SANDOZ MEMANTINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MEMANTINE HYDROCHLORIDE

Tersedia dari:

SANDOZ CANADA INCORPORATED

Kode ATC:

N06DX01

INN (Nama Internasional):

MEMANTINE

Dosis:

10MG

Bentuk farmasi:

TABLET

Komposisi:

MEMANTINE HYDROCHLORIDE 10MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

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

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2017-06-29

Karakteristik produk

_Sandoz Memantine _
_Page 1 of 37_
PRODUCT MONOGRAPH
PR
SANDOZ MEMANTINE
Memantine Hydrochloride Tablets, House standard
10 mg
N-methyl-D-aspartate (NMDA) receptor antagonist
Sandoz Canada Inc.
Date of revision: August 17, 2016
145 Jules-Léger
Boucherville, Quebec
J4B 7K8
Submission Control No: 196426
_Sandoz Memantine _
_Page 2 of 37_
PR SANDOZ MEMANTINE
Memantine Hydrochloride Tablets, House 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.
PHARMACOKINETICS
ABSORPTION:
Orally administered memantine is completely