SANDOZ MEMANTINE FCT TABLET

देश: कनाडा

भाषा: अंग्रेज़ी

स्रोत: Health Canada

सक्रिय संघटक:

MEMANTINE HYDROCHLORIDE

थमां उपलब्ध:

SANDOZ CANADA INCORPORATED

ए.टी.सी कोड:

N06DX01

INN (इंटरनेशनल नाम):

MEMANTINE

डोज़:

10MG

फार्मास्यूटिकल फॉर्म:

TABLET

रचना:

MEMANTINE HYDROCHLORIDE 10MG

प्रशासन का मार्ग:

ORAL

पैकेज में यूनिट:

30

प्रिस्क्रिप्शन प्रकार:

Prescription

चिकित्सीय क्षेत्र:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

APPROVED

प्राधिकरण की तारीख:

2014-03-14

उत्पाद विशेषताएं

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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