MINT-MEMANTINE TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEMANTINE HYDROCHLORIDE

Available from:

MINT PHARMACEUTICALS INC

ATC code:

N06DX01

INN (International Name):

MEMANTINE

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

MEMANTINE HYDROCHLORIDE 10MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2022-10-13

Summary of Product characteristics

PRODUCT MONOGRAPH
Pr
MINT-MEMANTINE
Memantine Hydrochloride Tablets 10 mg
Manufacturer’s Standard
N-methyl-D-aspartate (NMDA) receptor antagonist
MINT PHARMACEUTICALS INC.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Date of Preparation:
October 11, 2022
Control No. 257690
NAME OF DRUG
Pr
MINT-MEMANTINE
Memantine Hydrochloride Tablets 10 mg
Manufacturer’s Standard
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.
MINT-MEMANTINE Product Monograph
Page 3 of 47
PHARMACOKINETICS
ABSORPTION
Orally administered memantine is com