DESCRIPTION
EXELDERM (sulconazole nitrate) SOLUTION, 1.0% is a broad-spectrum antifungal agent intended for topical application. Sulconazole nitrate, the active ingredient in EXELDERM SOLUTION, is an imidazole derivative with antifungal and antiyeast activity.
Sulconazole nitrate 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 SOLUTION contains sulconazole nitrate 10 mg/mL in a solution of propylene glycol, poloxamer 407, polysorbate 20, butylated hydroxyanisole, and purified water, with sodium hydroxide and, if necessary, nitric acid added to adjust the pH.
INDICATIONS
EXELDERM (sulconazole nitrate) SOLUTION, 1.0% is a broad-spectrum antifungal agent indicated for the treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis and for the treatment of tinea versicolor. Effectiveness has not been proven in tinea pedis (athlete's foot).
Symptomatic relief usually occurs within a few days after starting EXELDERM SOLUTION and clinical improvement usually occurs within one week.
SIDE EFFECTS
There were no systemic effects and only infrequent cutaneous adverse reactions in 370 patients treated with sulconazole nitrate solution in controlled clinical trials. Approximately 1% of these patients reported itching and 1% burning or stinging. These complaints did not usually interfere with treatment.
