VAN-SERTRALINE CAPSULE

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Tillgänglig från:

VANC PHARMACEUTICALS INC

ATC-kod:

N06AB06

INN (International namn):

SERTRALINE

Dos:

25MG

Läkemedelsform:

CAPSULE

Sammansättning:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

Administreringssätt:

ORAL

Enheter i paketet:

100/500

Receptbelagda typ:

Prescription

Terapiområde:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produktsammanfattning:

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

Bemyndigande status:

CANCELLED POST MARKET

Tillstånd datum:

2019-08-07

Produktens egenskaper

1
PRODUCT MONOGRAPH
Pr
VAN-SERTRALINE
Sertraline hydrochloride Capsules
25 mg, 50 mg and 100 mg sertraline (as sertraline hydrochloride)
Antidepressant / Antipanic / Antiobsessional Agent
MANUFACTURER AND DISTRIBUTOR:
Vanc Pharmaceuticals Inc.
Date of Preparation:
Building 152, 11782 River Road
September 22, 2014
Richmond, BC V6X 1Z7
www.vancpharm.com
Control# 177605
2
PRODUCT MONOGRAPH
PR
VAN-SERTRALINE
Sertraline hydrochloride Capsules
25 mg, 50 mg and 100 mg
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 down
regulates 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 capsules 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
recomme