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Exelderm

Generic Name: Sulconazole Nitrate
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

Medically reviewed on Jul 2, 2018

Introduction

Antifungal; azole (imidazole derivative).1 2 3 18

Uses for Exelderm

Dermatophytoses

Treatment of tinea corporis (body ringworm) and tinea cruris (jock itch) caused by Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, or T. rubrum.1 2 3 5 11 12 13 14 15 20 21 25 26 27 39 40 43 45 56

Treatment of tinea pedis (athlete’s foot) 3 5 11 12 13 14 20 21 25 27 39 40 43 45 caused by E. floccosum, M. canis, T. mentagrophytes, or T. rubrum.2 3 5 11 12 13 14 15 20 21 25 26 27 39 40 43 45 56

Topical antifungals usually effective for treatment of uncomplicated tinea corporis or tinea cruris.40 58 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.39 40 43 44 45 56

Topical antifungals usually effective for treatment of uncomplicated tinea pedis.45 56 59 An oral antifungal may be necessary for treatment of hyperkeratotic areas on the soles, for chronic moccasin-type (dry-type) tinea pedis,15 and for tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).40 45 56

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).1 2 3 8 10

Topical antifungals usually effective;39 41 42 44 53 60 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.41 42 44 53 58

Cutaneous Candidiasis

Treatment of cutaneous candidiasis caused by Candida albicans.9 22

Exelderm Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a 1% cream or solution.1 3

Do not apply to the eye or administer orally or intravaginally.1 3 19

Apply a sufficient amount of cream or solution; rub gently into affected area and immediately surrounding healthy skin.1 3 14 15 26

Dosage

Adults

Dermatophytoses
Tinea Corporis or Tinea Cruris
Topical

Apply 1% cream or solution once or twice daily1 3 14 15 26 for 3 weeks.1 3

If clinical improvement does not occur after 4–6 weeks of treatment, reevaluate diagnosis.3 58

Tinea Pedis
Topical

Apply 1% cream twice daily3 14 15 26 for 4 weeks.1 3 58

If clinical improvement does not occur after 4–6 weeks of treatment, reevaluate diagnosis.3 58 Chronic moccasin-type (dry-type) tinea pedis may require 4–8 weeks or longer.15 40

Pityriasis (Tinea) Versicolor
Topical

Apply 1% cream or solution once or twice daily1 3 14 15 26 for 3 weeks.1 3

If clinical improvement does not occur after 4–6 weeks of treatment, reevaluate diagnosis.1 3

Special Populations

No special population dosage recommendations at this time.1 3

Cautions for Exelderm

Contraindications

Known hypersensitivity to sulconazole or any ingredient in the formulation.1 3 19 58

Warnings/Precautions

Warnings

Application Precautions

For external use only.1 3 Use only for topical application to the skin; not for ophthalmic or intravaginal use.1 3 19

Fetal/Neonatal Morbidity and Mortality

Embryotoxicity demonstrated in animals receiving oral sulconazole.1 3 19

Sensitivity Reactions

Hypersensitivity Reactions

Contact dermatitis reported following topical application of sulconazole2 11 or other imidazole-derivative azole antifungals.5 28 29 30 46 47 48

If irritation or sensitivity occurs, discontinue the drug and initiate appropriate therapy.1 3

Possible cross-sensitization among the imidazoles.4 28 29 30 46 47 48

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.39 40 45 56 58

Specific Populations

Pregnancy

Category C.1 3 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether distributed into milk.1 3 Caution advised.1 3

Pediatric Use

Safety and efficacy not established.1 3

Geriatric Use

Insufficient data from clinical studies to determine whether patients ≥65 years of age respond differently than younger adults.1 3 Clinical experience to date has not identified differences in responses between geriatric patients and younger adults.1 3

Common Adverse Effects

Pruritus,2 3 5 8 9 10 15 22 burning,1 3 5 8 10 15 22 25 stinging,1 3 10 15 erythema.2 3 5 8 10 22

Interactions for Exelderm

Weak inducer of CYP1A1 and CYP2B1.35

Drugs Metabolized by Hepatic Microsomal Enzymes

Potential pharmacokinetic interaction with drugs metabolized by CYP1A1 or 2B1;38 interaction unlikely with topical administration of sulconazole58 since only low amounts absorbed following topical application to skin.2 16 19 34

Exelderm Pharmacokinetics

Absorption

Bioavailability

Low amounts of sulconazole are absorbed systemically following topical application to skin.2 16 19 34

Distribution

Extent

Not known whether sulconazole is distributed into milk.1 3

Elimination

Elimination Route

Systemically absorbed drug is excreted in urine (6.7%) and feces (2%).16

Stability

Storage

Topical

Cream

≤40°C.3

Solution

≤40°C; protect from light.1 3

Actions and Spectrum

  • Imidazole-derivative azole antifungal.1 2 3 18

  • Usually fungistatic; may be fungicidal at high concentrations against very susceptible organisms.2 7

  • Presumably exerts its antifungal activity by altering cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition.2 24 Fungistatic activity may result from interference with ergosterol synthesis.2 43 57

  • Spectrum of antifungal activity includes many fungi, including yeasts and dermatophytes.1 2 3 7 17 18 23 37 Also has in vitro activity against some gram-positive bacteria.1 2 3 18 37

  • Dermatophytes: Active in vitro against Epidermophyton floccosum,1 2 3 18 Microsporum audouinii,18 M. canis,1 2 3 M. gypseum,2 18 Trichophyton mentagrophytes,1 2 3 18 T. rubrum,1 2 3 18 T. tonsurans,2 18 and T. violaceum.2

