Lack of effect of moderate hepatic impairment on the pharmacokinetics of oral oseltamivir and its metabolite oseltamivir carboxylate
Article first published online: 17 FEB 2005
British Journal of Clinical Pharmacology
Volume 59, Issue 5, pages 598–601, May 2005
How to Cite
Snell, P., Dave, N., Wilson, K., Rowell, L., Weil, A., Galitz, L. and Robson, R. (2005), Lack of effect of moderate hepatic impairment on the pharmacokinetics of oral oseltamivir and its metabolite oseltamivir carboxylate. British Journal of Clinical Pharmacology, 59: 598–601. doi: 10.1111/j.1365-2125.2005.02340.x
- Issue published online: 2 MAR 2005
- Article first published online: 17 FEB 2005
- Received 8 March 2004 Accepted 6 October 2004
- hepatic impairment;
- oseltamivir carboxylate;
To compare the pharmacokinetics of oseltamivir and oseltamivir carboxylate in hepatically impaired patients and healthy subjects.
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).
Oseltamivir and oseltamivir carboxylate Cmax were ≤6% and ≤19% lower, and their AUC(0,∞) 33% higher and ≤19% lower, respectively, in hepatically impaired patients compared with healthy subjects. These changes are within the safety limits for the drug.
The metabolism of oseltamivir is not compromised minimally in hepatically impaired patients. No dose adjustment is required in these patients when receiving oseltamivir.