Pharmacokinetics of oseltamivir in young and very elderly subjects

Annals of Pharmacotherapy

Volumn 40, Issue 10, 2006, Pages 1724-1730

  Abe, Masaichi ^a   Smith, James ^b   Urae, Akinori ^c   Barrett, Joanne ^d   Kinoshita, Haruki ^a   Rayner, Craig R ^d  

^a Chugai Clinical Research Center Co Ltd   (Japan)

^b F HOFFMANN LA ROCHE LTD   (Switzerland)

^c Mediscience Planning Inc   (Japan)

^d ROCHE PRODUCTS LTD   (United Kingdom)

Author keywords

Geriatrics; Oseltamivir; Pharmacokinetics

Indexed keywords

4 ACETAMIDO 5 AMINO 3 (1 ETHYLPROPOXY) 1 CYCLOHEXENE 1 CARBOXYLIC ACID; DRUG METABOLITE; OSELTAMIVIR; PLACEBO;

ADULT; AGE; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DOUBLE BLIND PROCEDURE; DROWSINESS; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG HALF LIFE; DRUG SAFETY; DRUG TOLERABILITY; HUMAN; HUMAN EXPERIMENT; JAPAN; KIDNEY CLEARANCE; KIDNEY FUNCTION; MALAISE; MALE; NORMAL HUMAN; PRIORITY JOURNAL; URINALYSIS; VIRUS ISOLATION;

ADULT; AGED, 80 AND OVER; AGING; ANTIVIRAL AGENTS; CROSS-OVER STUDIES; DOUBLE-BLIND METHOD; HUMANS; MALE; OSELTAMIVIR;

EID: 33749600731     PISSN: 10600280     EISSN: None     Source Type: Journal    
DOI: 10.1345/aph.1H174     Document Type: Article

References (25)

1. Nicholson KG. Human influenza. In: Nicholson KG, Webster RG, Hay AJ, eds. Textbook of influenza. Oxford: Blackwell Science, 1998:219-64.
2. Barker WH, Borisute H, Cox C. A study of the impact of influenza on the functional status of frail older people. Arch Intern Med 1998;158: 645-50.
3. Hayden FG. Advances in the prophylaxis and treatment of influenza illness. Based on a presentation by Frederick G. Hayden MD. Am J Manag Care 2000;6(suppl II):5247-54.
4. Nichol KL. Efficacy/clinical effectiveness of inactivated influenza virus vaccines in adults. In: Nicholson KG, Webster RG, Hay AJ, eds. Textbook of influenza. Oxford: Blackwell Science, 1998:358-72.
5. Mendel DB, Tai CY, Escarpe PA, et al. Oral administration of a prodrug of the influenza virus neuraminidase inhibitor GS 4071 protects mice and ferrets against influenza infection. Antimicrob Agents Chemother 1998;42:640-6.
6. Whitley RJ, Hayden FG, Reisinger KS, et al. Oral oseltamivir treatment of influenza in children. Pediatr Infect Dis J 2001;20:127-33.
7. Treanor JJ, Hayden FG, Vrooman PS, et al. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. US Oral Neuraminidase Study Group. JAMA 2000;283:1016-24.
8. Nicholson KG, Aoki FY, Osterhaus AD, et al. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomised controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group. Lancet 2000;355:1845-50.
9. Nordstrom BL, Sung I, Suter P, Szneke P. Risk of pneumonia and other complications of influenza-like illness in patients treated with oseltamivir. Curr Med Res Opin 2005;21:761-8.
10. Kaiser L, Wat C, Mills T, Mahoney P, Ward P, Hayden F. Impact of oseltamivir treatment on influenza-related lower respiratory tract complications and hospitalizations. Arch Intern Med 2003;163:1667-72.
11. Lin JT, Yu XZ, Cui DJ, et al. [A multicenter randomized controlled study of the efficacy and safety of oseltamivir in the treatment of influenza in a high risk population] Chinese. Zhonghua Jie He He Hu Xi Za Zhi 2004;27:455-9.
12. Hayden FG, Atmar RL, Schilling M, et al. Use of the selective oral neuraminidase inhibitor oseltamivir to prevent influenza. N Engl J Med 1999;341:1336-43.
13. Peters PH Jr, Gravenstein S, Norwood P, et al. Long-term use of oseltamivir for the prophylaxis of influenza in a vaccinated frail older population. J Am Geriatr Soc 2001;49:1025-31.
14. Hayden FG, Belshe R, Villanueva C, et al. Management of influenza in households: a prospective, randomized comparison of oseltamivir treatment with or without postexposure prophylaxis. J Infect Dis 2004;189:440-9.
15. Oo C, Barrett J, Hill G, et al. Pharmacokinetics and dosage recommendations for an oseltamivir oral suspension for the treatment of influenza in children. Paediatr Drugs 2001;3:229-36.
16. Oo C, Hill G, Dorr A, Liu B, Boellner S, Ward P. Pharmacokinetics of anti-influenza prodrug oseltamivir in children aged 1-5 years. Eur J Clin Pharmacol 2003;59:411-5.
17. Massarella JW, He GZ, Dorr A, Nieforth K, Ward P, Brown A. The pharmacokinetics and tolerability of the oral neuraminidase inhibitor oseltamivir (Ro 64-0796/GS4104) in healthy adult and elderly volunteers. J Clin Pharmacol 2000;40:836-43.
18. He G, Massarella J, Ward P. Clinical pharmacokinetics of the prodrug oseltamivir and its active metabolite Ro 64-0802. Clin Pharmacokinet 1999;37:471-84.
19. Wiltshire H, Wiltshire B, Citron A, et al. Development of a high-performance liquid chromatographic-mass spectrometric assay for the specific and sensitive quantification of Ro 64-0802, an anti-influenza drug, and its pro-drug, oseltamivir, in human and animal plasma and urine. J Chromatographr B Biomed Sci Appl 2000;745:373-88.
20. Cockcroft DW, Gault MH. Prediction of creatinine clearance from serum creatinine. Nephron 1976;16:31-41.
21. Data on file (internal report). Study NP15729: clinical study report: an open-label bioequivalence and food effect study of the clinical trial and market formulations of Ro 64-0796 in healthy subjects. Roche, Research Report W-144114/22 February 1999.
22. Snell P, Dave N, Wilson K, et al. Lack of effect of moderate hepatic impairment on the pharmacokinetics of oral oseltamivir and its metabolite oseltamivir carboxylate. Br J Clin Pharmacol 2005;59:598-601.
23. Turnheim K. When drug therapy gets old: pharmacokinetics and pharmacodynamics in the elderly. Exp Gerontol 2003;38:843-53.
24. Burkhardt H, Bojarsky G, Gretz N, Gladisch R. Creatinine clearance, Cockcroft-Gault formula and cystatin C: estimators of true glomerular filtration rate in the elderly? Gerontology 2002;48:140-6.
25. He G, Ruckle JL, Ninomiya Y, et al. The comparative pharmacokinetics and safety of the oral neuraminidase inhibitor oseltamivir when given in multiple doses to healthy Japanese and Caucasian subjects. Jpn J Clin Pharmacol Ther 2000;31:397-8.