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Titolo:
Thalidomide does not alter the pharmacokinetics of ethinyl estradiol and norethindrone
Autore:
Trapnell, CB; Donahue, SR; Collins, JM; Flockhart, DA; Thacker, D; Abernethy, DR;
Indirizzi:
US FDA, Rockville, MD 20857 USA US FDA Rockville MD USA 20857US FDA, Rockville, MD 20857 USA Georgetown Univ, Med Ctr, Div Clin Pharmacol, Washington, DC 20007 USA Georgetown Univ Washington DC USA 20007 armacol, Washington, DC 20007 USA
Titolo Testata:
CLINICAL PHARMACOLOGY & THERAPEUTICS
fascicolo: 6, volume: 64, anno: 1998,
pagine: 597 - 602
SICI:
0009-9236(199812)64:6<597:TDNATP>2.0.ZU;2-4
Fonte:
ISI
Lingua:
ENG
Soggetto:
PERFORMANCE LIQUID-CHROMATOGRAPHY; RECURRENT APHTHOUS STOMATITIS; VERSUS-HOST DISEASE; DRUG-INTERACTIONS; ETHINYLESTRADIOL; PLASMA; ETHYNYLESTRADIOL; RADIOIMMUNOASSAY; METABOLISM; AIDS;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
27
Recensione:
Indirizzi per estratti:
Indirizzo: Trapnell, CB GloboMax LLC, 7250 Pkwy Dr,Suite 430, Hanover, MD 21076 USA GloboMax LLC 7250 Pkwy Dr,Suite 430 Hanover MD USA 21076 USA
Citazione:
C.B. Trapnell et al., "Thalidomide does not alter the pharmacokinetics of ethinyl estradiol and norethindrone", CLIN PHARM, 64(6), 1998, pp. 597-602

Abstract

Objective: To evaluate the effect of thalidomide on the plasma pharmacokinetics of ethinyl estradiol (INN, ethinylestradiol) and norethindrone (PNN, norethisterone),Methods: Ten women who had undergone surgical sterilization were enrolled in an open-label crossover study conducted in the Georgetown University Clinical Research Center. The pharmacokinetics of single doses of 0.07 mg ethinyl estradiol and 2 mg norethindrone were measured at baseline and after 3 weeks of 200 mg thalidomide. Compliance with the thalidomide regimen was assessed with use of Medication Event Monitoring System (MEMS) caps. Results: No changes were observed in the pharmacokinetics of ethinyl estradiol or norethindrone with thalidomide therapy. The mean +/- SD area under the plasma concentration-time curve (AUC(0-infinity)) for ethinyl estradiolwas 6580 +/- 1100 ng.h/L at baseline and 5970 +/- 1560 ng h/L after the thalidomide regimen (paired t test, P > .05), The values for norethindrone were 103 +/- 54 mu g h/L and 107 +/- 58 mu g.h/L (paired t test, P > .05), Nochanges were observed for other pharmacokinetic parameters assessed for either ethinyl estradiol or norethindrone. No accumulation of thalidomide wasseen after 21 days of therapy: day 1 AUC(0-infinity) 41.1 +/- 13.9 mu g.h/mL; day 21 AUC(0-infinity) 59.6 +/- 27.3 mu g.h/mL, (paired t test, P > .05), No changes were observed for other pharmacokinetic parameters assessed for thalidomide between days 1 and 21, Thalidomide was well tolerated but caused variable degrees of sedation. The average thalidomide compliance rate was 97%,Conclusions: The pharmacokinetics of thalidomide do not change with 3 weeks of daily dosing. Thalidomide does not alter the pharmacokinetics of ethinyl estradiol or norethindrone. Therefore there is no drug interaction between thalidomide and these 2 drugs. The efficacy of oral contraceptives containing ethinyl estradiol and norethindrone should not be affected by concomitant thalidomide therapy.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 17/02/20 alle ore 17:14:00