ECORT CREAM

Country: Malaysia

Language: English

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

Active ingredient:

ECONAZOLE NITRATE; TRIAMCINOLONE

Available from:

DYNAPHARM (M) SDN BHD

INN (International Name):

ECONAZOLE NITRATE; TRIAMCINOLONE

Units in package:

15 gm Aluminium mcg/mL

Manufactured by:

DYNAPHARM (M) SDN BHD

Patient Information leaflet

ECORT CREAM
Econazole Nitrate / Triamcinolone Acetonide (1% / 0.1%)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What Ecort Cream is used for
2.
How Ecort Cream works
3.
Before you use Ecort Cream
4.
How to use Ecort Cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Ecort Cream
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ECORT CREAM IS USED FOR
It is used for topical treatment of
inflammatory fungal infection of skin
and inflammatory skin conditions
complicated by or threatened by bacterial
or fungal skin infection.
HOW ECORT CREAM WORKS
When applied externally, there is very
little absorption of Econazole Nitrate
through skin or mucous membranes.
When applied externally, Triamcinolone
Acetonide can be absorbed
systematically and occlusion or use over
extensive areas increases absorption of
topical applied drug. Metabolism is
mostly in the skin tissue.
BEFORE YOU USE ECORT CREAM
-
_When you must not use it _
Do not use in children under 2 years of
age except under the advice and
supervision of a doctor.
Do not use Ecort Cream if you have
history of sensitivity reaction to
Triamcinolone or other topical
corticosteroids or Econazole or other
Imidazole antifungal agents.
Tuberculosis of the skin and viral
diseases such as herpes simplex,
varicella, vaccine and acne vulgaris.
_Pregnancy and lactation _
Do not take Ecort Cream if you are
pregnant, trying to get pregnant or think
you may be pregnant.
Do not take Ecort 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 pregnant or
breastfeeding.
-
_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.
HOW TO USE ECORT CREAM
-
_How much to use _
Apply a thin film of the cream to the
affected area twice daily for 14 days.
Following

Summary of Product characteristics

ECORT CREAM
MAL19913384A
DESCRIPTION:
CREAM
Colour
:
White
Fragrance
:
Natural
CONTENT:
Econazole Nitrate
..................................................... 1% w/w
Triamcinolone Acetonide ..........................................
0.1% w/w
Preservative: Chlorocresol ........................................
0.2% w/w
PHARMACODYNAMICS:
Econazole is an imidazole antifungal agent and may act by interfering
with the permeability of the fungal cell
membrane. It has a wide antifungal spectrum and possesses some
antibacterial activity.
Triamcinolone Acetonide is an adrenocorticoid which when applied
externally will produce anti-inflammatory and
anti-allergic reactions 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, there is very little absorption of Econazole
Nitrate through skin or mucous membranes.
When applied externally, Triamcinolone Acetonide can be absorbed
systematically and occlusion or use over
extensive areas increases absorption of topical applied drug.
Metabolism is mostly in the skin tissue.
INDICATIONS:
For the topical treatment of inflammatory dermatomycoses and
inflammatory skin conditions complicated by or
threatened by bacterial or fungal skin infection.
RECOMMENDED DOSE:
Apply a thin film of the cream to the affected area twice daily for 14
days.
Following disappearance of the inflammation, consideration should be
given to continuing treatment with anti-fungal
therapy alone until two weeks after clinical cure have been achieved.
CONTRAINDICATIONS:
History of sensitivity reaction to Triamcinolone or other topical
corticosteroids or Econazole or other imidazole
antifungal agents. Tuberculosis of the skin, and viral diseases, e.g.