tto.». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Vancomycin | «Vancomycin is an antibiotic that belongs to a group of antibiotics called “glycopeptides”. Vancomycin works by eliminating certain bacteria that cause infections». | Hospira UK Ltd (2017) Package leaflet: Information for the user Vancomycin Hydrochloride 500 mg and 1 g Powder for Concentrate for Infusion Vancomycin hydrochloride. Disponible en: https://www.medicines.org.uk/emc/files/pil.386.pdf [Consultado: 26-05-2018] | «Vancomycin is used in in all age groups by infusion for the treatment of the following serious infections: - Infections of the skin and tissues below the skin. - Infections of bone and joints. - An infection of the lungs called "pneumonia". - Infection of the inside lining of the heart (endocarditis) and to prevent endocarditis in patients at risk when undergoing major surgical procedures. -Infection in central nervous system - Infection in the blood linked to the infections listed above». |
«Intravenous administration Adults and adolescents (from 12 years and older) The dosage will be calculated according to your body weight. The usual infusion dose is 15 to 20 mg for each kg of body weight. It is usually given every 8 to 12 hours. In some cases, your doctor may decide to give an initial dose of up to 30 mg for each kg of body weight. The maximum daily dose should not exceed 2 g. Use in children Children aged from one month to less than 12 years of age The dosage will be calculated according to your body weight. The usual infusion dose is 10 to 15 mg for each kg of body weight. It is usually given every 6 hours. Preterm and term newborn infants (from 0 to 27 days) The dosage will be calculated according to post-menstrual age (time elapsed between the first day of the last menstrual period and birth (gestational age) plus the time elapsed after birth (post-natal age). The elderly, pregnant women and patients with a kidney disorder, including those on dialysis, may need a different dose.Oral administration Adults and adolescents (from 12 to 18 years) The recommended dose is 125 mg every 6 hours. In some cases, your doctor may decide to give a higher daily dose of up to 500 mg every 6 hours. The maximum daily dose should not exceed 2 g. If you suffered other episodes (infection of the mucosa) before you may need different dose and different duration of the therapy. Use in children Neonates, infants and children less than 12 years old The recommended dose is 10 mg for each kg of body weight. It is usually given every 6 hours. The maximum daily dose should not exceed 2 g.» |
«Vancomycin can cause allergic reactions, although serious allergic reactions (anaphylactic shock) are rare. Tell your doctor immediately if you get any sudden wheeziness, difficulty in breathing, redness on the upper part of the body, rash or itching. The absorption of vancomycin from the gastrointestinal tract is negligible. However, if you have an inflammatory disorder of the digestive tract, especially if you also have a kidney disorder, side effects that occur when vancomycin is administered by infusion may appear. Common side effects (may affect up to 1 in 10 people): - Fall in blood pressure - Breathlessness, noisy breathing (a high pitched sound resulting from obstructed air flow in the upper airway) - Rash and inflammation of the lining of the mouth, itching, itching rash, hives - Kidney problems which may be detected primarily by blood tests - Redness of upper body and face, inflammation of a vein Uncommon side effects (may affect up to 1 in 100 people): - Temporary or permanent loss of hearing». |
