PMS-MEMANTINE TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

MEMANTINE HYDROCHLORIDE

Dostopno od:

PHARMASCIENCE INC

Koda artikla:

N06DX01

INN (mednarodno ime):

MEMANTINE

Odmerek:

10MG

Farmacevtska oblika:

TABLET

Sestava:

MEMANTINE HYDROCHLORIDE 10MG

Pot uporabe:

ORAL

Enote v paketu:

30/100

Tip zastaranja:

Prescription

Terapevtsko območje:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2009-11-04

Lastnosti izdelka

PRODUCT MONOGRAPH
PR
PMS-MEMANTINE
Memantine Hydrochloride Tablets, USP
5 mg and 10 mg
N-methyl-D-aspartate (NMDA) receptor antagonist
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
May 10, 2016
Montreal, Quebec
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 193961
_ _
_pms-MEMANTINE Product Monograph _
_Page 2 of 38_
NAME OF DRUG
PR
PMS-MEMANTINE
Memantine Hydrochloride Tablets, USP
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 co