Medicine Overview of Ecoren 1% Cream
Topical/Cutaneous
Nail fungal infections
Adult: As 1% cream or lotion: Apply once daily under occlusive dressing. For tinea pedis: As 1% cream or foam: Apply once daily for 4 wk.
Tinea cruris; Tinea versicolor; Tinea corporis
Adult: As 1% cream: Apply once daily for 2 wk.
Cutaneous candidiasis
Adult: As 1% cream: Apply bid (morning and evening) for 2 wk.
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<3 months: Safety and efficacy not established
Tinea pedis, cruris, corporis, versicolor:
Apply cream to affected area(s) qDay
Cutaneous candidiasis:
Apply cream to affected area(s) BID
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Avoid contact with eyes and mucous membranes. Pregnancy.
Lactation: excretion in milk unknown; use with caution
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1-10%
Erythema (3%)
Frequency Not Defined
Burning and stinging sensations, Pruritus
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Pregnancy
There are no available data on therapy use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.
In animal reproduction studies, econazole nitrate did not cause malformation in mice, rabbits and/or rats at oral doses 80 or 40 times the human dermal dose
Animal data
Econazole nitrate did not cause malformation in mice, rabbits and/or rats; fetotoxic or embryotoxic effects were observed in oral fertility studies in rats receiving 10 to 40 times the human dermal dose; similar effects were observed in embryofetal and pre- and postnatal developmental studies in mice, rabbits and/or rats receiving oral doses 80 or 40 times human dermal dose
Lactation
There is no information available on presence of drug in human milk, effects of drug on breastfed infant, or on milk production after topical application of drug to women who are breastfeeding
Not known whether product excreted in human milk; because many drugs excreted in human milk, exercise caution when drug administered to a nursing woman
Consider developmental and health benefits of breastfeeding along with mother’s clinical need for therapy and any potential adverse effect on breastfed infant from drug or maternal condition
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