IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE:
EXELDERM (sulconazole nitrate) Cream and Solution, 1.0% are antifungal agents indicated for the treatment of tinea pedis (athlete’s foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum
, Trichophyton mentagrophytes
, Epidermophyton floccosum
, and Microsporum canis,
* and for the treatment of tinea versicolor.
SUMMARY OF RISK INFORMATION FOR EXELDERM CREAM AND SOLUTION
EXELDERM (sulconazole nitrate) Cream and Solution, 1.0% are contraindicated in patients who have a history of hypersensitivity to any of its ingredients.
Use EXELDERM (sulconazole nitrate) Cream and Solution, as directed by your physician only. EXELDERM (sulconazole nitrate) Cream and Solution, 1.0% are for external use only. Avoid contact with the eyes. If irritation develops, the cream or solution should be discontinued and appropriate therapy instituted.
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.
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.
It is not known whether sulconazole nitrate is excreted in human milk. Caution should be exercised when sulconazole nitrate is administered to a nursing woman.
Safety and effectiveness in children have not been established.
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.
These preparations are not for ophthalmic, oral, or intravaginal use.
*Efficacy for this organism in the organ system was studied in fewer than 10 infections.
For topical use only. Please see Full Prescribing Information.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.