Topical antifungal and anti-inflammatory.
In vitro studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes.
Microbiology: Ketoconazole is broad-spectrum synthetic antifungal agent which inhibits the growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane.
Dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum; yeasts: Candida albicans and C. tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare). Development of resistance to ketoconazole has not been reported.
Pharmacokinetics: When Nizoral (ketoconazole) 2% Cream was applied dermally to intact or abraded skin of Beagle dogs for 28 consecutive days at a dose of 80 mg, plasma concentrations did not significantly differ from the lower detection limit (2 ng/mL) of the method employed. After a single topical application to the chest, back and arms of normal volunteers, systemic absorption of ketoconazole was not detected at the 5 ng/mL level in blood over a 72-hr period.
Two dermal irritancy studies, a human sensitization test, a phototoxicity study and a photoallergy study conducted in 38 male and 62 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity and no photoallergenic potential due to Nizoral Cream.
For topical application in the treatment of dermatophyte infections of the skin: Tinea corporis, tinea cruris, tinea manus and tinea pedis due to Trichophyton rubrum, Trichophyton mentagrophytes, Microsporum canis and Epidermophyton floccosum, as well as in the treatment of cutaneous candidiasis and tinea (pityriasis) versicolor.
For the treatment of seborrheic dermatitis, a skin condition related with the presence of Malassezia furfur.
Nizoral Cream provides anti-inflammatory effects and relieves pruritus symptom comparable to hydrocortisone 1%.
Nizoral Cream should be applied to affected areas once or twice daily (depending on the severity of infection) in patients with tinea corporis, tinea cruris, tinea manus, tinea pedis, cutaneous candidosis and once daily in patients with tinea versicolor. But twice daily in patients with seborrheic dermatitis.
Treatment should be continued for a sufficient period, at least until a few days after disappearance of all symptoms. The diagnosis should be reconsidered if no clinical improvement is noted after 4 weeks of treatment. General measures in regard to hygiene should be observed to control sources of infection or reinfection.
The usual duration of treatment is: Tinea versicolor 2-3 weeks, yeast infections 2-3 weeks, seborrheic dermatitis 2-4 weeks, tinea cruris 2-4 weeks, tinea corporis 3-4 weeks, tinea pedis 4-6 weeks.
Individuals who have shown hypersensitivity to any of the ingredients of Nizoral Cream. Do not use immediately after chronic use of local steroids.
Nizoral Cream is not for ophthalmic use.
General: If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued.
Carcinogenicity, Mutagenicity & Impairment of Fertility: Not relevant since Nizoral Cream applied topically is not absorbed.
Not relevant since Nizoral Cream applied topically is not absorbed.
A few instances of irritation and burning sensation have been observed during treatment with Nizoral Cream.
D01AC08 - ketoconazole ; Belongs to the class of imidazole and triazole derivatives. Used in the topical treatment of fungal infection.