APO-TRIMIPRAMINE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRIMIPRAMINE (TRIMIPRAMINE MALEATE)

Available from:

APOTEX INC

ATC code:

N06AA06

INN (International Name):

TRIMIPRAMINE

Dosage:

75MG

Pharmaceutical form:

CAPSULE

Composition:

TRIMIPRAMINE (TRIMIPRAMINE MALEATE) 75MG

Administration route:

ORAL

Units in package:

100/500/1000

Prescription type:

Prescription

Therapeutic area:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0102479005; AHFS:

Authorization status:

APPROVED

Authorization date:

2013-05-01

Summary of Product characteristics

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