Tablets

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. Ketoconazole should not be used for fungal meningitis because it penetrates poorly into the cerebral-spinal fluid.

Ketoconazole 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.

Shampoo

Ketoconazole 2% shampoo is indicated for the reduction of scaling due to dandruff.

Cream

Ketoconazole 2% cream is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes, (efficacy for this organism in this organ system was studied in fewer than ten infections), and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.

Tablets

Adults: The recommended starting dose of 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 ketoconazole 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. Ketoconazole 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 p.o. 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.

Shampoo

Moisten hair and scalp thoroughly with water.

Apply sufficient shampoo to produce enough lather to wash the scalp and hair gently massage it over the entire scalp area for approximately one minute.

Rinse the hair thoroughly with warm water.

Repeat, leaving the shampoo on the scalp for an additional 3 minutes.

After the second thorough rinse, dry the hair with a towel or warm air flow.

Shampoo twice a week for four weeks with at least three days between each shampooing and then intermittently as needed to maintain control.

Cream

Cutaneous candidiasis, tinea corporis, tinea cruris, and tinea (pityriasis) versicolor: It is recommended that ketoconazole 2% cream be applied once daily to cover the affected and immediate surrounding area. Clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment.

Seborrheic Dermatitis: Ketoconazole 2% cream should be applied to the affected area twice daily for four weeks or until clinical clearing.

If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.

Tablets

Nizoral is available as white, scored tablets containing 200 mg of ketoconazole debossed "JANSSEN" and on the reverse side debossed "NIZORAL".

Storage: Store at room temperature (59°-86°F/15°-30°C). Protect from moisture.

Shampoo

Nizoral 2% shampoo is a red-orange liquid supplied in a 4-fluid ounce nonbreakable plastic bottle.

Storage: Store at a temperature not above 25°C (77°F). Protect from light.

Cream

Nizoral 2% cream is supplied in 15, 30 and 60 gm tubes.

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