DECOCORT CREAM

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MICONAZOLE NITRATE; HYDROCORTISONE

Boleh didapati daripada:

HOE PHARMACEUTICALS SDN. BHD.

INN (Nama Antarabangsa):

MICONAZOLE NITRATE; HYDROCORTISONE

Unit dalam pakej:

15 gm

Dikeluarkan oleh:

HOE PHARMACEUTICALS SDN. BHD.

Risalah maklumat

_ CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
DECOCORT CREAM
Miconazole Nitrate / Hydrocortisone (2.0% w/w / 1.0% w/w)
_ _
WHAT IS IN THIS LEAFLET
1.
What Decocort Cream is used
for
2.
How Decocort Cream works
3.
Before you use Decocort
Cream
4.
How to use Decocort Cream
5.
While you are using Decocort
Cream
6.
Side effects
7.
Storage and Disposal of
Decocort Cream
8.
Product description
9. Manufacturer and Product
Registration Holder
10. Date of revision
This leaflet answers some common
questions about Decocort Cream. It
does not contain all the available
information. It does not take the
place of talking to your doctor or
pharmacist.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you using this medicine
against the benefits they expect it
will have for you.
If you have any concerns about
using this medicine, ask your doctor
or pharmacist.
Keep this leaflet with the medicine.
You may want to read it again
WHAT DECOCORT CREAM IS USED FOR
Decocort Cream is indicated for the
treatment of fungal infections
accompanied by inflammation, rash
infected by fungus and/or bacteria.
HOW DECOCORT CREAM WORKS
This medicine contains Miconazole
Nitrate which is has anti-fungal
properties.
BEFORE YOU USE DECOCORT CREAM
_-When you must not use it _
Do not use Decocort Cream:
•
if you are on warfarin therapy.
•
if you are taking medicine
containing any of the ingredients
listed at the end of this leaflet.
•
in untreated bacteria or viral
lesions; acne, sweat rash
_-Before you start to take it _
Tell your doctor or pharmacist:
•
If you are pregnant, breast-
feeding or trying for a baby, tell
your doctor or pharmacist before
using Decocort Cream. If you
have informed your doctor or
pharmacist already, follow
his/her instructions carefully.
_-Taking other medicines_
Tell your doctor about all the other
medicines and skin products you
use, including prescription and non-
prescription medicines, vitamins,
herbal supplements, and cosmetics.
There is no kind of drug interactions
with Decocort

Ciri produk

NAME AND STRENGTH OF ACTIVE SUBSTANCE :
Miconazole Nitrate 2.0% w/w and Hydrocortisone 1.0% w/w.
PRODUCT DESCRIPTION : A white cream. Other ingredients: Chlorocresol,
Cetomacrogol
1000, White Soft Paraffin, Liquid Paraffin, Propylene Glycol,
Cetostearyl Alcohol and Purified
Water.
PHARMACODYNAMICS : Miconazole is an imidazole antifungal agent which
interferes with
ergosterol synthesis and thereby alters the permeability of the cell
membrane of sensitive fungi.
Hydrocortisone is a topically active corticosteroid which has
anti-inflammatory action.
PHARMACOKINETICS : Miconazole has shown fungistatic activity, in
vitro, against a number of
fungi causing systemic mycoses such as _ Coccidioides immitis,
Histoplasma capsulatum, _
_Blastomyces dermatitides_ and _ Cryptococcus neoformans_. Miconazole
appears to act on the
fungal
cell
wall
and
membranes
inducing
permeability
changes
which
alter
the
ionic
macromolecular composition of the effected cells. At high
concentrations, Miconazole has shown
fungicidal
activity
against
various
organisms.
Miconazole
readily
penetrates
the
stratum
corneum of the skin and persists there for more than 4 days after
application. Less than 1% is
absorbed
into
the
blood.
Absorption
is
no
more
than
1.3%
from
the
vagina. Topical
corticosteroids
have
anti-inflammatory,
antipruritic
and
vasoconstrictive
actions.
When
administered topically, particularly under occlusive dressing or when
the skin is broken, sufficient
corticosteroid may be absorbed to give systemic effects. Only unbound
corticosteroids have
pharmacological effects or are metabolised. They are metabolised
mainly in the liver, also in the
kidneys and are excreted in the urine.
INDICATIONS : Superficial fungal infection accompanied by
inflammation, eczematous rash
superinfected by fungus and / or gram positive bacteria.
CONTRAINDICATIONS : It is contraindicated in individuals who are
hypersensitive to it or any
of its components, in untreated bacteria or viral lesions; rosacea
(acne rosacea), perioral
dermatitis.
ADVERSE EFFECTS : D