RHOTRIMINE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TRIMIPRAMINE (TRIMIPRAMINE MALEATE)

Available from:

SANOFI-AVENTIS CANADA 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

Prescription type:

Prescription

Therapeutic area:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Product summary:

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

Authorization status:

CANCELLED POST MARKET

Authorization date:

2007-03-29

Summary of Product characteristics

PRODUCT MONOGRAPH
RHOTRIMINE
®
(Trimipramine)
12.5, 25, 50 and 100 mg Tablets
75 mg Capsules
Tricyclic Antidepressant
sanofi-aventis Canada Inc.
Date of Preparation:
2150 St. Elzear Blvd. West
May 19, 2006
Laval, Quebec H7L 4A8
Control No. 105835
s-a Version 1.0 dated
2
ACTION
RHOTRIMINE (trimipramine) is a tricyclic antidepressant with sedative
properties. It has also
anticholinergic properties and potentiates the sympathetic responses,
presumably by blocking the
re-uptake of norepinephrine which has been released by the presynaptic
neurones. Trimipramine has
a quinidine-like effect on the heart and produces E.K.G and E.E.G.
changes similar to those of other
tricyclic antidepressants.
INDICATIONS
RHOTRIMINE (trimipramine) is indicated in the drug treatment of
depressive illness. It is
particularly effective in endogenous depression. It may also be useful
in some patients with neurotic
depression.
CONTRAINDICATIONS
RHOTRIMINE (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.
Monoamine oxidase inhibitors should not be administered concomitantly
with RHOTRIMINE and
a two-week delay is recommended before using the drug in patients who
have received an MAO
inhibitor. Treatment with RHOTRIMINE should be started with small
doses and increased
progressively, depending on tolerance and response.
Because of its anticholinergic properties, RHOTRIMINE is
contraindicated in patients with narrow
angle glaucoma and prostatic hypertrophy.
It is also contraindicated during the acute recovery phase following
myocardial infarction and in the
presence of acute congestive heart failure.
WARNINGS
Tricyclic antidepressants, particularly in high doses, have been
reported to produce arrhythmias,
sinus tachycardia, and prolongation of conduction time. A few
instances of unexpected death have
been reported in patients with cardiovascular disorders. Myocardial
infarction and stroke have also
been reported wi