SANDOZ SERTRALINE CAPSULE

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

متاح من:

SANDOZ CANADA INCORPORATED

ATC رمز:

N06AB06

INN (الاسم الدولي):

SERTRALINE

جرعة:

50MG

الشكل الصيدلاني:

CAPSULE

تركيب:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 50MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100/250

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

ملخص المنتج:

Active ingredient group (AIG) number: 0123417001; AHFS:

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2019-10-01

خصائص المنتج

_Sandoz Sertraline _
_Page 1 of 51_
PRODUCT MONOGRAPH
Pr
SANDOZ SERTRALINE
(Sertraline hydrochloride)
25 mg, 50 mg and 100 mg Capsules as sertraline
Antidepressant / Antipanic / Antiobsessional Agent
Sandoz Canada Inc.
110 rue de Lauzon
Boucherville, QC, Canada
Date of Revision: March 6, 2020
J4B 1E6
Control number: 236370
_Sandoz Sertraline _
_Page 2 of 51_
Pr
SANDOZ SERTRALINE
(Sertraline hydrochloride)
25 mg, 50 mg and 100 mg capsules as sertraline
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
, and 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 mcg/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 mcg/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
recommended that Sandoz Sertrali