Literature DB >> 15842560

Lack of effect of moderate hepatic impairment on the pharmacokinetics of oral oseltamivir and its metabolite oseltamivir carboxylate.

Paul Snell1, Nisha Dave, Katie Wilson, Lucy Rowell, Angelica Weil, Lawrence Galitz, Richard Robson.   

Abstract

AIMS: To compare the pharmacokinetics of oseltamivir and oseltamivir carboxylate in hepatically impaired patients and healthy subjects.
METHODS: Hepatically impaired patients (n = 11) and healthy subjects (n = 11) were individually paired on the basis of gender, age (+/-10 years) and body weight (+/-20%) and administered a single dose of oseltamivir (75 mg).
RESULTS: Oseltamivir and oseltamivir carboxylate C(max) were < or =6% and < or =19% lower, and their AUC(0,infinity) 33% higher and < or =19% lower, respectively, in hepatically impaired patients compared with healthy subjects. These changes are within the safety limits for the drug.
CONCLUSIONS: The metabolism of oseltamivir is not compromised [corrected] in hepatically impaired patients. No dose adjustment is required in these patients when receiving oseltamivir.

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Year:  2005        PMID: 15842560      PMCID: PMC1884852          DOI: 10.1111/j.1365-2125.2005.02340.x

Source DB:  PubMed          Journal:  Br J Clin Pharmacol        ISSN: 0306-5251            Impact factor:   4.335


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