Tamiflu Is Indicated for Treatment of Infants 2 Weeks and Older
TAMIFLU is indicated for the treatment of acute, uncomplicated illness due to influenza infection in patients 2 weeks of age and older who have been symptomatic for no more than 2 days.
Now patients 2 weeks of age and older may benefit from treatment with TAMIFLU for influenza.1
Results from 2 open-label pharmacokinetic and safety studies of 136 children 2 weeks to less than 1 year of age infected with influenza tested how well TAMIFLU was tolerated in this population. By extrapolation, a 3 mg/kg twice-daily dose for 5 days is expected to provide efficacy similar to that seen in older patients.1
The safety profile observed in infants less than 1 year of age was consistent with the established safety profile of pediatric subjects aged 1 year and above, with vomiting, diarrhea, and diaper rash being the most frequently reported adverse reactions.
Treatment Dosing of Tamiflu for
Influenza in Pediatric Patients Aged 2 Weeks to Less Than 1 Year
|Weight (kg)||Treatment dosing for 5 days||Prophylaxis dosing for 10 days||Volume of Oral Suspension (6 mg/mL) for each dose**||Number of bottles of Oral Suspension to dispense||Number of capsules and strength to dispense‡‡|
|Any weight||3 mg/kg twice daily||Not applicable*||0.5 mL/kg†||1 bottle||Not applicable|
TAMIFLU is not approved for prophylaxis of patients less than 1 year of age.
A 10-mL oral dosing dispenser is provided with the oral suspension. In the event that the dispenser provided is lost or damaged, another dosing dispenser may be used to deliver the volumes.
For patients less than 1 year of age, remove the provided 10-mL oral dosing dispenser from the packaging, and provide an appropriate dosing device that can accurately measure and administer small volumes.
Oral suspension is the preferred formulation for patients who cannot swallow capsules.
Select Important Safety Information
- TAMIFLU is contraindicated in patients who have had severe allergic reactions such as anaphylaxis or serious skin reactions such as toxic epidermal necrolysis, Stevens-Johnson syndrome, and erythema multiforme to any component of TAMIFLU.
- Influenza viruses change over time. Emergence of resistance mutations could decrease drug effectiveness. Other factors (for example, changes in viral virulence) might also diminish clinical benefit of antiviral drugs. Prescribers should consider available information on influenza drug susceptibility patterns and treatment effects when deciding whether to use TAMIFLU.
Please see the Tamiflu full Prescribing Information for complete safety information.