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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 EMA label. Tap a section to expand.
Posology Tamiflu hard capsules and Tamiflu suspension 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.
Commercially manufactured Tamiflu powder for oral suspension (6 mg/ml) is the preferred product for paediatric and adult patients who have difficulties swallowing capsules or where lower doses are needed.
Adults, and adolescents 13 years and over Treatment:
The recommended oral dose is 75 mg oseltamivir twice daily for 5 days for adolescents (13 to 17 years of age) and adults. Body Weight Recommended dose for 5 days Recommended dose for 10 days* Immunocompromised Patients > 40 kg 75 mg twice daily 75 mg twice daily * The recommended treatment duration in immunocompromised adults and adolescents is 10 days.
See Special Populations, Immunocompromised Patients for more information. Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
Post-exposure prevention:
The recommended dose for prevention of influenza following close contact with an infected individual is 75 mg oseltamivir once daily for 10 days for adolescents (13 to 17 years of age) and adults. Body Weight Recommended dose for 10 days Recommended dose for 10 days Immunocompromised Patients > 40 kg 75 mg once daily 75 mg once daily Therapy should begin as soon as possible within two days of exposure to an infected individual.
1). 4 Paediatric population Children 1 to 12 years of age Tamiflu 30 mg, 45 mg and 75 mg capsules and oral suspension are available for infants and children 1 year of age or older Treatment: The following weight-adjusted dosing regimens are recommended for treatment of infants and children 1 year of age or older: Body Weight Recommended dose for 5 days Recommended dose for 10 days* Immunocompromised Patients 10 kg to 15 kg 30 mg twice daily 30 mg twice daily > 15 kg to 23 kg 45 mg twice daily 45 mg twice daily > 23 kg to 40 kg 60 mg twice daily 60 mg twice daily > 40 kg 75 mg twice daily 75 mg twice daily *The recommended treatment duration in immunocompromised children (≥1 year old) is 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 9 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).
1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Oseltamivir in European Union.
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See Special Populations, Immunocompromised Patients for more information. Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
Post-exposure prevention:
The recommended post-exposure prevention dose of Tamiflu is: Body Weight Recommended dose for 10 days Recommended dose for 10 days For Immunocomprmised Patients 10 kg to 15 kg 30 mg once daily 30 mg once daily > 15 kg to 23 kg 45 mg once daily 45 mg once daily > 23 kg to 40 kg 60 mg once daily 60 mg once daily > 40 kg 75 mg once daily 75 mg once daily Prevention during an influenza epidemic in the community: Prevention during an influenza epidemic has not been studied in children below 12 years of age.
Infants 0 – 12 months of age Treatment:
The recommended treatment dose for infants 0 - 12 months of age is 3 mg/kg twice daily. 2). The following dosing regimen is recommended for treatment of infants 0 - 12 months of age: Body weight* Recommended dose for 5 days Recommended dose for 10 days** Immunocompromised Patients 3 kg 9 mg twice daily 9 mg twice daily 4 kg 12 mg twice daily 12 mg twice daily 5 kg 15 mg twice daily 15 mg twice daily 6 kg 18 mg twice daily 18 mg twice daily 7 kg 21 mg twice daily 21 mg twice daily 8 kg 24 mg twice daily 24 mg twice daily 9 kg 27 mg twice daily 27 mg twice daily 10 kg 30 mg twice daily 30 mg twice daily * This table is not intended to contain all possible weights for this population.
For all patients under the age of 1 year, 3 mg/kg should be used to determine dose regardless of the weight of the patient. Treatment should be initiated as soon as possible within the first two days of onset of symptoms of influenza.
** 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.
Post-exposure prevention:
The recommended prophylaxis dose for infants less than 1 year of age during a pandemic influenza outbreak is half of the daily treatment dose. This is based upon clinical data in infants and children 1 year of age or older and adults showing that a prophylaxis dose equivalent to half the daily treatment dose is clinically efficacious for the prevention of influenza.
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 during an influenza epidemic in the community:
Prevention during an influenza epidemic has not been studied in children […]
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 System Organ Class (SOC) Adverse reactions according to frequency 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 10 System Organ Class (SOC) Adverse reactions according to frequency Very common Common Uncommon Rare Respiratory, thoracic and mediastinal disorders Cough, Sore throat, Rhinorrhea Gastrointestinal 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 subcutaneous tissue disorders Eczema, Dermatitis, Rash, Urticaria Angioneurotic 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. ]) System Organ Class (SOC) Adverse reactions according to frequency 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 Gastrointestinal 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 […]