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Titolo:
EFFECT OF INFUSION RATE ON THE PHARMACOKINETICS AND TOLERANCE OF INTRAVENOUS DOLASETRON MESYLATE
Autore:
DIMMITT DC; HUNT TL; SPALITTO AJ; CRAMER MB; SHAH AK; ARUMUGHAM T; HAHNE W;
Indirizzi:
HOECHST MARION ROUSSEL,CLIN RES,POB 9627,F4-M3112 KANSAS CITY MO 64134 PPD PHARMACO AUSTIN TX 00000 PFIZER INC,DIV CENT RES GROTON CT 06340 GLAXO WELLCOME INC RES TRIANGLE PK NC 27709
Titolo Testata:
The Annals of pharmacotherapy
fascicolo: 1, volume: 32, anno: 1998,
pagine: 39 - 44
SICI:
1060-0280(1998)32:1<39:EOIROT>2.0.ZU;2-P
Fonte:
ISI
Lingua:
ENG
Soggetto:
POSTOPERATIVE NAUSEA; ORAL DOLASETRON; DOUBLE-BLIND; PHASE-I; ONDANSETRON; SURGERY; CHEMOTHERAPY; ANTAGONISTS; MESILATE; PHARMACOLOGY;
Keywords:
DOLASETRON MESYLATE; HYDRODOLASETRON; PHARMACOKINETICS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Science Citation Index Expanded
Citazioni:
39
Recensione:
Indirizzi per estratti:
Citazione:
D.C. Dimmitt et al., "EFFECT OF INFUSION RATE ON THE PHARMACOKINETICS AND TOLERANCE OF INTRAVENOUS DOLASETRON MESYLATE", The Annals of pharmacotherapy, 32(1), 1998, pp. 39-44

Abstract

OBJECTIVE: TO evaluate the safety, tolerance, and pharmacokinetics ofdolasetron mesylate and its active metabolite hydrodolasetron when dolasetron mesylate was administered intravenously at increasing infusion rates. DESIGN: A double-blind, placebo-controlled, parallel-group study. METHODS: Forty-nine healthy nonsmoking male volunteers were randomly assigned to receive intravenous doses of dolasetron mesylate 100 mg or placebo, Three groups of 16 subjects each (12 dolasetron mesylate, 4 placebo) received escalating infusion rates (50, 100, then 200 mg/min), Physical examinations, vital signs, laboratory tests, and adverse events were recorded before and after administration of the study drug. Serial blood samples and 12-lead electrocardiogram measurements were obtained for 24 hours after the infusion. Plasma samples were analyzed for dolasetron and hydrodolasetron. RESULTS: Dolasetron mesylate was well tolerated, with no apparent differences in vital signs or adverse event profiles among the different rates of infusion, In general, the pharmacokinetics of dolasetron and hydrodolasetron were superimposable among the three infusion rate groups. Plasma dolasetron concentrations declined rapidly in all three infusion rate groups, with mean elimination half-life (t(1/2)) of less than 10 minutes, The reduced metabolite hydrodolasetron, which accounts for most pharmacologic activity, formed rapidly, with maximum concentrations occurring between 0.4 and 0.5 hours and disappeared with a mean t(1/2) of 8-9 hours, The correlation coefficients of least-squares regression analysis between the pharmacokinetic parameters and the infusion rate of dolasetron were less than 0.083 and the slopes were not significantly different from 0, suggesting that none of the hydrodolasetron pharmacokinetic parameters were affected by rate of infusion.

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Documento generato il 29/11/20 alle ore 06:43:44