FDA expands tamiflu use to treat babies under one year old
(HealthDay)—Tamiflu (oseltamivir) can now be given to children as young as 2 weeks old under an expanded approval announced Friday by the U.S. Food and Drug Administration.
Tamiflu can be used as treatment in children aged 2 weeks to 1 year if they have had flu symptoms for no longer than two days. The drug is not approved to prevent flu in these children and the safety and effectiveness of Tamiflu in children younger than 2 weeks of age has not been established.
While there are fixed dosing regimens for children 1 year and older according to weight categories, dosing for children younger than 1 year must be calculated individually based on exact weight, the FDA stressed. Children 2 weeks to 1 year of age should receive 3 milligrams per kilogram of weight twice daily for five days.
"Pharmacists must provide the proper dispenser when filling a prescription so parents can measure and administer the correct dose to their children," Edward Cox, M.D., M.P.H., director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research, said in an FDA news release.
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