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Medicine information : TAMIFLU Suspension
| Drug class description : | Antiviral |
| Generic Name : | Oseltamivir |
| Drug description : | Powder for oral suspension, containing 39.4 mg oseltamivir phosphate per 1 g filling mixture. The reconstituted suspension contains 12 mg oseltamivir per ml. |
| Presentation : | Tamiflu 12 mg/ml powder for oral suspension. The powder is a granulate or clumped granulate with a white to light yellow colour. |
| Indications : | Treatment of influenza in adults and children one year of age or older who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms. This indication is based on clinical studies of naturally occurring influenza in which the predominant infection was influenza A. -Prevention of influenza - Post exposure prevention in adults and children one year of age or older following a contact with clinically diagnosed influenza case when influenza virus is circulating in the community. - The appropriate use of Tamiflu for prevention of influenza should be determined on a case by case basis by the circumstances and the population requiring protection. In exceptional situations (e.g. in case of a mismatch between the circulating and vaccine virus strains, and a pandemic situation) seasonal prevention could be considered in adults and children one year of age or older. Tamiflu is not a substitute for influenza vaccination. The use of antivirals for the treatment and prevention of influenza should be determined on the basis of official recommendations taking into consideration variability of epidemiology and the impact of the disease in different geographical areas and patient populations. |
| Adult Dosage : | Tamiflu suspension and Tamiflu capsules are bioequivalent formulations, 75 mg doses can be administered as either one 75 mg capsule or by administering one 30 mg dose plus one 45 mg dose of suspension. Adults, adolescents or children (>40 kg) who are able to swallow capsules may receive appropriate doses of Tamiflu capsules. The safety and efficacy of Tamiflu in children less than one year of age have not been established. Treatment of influenza Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza. For adults and adolescents 13 years or older the recommended oral dose is 75 mg oseltamivir twice daily, for 5 days. For children of 1 to 12 years of age: The recommended dose of Tamiflu oral suspension is indicated in the table below. The following weight adjusted dosing regimens are recommended for children one year or older: Body Weight Recommended dose for 5 days 15 kg 30 mg twice daily >15 kg to 23 kg 45 mg twice daily >23 kg to 40 kg 60 mg twice daily >40 kg 75 mg twice daily For dosing an oral dispenser with 30 mg, 45 mg, and 60 mg graduations is provided in the box. For accurate dosing the oral dispenser supplied should be used exclusively. Prevention of influenza Post exposure prevention For adults and adolescents 13 years or older, the recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days. Therapy should begin as soon as possible within two days of exposure to an infected individual. Children weighing > 40 kg, who are able to swallow capsules, may also receive prevention with a 75 mg capsule once daily for 10 days as an alternative to the recommended dose of Tamiflu suspension. The recommended prophylactic dose of Tamiflu suspension for children one year or older is: Body Weight Recommended dose for 10 days 15 kg 30 mg once daily >15 kg to 23 kg 45 mg once daily >23 kg to 40 kg 60 mg once daily >40 kg 75 mg once daily For dosing an oral dispenser with 30 mg, 45 mg, and 60 mg graduations is provided in the box. For accurate dosing the oral dispenser supplied should be used exclusively. It is recommended that Tamiflu powder for oral suspension be constituted by a pharmacist prior to dispensing to the patient. Prevention during an influenza epidemic in the community: The recommended dose for prevention of influenza during a community outbreak is 75 mg oseltamivir once daily for up to six weeks. Special populations Hepatic impairment No dose adjustment is required either for treatment or for prevention, in patients with hepatic dysfunction. Renal impairment Treatment of influenza: Dose adjustment is recommended for adults with severe renal impairment. Recommended doses are detailed in the table below. Creatinine clearance Recommended dose for treatment >30 (ml / min) 75 mg twice daily >10 to 30 (ml / min) 75 mg once daily or 30 mg suspension twice daily 10 (ml / min) Not recommended dialysis patients Not recommended Prevention of influenza: Dose adjustment is recommended for adults with severe renal impairment as detailed in the table below. Creatinine clearance Recommended dose for prevention >30 (ml / min) 75 mg once daily >10 to 30 (ml / min) 75 mg every second day or 30 mg suspension once daily 10 (ml / min) Not recommended dialysis patients Not recommended |
| Child Dosage : | See Adult Dosage |
