RATIO-MEMANTINE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

MEMANTINE HYDROCHLORIDE

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

N06DX01

INN (Διεθνής Όνομα):

MEMANTINE

Δοσολογία:

10MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

MEMANTINE HYDROCHLORIDE 10MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2018-06-19

Αρχείο Π.Χ.Π.

1
PRODUCT MONOGRAPH
PR
RATIO-MEMANTINE
MEMANTINE HYDROCHLORIDE 10 MG TABLETS
N-methyl-D-aspartate (NMDA) receptor antagonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
www.tevacanada.com
Date of Preparation :
May 9, 2013
Submission Control No: 164325
2
NAME OF DRUG
Pr
RATIO-MEMANTINE
MEMANTINE HYDROCHLORIDE TABLETS 10 MG
THERAPEUTIC CLASSIFICATION
N-methyl-D-aspartate (NMDA) receptor antagonist
A
CTION AND
C
LINICAL
P
HARMACOLOGY
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.
P
HARMACOKINETICS
A
BSORPTION
Orally administered memantine is completely absorbed. Oral
bioavailability is almost 100%.
Time to