Nizoral Cream (Ketoconazole)




Topical Antifungal

Action And Clinical Pharmacology: In vitro studies suggest that the antifungal properties of ketoconazole may be related to its ability to impair the synthesis of ergosterol, a component of fungal and yeast cell membranes. Without the availability of this essential sterol, there are morphological alterations of the fungal and yeast cell membranes manifested as abnormal membranous inclusions between the cell wall and the plasma membrane. The inhibition of ergosterol synthesis has been attributed to interference with the reactions involved in the removal of the 14-a-methyl group of the precursor of ergosterol, lanosterol. tag_IndicationsIndications

Indications And Clinical Uses: For the topical treatment of tinea pedis, tinea corporis and tinea cruris caused by T. rubrum, T. mentagrophytes and E. floccosum; and in the treatment of tinea versicolor (pityriasis) caused by M. furfur (P. orbiculare); and in the treatment of seborrheic dermatitis caused by P. ovale; and in the treatment of cutaneous candidiasis caused by C. albicans.

Contra-Indications: In persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.

Manufacturers’ Warnings In Clinical States: Ketoconazole cream should never be employed for the treatment of infections of the eye.

To prevent a rebound effect after stopping a prolonged treatment with topical corticosteroids, it is recommended to continue applying a mild topical corticosteroid in the morning and to apply ketoconazole cream in the evening, and to subsequently and gradually withdraw the steroid therapy over a period of 2 to 3 weeks.

Precautions: If a reaction suggesting sensitivity or chemical irritation should occur, use of ketoconazole cream should be promptly discontinued.

Pregnancy and Lactation: Limited short-term studies in animals and in human volunteers on whom limited quantities of ketoconazole cream were tested have failed to demonstrate absorption of ketoconazole in detectable amounts. Due to the teratogenic nature of the active ingredient, ketoconazole, caution should be exercised when ketoconazole cream is administered to pregnant or nursing women.

Cross sensitivity with miconazole and other imidazoles may exist and caution is suggested when ketoconazole cream is employed in patients with known sensitivities to imidazoles.

Adverse Reactions: Short-term studies indicate that ketoconazole cream is well tolerated by the skin. During clinical trials, 43 (5.0%) of 867 patients treated with the cream and 3 (1.8%) of 167 patients treated with placebo reported side effects consisting mainly of severe irritation, pruritus and stinging. One of the patients treated with ketoconazole cream 2% developed a painful allergic reaction (swelling of the foot).

In rare circumstances, allergic local skin phenomena such as contact dermatitis have been associated with ketoconazole cream or one of its components, namely sodium sulfite or propylene glycol.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: There has been no experience with overdosage of ketoconazole cream. Treatment should include general supportive measures.

Dosage And Administration: When clinically warranted, therapy with ketoconazole cream may be initiated while results of culture and susceptibility tests are pending. Treatment should be adjusted according to the findings.

Ketoconazole cream should be applied to the affected and immediate surrounding area in patients with the following conditions: (see Table I).

Dosage Conditions , Frequency, Duration

Tinea pedis , once daily, 4 to 6 weeks

Tinea corporis , once daily, 3 to 4 weeks

Tinea cruris , once daily, 2 to 4 weeks

Tinea versicolor , once daily, 2 to 3 weeks

Cutaneous candidiasis , once daily, 2 to 3 weeks

More resistant cases may be treated twice daily depending on patient response.

Seborrheic dermatitis: Use twice daily for 4 weeks.

The full course of therapy should be followed to reduce the possibility of recurrence. If however, there is no response within the recommended treatment period, the diagnosis should be re-evaluated.

The safety of ketoconazole cream has not been established with treatment periods exceeding those recommended; therefore, treatment must not exceed the recommended duration of therapy indicated above.

Availability And Storage: Each g of white, odorless cream contains: ketoconazole 20 mg (2%). Nonmedicinal ingredients: cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, sodium bisulfite, sorbitan monostearate and stearyl alcohol. Tubes of 30 g. Store at room temperature, below 25°C. Keep from freezing. (Shown in Product Recognition Section)

NIZORAL® Cream Janssen-Ortho Ketoconazole Topical Antifungal

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