ACT MEMANTINE TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

MEMANTINE HYDROCHLORIDE

Sẵn có từ:

TEVA CANADA LIMITED

Mã ATC:

N06DX01

INN (Tên quốc tế):

MEMANTINE

Liều dùng:

5MG

Dạng dược phẩm:

TABLET

Thành phần:

MEMANTINE HYDROCHLORIDE 5MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

30/100/500

Loại thuốc theo toa:

Prescription

Khu trị liệu:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2020-04-06

Đặc tính sản phẩm

_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