RIVA-MEMANTINE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

MEMANTINE HYDROCHLORIDE

Dostupno od:

LABORATOIRE RIVA INC.

ATC koda:

N06DX01

INN (International ime):

MEMANTINE

Doziranje:

10MG

Farmaceutski oblik:

TABLET

Sastav:

MEMANTINE HYDROCHLORIDE 10MG

Administracija rute:

ORAL

Jedinice u paketu:

30/100

Tip recepta:

Prescription

Područje terapije:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2010-05-13

Svojstava lijeka

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