Composition: Each 100 gm contains Ketoconazole 2 gm.
Mode of Action and Microbiology
CLARAZOLE is a broad-spectrum synthetic antifungal cream used for topical treatment of skin and mucous membrane fungal infections. The antifungal properties of CLARAZOLE cream is related to its ability to impair the synthesis of ergosterol, which is a vital compound of fungal and yeast cell membranes required for growth and functions of these organisms.
Ketoconazole inhibits the in vitro growth of the following dermatophytes and yeasts :
- Trichophyton …. Trichophyton red (Latin: Trichophyton rubrum) is a type of Trichophyton. This fungus is the most common cause of athlete’s foot, jock itch, and ringworm. It is also the most common cause of fungal nail infections.
- Microsporium is a genus of fungi that cause fungal infections of the skin.
- Epidermophyton ( is a genus of fungi that cause superficial fungal infections of the skin, including Epidermophyton floccosum that causes tinea of the body, jock itch, athlete’s foot), and fungal infection of toenails.
- Candida albicans , is the most famous species of the genus Candida, a fungal yeast that causes candidiasis( fungal vaginal infection), and it lives as a microbe within the normal human flora, and is present in the upper respiratory tract, mouth, intestines and vagina. Candida albicans is considered one of the most common yeasts and the cause of 90% of human infections, and because it is an opportunistic microbe; It can be fatal in some cases of cancer, organ transplantation.
- Candida tropicalis, is a type of yeast in the genus Candida. Candida tropical infection is treated with amphotericin B, quincandin, or long-acting triazole antifungals.
- Malassezia (formerly known as Pityrosporum) is a genus of fungi that are classified as yeasts. Malassezia is naturally present on the skin surfaces of many animals as well as humans. One of the most common infections caused by Malassezia fungi, (folliculitis)is an inflammatory skin disorder that usually manifests as an itchy rash on the upper torso of young to middle-aged adults.
Indications and Usage
CLARAZOLE cream is indicated for the topical treatment of:
- Tinea pedis (Athlete’s foot), tinea corporis, tinea cruris that is caused by Trichophyton rubrum, T. mentagrophytes & Epidermophyton floccosum .
- Tinea versicolor (pityriasis), which is caused by Malassezia furfur.
- Cutaneous candidiasis caused by candid species .
- Seborrheic dermatitis caused by Malassezia ovate (p. ovale).
CLARAZOLE cream is contraindicated in patients who have shown hypersensitivity to Ketoconazole or the excipients of this formulation.
CLARAZOLE cream is not for ophthalmic use.
General: If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued.
CLARAZOLE cream should be used during pregnancy only if the potential benefit justifies the potentialrisk to the fetus.
It is not known whether CLARAZOLE cream administered topically could result in sufficient systemic absorption to produce detectable quantities in breast milk or not Nevertheless, a decision should be made whether to discontinue nursing or discontinue the drug. taking into account the importance of the drug to the mother.
Safety and effectiveness in children have not been established.
Dosage and Administration
- For Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis or pityriasis versicolor: CLARAZOLE cream to be applied once a day to the affected and surrounded skin area once daily for 2 weeks in order to reduce the possibility of recurrence
- Patients with tinea versicolor usually require 3 weeks of treatment .
- Patients with tines pedis require 6 weeks of treatment.
- For seborrheic dermatitis: CLARAZOLE cream to be applied twice a day to the affected and surrounding skin area for 4 weeks or until clinical cure.
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