CORTISONE CREAM
Country: Մալայզիա
language: անգլերեն
source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
PIL active_ingredient:
HYDROCORTISONE ACETATE
MAH:
DYNAPHARM (M) SDN BHD
INN:
HYDROCORTISONE ACETATE
units_in_package:
15 gm
manufactured_by:
DYNAPHARM (M) SDN BHD
PIL
CORTISONE CREAM
Hydrocortisone Acetate (1 % w/w)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What CORTISONE CREAM is used
for
2.
How CORTISONE CREAM works
3.
Before you use CORTISONE
CREAM
4.
How to use CORTISONE CREAM
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
CORTISONE CREAM
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT CORTISONE CREAM IS USED
FOR
For the relief of the skin inflammation
and itching that is responsive to
corticosteroid.
HOW CORTISONE CREAM WORKS
Hydrocortisone will produce anti-
inflammatory and anti-allergic actions in
the skin.
BEFORE YOU USE CORTISONE CREAM
-
_When you must not use it _
Do not use CORTISONE CREAM if:
-
You have history of sensitivity reaction
to Hydrocortisone or other topical
corticosteroids.
-
Bacterial or fungal infections and viral
diseases, such as herpes simplex.
_Pregnancy and lactation _
Do not use CORTISONE CREAM if
you are pregnant, trying to get pregnant
or think you may be pregnant. It should
not be used in pregnant women in large
amounts or for prolonged period of time.
Do not use CORTISONE CREAM if
you are breast-feeding. Ask your doctor
or pharmacist for advice before taking
any medicine.
-
_Before you start use it _
Tell your doctor if you are having any
other medical conditions.
-
_Taking other medicines _
Tell your doctor if you are taking any
other medicines, including any that you
buy without a prescription from a
pharmacy, supermarket or health food
shop._ _
Urea may enhance the absorption of the
corticosteroid and this should be borne in
mind, especially when long term
treatment is contemplated.
HOW TO USE CORTISONE CREAM
-
_How much to use _
Apply a thin film of the cream to the
affected area.
Follow all directions given to you by
your doctor and pharmacist carefully.
They may differ from the information
contained in this leaflet. If you do not
understand the instructions on the label,
ask your doctor or pharmacist for help.
-
_When to use it
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SPC
CORTISONE CREAM
MAL19910181AZ
DESCRIPTION:
CREAM
Colour
: White
Fragrance
: Natural
CONTENT:
Hydrocortisone Acetate..............................................
1% w/w
PHARMACODYNAMICS:
Hydrocortisone is an adrenocorticoid which when applied externally
will produce anti-inflammatory and anti-allergic actions in
the skin. It diffuses across cell membranes and complexes with
specific cytoplasmic receptors. These complexes then enter the
cell nucleus, bind to DNA (chromatin), and stimulate transcription of
messenger RNA (mRNA) and subsequent protein synthesis of
various enzymes thought to be ultimately responsible for
anti-inflammatory effects of topical application of adrenocorticoids.
PHARMACOKINETICS:
When applied externally, Hydrocortisone can be absorbed systematically
and occlusion or use over extensive areas increases
absorption of topical applied drug. Metabolism is mostly in the skin
tissue.
INDICATION:
For the relief of the inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses.
RECOMMENDED DOSE:
Apply a thin film of the cream to the affected area 1 - 3 times daily.
Application once or twice a day is often feasible and
effective. However, frequency of application should be determined
according to severity of the condition while mild cases may
response to once a day application, more severe cases may require more
frequent application.
CONTRAINDICATION:
History of sensitivity reaction to Hydrocortisone or other topical
corticosteroids. Tuberculosis of the skin, bacterial or fungal
infections and viral diseases, e.g. herpes simplex, varicella,
vaccina, acne vulgaris. It should not be used in pregnant patients in
large amounts or for prolonged period of time.
WARNING AND PRECAUTIONS:
Treatment should be discontinued if irritation or sensitization
develops with the use of the cream and appropriate therapy
instituted. In the presence of an infection, the use of an appropriate
antifungal or antibacterial agent should be instituted. If a
favourable response does not occur promptly, the c
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