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.