Sertaconazole (Topical)

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

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

Inform your doctor if the area where you applied the medicine 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 getting better or if your condition worsens.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. The following points should be considered for this medicine:

Allergies

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

Pediatric

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 for use in children 12 years of age and older.

Geriatric

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 the use of topical sertaconazole in older adults 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 to determine the risk to infants when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although some medicines should not be used together at all, other times two different medicines may be used together even if an interaction might happen. 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.

Interactions with Food/Tobacco/Alcohol

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

Some side effects may happen that usually do not require medical attention. These side effects may go away during treatment as your body gets used to the medicine. Your health care professional may also provide ways to prevent or lessen some of these side effects. Contact your health care professional if any of the following side effects continue, are bothersome, or if you have questions about them:

Incidence unknown

• Blistering, burning, crusting, dryness or flaking of skin
• Itching, redness, skin rash, swelling, or soreness at the 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, consult your health care 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.

• Ertaczo

Available Dosage Forms:

• Cream

Therapeutic Class: Antifungal

Chemical Class: Imidazole

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.