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Titolo:
Concomitant use of mirtazapine and cimetidine: a drug-drug interaction study in healthy male subjects
Autore:
Sitsen, JMA; Maris, FA; Timmer, CJ;
Indirizzi:
NV Organon, NL-5340 BH Oss, Netherlands NV Organon Oss Netherlands NL-5340 BH ganon, NL-5340 BH Oss, Netherlands
Titolo Testata:
EUROPEAN JOURNAL OF CLINICAL PHARMACOLOGY
fascicolo: 5, volume: 56, anno: 2000,
pagine: 389 - 394
SICI:
0031-6970(200008)56:5<389:CUOMAC>2.0.ZU;2-I
Fonte:
ISI
Lingua:
ENG
Soggetto:
PHARMACOKINETIC INTERACTION; ENZYME-INHIBITION; IN-VITRO; LIVER; DISPOSITION; HUMANS; VIVO;
Keywords:
cimetidine; cytochrome P-450; mirtazapine;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
21
Recensione:
Indirizzi per estratti:
Indirizzo: Sitsen, JMA NV Organon, POB 20, NL-5340 BH Oss, Netherlands NV Organon POB20 Oss Netherlands NL-5340 BH Oss, Netherlands
Citazione:
J.M.A. Sitsen et al., "Concomitant use of mirtazapine and cimetidine: a drug-drug interaction study in healthy male subjects", EUR J CL PH, 56(5), 2000, pp. 389-394

Abstract

Objective: The objective of this study was to examine the pharmacokineticsand the tolerability/safety of mirtazapine and cimetidine separately and in combination following oral administration of multiple doses. Methods: This was a double-blind, placebo-controlled, two-period cross-over, multiple-dose pharmacokinetic interaction study in 12 healthy male subjects. They received either cimetidine (800 mg b.i.d.) or placebo in combination with (commercially available, racemic) mirtazapine (30 mg nocte). Cimetidine and placebo were administered for 14 days, with mirtazapine added during days 6-12 of each period. Serial blood samples for kinetic profiling were taken on day 5 and day 12 for cimetidine and on days 12-14 for mirtazapine. Results: The co-administration of cimetidine resulted in a statistically significant increase in the area under the curve (AUC(0-24)) and C-max of mirtazapine (54% and 22% respectively). The AUC(0-24) Of demethylmirtazapine increased only slightly, and there was no effect on C-max. The elimination half-lives for both mirtazapine and its demethyl metabolite were unaffectedby cimetidine co-administration. The trough and average plasma concentrations during the steady state were elevated during cimetidine treatment (62% and 54%, respectively). Mirtazapine had no effect on the pharmacokinetics of cimetidine. Conclusion: Go-administration of cimetidine (800 mg b.i.d.) and mirtazapine (30 mg nocte) resulted in increased steady-state plasma levels of mirtazapine (C-ss,C-min = +61%, P < 0.05; C-ss,C-av = + 54%, P < 0.05), probably as a result of increased bio-availability. The C-max ( + 22%, P < 0.05) and AUC(0-24) (+54%, P < 0.05) also increased. Due to the variability of the mirtazapine plasma levels in patients, the clinical meaning of these increases is probably limited. Go-administration of mirtazapine did not alter cimetidine pharmacokinetics.

ASDD Area Sistemi Dipartimentali e Documentali, Università di Bologna, Catalogo delle riviste ed altri periodici
Documento generato il 31/03/20 alle ore 16:16:51