Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
MEMANTINE HYDROCHLORIDE
ALEMBIC PHARMACEUTICALS LIMITED
N06DX01
MEMANTINE
10MG
TABLET
MEMANTINE HYDROCHLORIDE 10MG
ORAL
30/100
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0150423001; AHFS:
APPROVED
2014-06-04
______________________________________________________________________________ _Memantine Hydrochloride Product Monograph_ _ Page 1 of 39_ PRODUCT MONOGRAPH PR MEMANTINE HYDROCHLORIDE TABLETS 10 MG N-methyl-D-aspartate (NMDA) receptor antagonist MANUFACTURED BY: Alembic Pharmaceuticals Limited (Formulation Division), Village Panelav, P. O. Tajpura, Near Baska, Taluka-Halol, Panchmahal, Gujarat, India CANADIAN IMPORTER AND DISTRIBUTOR: SANIS HEALTH INC. 333, Champion street Suite 102, Dieppe New Brunswick E1A 1P2 CANADA DATE OF REVISION: June 12, 2018 Control Number # 216518 ______________________________________________________________________________ _Memantine Hydrochloride Product Monograph_ _ Page 2 of 39_ NAME OF DRUG PR 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) se Soma hati kamili