ACT CLOMIPRAMINE TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CLOMIPRAMINE HYDROCHLORIDE

Disponibil de la:

ACTAVIS PHARMA COMPANY

Codul ATC:

N06AA04

INN (nume internaţional):

CLOMIPRAMINE

Dozare:

10MG

Forma farmaceutică:

TABLET

Compoziție:

CLOMIPRAMINE HYDROCHLORIDE 10MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Rezumat produs:

Active ingredient group (AIG) number: 0109212001; AHFS:

Statutul autorizaţiei:

CANCELLED POST MARKET

Data de autorizare:

2016-02-19

Caracteristicilor produsului

PRODUCT MONOGRAPH
PR
ACT CLOMIPRAMINE
®
(CLOMIPRAMINE HYDROCHLORIDE)
10 MG, 25 MG AND 50 MG TABLETS
ANTIDEPRESSANT / ANTIOBSESSIONAL
Actavis PharmaCompany
DATE OF REVISION:
6733 Mississauga Road, Suite 400
February 18, 2015
Mississauga, Ontario
Canada, L5N 6J5
Control # 181494
- 2 -
PRODUCT MONOGRAPH
PR
ACT CLOMIPRAMINE
®
(clomipramine hydrochloride)
10 mg, 25 mg and 50 mg tablets
THERAPEUTIC CLASSIFICATION
Antidepressant
Antiobsessional
ACTIONS AND CLINICAL PHARMACOLOGY
ACT CLOMIPRAMINE (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, ACT CLOMIPRAMINE 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.
The action of ACT CLOMIPRAMINE 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 after drug withdrawal whic