Sulconazole (Monograph)
Brand name: Exelderm
Drug class: Azoles
ATC class: D01AC09
VA class: DE102
Chemical name: (±)-1-[2-[[(4-Chlorophenyl)methyl]thio]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate
Molecular formula: C18H15Cl3N2S•HNO3
CAS number: 61318-91-0
Introduction
Antifungal; azole (imidazole derivative).
Uses for Sulconazole
Dermatophytoses
Treatment of tinea corporis (body ringworm) and tinea cruris (jock itch) caused by Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, or T. rubrum.
Treatment of tinea pedis (athlete’s foot) caused by E. floccosum, M. canis, T. mentagrophytes, or T. rubrum.
Topical antifungals usually effective for treatment of uncomplicated tinea corporis or tinea cruris. An oral antifungal may be necessary when tinea corporis or tinea cruris is extensive, dermatophyte folliculitis is present, infection does not respond to topical therapy, or patient is immunocompromised because of coexisting disease or concomitant therapy.
Topical antifungals usually effective for treatment of uncomplicated tinea pedis. An oral antifungal may be necessary for treatment of hyperkeratotic areas on the soles, for chronic moccasin-type (dry-type) tinea pedis, and for tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).
Pityriasis (Tinea) Versicolor
Treatment of pityriasis (tinea) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).
Topical antifungals usually effective; an oral antifungal (with or without a topical antifungal) may be necessary in patients who have extensive or severe infections or failed to respond to or have frequent relapses with topical therapy.
Cutaneous Candidiasis
Treatment of cutaneous candidiasis† [off-label] caused by Candida albicans.
Sulconazole Dosage and Administration
Administration
Topical Administration
Apply topically to the skin as a 1% cream or solution.
Do not apply to the eye or administer orally or intravaginally.
Apply a sufficient amount of cream or solution; rub gently into affected area and immediately surrounding healthy skin.
Dosage
Adults
Dermatophytoses
Tinea Corporis or Tinea Cruris
TopicalApply 1% cream or solution once or twice daily for 3 weeks.
If clinical improvement does not occur after 4–6 weeks of treatment, reevaluate diagnosis.
Tinea Pedis
TopicalApply 1% cream twice daily for 4 weeks.
If clinical improvement does not occur after 4–6 weeks of treatment, reevaluate diagnosis. Chronic moccasin-type (dry-type) tinea pedis may require 4–8 weeks or longer.
Pityriasis (Tinea) Versicolor
Topical
Apply 1% cream or solution once or twice daily for 3 weeks.
If clinical improvement does not occur after 4–6 weeks of treatment, reevaluate diagnosis.
Special Populations
No special population dosage recommendations at this time.
Cautions for Sulconazole
Contraindications
Known hypersensitivity to sulconazole or any ingredient in the formulation.
Warnings/Precautions
Warnings
Application Precautions
For external use only. Use only for topical application to the skin; not for ophthalmic or intravaginal use.
Fetal/Neonatal Morbidity and Mortality
Embryotoxicity demonstrated in animals receiving oral sulconazole.
Sensitivity Reactions
Hypersensitivity Reactions
Contact dermatitis reported following topical application of sulconazole or other imidazole-derivative azole antifungals.
If irritation or sensitivity occurs, discontinue the drug and initiate appropriate therapy.
Possible cross-sensitization among the imidazoles.
General Precautions
Selection and Use of Antifungals
Prior to initiation of treatment, confirm diagnosis by direct microscopic examination of scrapings from infected tissue mounted in potassium hydroxide (KOH) or by culture.
Specific Populations
Pregnancy
Category C. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)
Lactation
Not known whether distributed into milk. Caution advised.
Pediatric Use
Safety and efficacy not established.
Geriatric Use
Insufficient data from clinical studies to determine whether patients ≥65 years of age respond differently than younger adults. Clinical experience to date has not identified differences in responses between geriatric patients and younger adults.
Common Adverse Effects
Pruritus, burning, stinging, erythema.
Drug Interactions
Weak inducer of CYP1A1 and CYP2B1.
Drugs Metabolized by Hepatic Microsomal Enzymes
Potential pharmacokinetic interaction with drugs metabolized by CYP1A1 or 2B1; interaction unlikely with topical administration of sulconazole since only low amounts absorbed following topical application to skin.
Sulconazole Pharmacokinetics
Absorption
Bioavailability
Low amounts of sulconazole are absorbed systemically following topical application to skin.
Distribution
Extent
Not known whether sulconazole is distributed into milk.
Elimination
Elimination Route
Systemically absorbed drug is excreted in urine (6.7%) and feces (2%).
Stability
Storage
Topical
Cream
≤40°C.
Solution
≤40°C; protect from light.
Actions and Spectrum
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Imidazole-derivative azole antifungal.
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Usually fungistatic; may be fungicidal at high concentrations against very susceptible organisms.
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Presumably exerts its antifungal activity by altering cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition. Fungistatic activity may result from interference with ergosterol synthesis.
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Spectrum of antifungal activity includes many fungi, including yeasts and dermatophytes. Also has in vitro activity against some gram-positive bacteria.
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Dermatophytes: Active in vitro against Epidermophyton floccosum, Microsporum audouinii, M. canis, M. gypseum, Trichophyton mentagrophytes, T. rubrum, T. tonsurans, and T. violaceum.
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Candida: Active in vitro against Candida albicans, C. glabrata (formerly Torulopsis glabrata), C. guilliermondii, C. krusei, C. parapsilosis, C. pseudotropicalis, and C. tropicalis.
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Other fungi: Active in vitro against Malassezia furfur (Pityrosporum orbiculare or P. ovale). Also active in vitro against Aspergillus, Blastomyces dermatitidis, Cryptococcus neoformans, Histoplasma capsulatum, and Paracoccidioides brasiliensis.
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Bacteria: Active in vitro against Bacillus subtilis, Clostridium perfringens, C. tetani, C. botulinum, Enterococcus faecalis, Erysipelothrix rhusiopathiae, Micrococcus luteus, Propionibacterium acnes, Staphylococcus aureus, S. epidermidis, and S. saprophyticus.
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Cross-resistance can occur among the azole antifungals. Some C. albicansisolates from patients undergoing long-term azole antifungal therapy show decreased in vitro susceptibility to sulconazole and other imidazole-derivative antifungals as well as to triazole derivatives.
Advice to Patients
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Importance of completing full course of treatment, even if symptoms improve.
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Importance of contacting clinician if skin condition worsens during treatment or if improvement does not occur after completing full course of therapy.
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Importance of discontinuing use and consulting clinician if treated area becomes irritated.
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Importance of applying to affected areas as directed and avoiding contact with eyes and not applying intravaginally.
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Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.
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Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.
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Importance of informing patients of other important precautionary information. (See Cautions.)
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
Routes |
Dosage Forms |
Strengths |
Brand Names |
Manufacturer |
---|---|---|---|---|
Topical |
Cream |
1% |
Exelderm (with propylene glycol) |
Westwood-Squibb |
Solution |
1% |
Exelderm (with propylene glycol) |
Westwood-Squibb |
AHFS DI Essentials™. © Copyright 2025, Selected Revisions July 1, 2007. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
† Off-label: Use is not currently included in the labeling approved by the US Food and Drug Administration.
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