Sulconazole Nitrate

Description

DESCRIPTION EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, USP, the active ingredient in EXELDERM CREAM, is an imidazole derivative with in vitro antifungal and antiyeast activity. Its chemical name is (±)-1-[2,4-dichloro- β -[( p -chlorobenzyl)-thiol]-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. EXELDERM 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 mono-stearate, glyceryl stearate (and) PEG-100 stearate, ascorbyl paImitate, and purified water, with sodium hydroxide and/or nitric acid added to adjust the pH. Chemical Structure

What Is Sulconazole Nitrate Used For?

INDICATIONS AND USAGE EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is an antifungal agent indicated for the treatment of tinea pedis (athlete's foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagro-phytes, Epidermophyton floccosum, and Microsporum canis,* and for the treatment of tinea versicolor. *Efficacy for this organism in the organ system was studied in fewer than ten infections.

Dosage and Administration

DOSAGE AND ADMINISTRATION A small amount of cream should be gently massaged into the affected and surrounding skin areas once or twice daily, except in tinea pedis, where administration should be twice daily. Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, tinea corporis/cruris and tinea versicolor should be treated for 3 weeks and tinea pedis for 4 weeks to reduce the possibility of recurrence. If significant clinical improvement is not seen after 4 to 6 weeks of treatment, an alternate diagnosis should be considered.

Side Effects (Adverse Reactions)

ADVERSE REACTIONS There were no systemic effects and only infrequent cutaneous adverse reactions in 1185 patients treated with sulconazole nitrate cream in controlled clinical trials. Approximately 3% of these patients reported itching, 3% burning or stinging, and 1% redness. These complaints did not usually interfere with treatment.

Contraindications

CONTRAINDICATIONS EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is contraindicated in patients who have a history of hypersensitivity to any of its ingredients.

Pregnancy and Breastfeeding

Pregnancy There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if clearly needed. Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses of 125 times the adult human dose (in mg/kg). The drug was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day. Sulconazole nitrate given orally to rats at a dose 125 times the human dose resulted in prolonged gestation and dystocia. Several females died during the prenatal period, most likely due to labor complications.

Nursing Mothers It is not known whether sulconazole nitrate is excreted in human milk. Caution should be exercised when sul- conazole nitrate is administered to a nursing woman.

How Supplied

HOW SUPPLIED EXELDERM (sulconazole nitrate, USP) CREAM, 1.0% is a smooth, glossy white to off-white cream having a slight characteristic odor. It is supplied as follows: 60 g tube – NDC 69489-711-60 Avoid excessive heat, above 40° C (104° F). To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. JOURNEY ® MEDICAL CORPORATION Manufactured for: Journey Medical Corp. Scottsdale, AZ 85258 www.JMCderm.com 141113 Revised March 2021