PMS-MEMANTINE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

MEMANTINE HYDROCHLORIDE

Mevcut itibaren:

PHARMASCIENCE INC

ATC kodu:

N06DX01

INN (International Adı):

MEMANTINE

Doz:

10MG

Farmasötik formu:

TABLET

Kompozisyon:

MEMANTINE HYDROCHLORIDE 10MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2009-11-04

Ürün özellikleri

PRODUCT MONOGRAPH
PR
PMS-MEMANTINE
Memantine Hydrochloride Tablets, USP
5 mg and 10 mg
N-methyl-D-aspartate (NMDA) receptor antagonist
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
May 10, 2016
Montreal, Quebec
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 193961
_ _
_pms-MEMANTINE Product Monograph _
_Page 2 of 38_
NAME OF DRUG
PR
PMS-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 co