ATC Class:D01AC09

VA Class:DE102

AHFS Class:

• Azoles 84:04.08.08

Generic Name(s):

• Sulconazole Nitrate

Chemical Name:

• (±)-1-[2-[[(4-Chlorophenyl)methyl]thio]-2-(2,4-dichlorophenyl)ethyl]-1 H -imidazole mononitrate

Molecular Formula:

• C₁₈H₁₅C_l3N₂S•HNO₃

Sulconazole nitrate, an imidazole derivative, is a synthetic azole antifungal agent.1,2,3,18

Dermatophytoses

Sulconazole nitrate is used topically for the treatment of certain dermatophytoses, including tinea corporis (body ringworm), tinea cruris (jock itch), and tinea pedis (athlete's foot) 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

Because tinea capitis (dermatophyte infections of the scalp),39,40,43,44,54,55,56 tinea barbae (dermatophyte infections of bearded areas of face and neck),40,54 and tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis)39,40,43,44,56 generally must be treated using oral antifungals, sulconazole nitrate is not indicated in the treatment of these dermatophytoses.

Tinea Corporis and Tinea Cruris

Sulconazole nitrate 1% cream or 1% solution is used topically for the treatment of tinea corporis or tinea cruris caused by E. floccosum , M. canis , T. mentagrophytes , or T. rubrum .1,2,3,5,11,12,20,21,27,39,40,43,45,56

Many clinicians consider topical imidazole-derivative azole antifungals (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole) or topical allylamine antifungals (e.g., naftifine, terbinafine) the drugs of first choice for the topical treatment of tinea corporis or tinea cruris,40,58 although other agents (e.g., ciclopirox olamine, butenafine hydrochloride, tolnafate, undecylenic acid) also can be effective in the treatment of these infections.39,40,43,44,45,56 Tinea corporis and tinea cruris generally can be effectively treated using a topical antifungal; however, an oral antifungal may be necessary if the disease is extensive, dermatophyte folliculitis is present, the infection does not respond to topical therapy, or the patient is immunocompromised because of a coexisting disease or concomitant therapy.39,40,43,44,45,56

Results of several controlled studies in otherwise healthy adults with tinea corporis or tinea cruris indicate that topical sulconazole nitrate 1% cream is at least as effective as topical clotrimazole 1% cream in clearing signs and symptoms of these dermatophyte infections (e.g., erythema, scaling, maceration, pruritus, fissuring, vesiculation).11,20,26 In a controlled study comparing once daily application of sulconazole nitrate 1% cream and twice-daily application of clotrimazole 1% cream in otherwise healthy adults with tinea corporis or tinea cruris, complete clearance of lesions and a mycologic cure was obtained in 100% of patients in both groups after 3 weeks of treatment.26

In comparative studies evaluating sulconazole nitrate 1% cream and miconazole nitrate 2% cream administered twice daily for 3 weeks for the treatment of tinea corporis or tinea cruris in otherwise healthy adults 18-67 years of age, sulconazole nitrate was at least as effective or slightly more effective than miconazole nitrate in reducing signs and symptoms of these infections and in producing mycologic cures;5,12,25 there was some evidence that the response to sulconazole nitrate may be more rapid than the response to miconazole nitrate.12,25 Signs and symptoms of tinea corporis or tinea cruris (e.g., erythema, scaling, maceration, pruritus, fissuring) were completely cleared in 92-93% of those who received sulconazole nitrate and in 71-90% of those who received miconazole nitrate.12,25 In one study, a mycologic cure was attained within 3 weeks in more than 90% of patients treated with either drug, but the relapse rate 3-6 weeks after completion of therapy was 16 or 35% in those who received sulconazole nitrate or miconazole nitrate, respectively.5

Tinea Pedis

Sulconazole nitrate 1% cream is used topically for the treatment of tinea pedis caused by E. floccosum , M. canis , T. mentagrophytes , or T. rubrum ;3,5,11,12,13,14,20,21,25,27,39,40,43,45 sulconazole nitrate 1% solution has not been evaluated for the treatment of this condition.1

Interdigital and vesiculobullous forms of tinea pedis generally can be treated effectively using topical therapy with an imidazole-derivative azole antifungal (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole), an allylamine antifungal (e.g., naftifine, terbinafine), or other topical agents such as ciclopirox olamine, butenafine hydrochloride, tolnaftate, or undecylenic acid.43,45,56,59 Because tinea pedis often involves a mixed infection, imidazole derivatives offer an advantage over some other agents for the treatment of these infections since the drugs are active against both dermatophytes and yeasts.40

