Apo-Sertraline 50 mg Capsules

País: Malasia

Idioma: inglés

Fuente: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Ingredientes activos:

SERTRALINE HYDROCHLORIDE

Disponible desde:

PHARMAFORTE (MALAYSIA) SDN. BHD.

Designación común internacional (DCI):

SERTRALINE HYDROCHLORIDE

Unidades en paquete:

100Capsule Capsules

Fabricado por:

APOTEX INC

Información para el usuario

NOT FOUND
The requested URL /front-end/attachment/681/pharma/240256/Please refer
to E12(6).pdf was not found on this server.

Ficha técnica

APO-SERTRALINE
SERTRALINE HYDROCHLORIDE CAPSULES
EQUIVALENT TO 50MG SERTRALINE
ANTIDEPRESSANT
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
dose,
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.
Pharmacokinetics
Following multiple oral once-daily doses of 200 mg, the mean
peak plasma concentration (C
max
) of sertraline is 0.19 µg/ml
occurring between 6 to 8 hours post-dose. 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 proportionally 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
APO-SERTRALINE
(sertraline
hydrochloride) be administered with meals.
Sertraline is extensively metabolized to N-desmethylsertraline,
which shows negligible pharmacological activity. Both sertraline
and N-desmethylsertraline undergo oxidative deamination and
subsequent
reduction,
hydroxylation
and
glucuronide
conjugation. Biliary excretion of metabolites is significant.
Approximately 98% of sertraline is plasma protein bound. The
interactions between sertraline and other highly protein bound
drugs have not been fully evaluated (see PRECAUTIONS).
The pharmacokinetics of sertraline itself appears to be similar in
young
and
elderly
subjects.
Plasma
levels
of
N-
desmethylsertraline
show
a
3-fold
elevation
in
the
elderly
following multiple dosing, however, th