Hospira UK Ltd (2017) Package leaflet: Information for the user Vancomycin Hydrochloride 500 mg and 1 g Powder for Concentrate for Infusion Vancomycin hydrochloride. Disponible en: https://www.medicines.org.uk/emc/files/pil.386.pdf [Consultado: 26-05-2018] | «Vancocin Matrigel Capsules 125mg; Vancocin Powder for Solution; Vancomycin 1000 mg powder for concentrate for solution for infusion; Vancomycin 1g Powder for Solution for Infusion; ancomycin 500 mg powder for concentrate for solution for infusion; Vancomycin Hydrochloride 500 mg and 1 g Powder for Concentrate for Infusion; Vancomycin Powder for Infusion 1g; Vancomycin Powder for Infusion 500mg; Vancomycin, 1000 mg, powder for solution for infusion; Vancomycin, 500 mg, powder for solution for infusion». | Precautions: «Do not use Vancomycin Hydrochloride If you are allergic to vancomycin or any of the other ingredients of this medicine. Talk to your doctor or hospital pharmacist or nurse before using Vancomycin if: - You suffered a previous allergic reaction to teicoplanin because this could mean you are also allergic to vancomycin. - You have a hearing disorder, especially if you are elderly (you may need hearing tests during treatment). - You have kidney disorder (you will need to have your blood and kidneys tested during treatment). - You are receiving vancomycin by infusion for the treatment of the diarrhoea associated to Clostridium difficile infection instead of orally. Talk to your doctor or hospital pharmacist or nurse during treatment with Vancomycin if: - You are receiving vancomycin for a long time (you may need to have your blood, hepatic and kidneys tested during treatment). - You develop any skin reaction during the treatment. - You develop severe or prolonged diarrhoea during or after using vancomycin, consult your doctor immediately. This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics. Children Vancomycin will be used with particular care in premature infants and young infants, because their kidneys are not fully developed and they may accumulare vancomycin in the blood. This age group may need blood tests for controlling vancomycin levels in blood. Take special care with Vancomycin: • if you have kidney problems • if you have hearing difficulties». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Vancomicina | «Bactericida. Inhibe la biosíntesis de la pared celular bacteriana, interfiere en la síntesis de ARN y daña la membrana celular bacteriana». | Vademecum (2016) Vancomicina. Disponible en: https://www.vademecum.es/principios-activos-vancomicina-J01XA01 [Consultado: 29-05-2018] | «Infecciones graves causadas por bacterias gram+ sensibles a la vancomicina que no pueden tratarse, no responden o son resistentes a otros antibióticos, como penicilinas o cefalosporinas: endocarditis, infecciones óseas (osteomielitis), neumonía, infecciones de tejidos blandos; profilaxis perioperatoria contra la endocarditis bacteriana en pacientes con alto riesgo de desarrollar endocarditis bacteriana cuando son sometidos a intervenciones quirúrgicas mayores (por ejemplo, intervenciones cardiacas y vasculares) y no se les puede administrar un agente antibacteriano betalactámico apropiado». | «Perfus. IV (en mín. 60 min). Ads. y adolescentes > 12 años: 1 g/12 h o 500 mg/6 h o 30-40 mg/kg/día en 2-4 dosis; endocarditis bacteriana: 1 g/12 h 4 sem sola o combinada (gentamicina más rifampicina, gentamicina, estreptomicina); endocarditis enterocócica: 6 sem en tto. concomitante con aminoglucósido. Niños 1 mes-12 años: 10 mg/kg/6 h. Recién nacidos (a término): 0-7 días de edad: inicial 15 mg/kg seguido de 10 mg/kg/12 h; de 7 a 30 días de edad: inicial 15 mg/kg seguido de 10 mg/kg/8 h». I.R.: administrar 250 mg-1 g cada varios días en lugar de diariamente. En anuria, administrar 1 g cada 7-10 días. Diálisis: inicial 15 mg/kg seguido de 1,9 mg/kg/24 h. |
«Descenso de la presión sanguínea; disnea, estridor; exantema e inflamación de las mucosas, prurito, urticaria; I.R. manifiesta principalmente por aumento de creatinina sérica; flebitis y rubefacción de la parte superior del cuerpo y cara». |
Vademecum (2016) Vancomicina. Disponible en: https://www.vademecum.es/principios-activos-vancomicina-J01XA01 [Consultado: 29-05-2018] | «VANCOMICINA ACCORD Vial 1 g IV VANCOMICINA ACCORD Vial 500 mg IV VANCOMICINA CNP Polvo para sol. para perfusión 1000 mg VANCOMICINA CNP Polvo para sol. para perfusión 500 mg VANCOMICINA NORMON EFG Vial 1 g VANCOMICINA NORMON EFG Vial 500 mg VANCOMICINA PFIZER Polvo para concent. para sol. para perf. 1000 mg VANCOMICINA PFIZER Polvo para concentrado para sol. para perf. 500 mg VANCOMICINA SALA Polvo para sol. iny. 1 g VANCOMICINA SALA Polvo para sol. iny. 500 mg» |