In controlled clinical studies, topical sulconazole nitrate 1% cream generally has been as effective (or slightly more effective) and as well tolerated as topical clotrimazole 1% cream11,14,20 or topical miconazole nitrate 2% cream5,12,13,25 for the treatment of tinea pedis. In controlled studies involving immunocompetent patients 3-74 years of age with acute tinea pedis, 3-5 weeks of treatment with sulconazole nitrate 1% cream, clotrimazole 1% cream, or miconazole nitrate 2% cream was associated with complete clearance or partial improvement of lesions in 63-91, 62-87, or 82% of patients, respectively, and mycologic cures in 75-100, 65, or 70-81% of patients, respectively.13,14

Topical sulconazole nitrate has been effective in some patients for the treatment of chronic moccasin-type (dry-type) tinea pedis.15 In a placebo-controlled study in patients 12-78 years of age with chronic moccasin-type tinea pedis caused by T. rubrum who were randomized to receive sulconazole nitrate 1% cream or vehicle placebo twice daily for 4-6 weeks, a mycologic cure was attained in 70% of those who received the drug and 30% of those who received placebo;15 2 weeks after completion of treatment, there were relapses (confirmed by culture and KOH wet mounts) in 23 and 71% of patients, respectively.15 Patients with chronic moccasin-type tinea pedis generally have less of a response to topical antifungal agent therapy than patients with acute tinea pedis, and the relapse rate is high.15,40 Therefore, some clinicians suggest that topical antifungal agent therapy should be continued for 4-8 weeks or longer in these patients15,40 or, alternatively, an oral antifungal agent (e.g., griseofulvin, itraconazole, terbinafine hydrochloride) may be indicated.40,45,56

Pityriasis (Tinea) Versicolor

Sulconazole nitrate 1% cream or 1% solution is used topically for the treatment of pityriasis (tinea) versicolor, a superficial infection caused by Malassezia furfur ( Pityrosporum orbiculare or P. ovale ).1,2,3,8,10

Pityriasis versicolor generally can be treated topically with an imidazole-derivative azole antifungal (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole), an allylamine antifungal (e.g., terbinafine), ciclopirox olamine, or certain other topical therapies (e.g., selenium sulfide 2.5%).39,41,42,44,53,60 However, an oral antifungal (e.g., itraconazole, ketoconazole) may be indicated, with or without a topical antifungal, for patients who have extensive or severe infections or who fail to respond to or have frequent relapses with topical therapy.41,42,44,53,58

Results of controlled studies indicate that topical sulconazole nitrate is as effective as other topical imidazole derivatives used for the treatment of pityriasis versicolor (e.g., clotrimazole, miconazole).8,10 In a study in patients with pityriasis versicolor who received topical treatment with the drugs twice daily for 3 weeks, there was complete clearance of lesions in 89 or 82% of patients who received sulconazole nitrate 1% cream or miconazole nitrate 2% cream, respectively.10 In another study in patients randomized to receive topical sulconazole nitrate 1% solution once daily or topical clotrimazole 1% solution twice daily for 3 weeks, there was complete clearance of pityriasis versicolor lesions (with or without abnormal pigmentation) in 68% of those who received sulconazole and 83% of those who received clotrimazole; a mycologic cure (confirmed by negative KOH microscopic wet mounts) was maintained for an additional 3 weeks in 79 and 92% of patients, respectively.8

Cutaneous Candidiasis

Sulconazole nitrate has been used topically for the treatment of cutaneous infections caused by Candida albicans †, but safety and efficacy of the drug for these infections have not been established.9,22 Sulconazole nitrate 1% cream appears to be as effective as topical miconazole nitrate 2% cream or topical clotrimazole 1% cream in improving manifestations of cutaneous candidiasis.9,22

Other Uses

Sulconazole nitrate has been effective when used topically for the treatment of superficial bacterial skin infections including impetigo† and ecthyma† caused by Streptococcus pyogenes (group A β-hemolytic streptococci) or Staphylococcus aureus .6 In a limited study, topical sulconazole nitrate 1% cream was as effective as topical miconazole nitrate 2% cream for the treatment of impetigo and more effective than topical miconazole nitrate for the treatment of ecthyma.6

