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Titolo:
Effect of hormonal contraceptives on the pharmacokinetics of trovafloxacinin women
Autore:
Amsden, GW; Mohamed, MA; Menhinick, AM;
Indirizzi:
Bassett Healthcare, Clin Pharmacol Res Ctr, Cooperstown, NY 13326 USA Bassett Healthcare Cooperstown NY USA 13326 tr, Cooperstown, NY 13326 USA Bassett Healthcare, Res Inst, Cooperstown, NY 13326 USA Bassett Healthcare Cooperstown NY USA 13326 st, Cooperstown, NY 13326 USA Bassett Healthcare, Dept Pharm, Cooperstown, NY 13326 USA Bassett Healthcare Cooperstown NY USA 13326 rm, Cooperstown, NY 13326 USA Bassett Healthcare, Dept Med, Cooperstown, NY 13326 USA Bassett Healthcare Cooperstown NY USA 13326 ed, Cooperstown, NY 13326 USA
Titolo Testata:
CLINICAL DRUG INVESTIGATION
fascicolo: 4, volume: 21, anno: 2001,
pagine: 281 - 286
SICI:
1173-2563(2001)21:4<281:EOHCOT>2.0.ZU;2-G
Fonte:
ISI
Lingua:
ENG
Soggetto:
MENSTRUAL-CYCLE PHASE; 3-MONTH INTRAINDIVIDUAL VARIABILITY; ORAL-CONTRACEPTIVES; PHARMACODYNAMICS; BIOAVAILABILITY; QUANTIFICATION; VOLUNTEERS; SEX;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
13
Recensione:
Indirizzi per estratti:
Indirizzo: Amsden, GW Bassett Healthcare, Clin Pharmacol Res Ctr, 1 Atwell Rd, Cooperstown, NY 13326 USA Bassett Healthcare 1 Atwell Rd Cooperstown NY USA 13326326 USA
Citazione:
G.W. Amsden et al., "Effect of hormonal contraceptives on the pharmacokinetics of trovafloxacinin women", CLIN DRUG I, 21(4), 2001, pp. 281-286

Abstract

Objective: To study the impact of hormone-based contraceptives on the pharmacokinetics of oral trovafloxacin. Methods: 20 healthy premenopausal women. 10 taking hormonal contraception and 10 using non-hormonal methods. received a single 200mg oral dose of trovafloxacin. 16 plasma samples were collected prior to and for 24 hours after drug administration. Results: Despite the high incidence of central nervous system- and gastrointestinal-related adverse events (greater than or equal to 80% in hormonal and non-hormonal groups), all participants completed the study. Results demonstrated that women using hormonal methods of contraception had significantly lower peak plasma concentrations (1.92 vs 2.27 mg/L, p = 0.03) than those using non-hormonal methods. They also demonstrated significantly higher clearance rates (9.96 vs 7.62 L/h, p < 0.004) and lower exposures (AUC) [20.8 vs 26.7 mg/L .h, p < 0.004] to the drug. Conclusions: Based on previous studies, it is thought that the changes in trovafloxacin pharmacokinetics are secondary to induction or competition atcytochrome P-450 2C19 with the progestin components and/or an increase in phase II conjugation reactions by the estrogen components. However. a hormone-induced change in bioavailability cannot be ruled out as being responsible for the changes reported. The clinical significance of this interaction needs to be studied more fully. However. based on presently accepted pharmacodynamic drug administration parameters, the clinical effectiveness of trovafloxacin when used in premenopausal women receiving hormone-based contraceptives may be less than optimal, especially against pathogens with borderline sensitivities.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 20/01/20 alle ore 21:58:43