Spectazole (Topical)

Econazole topical is used to treat infections caused by a fungus or yeast. It works by killing the fungus or yeast or stopping it from growing.

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.

It is very important for your doctor to check your progress during regular visits. This allows your doctor to see if the medicine is working well and to check for any problems or side effects that may be caused by this medicine.

Do not use this medicine for a skin issue that has not been reviewed by your doctor.

If your skin issue does not improve within 2 weeks or gets worse, consult your doctor.

Contact your doctor immediately if you experience a skin rash, burning, stinging, swelling, redness, or irritation on the skin.

Good health habits are also necessary for patients using this medicine to help clear up your infection completely and to help prevent it from coming back.

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 your feet, especially between the toes, after bathing.
• Avoid wearing socks made from wool or synthetic materials (e.g., 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 (e.g., shoes with holes).
• Use a bland, absorbent powder (e.g., talcum powder) or an antifungal powder (e.g., 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 in between the times you use the cream.
• If you have any questions about these instructions, consult 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 keep the groin area cool and dry:

• Avoid wearing tight-fitting underwear or underwear made from synthetic materials (e.g., rayon or nylon). Instead, wear loose-fitting, cotton underwear.
• Use a bland, absorbent powder (e.g., talcum powder) or an antifungal powder (e.g., 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, consult your doctor.

In deciding to use a medicine, you and your doctor need to weigh the risks of taking it against the benefits it may provide. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies so far have not shown any specific problems in children aged 12 years and older that would limit the usefulness of econazole topical foam. However, safety and effectiveness have not been established in children younger than 12 years.

There is no information available on how age affects the use of econazole topical cream in children. Safety and effectiveness have not been established.

Geriatric

Studies so far have not found any specific problems in elderly patients that would limit the usefulness of econazole topical foam.

There is no information available on how age affects the use of econazole topical cream in elderly patients. Safety and effectiveness have not been established.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. In these cases, your doctor may need to adjust the dose, or other precautions may be necessary. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions are based on their potential significance and may not include all possible interactions.

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

• Warfarin

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or certain types of food because interactions may occur. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

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 signs 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.

In the U.S.

• Ecoza
• Spectazole

Available Dosage Forms:

• Cream
• Foam

Therapeutic Class: Antifungal

Chemical Class: Imidazole

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.