«No tomar vancomicina en caso de hipersensibilidad. Precauciones: perfundir en un periodo no < 60 min ; ancianos, alteración renal, pérdida auditiva previa, concomitancia con fármacos oto o nefrotóxicos; realizar hemograma periódico en tto. prolongado o en concomitancia con fármacos nefrotóxicos u ototóxicos; monitorizar función renal y la capacidad auditiva; se ha asociado a eritema y reacción anafilactoide en niños y en concomitancia con anestésicos; riesgo de colitis pseudomembranosa y crecimiento de microorganismos no susceptibles; evitar extravasación en infus. IV.; hipersensibilidad a teicoplanina. En caso de insuficiencia renal: administrar 250 mg-1 g cada varios días en lugar de diariamente. En anuria, administrar 1 g cada 7-10 días. Diálisis: inicial 15 mg/kg seguido de 1,9 mg/kg/24 h». | Irene Abellán Serrano |
| Pharmacology | Antiinfectives for systemic use | Infectious diseases | Voriconazole | «Voriconazole is an antifungal medicine. It works by killing or stopping the growth of the fungi that cause infections». |
Accord-UK Ltd (2016) Package leaflet: Information for the user Voriconazole 50mg and 200mg Film-coated Tablets. Disponible en: https://www.medicines.org.uk/emc/files/pil.7319.pdf [Consultado: 26-05-2018] | «It is used for the treatment of patients (adults and children over the age of 2) with: • invasive aspergillosis (a type of fungal infection due to Aspergillus sp) • candidaemia (another type of fungal infection due to Candida sp) in non-neutropenic patients (patients without abnormally low white blood cells count). • serious invasive Candida sp. infections when the fungus is resistant to fluconazole (another antifungal medicine) • serious fungal infections caused by Scedosporium sp. or Fusarium sp. (two different species of fungi). Voriconazole Tablets are intended for patients with worsening, possibly life-threatening, fungal infections. Prevention of fungal infections in high risk bone marrow transplant recipients». |
«Adults: Loading dose regimen (first 24 hours): Intravenous: 6 mg/kg every 12 hours/Oral: Patients 40 kg and above: 400 mg every 12 hours; Patients less than 40 kg: 200 mg every 12 hours. Maintenance dose (after first 24 hours): Intravenous: 4 mg/kg twice daily/Oral: Patients 40 kg and above: 200 mg twice daily; Patients less than 40 kg: 100 mg twice daily.Treatment duration should be as short as possible depending on the patient's clinical and mycological response. Long term exposure to Voriconazole Tablets greater than 180 days (6 months) requires careful assessment of the benefit-risk balance. Dosage adjustment (adults) If patient response to treatment is inadequate, the maintenance dose may be increased to 300 mg twice daily for oral administration. For patients less than 40 kg the oral dose may be increased to 150 mg twice daily. If patient is unable to tolerate treatment at a higher dose reduce the oral dose by 50 mg steps to the 200 mg twice daily (or 100 mg twice daily for patients less than 40 kg) maintenance dose. Children (2 to <12 years) and young adolescents with low body weight (12 to 14 years and <50 kg): Loading dose regimen (first 24 hours): Intravenous: 9 mg/kg every 12 hours/Oral: not recommended; Maintenance dose (after first 24 hours): 8 mg/kg twice daily/Oral: 9 mg/kg twice daily (a maximum dose of 350 mg twice daily). It should be noted that an 8 mg/kg intravenous dose will provide voriconazole exposure approximately 2-fold higher than a 9 mg/kg oral dose. All other adolescents (12 to 14 years and ≥ 50 kg; 15 to 17 years regardless of body weight) Voriconazole should be dosed as adults. Dosage adjustment (children [2 to <12 years] and young adolescents with low body weight [12 to 14 years and <50 kg]) If patient response to treatment is inadequate, the dose may be increased by 1 mg/kg steps (or by 50 mg steps if the maximum oral dose of 350 mg was used initially). If patient is unable to tolerate treatment, reduce the dose by 1 mg/kg steps (or by 50 mg steps if the maximum oral dose of 350 mg was used initially). Elderly patients No dose adjustment is necessary for elderly patients. No adjustment is necessary for oral dosing for patients with mild to severe renal impairment». |
