ACT MEMANTINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEMANTINE HYDROCHLORIDE

Available from:

TEVA CANADA LIMITED

ATC code:

N06DX01

INN (International Name):

MEMANTINE

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

MEMANTINE HYDROCHLORIDE 5MG

Administration route:

ORAL

Units in package:

30/100/500

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2020-04-06

Summary of Product characteristics

_Page 1 of 33_
PRODUCT MONOGRAPH
PR
ACT 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.: 237118
Date of Revision:
April 3, 2020
_Page 2 of 33_
PR
ACT 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.
PHARMACOKINETICS
ABSORPTION
Orally administered memantine is completely absorbed. Oral
bioavailability is almost 100%.
Time