Tamiflu® for prevention and treatment during an influenza epidemic
Earlier this year, the European Medicines Agency updated the product information for Tamiflu® to ensure that as many people as possible can benefit from the medicine in connection with an influenza epidemic. Below is an excerpt of the updated guidelines for doctors.
Tamiflu® is not a substitute for influenza vaccination.
Treatment with Tamiflu®
During a pandemic influenza outbreak, Tamiflu® is indicated for treatment of infants and children (0 months of age and older) and adults with typical influenza symptoms.
The treatment should start as soon as possible within 48 hours after the symptoms appear – cf. clinical studies.
Prevention with Tamiflu®
Tamiflu® can be used for preventing influenza in infants, children and adults exposed to an individual infected with influenza.
During the current pandemic, doctors may also consider using the medicine as general prevention of influenza in infants, children and adults.
The patient should start using the treatment as soon as possible within 48 hours after he or she has been exposed to an infected individual.
Dosage
In situations where commercially manufactured Tamiflu® oral suspension is not readily available, adults, adolescents and children who are unable to swallow capsules can get the appropriate dose of Tamiflu® by opening the capsules and mixing the contents with a suitable, small amount (1 teaspoon maximum) of sweetened food products. This may be regular or sugar-free chocolate syrup, honey (only for children 2 years or older), light brown or table sugar dissolved in water, dessert toppings, sweetened condensed milk, apple sauce or yoghurt. This should mask the bitter taste of the Tamiflu®. The patient should swallow the mixture immediately. You can find a more detailed description in the package leaflet of the relevant strength at www.indlaegsseddel.dk.
Dosage of Tamiflu® for treatment
The recommended oral dose for all persons 13 years of age and older is 75 mg oseltamivir twice daily for 5 days.
The following doses (adjusted relative to body weight) are recommended for children 1 to 12 years of age:
|
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 |
Children weighing more than 40 kg and can swallow capsules may take an adult dose of 75 mg twice daily for 5 days as an alternative to the recommended dose of Tamiflu® suspension.
The recommended dose for infants younger than 12 months is 2-3 mg/kg of body weight twice daily for 5 days, see the table below.
|
Age |
Recommended dose for 5 days |
|
> 3 months to 12 months |
3 mg/kg twice daily |
|
> 1 months to 3 months |
2.5 mg/kg twice daily |
|
o to 1 month* |
2 mg/kg twice daily |
* There is no data available regarding the administration of Tamiflu® to infants less than one month of age.
Dosage of Tamiflu® to prevent influenza after exposure to an infected individual
The recommended dose for all persons 13 years of age and older is 75 mg oseltamivir once daily for 10 days.
The following doses are recommended for children 1 to 12 years of age:
|
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 |
Children weighing more than 40 kg and can swallow capsules may take an adult dose of 75 mg capsules once daily for 10 days as an alternative to the recommended dose of Tamiflu® suspension.
The following doses are recommended for infants less than 12 months of age:
|
Age |
Recommended dose for 10 days |
|
> 3 months to 12 months |
3 mg/kg once daily |
|
> 1 months to 3 months |
2.5 mg/kg once daily |
|
o to 1 month* |
2 mg/kg once daily |
* There is no data available regarding the administration of Tamiflu® to infants less than one month of age.
Dosage of Tamiflu® to prevent an epidemic influenza outbreak
The recommended dose is 75 mg oseltamivir once daily for up to 6 weeks to prevent influenza, once there is an epidemic influenza outbreak. The Danish Medicines Agency assesses that the recommended dose applies to all persons 13 years of age and older.
Special populations
For treatment of patients with hepatic and/or renal impairment, please see the summary of product characteristics in the factbox to the right.
For further information, please contact Senior Medical Officer Dorthe Meyer, tel.: +45 4488 9647.
Danish Medicines Agency, last updated 19 November 2009
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