«Serious side effects – Stop taking Voriconazole Tablets and see a doctor immediately • Rash • Jaundice; Changes in blood tests of liver function • Pancreatitis. Other side effects Very common side effects (may affect more than 1 in 10 people): • Visual impairment (change in vision including blurred vision, visual colour alterations, abnormal intolerance to visual perception of light, colour blindness, eye disorder, halo vision, night blindness, swinging vision, seeing sparks, visual aura, visual acuity reduced, visual brightness, loss of part of the usual field of vision, spots before the eyes) • Fever • Rash • Nausea, vomiting, diarrhoea • Headache • Swelling of the extremities • Stomach pains • Breathing difficulties • Elevated liver enzymes Common side effects (may affect up to 1 in 10 people): • Inflammation of the sinuses, inflammation of the gums, chills, weakness • Low numbers of some types, including severe, of red (sometimes immune-related) and/or white blood cells (sometimes with fever), low numbers of cells called platelets that help the blood to clot • Allergic reaction or exaggerated immune response • Low blood sugar, low blood potassium, low sodium in the blood • Anxiety, depression, confusion, agitation, inability to sleep, hallucinations • Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations, increase in muscle tone, sleepiness, dizziness • Bleeding in the eye. • Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting • Low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot) • Acute breathing difficulty, chest pain, swelling of the face (mouth, lips and around eyes), fluid accumulation in the lungs • Constipation, indigestion, inflammation of the lips • Jaundice, inflammation of the liver and liver injury • Skin rashes which may lead to severe blistering and peeling of the skin characterised by a flat red area on the skin that is covered with small confluent bumps, redness of the skin • Itchiness • Hair loss • Back pain • Kidney failure, blood in the urine, changes in kidney function tests». |
Accord-UK Ltd (2016) Package leaflet: Information for the user Voriconazole 50mg and 200mg Film-coated Tablets. Disponible en: https://www.medicines.org.uk/emc/files/pil.7319.pdf [Consultado: 26-05-2018] | «VFEND 200 mg film-coated tablets; VFEND 200 mg powder and solvent for solution for infusion;VFEND 200 mg powder for solution for infusion; VFEND 40 mg/ml powder for oral suspension; VFEND 50 mg film-coated tablets; Voriconazole 200 mg powder for solution for infusion; Voriconazole 200 mg Tablets; Voriconazole 200mg film-coated tablets; Voriconazole 200mg Powder for Solution for Infusion; Voriconazole 50 mg Film-Coated Tablets; Voriconazole 50mg Tablets; Voriconazole Accord Film-coated Tablets; Voriconazole Actavis 200mg Film-coated Tablets; Voriconazole Actavis 200mg Powder for Solution for Infusion; Voriconazole Actavis 50mg Film-coated Tablets; Voriconazole Milpharm 200 mg film-coated tablets; Voriconazole Milpharm 50 mg film-coated tablets». | Precautions: «Do not take Voriconazole Tablets: • if you are allergic to voriconazole. It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription, or herbal medicines. Talk to your doctor, pharmacist or nurse if: • you have had an allergic reaction to other azoles; • you are suffering from, or have ever suffered from liver disease. If you have liver disease, your doctor may prescribe a lower dose of Voriconazole Tablets. Your doctor should also monitor your liver function while you are being treated with Voriconazole Tablets by doing blood tests • you are known to have cardiomyopathy, irregular heart beat, slow heart rate or an abnormality of electrocardiogram (ECG) called ‘long QTc syndrome’. You should avoid any sunlight and sun exposure while being treated. It is important to cover sun exposed areas of skin and use sunscreen with high sun protection factor (SPF), as an increased sensitivity of skin to the sun’s UV rays can occur. These precautions are also applicable to children. While being treated with Voriconazole Tablets: • tell your doctor immediately if you develop - sunburn - severe skin rash or blisters - bone pain. Children and adolescents Voriconazole Tablets should not be given to children younger than 2 years of age». |
