Nizoral (Ketoconazole) - Indications and Dosage

INDICATIONS AND USAGE

NIZORAL® (ketoconazole) Tablets are indicated for the treatment of the following systemic fungal infections: candidiasis, chronic mucocutaneous candidiasis, oral thrush, candiduria, blastomycosis, coccidioidomycosis, histoplasmosis, chromomycosis, and paracoccidioidomycosis. NIZORAL® Tablets should not be used for fungal meningitis because it penetrates poorly into the cerebral-spinal fluid.

NIZORAL® Tablets are also indicated for the treatment of patients with severe recalcitrant cutaneous dermatophyte infections who have not responded to topical therapy or oral griseofulvin, or who are unable to take griseofulvin.

DOSAGE AND ADMINISTRATION

Adults:   The recommended starting dose of NIZORAL® (ketoconazole) Tablets is a single daily administration of 200 mg (one tablet). In very serious infections or if clinical responsiveness is insufficient within the expected time, the dose of NIZORAL® Tablets may be increased to 400 mg (two tablets) once daily.

Children:   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.

There should be laboratory as well as clinical documentation of infection prior to starting ketoconazole therapy. Treatment should be continued until tests indicate that active fungal infection has subsided. Inadequate periods of treatment may yield poor response and lead to early recurrence of clinical symptoms. Minimum treatment for candidiasis is one or two weeks. Patients with chronic mucocutaneous candidiasis usually require maintenance therapy. Minimum treatment for the other indicated systemic mycoses is six months.

Minimum treatment for recalcitrant dermatophyte infections is four weeks in cases involving glabrous skin. Palmar and plantar infections may respond more slowly. Apparent cures may subsequently recur after discontinuation of therapy in some cases.

HOW SUPPLIED

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.

U.S. Patent 4,335,125

Rev. March 1997, July 1998

JANSSEN PHARMACEUTICA

Titusville, NJ 08560-0200