Ecozol 0.01

INDICATIONS

Econazole Nitrate is indicated for topical application-

In the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum,
In the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

PHARMACOLOGY

Econazole Nitrate interferes with fungal oxidative enzymes to cause lethal accumulation of H2O2. They also reduce the formation of ergosterol, an important constituent of fungal cell wall.

DOSAGE & ADMINISTRATION

Econazole vaginal tablet: One tablet should be inserted deep into the vagina at bed time for three consecutive nights. Treatment should be continued even if menstruation occurs. Although a three night course of treatment is often sufficient longer courses are advisable for women with recurrent vaginal infections.Econazole 30 gm cream: The supplied applicator should be filled with econazole cream and then inserted deep into the vagina at bedtime once or twice daily.Econazole 10 gm cream: Apply sparingly to the affected area once or twice daily until improvement occurs.Sufficient Econazole cream should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis. Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

INTERACTION

Warfarin: Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulation effect. Most cases reported product application with use under occlusion, genital application, or application to large body surface area which may increase the systemic absorption of econzole 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. Carcinogenicity Studies: Long-term animal studies to determine carcinogenic potential have not been performed.

SIDE EFFECTS

During clinical trials, approximately 3% of patients treated with econazole nitrate 1% cream reported sideeffects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging, and erythema. One case of a pruritic rash has also been reported.

PREGNANCY & LACTATION

Intravaginal administration in humans has not shown prolonged gestation or other adverse reproductive effects attributable to econazole nitrate therapy.Pregnancy Category C. Econazole nitrate should be used in the first trimester of pregnancy only when the physician considers it essential to the welfare of the patient. The drug should be used during the second and third trimesters of pregnancy only if clearly needed.It is not known whether econazole nitrate is excreted in human milk. Caution should be exercised when econazole nitrate is administered to a nursing woman.

PRECAUTIONS & WARNINGS

Econazole nitrate is not for ophthalmic use.  If a reaction suggesting sensitivity or chemical irritation should occur, use of the medication should be discontinued. For external use only. Avoid introduction of Econazole Nitrate Cream into the eyes.

THERAPEUTIC CLASS

Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations

STORAGE CONDITIONS

Do not use later than date of expiry. Keep all medicine out of the reach of children. To be dispensed only on the prescription of a registered physician.