RIVA-MEMANTINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MEMANTINE HYDROCHLORIDE

Tersedia dari:

LABORATOIRE RIVA INC.

Kode ATC:

N06DX01

INN (Nama Internasional):

MEMANTINE

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

MEMANTINE HYDROCHLORIDE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2010-05-13

Karakteristik produk

PRODUCT MONOGRAPH
PR
RIVA-MEMANTINE
Memantine Hydrochloride Tablets, USP
10 mg
N-methyl-D-aspartate (NMDA) receptor antagonist
LABORATOIRE RIVA INC.
660 Industriel Blvd.
Blainville, Quebec, Canada.
J7C 3V4
www.labriva.com
DATE OF REVISION:
Aug. 04, 2016
SUBMISSION CONTROL NO: 196212
56
_RIVA-MEMANTINE Product Monograph _
_Page 2 of 38_
NAME OF DRUG
PR
RIVA-MEMANTINE
Memantine Hydrochloride Tablets, USP
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) seen
with
acetylcholinesterase
inhibitors.
Memantine
showed
antagonist
effects
at
the
5HT
3
receptor with a potency similar to that for the NMDA receptor.
_In vitro_
studies have shown that memantine does not affect the reversible
inhibition of
acetylcholinesterase by donepezil or galantamine.
PHARMACOKINETICS
ABSORPTION
Orally administered memantine is completely abs