Econazole

Ecoza (econazole nitrate) topical foam, 1%, is indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older. Ecoza is an azole antifungal indicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes , and Epidermophyton floccosum in patients 12 years of age and older. ( 1 )

• Ecoza topical foam, 1% is for topical use only
• Ecoza topical foam, 1% is not for oral, ophthalmic, or intravaginal use
• Ecoza topical foam, 1% should be applied to cover affected areas once daily for 4 weeks
• For topical use only; not for oral, ophthalmic, or intravaginal use
• Apply once daily for 4 weeks

Foam, 1%. Each gram of Ecoza topical foam, 1%, contains 10 mg of econazole nitrate in a white to off-white foam. Foam, 1%. ( 3 )

• Of the 173 subjects treated with Ecoza topical foam, 1% in the clinical trials, 2 subjects were 12 to 17 years old
• In a pediatric maximal use trial, Ecoza topical foam, 1% was applied once daily to eighteen subjects aged 12 to 17 years with interdigital tinea pedis for 28 days [ see Clinical Pharmacology ]
• The safety findings for subjects 12 to 17 years were similar to those in adult population

Of the 173 subjects treated with Ecoza topical foam, 1% in the adult clinical trials, 6 subjects were 65 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

• See FDA-approved patient labeling (Patient Information) The patient should be instructed as follows: Inform patients that Ecoza (econazole nitrate) topical foam, 1% is for topical use only
• Ecoza (econazole nitrate) topical foam, 1% is not intended for oral, intravaginal, or ophthalmic use
• Ecoza topical foam, 1% is flammable; avoid heat, flame, and smoking during and immediately following application
• If a reaction suggesting sensitivity or chemical irritation develops with the use of Ecoza topical foam, 1%, use of the medication should be discontinued

• None
• None

7.1 Warfarin Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulant effect. Most cases reported product application with use under occlusion, genital application, or application to a large body surface area which may increase the systemic absorption of econazole nitrate. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.

Contents are flammable. Instruct the patient to avoid heat, flame, and/or smoking during and immediately following application. ( 5.1 ) 5.1 Flammability Ecoza topical foam is flammable. Avoid heat, flame, and smoking during and immediately following application. Contents under pressure. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C) even when empty. Do not store in direct sunlight.

During clinical trials with Ecoza topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Ecoza and vehicle arms. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Resilia Pharmaceuticals at 1-888-998-0770 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …

8.1 Pregnancy Pregnancy Category C There are no adequate and well-controlled trials with Ecoza topical foam in pregnant women. Ecoza topical foam should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Econazole nitrate has not been shown to be teratogenic when administered orally to mice, rabbits or rats. …

Store at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Do not refrigerate or freeze. Ecoza topical foam is flammable. …

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.