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- Title
Pharmacokinetics of oseltamivir in infants under the age of 1 year.
- Authors
Dixit, Rashmi; Matthews, Slade; Khandaker, Gulam; Walker, Karen; Festa, Marino; Booy, Robert
- Abstract
Background: Oseltamivir is the only antiviral treatment recommended for influenza in young children over the age of 1 year. There is scant data on oseltamivir pharmacokinetics (PK) in infants <1 year. We set out to perform PK measurements in infants who received oseltamivir. Methods: This study was a prospective, uncontrolled, open label evaluation of the pharmacokinetics of oseltamivir metabolism, safety of oseltamivir, viral clearance in infants <12 months diagnosed with influenza by nasopharyngeal influenza nucleic acid antigen test (NAAT). Blood levels of the prodrug oseltamivir and its active carboxylate were measured prior to a dose of oseltamivir and at 4 time points afterwards, to calculate C (ng/mL), T (h), AUC (ng h/mL) and time for AUC (h). Results: Four children with influenza A received oral oseltamivir, 2.35-3 mg/kg/dose. This dose range produced a target oseltamivir carboxylate plasma concentration in excess of the proposed 12-h target AUC of 3800 ng h/mL, selected from earlier studies to avert resistance. One patient developed GIT adverse event: dry retching. Conclusion: Oseltamivir was well tolerated at a dose of 2.35-3 mg/kg/dose twice a day in infants under the age of 1 year. In general agreement with earlier data, these doses produced a target oseltamivir carboxylate plasma exposure in excess of the proposed 12-h target exposure of AUC equal to 3800 ng h/mL in two patients. The limited plasma concentration data in the remaining two patients were not inconsistent with the target exposure being reached.
- Subjects
OSELTAMIVIR; INFANT disease treatment; INFLUENZA diagnosis; MEDICATION safety; DRUG dosage; PHARMACOKINETICS; THERAPEUTICS
- Publication
Clinical & Translational Medicine, 2016, Vol 5, Issue 1, p1
- ISSN
2001-1326
- Publication type
Article
- DOI
10.1186/s40169-016-0118-1