KEZORAL CREAM

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

KETOCONAZOLE

Boleh didapati daripada:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

INN (Nama Antarabangsa):

KETOCONAZOLE

Unit dalam pakej:

15gm0 mcg/mL; 15gm0 mcg/mL; 30 gm mcg/mL

Dikeluarkan oleh:

DUOPHARMA MANUFACTURING (BANGI) SDN BHD

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
1
KEZORAL CREAM
Ketoconazole (2% w/w)
WHAT IS IN THE LEAFLET
1.
What Kezoral is used for
2.
How Kezoral works
3.
Before you use Kezoral
4.
How to use Kezoral
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Kezoral
8.
Product Descriptio
n
9.
Manufacturer
and
Product
Registration Hold
er
10
.
Date of Revision
WHAT KEZORAL IS USED FOR
Kezoral
Cream
is
used
for
fungal and yeast infections of
the skin in adults.
Infections may appear on the:
•
Tru
nk, chest or back (
_tinea_
_Corporis,_
_pityriasis_
_versicolor_
)
• H
ands or feet (
_Tinea pedis_
)
• Scalp
or face (
_Seborrhoeic_
_d_
_ermatitis_
)
• Groin or genitals (
_tinea_
_cruris_
)
HOW KEZ
ORAL WORKS
Kezoral
Cream
works
by
killing the fungus that causes
the infection.
Ask your doctor if you have
any questions about why this
medicine has been prescribed
for you. Your doctor may have
prescribed
it
for
another
reason.
BEFORE YOU USE KEZORAL
-
_When you must not take it_
Do not use Kezoral Cream:
•
If
you
are
allerg
ic
to
pr
opylene
glycol
an
d
ket
oconazole
• For eye infections
I
f you are not sure, talk to your
doctor
or
pharmacist
before
using Kezoral Cream.
-
_Before you start to use it_
Persons
sensitive
to
miconazole or other imidazoles
may
be
sensitiv
e
to
ket
oconazole also.
Talk
to
your
doctor
or
pharmacist
before
using
this
medicine if you have recently
used
a
cream,
ointment
or
lotion on your skin infection
that
contains
a
steroid.
You
should continue to apply a mild
steroid
(such
as
hydrocortisone)
cream,
ointment
or
lotion
in
the
morning
whilst
applying
Kezoral Cream in the evening.
The mild steroid treatment can
then be gradually stopped over
a period of 2-3 weeks.
-
_Taking other medicines_
Kezoral
Cream
does
not
norm
ally
react
with
other
m
edicines. However, tell your
doctor or pharmacist if you are
taking or ha
ve recently taken
any
other
medicines.
This
includes
medicines
that
you
buy without a prescription
or
her
bal medici
nes.
HOW TO USE KEZORAL
Always
use
this

Ciri produk

DESCRIPTION
1500008660 N1
Revision Date: May 2019
KEZORAL CREAM: WHITE COLOUR, HOMOGENOUS CREAM CONTAINING KETOCONAZOLE 2%.
Preservatives : Methylparaben 0.25%
Propylparaben 0.048%
Ketoconazole is fungistatic, and may be fungicidal, depending on
concentration.
Ketoconazole
interferes
with
cytochrome
P-450
activity,
which
is
necessary
for
the
demethylation
of
14-alpha-methylsterols to ergosterol. Ergosterol, the principal sterol
in the fungal cell membrane, becomes depleted. This damages the
cell membrane, producing alterations in membrane functions and
permeability.
In
_Candida _
_albicans_
,
ketoconazole
inhibits
transformation of blastospores into invasive mycelial form.
Indicated as a primary agent in the topical treatment of dermatophyte
infections of the skin: Tinea corporis (ringworm of the body) and
tinea
cruris
(ringworm
of
the
groin;
jock
itch)
caused
by
_Trichophyton _
_rubrum, _
_T. _
_mentagrophytes _
_and _
_Epidermophyton _
_floccosum (Acrotheium floccosum),_
tinea pedis (athlete's foot), as
well as in the treatment of pityriasis versicolor (tinea versicolor;
"sun
fungus")
caused
by
_Malassezia _
_furfur _
_(Pityrosporum _
_orbiculare)_
and cutaneous candidiasis caused by
_Candida_
species.
Kezoral
Cream
can
be
used
in
the
treatment
of
seborrhoeic
dermatitis.
PHARMACODYNAMICS
INDICATIONS
No systemic absorption detected at a sensitivity level of 5 nanogram
per ml in the blood over a 72-hour period following a single topical
application to the chest, back and arms of normal volunteers.
Kezoral cream should be applied in sufficient quantity to cover
affected
and
surrounding
areas,
the
cream
gently
rubbed
in
to
enhance its effect. The patient must be counselled in regards to
compliance with the full course of therapy and that some fungal
infections may require prolonged therapy.
_CROSS-SENSITIVITY AND/OR RELATED PROBLEMS_
Person sensitive to miconazole or other imidazoles may be sensitive
to ketoconazole also.
_CARCINOGENICITY_
A long-term feeding studies in Swiss albino mice and Wistar rats has
shown n