Indications

Sulderm is a broad-spectrum antifungal agent 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. Effectiveness has not been proven in tinea pedis (athlete's foot). Symptomatic relief usually occurs within a few days after starting
Sulderm and clinical improvement usually occurs within one week.

Pharmacology

Sulconazole nitrate is an imidazole derivative that inhibits the growth of the common pathogenic dermatophytes including Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton
floccosum, and Microsporum canis. It also inhibits the organism responsible for tinea versicolor, Malassezia furfur, and certain gram positive bacteria. A maximization test with sulconazole nitrate
solution showed no evidence of irritation or contact sensitization.

Dosage & Administration

A small amount of the solution should be gently massaged into the affected and surrounding skin areas once or twice daily. Symptomatic relief usually occurs within a few days after starting
Sulconazole nitrate, and clinical improvement usually occurs within one week. To reduce the possibility of recurrence, tinea cruris, tinea corporis, and tinea versicolor should be treated for 3 weeks. If
significant clinical improvement is not seen after 4 weeks of treatment, an alternate diagnosis should be considered.

Pediatric Use: Safety and effectiveness in children have not been established.

Geriatric Use: Clinical studies of Sulconazole Nitrate, 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.

Contraindications

Sulconazole nitrate is contraindicated in patients who have a history of hypersensitivity to any of the ingredients.

Side Effects

There were no systemic effects and only infrequent cutaneous adverse reactions in 370 patients treated with Sulderm 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.

Pregnancy & Lactation

US FDA pregnancy category C. Animal studies have revealed evidence of embryotoxicity in rats at doses 125 times the human dose (in mg/kg); this dose given orally to rats led to prolonged gestation
and dystocia, and several females died during the perinatal period (likely due to labor complications). Animal studies have failed to reveal evidence of teratogenicity in rats or rabbits at oral doses of 50
mg/kg/day. There are no controlled data in human pregnancy.

Excreted into human milk: Unknown. Excreted into animal milk: Data not available

Precautions & Warnings

General: Sulderm is for external use only. Avoid contact with the eyes. If irritation develops, the solution should be discontinued and appropriate therapy instituted.

Information for Patients: Patients should be told to use Sulderm as directed by the physician, to use it externally only, and to avoid contact with the eyes.

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.

Therapeutic Class

Topical Antifungal preparations