Pronunciation:

ser-ta-KON-a-zole

Brand Names:

• Ertaczo

Dosage Forms:

• Cream

Classifications:

Therapeutic—

Antifungal

Chemical—

Imidazole

Uses of This Medicine:

Sertaconazole is used to treat infections caused by a fungus. It works by killing the fungus or yeast or preventing its growth. Sertaconazole is applied to your skin to treat athlete's foot (tinea pedis).

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

Before Using This Medicine:

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.

Children—

This medicine has been tested in children and has not been shown to cause different side effects or problems than it does in adults. This medicine is to be used in children 12 years of age and older.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of topical sertaconazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Breast-feeding—

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.

Other medicines—

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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 of This Medicine:

Use sertaconazole as directed by your doctor. Your hands should be washed after applying the medicine to the affected area(s) of your skin. Avoid contact with the eyes, nose, mouth and other mucus membranes. Sertaconazole is for external use only.

Dry the affected area(s) thoroughly before application, if you wish to use sertaconazole after bathing.

Use your medicine for the full treatment time recommended by your doctor, even though symptoms may have improved.

Avoid the use of bandages or gauze (occlusive dressings) unless otherwise directed by your doctor.

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 athlete's foot:
    • Adults—Apply enough sertaconazole to cover the affected and surrounding skin areas and rub in gently
    • Children over the age of 12—Apply enough sertaconazole to cover the affected and surrounding skin areas and rub in gently

Missed dose—

If you miss a dose of this medicine, take 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. Do not double doses.

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 While Using This Medicine:

Inform your doctor if the area of application shows signs of increased skin irritation, redness, itching, burning, blistering, swelling or oozing.

It is very important that you check with your doctor in 2 weeks if your symptoms are not improving or if your conditions become worse.

Side Effects of This Medicine:

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence unknown

Blistering, burning, crusting, dryness or flaking of skin

itching, redness, skin rash, swelling, or soreness at application site

darkening of skin

dry skin

flushing and redness of skin

scaling, severe redness, soreness or swelling of skin

peeling or loosening of skin

skin tenderness

unusually warm skin

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.