APO-CLOMIPRAMINE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CLOMIPRAMINE HYDROCHLORIDE

Disponibil de la:

APOTEX INC

Codul ATC:

N06AA04

INN (nume internaţional):

CLOMIPRAMINE

Dozare:

25MG

Forma farmaceutică:

TABLET

Compoziție:

CLOMIPRAMINE HYDROCHLORIDE 25MG

Calea de administrare:

ORAL

Unități în pachet:

100/500

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0109212003; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2018-11-05

Caracteristicilor produsului

0
PRODUCT MONOGRAPH
APO-CLOMIPRAMINE
CLOMIPRAMINE HYDROCHLORIDE TABLETS
10 MG, 25 MG AND 50 MG CLOMIPRAMINE HYDROCHLORIDE
ANTIDEPRESSANT / ANTIOBSESSIONAL
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
DATE OF REVISION:
CANADA M9L 1T9
October 31, 2018
Submission Control Number: 203894
1
PRODUCT MONOGRAPH
APO-CLOMIPRAMINE
Clomipramine Hydrochloride Tablets
10 mg, 25 mg and 50 mg clomipramine hydrochloride
THERAPEUTIC CLASSIFICATION
Antidepressant
Antiobsessional
ACTIONS AND CLINICAL PHARMACOLOGY
Clomipramine hydrochloride is a tricyclic agent with both
antidepressant and antiobsessional
properties. Like other tricyclics, clomipramine inhibits
norepinephrine and serotonin uptake into
central nerve terminals, possibly by blocking the membrane-pump of
neurons. Clomipramine
thereby increases the concentration of transmitter monoamines at
receptor sites. Clomipramine is
presumed to influence depression and obsessive and compulsive behavior
through its effects on
serotonergic neurotransmission. The actual neurochemical mechanism is
unknown, but
clomipramine’s capacity to inhibit serotonin reuptake is thought to
be important. Clomipramine
appears to have a mild sedative effect that may be helpful in
alleviating the anxiety component
often accompanying depression.
As with other tricyclic compounds, clomipramine hydrochloride
possesses anticholinergic
properties which are responsible for certain side effects. It also has
weak antihistamine and
antiserotonin properties, lowers the convulsive threshold, potentiates
the effect of norepinephrine
and other drugs acting on the central nervous system, has a
quinidine-like effect on the heart and
may impair cardiac conduction.
2
The action of clomipramine hydrochloride on the human
electroencephalogram is one of
desynchronization. Clomipramine causes a persistent increase in the
frequency of shifts into
stage I sleep and produces marked reduction or suppression of rapid
eye movement sleep (REM
or paradoxical sleep). Partial recovery occurs within 3 to 4 weeks as
does a rebound af