NU-SERTRALINE CAPSULES

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

متاح من:

NU-PHARM INC

ATC رمز:

N06AB06

INN (الاسم الدولي):

SERTRALINE

جرعة:

25MG

الشكل الصيدلاني:

CAPSULE

تركيب:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

ملخص المنتج:

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

الوضع إذن:

CANCELLED POST MARKET

تاريخ الترخيص:

2012-09-04

خصائص المنتج

0
PRODUCT MONOGRAPH
NU-SERTRALINE
Sertraline Hydrochloride Capsules
Equivalent to 25, 50 and 100 mg Sertraline
Antidepressant / Antipanic / Antiobsessional Agent
NU-PHARM INC.
DATE OF PREPARATION:
50 Mural Street, Units 1 & 2
January 2, 2003
Richmond Hill, Ontario
DATE OF REVISION:
L4B 1E4 July 28, 2005
_Control # 096152_
1
PRODUCT MONOGRAPH
NU-SERTRALINE
Sertraline Hydrochloride Capsules
Equivalent to 25, 50 and 100 mg
THERAPEUTIC CLASSIFICATION
Antidepressant – Antipanic – Antiobsessional Agent
ACTIONS AND CLINICAL PHARMACOLOGY
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 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
:
g/mL occurring between 6 to 8 hours post-dose. The area under the
plasma
concentration time curve is 2.8 mg
q
hr/L. For desmethylsertraline, C
max
is 0.14
:
g/mL, the half-life
65 hours and the area under the curve 2.3 mg
q
hr/L. Following single or multiple oral once-daily
2
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 NU-
SERT