IMPORTANT SAFETY INFORMATION
INDICATIONS AND USAGE: EXELDERM
® (sulconazole nitrate) Cream and Solution, 1.0% are antifungal agents 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. *Efficacy for this organism in the organ system was studied in
fewer than 10 infections. EXELDERM
® Cream is also indicated for the treatment of
tinea pedis (athlete's foot). Effectiveness of EXELDERM
® Solution has not been proven in
tinea pedis.
SUMMARY OF RISK INFORMATION FOR EXELDERM® CREAM AND SOLUTION
CONTRAINDICATIONS: EXELDERM
® (sulconazole nitrate) Cream and Solution, 1.0% are contraindicated in patients who have a history of hypersensitivity to any of its ingredients.
PRECAUTIONS: 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 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.
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.
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.
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.
