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Zolpak
  • Professionals
  • FDA PI

Zolpak

Generic name: econazole nitrate
Dosage form: cream
Drug class:Topical antifungals

Medically reviewed by Drugs.com. Last updated on Nov 1, 2020.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

Rx Only

For Topical Use Only

Zolpak Description

Econazole Nitrate Cream contains the antifungal agent, econazole nitrate 1% in a water miscible base consisting of pegoxol 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole, and purified water. The white to off-white soft cream is for topical use only.

Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl) methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows:

Zolpak - Clinical Pharmacology

After topical application to the skin of normal subjects, systemic absorption of econazole nitrate is extremely low. Although most of the applied drug remains on the skin surface, drug concentrations were found in the stratum corneum which, by far, exceeded the minimum inhibitory concentration for dermatophytes. Inhibitory concentrations were achieved in the epidermis and as deep as the middle region of the dermis. Less than 1% of the applied dose was recovered in the urine and feces.

Microbiology

Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

DermatophytesYeasts
Epidermophyton floccosumCandida albicans
Microsporum audouiniMalassezia furfur
Microsporum canis
Microsporum gypseum
Trichophyton mentagrophytes
Trichophyton rubrum
Trichophyton tonsurans