Aurasert 50mg Tablets

Land: Malaysia

Språk: engelska

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

Aktiva substanser:

SERTRALINE HYDROCHLORIDE

Tillgänglig från:

UNIMED SDN BHD

INN (International namn):

SERTRALINE HYDROCHLORIDE

Enheter i paketet:

28Tablet Tablets; 100 Tablet Tablets

Tillverkad av:

Aurobindo Pharma Limited (Unit III),

Bipacksedel

AURASERT TABLETS
Sertraline Tablets (50mg, 100mg)
1
_Consumer Medication Information Leaflet (RiMUP)_
WHAT IS IN THIS LEAFLET
1.
What Aurasert is used for
2.
How Aurasert works
3.
Before you use Aurasert
4.
How to use Aurasert
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Aurasert
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT AURASERT IS USED FOR
•
For
the
treatment
of
symptoms
of
depressive
illness
including
accompanying symptoms of anxiety. It
is also indicated in preventing relapse
of the initial episode of depression or
recurrence
of
further
depressive
episodes
including
accompanying
symptoms of anxiety.
•
In
the
treatment
of
obsessions
(persistent,
obsessive
thoughts)
and
compulsions (uncontrollable, repetitive
behavior)
in
patients
with
obsessive
compulsive disorder (OCD).
•
For the treatment of panic disorder with
or without agoraphobia (fear of public
or open spaces).
HOW AURASERT WORKS
Aurasert contains the active ingredient
Sertraline
and
is
one
of
a
group
of
medicines called Selective Serotonin Re-
uptake Inhibitors (SSRIs); Serotonin is
one of the chemicals in your brain which
helps
control
your
mood.
Sertraline
blocks the reabsorption of serotonin by
the nerve cells, thereby increasing the
amount of serotonin in your brain.
BEFORE YOU USE AURASERT
-
_When you must not use it _
Do not take sertraline if:
•
You are allergic to sertraline or any
of
the
other
ingredients
of
this
medicine
(see
section
PRODUCT
DESCRIPTION
).
•
You are taking or have recently taken
medicines called monoamine oxidase
inhibitors
(MAOIs,
including
selegiline
and
moclobemide)
or
MAOI like drugs (such as linezolid).
•
Aurasert
should
not
be
used
concomitantly
to
patients
taking
monoamine oxidase inhibitors, while
switching from an MAOI to sertraline
or vice-versa, a washout period of at
least 14 days should elapse.
•
Do
not
take
Aurasert
if
you
are
currently taking pimozide.
Taking
Sertaline
with
a
MAOI
may
cause
a
serious,
fatal
reaction
wit

Produktens egenskaper

D3 PACKAGE INSERT
Aurasert 50 (Sertraline Tablets 50mg)
Aurasert 100 (Sertraline Tablets 100mg)
DESCRIPTION AND COMPOSITION:
AURASERT 50
White coloured, biconvex, capsule shaped, film coated tablets debossed
with 'A' on one side
and with a score line in between '8' and '1' on the other side.
Each film-coated tablet contains: Sertraline hydrochloride equivalent
to sertraline 50mg
AURASERT 100
White coloured, biconvex, capsule shaped film coated tablets debossed
with 'A' on one side
and '82' on the other side.
Each film-coated tablet contains: Sertraline hydrochloride equivalent
to sertraline 100mg
PHARMACODYNAMICS:
Sertraline is a potent and selective inhibitor of neuronal serotonin
(5-HT) reuptake. It has
only a weak effect on Neuronal uptake of nor-epinephrine and dopamine.
Sertraline's
inhibition of serotonin reuptake enhances serotonergic transmission.
_In vitro _studies have shown that sertraline has no significant
affinity for adrenergic,
muscarinic, cholinergic, gamma aminobutyric acid (GABA), dopaminergic,
serotonergic
(5HT1A, 5HT1B, 5HT2) histaminergic or benzodiazepine receptors.
PHARMACOKINETICS
The gastrointestinal absorption of sertraline is slow but consistent.
Sertraline undergoes
extensive first pass metabolism in the liver. The bioavailability is
slightly increased if
sertraline is taken with food. Mean peak plasma concentrations of
about 20-55 mcg/l occur
between 4.5-8.4 hours after administration of a single 100mg dose.
Sertraline is
approximately 98% bound to plasma proteins. Both sertraline and its
metabolites are
extensively distributed into tissues. The metabolite
n-desmethylsertraline exhibits only
about 1/8 of its activity. It does not contribute to the
antidepressant activity or toxicity of
the parent compound. Both sertraline and its metabolite undergo
oxidative deamination
and subsequent reduction, hydroxylation and glucuronide conjugation.
Only 0.2% of the
unchanged drug is excreted through the kidneys. The elimination
half-life of sertraline is 24
to 26 hours. The pharmacokinetics of