Administration

Sulconazole nitrate is applied topically to the skin as a 1% cream or 1% solution.1,3 These topical preparations are for external use only, and should not be applied to the eye and should not be administered intravaginally.1,3,19 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.1,3,14,15,26 For once-daily dosing, some clinicians recommend that the drug be applied at bedtime.26

Dosage

Dermatophytoses

For the topical treatment of tinea corporis or tinea cruris, sulconazole nitrate 1% cream or 1% solution should be applied once or twice daily.1,3,14,15,26 For the topical treatment of tinea pedis, sulconazole nitrate 1% cream should be applied twice daily.3,14,15,26 Symptomatic relief usually is evident within a few days and clinical improvement should be evident within 1 week.1,3 The usual duration of treatment to reduce the possibility of recurrence is 2-3 weeks for tinea corporis or tinea cruris1 or 4 weeks for tinea pedis.3,58 If clinical improvement does not occur after 4-6 weeks, the diagnosis should be reevaluated.1,3,58 Patients with chronic moccasin-type (dry-type) tinea pedis may require more prolonged therapy (e.g., 4-8 weeks or longer).15,40

Pityriasis (Tinea) Versicolor

For the topical treatment of pityriasis (tinea) versicolor, sulconazole nitrate 1% cream or 1% solution should be applied once or twice daily.1,3,14,15,26 The usual duration of treatment to reduce the possibility of recurrence is 2-3 weeks.1,3,58 If clinical improvement does not occur after 4-6 weeks, the diagnosis should be reevaluated.1,3,58

Sulconazole nitrate generally is well tolerated when applied topically.1,2,3,5,6,10,12,13,14,20 The most frequent adverse reactions to topical sulconazole nitrate are mild to moderate local reactions;1,2,3,5,8,9,10,15,22,25 these reactions rarely have been severe enough to require discontinuance of the drug.1,2,3,5,10,11,15,22,25,26

Adverse systemic effects have not been reported to date with topical sulconazole nitrate.1,2,3,5,10,22,26,27

Local Effects and Sensitivity Reactions

The most frequent adverse local effects that have been reported in patients receiving sulconazole nitrate 1% cream or 1% solution are pruritus,2,3,5,8,9,10,15,22 erythema,2,3,5,8,10,22 burning,1,3,5,8,10,15,22,25 irritation,2 and stinging or tingling.1,3,10,15 These adverse local effects have been reported in 1-3% of patients receiving topical sulconazole nitrate in clinical studies.1,3 Adverse local reactions that have been reported rarely in patients receiving topical sulconazole nitrate include skin edema,2 dryness,10 scaling,10 fissuring,10 cracking,10 generalized red papules,14 and severe eczema.21 In some controlled clinical studies, similar local effects (i.e., pruritus, erythema, burning, stinging) occurred in patients receiving vehicle placebo, and it has been suggested that the vehicle may have contributed to these adverse effects.15,26 In addition, some of these local effects (i.e., erythema, scaling, pruritus, fissuring, pustulation, vesiculation) also are symptoms of dermatophytoses, and it may be difficult to differentiate those that are related to the infection and those that may be related to the drug.2,25,58

It has been suggested that burning or irritation reported following topical application of sulconazole nitrate or other imidazole-derivative azole antifungal agents may reflect an irritant or contact sensitivity.58 Although there was no evidence of contact sensitization or irritation in early studies evaluating the safety of sulconazole nitrate,1,3,18 contact dermatitis2,11 and papular rash14 have been reported rarely following topical application of sulconazole nitrate 1% cream. Contact dermatitis also has been reported following topical application of other imidazole-derivative azole antifungal agents (e.g., clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, tioconazole).5,28,29,30,46,47,48

Cross-sensitization appears to occur among the imidazole derivatives;4,28,29,30,46,47,48 however, cross-sensitivity appears to be unpredictable.4,20,46,47,48 While some patients with positive reactions to patch testing with sulconazole have had negative reactions to patch testing with clotrimazole, econazole, ketoconazole, miconazole, and/or tioconazole,4,28,48 other patients with positive reactions to sulconazole also have had positive reactions to one or more of these other imidazole derivatives (e.g., econazole, miconazole, tioconazole).28,48 (See Cautions: Precautions and Contraindications.)

