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 and 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.
