Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Janssen-Cilag Limited, 50-100 Holmers Farm Way, High Wycombe, Buckinghamshire, HP12 4EG, UK
Pharmacotherapeutic group: Antifungals For Topical Use, Imidazole and triazole derivatives, econazole
ATC code: D01AC03
Econazole nitrate is a broad spectrum antimycotic with activity against dermatophytes, yeasts and moulds. A clinically relevant action against Gram positive bacteria has also been found.
Econazole nitrate is only slightly absorbed from the skin. No active drug has been detected in the serum. Radio labelling shows that less than 0.1% of an oral dose is absorbed. Peak serum levels are achieved after 2 hours and 90% binds to plasma proteins. Metabolism is limited but occurs primarily in the liver with excretion of metabolites in the urine.
Low neonatal survival and fetal toxicity was associated only with maternal toxicity. In animal studies, econazole nitrate has shown no teratogenic effects but was foetotoxic in rodents at maternal subcutaneous doses of 20 mg/kg/day and at maternal oral doses of 10 mg/kg/day. The significance of this in humans is unknown.
Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups.
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