Nazione: Canada
Lingua: inglese
Fonte: Health Canada
MOCLOBEMIDE
TEVA CANADA LIMITED
N06AG02
MOCLOBEMIDE
150MG
TABLET
MOCLOBEMIDE 150MG
ORAL
100/500
Prescription
MONOAMINE OXIDASE INHIBITORS
Active ingredient group (AIG) number: 0122658002; AHFS:
CANCELLED POST MARKET
2018-04-10
TEVA-MOCLOBEMIDE Product Monograph Page 1 of 34 PRODUCT MONOGRAPH Pr TEVA-MOCLOBEMIDE (moclobemide) 100 mg, 150 mg & 300 mg Film-Coated Tablets Teva Standard ANTIDEPRESSANT Teva Canada Limited 30 Novopharm Court Toronto, Ontario Canada M1B 2K9 www.tevacanada.com Date of Revision: June 01, 2016 SUBMISSION CONTROL # 194672 TEVA-MOCLOBEMIDE Product Monograph Page 2 of 34 PR TEVA-MOCLOBEMIDE (moclobemide) 100 mg, 150 mg & 300 mg Film-Coated Tablets ACTIONS AND CLINICAL PHARMACOL OGY TEVA-MOCLOBEMIDE (moclobemide) is a short-acting, Reversible Inhibitor of Monoamine oxidase type A (RIMA). It is a benzamide derivative which inhibits the deamination of serotonin, noradrenaline and dopamine. This action leads to increased concentrations of these neurotransmitters, which may account for the antidepressant activity of moclobemide. Monoamine oxidases are currently subclassified into two types, A and B, which differ in their substrate specificity. Moclobemide preferentially inhibits MAO-A; at a 300 mg dose, the inhibition of MAO-A is approximately 80%, while that of MAO-B is approximately 20 - 30%. The estimated MAO-A inhibition is short-lasting (maximum 24 hours) and reversible. PHARMACOKINETICS VOLUNTEERS _General: _Following oral administration, moclobemide is 98% absorbed from the gastrointestinal tract. Due to hepatic first pass effect, absolute bioavailability is approximately 55% after single doses, but 90% after multiple doses. The apparent volume of distribution is approximately 1.2 L/kg, indicating extensive tissue distribution. Moclobemide is extensively metabolized, largely via oxidative reactions on the morpholine moiety of the molecule. While 95% of the administered dose is excreted in the urine, less than 1% of this is in the unchanged form. Active metabolites recovered _in vitro _or in animal experiments are present only at very low concentrations in the systemic circulation in man. Moclobemide is 50% bound to plasma proteins, mainly to albumin. The presence of food reduces the rate, but not the extent of moc Leggi il documento completo