title: Lack of effect of moderate hepatic impairment on the pharmacokinetics of oral oseltamivir and its metabolite oseltamivir carboxylate.
abstract: 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.
authors.affiliation: Department of Research and Development, Roche Products Ltd, Welwyn Garden City, Hertfordshire AL7 3AY, UK. paul.snell@roche.com
authors.forename: Paul
authors.initials: P
authors.lastname: Snell
authors.forename: Nisha
authors.initials: N
authors.lastname: Dave
authors.forename: Katie
authors.initials: K
authors.lastname: Wilson
authors.forename: Lucy
authors.initials: L
authors.lastname: Rowell
authors.forename: Angelica
authors.initials: A
authors.lastname: Weil
authors.forename: Lawrence
authors.initials: L
authors.lastname: Galitz
authors.forename: Richard
authors.initials: R
authors.lastname: Robson
mesh_terms: 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
chemical_list: D000081:Acetamides; D053139:Oseltamivir