Страна: Канада
Язык: английский
Источник: Health Canada
TRIMIPRAMINE (TRIMIPRAMINE MALEATE)
AA PHARMA INC
N06AA06
TRIMIPRAMINE
25MG
TABLET
TRIMIPRAMINE (TRIMIPRAMINE MALEATE) 25MG
ORAL
100/500/1000
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0102479002; AHFS:
APPROVED
2010-06-09
PRODUCT MONOGRAPH TRIMIPRAMINE TRIMIPRAMINE TABLETS BP 12.5, 25, 50 AND 100 MG TRIMIPRAMINE (AS MALEATE) TRIMIPRAMINE CAPSULES 75 MG TRIMIPRAMINE (AS MALEATE) TRICYCLIC ANTIDEPRESSANT AA PHARMA INC. DATE OF PREPARATION: 100 KING STREET WEST JUNE 1, 2010 SUITE 5700 TORONTO, ONTARIO M5X IC7 CONTROL NO. 138861 2 PRODUCT MONOGRAPH NAME OF DRUG TRIMIPRAMINE Trimipramine Tablets BP 12.5, 25, 50 and 100 mg Trimipramine (as maleate) Trimipramine Capsules 75 mg Trimipramine (as maleate) THERAPEUTIC CLASSIFICATION Tricyclic Antidepressant ACTIONS AND CLINICAL PHARMACOLOGY Trimipramine is a tricyclic antidepressant with sedative properties. It also has anti-cholinergic properties, and potentiates sympathetic responses, presumably by blocking the re-uptake of noradrenaline which has been released by the presynaptic neurones. Trimipramine has a quinidine-like effect on the heart and produces ECG and EEG changes similar to those of other tricyclic antidepressants. A comparative bioavailability study was performed using healthy human volunteers. The rate and extent of absorption of trimipramine following a single 150 mg (2 x 75 mg capsules) oral dose of TRIMIPRAMINE and SURMONTIL were measured and compared. The results are summarized as follows: 3 GEOMETRIC MEAN ARITHMETIC MEAN (C.V.) PARAMETER TRIMIPRAMINE SURMONTIL RATIO OF MEANS (%) AUC T (ng·hr/mL) 1037 1235 (66) 1015 1266 (75) 102.2 AUC l (ng·hr/mL) 1165 1393 (67) 1143 1447 (78) 101.9 C max (ng/mL) 85.6 94.2 (42) 81.7 92.7 (58) 104.8 T max * (hr) 3.2 (1.2) 3.0 (1.5) — t 1/2 * (hr) 25.3 (13.3) 26.4 (14.3) — For the T max and t 1/2 parameters, these are the arithmetic means (standard deviations). INDICATIONS TRIMIPRAMINE (trimipramine) is indicated in the drug treatment of depressive illness. It is effective in endogenous depression. CONTRAINDICATIONS TRIMIPRAMINE (trimipramine) is contraindicated in cases of known hypersensitivity to the drug. The possibility of cross-sensitivity with other dibenzazepine compounds should also be kept in mind. Trimipramine should not b Прочитать полный документ