title: Oseltamivir pharmacokinetics, dosing, and resistance among children aged <2 years with influenza.
abstract: BACKGROUND
  Children <2 years of age are at high risk of influenza-related mortality and morbidity. However, the appropriate dose of oseltamivir for children <2 years of age is unknown.
  
  
  METHODS
  The National Institute of Allergy and Infectious Diseases Collaborative Antiviral Study Group evaluated oseltamivir in infants aged <2 years in an age-de-escalation, 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 0-8 months of age, although there was a greater degree of variability in infants <3 months of age. In subjects 9-11 months of age, a dose of 3.5 mg/kg produced drug exposures within the target range. Six of 10 subjects aged 12-23 months receiving the Food and Drug Administration-approved unit dose for this age group (ie, 30 mg) had oseltamivir carboxylate exposures below the target range. Virus from 3 subjects developed oseltamivir resistance during antiviral treatment.
  
  
  CONCLUSIONS
  The appropriate twice-daily oral oseltamivir dose for infants ≤8 months of age is 3.0 mg/kg, while the dose for infants 9-11 months old is 3.5 mg/kg.
authors.affiliation: Department of Pediatrics, University of Alabama at Birmingham, AL 35233, USA. dkimberlin@peds.uab.edu
authors.forename: David W
authors.initials: DW
authors.lastname: Kimberlin
authors.forename: Edward P
authors.initials: EP
authors.lastname: Acosta
authors.forename: Mark N
authors.initials: MN
authors.lastname: Prichard
authors.forename: Pablo J
authors.initials: PJ
authors.lastname: Sánchez
authors.forename: Krow
authors.initials: K
authors.lastname: Ampofo
authors.forename: David
authors.initials: D
authors.lastname: Lang
authors.forename: Negar
authors.initials: N
authors.lastname: Ashouri
authors.forename: John A
authors.initials: JA
authors.lastname: Vanchiere
authors.forename: Mark J
authors.initials: MJ
authors.lastname: Abzug
authors.forename: Nazha
authors.initials: N
authors.lastname: Abughali
authors.forename: Mary T
authors.initials: MT
authors.lastname: Caserta
authors.forename: Janet A
authors.initials: JA
authors.lastname: Englund
authors.forename: Sunil K
authors.initials: SK
authors.lastname: Sood
authors.forename: Michael G
authors.initials: MG
authors.lastname: Spigarelli
authors.forename: John S
authors.initials: JS
authors.lastname: Bradley
authors.forename: Judy
authors.initials: J
authors.lastname: Lew
authors.forename: Marian G
authors.initials: MG
authors.lastname: Michaels
authors.forename: Wen
authors.initials: W
authors.lastname: Wan
authors.forename: Gretchen
authors.initials: G
authors.lastname: Cloud
authors.forename: Penelope
authors.initials: P
authors.lastname: Jester
authors.forename: Fred D
authors.initials: FD
authors.lastname: Lakeman
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Whitley
mesh_terms: D000284:Administration, Oral; D024882:Drug Resistance, Viral; D005260:Female; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D007251:Influenza, Human / Q000188:drug therapy* / Q000821:virology*; D008297:Male; D009975:Orthomyxoviridae / Q000187:drug effects* / Q000302:isolation & purification*; D053139:Oseltamivir / Q000008:administration & dosage* / Q000493:pharmacokinetics* / Q000494:pharmacology
chemical_list: D053139:Oseltamivir