EPIDUO 0.1% 2.5% GEL

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

ADAPALENE; BENZOYL PEROXIDE

Boleh didapati daripada:

ZUELLIG PHARMA SDN BHD

INN (Nama Antarabangsa):

ADAPALENE; BENZOYL PEROXIDE

Unit dalam pakej:

15 gm; 5 gm mcg/mL; 15 gm mcg/mL; 30 gm

Dikeluarkan oleh:

LABORATOIRES GALDERMA

Risalah maklumat

_Consumer Medication Information Leaflet (RiMUP) _
EPIDUO
®
GEL
Adapalene / Benzoyl peroxide (0.1%w/w / 2.5%w/w)
WHAT IS IN THIS LEAFLET
1.
What Epiduo Gel is used
for
2.
How Epiduo Gel works
3.
Before
you
use
Epiduo
Gel
4.
How to use Epiduo Gel
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Epiduo Gel
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT EPIDUO GEL IS USED FOR
Epiduo
Gel
is
used
for
the
treatment of acne.
HOW
EPIDUO
GEL
WORKS
Epiduo Gel combines two active
substances,
which
act
through
different,
but
complementary,
mechanisms of action.
ADAPALENE
:
Adapalene
is
a
chemically
stable, naphthoic acid derivative
with
retinoid-
like
activity.
Biochemical
and
pharmacological profile studies
have
demonstrated
that
adapalene acts in the pathology
of Acne vulgaris: it is a potent
modulator
of
cellular
differentiation and keratinisation
and
it
has
anti-
inflammatory
properties.
Mechanistically,
adapalene
binds to specific retinoic acid
nuclear
receptors.
Current
evidence suggests that topical
adapalene
normalizes
the
differentiation of
follicular
epithelial
cells
resulting
in
decreased
microcomedone
formation.
Adapalene
inhibits
the
chemotactic
(directional)
and chemokinetic (random)
responses
of
human
polymorphonuclear
leucocytes
in in vitro assay models; it also
inhibits
the
metabolism
of
arachidonic
acid
to
inflammatory mediators. In
vitro
studies
have
shown
inhibition of the AP-1 factors
and
the
inhibition
of
the
expression of toll like receptors
2. This profile suggests that the
cell
mediated
inflammatory
component of acne is reduced
by adapalene.
BENZOYL PEROXIDE
:
Benzoyl
peroxide
has
been
shown
to
have
antimicrobial
activity; particularly against P.
acnes,
which
is
abnormally
present
in
the
acne-affected
pilosebaceous unit. Additionally,
benzoyl
peroxide
has
demonstrated
exfoliative
and
keratolytic activities.
Benzoyl
peroxide
is
also
sebostatic,
counteracting
the
excessive
sebum
production
associated with acne.
BEFORE YOU USE EPIDUO

Ciri produk

POM only
For Topical Use only
Name of Medicinal Product
Epiduo 0.1%/2.5% gel
Active Ingredients
1g of gel contains:
Adapalene 1 mg (0.1%)
Benzoyl Peroxide 25 mg (2.5%)
Dosage Form
Gel
Product Description
A white to very pale yellow opaque gel
Pharmacodynamics
Pharmacotherapeutic group:
Anti-Acne Preparations for Topical Use
ATC code: D10AD53
Mechanism of action and Pharmacodynamic effects:
EPIDUO combines two active substances . which act
through different, but complementary, mechanisms of action.
-Adapalene:
Adapalene is a chemically stable, naphthoic
acid derivative with retinoid-like activity. Biochemical and
pharmacological profile studies have demonstrated that
adapalene acts in the pathology of Acne vulgaris: it is a
potent modulator of cellular differentiation and keratinisation
and it has anti-inflammatory properties. Mechanistically,
adapalene binds to specific retinoic acid nuclear receptors.
Current evidence suggests that topical adapalene normalizes
the differentiation of follicular epithelial cells resulting in
decreased microcomedone formation. Adapalene inhibits the
chemotactic (directional) and chemokinetic (random)
responses of human polymorphonuclear leucocytes in in
vitro assay models; it also inhibits the metabolism of
arachidonic acid to inflammatory mediators. In vitro studies
have shown inhibition of the AP-1 factors and the inhibition of
the expression of toll like receptors 2. This profile suggests
that the cell mediated inflammatory component of acne is
reduced by adapalene.
-
Benzoyl peroxide:
Benzoyl peroxide has been shown to
have antimicrobial activity; particularly against P. acnes,
which is abnormally present in the acne-affected
pilosebaceous unit. Additionally benzoyl peroxide has
demonstrated exfoliative and keratolytic activities.
Benzoyl peroxide is also sebostatic, counteracting the
excessive sebum production associated with acne.
Clinical efficacy of Epiduo in patients aged 12 years and
older:
The safety and efficacy of EPIDUO applied once daily for the
treatment of acne vul