Exelderm (sulconazole nitrate)

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Sulconazole nitrate is applied topically to the skin as a 1% cream or 1% solution. These topical preparations are for external use only, and should not be applied to the eye and should not be administered intravaginally. A sufficient amount of sulconazole nitrate 1% cream or 1% solution should be applied to the affected and surrounding areas of skin and rubbed in gently. For once-daily dosing, some clinicians recommend that the drug be applied at bedtime.

Since only small amounts of sulconazole nitrate are absorbed following topical administration, drug interactions are unlikely in patients receiving the drug. While results of an in vitro study indicate that sulconazole may act as a weak inducer of cytochrome P-450 microsomal isoenzymes CYP1A1 and CYP2B1 and the drug therefore theoretically could induce the metabolism of warfarin or other drugs metabolized by these isoenzymes, it is unlikely that such drug interactions would occur with usual topical application of sulconazole nitrate.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

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There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

• No disease contraindications

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Rare or Very Rare

• Anaphylaxis
• Angioedema

More Frequent

• Pruritus of skin
• Skin inflammation
• Skin irritation

Rare or Very Rare

• Abnormal hair texture
• Alopecia
• Cheilitis
• Dermatitis due to topical drug
• Dry skin
• Erythema
• Hair discoloration
• Skin rash
• Stinging of skin

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Sulconazole nitrate has been found to be embryotoxic in rats when given in doses that are 125 times the adult human dosage (on a mg/kg basis). The drug was not teratogenic when given orally to rats or rabbits at dosages of 50 mg/kg daily.

Prolonged gestation and dystocia occurred in rats receiving oral sulconazole in a dosage 125 times the usual human dosage; several maternal rats died during the prenatal period, possibly because of labor complications. Similar effects on parturition (e.g., dystocia, prolonged gestation) also have been reported in animal studies with high doses of other imidazole-derivative azole antifungal agents (e.g., econazole, ketoconazole, miconazole, tioconazole). There are no adequate and controlled studies to date using topical sulconazole nitrate in pregnant women, and the drug should be used during pregnancy only when clearly needed.

Since it is not known whether sulconazole nitrate is distributed into milk following topical application, the drug should be used with caution in nursing women.

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