NOVO-MEMANTINE TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

MEMANTINE HYDROCHLORIDE

Disponível em:

TEVA CANADA LIMITED

Código ATC:

N06DX01

DCI (Denominação Comum Internacional):

MEMANTINE

Dosagem:

5MG

Forma farmacêutica:

TABLET

Composição:

MEMANTINE HYDROCHLORIDE 5MG

Via de administração:

ORAL

Unidades em pacote:

30/100

Tipo de prescrição:

Prescription

Área terapêutica:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Resumo do produto:

Active ingredient group (AIG) number: 0150423002; AHFS:

Status de autorização:

CANCELLED PRE MARKET

Data de autorização:

2015-10-16

Características técnicas

1
PRODUCT MONOGRAPH
PR
NOVO-MEMANTINE
Memantine Hydrochloride Tablets 5 mg and 10 mg
N-methyl-D-aspartate (NMDA) receptor antagonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Submission Control No: 121195, 174595
Date of Preparation:
July 7, 2014
2
NAME OF DRUG
Pr
NOVO-MEMANTINE
Memantine Hydrochloride Tablets 5 mg and 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)
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.
3
PHARMACOKINETICS
ABSORPTION
Orally administered memantine is completely absorbed. Oral
bioavailability is almost
100%. Time to maxi