MEMANTINE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

MEMANTINE HYDROCHLORIDE

Boleh didapati daripada:

SANIS HEALTH INC

Kod ATC:

N06DX01

INN (Nama Antarabangsa):

MEMANTINE

Dos:

10MG

Borang farmaseutikal:

TABLET

Komposisi:

MEMANTINE HYDROCHLORIDE 10MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2015-07-22

Ciri produk

_MEMANTINE _
_Page 1 of 35_
PRODUCT MONOGRAPH
PR
MEMANTINE
Memantine Hydrochloride Tablets
10 mg
N-methyl-D-aspartate (NMDA) receptor antagonist
Sanis Health Inc.
Date of Preparation:
1 President’s Choice Circle
March 24, 2017
Brampton, Ontario
L6Y 5S5
Submission Control No.: 202483
_MEMANTINE _
_Page 2 of 35_
PR
MEMANTINE
Memantine Hydrochloride Tablets
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.
PHARMACOKINETICS
ABSORPTION
Orally administered memantine is completely absorbed. Oral
bioavailability is almost 100%.
Time to maximum plasma concentration (t
max
) following single oral doses of 10 to 40 mg
memantine ranged between 3 to 8 hours. It has a