Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
SERTRALINE (SERTRALINE HYDROCHLORIDE)
SANDOZ CANADA INCORPORATED
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
2019-07-15
_Sandoz Sertraline _ _Page 1 of 51_ PRODUCT MONOGRAPH Pr SANDOZ SERTRALINE (Sertraline hydrochloride) 25 mg, 50 mg and 100 mg Capsules as sertraline Antidepressant / Antipanic / Antiobsessional Agent Sandoz Canada Inc. 110 rue de Lauzon Boucherville, QC, Canada Date of Revision: March 6, 2020 J4B 1E6 Control number: 236370 _Sandoz Sertraline _ _Page 2 of 51_ Pr SANDOZ SERTRALINE (Sertraline hydrochloride) 25 mg, 50 mg and 100 mg capsules as sertraline 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 , and 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 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 Sandoz Sertrali Perskaitykite visą dokumentą