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  • CLASSES

    Topical Dermatological Antifungals

    DEA CLASS

    Rx

    DESCRIPTION

    Topical imidazole antifungal 
    Active against dermatophytes and Candida albicans
    For treatment of cutaneous candidiasis and tinea infections, including tinea versicolor

    COMMON BRAND NAMES

    Ecoza, Spectazole

    HOW SUPPLIED

    Econazole/Econazole Nitrate/Spectazole Topical Cream: 1%
    Ecoza Topical Foam: 1%

    DOSAGE & INDICATIONS

    For the treatment of tinea cruris, tinea corporis, or tinea versicolor caused by susceptible fungi.
    Topical dosage (cream)
    Adults

    Apply a sufficient amount of cream to the affected areas once daily. Tinea cruris and corporis should be treated for 2 weeks to reduce the possibility of recurrence. Patients with tinea versicolor usually exhibit clinical and mycological clearing after 2 weeks of treatment.

    For the treatment of cutaneous candidiasis.
    Topical dosage (cream)
    Adults

    Apply a sufficient amount of cream to the affected areas twice daily. The recommended duration of therapy is 2 weeks.

    For the treatment of tinea pedis caused by susceptible fungi.
    Topical dosage (cream)
    Adults

    Apply a sufficient amount of cream to the affected areas once daily. Treat for 1 month to reduce the possibility of recurrence.

    Topical dosage (foam)
    Adults, Adolescents, and Children >= 12 years

    Apply topically to affected areas once daily for 4 weeks.

    MAXIMUM DOSAGE

    Adults

    Maximum dosage information not available.

    Geriatric

    Maximum dosage information not available.

    Adolescents

    Maximum dosage information for the foam is not available; safety and efficacy not established for the cream.

    Children

    12 years: Maximum dosage information for the foam is not available; safety and efficacy not established for the cream.
    < 12 years: Safety and efficacy not established.

    Infants

    Safety and efficacy not established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Econazole is poorly absorbed into the systemic circulation through intact skin; < 1% is recovered in the urine and feces. Therefore, no dosage adjustments are necessary.

    Renal Impairment

    Econazole is poorly absorbed into the systemic circulation through intact skin; < 1% is recovered in the urine and feces. Therefore, no dosage adjustments are necessary.

    ADMINISTRATION

    Topical Administration

    Wash hands before and after use.
    Applied topically to affected areas of the skin. Avoid contact with the eyes.
    Avoid heat, flame, and smoking during an immediately after applying the foam formulation.

    STORAGE

    Ecoza:
    - Avoid exposure to heat
    - Do not freeze
    - Do not refrigerate
    - Flammable, keep away from heat and flame
    - Protect from direct sunlight
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F
    Spectazole:
    - Store below 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Ophthalmic administration, vaginal administration

    Econazole is for external use only; it is not for oral administration, ophthalmic administration, or vaginal administration.

    Pregnancy

    Econazole is classified as pregnancy category C. It has not been shown to be teratogenic when administered orally to mice, rabbits, or rats. Fetotoxic or embryotoxic effects were observed in oral studies with rats receiving 10—80 times the human dermal dose. According to the manufacturer, econazole should be used during the first trimester of pregnancy only when considered essential to the welfare of the patient and during the second or third trimester of pregnancy only when clearly needed.

    Breast-feeding

    Data are limited regarding use of econazole during breast-feeding and its' excretion in human milk is unknown.  Systemic absorption following topical application is extremely low which suggests that very little drug would be excreted into breast-milk; however, according to the manufacturer, caution is advised when administering to nursing mothers. Instruct mothers not to apply econazole topically to the breast while breast-feeding. Fluconazole, clotrimazole, miconazole, and nystatin may be potential alternatives to consider during breast-feeding. However, site of infection, local susceptibility patterns, and specific microbial susceptibility should be assessed before choosing an alternative agent. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested or administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    Children, infants, neonates

    Safety and efficacy of the econazole cream formulation have not been established in pediatric patients; use of the foam formulation has not been established in neonates, infants, or children < 12 years of age. Safety of the foam formulation was evaluated in a clinical trial involving 18 children/adolescents, ages 12—17 years. After 28 days of treatment, the safety findings were similar to those in the adult population.

    Tobacco smoking

    Econazole foam is flammable. Avoid heat, flame, and tobacco smoking during and immediately following application. Do not puncture or burn the foam container, as the contents are under pressure.

    ADVERSE REACTIONS

    Moderate

    erythema / Early / 3.0-3.0

    Mild

    pruritus / Rapid / 3.0-3.0
    skin irritation / Early / 3.0-3.0
    rash (unspecified) / Early / Incidence not known

    DRUG INTERACTIONS

    Corticosteroids: (Minor) In vitro studies indicate that corticosteroids inhibit the antifungal activity of econazole against C. albicans in a concentration-dependent manner. When the concentration of the corticosteroid was equal to or greater than that of econazole on a weight basis, the antifungal activity of econazole was substantially inhibited. When the corticosteroid concentration was one-tenth that of econazole, no inhibition of antifungal activity was observed.
    Nystatin: (Moderate) The combination of econazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
    Warfarin: (Moderate) Coadministation of econazole and warfarin has resulted in enhanced anticoagulant effect. In many of these cases, absorption of econazole may have been increased by applying the drug under occlusion, to the genitals, or over large body surface areas. If these drugs are used in combination, closely monitor the International Normalized Ratio (INR) and/or prothrombin time.

    PREGNANCY AND LACTATION

    Pregnancy

    Econazole is classified as pregnancy category C. It has not been shown to be teratogenic when administered orally to mice, rabbits, or rats. Fetotoxic or embryotoxic effects were observed in oral studies with rats receiving 10—80 times the human dermal dose. According to the manufacturer, econazole should be used during the first trimester of pregnancy only when considered essential to the welfare of the patient and during the second or third trimester of pregnancy only when clearly needed.

    Data are limited regarding use of econazole during breast-feeding and its' excretion in human milk is unknown.  Systemic absorption following topical application is extremely low which suggests that very little drug would be excreted into breast-milk; however, according to the manufacturer, caution is advised when administering to nursing mothers. Instruct mothers not to apply econazole topically to the breast while breast-feeding. Fluconazole, clotrimazole, miconazole, and nystatin may be potential alternatives to consider during breast-feeding. However, site of infection, local susceptibility patterns, and specific microbial susceptibility should be assessed before choosing an alternative agent. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested or administered drug, health care providers are encouraged to report the adverse effect to the FDA.

    MECHANISM OF ACTION

    Like other imidazoles, econazole exerts its effect by disrupting normal fungal cell membrane permeability. Ergosterol is an essential component of the fungal cell membrane. Econazole may inhibit ergosterol synthesis by interacting with 14-alpha-lanosterol demethylase, a cytochrome P-450 enzyme necessary for converting lanosterol to ergosterol. Inhibition of ergosterol synthesis results in increased cellular permeability, causing leakage of cellular contents such as phosphorous-containing compounds and potassium. Econazole is usually fungistatic.

    PHARMACOKINETICS

    Econazole is applied topically to the skin. It is not for ophthalmic use. Less than 1% of an applied dose is recovered in urine and feces.

    Topical Route

    Following topical application of econazole, systemic absorption is extremely low. Although most of the applied drug remains on the skin surface, drug concentrations found in the stratum corneum greatly exceed the MIC for dermatophytes. Inhibitory concentrations are achieved in the epidermis and as deep as the middle region of the dermis. Use of an occlusive dressing appears to only slightly increase the extent of dermal penetration of the drug.