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Dancel 2%

Cream

Generic: Ketoconazole

Incepta Pharmaceuticals Ltd.

Therapeutic Class: Imidazole Antifungal

Indications

Cream: tinea corporis, tinea cruris, tinea pedis, cutaneous candidiasis, pityriasis versicolor and seborrhoeic dermatitis. Tablet: because of the risk of liver injury, oral ketoconazole is no longer recommended for routine fungal infections and is used only under specialist supervision.

Pharmacology

Ketoconazole inhibits fungal ergosterol synthesis by blocking cytochrome P450 14-alpha-demethylase, damaging the fungal cell membrane. At high doses it also inhibits adrenal steroid synthesis.

Dosage & Administration

Cream 2%: apply to the affected area once or twice daily, usually for 2-4 weeks. Tablet: 200 mg once daily with food, only as directed by a specialist physician.

Side Effects

Cream: local irritation, itching or burning. Tablet: nausea, vomiting, abdominal pain, headache, raised liver enzymes; rarely serious liver injury, adrenal insufficiency and QT prolongation.

Precautions & Warnings

Oral use requires liver function tests before and during treatment; stop if signs of hepatitis appear. Tablets have many serious drug interactions. Cream is for external use only; avoid contact with the eyes.

Contraindications

Hypersensitivity to ketoconazole. Tablets: acute or chronic liver disease, pregnancy and breast-feeding, and concomitant use with drugs such as simvastatin, lovastatin, cisapride, pimozide, quinidine and oral midazolam.

Storage Conditions

Store below 30°C in a cool, dry place, away from light. Keep out of the reach of children.

This information is for reference only. Always consult a qualified doctor or pharmacist before taking any medicine.

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