MEMANTINE HYDROCHLORIDE TABLETS

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

MEMANTINE HYDROCHLORIDE

Boleh didapati daripada:

ALEMBIC PHARMACEUTICALS LIMITED

Kod ATC:

N06DX01

INN (Nama Antarabangsa):

MEMANTINE

Dos:

10MG

Borang farmaseutikal:

TABLET

Komposisi:

MEMANTINE HYDROCHLORIDE 10MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0150423001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2014-06-04

Ciri produk

______________________________________________________________________________
_Memantine Hydrochloride Product Monograph_
_ Page 1 of 39_
PRODUCT MONOGRAPH
PR MEMANTINE HYDROCHLORIDE TABLETS
10 MG
N-methyl-D-aspartate (NMDA) receptor antagonist
MANUFACTURED BY:
Alembic Pharmaceuticals Limited
(Formulation Division),
Village Panelav, P. O. Tajpura, Near Baska,
Taluka-Halol, Panchmahal, Gujarat, India
CANADIAN IMPORTER AND DISTRIBUTOR:
SANIS HEALTH INC.
333, Champion street
Suite 102, Dieppe
New Brunswick E1A 1P2
CANADA
DATE OF REVISION:
June 12, 2018
Control Number # 216518
______________________________________________________________________________
_Memantine Hydrochloride Product Monograph_
_ Page 2 of 39_
NAME OF DRUG
PR MEMANTINE HYDROCHLORIDE TABLETS
10 MG
THERAPEUTIC CLASSIFICATION
N-methyl-D-aspartate (NMDA) receptor antagonist
ACTION AND CLINICAL PHARMACOLOGY
Persistent activation of the central nervous system
N-methyl-D-aspartate (NMDA) receptors by
the excitatory amino acid glutamate has been hypothesized to
contribute to the symptomatology
of Alzheimer’s disease. Memantine is postulated to exert its
therapeutic effect through its action
as a low to moderate affinity uncompetitive (open channel) NMDA
receptor antagonist, which
binds preferentially to the NMDA receptor-operated cation channels. It
blocks the effects of
pathologically elevated sustained levels of glutamate that may lead to
neuronal dysfunction.
There is no clinical evidence that memantine prevents or slows
neurodegeneration or alters the
course of the underlying dementing process in patients with
Alzheimer’s disease. Memantine
exhibits low to negligible affinity for other receptors (GABA,
benzodiazepine, dopamine,
adrenergic,
noradrenergic,
histamine
and
glycine)
or
voltage-dependent
Ca
2+
,
Na
+
or
K
+
channels. In addition, it does not directly affect the acetylcholine
receptor or cholinergic
transmission, which have been implicated in the cholinomimetic side
effects (e.g., increased
gastric
acid
secretion,
nausea
and
vomiting)
se