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General

EXELDERM (sulconazole nitrate) 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.

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. Several females died during the perinatal period, most likely due to labor complications. Sulconazole nitrate was not teratogenic in rats or rabbits at oral doses of 50 mg/kg/day.

There are no adequate and well-controlled studies in pregnant women. Sulconazole nitrate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when sulconazole nitrate is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in children have not been established.

Geriatric Use

Clinical studies of EXELDERM (sulconazole) SOLUTION, 1.0%, did not include sufficient numbers of patients aged 65 years and over to determine whether they respond differently than younger patients. Other reported clinical experience has not identified differences in responses between elderly and younger patients.

Last reviewed on RxList: 7/23/2009
This monograph has been modified to include the generic and brand name in many instances.