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TAMIFLU is a brand name for Oseltamivir. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Treatment of influenza Tamiflu is indicated in adults and children including full term neonates 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. Prevention of…
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Tamiflu suspension and Tamiflu hard capsules are bioequivalent formulations. 75 mg doses can be administered as either - one 75 mg capsule or - one 30 mg capsule plus one 45 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. Treatment Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
For adolescents (13 to 17 years of age) and adults:
The recommended oral dose is 75 mg oseltamivir twice daily for 5 days (or 10 days in immunocompromised patients).
Paediatric population For infants and children1 year of age or older:
The recommended dose of Tamiflu 6 mg/ml oral suspension is indicated in the table below. Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu 6 mg/ml suspension. 5 ml twice daily *The recommended duration in immunocompromised patients (≥1 year old) is 10 days.
See Special Populations, Immunocompromised Patients for more information. Children weighing > 40 kg and who are able to swallow capsules may receive treatment with the adult dosage of 75 mg capsules twice daily for 5 days as an alternative to the recommended dose of Tamiflu suspension.
For infants less than 1 year of age:
The recommended treatment dose for infants 0 - 12 months of age is 3 mg/kg twice daily. 2). 1 ml steps) should be used for dosing children 0 - 12 months of age requiring 1 ml to 3 ml of Tamiflu 6 mg/ml oral suspension. For higher doses the 10 ml syringe should be used.
0 ml twice daily 10 ml * This table is not intended to contain all possible weights for this population. **The recommended duration in immunocompromised infants (0-12 months old) is 10 days. See Special Populations, Immunocompromised Patients for more information.
e. those with a post-conceptual age less than 36 weeks. Insufficient data are available for these patients, in whom different dosing may be required due to the immaturity of physiological functions. Prevention Post-exposure prevention For adolescents (13 to 17 years of age) and adults: The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days.
Summary of the safety profile The overall safety profile of Tamiflu is based on data from 6049 adult/adolescent and 1473 paediatric patients treated with Tamiflu or placebo for influenza, and on data from 3990 adult/adolescent and 253 paediatric patients receiving Tamiflu or placebo/no treatment for the prophylaxis of influenza in clinical trials.
In addition, 245 immunocompromised patients (including 7 adolescents and 39 children) received Tamiflu for the treatment of influenza and 475 immunocompromised patients (including 18 children, of these 10 Tamiflu and 8 placebo) received Tamiflu or placebo for the prophylaxis of influenza.
In adults/adolescents, the most commonly reported adverse reactions (ARs) were nausea and vomiting in the treatment studies, and nausea in the prevention studies. The majority of these ARs were reported on a single occasion on either the first or second treatment day and resolved spontaneously within 1-2 days.
In children, the most commonly reported adverse reaction was vomiting. In the majority of patients, these ARs did not lead to discontinuation of Tamiflu. The following serious adverse reactions have been rarely reported since oseltamivir has been marketed: Anaphylactic and anaphylactoid reactions, hepatic disorders (fulminant hepatitis, hepatic function disorder and jaundice), angioneurotic oedema, Stevens-Johnson syndrome and toxic epidermal necrolysis, gastrointestinal bleeding and neuropsychiatric disorders.
) Tabulated list of adverse reactions The ARs listed in the tables below fall into the following categories: Very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), and very rare (< 1/10,000).
ARs are added to the appropriate category in the tables according to the pooled analysis from clinical studies.
Oseltamivir is effective only against illness caused by influenza viruses. 1). 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. 1). Therefore, prescribers should take into account the most recent information available on oseltamivir susceptibility patterns of the currently circulating viruses when deciding whether to use Tamiflu.
Severe concomitant condition 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.
1). Cardiac / respiratory disease Efficacy of oseltamivir in the treatment of subjects with chronic cardiac disease and/or respiratory disease has not been established. 1). Paediatric population No data allowing a dose recommendation for premature children (<36 weeks post-conceptual age) are currently available.
Severe renal impairment Dose adjustment is recommended for both treatment and prevention in adolescents (13 to 17 years of age) and adults with severe renal impairment. 2). Neuropsychiatric events Neuropsychiatric events have been reported during administration of Tamiflu in patients with influenza, especially in children and adolescents.
These events are also experienced by patients with influenza without oseltamivir administration. 8). Excipients This medicinal product contains sorbitol. Patients with hereditary fructose intolerance (HFI) should not take thismedicinal product.
Sorbitol may cause gastrointestinal discomfort and mild laxative effect. This medicinal product contains sodium benzoate. Sodium benzoate (E211) may increase jaundice in newborn babies (up to 4 weeks old).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Therapy should begin as soon as possible within two days of exposure to an infected individual.
