Ketoconazole Cream (Ketoconazole Cream) Drug Information: Clinical Pharmacology

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May 27, 2012

Ketoconazole Cream

Ringworm »

Ringworm facts

Ringworm is a common fungal infection of the skin and is not due to a worm.
The medical term for ringworm is tinea. The condition is further named for the site of the body where the infection occurs.
Ringworm causes a scaly, crusted rash that may itch.
Ringworm can be successfully treated with antifungal medications used either topically or orally.

What does the term ringworm mean?

The term ringworm or ringworms refers to fungal infections that are on the surface of the skin. The name is derived from the early belief that the infection was due to a worm, which it is not. Ringworm is a fungal infection in the skin. Nevertheless, the name ringworm remains. Some of these fungi produce round spots on the skin, but many do not. On the other hand, many round, red spots on the skin are not due to a fungal infection. A physical examination of the affected s...

Read the Ringworm article »

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Ketoconazole Cream

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CLINICAL PHARMACOLOGY

When ketoconazole cream, 2% was applied dermally to intact or abraded skin of beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method having a lower detection limit of 2 ng/mL.

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-hour 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 ketoconazole cream, 2%.

Microbiology: Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability of the cell membrane: der-matophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floc-cosum; yeasts: Candida albicans, Malassezia ovale (Pityrosporum ovale) and C. tropicalis; and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare). Only those organisms listed in the INDICATIONS section have been proven to be clinically affected. Development of resistance to ketoconazole has not been reported.

Mode of Action: In vitro studies suggest that ketoconazole impairs the synthesis of ergosterol, which is a vital component of fungal cell membranes. It is postulated that the therapeutic effect of ketoconazole in seborrheic dermatitis is due to the reduction of M. ovale, but this has not been proven.

Last reviewed on RxList: 9/11/2008
This monograph has been modified to include the generic and brand name in many instances.