DOM-SERTRALINE CAPSULE

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

זמין מ:

DOMINION PHARMACAL

קוד ATC:

N06AB06

INN (שם בינלאומי):

SERTRALINE

כמות:

100MG

טופס פרצבטיות:

CAPSULE

הרכב:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 100MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

leaflet_short:

Active ingredient group (AIG) number: 0123417002; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2002-05-31

מאפייני מוצר

PRODUCT MONOGRAPH
Pr
DOM-SERTRALINE
Sertraline Hydrochloride Capsules
25 mg, 50 mg and 100 mg
Sertraline (as sertraline hydrochloride)
ANTIDEPRESSANT / ANTIPANIC / ANTIOBSESSIONAL AGENT
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
May 15, 2018
Submission Control No: 215667
_Dom-SERTRALINE Product Monograph _
_Page 2 of 52_
PRODUCT MONOGRAPH
PR
DOM-SERTRALINE
Sertraline Hydrochloride Capsules
25 mg, 50 mg and 100 mg
Sertraline (as sertraline hydrochloride)
THERAPEUTIC CLASSIFICATION
Antidepressant - Antipanic - Antiobsessional Agent
ACTION 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
downregulates 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
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 appe