Econazole Nitrate

SPECTAZOLE Cream contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of pegoxol 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole, and purified water. The white to off-white soft cream is for topical use only.

Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl) methoxy}-2-(2,4-dichlorophenyl)ethyl]- 1H-imidazole mononitrate. Its structure is as follows:

During clinical trials, approximately 3% of patients treated with econazole nitrate 1% cream reported side effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging, and erythema. One case of pruritic rash has also been reported.

Econazole topical is an antifungal medication. Econazole topical prevents fungus from growing on your skin.

Econazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, tinea versicolor (a fungus that discolors the skin), and yeast infections.

Econazole topical may also be used for purposes other than those listed in this medication guide.

Apply the missed dose as soon as you remember. However, if it is almost time for your next regularly scheduled dose, skip the dose you missed and apply only the regular amount of econazole topical. Do not use a double dose unless otherwise directed by your doctor.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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.60 61

Treatment of tinea pedis (athlete’s foot) caused by E. floccosum, M. audouinii, M. canis, M. gypseum, T. mentagrophytes, T. rubrum, or T. tonsurans.60 61

Topical antifungals usually effective for treatment of uncomplicated tinea corporis or tinea cruris.46 47 50 51 52 62 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.46 47 50 51 52 62

Topical antifungals usually effective for treatment of uncomplicated tinea pedis.46 47 50 51 52 62 An oral antifungal may be necessary for treatment of hyperkeratotic areas on the palms and soles,47 52 for chronic moccasin-type (dry-type) tinea pedis,46 47 51 and for tinea unguium (fingernail or toenail dermatophyte infections, onychomycosis).46 47 50 51 52 62

Pityriasis (Tinea) Versicolor

Treatment of pityriasis (tinea) versicolor caused by Malassezia furfur (Pityrosporum orbiculare or P. ovale).60 61 62

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.48 49 51 62

Cutaneous Candidiasis

Treatment of cutaneous candidiasis caused by Candida albicans.60 61

Contraindications

Known hypersensitivity to econazole or any ingredient in the formulation.60 61

Warnings/Precautions

Warnings

For external use only.60 61 Use only for topical application to the skin; not for ophthalmic60 61 or intravaginal use.39

Fetotoxicity and embryotoxicity demonstrated in animals receiving oral econazole.60 61 (See Pregnancy under Cautions.)

Sensitivity Reactions

Contact dermatitis reported following topical application of econazole or other imidazole-derivative azole antifungals.55 56 57 58 59

If irritation or sensitivity occurs, discontinue the drug.60 61

Possible cross-sensitization among the imidazoles.44 45 55 56 57 58 59

Specific Populations

Category C.60 61

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.60 61 (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Distributed into milk following oral administration in rats; not known whether distributed into human milk.60 61 Use caution.60 61

No unusual adverse effects reported when used in children ≥3 months of age.16 24

Common Adverse Effects

Burning,14 60 61 stinging,15 17 60 61 pruritus,19 60 61 erythema.14 60 61

Specific Drugs

Absorption

Bioavailability

Minimal systemic absorption occurs following topical application to skin.13 60 61

Distribution

Extent

About 7.6–9.6% of a topical dose found in stratum corneum;13 also found in epidermis and middle region of dermis.13 60 61

Distributed into milk following oral administration in rats; not known whether distributed into human milk.60 61

Elimination

Elimination Route

Systemically absorbed drug excreted in urine and feces (<1% of topical dose).2 11 13 60 61