Glevate Cream 0.05%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

CLOBETASOL PROPIONATE

Boleh didapati daripada:

Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.

INN (Nama Antarabangsa):

CLOBETASOL PROPIONATE

Unit dalam pakej:

15gm mcg/mL

Dikeluarkan oleh:

GLENMARK PHARMACEUTICALS LTD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
GLEVATE
_™_
_ _
CREAM
_ _
Clobetasol Propionate (0.05% w/w)
1
WHAT IS IN THIS LEAFLET
1. What Glevate Cream is used for
2. How Glevate Cream works
3. Before you use Glevate Cream
4. How to use Glevate Cream
5. While you are using it
6. Side effects
7. Storage and Disposal of Glevate
Cream
8. Product Description
9.
Manufacturer
and
Product
Registration Holder
10. Date of revision
WHAT GLEVATE CREAM IS USED FOR
Glevate Cream is used in short courses
for the treatment of more resistant skin
problems
such
as
psoriasis,
severe
forms
of
eczema,
lichen
planus,
discoid lupus erythematosus and when
milder topical corticosteroids cannot
treat the skin condition effectively.
HOW GLEVATE CREAM WORKS
Glevate Cream contains a medicine
called clobetasol propionate. It is in a
class
of
medications
called
corticosteroids.
Topical
corticosteroids
are
used
to
help
reduce
inflammation
in
the
affected area which helps to reduce
redness and itchiness on the skin.
BEFORE YOU USE GLEVATE CREAM
_- When you must not use it _
Do not use Glevate Cream
•if you are allergic (hypersensitive)
to clobetasol propionate or any of the
other ingredients of this medicine
•to treat any of the following skin
problems, it could make them worse:
-acne
-severe
flushing
of
skin
on
and
around your nose.
-spotty
red
rashes
around
your
mouth.
-itching around your anus or genitals
(penis or vagina)
-infected skin (unless the infection is
being treated with an anti-infective
medicine at the same time)
-widespread
thick,
scaly
patches
psoriasis.
Do not use if any of the above apply
to you. If you are not sure, talk to
your
doctor
or
pharmacist
before
using Glevate Cream.
_- Before you start to use it _
Please
consult
your
doctor
or
pharmacist
before
using
Glevate
Cream
_-Use in Pregnancy and Lactation _
Topical steroids should not be used in
large amounts or for prolonged period
in pregnancy.
Because many medicines are excreted
in
human
milk,
caution
should
be
exercised
when
administered
to
a
nursing wo

Ciri produk

_For the use only of a Registered Medical Practitioner or a Hospital
or a Laboratory_
PRODUCT REGISTRATION HOLDER:
Glenmark Pharmaceuticals (Malaysia)
Sdn Bhd (660397-W)
D-31-02, Menara Suezcap 1,
No. 2, Jalan Kerinchi,
59200 Kuala Lumpur, Malaysia
PE00000 MY
PE00000 MY
PHARMACOKINETICS
Clobetasol Propionate is absorbed through the skin in varying
proportions of the
applied dose depending upon the severity of the damage to the stratum
corneum
barrier that has resulted from the skin disease being treated. It is
probable that no
more than 5% of the applied dose is absorbed from normal skin but much
may be
absorbed from inflamed skin or under occlusion which greatly increases
the
permeability of the stratum corneum.
INDICATIONS
Glevate Cream is of particular value when used in short courses for
the treatment of
more resistant dermatoses such as psoriasis, (excluding widespread
plague
psoriasis) recalcitrant eczema, lichen planus, discoid lupus
erythematosus and
other
skin
conditions
which
do
not
respond
satisfactorily
to
less
active
corticosteroids.
CONTRAINDICATIONS
It is contraindicated in patients who are hypersensitive to any of the
ingredients
contained in it.
As with other topical corticosteroids, this product should not be used
in rosacea,
acne, perioral dermatitis, primary cutaneous viral infections (herpes
simplex,
chickenpox), fungal infections (candidiasis, tinea) and bacterial
infections.
SIDE EFFECTS / ADVERSE REACTIONS
Prolonged and intensive treatment with highly active corticosteroid
preparations
may cause local atrophic changes, such as thinning, striae, and
dilatation of the
superficial blood vessels, particularly when occlusive dressings are
used or when
skin folds are involved.
There are reports of pigmentation changes and hypertrichosis with
topical steroids.
In rare instances, treatment of psoriasis with corticosteroids (or its
withdrawal) is
thought to have provoked the pustular form of the disease.
Glevate Cream is usually well tolerated, but if signs of
hypersensitivity appear,
application s