RAN-SERTRALINE CAPSULE

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Boleh didapati daripada:

RANBAXY PHARMACEUTICALS CANADA INC.

Kod ATC:

N06AB06

INN (Nama Antarabangsa):

SERTRALINE

Dos:

100MG

Borang farmaseutikal:

CAPSULE

Komposisi:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 100MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2022-10-21

Ciri produk

PRODUCT MONOGRAPH
PR
RAN™-SERTRALINE
Sertraline Hydrochloride Capsules
25 mg, 50 mg and 100 mg
Sertraline (as sertraline hydrochloride)
ANTIDEPRESSANT / ANTIPANIC / ANTIOBSESSIONAL AGENT
Ranbaxy Pharmaceuticals Canada Inc.
126 East Drive
Brampton, Ontario
L6T 1C1
Date of Revision:
June 13, 2018
Submission Control No.: 215979
RAN trademark owned by Sun Pharmaceutical Industries Ltd.
Pr
_RAN™-SERTRALINE Product Monograph _
_Page 2 of 52_
PRODUCT MONOGRAPH
PR
RAN™-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
d