NIZORAL CREAM 2%

País: Cingapura

Língua: inglês

Origem: HSA (Health Sciences Authority)

Ingredientes ativos:

KETOCONAZOLE

Disponível em:

JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD

Código ATC:

D01AC08

Dosagem:

20 mg/g

Forma farmacêutica:

CREAM

Composição:

KETOCONAZOLE 20 mg/g

Via de administração:

TOPICAL

Tipo de prescrição:

General Sale List

Fabricado por:

JANSSEN PHARMACEUTICA NV

Status de autorização:

ACTIVE

Data de autorização:

1988-05-13

Folheto informativo - Bula

NIZORAL
® (KETOCONAZOLE)
CREAM
_ (_
For external use only)
Before you start to take your medicine, please read this leaflet
carefully all the way through as it
contains important information. If there is anything that you do not
understand or if you need
further information or advice, you should ask your doctor or
pharmacist who will be pleased to
help you. Please do not throw this leaflet away until you have
finished taking the full course of
your medicine. You may need to refer to it again.
WHAT IS NIZORAL
® CREAM FOR?
NIZORAL
®
Cream 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.
NIZORAL
®
Cream 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).
WHEN NOT TO USE NIZORAL
® CREAM
Do not use NIZORAL
®
Cream if you know you are
HYPERSENSITIVE
(allergic) to it. Symptoms of
hypersensitivity include itching and red skin which may occur after
you have applied NIZORAL
®
Cream.
WHAT SPECIAL PRECAUTIONS SHOULD YOU TAKE?
DO NOT APPLY NIZORAL
® CREAM TO THE EYES.
Wash your hands carefully after you have applied NIZORAL
®
Cream.
PREGNANCY AND BREAST-FEEDING
There are no known risks with the use of NIZORAL
®
Cream in pregnancy or breast-feeding.
OTHER MEDICINES
If you are also using corticosteroids (cortisone-type medicines in
cream, ointment or lotion), check
with your doctor or pharmacist before starting treatment with NIZORAL
®
Cream.
HOW TO USE NIZORAL
® CREAM AND HOW MUCH
You should apply NIZORAL
®
Cream once or twice a day as instructed by your doctor. Depending
on the type of infection, treatment may last 2 to 6 weeks. Usually you
will see signs of
improvement after 4 weeks. If this is not the case, talk to your
doctor.
DO NOT STOP USING THE CREAM UNTIL A FEW DAYS AFTER ALL SYMPTOMS HAVE
COMPLETELY DISAPPEARED.
•
To open the tube, unscrew the cap and then pierce the seal of the tube
using the

Características técnicas

1/5
PRODUCT NAME
NIZORAL
®
(ketoconazole) 2% Cream
DOSAGE FORMS AND STRENGTHS
Cream for topical application to the skin.
Each gram contains 20 mg ketoconazole.
For excipients, see
_List of Excipients_
.
CLINICAL INFORMATION
INDICATIONS
NIZORAL
®
2% Cream 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.
NIZORAL
®
2% Cream is also indicated for the treatment of seborrheic dermatitis,
a skin
condition associated with the presence of
_Malassezia furfur_
.
DOSAGE AND ADMINISTRATION
DOSAGE
Cutaneous
candidosis,
tinea
corporis,
tinea
cruris,
tinea
manus,
tinea
pedis
and
tinea
(pityriasis) versicolor: it is recommended that NIZORAL
®
2% Cream be applied once daily
to cover the affected and immediate surrounding area.
Seborrheic dermatitis: NIZORAL
®
2% Cream should be applied to the affected area once or
twice daily.
The usual duration of treatment is tinea versicolor 2-3 weeks, yeast
infections 2-3 weeks,
tinea cruris 2-4 weeks, tinea corporis 3-4 weeks, tinea pedis 4-6
weeks.
The usual initial duration of treatment in seborrheic dermatitis is 2
to 4 weeks. Maintenance
therapy is applied once or twice weekly in seborrheic dermatitis.
Treatment should be continued, until a few days after disappearance of
all symptoms. The
diagnosis should be reconsidered if no clinical improvement is noted
after 4 weeks of
treatment.
SPECIAL POPULATIONS
_ _
_PEDIATRICS _
There are limited data on the use of ketoconazole 2% cream in
pediatric patients.
ADMINISTRATION
2/5
Topical administration to the skin.
CONTRAINDICATIONS
NIZORAL
®
2% Cream is contraindicated in individuals with a known
hypersensitivity to any
of its ingredients.
WARNINGS AND PRECAUTIONS
NIZORAL
®
2% Cream is not for ophthalmic use.
If coadministered wit