Sulconazole

SULCONAZOLE NITRATE topical 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 SULCONAZOLE NITRATE topical solution and clinical improvement usually occurs within one week.

A small amount of solution should be gently massaged into the affected and surrounding skin areas once or twice daily. Symptomatic relief usually occurs within a few days after starting SULCONAZOLE NITRATE topical solution 1.0%, and clinical improvement usually occurs within 1 week. To reduce the possibility of recurrence, tinea cruris, tinea corporis, and tinea versicolor should be treated for 3 weeks. If significant clinical improvement is not seen after 4 weeks of treatment, an alternate diagnosis should be considered.

SULCONAZOLE NITRATE topical solution 1.0% is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.

General SULCONAZOLE NITRATE topical solution 1.0% is for external use only. Avoid contact with the eyes. If irritation develops, the solution should be discontinued and appropriate therapy instituted. Information for Patients Patients should be told to use SULCONAZOLE NITRATE topical solution as directed by the physician, to use it externally only, and to avoid contact with the eyes. Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term animal studies to determine carcinogenic potential have not been performed. In vitro studies have shown no mutagenic activity. Pregnancy Pregnancy Category C Sulconazole nitrate has been shown to be embryotoxic in rats when given in doses 125 times the human dose (in mg/kg). The drug at this dose given orally to rats also resulted in prolonged gestation and dystocia.

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.

It is supplied as follows: 30 mL plastic bottle – NDC 72143-321-30 Avoid excessive heat, above 40° C (104° F), and protect from light.