For infants and children 1 year of age or older:
Tamiflu 30 mg and 45 mg capsules are available as an alternative to the recommended dose of Tamiflu 6 mg/ml suspension. 5 ml once daily Children weighing > 40 kg and who are able to swallow capsules may receive prophylaxis with a 75 mg capsule once daily for 10 days as an alternative to the recommended dose of Tamiflu suspension.
For infants less than 1 year of age:
The recommended prophylaxis dose for infants less than 12 months during a pandemic influenza outbreak is half of the daily treatment dose. 2 for exposure simulation). 1 ml steps) should be used for dosing children below 1 year of age requiring 1 ml to 3 ml of Tamiflu 6 mg/ml oral suspension.
For higher doses the 10 ml syringe should be used. The following dosing regimen is recommended for infants less than 1 year […]
Treatment and prevention of influenza in adults and adolescents:
In adult/adolescent treatment and prevention studies, ARs that occurred the most frequently at the recommended dose (75 mg bid for 5 days for treatment and 75 mg od for up to 6 weeks for prophylaxis) are shown in Table 1. The safety profile reported in subjects who received the recommended dose of Tamiflu for prophylaxis (75 mg once daily for up to 6 weeks) was qualitatively similar to that seen in the treatment studies, despite a longer duration of dosing in the prophylaxis studies.
Table 1 Adverse reactions in studies investigating Tamiflu for treatment and prevention of influenza in adults and adolescents or through post-marketing surveillance Adverse reactions according to frequencySystem Organ Class (SOC) Very common Common Uncommon Rare Infections and infestations Bronchitis, Herpes simplex, Nasopharyngitis , Upper respiratory tract infections, Sinusitis Blood and lymphatic system disorders Thrombocytopenia Immune system disorders Hypersensitivity reaction Anaphylactic reactions, Anaphylactoid reactions Psychiatric disorders Agitation, Abnormal behaviour, Anxiety, Confusion, Delusions, Delirium, Hallucination, Nightmares, Self-injury Nervous system disorders Headache Insomnia Altered level of consciousness, Convulsion Eye disorders Visual disturbance Cardiac disorders Cardiac arrhythmia Respiratory, thoracic and mediastinal disorders Cough, Sore throat, Rhinorrhea Gastrointestina l disorders Nausea Vomiting Abdominal pain (incl.
upper abdominal pain), Dyspepsia Gastrointestinal bleedings, Haemorrhagic colitis Hepatobiliary disorders Elevated liver enzymes Fulminant hepatitis, Hepatic failure, Hepatitis Skin and Eczema, Angioneurotic Adverse reactions according to frequencySystem Organ Class (SOC) Very common Common Uncommon Rare subcutaneous tissue disorders Dermatitis, Rash, Urticaria oedema, Erythema multiforme, Stevens-Johnson syndrome, Toxic epidermal necrolysis General disorders and administration site conditions Pain Dizziness (incl.
vertigo), Fatigue, Pyrexia, Pain in limb Treatment and prevention of influenza in children: A total of 1473 children (including otherwise healthy children aged 1-12 years old and asthmatic children aged 6-12 years old) participated in clinical studies of oseltamivir given for the treatment of influenza.
Of those, 851 children received treatment with oseltamivir suspension. A total of 158 children received the recommended dose of Tamiflu once daily in a post-exposure prophylaxis study in households (n = 99), a 6-week paediatric seasonal prophylaxis study (n = 49) and a 12-week paediatric seasonal prophylaxis study in immunocompromised subjects (n = 10).
Table 2 shows the most frequently reported ARs from paediatric clinical trials. ]) Adverse reactions according to frequencySystem Organ Class (SOC) Very common Common Uncommon Rare Infections and infestations Otitis media, Nervous system disorders Headache Eye disorders: Conjunctivitis (including red eyes, eye discharge and eye pain) Ear and labyrinth disorders: Earache Tympanic membrane disorder Respiratory, thoracic and mediastinal disorders Cough, Nasal congestion Rhinorrhoea Gastrointestina l disorders Vomiting Abdominal pain (incl.
upper abdominal pain), Dyspepsia, Nausea Skin and subcutaneous tissue disorders Dermatitis (including allergic and atopic dermatitis) Description of selected adverse reactions Psychiatric disorders and nervous system disorders Influenza can be associated with a variety of neurologic and behavioural symptoms which can include events such as hallucinations, delirium, and abnormal behaviour, in some cases resulting in fatal outcomes.
These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease. In patients with influenza who were receiving Tamiflu, there have been postmarketing reports of convulsions and delirium (including symptoms such as […]