PHL-SERTRALINE CAPSULE

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Disponible depuis:

PHARMEL INC

Code ATC:

N06AB06

DCI (Dénomination commune internationale):

SERTRALINE

Dosage:

50MG

forme pharmaceutique:

CAPSULE

Composition:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 50MG

Mode d'administration:

ORAL

Unités en paquet:

250

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

CANCELLED POST MARKET

Date de l'autorisation:

2011-02-28

Résumé des caractéristiques du produit

PRODUCT MONOGRAPH
Pr
PHL-SERTRALINE
(Sertraline hydrochloride capsules)
25 mg, 50 mg and 100 mg
Sertraline, as sertraline hydrochloride
Antidepressant / Antipanic / Antiobsessional Agent
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Revision:
July 11, 2013
Submission Control No: 166014
Pr
_phl-SERTRALINE Product Monograph _
_Page 2 of 47_ PRODUCT MONOGRAPH
PR
PHL-SERTRALINE
(Sertraline hydrochloride Capsules)
25 mg, 50 mg and 100 mg
Sertraline, as sertraline hydrochloride
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 bioavailab