NU-SERTRALINE CAPSULES

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

제공처:

NU-PHARM INC

ATC 코드:

N06AB06

INN (국제 이름):

SERTRALINE

복용량:

25MG

약제 형태:

CAPSULE

구성:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2012-09-04

제품 특성 요약

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