Econazole (Monograph)

Drug class: Azoles
ATC class: D01AC03
VA class: DE102
Chemical name: (±)-1-[2-[(4-Chlorophenyl)methoxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate
Molecular formula: C₁₈H₁₅Cl₃N₂OβHNO₃
CAS number: 68797-31-9

Introduction

Antifungal; azole (imidazole derivative).

Uses for Econazole

Dermatophytoses

Treatment of tinea corporis (body ringworm) and tinea cruris (jock itch) caused by Epidermophyton floccosum, Microsporum audouinii, M. canis, M. gypseum, Trichophyton mentagrophytes, T. rubrum, or T. tonsurans.

Treatment of tinea pedis (athlete’s foot) caused by E. floccosum, M. audouinii, M. canis, M. gypseum, T. mentagrophytes, T. rubrum, or T. tonsurans.

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 is chronic or 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 palms and 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 have failed to respond to or have frequent relapses with topical therapy.

Cutaneous Candidiasis

Treatment of cutaneous candidiasis caused by Candida albicans.

Econazole Dosage and Administration

Administration

Topical Administration

Apply topically to the skin as a 1% cream.

Do not apply to the eye or administer intravaginally.

Apply a sufficient amount of cream to cover affected areas.

Dosage

Pediatric Patients

Dermatophytoses

Tinea Corporis or Tinea Cruris

Topical

Apply once daily for 2 weeks.

If clinical improvement does not occur after treatment, reevaluate diagnosis. Occasionally, a treatment duration of ≥6 weeks may be necessary.

Tinea Pedis

Topical

Apply once daily for 1 month.

If clinical improvement does not occur after treatment, reevaluate diagnosis. Occasionally, a treatment duration of ≥6 weeks may be necessary.

Pityriasis (Tinea) Versicolor

Topical

Apply once daily for 2 weeks.

If clinical improvement does not occur after treatment, reevaluate diagnosis.

Cutaneous Candidiasis

Topical

Apply twice daily (morning and evening) for 2 weeks.

If clinical improvement does not occur after treatment, reevaluate diagnosis. Occasionally, a treatment duration of ≥6 weeks may be necessary.

Adults

Dermatophytoses

Tinea Corporis or Tinea Cruris

Topical

Apply once daily for 2 weeks.

If clinical improvement does not occur after treatment, reevaluate diagnosis. Occasionally, a treatment duration of ≥6 weeks may be necessary.

Tinea Pedis

Topical

Apply once daily for 1 month.

If clinical improvement does not occur after treatment, reevaluate diagnosis. Occasionally, a treatment duration of ≥6 weeks may be necessary.

Pityriasis (Tinea) Versicolor

Topical

Apply once daily for 2 weeks.

If clinical improvement does not occur after treatment, reevaluate diagnosis.

Cutaneous Candidiasis

Topical

Apply twice daily (morning and evening) for 2 weeks.

If clinical improvement does not occur after treatment, reevaluate diagnosis. Occasionally, a treatment duration of ≥6 weeks may be necessary.

Special Populations

No special population dosage recommendations at this time.

Cautions for Econazole

Contraindications

Known hypersensitivity to econazole or any ingredient in the formulation.

Warnings/Precautions

Warnings

Administration Precautions

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

Fetal/Neonatal Morbidity and Mortality

Fetotoxicity and embryotoxicity demonstrated in animals receiving oral econazole. (See Pregnancy under Cautions.)

Sensitivity Reactions

Hypersensitivity Reactions

Contact dermatitis reported following topical application of econazole or other imidazole-derivative azole antifungals.

If irritation or sensitivity occurs, discontinue the drug.

Possible cross-sensitization among the imidazoles.

Specific Populations

Pregnancy

Category C.

Use during first trimester of pregnancy only when considered essential to the welfare of the patient; use during second and third trimesters only if clearly needed. (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Distributed into milk following oral administration in rats; not known whether distributed into human milk. Use caution.

Pediatric Use

No unusual adverse effects reported when used in children ≥3 months of age.

Common Adverse Effects

Burning, stinging, pruritus, erythema.

Drug Interactions

Specific Drugs

Econazole Pharmacokinetics

Absorption

Bioavailability

Minimal systemic absorption occurs following topical application to skin.

Distribution

Extent

About 7.6–9.6% of a topical dose found in stratum corneum; also found in epidermis and middle region of dermis.

Distributed into milk following oral administration in rats; not known whether distributed into human milk.

Elimination

Elimination Route

Systemically absorbed drug excreted in urine and feces (<1% of topical dose).

Stability

Storage

Topical

Cream

20–25°C or <30°C.

Actions and Spectrum

• Imidazole-derivative azole antifungal.

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

• 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.

• Spectrum of antifungal activity includes many fungi, including yeasts and dermatophytes. Also has in vitro activity against some gram-positive bacteria and Trichomonas vaginalis.

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

• Other fungi: Active in vitro against Malassezia furfur (Pityrosporum orbiculare) and Candida albicans, C. guillermondii, C. parapsilosis, and C. tropicalis. Also active in vitro against Aspergillus, Cladosporium, and Sporothrix.

• Bacteria: Active in vitro against Corynebacterium diphtheriae, Staphylococcus aureus, S. epidermidis, and Streptococcus pyogenes.

• Cross-resistance can occur among the azole antifungals.

Advice to Patients

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

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

• Importance of discontinuing use and contacting clinician if signs or symptoms of irritation or sensitization occur.

• Importance of applying to affected areas as directed and avoiding contact with eyes and not applying intravaginally.

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

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

• 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.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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