Ecostatin (Econazole Nitrate)

ECOSTATIN® Preparations

Westwood-Squibb

Econazole Nitrate

Antifungal Agent

Action And Clinical Pharmacology: Econazole exhibits antifungal activity against a wide variety of fungi, including dermatophytes, pathogenic yeasts, and moulds. Susceptible pathogenic organisms include C. albicans and other Candida species, T. rubrum, T. mentagrophytes, E. floccosum and M. furfur. It appears to act by altering the internal structure or cell membrane permeability of the fungus. tag_IndicationsIndications

Indications And Clinical Uses: Cream: The treatment of infections caused by susceptible dermatophyte and candida species including tinea pedis, tinea cruris, tinea corporis, tinea versicolor and cutaneous candidiasis. It is not indicated for moderate or severe paronychia or onychomycosis.

Ovules: Local treatment of vulvovaginal candidiasis (moniliasis).

Contra-Indications: Hypersensitivity to econazole or any of the cream’s or ovule’s components.

Precautions: If marked irritation or sensitization should occur during topical or intravaginal use, discontinue econazole therapy. Cream not for ophthalmic use.

Intractable candidiasis may be the presenting symptom of unrecognized diabetes. Appropriate urine/blood studies may be indicated in patients not responding to the treatment.

During the vaginal treatment period, it may be advisable to instruct the patient to abstain from intercourse or, alternatively, to recommend the use of a condom.

Pregnancy: Since econazole is absorbed in small amounts from the human vagina, it should not be used in the first trimester of pregnancy unless deemed essential for the patient’s welfare.

Advise pregnant patients to exercise caution in the use of the vaginal applicator.

Adverse Reactions: Econazole nitrate is usually well tolerated. Adverse effects are limited to occasional local skin irritation manifested by erythema, pruritus, and burning or stinging sensation; cessation of therapy is rarely warranted.

Dosage And Administration: Cream: Apply twice daily, in the morning and evening. The cream should be massaged gently into the affected and surrounding skin areas.

Clinical improvement usually occurs promptly; however, complete disappearance of the symptoms of the disease may require prolonged treatment. Candida infections should be treated for at least 2 weeks and dermatophyte infections for 1 month to reduce the risk of recurrence. If no improvement has occurred after 1 month of treatment with econazole topical cream, the diagnosis should be reassessed.

Ovules: WIth the patient in the supine position, insert 1 ovule high into the vagina, by means of the applicator, at bedtime for 3 consecutive days.

Therapy should be continued during menstruation. Continue administration for the complete 3 day period even if the signs and symptoms of the disease disappear.

Although a 3 day course of therapy usually suffices, occasionally it may be necessary to institute a second course of therapy.

Availability And Storage: Cream: Each g of cream contains: econazole nitrate 1.0%. Nonmedicinal ingredients: benzoic acid, butylated hydroxyanisole, fragrance, mineral oil, palm oil, polyethylene glycol, polyethylene glycol stearate and water. Tubes of 15 and 30 g. Store at room temperature (15 to 25°C).

Ovules: Each creamy white to yellowish egg shaped ovule contains: econazole nitrate 150 mg. Nonmedicinal ingredients: hydrogenated vegetable oil. Packages of 3 ovules plus a reusable applicator. Store at room temperature. Avoid prolonged storage at temperatures above 30°C.

ECOSTATIN® Preparations Westwood-Squibb Econazole Nitrate Antifungal Agent

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