NIZORAL SHAMPOO 2%

Country: Malaysia

Bahasa: Inggeris

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

Bahan aktif:

Ketoconazole

Boleh didapati daripada:

JOHNSON & JOHNSON SDN BHD

INN (Nama Antarabangsa):

Ketoconazole

Unit dalam pakej:

100ml mL

Dikeluarkan oleh:

JANSSEN PHARMACEUTICA N.V.

Risalah maklumat

NIZORAL
®
SHAMPOO 2%
Ketoconazole (20mg/g)
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
_ _
_ _
_ _
WHAT IS IN THIS LEAFLET
1.
What Nizoral Shampoo is used for
2.
How Nizoral Shampoo works
3.
Before you use Nizoral Shampoo
4.
How to use Nizoral Shampoo
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of Nizoral
Shampoo
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT NIZORAL SHAMPOO IS USED FOR
Nizoral Shampoo is used to treat and
prevent skin infections caused by fungi
or yeasts. Both skin and scalp can be
treated with the shampoo.
HOW NIZORAL SHAMPOO WORKS
Nizoral Shampoo rapidly relieves
scaling
and pruritis, which are usually
associated
with seborrheic dermatitis,
pityriasis
capitis (dandruff) and pityriasis
versicolor.
BEFORE YOU USE NIZORAL SHAMPOO
-
_When you must not use it_
If you know you are hypersensitive
(allergic) to the formulation of this
product. Symptoms of
hypersensitivity
include itching and red
skin, occurring
after application.
_Pregnancy and lactation_
There is no known risk with the use of
Nizoral Shampoo in pregnancy or breast-
feeding.
-
_Before you start use it_
Tell your healthcare professional (doctor
or pharmacist) if you have allergies to
any other medicines, foods, preservatives
or dyes.
-
_Taking other medicines_
_ _
If you are using Corticosteroids
(cortisone-type medicines) in creams,
ointment or lotion.
If you are using such
a medicine, check
with your doctor or
pharmacist before
starting treatment with
Nizoral Shampoo.
You may start with
Nizoral Shampoo
right away, but do not
stop using the
corticosteroid from one
day to the next.
The skin might react by
redness and
itching.
It is recommended that the steroid
therapy be gradually withdrawn over a
period of 2 – 3 weeks, while using
Nizoral Shampoo to prevent any
potential rebound effect.
If in doubt, please consult your
healthcare professional.
HOW TO USE NIZORAL SHAMPOO
-
_How much to use_
Wash the infected parts of the skin or
scalp with Nizoral Shampoo

Ciri produk

LCN
NIZORAL


SHAMPOO 2%
FOR TOPICAL USE ONLY
DESCRIPTION
NIZORAL
Shampoo 2% contains the synthetic broad spectrum antifungal agent,
ketoconazole. One gram contains 20mg ketoconazole. The shampoo
formulation consists
of sodium lauryl ether sulphate, disodium monolauryl ether
sulphosuccinate, coconut
fatty acid diethanolamide, laurdimonium hydrolyzed animal collagen,
macrogol 120
methyl glucose diolaete, sodium chloride, hydrochloric acid, imidurea,
perfume bouquet,
sodium hydroxide, erythrosine sodium and purified water.
PROPERTIES
_Pharmacodynamics _
Ketoconazole, a synthetic imidazole dioxolane derivative, has a potent
antifungal activity
against dermatophytes, such as
_Trichophyton_
spp.,
_Epidermophyton _
spp.,
_Microsporum _
spp.,
and yeasts, such as
_Candida _
spp. and
_Malassezia_
spp. (
_Pityrosporum _
spp.)
_._
NIZORAL
Shampoo 2% rapidly relieves scaling and pruritus, which are usually
associated
with seborrhoeic dermatitis, pityriasis capitis (dandruff) and
pityriasis versicolor.
_Pharmacokinetics _
Plasma concentrations of ketoconazole were not detectable after
topical administration of
NIZORAL Shampoo 2% on the scalp. Plasma levels were detected after
topical
administration of NIZORAL Shampoo 2% on the whole body.
INDICATIONS
Treatment and prophylaxis of infections in which the yeast
_Malassezia_
(previously called
_ _
_Pityrosporum_
) is involved, such as pityriasis versicolor (localised), seborrhoeic
dermatitis
and pityriasis capitis (dandruff).
CONTRAINDICATIONS
NIZORAL Shampoo 2% is contraindicated in individuals with a known
hypersensitivity to
any of its ingredients.
WARNINGS & PRECAUTIONS
In patients who have been on prolonged treatment with topical
corticosteroids, it is
recommended that the steroid therapy be gradually withdrawn over a
period of 2 to 3 weeks,
while using NIZORAL Shampoo 2% to prevent any potential rebound
effect.
Avoid contact with the eyes. If the shampoo should get into the eyes,
they should be
bathed with cold water.
®
PREGNANCY & LACTATION
There are no adequate and wel