Aetos Ketoconazole Cream 2% ww

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

KETOCONAZOLE

Boleh didapati daripada:

ABIOTIDE SDN. BHD.

INN (Nama Antarabangsa):

KETOCONAZOLE

Unit dalam pakej:

15 gm

Dikeluarkan oleh:

HOVID BERHAD

Risalah maklumat

AETOS KETOCONAZOLE CREAM 2% W/W
Ketoconazole (2% w/w)
1
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
WHAT IS IN THIS LEAFLET
1.
What
Aetos
Ketoconazole
Cream
2% w/w is used for
2.
How Aetos Ketoconazole Cream 2%
w/w works
3.
Before you use Aetos Ketoconazole
Cream 2% w/w
4.
How
to
use
Aetos
Ketoconazole
Cream 2% w/w
5.
While you are using it
6.
Side effects
7.
Storage
and
Disposal
of
Aetos
Ketoconazole Cream 2% w/w
8.
Product Description
9.
Manufacturer
and
Product
Registration Holder
10.
Date of revision
11.
Serial Number
WHAT AETOS KETOCONAZOLE CREAM 2%
W/W
IS USED FOR
Aetos Ketoconazole Cream 2% w/w is a
medicine
for
treating
skin
infections
caused by fungi or yeasts.
It is used for treating skin infections on
the
trunk, groin,
feet
or
hands.
Aetos
Ketoconazole
Cream
2%
w/w
is
also
used to treat skin infections that usually
occur on the face and on the chest with
reddish
brown
patches
and
yellow
or
white scaling (seborrheic dermatitis).
HOW AETOS KETOCONAZOLE CREAM 2%
W/W WORKS
Aetos
Ketoconazolde
Cream
2%
w/w
works by killing the fungus that causes
the infection.
BEFORE
YOU
USE
AETOS
KETOCONAZOLE
CREAM 2% W/W
-
_When you must not use it _
Do not use Aetos Ketoconazole Cream
2%
w/w
if
you
know
you
are
hypersensitive (allergic) to it. Symptoms
of hypersentivity include itching and red
skin which may occur after you have
applied Aetos Ketoconazole Cream 2%
w/w.
_ _
-
_Before you start to use it _
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
Aetos
Ketoconazole
Cream
2%
w/w
in
the
evening.
The
mild
steroid
treatment
can
then be gradually stopped over a
period of 2 – 3 weeks.
If you have questions about stopping
your steroid cream, ointment or lotion,
ask your doctor or pharmacist.
_Pregnancy and lactation _
There are no known risks with the use
of Aetos Ketoconaz

Ciri produk

DESCRIPTION
White to off white, opaque cream.
COMPOSITION
Ketoconazole 2% w/w.
PHARMACODYNAMICS
PHARMACODYANMIC PROPERTIES
Pharmacotherapeutic group: Antifungals for Topical Use, Imidzole
and triazole derivatives, ATC code: D01AC08.
MECHANISM OF ACTION:
Ketoconazole inhibits the biosynthesis of ergosterol in fungi and
changes
the
composition
of
other
lipid
components
in
the
membrane.
PHARMACODYNAMIC EFFECTS
Usually ketoconazole cream acts rapidly on pruritus, which is
commonly seen in dermatophyte and yeast infections, as well as
skin conditions associated with the presence of _ Malassezia spp._
This symptomatic improvement is observed before the first signs of
healing are observed.
MICROBIOLOGY
Ketoconazole, a synthetic imidazole dioxolane derivative, has a
potent
antimycotic
activity
against
dermatophytes
such
as
_Trichophyton spp., Epidermophyton floccosum_ and _ Microsporum _
_spp._ and against yeasts, including _ Malassezia spp._ and _ Candida
_
_spp._ especially the effect on _Malassezia spp._ is very pronounced.
PHARMACOKINETICS
Plasma concentrations of ketoconazole were not detectable after
topical administration of Aetos Ketoconazole Cream 2% w/w in
adults on the skin.
INDICATIONS
Aetos
Ketoconazole
Cream
2%
w/w
is
indicated
for
topical
application in the treatment of dermatophyte infections of the skin:
tinea corporis, tinea cruris, tinea manus and tinea pedis due to
_Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum _
_canis _and_ Epidermophyton floccosum,_ as well as in the treatment
of cutaneous candidosis and tinea (pityriasis) versicolor.
Aetos Ketoconazole Cream 2% w/w is also indicated for the
treatment of seborrheic dermatitis, a skin condition associated with
the presence of _Malassezia furfur._
CONTRAINDICATIONS
Aetos Ketoconazole Cream is contraindicated in individuals who
have
shown
hypersensitivity
to
ketoconazole
and
any
of
its
ingredients.
WARNINGS AND PRECAUTIONS
Aetos Ketoconazole Cream 2% w/w is not for ophthalmic use.
If
coadministered
with
a
topical
corticosteroid,
to
pre