Nizoral Cream: Information

KetoconazoleTopical Antifungal

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.

Indications

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.

Contraindications

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

Warnings

Ketoconazole cream should never be employed for the treatment of infections of the eye.

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 the 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 Effects

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).

Overdose

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

Dosage

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.

The cream should be applied to the affected and immediate surrounding area in patients with the following conditions: Tinea pedis: Use once daily for 4 to 6 weeks.

Tinea corporis: Use once daily for 3 to 4 weeks.

Tinea cruris: Use once daily for 2 to 4 weeks.

Tinea versicolor: Use once daily for 2 to 3 weeks.

Cutaneous candidiasis: Use once daily for 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.

Supplied

Each g of white, odorless cream contains: ketoconazole 20 mg (2%).

Nonmedicinal ingredients: cetyl alcohol, isopropyl myristate, polysorbate, propylene glycol, purified water, sodium bisulfite, sorbitan monostearate and stearyl alcohol.

Tubes of 30 g.