Ketoconazole

Visa No.: 540100991324 (VN-18915-15)

Product: Nizoral

API: Ketoconazol

Product Category: Antifungal

Version approved leaflet: 33744e/QLD-ĐK_22/09/2025

INDICATIONS

Nizoral cream is indicated for topical treatment of superficial fungal infections of the skin, including: Tinea corporis, tinea cruris, tinea manuum, tinea pedis caused by trichophyton rubrum, trichophyton mentagrophytes, Microsporum canis, and Epidermophyton floccosum, cutaneous candidiasis, pityriasis versicolor

Nizoral cream is also indicated for the treatment of seborrheic dermatitis, a skin disorder associated with the presence of Malassezia furfur.
 

DOSAGE AND ADMINISTRATION

Dosage
Ketoconazole cream is used in adults.
Cutaneous candidiasis, tinea corporis, tinea cruris, tinea manuum, tinea pedis, and pityriasis versicolor:
Nizoral cream is recommended to be applied topically once daily to the infected area and the surrounding skin.
Seborrheic dermatitis:
Apply Nizoral cream to the affected area once or twice daily.

Usual duration of treatment: Pityriasis 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 initial treatment duration for seborrheic dermatitis is usually 2–4 weeks.
Maintenance treatment for seborrheic dermatitis consists of application once or twice weekly.
Treatment should be continued for several days after all symptoms have resolved.
The diagnosis should be reviewed if no clinical improvement is observed after 4 weeks of treatment.

Special Population
Children
Information on efficacy and safety in children (≤17 years of age) has not been established..
Method of administration 
For cutaneous use only
 

CONTRAINDICATIONS

Hypersensitivity to ketoconazole or to any of the excipients.

WARNINGS AND PRECAUTIONS

Read the instructions carefully before use.
If further information is required, consult a physician or pharmacist.
Keep out of reach of children.