Topical sulconazole nitrate has not been associated with phototoxic or photosensitivity reactions.1,3,18

Precautions and Contraindications

Sulconazole nitrate is contraindicated in patients who are hypersensitive to the drug or any ingredient in the formulation,1,3,19,58 and should be used with caution in patients who are hypersensitive to other azole antifungal agents (imidazole or triazole derivatives).58

Prior to initiation of sulconazole nitrate treatment, the diagnosis should be confirmed using appropriate microbiologic studies (e.g., direct microscopic examination of potassium hydroxide [KOH] wet mount and/or culture).39,40,45,56,58

Patients receiving topical sulconazole nitrate should be instructed to use the medication for the full, prescribed treatment period, even if manifestations improve, to reduce the possibility of recurrence.1,3,39 (See Dosage and Administration: Dosage.)

Patients also should be advised to contact their clinician if improvement does not occur after the recommended treatment period so that the diagnosis can be reevaluated.1,3

If a reaction suggesting irritation or sensitivity occurs during topical sulconazole nitrate treatment, the drug should be discontinued and appropriate therapy initiated.1,3

The fact that patients with contact sensitivity to one imidazole-derivative azole antifungal agent may be sensitive to other similar drugs should be considered.28,46,47,48

Pediatric Precautions

Safety and efficacy of sulconazole nitrate have not been established in children.1,3

Geriatric Precautions

Only a limited number of patients 65 years of age or older have been treated with sulconazole 1% cream or lotion in clinical trials.1,3 Clinical experience to date has not identified differences in responses between geriatric patients and younger adults.1,3

Mutagenicity and Carcinogenicity

In vitro studies, including the Ames microbial ( Salmonella ) mutagen test, have not shown sulconazole nitrate to be mutagenic.1,3,18 Long-term animal studies have not been performed to determine the carcinogenic potential of sulconazole nitrate.1,3

Pregnancy and Lactation

Pregnancy

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).1,3,19 The drug was not teratogenic when given orally to rats or rabbits at dosages of 50 mg/kg daily.1,3,19

Prolonged gestation and dystocia occurred in rats receiving oral sulconazole in a dosage 125 times the usual human dosa several maternal rats died during the prenatal period, possibly because of labor complications.1,3,19 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).33,49,50,51 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.1,3

Lactation

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.1,3

Since only small amounts of sulconazole nitrate are absorbed following topical administration,2,16,19,34 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 CYP2B135 and the drug therefore theoretically could induce the metabolism of warfarin or other drugs metabolized by these isoenzymes,38 it is unlikely that such drug interactions would occur with usual topical application of sulconazole nitrate.58

Acute Toxicity

Limited information is available on the acute toxicity of sulconazole nitrate in humans.18 In an exaggerated use study in healthy adults, topical application of sulconazole nitrate 1% cream (5 g twice daily for 19 days) on the back did not result in abnormal hepatic, hematologic, or renal function tests.18 In a 3-month study in dogs receiving oral sulconazole in a dosage of 100 mg/kg daily, the drug produced increased serum concentrations of hepatic enzymes and ocular lens opacities.18

Mechanism of Action

Antifungal Effects

Sulconazole nitrate usually is fungistatic in action, but may have growth phase-dependent fungicidal activity at high concentrations or against very susceptible organisms.2,7

The antifungal activity of sulconazole, like that of most other imidazole-derivative azole antifungal agents (e.g., butoconazole, clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, tioconazole) and triazole-derivative azole antifungal agents (e.g., fluconazole, itraconazole, terconazole), appears to involve several different mechanisms.2,7 While the azole antifungal agents have some antifungal effects (especially those related to fungistatic activity) that are common to the entire group, some of the drugs have additional mechanisms of action that distinguish them from other azoles.2

The fungistatic activity of azole antifungal agents, including sulconazole, appears to result from interference with ergosterol synthesis, the principal sterol needed for incorporation into areas of newly synthesized fungal cell membranes.2,43,57 The nitrogen group contained in azole antifungal agents binds to the heme iron of the cytochrome P-450 isoenzyme 14-α-demethylase in susceptible fungi, thereby inhibiting the binding of lanosterol to the enzyme.57 In actively growing yeast and dermatophyte cells, lanosterol accumulates, causing changes in membrane permeability and alterations in cell volume, secondary metabolic effects, and defective cell division and growth inhibition.2,24 Increased membrane permeability permits simultaneous suppression of influx and stimulation of efflux of 2-deoxyglucose, rapid release of sorbose, potassium and phosphate ions, and induction of hydrogen ion influx.2 There is evidence from in vitro studies that sulconazole inhibits synthesis of cellular DNA and RNA and also increases degradation of DNA and RNA.2 The selectivity of azole antifungal agents for pathogenic organisms compared with host (mammalian) cells appears to depend on the relative affinities of the various drugs for mammalian versus fungal cytochrome P-450 sterol demethylases.57

