PHL-SERTRALINE CAPSULE

Country: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Fáanlegur frá:

PHARMEL INC

ATC númer:

N06AB06

INN (Alþjóðlegt nafn):

SERTRALINE

Skammtar:

25MG

Lyfjaform:

CAPSULE

Samsetning:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

100/250

Gerð lyfseðils:

Prescription

Lækningarsvæði:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Vörulýsing:

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

Leyfisstaða:

CANCELLED PRE MARKET

Leyfisdagur:

2010-06-30

Vara einkenni

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