INCEPTA PHARMACEUTICALS LTD.
Econazole Cream: All fungal skin infections due to dermatophytes, yeasts, moulds and other fungi. These include Vulvo-vaginal candidiasis, Candidial napkin rash, and other candidial infection, Ringworm (tinea) infections, Athlete's foot, Paronychia, Pityriasis versicolor and Balanitis. Econazole-G Cream: Vulvo-vaginal candidiasis or any other fungal infection of vagina. Econazole VT: Vulvo-vaginal candidiasis or any other fungal infection of vagina. For the treatment of onychomycosis, local therapy with Econazole cream, combined with an oral antimycotic, is recommended.
Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations
Econazole modifies the permeability of cell wall membrane in fungi; may interfere with RNA and protein synthesis, and lipid metabolism.
Econazole Cream is applied to the affected skin areas once or twice daily, in the morning and/or in the evening and gently rubbed in with the clean finger. For mycoses of the hands, application is recommended following each washing of the hands. For the treatment of onychomycosis, occlusive dressings are recommended. Econazole-G Cream is applied with the applicator par vaginally once or twice daily. Econazole VT is applied with the applicator par vaginally one tablet once or twice daily. In order to prevent relapse, treatment should be continued for 2 weeks after clinical cure.
Although not studied, based on the chemical similarity of enconazole with other imidazole compounds, a theoretical potential for competitive interaction with compounds metabolized by CYP3A4/2C9 exists. Due to the limited systemic availability after vaginal application (see Pharmacokinetics under Actions), clinically relevant interactions are unlikely to occur, in patients on oral anticoagulants eg, warfarin and acenocoumarol, caution should be exercised and monitoring of the anticoagulant effect should be considered.
Hypersensitivity to any component of Econazole.
Rarely, transient local mild irritation, itching & redness may occur immediately after application. Econazole has minimal allergic effect. It is well tolerated, even by delicate skin. Local irritations are not likely to occur, except in rare cases, e.g., in eczematous skin areas. In such cases, anti-eczematous treatment is recommended for several days before therapy with Econazole is initiated.
During pregnancy: There is no information of any abnormality or adverse event in neonates while Econazole Cream / VT had been used during pregnancy. During lactation: As the systemic absorption of Econazole Nitrate cream is extremely low after topical/vaginal use, excretion in breast milk is likely to be negligible. So, it can be used topically/vaginally during lactation if needed.
Econazole Cream / VT is intended for topical and vaginal use. If accidental ingestion of large quantities of the product occurs, an appropriate method of gastric emptying may be used if considered desirable.
Hypersensitivity has rarely been recorded. If something like this occur, administration of the product should be discontinued. The infected area should be kept clean and dry during treatment.