Sulconazole Nitrate Cream
Dosage form: cream
Drug class:Topical antifungals
Medically reviewed by Drugs.com. Last updated on Jan 24, 2022.
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Rx only
For topical use only. Not for ophthalmic use.
DESCRIPTION
Sulconazole Nitrate Cream 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in Sulconazole Nitrate Cream, is an imidazole derivative with in vitro antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-Dichloro-β-[(p-chlorobenzyl)thio] phenethyl]imidazole mononitrate and it has the following chemical structure:
Sulconazole nitrate, USP is a white to off-white crystalline powder with a molecular weight of 460.77. It is freely soluble in pyridine; slightly soluble in ethanol, acetone, and chloroform; and very slightly soluble in water. It has a melting point of about 130°C.
Sulconazole Nitrate Cream contains sulconazole nitrate, USP 10 mg/g in an emollient cream base consisting of propylene glycol, stearyl alcohol, isopropyl myristate, cetyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl stearate (and) PEG-100 stearate, ascorbyl palmitate, and purified water, with sodium hydroxide and/or nitric acid added to adjust the pH.
CLINICAL PHARMACOLOGY
Sulconazole nitrate is an imidazole derivative with broad-spectrum antifungal activity that inhibits the growth in vitro of the common pathogenic dermatophytes, including Trichophyton rubrum, Trichophyton mentagro- phytes, Epidermophyton floccosum and Microsporum canis. It also inhibits (in vitro) the organism responsible for tinea versicolor, Malassezia furfur. Sulconazole nitrate has been shown to be active in vitro against the following microorganisms, although clinical efficacy has not been established: Candida albicans and certain gram-positive bacteria.
A modified Draize test showed no allergic contact dermatitis and a phototoxicity study showed no phototoxic or photoallergic reaction to Sulconazole Nitrate Cream. Maximization tests with Sulconazole Nitrate Cream showed no evidence of contact sensitiza...
