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Pharmacokinetic dose-proportionality study at steady state of mirtazapine from Remeron® tablets

1995; Wiley; Volume: 10; Issue: S2 Linguagem: Inglês

10.1002/hup.470100804

1099-1077

C. J. Timmer, Andreas Lohmann, C. P. A. Mink,

Bipolar Disorder and Treatment

Human Psychopharmacology: Clinical and ExperimentalVolume 10, Issue S2 p. S97-S106 Article Pharmacokinetic dose-proportionality study at steady state of mirtazapine from Remeron® tablets C. J. Timmer, Corresponding Author C. J. Timmer N. V. Organon, Department of Drug Metabolism and Kinetics, P.O. Box 20, 5340 BH Oss/The NetherlandsN. V. Organon, Department of Drug Metabolism and Kinetics, P.O. Box 20, 5340 BH Oss/The NetherlandsSearch for more papers by this authorA. A. M. Lohmann, A. A. M. Lohmann Thiemann Arzneimittel GmbH, Waltrop, GermanySearch for more papers by this authorC. P. A. Mink, C. P. A. Mink N. V. Organon, Department of Drug Metabolism and Kinetics, P.O. Box 20, 5340 BH Oss/The NetherlandsSearch for more papers by this author C. J. Timmer, Corresponding Author C. J. Timmer N. V. Organon, Department of Drug Metabolism and Kinetics, P.O. Box 20, 5340 BH Oss/The NetherlandsN. V. Organon, Department of Drug Metabolism and Kinetics, P.O. Box 20, 5340 BH Oss/The NetherlandsSearch for more papers by this authorA. A. M. Lohmann, A. A. M. Lohmann Thiemann Arzneimittel GmbH, Waltrop, GermanySearch for more papers by this authorC. P. A. Mink, C. P. A. Mink N. V. Organon, Department of Drug Metabolism and Kinetics, P.O. Box 20, 5340 BH Oss/The NetherlandsSearch for more papers by this author First published: July 1995 https://doi.org/10.1002/hup.470100804Citations: 29AboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinkedInRedditWechat Abstract Steady-state dose proportionality of mirtazapine, the active constituent of Remeron® tablets, a new antidepressant developed under the laboratory code Org 3770, was investigated. Each of 27 young healthy male subjects received a single daily oral dose of mirtazapine in the form of standard Remeron® tablets, beginning with 15 mg per day and advancing at five-day intervals to the next higher dose. The oral doses of mirtazapine were 15, 30, 45, 60 and 75 mg per day. Serial blood samples were taken on the fifth day of each dosing period and at several other times in order to check whether the steady state had been reached. In addition, blood samples were taken up to 120 hours after the last dose of 75 mg in order to accurately determine the elimination half-life. Plasma levels of mirtazapine were determined by capillary gas chromatography with nitrogen sensitive detection. Pharmacokinetic parameters were calculated from the plasma mirtazapine levels and subjected to analysis of variance. The steady state was attained on the fifth day of each dosing period. Pharmacokinetics of mirtazapine was found to be essentially linear in the dose range studied. Mean ± SD of the elimination half-life were accurately determined as 21.5 ± 5.0 h (n = 27), range 13.1–33.6 h. Citing Literature Volume10, IssueS2Supplement: Mirtazapine—Noradrenergic and Specific Serotonergic Antidepressant (NaSSA)July 1995Pages S97-S106 RelatedInformation