Ecoza (econazole nitrate)

Ecoza is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

Ecoza should be applied to cover affected areas once daily for 4 weeks.

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.

• There are no available data on Ecoza use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
• There is no information available on the presence of econazole nitrate in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production after topical application of Ecoza to women who are breastfeeding.
• It is not known whether econazole nitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when econazole nitrate is administered to a nursing woman.