EXELDERM® Cream and Solution
Broad-spectrum, topical antifungal agent effective against common fungal infections2
- Available as a cream or a solution
- Convenient once- or twice-daily application. Athlete’s foot should be treated with EXELDERM® Cream twice a day2
- Majority of patients experience early relief of symptoms2
- Ringworm, jock itch, and tinea versicolor should be treated for 3 weeks to reduce the possibility of recurrence2
- Athlete’s foot should be treated with EXELDERM® Cream for 4 weeks to reduce the possibility of recurrence2
EXELDERM® Cream for athlete’s foot
Male patient diagnosed with tinea pedis (athlete’s foot). Patient complained about severe discomfort from itching, swelling, and redness. After EXELDERM® Cream was applied twice daily for 30 days, patient was clear of all signs and symptoms of athlete’s foot.
Photographs courtesy of Stephen Mahoney, MD.
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.