Երկիր: Կանադա
Լեզու: անգլերեն
Աղբյուրը: Health Canada
TRIMIPRAMINE (TRIMIPRAMINE MALEATE)
APOTEX INC
N06AA06
TRIMIPRAMINE
12.5MG
TABLET
TRIMIPRAMINE (TRIMIPRAMINE MALEATE) 12.5MG
ORAL
100/500/1000
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0102479001; AHFS:
APPROVED
2013-05-01
PRODUCT MONOGRAPH APO-TRIMIPRAMINE TRIMIPRAMINE TABLETS BP 12.5, 25, 50 AND 100 MG TRIMIPRAMINE (AS MALEATE) TRIMIPRAMINE CAPSULES 75 MG TRIMIPRAMINE (AS MALEATE) TRICYCLIC ANTIDEPRESSANT APOTEX INC. DATE OF PREPARATION: 150 SIGNET DRIVE APRIL 23, 2013 TORONTO, ONTARIO M9L 1T9 CONTROL NO.: 163604 2 PRODUCT MONOGRAPH NAME OF DRUG APO-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 APO-TRIMIPRAMINE and SURMONTIL were measured and compared. The results are summarized as follows: 3 GEOMETRIC MEAN ARITHMETIC MEAN (C.V.) PARAMETER APO-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 APO-TRIMIPRAMINE (trimipramine) is indicated in the drug treatment of depressive illness. It is effective in endogenous depression. CONTRAINDICATIONS APO-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 sho Կարդացեք ամբողջական փաստաթուղթը