DOM-SERTRALINE CAPSULE

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

SERTRALINE (SERTRALINE HYDROCHLORIDE)

Disponível em:

DOMINION PHARMACAL

Código ATC:

N06AB06

DCI (Denominação Comum Internacional):

SERTRALINE

Dosagem:

50MG

Forma farmacêutica:

CAPSULE

Composição:

SERTRALINE (SERTRALINE HYDROCHLORIDE) 50MG

Via de administração:

ORAL

Unidades em pacote:

100

Tipo de prescrição:

Prescription

Área terapêutica:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Resumo do produto:

Active ingredient group (AIG) number: 0123417001; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2002-05-31

Características técnicas

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