TEVA-MOCLOBEMIDE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MOCLOBEMIDE

Tersedia dari:

TEVA CANADA LIMITED

Kode ATC:

N06AG02

INN (Nama Internasional):

MOCLOBEMIDE

Dosis:

150MG

Bentuk farmasi:

TABLET

Komposisi:

MOCLOBEMIDE 150MG

Rute administrasi :

ORAL

Unit dalam paket:

100/500

Jenis Resep:

Prescription

Area terapi:

MONOAMINE OXIDASE INHIBITORS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2018-04-10

Karakteristik produk

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