TEVA-MAPROTILINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MAPROTILINE HYDROCHLORIDE

Available from:

TEVA CANADA LIMITED

ATC code:

N06AA21

INN (International Name):

MAPROTILINE

Dosage:

25MG

Pharmaceutical form:

TABLET

Composition:

MAPROTILINE HYDROCHLORIDE 25MG

Administration route:

ORAL

Units in package:

BTLS/100&500,BXS/100U DOS

Prescription type:

Prescription

Therapeutic area:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0111022003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2018-04-30

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
TEVA-MAPROTILINE
(Maprotiline Hydrochloride)
25, 50 and 75 mg Tablets
USP
Antidepressant
Teva Canada Limited
Date of Preparation:
30 Novopharm Court
September 19, 2011
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Submission Control#: 149911
2
PRODUCT MONOGRAPH
TEVA-MAPROTILINE
(Maprotiline Hydrochloride)
25, 50 and 75 mg Tablets
USP
THERAPEUTIC CLASSIFICATION
Antidepressant
ACTION AND CLINlCAl PHARMACOLOGY
TEVA-MAPROTILINE (maprotiline hydrochloride) has been shown to exhibit
an
antidepressant
action.
Noradrenaline
in
the
brain
and
peripheral
tissues
is
strongly inhibited by maprotiline, though it is ,notable in its lack
of inhibition of
serotonergic uptake. It has markedly less pronounced alpha adrenergic
blocking
activity than amitriptyline. In the pharmacologic profile of
maprotiline, a strong
antihistaminic and a weaker anticholinergic action are seen.
Maprotiline also
exerts a sedative effect on the anxiety component of depressive
illness. It is
postulated
that
maprotiline
exerts
its
antidepressant
action
by
inhibition
of
presynaptic uptake of catecholamines, thereby increasing their
concentration at
the synaptic clefts of the brain. The effect of maprotiline on the EEG
in single
doses revealed a rise in the alpha-wave density, a reduction of the
alpha-wave
frequency and an increase in the alpha-wave amplitude. However,
maprotiline,
as with other tricyclic antidepressants lowers the convulsive
threshold. In one as
3
yet uncorroborated "sleep study", it appears that maprotiline
increases the REM
phase of sleep in depressed patients, from its initially reduced base
line, whereas
imipramine reduced the REM phase of sleep.
Maprotiline is completely absorbed after oral administration in man.
The binding
to serum proteins was found to be 88%. In man, the half-life of
unchanged
maprotiline is relatively long and ranged from 27.4 to 57.6 hours.
Following
repeated daily doses of maprotiline, a plasma steady state
concentration was
reached in the second week, with the majority of subjects re