Posaconazole pharmacokinetics, safety, and tolerability in subjects with varying degrees of chronic renal disease

Journal of Clinical Pharmacology

Volumn 45, Issue 2, 2005, Pages 185-192

  Courtney, R ^a   Sansone, Angela ^a   Smith, W ^b   Marbury, T ^c   Statkevich, P ^a   Martinho, M ^a   Laughlin, M ^a   Swan, S ^d  

^a MERCK RESEARCH LABORATORIES   (United States)

^b New Orleans Center for Clinical Research   (United States)

^c ORLANDO CLINICAL RESEARCH CENTER   (United States)

^d HENNEPIN COUNTY MEDICAL CENTER   (United States)

Author keywords

Drug safety; Drug tolerability; Fungal infections; Pharmacokinetics; Posaconazole

Indexed keywords

ANTIFUNGAL AGENT; POSACONAZOLE;

ADULT; AGED; AREA UNDER THE CURVE; ARTICLE; BLOOD SAMPLING; CHRONIC KIDNEY DISEASE; CLINICAL ARTICLE; CORRELATION ANALYSIS; CREATININE CLEARANCE; DIARRHEA; DOSE RESPONSE; DRUG SAFETY; DRUG TOLERABILITY; FEMALE; HEMODIALYSIS; HUMAN; KIDNEY DISEASE; LIVER FUNCTION TEST; MALE; MYCOSIS; PROTEIN BINDING; SOMNOLENCE;

ADMINISTRATION, ORAL; ALANINE TRANSAMINASE; AREA UNDER CURVE; ASPARTATE AMINOTRANSFERASES; BIOLOGICAL AVAILABILITY; CREATININE; DIETARY FATS; DRUG ADMINISTRATION SCHEDULE; EATING; FEMALE; HALF-LIFE; HUMANS; KIDNEY FAILURE, CHRONIC; LIVER FUNCTION TESTS; MALE; METABOLIC CLEARANCE RATE; MIDDLE AGED; PROTEIN BINDING; RENAL DIALYSIS; SUSPENSIONS; TREATMENT OUTCOME; TRIAZOLES;

EID: 16844387466     PISSN: 00912700     EISSN: None     Source Type: Journal    
DOI: 10.1177/0091270004271402     Document Type: Article

References (25)

1. Manavathu EK, Cutright JL, Loebenberg D, Chandrasekar PH. A comparative study of the in vitro susceptibilities of clinical and laboratory-selected resistant isolates of Aspergillus spp. to amphotericin B, itraconazole, voriconazole and posaconazole (SCH 56592). J Antimicrob Chemother. 2000;46:229-234.
2. Pfaller MA, Messer SA, Hollis RJ, Jones RN. In vitro activities of posaconazole (Sch 56592) compared with those of itraconazole and fluconazole against 3,685 clinical isolates of Candida spp. and Cryptococcus neoformans. Antimicrob Agents Chemother. 2001;45:2862-2864.
3. Pfaller MA, Messer SA, Hollis RJ, Jones RN. Antifungal activities of posaconazole, ravuconazole, and voriconazole compared to those of itraconazole and amphotericin B against 239 clinical isolates of Aspergillus spp. and other filamentous fungi: report from SENTRY Antimicrobial Surveillance Program, 2000. Antimicrob Agents Chemother. 2002;46:1032-1037.
4. Sun QN, Fothergill AW, McCarthy DI, Rinaldi MG, Graybill JR. In vitro activities of posaconazole, itraconazole, voriconazole, amphotericin B, and fluconazole against 37 clinical isolates of zygomycetes. Antimicrob Agents Chemother. 2002;46:1581-1582.
5. Hachem RY, Raad II, Afif CM, et al. An open, non-comparative multicenter study to evaluate efficacy and safety of posaconazole (SCH 56592) in the treatment of invasive fungal infections (IFI) refractory (R) to or intolerant (I) to standard therapy (ST) [abstract]. Paper presented at: 40th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); September 17-20, 2000; Toronto, Ontario, Canada.
6. Ullmann AJ, Comely OA, Burchardt A, et al. Safety and efficacy of posaconazole (POS) in a pharmacokinetic study in patients with febrile neutropenia (FN) or refractory invasive fungal infections (rIFI). Poster presented at: 43rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); September 14-17, 2003; Chicago.
7. Walsh T, Patterson T, Langston A, et al. Posaconazole for treatment of invasive aspergillosis in patients who are refractory to or intolerant of conventional therapy: an externally controlled blinded trial [abstract]. Blood. 2003;102:195-196.
8. Paya CV. Prevention of fungal and hepatitis virus infections in liver transplantation. Clin Infect Dis. 2001;33(suppl 1):S47-S52.
9. Altiparmak MR, Apaydin S, Trablus S, et al. Systemic fungal infections after renal transplantation. Scand J Infect Dis. 2002;34:284-288.
10. Paya CV. Fungal infections in solid-organ transplantation. Clin Infect Dis. 1993;16:677-688.
11. Wingard JR, Leather HL. Empiric antifungal therapy for the neutropenic patient. Oncology (Huntingt). 2001;15:351-363.
12. Wingard JR. Infections due to resistant Candida species in patients with cancer who are receiving chemotherapy. Clin Infect Dis. 1994;9(suppl 1):S49-S53.
13. Marty F, Mylonakis E. Antifungal use in HIV infection. Expert Opin Pharmacother. 2002;3:91-102.
14. Deray G. Amphotericin B nephrotoxicity. J Antimicrob Chemother. 2002;49(suppl 1):37-41.
15. VFEND IV (voriconazole) prescribing information. New York: Pfizer; 2003.
16. Sporanox (intraconazole) prescribing information. Beerse, Belgium: Janssen Pharmaceutica NV; 2002.
17. Krieter P, Flannery B, Musick T, Gohdes M, Martinho M, Courtney R. Disposition of posaconazole following single-dose oral administration in healthy subjects. Antimicrob Agents Chemother. 2004;48:3543-3551.
18. Gibaldi M, Perrier D. Pharmacokinetics. 2nd ed. New York: Marcel Dekker; 1982.
19. Courtney R, Sansone A, Kantesaria B, Soni PN, Laughlin M. Effect of ethnicity on the pharmacokinetics of posaconazole in healthy volunteers. Paper presented at: 43rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); September 14-17, 2003; Chicago.
20. Courtney R, Sansone A, Statkevich P, Martinho M, Zhang M, Laughlin M. Effect of age and gender on the pharmacokinetics of posaconazole in healthy volunteers. Poster presented at: 43rd Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC); September 14-17, 2003; Chicago.
21. Courtney R, Pai S, Laughlin M, Lim J, Batra V. Pharmacokinetics, safety, and tolerability of oral posaconazole administered in single and multiple doses in healthy adults. Antimicrob Agents Chemother. 2003;47:2788-2795.
22. Diflucan (fluconazole) prescribing information. New York: Pfizer; 2001.
23. Hoffman HL, Rathbun RC. Review of the safety and efficacy of voriconazole. Expert Opin Investig Drugs. 2002;11:409-429.
24. Ullmann AJ. Review of the safety, tolerability, and drug interactions of the new antifungal agents caspofungin and voriconazole. Curr Med Res Opin. 2003;19:263-271.
25. Food and Drug Administration. Background document for the antiviral drug products advisory committee meeting, voriconazole tablets and injection, Pfizer Global Research and Development, NDAs 21-266 and 21-267. Rockville, Md: Food and Drug Administration; 2001:1-56.