CLOBUTRATE CREAM 0.05% WW

Χώρα: Μαλαισία

Γλώσσα: Αγγλικά

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

Δραστική ουσία:

CLOBETASONE BUTYRATE

Διαθέσιμο από:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Διεθνής Όνομα):

CLOBETASONE BUTYRATE

Μονάδες σε πακέτο:

50 x 15 gm

Κατασκευάζεται από:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Φύλλο οδηγιών χρήσης

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
CLOBUTRATE CREAM 0.05% W/W
Clobetasone Butyrate 0.05% w/w
WHAT IS IN THIS LEAFLET:
1.
What Clobutrate Cream 0.05% w/w
is used for
2.
How Clobutrate Cream 0.05% w/w
works
3.
Before you use
Clobutrate
Cream
0.05% w/w
4.
How
to
use
Clobutrate
Cream
0.05% w/w
5.
While you are using it
6.
Side Effects
7.
Storage and Disposal of Clobutrate
Cream 0.05% w/w
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT CLOBUTRATE CREAM 0.05% W/W IS
USED FOR
Clobutrate Cream relieves the symptoms
of certain skin problems. These include:

atopic eczema

skin
inflammation
including
seborrhoeic
dermatitis
(scaly
patches,
red
skin
and
stubborn
dandruff
that
mainly
affect
the
scalp) and a type of skin reaction
triggered
by
exposure
to
sunlight
(photodermatitis)

skin
rash
due
to
allergy
or
a
substance
that
irritates
your
skin
(irritant
and
allergic
contact
dermatitis)

nappy rash

inflammation of the outer ear canal

prurigo nodularis (itchy nodules on
the skin)

insect bites
HOW
CLOBUTRATE
CREAM
0.05%
W/W
WORKS?
Clobutrate
cream
contains
a
medicine
called clobetasone butyrate. It belongs to
a group of medicines called steroids. It
helps to reduce swelling and irritation.
BEFORE
YOU
USE
CLOBUTRATE
CREAM
0.05% W/W
-
_When you must not use it _

If
you
are
allergic
(hypersensitive) to Clobetasone
Butyrate
or
any
of
the
other
ingredients of Clobutrate Cream
0.05% w/w.

If you are planning to use it for
the
treatment
of
untreated
cutaneous
infection,
rosacea
(redness of skin), acne vulgaris,
pruritus without inflammation.
-
_Before you start to use it _
You must tell your doctor if:

you have allergies to any medicine
which you have taken previously to
treat your current condition.

you are pregnant, trying to become
pregnant or breast-feeding.
_Pregnancy and breastfeeding _
Safety of its use during prenancy and
breastfeeding have not been established.
Women
who
are
pregnant
and
breastfeeding
should
consult
a
doc

Αρχείο Π.Χ.Π.

7218-00
CLOBUTRATE CREAM 0.05% W/W
NAME AND STRENGTH OF ACTIVE INGREDIENT(S):
Clobetasone Butyrate 0.05% w/w
PRODUCT DESCRIPTION:
Clobutrate Cream 0.05% w/w : A smooth white cream 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
mechanism 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 absoprtion 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._ _
COMPOSITION:
Clobetasone Butyrate 0.05% w/w:
Each gram of cream contains 0.5mg of Clobetasone Butyrate
INDICATION:
Clobutrate Cream is a moderately potent topical corticosteroid
indicated for adults, elderly, children and infants for the
relief of the inflammatory and pruritic manifestations of steroid
responsive dermatoses.
These include the following:
-
Atopic d