Irene Abellán Serrano | Farmacología | Antiinfecciosos para uso sistémico | Enfermedades infecciosas | Voriconazol | «Antimicótico derivado del triazol. Inhibe la 14-alfa-esterol desmetilasa fúngica, enzima esencial en la biosíntesis de ergosterol. «Antifúngico frente a especies de Candida y fungicida frente a Aspergillus, Scedosporium o Fusarium». | Vademecum (2015) Voriconazol. Disponible en: https://www.vademecum.es/principios-activos-voriconazol-J02AC03 [Consultado: 29-05-2018] | «Ads. y niños > 2 años para: aspergilosis invasiva, candidemia en no neutropénicos, infecciones invasivas graves por Candida (incluyendo C. krusei) resistentes a fluconazol, infecciones graves por Scedosporium spp. y Fusarium spp, profilaxis de infecciones fúngicas invasivas en los receptores de trasplantes alogénicos de células madre hematopoyéticas (TCMH) de alto riesgo». | «Tto.: ads. y adolescentes de 12-14 años con p.c. ≥ 50 kg y de 15-17 años con independencia del p.c.: perfus. IV (previa reconstitución y dilución, no en bolus) durante 1-3 h, velocidad máx. 3 mg/kg/h; dosis de carga (1 as 24 h): 6 mg/kg/12 h; mantenimiento: 4 mg/kg 2 veces/día y si no se tolera reducir a 3 mg/kg 2 veces/día; máx. 6 meses. Oral, dosis de carga, p.c. ≥ 40 kg: 400 mg/12 h, p.c. < 40 kg: 200 mg/12 h; mantenimiento, p.c. ≥ 40 kg: 200 mg 2 veces/día y si respuesta es insuficiente 300 mg 2 veces/día, p.c. < 40 kg: 100 mg 2 veces/día y si respuesta es insuficiente 150 mg 2 veces/día. Si estas dosis altas no se toleran reducir en pasos de 50 mg hasta: 200 mg 2 veces/día si p.c. ≥ 40 kg, 100 mg 2 veces/día si p.c. < 40 kg. Niños 2-< 12 años y adolescentes de 12-14 años con p.c. < 50 kg: perfus. IV previa reconstitución y dilución, no en bolus) durante 1-3 h, velocidad máx. 3 mg/kg/h; dosis de carga (1 as 24 h): 9 mg/kg/12 h; mantenimiento: 8 mg/kg 2 veces/día. Oral, dosis de carga: no se recomienda; mantenimiento: 9 mg/kg 2 veces/día (dosis máx. 350 mg 2 veces/día). Si repuesta insuficiente, aumentar dosis en pasos de 1 mg/kg (o en 50 mg si 1º se usó dosis oral máx. de 350 mg). Si no se tolera reducir en pasos de 1 mg/kg (o en 50 mg si 1º se usó dosis oral máx. de 350 mg). - Profilaxis: iniciar el día del trasplante, duración 100 días (en caso de inmunosupresión persistente o enf. de injerto contra huésped prolongar 180 días). Mismas dosis que en tto. Cirrosis hepática leve-moderada: ½ dosis mantenimiento». |
«Gastroenteritis, sinusitis, gingivitis; carcinoma de células escamosas; agranulocitosis, pancitopenia, trombocitopenia, anemia; hipersensibilidad; edema periférico, hipoglucemia, hipopotasemia, hiponatremia; depresión, alucinaciones, ansiedad, insomnio, agitación, estado confusional; cefalea, convulsión, temblores, parestesia, hipertonía, somnolencia, síncope, mareos; alteración visual (visión borrosa, cromatopsia, fotofobia), hemorragia de la retina; arritmia supraventricular, taquicardia, bradicardia; hipotensión, flebitis; dificultad respiratoria, s. de distrés respiratorio agudo, edema pulmonar; dolor abdominal, náuseas, vómitos, diarrea, dispepsia, estreñimiento, queilitis; PFH elevadas, ictericia, ictericia colestática, hepatitis; erupción/exantema, dermatitis exfoliativa, erupción maculopapular, prurito, alopecia, eritema; dolor de espalda; fallo renal agudo, hematuria; pirexia, dolor torácico, edema facial, astenia, enf. de tipo gripal, escalofríos; aumentado de creatinina». | Vademecum (2015) Voriconazol. Disponible en: https://www.vademecum.es/principios-activos-voriconazol-J02AC03 [Consultado: 29-05-2018] | «VFEND Comp. recub. 200 mg VFEND Comp. recub. 