  • Candida: Active in vitro against Candida albicans,2 7 17 18 23 C. glabrata (formerly Torulopsis glabrata),2 C. guilliermondii,2 17 C. krusei,2 17 C. parapsilosis,2 17 C. pseudotropicalis,2 17 and C. tropicalis.2 17

  • Other fungi: Active in vitro against Malassezia furfur (Pityrosporum orbiculare or P. ovale).1 2 3 Also active in vitro against Aspergillus,2 Blastomyces dermatitidis,2 Cryptococcus neoformans,2 18 Histoplasma capsulatum,2 and Paracoccidioides brasiliensis.2 17 23

  • Bacteria: Active in vitro against Bacillus subtilis,2 Clostridium perfringens,2 C. tetani,2 C. botulinum,2 Enterococcus faecalis,2 Erysipelothrix rhusiopathiae,6 Micrococcus luteus,2 Propionibacterium acnes,18 Staphylococcus aureus,2 S. epidermidis,2 and S. saprophyticus.2

  • Cross-resistance can occur among the azole antifungals.23 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.23

Advice to Patients

  • Importance of completing full course of treatment, even if symptoms improve.1 3

  • Importance of contacting clinician if skin condition worsens during treatment or if improvement does not occur after completing full course of therapy.1 3

  • Importance of discontinuing use and consulting clinician if treated area becomes irritated.1 3

  • Importance of applying to affected areas as directed1 3 and avoiding contact with eyes and not applying intravaginally.1 3 19

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1 3

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 3

  • Importance of informing patients of other important precautionary information.1 3 (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.

Sulconazole Nitrate

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 2018, Selected Revisions July 1, 2007. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

1. Westwood Squibb Pharmaceuticals. Exelderm (sulconazole nitrate) 1% solution prescribing information. Princeton, NJ; 2006 Apr.

2. Benfield P, Clissold SP. Sulconazole: a review of its antimicrobial activity and therapeutic use in superficial dermatomycoses. Drugs. 1988; 35:143-53. http://www.ncbi.nlm.nih.gov/pubmed/3281821?dopt=AbstractPlus

3. Westwood Squibb Pharmaceuticals. Exelderm (sulconazole nitrate) 1% cream prescribing information. Buffalo, NY; 2003 May 29.

4. Bigardi AS, Pigatto PD, Altomare G. Allergic contact dermatitis due to sulconazole. Contact Dermatitis. 1992; 26:281-2. http://www.ncbi.nlm.nih.gov/pubmed/1395584?dopt=AbstractPlus

5. Tanenbaum L, Anderson C, Rosenberg MJ et al. Sulconazole nitrate 1.0 percent cream: a comparison with miconazole in the treatment of tinea pedis and tinea cruris/corporis. Cutis. 1982; 30:105-7, 115, 118. http://www.ncbi.nlm.nih.gov/pubmed/6749440?dopt=AbstractPlus

6. Nolting S, Strauss WB. Treatment of impetigo and ecthyma: a comparison of sulconazole with miconazole. Int J Dermatol. 1988; 27:716-9. http://www.ncbi.nlm.nih.gov/pubmed/3069760?dopt=AbstractPlus

7. Beggs WH. Influence of growth phase on the susceptibility of Candida albicans to butoconazole, oxiconazole, and sulconazole. J Antimicrob Chemother. 1985; 16:397-9. http://www.ncbi.nlm.nih.gov/pubmed/3902762?dopt=AbstractPlus

8. Tham SN. Treatment of pityriasis versicolor: comparison of sulconazole nitrate 1% solution and clotrimazole 1% solution. Australas J Dermatol. 1987; 28:123-5. http://www.ncbi.nlm.nih.gov/pubmed/3332758?dopt=AbstractPlus

9. Rajan VS, Thirumoorthy T. Treatment of cutaneous candidiasis: a double blind, parallel comparison of sulconazole nitrate 1% cream and clotrimazole 1% cream. Australas J Dermatol. 1983;24:33-6.

10. Tanenbaum L, Anderson C, Rosenberg MJ et al. 1% sulconazole cream v 2% miconazole cream in the treatment of tinea versicolor. Arch Dermatol. 1984; 120:216-9. http://www.ncbi.nlm.nih.gov/pubmed/6364994?dopt=AbstractPlus

11. Lassus A, Forström S, Salo O. A double-blind comparison of sulconazole nitrate 1% cream with clotrimazole 1% cream in the treatment of dermatophytoses. Br J Dermatol. 1983; 108:195-8. http://www.ncbi.nlm.nih.gov/pubmed/6337618?dopt=AbstractPlus

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14. Cuce LC. Sulconazole nitrate 1% cream vs clotrimazole 1% cream in the treatment of tinea pedis. Curr Ther Res. 1989; 45:421-7.

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17. Hernández Molina JM, Llosá J, Martinez Brocal A et al. In vitro activity of cloconazole, sulconazole, butoconazole, isoconazole, fenticonazole, and five other antifungal agents against clinical isolates of Candida albicans and Candida spp. Mycopathologia. 1992; 118:15-21. http://www.ncbi.nlm.nih.gov/pubmed/1406898?dopt=AbstractPlus

18. Westwood Squibb Pharmaceuticals. Exelderm (sulconazole nitrate 1%) cream and solution product monograph. Buffalo, NY.

19. Westwood Squibb Pharmaceuticals. Exelderm (sulconazole nitrate) product information. Buffalo, NY; 1990 Aug.

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