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NIZORAL® Tablets should be used only when other effective antifungal therapy is not available or tolerated and the potential benefits are considered to outweigh the potential risks.
NIZORAL® (ketoconazole) Tablets are indicated for the treatment of the following systemic fungal infections in patients who have failed or who are intolerant to other therapies: blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. NIZORAL® Tablets should not be used for fungal meningitis because it penetrates poorly into the cerebrospinal fluid.
DOSAGE AND ADMINISTRATION
There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole therapy. The usual duration of therapy for systemic infection is 6 months. Treatment should be continued until active fungal infection has subsided.
The recommended starting dose of NIZORAL® (ketoconazole) Tablets is a single daily administration of 200 mg (one tablet). If clinical responsiveness is insufficient within the expected time, the dose of NIZORAL® Tablets may be increased to 400 mg (two tablets) once daily.
In small numbers of children over 2 years of age, a single daily dose of 3.3 to 6.6 mg/kg has been used. NIZORAL® Tablets have not been studied in children under 2 years of age.
NIZORAL® (ketoconazole) is available as white, scored tablets containing 200 mg of ketoconazole debossed “JANSSEN” and on the reverse side debossed “NIZORAL”. They are supplied in bottles of 100 tablets (NDC 50458-220-10).
Store at controlled room temperature 15°-25°C (59°-77°F).
Protect from moisture.
Keep out of reach of children.
Janssen Pharmaceuticals, Inc, Titusville, New Jersey 08560. Revised: July 2013
Last reviewed on RxList: 8/2/2013
This monograph has been modified to include the generic and brand name in many instances.
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