50 mg VFEND Polvo para sol. para perfusión 200 mg/vial VFEND Polvo para susp. oral 40 mg/ml VORICONAZOL ACCORD Comp. recub. con película 200 mg VORICONAZOL ACCORD Comp. recub. con película 50 mg VORICONAZOL ACCORD Polvo para sol. para perfusión 200 mg VORICONAZOL AUROVITAS SPAIN Polvo para sol. para perfusión 200 mg VORICONAZOL DR. REDDYS Polvo para sol. para perfusión 200 mg VORICONAZOL KERN PHARMA Comp. recub. con película 200 mg VORICONAZOL KERN PHARMA Comp. recub. con película 50 mg VORICONAZOL KERN PHARMA Polvo para sol. para perfusión 200 mg VORICONAZOL NORMON Comp. recub. con película 200 mg VORICONAZOL NORMON Comp. recub. con película 50 mg VORICONAZOL NORMON Polvo para sol. para perfusión 200 mg VORICONAZOL SANDOZ Comp. recub. con película 200 mg VORICONAZOL SANDOZ Comp. recub. con película 50 mg VORICONAZOL SANDOZ Polvo para sol. para perfusión 200 mg VORICONAZOL TEVA Comp. recub. con película 200 mg VORICONAZOL TEVA Comp. recub. con película 50 mg VORICONAZOL TEVA Polvo para sol. para perfusión 200 mg» |
«No puede tomar voriconazol en los siguientes casos: hipersensibilidad. Concomitancia con: terfenadina, astemizol, cisaprida, pimozida y quinidina por riesgo de prolongación intervalo QTc; rifampicina, carbamazepina y fenobarbital; dosis altas de ritonavir (≥ 400 mg 2 veces/día); dosis de efavirenz ≥ 400 mg/día; alcaloides ergotamínicos por riesgo de ergotismo; sirolimús; hipérico. Precauciones: hipersensibilidad previa a compuestos azólicos. Prolongación QT adquirida o congénita, cardiomiopatía (en particular con insuf. cardíaca asociada), bradicardia sinusal, arritmia sintomática, concomitancia con prolongadores QT; antes y durante tto. monitorizar y corregir alteraciones electrolíticas (hipopotasemia, hipomagnesemia e hipocalcemia). Comunicadas reacciones de toxicidad hepática, I.R. aguda y efectos adversos visuales prolongados. Monitorizar: función hepática al inicio y al menos 1 vez/sem. durante 1 er mes de tto. y en caso de alteración de PFH durante el tto. Si el tto. se prolonga, realizar PFH 1 vez/mes (si no hay cambios en PFH) y considerar suspensión si hay signos de enf. hepática, en I.H. grave valorar riesgo/beneficio; función renal; función pancreática (especialmente en niños y con riesgo de pancreatitis aguda); erupción cutánea y si la lesión progresa suspender. Evitar exposición a luz solar, se ha asociado con fotoxicidad, pseudoporfiria y con tto. prolongado notificado carcinoma de células escamosas de la piel (suspender), mayor riesgo en niños (hacer seguimiento tras suspender tto.) ; evaluar beneficio/riesgo de tto. > 6 meses. No asociar salvo beneficio > riesgo con dosis bajas de ritonavir (100 mg 2 veces/día), con fenitoína (monitorizar concentración y aumentar mantenimiento a 5 mg/kg 2 veces/día IV o a 400 mg 2 veces/día oral, 200 mg 2 veces/día si p.c. < 40 kg)o con rifabutina (monitorizar recuento total células sanguíneas y efectos adversos, y aumentar mantenimiento a 5 mg/kg 2 veces/día IV o a 350 mg 2 veces/día oral, 200 mg 2 veces/día si p.c. < 40 kg); monitorizar efectos adversos y toxicidad de metadona (puede precisar reducción de dosis); asociado con opiáceos de acción corta (alfentanilo, fentanilo, sulfentanilo) o de acción prolongada (oxicodona, hidrocodona) sustratos del CYP3A4, monitorizar intensa y frecuentemente efectos adversos asociados a opiáceos y considerar ajuste de dosis; monitorizar efectos adversos de voriconazol si se usa secuencialmente tras fluconazol; con efavirenz, aumentar dosis mantenimiento de voriconazol a 400 mg/12 h y reducir dosis de efavirenz a 300 mg/24 h; riesgo de aumentar nivel de everolimús, sin datos suficientes para recomendar dosis, asociación no recomendada. Eficacia/seguridad no establecidas en niños < 2 años. IV, además: vigilar reacciones relacionadas con la perfus. En caso de insuficiencia hepática, monitorizar función hepática y bilirrubina. Con cirrosis leve-moderada, ½ dosis mantenimiento. En I.H. grave valorar riesgo/beneficio. En caso de insuficiencia renal monitorizar función renal y nivel de creatinina sérica». | Irene Abellán Serrano |