DERMOVATE OINTMENT 0.05%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOBETASOL PROPIONATE

Boleh didapati daripada:

GLAXOSMITHKLINE PHARMACEUTICAL SDN. BHD.

INN (Nama Antarabangsa):

CLOBETASOL PROPIONATE

Unit dalam pakej:

30 gm; 15gm0 mcg/mL; 100gm mcg/mL

Dikeluarkan oleh:

GLAXO WELLCOME OPERATIONS

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
DERMOVATE CREAM / OINTMENT
_ _
Clobetasol propionate (0.05% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Dermovate is used for
2.
How Dermovate works
3.
Before you use Dermovate
4.
How to use Dermovate
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of
Dermovate
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of Revision
WHAT DERMOVATE IS USED FOR
Dermovate Cream and Ointment
relieves the symptoms of certain
skin problems
•
frequently relapsing
eczemas
•
psoriasis (thickened patches
of inflamed, red skin, often
covered by silvery scales)
•
lichen planus (a skin disease
that causes itchy, reddish-
purple, flat-topped bumps
on the wrists, forearms or
lower legs)
•
discoid lupus erythematosus
(a disease of the skin most
often affecting the face, ears
and scalp causing scarring
and increased sensitivity of
the affected skin to
sunlight)
•
conditions which do not
respond satisfactorily to less
potent steroids.
For children over the age of
oneyear Dermovate Cream and
Ointment is used for dermatitis
that has not responded to milder
steroid creams or ointments.
HOW DERMOVATE WORKS
The name of your medicine is
Dermovate Cream and
Ointment. Dermovate Cream
and Ointment contains
clobetasol propionate which
belongs to a group of medicines
called steroids. Steroids help to
reduce redness, swelling and
irritation of the skin.
BEFORE YOU USE DERMOVATE
-
_When you must not use it _
Don’t use Dermovate Cream
and Ointment to treat any of the
following skin problems, it
could make them worse:
•
infected skin (unless the
infection is being treated
with an anti-infective
medicine at the same time)
•
acne
•
rosacea (a facial skin
condition where the nose,
cheeks, chin, forehead or
entire face are unusually
red, with or without tiny
visible blood vessels,
bumps (papules) or pus-
filled bumps (pustules))
•
rashes around the mouth
•
itchy skin which is not
inflamed
•
around the anus or genitals
(penis and vagina)
•

Ciri produk

CONFIDENTIAL
[GSK LOGO]
DERMOVATE
CLOBETASOL PROPIONATE
QUALITATIVE AND QUANTITATIVE COMPOSITION
_DERMOVATE _
Cream and Ointment contains Clobetasol
_ _
propionate 0.05 % w/w.
PRODUCT DESCRIPTION
_DERMOVATE_
Cream is a smooth white to off-white cream containing 0.05% w/w
Clobetasol 17-propionate in a water miscible cream base.
_DERMOVATE_
Cream also
contains Chlorocresol 0.075% w/w as preservative.
_DERMOVATE_
Ointment is a smooth white to off-white translucent ointment
containing
0.05% w/w Clobetasol 17-propionate in a paraffin base
.
CLINICAL INFORMATION
INDICATIONS
_ DERMOVATE_
is a very potent topical corticosteroid indicated for adults, elderly
and children
over 1 year for the relief of the inflammatory and pruritic
manifestations of steroid responsive
dermatoses.
These include the following:
-
Psoriasis (excluding widespread plaque psoriasis)
-
Recalcitrant dermatoses
-
Lichen planus
-
Discoid lupus erythematosus
-
Other conditions which do not respond satisfactorily to less potent
steroids.
DOSAGE AND ADMINISTRATION
Pharmaceutical form: Cream and Ointment
_ _
_OINTMENT _
Ointments are especially appropriate for dry, lichenified or scaly
lesions.
_CREAM _
Creams are especially appropriate for moist or weeping surfaces.
CONFIDENTIAL
ADULTS, ELDERLY AND CHILDREN OVER 1 YEAR
Apply thinly and gently rub in using only enough to cover the entire
affected area once or twice a
day for up to 4 weeks until improvement occurs, then reduce the
frequency of application or
change the treatment to a less potent preparation. Allow adequate time
for absorption after each
application before applying an emollient.
Repeated short courses of
_DERMOVATE_
may be used to control exacerbations.
In more resistant lesions, especially where there is hyperkeratosis,
the effect of
_DERMOVATE_
can be enhanced, if necessary, by occluding the treatment area with
polythene film.
Overnight occlusion only is usually adequate to bring about a
satisfactory response. Thereafter
improvement can usually be maintained by application without
occlusi