CLOBESOL OINTMENT 0.05%ww

Country: Malaysia

Bahasa: Inggeris

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

Beli sekarang

Risalah maklumat Risalah maklumat (PIL)
14-01-2018
Ciri produk Ciri produk (SPC)
14-01-2018

Bahan aktif:

CLOBETASOL PROPIONATE

Boleh didapati daripada:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

CLOBETASOL PROPIONATE

Unit dalam pakej:

15 gm; 15 gm

Dikeluarkan oleh:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

                                _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
CLOBESOL OINTMENT 0.05% W/W
Clobetasol Propionate 0.05% w/w
WHAT IS IN THIS LEAFLET:
1.
What Clobesol Ointment 0.05% w/w
is used for
2.
How Clobesol Ointment 0.05% w/w
works
3.
Before you use Clobesol Ointment
0.05% w/w
4.
How
to
use
Clobesol
Ointment
0.05% w/w
5.
While you are using it
6.
Side Effects
7.
Storage
and
Disposal
of
Clobesol
Ointment 0.05% w/w
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT CLOBESOL OINTMENT 0.05% W/W IS
USED FOR
It
is
used
in
short
courses
for
the
treatment of more resistant dermatoses
such as psoriasis, eczemas, lichen planus,
discoid
lupus
erythematosus
and
other
conditions
which
do
not
respond
satisfactorily to less active steroids.
HOW
CLOBESOL
OINTMENT
0.05%
W/W
WORKS
Clobesol Ointment is a type of topical
steroids. “Topical” means it is put on the
skin. It works by reducing redness and
itchiness of certain skin problems.
BEFORE
YOU
USE
CLOBESOL
OINTMENT
0.05% W/W
-
_When you must not use it_
If you are planning to use it for the
treatment of:-

untreated
cutaneous
infections
caused by fungi or bacteria,

viral skin infections like herpes
simplex and chicken pox.

Using it around the anus (back
passage)
or
genitals
(private
parts)

Using it on the face where the
skin thins easily

Using it on a child under one
year of age

Letting it get into the eyes as
glaucoma (increased pressure in
the eyes) might occur.

Using it for long periods of time.
You
should
discuss
with
your
doctor if no improvement is seen
after 4 weeks of treatment.
-
_Before you start to use it _
You must tell your doctor if:

You are allergic (hypersensitive)
to Clobetasol Propionate or any
of
the
other
ingredients
of
Clobesol Ointment 0.05% w/w.

You have acne or a condition
called rosacea (severe flushing
of the skin on and around the
nose)
or
perioral
dermatitis
(spotty
red
rash
around
the
mouth).

You have a skin condition called
Psoriasis.

you
are
pregnant,
trying
to

                                
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Ciri produk

                                7199-00
CLOBESOL OINTMENT 0.05% W/W
NAME AND STRENGTH OF ACTIVE INGRDIENT(S):
Clobetasol Propionate 0.05% w/w
PRODUCT DESCIPTION:
A semi-transparent, unctuous off -white ointment in aluminium tubes
with white caps.
PHARMACODYNAMICS:
MECHANISM OF ACTION
Topical corticosteroids act as anti-inflammatory agents via multiple
mechanisms to inhibit late phase allergic
reactions including decreasing the density of mast cells, decreasing
chemotaxis and activation of eosinophils,
decreasing
cytokine
production
by
lymphocytes,
monocytes,
mast
cells
and
eosinophils,
and
inhibiting
the
metabolism of arachidonic acid.
PHARMACODYNAMIC EFFECTS
Topical corticosteroids have anti-inflammatory , antipruritic, and
vasoconstrictive properties.
PHARMACOKINETICS:
ABSORPTION
Topical corticosteroids can be systemically absorbed from intact
healthy skin. The extent of percutaneous absorption
of topical corticosteroids is determined by many factors, including
the vehicle and the integrity of the epidermal
barrier.
Occlusion,
inflammation
and/or
other
disease
processes
in
the
skin
may
also
increase
percutaneous
absorption.
DISTRIBUTION
The use of pharmacodynamic endpoints for assessing the systemic
exposure of topical corticosteroids is necessary
due to the fact that circulating levels are well below the level of
detection.
METABOLISM
Once absorbed through the skin, topical corticosteroids are handled
through pharmacokinetic pathways similar to
systemically administered corticosteroids. They are metabolised,
primarily in the liver.
ELIMINATION
Topical corticosteroids are excreted by the kidneys. In addition, some
corticosteroids and their metabolites are also
excreted in the bile.
INDICATION:
Clobetasol propionate is a very active topical corticosteroid which is
of particular value when used in short courses
for the treatment of more resistant dermatoses such as psoriasis
(excluding widespread plaque psoriasis), recalcitrant
eczemas lichen planus, discoid lupus erythematosus, and other
conditions which do not respond satisfactorily to less
a
                                
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