Land: Singapore
Språk: engelsk
Kilde: HSA (Health Sciences Authority)
KETOCONAZOLE
JOHNSON & JOHNSON INTERNATIONAL (SINGAPORE) PTE LTD
D01AC08
20 mg/g
CREAM
KETOCONAZOLE 20 mg/g
TOPICAL
General Sale List
JANSSEN PHARMACEUTICA NV
ACTIVE
1988-05-13
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 read_full_document
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 read_full_document