Land: Kanada
Sprache: Englisch
Quelle: Health Canada
SERTRALINE (SERTRALINE HYDROCHLORIDE)
RANBAXY PHARMACEUTICALS CANADA INC.
N06AB06
SERTRALINE
25MG
CAPSULE
SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG
ORAL
250
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0123417003; AHFS:
CANCELLED POST MARKET
2022-10-21
PRODUCT MONOGRAPH PR RAN™-SERTRALINE Sertraline Hydrochloride Capsules 25 mg, 50 mg and 100 mg Sertraline (as sertraline hydrochloride) ANTIDEPRESSANT / ANTIPANIC / ANTIOBSESSIONAL AGENT Ranbaxy Pharmaceuticals Canada Inc. 126 East Drive Brampton, Ontario L6T 1C1 Date of Revision: June 13, 2018 Submission Control No.: 215979 RAN trademark owned by Sun Pharmaceutical Industries Ltd. Pr _RAN™-SERTRALINE Product Monograph _ _Page 2 of 52_ PRODUCT MONOGRAPH PR RAN™-SERTRALINE Sertraline Hydrochloride Capsules 25 mg, 50 mg and 100 mg Sertraline (as sertraline hydrochloride) THERAPEUTIC CLASSIFICATION Antidepressant - Antipanic - Antiobsessional Agent ACTION AND CLINICAL PHARMACOLOGY 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 mcg/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 mcg/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 d Lesen Sie das vollständige Dokument