SANDOZ SERTRALINE CAPSULE

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

から入手可能:

SANDOZ CANADA INCORPORATED

ATCコード:

N06AB06

INN（国際名）:

SERTRALINE

投薬量:

25MG

医薬品形態:

CAPSULE

構図:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 25MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

製品概要:

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

認証ステータス:

CANCELLED POST MARKET

承認日:

2019-07-15

製品の特徴

_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