Страна: Канада
Език: английски
Източник: Health Canada
SERTRALINE (SERTRALINE HYDROCHLORIDE)
MELIAPHARM INC
N06AB06
SERTRALINE
100MG
CAPSULE
SERTRALINE (SERTRALINE HYDROCHLORIDE) 100MG
ORAL
100/250
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0123417002; AHFS:
CANCELLED POST MARKET
2014-06-25
PRODUCT MONOGRAPH Pr SERTRALINE (Sertraline hydrochloride capsules) 25 mg, 50 mg and 100 mg Sertraline, as sertraline hydrochloride Antidepressant / Antipanic / Antiobsessional Agent MELIAPHARM INC. 6111 Royalmount Ave., Suite 100 Montreal, Quebec H4P 2T4 Date of Revision: July 11, 2013 Submission Control No: 166018 Pr _SERTRALINE Product Monograph _ _Page 2 of 47_ PRODUCT MONOGRAPH PR SERTRALINE (Sertraline hydrochloride Capsules) 25 mg, 50 mg and 100 mg Sertraline, as sertraline hydrochloride 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 reuptake 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 downregulates 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-HT1A, 5-HT1B, 5-HT2) or benzodiazepine binding sites. In placebo-controlled studies in normal volunteers, sertraline hydrochloride 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 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 bioavailability by Прочетете целия документ