Like some other imidazole derivatives (e.g., butoconazole, clotrimazole, miconazole, tioconazole), sulconazole can exhibit fungicidal activity at high concentrations apparently as the result of a direct physiochemical effect on the fungal cell membrane.2,7,24 This effect may involve hydrophobic interactions between the drug and unsaturated fatty acid components of the fungal cell membrane.2

Antibacterial Effects

Sulconazole, like some other azole antifungal agents, has some antibacterial activity against gram-positive organisms; however, this effect cannot be explained on the basis of inhibition of ergosterol synthesis since bacteria generally do not contain membrane sterols.2,6,31,32 It has been suggested that the antibacterial effects of sulconazole and other azole antifungal agents may be similar to the direct physiochemical effect of these agents on fungi and may involve interactions with unsaturated fatty acids in bacterial cell membranes.2,24 While fungi and many gram-positive bacteria may contain substantial amounts of free fatty acids, mammalian cells and gram-negative bacteria generally contain little or none.24

Spectrum

Sulconazole nitrate is active against many fungi, including most dermatophytes and yeasts.1,2,3,7,17,18,23,37 The drug also has some activity against gram-positive bacteria.1,2,3,18,37

Like other azole antifungal agents (imidazole and triazole derivatives), results of in vitro sulconazole susceptibility tests are method dependent, and minimum inhibitory concentrations (MICs) vary depending on the culture medium used, incubation time, pH, inoculum, and presence of serum.2,17,23,52 In addition, currently available in vitro tests do not necessarily reflect the in vivo susceptibility of some fungi (especially Candida ).23,52 Optimal methods for antifungal agent in vitro susceptibility testing have been difficult to identify and are still being investigated.23,52

Fungi

Sulconazole is active in vitro against most pathogenic dermatophytes, including Epidermophyton floccosum ,1,2,3,18 Microsporum audouini ,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 and also is active in vitro against Malassezia furfur ( Pityrosporum orbiculare or P. ovale ).1,2,3 While E. floccosum and M. canis usually are inhibited in vitro by sulconazole concentrations of 0.08 mcg/mL or less, M. gypseum and T. mentagrophytes generally are inhibited in vitro by sulconazole concentrations of 0.31-2.5 mcg/mL.2

Sulconazole is active in vitro against Candida , including 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 Susceptible Candida generally are inhibited in vitro by sulconazole concentrations of 10 mcg/mL or less.2,17

Sulconazole also has some in vitro activity against other fungi, including Aspergillus ,2 Blastomyces dermatitidis ,2 Cryptococcus neoformans ,2,18 Histoplasma capsulatum ,2 and Paracoccidioides brasiliensis .2,17,23

Bacteria

Sulconazole is active in vitro against some aerobic and anaerobic gram- positive bacteria, but has been inactive against gram-negative bacteria tested.2 In vitro, sulconazole concentrations of 6.25 mcg/mL or less generally inhibit Staphylococcus aureus ,2 S. epidermidis ,2 S. saprophyticus ,2 Enterococcus faecalis (formerly Streptococcus faecalis ),2 Micrococcus luteus ,2 Bacillus subtilus ,2 and Erysipelothrix rhusiopathiae .6 The drug also has some activity against some gram-positive anaerobes, including Clostridium 2 and Propionibacterium acnes .18 Clostridium perfringens , C. tetani , and C. botulinum generally are inhibited in vitro by sulconazole concentrations of 12.5 mcg/mL or less.2

Resistance

Cross resistance can occur among the azole antifungals.23 Clinical isolates of Candida albicans obtained from patients with chronic mucocutaneous candidiasis who had received long-term therapy with azole antifungal agents have been found to have decreased in vitro susceptibility to several imidazole derivatives (butoconazole, clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, sulconazole, tioconazole) and triazole derivatives (itraconazole, terconazole).23

Pharmacokinetics

Absorption

Small amounts of sulconazole nitrate are absorbed systemically following topical application to skin.2,16,19,34 In a study evaluating percutaneous absorption following topical application of 1 g of radiolabeled sulconazole nitrate 1% cream to the flexural forearms of healthy adults, approximately 80% of the dose was recovered from the skin after 8 hours and approximately 12% of the dose was absorbed through the skin in the presence or absence of the stratum corneum.19

