SANDOZ MEMANTINE FCT TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

MEMANTINE HYDROCHLORIDE

Available from:

SANDOZ CANADA INCORPORATED

ATC code:

N06DX01

INN (International Name):

MEMANTINE

Dosage:

10MG

Pharmaceutical form:

TABLET

Composition:

MEMANTINE HYDROCHLORIDE 10MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2014-03-14

Summary of Product characteristics

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_Sandoz Memantine FCT _
_Page 1 of 35_
PRODUCT MONOGRAPH
PR
SANDOZ MEMANTINE FCT
Memantine Hydrochloride Tablets
10 mg
N-methyl-D-aspartate (NMDA) receptor antagonist
Sandoz Canada Inc.
Date of Revision: September 16, 2015
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 186811
_ _
_Sandoz Memantine FCT _
_Page 2 of 35_
PR
SANDOZ MEMANTINE FCT
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
m