Q-SERTRALINE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Available from:

QD PHARMACEUTICALS ULC

ATC code:

N06AB06

INN (International Name):

SERTRALINE

Dosage:

25MG

Pharmaceutical form:

CAPSULE

Composition:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Therapeutic area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product summary:

Active ingredient group (AIG) number: 0123417003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2015-08-21

Summary of Product characteristics

1
PRODUCT MONOGRAPH
PR
Q-SERTRALINE
(sertraline hydrochloride)
25 mg, 50 mg, and 100 mg Capsules
ANTIDEPRESSANT / ANTIPANIC / ANTIOBSESSIONAL AGENT
QD PHARMACEUTICALS ULC
85 Advance Rd.
Toronto, ON
M8Z 2S6
Date of Revision: August 27, 2014
Control number: 176782
2
NAME OF DRUG
PR
Q-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 Q-
Sertraline be administered with meals.
2
2
Sertraline is extensively metabolized to N-desmethylsertralin