Population pharmacokinetics of oseltamivir: Pediatrics through geriatrics

Antimicrobial Agents and Chemotherapy

Volumn 57, Issue 8, 2013, Pages 3470-3477

  Kamal, Mohamed A ^a   Van Wart, Scott A ^b,e   Rayner, Craig R ^a,c,d   Subramoney, Vishak ^a   Reynolds, Daniel K ^b   Bulik, Catharine C ^b   Smith, Patrick F ^a,c   Bhavnani, Sujata M ^b,e   Ambrose, Paul G ^b,e,f   Forrest, Alan ^b,e  

^a HOFFMANN LA ROCHE INC   (United States)

^b INSTITUTE FOR CLINICAL PHARMACODYNAMICS   (United States)

^c D3 Limited   (Hong Kong)

^d MONASH UNIVERSITY   (Australia)

^e UNIVERSITY AT BUFFALO   (United States)

^f UNIVERSITY OF OXFORD   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

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

ADOLESCENT; ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BODY WEIGHT; CHILD; CREATININE CLEARANCE; DRUG ABSORPTION; DRUG BLOOD LEVEL; DRUG CLEARANCE; DRUG DISTRIBUTION; DRUG ELIMINATION; DRUG SAFETY; FEMALE; FIRST PASS EFFECT; GERIATRICS; HUMAN; INFLUENZA; MAJOR CLINICAL STUDY; MALE; MAXIMUM PLASMA CONCENTRATION; MULTICENTER STUDY (TOPIC); PEDIATRICS; PHARMACOKINETICS; PLASMA CONCENTRATION-TIME CURVE; PRIORITY JOURNAL; SINGLE DRUG DOSE; TREATMENT DURATION;

ADOLESCENT; ADULT; AGED; AGED, 80 AND OVER; ANTIVIRAL AGENTS; AREA UNDER CURVE; BODY WEIGHT; CHILD; CHILD, PRESCHOOL; CLINICAL TRIALS AS TOPIC; CREATININE; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HUMANS; INFANT; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; MODELS, BIOLOGICAL; MODELS, THEORETICAL; OSELTAMIVIR; PREDICTIVE VALUE OF TESTS; YOUNG ADULT;

EID: 84880320916     PISSN: 00664804     EISSN: 10986596     Source Type: Journal    
DOI: 10.1128/AAC.02438-12     Document Type: Article

References (28)

