SERTRALINE CAPSULE

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Disponible desde:

MELIAPHARM INC

Código ATC:

N06AB06

Designación común internacional (DCI):

SERTRALINE

Dosis:

100MG

formulario farmacéutico:

CAPSULE

Composición:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 100MG

Vía de administración:

ORAL

Unidades en paquete:

100/250

tipo de receta:

Prescription

Área terapéutica:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0123417002; AHFS:

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2014-06-25

Ficha técnica

PRODUCT MONOGRAPH
Pr
SERTRALINE
(Sertraline hydrochloride capsules)
25 mg, 50 mg and 100 mg
Sertraline, as sertraline hydrochloride
Antidepressant / Antipanic / Antiobsessional Agent
MELIAPHARM INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Revision:
July 11, 2013
Submission Control No: 166018
Pr
_SERTRALINE Product Monograph _
_Page 2 of 47_ PRODUCT MONOGRAPH
PR
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 bioavailability by