DESTIQ ER 50 MG TABLETS

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DESVENLAFAXINE SUCCINATE MONOHYDRATE

Boleh didapati daripada:

GENPHARMA SDN. BHD

INN (Nama Antarabangsa):

DESVENLAFAXINE SUCCINATE MONOHYDRATE

Unit dalam pakej:

14 x 2 Tablets

Dikeluarkan oleh:

Alembic Pharmaceuticals Limited (Formulation Division)

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP_
)
DESTIQ ER TABLETS
Desvenlafaxine Extended Release Tablets (50 mg, 100 mg)
WHAT IS IN THIS LEAFLET
1.
What DESTIQ is used for
2.
How DESTIQ works
3.
Before you use DESTIQ
4.
How to use DESTIQ
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of DESTIQ
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT DESTIQ IS USED FOR
DESTIQ
is
used
in
the
treatment
of
major depressive disorder (MDD).
HOW DESTIQ WORKS
DESTIQ
belongs
to
a
class
of
medications
called
serotonin-
noradrenaline
reuptake
inhibitors
(SNRIs).
Serotonin
and
noradrenaline
are
chemical
messengers
that
allow
certain
nerves
in
the
brain
to
work.
DESTIQ
tablets
increase
the
level
of
these two messengers. Experts think this
is how it helps to restore your feeling of
wellness.
BEFORE YOU USE DESTIQ
-
_When you must not use it _
_ _
Do not take DESTIQ
•
if you are allergic to desvenlafaxine,
venlafaxine
or
any
of
the
other
ingredients of this medicine
•
if you are also taking, or have taken
within the last 14 days, any medicines
known
as
Monoamine
oxidase
inhibitors
(MAOIs),
used
to
treat
depression
or
Parkinson’s
disease.
Taking
a
reversible
MAOI
together
with DESTIQ or in whom intravenous
methylene blue has been administered
can
cause
serious
or
even
life-
threatening
side
effects.
Also,
you
must wait at least 7 days after you stop
taking DESTIQ before you take any
MAOI.
_Pregnancy and lactation _
_ _
You
should
use
DESTIQ
only
after
discussing the potential benefits and the
potential
risks
to
your
unborn
child
with your doctor.
DESTIQ crosses the human placenta.
If you are taking this medicine during
pregnancy,
your
baby
may
not
feed
properly,
have
trouble
breathing,
or
may
encounter
prolonged
hospitalization. If your baby has these
symptoms when it is born and you are
concerned,
contact
your
doctor
who
will be able to advise you.
Consuming DESTIQ during pregnancy
may
cause
high
blood
pressure,
sometimes
associated
with
flui

Ciri produk

150 mm
Front Side
480 mm
1.
NAME OF THE MEDICINAL PRODUCT
Destiq ER 50mg Tablet
Destiq ER 100mg Tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Desvenlafaxine Succinate Monohydrate 75.87 mg is equivalent to
Desvenlafaxine
50mg
Desvenlafaxine Succinate Monohydrate 151.77mg is equivalent to
Desvenlafaxine
100mg
3.
PHARMACEUTICAL FORM
Destiq ER 50mg Tablet
Light pink colored, round, biconvex, film coated tablets, debossed
with '50' on one
side and plain on other side
Destiq ER 100mg Tablet
Dark brown to red colored, round, biconvex film coated tablets,
debossed with '100'
on one side and plain on other side
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Desvenlafaxine succinate, a selective serotonin and norepinephrine
reuptake
inhibitor (SNRI), is indicated for the treatment of major depressive
disorder (MDD).
The efficacy of Desvenlafaxine succinate has been established in four
8-week,
placebo controlled studies of outpatients who met DSM-IV criteria for
major
depressive disorder.
A major depressive episode (DSM-IV) implies a prominent and relatively
persistent
(nearly every day for at least 2 weeks) depressed or dysphoric mood
that usually
interferes with daily functioning, and includes at least 5 of the
following 9 symptoms:
depressed mood, loss of interest in usual activities, significant
change in weight
and/or appetite, insomnia or hypersomnia, psychomotor agitation or
retardation,
increased fatigue, feelings of guilt or worthlessness, slowed thinking
or impaired
concentration, or a suicide attempt or suicidal ideation.
The efficacy of Desvenlafaxine succinate in maintaining a response in
major
depressive disorder for up to 24 weeks following 12 weeks of acute
treatment was
demonstrated in a placebo-controlled trial. Nevertheless, the
physician who elects
to use Desvenlafaxine succinate for extended periods, i.e., beyond 9
months,
should continue to periodically re-evaluate the long-term usefulness
of the drug for
the individual patients.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_MAJOR DEPRESSIVE DIS