1. Dutkowski R, Smith JR, Davies BE. 2010. Safety and pharmacokinetics of oseltamivir at standard and high dosages. Int. J. Antimicrob. Agents 35: 461-467.
2. Dutkowski R, Thakrar B, Froehlich E, Suter P, Oo C, Ward P. 2003. Safety and pharmacology of oseltamivir in clinical use. Drug Saf. 26:787-801.
3. Nicholson KG, Aoki FY, Osterhaus AD. 2000. Efficacy and safety of oseltamivir in treatment of acute influenza: a randomized controlled trial. Neuraminidase Inhibitor Flu Treatment Investigator Group. Lancet 355: 1845-1850.
4. Treanor JJ, Hayden FG, Vrooman PS. 2000. Efficacy and safety of the oral neuraminidase inhibitor oseltamivir in treating acute influenza: a randomized controlled trial. U.S. Oral Neuraminidase Study Group. JAMA 283:1016-1024.
5. Hayden FG, Treanor JJ, Fritz RS. 1999. Use of the oral neuraminidase inhibitor oseltamivir in experimental human influenza: randomized controlled trials for prevention and treatment. JAMA 282:1240-1246.
6. Welliver R, Monto AS, Carewicz O. 2001. Effectiveness of oseltamivir in preventing influenza in household contacts: a randomized controlled trial. JAMA 285:748-754.
7. Davies BE. 2010. Pharmacokinetics of oseltamivir: an oral antiviral for the treatment and prophylaxis of influenza in diverse populations. J. Antimicrob. Chemother. 65(Suppl 2):ii5-ii10.
8. He G, Massarella J, Ward P. 1999. Clinical pharmacokinetics of the prodrug oseltamivir and its active metabolite Ro 64-0802. Clin. Pharmacokinet. 37:471-484.
9. Parrott N, Davies B, Hoffmann G, Koerner A, Lave T, Prinssen E, Theogaraj E. 2011. Development of a physiologically based model for oseltamivir and simulation of pharmacokinetics in neonates and infants. Clin. Pharmacokinet. 50:613-623.
10. Rayner CR, Chanu P, Gieschke R, Boak LM, Jonsson EN. 2008. Population pharmacokinetics of oseltamivir when coadministered with probenecid. J. Clin. Pharmacol. 48:935-947.
11. Hayden FG, Jennings L, Robson R, Schiff G, Jackson H, Rana B, McClelland G, Ipe D, Roberts N, Ward P. 2000. Oral oseltamivir in human experimental influenza B infection. Antivir. Ther. 5:205-213.
12. Whitley RJ, Hayden FG, Reisinger KS, Young N, Dutkowski R, Ipe D, Mills RG, Ward P. 2001. Oral oseltamivir treatment of influenza in children. Pediatr. Infect. Dis. J. 20:127-133.
13. Toovey S, Rayner C, Prinssen E, Chu T, Donner B, Thakrar B, Dutkowski R, Hoffmann G, Breidenbach A, Lindemann L, Carey E, Boak L, Gieschke R, Sacks S, Solsky J, Small I, Reddy D. 2008. Assessment of neuropsychiatric adverse events in influenza patients treated with oseltamivir: a comprehensive review. Drug Saf. 31:1097-1114.
14. Cockcroft DW, Gault MH. 1976. Prediction of creatinine clearance from serum creatinine. Nephron 16:31-41.
15. Pai MP, Paloucek FP. 2000. The origin of the ideal body weight equations. Ann. Pharmacol. 34:1066-1069.
16. Schwartz GJ, Muñoz A, Schneider MF, Mak RH, Kaskel F, Warady BA, Furth SL. 2009. New equations to estimate GFR in children with CKD. J. Am. Soc. Nephrol. 20:629-637.
17. Bergstrand M, Hooker AC, Wallin J, Karlsson MO. 2011. Predictioncorrected visual predictive checks for diagnosing nonlinear mixed-effects models. AAPS J. 13:143-151.
18. Pai MP, Lodise TP, Jr. 2011. Oseltamivir and oseltamivir carboxylate pharmacokinetics in obese adults: dose modification for weight is not necessary. Antimicrob. Agents Chemother. 55:5640-5645.
19. Meibohm B, Laer S, Panetta J, Barrett J. 2005. Population pharmacokinetic studies in pediatrics: issues in design and analysis. AAPS J. 7:E475-E487.
20. Shi D, Yang D, Prinssen EP, Davies BE, Yan B. 2011. Surge in expression of carboxylesterase 1 during the post-neonatal stage enables a rapid gain of the capacity to activate the anti-influenza prodrug oseltamivir. J. Infect. Dis. 203:937-942.
21. Abdel-Rahman S, Newland J, Kearns G. 2011. Pharmacologic considerations for oseltamivir disposition. Focus on the neonate and young infant. Pediatr. Drugs 13:19-31.
22. Yang D, Pearce RE, Wang X. 2009. Human carboxylesterase HCE1 and HCE2: ontogenic expression, inter-individual variability and differential hydrolysis of oseltamivir, aspirin, deltamethrin and permethrin. Biochem. Pharmacol. 77:238-247.
23. Alcorn J, McNamara PJ. 2002. Ontogeny of hepatic and renal systemic clearance pathways in infants. Part II. Clin. Pharmacokinet. 41:1077-1094.
24. Chen N, Aleksa K, Woodland C, Rieder M, Koren G. 2006. Ontogeny of drug elimination by the human kidney. Pediatr. Nephrol. 21:160-168.
25. Kearns G, Abdel-Rahman S, Alander S, Blowey D, Leeder J, Kauffman R. 2003. Developmental pharmacology-drug disposition, action and therapy in infants and children. N. Engl. J. Med. 349:1157-1167.
26. Mangoni A, Jackson HD. 2004. Age-related changes in pharmacokinetics and pharmacodynamics: basic principles and practical applications. Br. J. Clin. Pharmacol. 57:6-14.
27. Abe M, Smith J, Urae A, Barrett J, Kinoshita H, Rayner C. 2006. Pharmacokinetics of oseltamivir in young and very elderly subjects. Ann. Pharmacother. 40:1724-1730.
28. Rayner CR, Bulik CC, Kamal MA, Reynolds DK, Toovey S, Hammel JP, Smith PF, Bhavnani SM, Van Wart SA, Ambrose PG, Forrest A. 2013. Pharmacokinetic- pharmacodynamic determinants of oseltamivir efficacy using data from phase 2 inoculation studies. Antimicrob. Agents Chemother. 57:3478-3487.