Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Cream, External, as nitrate:
Exelderm: 1% (15 g [DSC], 30 g [DSC], 60 g) [contains cetyl alcohol, propylene glycol]
Generic: 1% (60 g)
Solution, External, as nitrate:
Exelderm: 1% (30 mL) [contains propylene glycol]
Generic: 1% (30 mL [DSC])
Pharmacology
Mechanism of Action
Substituted imidazole derivative which inhibits metabolic reactions necessary for the synthesis of ergosterol, an essential membrane component. The end result is usually fungistatic; however, sulconazole may act as a fungicide in Candida albicans and Candida parapsilosis during certain growth phases.
Pharmacokinetics/Pharmacodynamics
Absorption
Topical: ~8.7% percutaneously (Franz 1988)
Excretion
Primarily urine
Use: Labeled Indications
Fungal infections:
Cream: Treatment of tinea pedis (athlete's foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; treatment of tinea versicolor
Solution: Treatment of tinea cruris and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; treatment of tinea versicolor
Limitations of use: Effectiveness has not been proven in tinea pedis (athlete's foot).
Contraindications
Hypersensitivity to sulconazole or any component of the formulation
Dosage and Administration
Dosing: Adult
Tinea corporis/tinea cruris/tinea versicolor: Topical: Apply a small amount to the affected and surrounding skin areas once or twice daily for 3 weeks
Tinea pedis: Topical: Cream: Apply a small amount to the affected area twice daily for 4 weeks
Dosing: Geriatric
Refer to adult dosing.
Administration
For external use only; avoid contact with the eyes. Apply a small amount and gently massage into affected and surrounding skin areas.
Storage
Avoid excessive heat, above 40°C (104°F); protect solution from light.
Drug Interactions
There are no known significant interactions.
Adverse Reactions
1% to 10%:
Central nervous system: Localized burning
Dermatologic: Localized erythema, pruritus, stinging of the skin
Warnings/Precautions
Concerns related to adverse effects:
- Irritation: Discontinue if sensitivity or irritation occurs.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Other warnings/precautions:
- Appropriate use: For topical use only; avoid contact with eyes.
Pregnancy
Pregnancy Risk Factor
C
Pregnancy Considerations
Adverse events have been observed in animal reproduction studies with large doses administered orally. Systemic absorption is limited following topical administration.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Have patient report immediately to prescriber skin irritation (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
