Brand Name

    US Brand Name

    Ecoza

    Spectazole


    Description

    Econazole topical is used to treat infections caused by a fungus or yeast. It works by killing the fungus or yeast or preventing its growth.

    Econazole cream is used to treat:

    • Ringworm of the body (tinea corporis);
    • Ringworm of the foot (tinea pedis; athlete's foot);
    • Ringworm of the groin (tinea cruris; jock itch);
    • Sun fungus (tinea versicolor); and
    • Yeast infection of the skin (cutaneous candidiasis).

    Econazole foam is used to treat ringworm of the foot between the toes (interdigital tinea pedis; athlete's foot).

    This medicine is available only with your doctor's prescription.

    This product is available in the following dosage forms:

    • Cream
    • Foam

    Before Using

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of econazole topical foam in children 12 years of age and older. However, safety and efficacy have not been established in children younger than 12 years of age.

    No information is available on the relationship of age to the effects of econazole topical cream in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of econazole topical foam in the elderly.

    No information is available on the relationship of age to the effects of econazole topical cream in the geriatric population. Safety and efficacy have not been established.

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

    Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

    • Warfarin

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


    Proper Use

    It is very important that you use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects or skin irritation.

    This medicine is for use on the skin only. Do not get it in your eyes, nose, mouth, or vagina.

    Wash your hands before and after using this medicine.

    Apply enough medicine to cover the affected and surrounding skin areas, and rub in gently.

    For patients using the foam:

    • This medicine should come with a patient information insert. Read and follow these instructions carefully. Ask your doctor if you have any questions.
    • This medicine is flammable. Do not use it near heat, an open flame, or while smoking. Do not puncture, break, or burn the medicine container.

    To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment, even if your symptoms begin to clear up after a few days. Since fungus or yeast infections may be very slow to clear up, you may have to continue using this medicine every day for several weeks or more. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses.

    Dosing

    The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

    The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

    • For topical dosage form (cream):
      • For cutaneous candidiasis:
        • Adults—Apply to the affected area(s) two times a day (morning and evening) for 2 weeks.
        • Children—Use and dose must be determined by your doctor.
      • For tinea corporis, tinea cruris, tinea pedis, or tinea versicolor:
        • Adults—Apply to the affected area(s) once a day for 2 to 4 weeks.
        • Children—Use and dose must be determined by your doctor.
    • For topical dosage form (foam):
      • For interdigital tinea pedis:
        • Adults and children 12 years of age and older—Apply to the affected area(s) once a day for 4 weeks.
        • Children younger than 12 years of age—Use and dose must be determined by your doctor.

    Missed Dose

    If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

    Storage

    Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

    Keep out of the reach of children.

    Do not keep outdated medicine or medicine no longer needed.

    Ask your healthcare professional how you should dispose of any medicine you do not use.


    Precautions

    It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and check you for any problems or unwanted effects that may be caused by this medicine.

    Do not use this medicine for a skin problem that has not been checked by your doctor.

    If your skin problem does not improve within 2 weeks or more, or if it becomes worse, check with your doctor.

    Check with your doctor right away if you have a skin rash, burning, stinging, swelling, redness, or irritation on the skin.

    Good health habits are also required for patients using this medicine to help clear up your infection completely and to help make sure it does not return.

    For patients using the cream for athlete's foot (tinea pedis; ringworm of the foot), the following instructions will help keep the feet cool and dry:

    • Carefully dry the feet, especially between the toes, after bathing.
    • Avoid wearing socks made from wool or synthetic materials (eg, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if your feet sweat a lot.
    • Wear sandals or well-ventilated shoes (eg, shoes with holes).
    • Use a bland, absorbent powder (eg, talcum powder) or an antifungal powder (eg, tolnaftate) between the toes, on the feet, and in socks and shoes one or two times a day. It is best to use the powder between the times you use the cream.
    • If you have any questions about these instructions, check with your doctor.

    For patients using the cream for ringworm of the groin (tinea cruris; jock itch), the following instructions will help reduce chafing and irritation and will also help keep the groin area cool and dry:

    • Avoid wearing underwear that is tight-fitting or made from synthetic materials (eg, rayon or nylon). Instead, wear loose-fitting, cotton underwear.
    • Use a bland, absorbent powder (eg, talcum powder) or an antifungal powder (eg, tolnaftate) on the skin. It is best to use the powder between the times you use the cream.
    • If you have any questions about these instructions, check with your doctor.

    Side Effects

    Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

    Check with your doctor immediately if any of the following side effects occur:

    Less common

    • Burning, itching, stinging, redness, or other sign of irritation at the application site
    • rash

    Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

    Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.






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