RATIO-SERTRALINE CAPSULE

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Tillgänglig från:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

ATC-kod:

N06AB06

INN (International namn):

SERTRALINE

Dos:

25MG

Läkemedelsform:

CAPSULE

Sammansättning:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

Administreringssätt:

ORAL

Enheter i paketet:

100

Receptbelagda typ:

Prescription

Terapiområde:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produktsammanfattning:

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

Bemyndigande status:

CANCELLED POST MARKET

Tillstånd datum:

2014-09-19

Produktens egenskaper

PRODUCT MONOGRAPH
PR
RATIO-SERTRALINE
(SERTRALINE HYDROCHLORIDE CAPSULES)
25 MG, 50 MG & 100 MG
ANTIDEPRESSANT/ANTIPANIC/ANTIOBSESSIONAL AGENT
RATIOPHARM INC.
17 800 Lapointe
Mirabel, Quebec
Canada, J7J 1P3
Control No. : 136354
Date of Preparation:
May 09, 2002
Date of Revision:
February 19, 2010
Product Monograph – ratio-SERTRALINE
Page 2 of 57
PRODUCT MONOGRAPH
Pr
RATIO-SERTRALINE
(SERTRALINE HYDROCHLORIDE)
25 MG, 50 MG & 100 MG
CAPSULES
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
re-uptake 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- HT1 A, 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
Product Monograph – ratio-SERTRALINE
Page 3 of 57
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 bioavailabili