MINACORT CREAM

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

MICONAZOLE NITRATE; HYDROCORTISONE ACETATE

Boleh didapati daripada:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

INN (Nama Antarabangsa):

MICONAZOLE NITRATE; HYDROCORTISONE ACETATE

Unit dalam pakej:

15 gm; 50 x 15 gm

Dikeluarkan oleh:

MALAYSIAN PHARMACEUTICAL INDUSTRIES SDN. BHD.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
MINACORT CREAM
Miconazole Nitrate / Hydrocortisone Acetate (2%w/w / 1%w/w)
WHAT IS IN THIS LEAFLET:
1.
What Minacort Cream is used for
2.
How Minacort Cream works
3.
Before you use Minacort Cream
4.
How to use Minacort Cream
5.
While you using it
6.
Side Effects
7.
Storage and Disposal of Minacort
Cream
8.
Product description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of Revision
WHAT MINACORT CREAM IS USED FOR
It
is
indicated
for
the
treatment
of
inflamed
skin
infections
caused
by
certain fungi and bacteria.
HOW MINACORT CREAM WORKS?
Miconazole
Nitrate
and
Hydrocortisone Acetate are the active
ingredients
of
Minacort
Cream.
Miconazole is an antifungal agent with
some
antibacterial
activity.
Hydrocortisone is a less potent ‘topical
steroid’ which reduces inflammation,
swelling,
redness
and
itching
of
the
skin.
BEFORE YOU USE MINACORT CREAM
_-When you must not use it _
Do not use Minacort Cream if
•
you are allergic (hypersensitive) to
miconazole
or
hydrocortisone
or
any
of
the
other
ingredients
of
Minacort
Cream.
(listed
under
Product Description)
•
you have any other skin infection
such
as
skin
tuberculosis,
cold
sores,
herpes,
chicken
pox
or
shingles.
_ _
_ _
_-Before you start to use it _
You must tell your doctor if:
•
you have allergies to any medicine
which you have used previously to
treat your current condition.
_-Pregnancy and breastfeeding _
Tell your doctor if you are pregnant,
planning
for
pregnancy
or
breast-
feeding before using any medicine.
Minacort
Cream
should
be
used
cautiously
during
pregnancy
and
lactation
period.
Avoid
treatment
of
large
surfaces
and
application
under
occlusive dressing.
_ _
_-Taking other medicines _
You must tell your doctor if you are:
-
on
warfarin
therapy
(blood
thinning agent).
-
taking
any
other
medicines,
including
any
that
you
buy
without
a
prescription
from
a
pharmacy, supermarket or health
food shop.
HOW TO USE MINACORT
CREAM
-
_How much to use _
Apply
the
cream
with
your
finger
gently on

Ciri produk

7161-04
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S) :
Each gram contains:
Miconazole Nitrate………………………….………………..
20mg
Hydrocortisone
Acetate……………………………………….10mg
PRODUCT DESCRIPTION:
A white to off-white cream base with whitening bouquet fragrance in
printed aluminium tubes with
white caps.
PHARMACODYNAMICS
:
Miconazole is an imidazole antifungal agent and may act by interfering
with the permeability of the
fungal cell membrane. It inhibit several genera of fungi, including
dermatophytes and yeasts, and gram
+ve bacteria.
Hydrocortisone produces dramatic suppression of skin disease, such as
eczema, infantile eczema, atopic
dermatitis, dermatitis herpetiformis, contact dermatitis, seborrhoeic
dermatitis, neurodermatitis, some
forms of psoriasis and intertrigo, in which inflammation is a
prominent feature. Miconazole in
combination
with
hydrocortisone
acts
very
rapidly
on
pruritus,
which
frequently
accompanies
dermatophyte and yeast infections.
PHARMACOKINETICS:
There is little absorption through skin or mucous membrane when
Miconazole is applied topically.
Miconazole readily penetrates the stratum corneum of the skin and
persists there for more than 4 days
after application, which probably contributes to its efficacy against
the dermatophytes. From topical
sites, only trace amount of Miconazole appeared in blood or urine.
Hydrocortisone Acetate is absorbed
through the skin, particularly in denuded area. It is metabolised in
the liver and most body tissues to
hydrogenated
and
degraded
forms
such
as
tetrahydrocortisone
and
tetrahydrocortisol.
These
are
excreted in the urine, mainly conjugated as glucuronides, together
with a very small proportion of
unchanged hydrocortisone. The biological half-life is about 100
minutes. More than 90% bound to
plasma proteins.
INDICATION:
Topical treatment of fungal infections associated with inflammatory
symptoms. It may also be used for
mycotic affections with bacterial superinfection.
RECOMMENDED DOSAGE:
Apply thinly once o