البلد: كندا
اللغة: الإنجليزية
المصدر: Health Canada
SERTRALINE (SERTRALINE HYDROCHLORIDE)
MYLAN PHARMACEUTICALS ULC
N06AB06
SERTRALINE
25MG
CAPSULE
SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG
ORAL
100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0123417003; AHFS:
CANCELLED POST MARKET
2018-02-07
1 PRODUCT MONOGRAPH PR MYLAN-SERTRALINE (sertraline hydrochloride) 25 mg, 50 mg, and 100 mg Capsules ANTIDEPRESSANT / ANTIPANIC / ANTIOBSESSIONAL AGENT MYLAN PHARMACEUTICALS ULC 85 Advance Rd. Toronto, ON M8Z 2S6 Date of Revision: August 29, 2018 Control number: 218939 2 NAME OF DRUG PR MYLAN-SERTRALINE (sertraline hydrochloride) 25 mg, 50 mg and 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 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 about 40%: it is recommended that MYLAN-SERTRALINE be administered with meals. Sertraline is extensively metabolized to N-desmethy اقرأ الوثيقة كاملة