Država: Kanada
Jezik: engleski
Izvor: Health Canada
SERTRALINE (SERTRALINE HYDROCHLORIDE)
RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED
N06AB06
SERTRALINE
50MG
CAPSULE
SERTRALINE (SERTRALINE HYDROCHLORIDE) 50MG
ORAL
100/250
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0123417001; AHFS:
CANCELLED POST MARKET
2014-09-24
PRODUCT MONOGRAPH PR RATIO-SERTRALINE (SERTRALINE HYDROCHLORIDE CAPSULES) 25 MG, 50 MG & 100 MG ANTIDEPRESSANT/ANTIPANIC/ANTIOBSESSIONAL AGENT RATIOPHARM INC. 17 800 Lapointe Mirabel, Quebec Canada, J7J 1P3 Control No. : 136354 Date of Preparation: May 09, 2002 Date of Revision: February 19, 2010 Product Monograph – ratio-SERTRALINE Page 2 of 57 PRODUCT MONOGRAPH Pr RATIO-SERTRALINE (SERTRALINE HYDROCHLORIDE) 25 MG, 50 MG & 100 MG CAPSULES THERAPEUTIC CLASSIFICATION Antidepressant/Antipanic/Antiobsessional Agent ACTION The mechanism of action of sertraline is presumed to be linked to its ability to inhibit the neuronal re-uptake of serotonin. It has only very weak effects on norepinephrine and dopamine neuronal reuptake. At clinical doses, sertraline blocks the uptake of serotonin into human platelets. Like most clinically effective antidepressants, sertraline down regulates brain norepinephrine and serotonin receptors in animals. In receptor binding studies, sertraline has no significant affinity for adrenergic ( _alpha_ 1 , _alpha_ 2 , & _beta_ ), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5- HT1 A, 5-HT1B, 5-HT2) or benzodiazepine binding sites. In placebo-controlled studies in normal volunteers, sertraline hydrochloride capsules did not cause sedation and did not interfere with psychomotor performance. Pharmacokinetics: Following multiple oral once-daily doses of 200 mg, the mean peak plasma concentration (C max ) of sertraline is 0.19 μg/mL occurring between 6 to 8 hours post-dose. The area under the plasma Product Monograph – ratio-SERTRALINE Page 3 of 57 concentration time curve is 2.8 mg hr/l. For desmethylsertraline, C max is 0.14 μg/mL, the half-life 65 hours and the area under the curve 2.3 mg hr/l. Following single or multiple oral once-daily doses of 50 to 400 mg/day the average terminal elimination half-life is approximately 26 hours. Linear dose proportionality has been demonstrated over the clinical dose range of 50 to 200 mg/day. Food appears to increase the bioavailabili Pročitajte cijeli dokument