Lack of effect of moderate hepatic impairment on the pharmacokinetics of oral oseltamivir and its metabolite oseltamivir carboxylate.
OBJECTIVE
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.
Snell
Paul
P
Department of Research and Development, Roche Products Ltd, Welwyn Garden City, Hertfordshire AL7 3AY, UK. paul.snell@roche.com
Dave
Nisha
N
Wilson
Katie
K
Rowell
Lucy
L
Weil
Angelica
A
Galitz
Lawrence
L
Robson
Richard
R
D000081:Acetamides / Q000008:administration & dosage / Q000378:metabolism / Q000493:pharmacokinetics*; D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D019540:Area Under Curve; D005260:Female; D006801:Humans; D008107:Liver Diseases / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D053139:Oseltamivir
D000081:Acetamides; D053139:Oseltamivir