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Ketoconazole USP

Ketotab 200 mg 4X10 Tablet


Ketoconazole is a synthetic imidazole derivative with a potent activity against dermatophytes, yeasts and other pathogenic fungi, after oral administration.

Each tablet contains Ketoconazole BP 200 mg.

1.Treatment of superficial and deep mycoses : Infections of the skin, hair and nails by dermatophytes and/or yeasts (dermatomycosis, onychomycosis, perionyxis, pityriasisversicolor, chronic mucocutaneous candidiasis etc.) especially when topical treatment is difficult or not very effective, owing to involvement of large skin surfaces or to lesions affecting deeper dermal layers, nails and hairs ; Yeast infection of the mouth (oral thrush, perleche) and the gastrointestinal tract ; Vaginal candidiasis, especially chronic recurrent cases or cases responding poorly to topcial treatment ; Systemic mycotic infections such as systemic candidiasis, paracoccidioidomycosis, histoplasmosis, coccidioidomycosis etc. 2. Maintenance treatment to prevent recurrence in systemic mycotic infections and in chronic mucocutaneous candidiasis. 3. Prophylactic treatment to prevent mycotic infection in patients with reduced host defenses, e.g., patients with cancer, organ transplant and burns.

Vaginal candidiasis: 1 tablet b.i.d. for 5 days. All other indications: Adults: 1 tablet (200 mg) once daily until at least one week after the symptoms have disappeared and the cultures have become negative. Children: 3 to 5 mg/kg/day

Ketoconazole is very well tolerated. Nausea and itching may occasionally occur. In some patients, an idosyncratic liver reaction may occur.

The liver function of the patients should be monitored during and after treatment.

Category: C. There is no adequate and well controlled studies in pregnant women. Ketoconazole Tablets should not be used during pregnancy and lactation.

Ketoconazole may influence the pharmacokineties of other drug or other drug may influence the pharmacokineties properties of ketoconazole. This interaction studies have only been performed in adults from study in pediatric patients is unknown.

Ketoconazole is contraindicated in pregnancy and in patients with acute liver pathology.

Store in a cool and dry place, protect from light and moisture.

Each box contains 4x10 tablets in blister packing.