Distribution

Information on distribution of sulconazole nitrate into human body tissues and fluids following topical application to the skin is not available.58 Studies in rats involving topical application of high doses of sulconazole nitrate indicate that highest concentrations of the drug are attained in the skin (at the site of application); moderate concentrations are attained in the adrenal glands, liver, kidneys, and lungs; and low concentrations are attained in the spleen, brain, and muscle.34

It is not known whether sulconazole is distributed into human milk.1,3

Elimination

Systemically absorbed sulconazole nitrate is eliminated in urine and feces.16,19 Following topical application of approximately 4.5 g of radiolabeled sulconazole nitrate 1% cream twice daily for 1 day on the abdomen of healthy adults, radioactivity was detected in both urine and feces for up to 7 days; approximately 6.7 and 2% of the topical dose was eliminated in urine and feces, respectively.16

Chemistry and Stability

Chemistry

Sulconazole nitrate, an imidazole derivative, is a synthetic azole antifungal agent.1,2,3,18 Sulconazole is structurally related to other imidazole-derivative azole antifungals (e.g., butoconazole, clotrimazole, econazole, ketoconazole, miconazole, oxiconazole, tioconazole).2,23 The drug differs from econazole in that a thiol group is substituted for the oxygen group.2

Sulconazole nitrate occurs as a white to off-white, crystalline powder.1,3 Sulconazole is very slightly soluble in water and slightly soluble in alcohol.1,3

For topical use, sulconazole nitrate is commercially available as a 1% cream or 1% solution.1,3 Each gram of the cream contains 10 mg of sulconazole nitrate in an emulsion consisting of propylene glycol, stearyl alcohol, isopropyl myristate, cetyl alcohol, polysorbate 60, sorbitan monostearate, glyceryl stearate, polyethylene glycol 100 stearate, ascorbyl palmitate, and purified water; sodium hydroxide and/or nitric acid is added to adjust pH.3 Each mL of the solution contains 10 mg of sulconazole nitrate in a solution of propylene glycol, poloxamer 407, polysorbate 20, butylated hydroxyanisole, and purified water; sodium hydroxide and/or nitric acid is added to adjust pH.1

Stability

Sulconazole nitrate 1% cream or 1% solution should be stored at 40°C or lower.1,3 The topical solution should be protected from light.1,3

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. [PubMed 3281821]

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. [PubMed 1395584]

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. [PubMed 6749440]

6. Nolting S, Strauss WB. Treatment of impetigo and ecthyma: a comparison of sulconazole with miconazole. Int J Dermatol . 1988; 27:716-9. [PubMed 3069760]

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. [PubMed 3902762]

8. Tham SN. Treatment of pityriasis versicolor: comparison of sulconazole nitrate 1% solution and clotrimazole 1% solution. Australas J Dermatol . 1987; 28:123-5. [PubMed 3332758]

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. [PubMed 6354167]

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. [PubMed 6364994]

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. [PubMed 6337618]

12. Avila JM. Treatment of dermatomycoses with sulconazole 1% nitrate cream or miconazole nitrate 2% cream: a double-blind comparative study. Curr Ther Res . 1985; 38:328-33.

13. Woscoff A, Carabeli S. Treatment of tinea pedis with sulconazole nitrate 1% cream or miconazole nitrate 2% cream. Curr Ther Res . 1986; 39:753-7.

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

15. Akers WA, Lane A, Lynfield Y et al. Sulconazole nitrate 1% cream in the treatment of chronic moccasin-type tinea pedis caused by Trichophyton rubrum . J Am Acad Dermatol . 1989; 21:686-9. [PubMed 2681281]

16. Franz TJ, Lehman P. Percutaneous absorption of sulconazole nitrate in humans. J Pharm Sci . 1988; 77:489-91. [PubMed 3171926]

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. [PubMed 1406898]

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.

20. McVie DH, Littlewood S, Allen BR et al. Sulconazole versus clotrimazole in the treatment of dermatophytosis. Clin Exp Dermatol . 1986; 11:613-8. [PubMed 3311492]

21. Lassus A, Forsström S. A double-blind parallel study comparing sulconazole with econazole in the treatment of dermatophytoses. Mykosen . 1984; 27:592-8. [PubMed 6395015]

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