Страна: Канада
мова: англійська
Джерело: Health Canada
MEMANTINE HYDROCHLORIDE
TEVA CANADA LIMITED
N06DX01
MEMANTINE
10MG
TABLET
MEMANTINE HYDROCHLORIDE 10MG
ORAL
100
Prescription
MISCELLANEOUS CENTRAL NERVOUS SYSTEM AGENTS
Active ingredient group (AIG) number: 0150423001; AHFS:
CANCELLED POST MARKET
2018-06-19
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 Прочитайте повний документ