PHL-SERTRALINE CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Commercializzato da:

PHARMEL INC

Codice ATC:

N06AB06

INN (Nome Internazionale):

SERTRALINE

Dosaggio:

100MG

Forma farmaceutica:

CAPSULE

Composizione:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 100MG

Via di somministrazione:

ORAL

Confezione:

250

Tipo di ricetta:

Prescription

Area terapeutica:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2011-05-31

Scheda tecnica

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