| Elderly Dosage : | No dose adjustment is required, unless there is evidence of severe renal impairment. |
| Contra Indications : | Hypersensitivity to oseltamivir phosphate or to any of the excipients. |
| Special Precautions : | Oseltamivir is effective only against illness caused by influenza viruses. There is no evidence for efficacy of oseltamivir in any illness caused by agents other than influenza viruses. The safety and efficacy of oseltamivir for the treatment and prevention of influenza in children of less than one year of age have not been established. No information is available regarding the safety and efficacy of oseltamivir in patients with any medical condition sufficiently severe or unstable to be considered at imminent risk of requiring hospitalisation. The safety and efficacy of oseltamivir in either treatment or prevention of influenza in immunocompromised patients have not been established. Efficacy of oseltamivir in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established. No difference in the incidence of complications was observed between the treatment and placebo groups in this population. Tamiflu is not a substitute for influenza vaccination. Use of Tamiflu must not affect the evaluation of individuals for annual influenza vaccination. The protection against influenza lasts only as long as Tamiflu is administered. Tamiflu should be used for the treatment and prevention of influenza only when reliable epidemiological data indicate that influenza virus is circulating in the community. Severe renal impairment Dose adjustment is recommended for both treatment and prevention in adults with severe renal insufficiency. There are no data concerning the safety and efficacy of oseltamivir in children with renal impairment (See Dosage). This medicinal product contains 26 g of sorbitol. One dose of 45 mg oseltamivir administered twice daily delivers 2.6 g of sorbitol. For subjects with hereditary fructose intolerance this is above the recommended daily maximum limit of sorbitol. |
| Interactions : | Pharmacokinetic properties of oseltamivir, such as low protein binding and metabolism independent of the CYP450 and glucuronidase systems, suggest that clinically significant drug interactions via these mechanisms are unlikely. No dose adjustment is required when co-administering with probenecid in patients with normal renal function. Co-administration of probenecid, a potent inhibitor of the anionic pathway of renal tubular secretion results in an approximate 2-fold increase in exposure to the active metabolite of oseltamivir. Oseltamivir has no kinetic interaction with amoxicillin, which is eliminated via the same pathway suggesting that oseltamivir interaction with this pathway is weak. Clinically important drug interactions involving competition for renal tubular secretion are unlikely, due to the known safety margin for most of these substances, the elimination characteristics of the active metabolite (glomerular filtration and anionic tubular secretion) and the excretion capacity of these pathways. However, care should be taken when prescribing oseltamivir in subjects when taking co-excreted agents with a narrow therapeutic margin (e.g. chlorpropamide, methotrexate, phenylbutazone). No pharmacokinetic interactions between oseltamivir or its major metabolite have been observed when co-administering oseltamivir with paracetamol, acetyl-salicylic acid, cimetidine or with antacids (magnesium and aluminium hydroxides and calcium carbonates). Pregnancy and lactation There are no adequate data from the use of oseltamivir in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal or postnatal development. Oseltamivir should not be used during pregnancy unless the potential benefit to the mother justifies the potential risk to the foetus. In lactating rats, oseltamivir and the active metabolite are excreted in the milk. It is not known whether oseltamivir or the active metabolite are excreted in human milk. Oseltamivir should be used during lactation only if the potential benefit for the mother justifies the potential risk for the nursing infant. |
| Adverse Reactions : | Treatment of influenza in adults and adolescents: A total of 2107 patients participated in phase III studies in the treatment of influenza. The most frequently reported undesirable effects were nausea, vomiting and abdominal pain. The majority of these events were reported on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 days. All events that were reported commonly, (i.e. at an incidence of at least 1 %, irrespective of causality) in subjects receiving oseltamivir 75 mg twice daily, are included in the table below. Treatment of influenza in elderly: In general, the safety profile in the elderly patients was similar to adults aged up to 65 years: the incidence of nausea was lower in oseltamivir treated elderly persons (6.7 %) than in those taking placebo (7.8 %) whereas the incidence of