BIO CLOBETATE CREAM 0.05%ww

Țară: Malaezia

Limbă: engleză

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

Ingredient activ:

CLOBETASOL PROPIONATE

Disponibil de la:

Top Biopharma Sdn Bhd

INN (nume internaţional):

CLOBETASOL PROPIONATE

Unități în pachet:

15 gm

Produs de:

POLIPHARM CO., LTD.

Prospect

Consumer Medication Information Leaflet (RiMUP)
1
BIO CLOBETATE CREAM 0.05%w/w
Clobetasol propionate (0.05% w/w)
What is in this leaflet
1.
What Bio Clobetate cream is
used for
2.
How Bio Clobetate cream works
3.
Before you use Bio Clobetate
cream
4.
How to use Bio Clobetate cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Bio Clobetate cream
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
What Bio Clobetate cream is used
for
Bio Clobetate cream
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 one
year Bio Clobetate cream is used
for dermatitis that has not
responded to milder steroid creams.
How Bio Clobetate cream works
The name of your medicine is
Bio Clobetate cream. Bio
Clobetate cream 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 Bio Clobetate
cream
-
When you must not use it
Don’t use Bio Clobetate cream
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

Caracteristicilor produsului

Font size: 10, Times New Roman
PACKAGE INSERT
BIO CLOBETATE CREAM 0.05%w/w
(Clobetasol Propionate 0.05%w/w)
Name and Strength of active ingredient
BIO CLOBETATE CREAM 0.05%w/w contains Clobetasol propionate 0.05%w/w.
Product description
BIO CLOBETATE CREAM 0.05%w/w is smooth, white, water soluble,
characteristic odor cream.
BIO CLOBETATE CREAM 0.05%w/w also contains Chlorocresol 0.1%w/w as
preservative.
Pharmacological properties
Pharmacodynamics
ATC code
D07AD Corticosteroids, very potent (group IV)
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.
Mean peak plasma clobetasol propionate concentrations of 0.63
nanograms/ml occurred in one study eight hours after the
second application (13 h after an initial application) of 30 g
clobetasol propionate 0.05 % ointment to normal individuals
with healthy skin. Following the application of a second dose of 30 g
clobetasol propionate cream 0.05 %, mean peak
plasma concentrations were slightly higher than the ointment and
occurred 10 h after application. In a separate study,
mean peak plasma concentrations of approximately 2.3 nanograms/ml and
4.6 nanograms/ml occurred respectively in
patients with psoriasis and eczema three hours after a single
application o