TEVA-MOCLOBEMIDE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

MOCLOBEMIDE

MAH:

TEVA CANADA LIMITED

ATC_code:

N06AG02

INN:

MOCLOBEMIDE

dosage:

150MG

pharmaceutical_form:

TABLET

composition:

MOCLOBEMIDE 150MG

administration_route:

ORAL

units_in_package:

100/500

prescription_type:

Prescription

therapeutic_area:

MONOAMINE OXIDASE INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0122658002; AHFS:

authorization_status:

CANCELLED POST MARKET

authorization_date:

2018-04-10

SPC

TEVA-MOCLOBEMIDE Product Monograph Page 1 of 34
PRODUCT
MONOGRAPH
Pr
TEVA-MOCLOBEMIDE
(moclobemide)
100 mg, 150 mg & 300 mg Film-Coated
Tablets
Teva Standard
ANTIDEPRESSANT
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Revision:
June 01, 2016
SUBMISSION CONTROL # 194672
TEVA-MOCLOBEMIDE Product Monograph Page 2 of 34
PR
TEVA-MOCLOBEMIDE
(moclobemide)
100 mg, 150 mg & 300 mg Film-Coated
Tablets
ACTIONS AND CLINICAL PHARMACOL
OGY
TEVA-MOCLOBEMIDE (moclobemide) is a short-acting, Reversible Inhibitor
of Monoamine
oxidase type A (RIMA). It is a benzamide derivative which inhibits the
deamination of serotonin,
noradrenaline and dopamine. This action leads to increased
concentrations of these neurotransmitters,
which may account for the antidepressant activity of moclobemide.
Monoamine oxidases are currently subclassified into two types, A and
B, which differ in their
substrate specificity. Moclobemide preferentially inhibits MAO-A; at a
300 mg dose, the inhibition
of MAO-A is approximately 80%, while that of MAO-B is approximately 20
- 30%. The estimated
MAO-A inhibition is short-lasting (maximum 24 hours) and reversible.
PHARMACOKINETICS
VOLUNTEERS
_General: _Following oral administration, moclobemide is 98% absorbed
from the gastrointestinal
tract. Due to hepatic first pass effect, absolute bioavailability is
approximately 55% after single
doses, but 90% after multiple doses. The apparent volume of
distribution is approximately 1.2 L/kg,
indicating extensive tissue distribution.
Moclobemide is extensively metabolized, largely via oxidative
reactions on the morpholine moiety
of the molecule. While 95% of the administered dose is excreted in the
urine, less than 1% of this is
in the unchanged form. Active metabolites recovered _in vitro _or in
animal experiments are present
only at very low concentrations in the systemic circulation in man.
Moclobemide is 50% bound to
plasma proteins, mainly to albumin. The presence of food reduces the
rate, but not the extent of
moc