Generic

Econazole Nitrate

Indications

Topical application of Econazole Nitrate is indicated for 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, as well as cutaneous candidiasis and tinea versi

Pharmacology

Econazole Nitrate inhibits fungal oxidative enzymes, resulting in a deadly buildup of H2O2. They also inhibit the synthesis of ergosterol, a key component of the 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

Concurrent treatment of econazole with warfarin has resulted in a stronger anticoagulant impact. The majority of patients reported using the product with occlusion, vaginal application, or application to a wide body surface area, all of which might enhance econzole nitrate systemic absorption. In patients who apply econazole to large body surface areas, the vaginal area, or under occlusion, monitoring of the International Normalized Ratio (INR) and/or prothrombin time may be recommended.

Carcinogenicity Trials: There have been no long-term animal studies to evaluate carcinogenic potential.

Contraindications

Individuals who have proven hypersensitivity to any of the components in Econazole should avoid it.

Side Effects

During clinical studies, about 3% of patients treated with econazole nitrate 1% cream had adverse effects that were considered to be caused by the medication, with the most common ones being burning, itching, stinging, and erythema. A pruritic rash has also been noted in one case.

Pregnancy & Lactation

In humans, intravaginal injection of econazole nitrate has not resulted in extended gestation or any severe reproductive consequences.

Pregnancy Classification C. Econazole nitrate should only be taken in the first trimester of pregnancy if the doctor believes it is necessary for the patient's health. Only if obviously needed should the medication be taken throughout the second and third trimesters of pregnancy.

The presence of econazole nitrate in human milk is unknown. When administering econazole nitrate to a breastfeeding mother, use caution.

Precautions & Warnings

Econazole nitrate is not intended for use in the eyes. If a response that suggests sensitivity or chemical irritation occurs, the drug should be stopped immediately. Only for external usage. Econazole Nitrate Cream should not be applied to the eyes.

Therapeutic Class

Drugs used in Vaginal and Vulval condition, Topical Antifungal preparations

Storage Conditions

Do not use beyond the expiration date. Keep any medications out of children's reach. Only on a qualified physician's prescription can it be dispensed.

Pharmaceutical Name

Incepta Pharmaceuticals Ltd.