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Oseltamivir Pharmacokinetics, Dosing, and Resistance in Children From Birth to Two Years of Age with Influenza

tetano

Editor, Senior Moderator
J Infect Dis. 2012 Dec 10. [Epub ahead of print]
Oseltamivir Pharmacokinetics, Dosing, and Resistance in Children From Birth to Two Years of Age with Influenza.
Kimberlin DW, Acosta EP, Prichard MN, S?nchez PJ, Ampofo K, Lang D, Ashouri N, Vanchiere JA, Abzug MJ, Abughali N, Caserta MT, Englund JA, Sood SK, Spigarelli MG, Bradley JS, Lew J, Michaels MG, Wan W, Cloud G, Jester P, Lakeman FD, Whitley RJ; for the National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group.
Source

Department of Pediatrics, University of Alabama at Birmingham.
Abstract

Background. Children under 2 years of age are at high risk of influenza-related mortality and morbidity. However, the appropriate dose of oseltamivir for children under 2 years of age is unknown.Methods. The National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group evaluated oseltamivir in infants from birth to 2 years of age in an age-deescalation, adaptive design with a targeted systemic exposure.Results. From 2006 to 2010, 87 subjects enrolled. An oseltamivir dose of 3.0 mg/kg produced drug exposures within the target range in subjects 0 through 8 months of age, although there was a greater degree of variability in infants under 3 months of age. In subjects 9 through 11 months of age, a dose of 3.5 mg/kg produced drug exposures within the target range. Six of ten subjects 12 through 23 months of age receiving the FDA-approved unit dose for this age group of 30 mg had oseltamivir carboxylate exposures below the target range. Virus from three subjects developed oseltamivir resistance during antiviral treatment.Conclusions. The appropriate twice-daily oral oseltamivir dose for infants birth through 8 months of age is 3.0 mg/kg, while the dose for infants 9 through 11 months is 3.5 mg/kg.

PMID:
23230059
[PubMed - as supplied by publisher]

http://www.ncbi.nlm.nih.gov/pubmed/23230059
 
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