Phytoral

Phytoral Mechanism of Action

ketoconazole

Manufacturer:

Micro Labs

Distributor:

Zizawa Healthcare
Full Prescribing Info
Action
Synthetic broad-spectrum antifungal agent.
Pharmacology: Mechanism 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.
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.
Dermatophytes: Trichophyton rubrum, T. mentagrophytes, T. tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton floccosum.
Yeasts: Candida albicans, Malassezia ovale (Pityrosporum ovale) and C. tropicalis and the organism responsible for tinea versicolor, Malassezia furfur (Pityrosporum orbiculare).
Ointment: Only those organisms listed under Indications have been proven to be clinically affected. Development of resistance to ketoconazole has not been reported.
Pharmacokinetics: Tablet: Mean plasma levels of approximately 3.5 mg/mL are reached within 1-2 hrs following oral administration of a single 200-mg dose taken with meal. Subsequent plasma elimination is biphasic with a half-life of 2 hrs during the first 10 hrs and 8 hrs, thereafter. Following absorption, ketoconazole is converted into several inactive metabolites. About 13% of the drug is excreted in urine, 2-4% as unchanged drug. The major route of excretion is through faeces (about 57% of a dose), consisting of 20-65% of the unchanged drug and the rest as metabolite.
Ointment: When ketoconazole 2% ointment 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-hr period. Ketoconazole does not penetrate beyond the epidermis, non-percutaneous absorption is detected.
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