EBIXA TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEMANTINE HYDROCHLORIDE

Available from:

LUNDBECK CANADA INC

ATC code:

N06DX01

INN (International Name):

MEMANTINE

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

MEMANTINE HYDROCHLORIDE 10MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2004-12-08

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
Ebixa
®
Memantine Hydrochloride Tablets 10 mg
N-methyl-D-aspartate (NMDA) receptor antagonist
Lundbeck Canada Inc.
Date of revision:
1000 De La Gauchetière Street West May 14, 2015
Suite 500
Montreal (Quebec), Canada
H3B 4W5
Control No. 181785
- 1 -
NAME OF DRUG
PR
Ebixa
®
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.
- 2 -
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 maximum p