SURMONTIL TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

TRIMIPRAMINE (TRIMIPRAMINE MALEATE)

Disponibbli minn:

SANOFI-AVENTIS CANADA INC

Kodiċi ATC:

N06AA06

INN (Isem Internazzjonali):

TRIMIPRAMINE

Dożaġġ:

50MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

TRIMIPRAMINE (TRIMIPRAMINE MALEATE) 50MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Sommarju tal-prodott:

Active ingredient group (AIG) number: 0102479003; AHFS:

L-istatus ta 'awtorizzazzjoni:

CANCELLED POST MARKET

Data ta 'l-awtorizzazzjoni:

2006-07-28

Karatteristiċi tal-prodott

PRODUCT MONOGRAPH
SURMONTIL
®
(Trimipramine)
25 mg and 50 mg Tablets
Tricyclic Antidepressant
sanofi-aventis Canada Inc.
Date of Preparation:
2150 St. Elzear Blvd. West
June 12, 2006
Laval, Quebec H7L 4A8
Submission Control No. 106414
s-a Version 1.0 dated
2
ACTION
SURMONTIL (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
SURMONTIL (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
SURMONTIL (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 SURMONTIL
and a two-week delay is recommended before using the drug in patients
who have received an
MAO inhibitor. Treatment with SURMONTIL should be started with small
doses and increased
progressively, depending on tolerance and response.
Because of its anticholinergic properties, SURMONTIL 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 with drugs of this c