Country: Canada
Language: English
Source: Health Canada
SERTRALINE (SERTRALINE HYDROCHLORIDE)
NU-PHARM INC
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
2012-09-04
0 PRODUCT MONOGRAPH NU-SERTRALINE Sertraline Hydrochloride Capsules Equivalent to 25, 50 and 100 mg Sertraline Antidepressant / Antipanic / Antiobsessional Agent NU-PHARM INC. DATE OF PREPARATION: 50 Mural Street, Units 1 & 2 January 2, 2003 Richmond Hill, Ontario DATE OF REVISION: L4B 1E4 July 28, 2005 _Control # 096152_ 1 PRODUCT MONOGRAPH NU-SERTRALINE Sertraline Hydrochloride Capsules Equivalent to 25, 50 and 100 mg THERAPEUTIC CLASSIFICATION Antidepressant – Antipanic – Antiobsessional Agent ACTIONS 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 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–HT1A, 5–HT1B, 5–HT2) or benzodiazepine binding sites. In placebo–controlled studies in normal volunteers, sertraline 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 : g/mL occurring between 6 to 8 hours post-dose. The area under the plasma concentration time curve is 2.8 mg q hr/L. For desmethylsertraline, C max is 0.14 : g/mL, the half-life 65 hours and the area under the curve 2.3 mg q hr/L. Following single or multiple oral once-daily 2 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 NU- SERT Read the complete document