TRIMIPRAMINE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

TRIMIPRAMINE (TRIMIPRAMINE MALEATE)

MAH:

AA PHARMA INC

ATC_code:

N06AA06

INN:

TRIMIPRAMINE

dosage:

12.5MG

pharmaceutical_form:

TABLET

composition:

TRIMIPRAMINE (TRIMIPRAMINE MALEATE) 12.5MG

administration_route:

ORAL

units_in_package:

100

prescription_type:

Prescription

therapeutic_area:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0102479001; AHFS:

authorization_status:

APPROVED

authorization_date:

2010-06-09

SPC

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