DIPROSONE CREAM 0.05% W/W

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

BETAMETHASONE DIPROPIONATE

Boleh didapati daripada:

MERCK SHARP & DOHME (MALAYSIA) SDN BHD

INN (Nama Antarabangsa):

BETAMETHASONE DIPROPIONATE

Unit dalam pakej:

5gm mcg/mL; 15gm mcg/mL; 450gm mcg/mL; 15 gm mcg/mL

Dikeluarkan oleh:

PT MERCK SHARP DOHME PHARMA Tbk

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
DIPROSONE
® CREAM
_ _
Betamethasone dipropionate (0.05% w/w)
__________________________________________________________________________________________________________
1
WHAT IS IN THIS LEAFLET
1.
What
_DIPROSONE CREAM_
is
used for
2.
How
_DIPROSONE CREAM_
works
3.
Before you use
_DIPROSONE _
_CREAM_
4.
How to use
_DIPROSONE CREAM_
5.
While you are using
_DIPROSONE _
_CREAM_
6.
Side effects
7.
Storage and Disposal of
_DIPROSONE CREAM_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _DIPROSONE CREAM_ IS USED
FOR
In adults and children,
_DIPROSONE _
_CREAM _
is used to treat skin
problems, including eczema, and all
types of dermatitis and psoriasis of the
scalp, hands and feet.
Eczema is a common skin disease,
which causes itchy skin condition
with redness, swelling, oozing of
fluid, and crusting which may lead to
scaling. Dermatitis is inflammation of
the skin. Psoriasis is a skin disease in
which raised, rough, reddened areas
covered with dry, fine silvery scales
develop on the elbows, knees, scalp
and other parts of the body.
HOW _DIPROSONE CREAM_ WORKS
_DIPROSONE CREAM_
contains the
active ingredient betamethasone
dipropionate.
Betamethasone dipropionate belongs
to a group of medicines called topical
corticosteroids which are used on the
surface of the skin to reduce the
redness and itchiness caused by
certain skin problems.
BEFORE YOU USE _DIPROSONE _
_CREAM_
_- When you must not use it _
DO NOT USE _DIPROSONE CREAM_
•
If you are allergic to
betamethasone dipropionate or
other steroids or any of the other
ingredients in this medicine
(listed in
_“INGREDIENT”_
).
_- Before you start to use it _
Talk to your doctor or pharmacist
before using
_DIPROSONE CREAM_
.
PREGNANCY, BREAST-FEEDING AND
FERTILITY
If you are pregnant or breast-feeding,
think you may be pregnant or are
planning to have a baby, ask your
doctor or pharmacist for advice before
taking this medicine.
_ _
_- Taking other medicines _
Tell your do

Ciri produk

LPC -MK1460 -DPL -MTL -082017
DIPROSONE ® Cream
Brand of betamethasone dipropionate
FOR DERMATOLOGICAL USE ONLY
Description: Betamethasone dipropionate, a synthetic fluorinated corticosteroid, has the
chemical name 9 -fluoro -16 -methylprednisolone -17, 21 -dipropionate.
DIPROSONE Cream provides in each gram 0.64 mg of betamethasone dipropionate,
equivalent to 0.5 mg (0.05%) of betamethasone in a hydrating, hypo -allergenic paraben free
cream base containing white petrolatum, mineral oil, cetomacrogol 1000, c etostearyl alcohol,
sodium phosphate monobasic dihydrate and phosphoric acid with chlorocresol as a
preservative.
Appearance:
Smooth, uniform white cream free from lumps and foreign matters.
Actions: DIPROSONE Cream is effective because of its anti -infla mmatory, antipruritic and
vasoconstrictive action. DIPROSONE Cream demonstrates these activities in a sustained
manner, thereby permitting twice a day or, in some cases, once -a-day application.
Preclinical information:
Carcinogenesis, Mutagenesis and Imp airment of Fertility: Long -term animal studies have not
been performed to evaluate the carcinogenic potential of betamethasone dipropionate or the
effect of fertility of to pically applied corticosteroids.
Betamethasone dipropionate was negative in the ba cterial mutagenicity assay ( Salmonella
typhimurium and Escherichia coli ), and in the mammalian cell mutagenicity assay
(CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration
assay, and equivocal in the in vivo mouse bone marrow micronucleus assay. This pattern of
response is similar to that of dexamethasone and hydrocortisone.
Betamethasone dipropionate had been shown to be fetotoxic (increased incidence of
resorptions) and teratogenic in rabbits when given by the intramuscula r route at doses of