vomiting was higher in those who received oseltamivir (4.7 %) than among placebo recipients (3.1 %). The adverse event profile in adolescents and in the patients with chronic cardiac and/or respiratory disease was qualitatively similar to that of healthy young adults. Prevention of influenza. In prevention studies, where the dosage of oseltamivir was 75 mg once daily for up to 6 weeks, adverse events reported more commonly in subjects receiving oseltamivir compared to subjects receiving placebo (in addition to the events listed in the table below) were: Aches and pains, rhinorrhoea, dyspepsia and upper respiratory tract infection. There were no clinically relevant differences in the safety profile of the elderly subjects, who received oseltamivir or placebo, compared with the younger population. Most Frequent Adverse Events in Studies in Naturally Acquired Influenza System Organ Class Adverse Event Treatment Prevention Placebo (N = 1050) Oseltamivir 75 mg twice daily (N = 1057) Placebo (N = 1434) Oseltamivir 75 mg once daily (N = 1480) Gastrointestinal Disorders Vomiting 2 3.0 % 8.0 % 1.0 % 2.1 % Nausea 1, 2 5.7 % 7.9 % 3.9 % 7.0 % Diarrhoea 8.0 % 5.5 % 2.6 % 3.2 % Abdominal Pain 2.0 % 2.2 % 1.6 % 2.0 % Infections and Infestations Bronchitis 5.0 % 3.7 % 1.2 % 0.7 % Bronchitis acute 1.0 % 1.0 % - - General Disorders Dizziness 3.0 % 1.9 % 1.5 % 1.6 % Fatigue 0.7 % 0.8 % 7.5 % 7.9 % Neurological Disorders Headache 1.5 % 1.6 % 17.5 % 20.1 % Insomnia 1.0 % 1.0 % 1.0 % 1.2 % 1 Subjects who experienced nausea alone; excludes subjects who experienced nausea in association with vomiting. 2 The difference between the placebo and oseltamivir groups was statistically significant. Treatment of influenza in children: A total of 1032 children aged 1 to 12 years (including 695 otherwise healthy children aged 1 to 12 years and 334 asthmatic children aged 6 to 12 years) participated in phase III studies of oseltamivir given for the treatment of influenza. A total of 515 children received treatment with oseltamivir suspension. Adverse events occurring in greater 1 % of children receiving oseltamivir are listed in the table below. The most frequently reported adverse event was vomiting. Other events reported more frequently by oseltamivir treated children included abdominal pain, epistaxis, ear disorder and conjunctivitis. These events generally occurred once, resolved despite continued dosing and did not cause discontinuation of treatment in the vast majority of cases. Most Frequent Adverse Events in Studies Naturally Acquired Influenza in Children [Adverse Events Occurring on Treatment in > 1% of Paediatric Patients] Treatment a Treatment b Prevention b Adverse Event Placebo N=517 Oseltamivir 2 mg/kg bid N=515 Oseltamivir 30 to 75 mg c N=158 Oseltamivir 30 to 75 mg c N=99 Vomiting 48 (9.3%) 77 (15.0%) 31 (19.6%) 10 (10.1%) Diarrhoea 55 (10.6%) 49 (9.5%) 5 (3.2%) 1 (1.0%) Otitis media 58 (11.2%) 45 (8.7%) 2 (1.3%) 2 (2.0%) Abdominal pain 20 (3.9%) 24 (4.7%) 3 (1.9%) 3 (3.0%) Asthma (including aggravated) 19 (3.7%) 18 (3.5%) - 1 (1.0%) Nausea 22 (4.3%) 17 (3.3%) 10 (6.3%) 4 (4.0%) Epistaxis 13 (2.5%) 16 (3.1%) 2 (1.3%) 1 (1.0%) Pneumonia 17 (3.3%) 10 (1.9%) - - Ear disorder 6 (1.2%) 9 (1.7%) - - Sinusitis 13 (2.5%) 9 (1.7%) - - Bronchitis 11 (2.1%) 8 (1.6%) 3 (1.9%) - Conjunctivitis 2 (0.4%) 5 (1.0%) - - Dermatitis 10 (1.9%) 5 (1.0%) 1 (0.6%) - Lymphadeonpathy 8 (1.5%) 5 (1.0%) 1 (0.6%) - Tympanic membrane disorder 6 (1.2%) 5 (1.0%) - - a Pooled data from Phase III trials of Tamiflu treatment of naturally acquired influenza. b Uncontrolled study comparing treatment (twice-daily dosing for 5 days) with prevention (once-daily dosing for 10 days). c 30 to 75 mg = age-based dosing. Adverse events included are: all events reported in the treatment studies with a frequency 1% in the oseltamivir 2 mg/kg bid group In general, the adverse event profile in the children with asthma was qualitatively similar to that of otherwise healthy children. Prevention of influenza in children Paediatric patients aged 1 to 12 years participated in a post exposure prevention study in households, both as index cases (n=134) and as contacts (n=222). Gastrointestinal events, particularly vomiting were the most frequently reported. The adverse events were consistent with those previously observed (see table above). Observed during clinical practice: The following adverse reactions have been reported during postmarketing use of oseltamivir: dermatitis, rash, eczema, urticaria, angioneurotic oedema, hypersensitivity reactions, including anaphylactic/anaphylactoid reactions, as well as very rare reports of severe skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme. Additionally, there are very rare reports of hepatobiliary system disorders, including hepatitis and elevated liver enzymes in patients with influenza-like illness. |
| Manufacturer : | Roche |
| Drug Availability : | (POM) |
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