GD-SERTRALINE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Available from:

GENMED A DIVISION OF PFIZER CANADA ULC

ATC code:

N06AB06

INN (International Name):

SERTRALINE

Dosage:

50MG

Pharmaceutical form:

CAPSULE

Composition:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 50MG

Administration route:

ORAL

Units in package:

250

Prescription type:

Prescription

Therapeutic area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0123417001; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2016-05-31

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
GD*-SERTRALINE
(SERTRALINE HYDROCHLORIDE)
25, 50 AND 100 MG CAPSULES
ANTIDEPRESSANT / ANTIPANIC / ANTIOBSESSIONAL AGENT
GenMed, a division of Pfizer Canada Inc.
Date of Revision:
17300 Trans Canada Highway
April 9, 2014
Kirkland, Quebec, H9J 2M5
Control Number: 173320
*GD is a trademark of Pfizer Canada Inc.
GenMed, a division of Pfizer Canada Inc., Licensee
© Pfizer Canada Inc. 2014
IMPORTANT: PLEASE READ
_GD-sertraline (sertraline hydrochloride) Product Monograph _
_Page 2 of 58 _
NAME OF DRUG
PR
GD-SERTRALINE
(sertraline hydrochloride)
25, 50, 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 (alpha1, alpha2 & 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 (Cmax) 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, Cmax 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