RATIO-MEMANTINE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

MEMANTINE HYDROCHLORIDE

Disponible des:

TEVA CANADA LIMITED

Codi ATC:

N06DX01

Designació comuna internacional (DCI):

MEMANTINE

Dosis:

10MG

formulario farmacéutico:

TABLET

Composición:

MEMANTINE HYDROCHLORIDE 10MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Resumen del producto:

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

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2018-06-19

Fitxa tècnica

1
PRODUCT MONOGRAPH
PR
RATIO-MEMANTINE
MEMANTINE HYDROCHLORIDE 10 MG TABLETS
N-methyl-D-aspartate (NMDA) receptor antagonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Preparation :
May 9, 2013
Submission Control No: 164325
2
NAME OF DRUG
Pr
RATIO-MEMANTINE
MEMANTINE HYDROCHLORIDE TABLETS 10 MG
THERAPEUTIC CLASSIFICATION
N-methyl-D-aspartate (NMDA) receptor antagonist
A
CTION AND
C
LINICAL
P
HARMACOLOGY
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.
P
HARMACOKINETICS
A
BSORPTION
Orally administered memantine is completely absorbed. Oral
bioavailability is almost 100%.
Time to