JAMP-MEMANTINE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

MEMANTINE HYDROCHLORIDE

Tersedia dari:

JAMP PHARMA CORPORATION

Kode ATC:

N06DX01

INN (Nama Internasional):

MEMANTINE

Dosis:

5MG

Bentuk farmasi:

TABLET

Komposisi:

MEMANTINE HYDROCHLORIDE 5MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2021-12-07

Karakteristik produk

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_JAMP-Memantine-Product Monograph_ Page 1 of 33
PRODUCT MONOGRAPH
Pr
JAMP-Memantine
Memantine Hydrochloride Tablets
5 mg and 10 mg
N-methyl-D-aspartate (NMDA) receptor antagonist
CONTROL NO. 258466
JAMP Pharma
Corporation
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of
Revision:
December 6, 2021
_ Pr_
_JAMP-Memantine-Product Monograph_ Page 2 of 33
NAME OF DRUG
PR
JAMP-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
voltagemax-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
Ora