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

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.

journal_name

Br J Clin Pharmacol

authors

Snell P,Dave N,Wilson K,Rowell L,Weil A,Galitz L,Robson R

doi

10.1111/j.1365-2125.2005.02340.x

keywords:

subject

Has Abstract

pub_date

2005-05-01 00:00:00

pages

598-601

issue

5

eissn

0306-5251

issn

1365-2125

pii

BCP2340

journal_volume

59

pub_type

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