Isocort Cream

国: マレーシア

言語: 英語

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

有効成分:

DIFLUCORTOLONE VALERATE; ISOCONAZOLE NITRATE

から入手可能:

HOE PHARMACEUTICALS SDN. BHD.

INN（国際名）:

DIFLUCORTOLONE VALERATE; ISOCONAZOLE NITRATE

パッケージ内のユニット:

15 gm

製:

HOE PHARMACEUTICALS SDN. BHD.

情報リーフレット

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
_ _
ISOCORT CREAM
Isoconazole nitrate/Diflucortolone Valerate (1.0% w/w / 0.1% w/w)
1
WHAT IS IN THIS LEAFLET
1.
What Isocort Cream is used
for
2.
How Isocort Cream works
3.
Before you use Isocort Cream
4.
How to use Isocort Cream
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of
Isocort Cream
8.
Product description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT ISOCORT CREAM IS USED FOR
Isocort
Cream
is
an
initial
or
interim
treatment
of
those
superficial fungal infections of the
skin
which
are
accompanied
by
highly
inflammatory
or
eczematous skin conditions, e.g in
the
region
of
the
hands,
the
interdigital spaces of the feet, and
the
inguinal
(groin)
and
genital
regions.
HOW ISOCORT CREAM WORKS
Isocort
Cream
has
two
active
ingredients which are Isoconazole
Nitrate
dan
Diflucortolone
Valerate.
Isoconazole nitrate display a very
broad
spectrum
of
antimicrobial
action.
It
is
effective
against
fungus and yeast, yeast-like fungi
(including the causative organism
of pityriasis versicolor) and molds,
as
well
as
against
gram-positive
bacteria
in-vitro
and
against
the
causative organism of erythrasma
(bacterial
infection
at
folds
of
skin).
Diflucortolone
valerate
prevent
inflammation in inflammatory and
allergic skin conditions and relieve
the uncomfortable skin sensation
such
as
itchiness,
burning
and
pain.
Ask your pharmacist or doctor if
you have any questions about this
medicine.
BEFORE YOU USE ISOCORT CREAM_ _
_ _
_-When you must not use it_
Do not take Isocort Cream if you
have an allergy to:
•
Any of the ingredients listed at
the end of this leaflet
_-Pregnancy _
There are no data from the use of
Isoconazole
nitrate
or
Diflucortolone valerate in pregnant
women.
In
general,
the
use
of
topical
preparations
containing
glucocorticoids should be avoided
during
the
first
trimester
of
pregnancy.
_-Lactation _
It is unknown whether Isoconazole
nitrate
or
Diflucortolone
valerate
are excreted in human milk. A risk
to
the
suck

製品の特徴

PRODUCT DESCRIPTION:
White to off-white cream.
NAME AND STRENGTH OF ACTIVE SUBSTANCE:
Isoconazole Nitrate 1% w/w and
Diflucortolone Valerate 0.1% w/w.
PHARMACODYNAMICS:
Isoconazole Nitrate is for use in the treatment of superficial
fungal diseases of the skin. It displays a very broad spectrum of
antimicrobial action. It is
effective against dermatophytes and yeasts, yeast-like fungi
(including the causative organism
of pityriasis versicolor) and molds, as well as against gram-positive
bacteria in-vitro and against
the causative organism of erythrasma.
Diflucortolone Valerate suppresses inflammation in inflammatory and
allergic skin conditions
and alleviates the subjective complaints such as pruritus, burning and
pain.
PHARMACOKINETICS
ISOCONAZOLE NITRATE:
Isoconazole penetrates rapidly into human skin. It is not
metabolically
inactivated in the skin. Systemic load due to percutaneous absorption
is low.
DIFLUCORTOLONE
VALERATE:
Isoconazole
does
not
influence
penetration
and
percutaneous
absorption of Diflucortolone Valerate. Diflucortolone Valerate is
partly hydrolysed in the skin
to the likewise effective diflucortolone. The portion of the
corticosteroid which is percutaneous-
ly absorbed is low. Entering the systemic circulation, Diflucortolone
Valerate is hydrolysed to
diflucortolone and the corresponding fatty acid within minutes.
INDICATION:
Initial or interim treatment of those superficial fungal infections of
the skin
which are accompanied by highly inflammatory or eczematous skin
conditions, e.g. in the
region of the hands, the interdigital spaces of the feet, and the
inguinal and genital regions.
CONTRAINDICATIONS:
Tuberculous or syphilitic processes in the area to be treated; virus
diseases (e.g. varicella, herpes zoster), rosacea, perioral dermatitis
and postvaccination skin
reactions in the area to be treated.
Hypersensitivity to the active substances or to any of the excipients.
EFFECTS ON ABILITY TO DRIVE AND USE MACHINES:
No study have been done.
ISOCORT CREAM
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