DULOX 30 (Duloxetine Hydrochloride Delayed Release Capsules 30mg)

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

DULOXETINE HYDROCHLORIDE

Boleh didapati daripada:

CAMBER LABORATORIES SDN. BHD.

INN (Nama Antarabangsa):

DULOXETINE HYDROCHLORIDE

Unit dalam pakej:

10x7s Capsules; 4x7s Capsules

Dikeluarkan oleh:

Hetero Labs Limited

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
DULOX 30/60 (DULOXETINE HYDROCHLORIDE DELAYED
RELEASE CAPSULES 30MG / 60MG)
Duloxetine hydrochloride (30mg/60 mg)
WHAT IS IN THIS LEAFLET
1.
What
_DULOX 30 & 60 _
is used for
2.
How
_DULOX 30 & 60 _
works
3.
Before you use
_DULOX 30 & 60 _
4.
How to use
_DULOX 30 & 60 _
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
_DULOX 30 _
_& 60 _
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
WHAT _DULOX 30 & 60 _IS USED FOR
Duloxetine is used to treat major
depressive disorder and general anxiety
disorder.
Duloxetine
is
also
used
to
treat
pain
caused by nerve damage in people with
diabetes (diabetic neuropathy).
HOW _DULOX 30 & 60 _ WORKS
Duloxetine affects chemicals in the brain
that may become unbalanced and cause
depression.
BEFORE YOU USE _DULOX 30 & 60 _
_- When you must not use it _
_Pregnancy and lactation _
Do not take
_DULOX 30 & 60 _
if you
are pregnant, trying to get pregnant or
think you may be pregnant.
Do not take
_DULOX 30 & 60 _
if you
are breast-feeding. Ask your doctor or
pharmacist
for
advice
before
taking
any medicine.
-
_Before you start to use it _
_ _
Do not use this medication if you are
allergic
to
duloxetine,
or
if
you
have
untreated
or
uncontrolled
high
blood
pressure
.
DO
NOT
USE
DULOXETINE
IF
YOU
HAVE
TAKEN AN MAO INHIBITOR IN THE PAST 14
DAYS.
A dangerous drug interaction could
occur.
MAO
inhibitors
include
furazolidone,
isocarboxazid,
linezolid,
phenelzine,
rasagiline,
selegiline,
and
tranylcypromine. After you stop taking
duloxetine, you must wait at least 5 days
before you start taking an MAOI.
To make sure duloxetine is safe for you,
tell your doctor if you have:
•
liver or kidney disease;
•
seizures or epilepsy;
•
a bleeding or blood clotting
disorder;
•
high blood pressure;
•
glaucoma;
•
bipolar
disorder
(manic
depression);
•
a history of drug abuse or
suicidal thoughts
Some young people have thoughts about
suicide
when
first
taking
an
antidepressant. Your d

Ciri produk

DULOXETINE HYDROCHLORIDE DELAYED RELEASE CAPSULES 30 & 60 MG
NAME OF THE PRODUCT
DULOX 30 (Duloxetine Hydrochloride Delayed Release Capsules 30 mg)
DULOX 60 (Duloxetine Hydrochloride Delayed Release Capsules 60 mg)
NAME AND STRENGTH OF ACTIVE INGREDIENT
Name : Duloxetine Hydrochloride Capsules Strength : 30 mg
Name : Duloxetine Hydrochloride Capsules Strength : 60 mg
PRODUCT DESCRIPTION
DULOX 30 (DULOXETINE HYDROCHLORIDE DELAYED RELEASE CAPSULES 30MG)
Opaque blue cap / Opaque white body size '3' hard gelatin capsules
imprinted with 'H' on cap and '191' on body with golden yellow ink,
filled with white to off
white colored pellets.
DULOX 60 (DULOXETINE HYDROCHLORIDE DELAYED RELEASE CAPSULES 60MG)
Opaque blue cap / Opaque green body size '1' hard gelatin capsules
imprinted with 'H' on cap and '192' on body with white ink, filled
with white to off white
colored pellets.
PHARMACODYNAMICS
Pharmacotherapeutic group: Other antidepressants. ATC code: N06AX21.
Mechanism of action
Duloxetine is a combined serotonin (5-HT) and noradrenaline (NA)
reuptake inhibitor. It weakly inhibits dopamine reuptake, with no
significant affinity for
histaminergic, dopaminergic, cholinergic, and adrenergic receptors. It
was reported that duloxetine dose-dependently increases extracellular
levels of
serotonin and noradrenaline in various brain areas.
Pharmacodynamic effects
Duloxetine normalised pain thresholds in several models of neuropathic
and inflammatory pain and attenuated pain behaviour in a model of
persistent pain.
The pain inhibitory action of duloxetine is believed to be a result of
potentiation of descending inhibitory pain pathways within the central
nervous system.
PHARMACOKINETICS
Duloxetine is administered as a single enantiomer. Duloxetine is
extensively metabolised by oxidative enzymes (CYP1A2 and the
polymorphic CYP2D6),
followed by conjugation. The pharmacokinetics of duloxetine
demonstrate large intersubject variability (generally 50-60%), partly
due to gender, age,
smoking status, and CYP2D6 metaboliser status.