Pediaderm AF

Nystatin is an antifungal medication. Nystatin prevents fungus from growing on your skin.

Nystatin topical (for the skin) is used to treat skin infections caused by yeast.

Nystatin topical is not for use to treat a vaginal yeast infection.

Nystatin topical may also be used for purposes not listed in this medication guide.

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not use nystatin topical to treat any skin condition that has not been checked by your doctor.

Wash your hands before and after using this medication.

Clean and dry the skin before you apply nystatin topical.

Do not cover treated skin with bandages or dressings that do not allow air circulation unless your doctor tells you to.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Call your doctor if your symptoms do not improve, or if they get worse while using nystatin topical.

Do not share this medication with another person, even if they have the same symptoms you have.

Store at room temperature away from moisture and heat.

Avoid getting this medication in your eyes or mouth. If this does happen, rinse with water.

Avoid wearing tight-fitting, synthetic clothing (such as nylon) that doesn't allow air circulation. Wear clothing made of loose cotton and other natural fibers until your infection is healed.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using nystatin topical and call your doctor at once if you have severe burning, itching, rash, pain, or other irritation where the medicine is applied.

Less serious side effects may include mild itching or irritation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

It is not likely that other drugs you take orally or inject will have an effect on topically applied nystatin topical. But many drugs can interact with each other. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Nystatin cream is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

This cream is not indicated for systemic, oral, intravaginal or ophthalmic use.

The frequency of adverse events reported in patients using nystatin cream is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application.

(See PRECAUTIONS: General.)

Applies to nystatin topical: topical cream, topical kit, topical ointment, topical powder, vaginal tablet

Dermatologic

Dermatologic side effects associated with nystatin topical (the active ingredient contained in Pediaderm AF) powder, cream, and ointment have included skin irritation, burning, itching, rash, eczema, and pain on application in less than 0.1% of patients.[Ref]

Genitourinary

Genitourinary side effects associated with nystatin vaginal tablets have included vaginal irritation, burning, and itching. At least one case of severe vulvovaginitis has also been reported.[Ref]

A 64-year-old female experienced severe vulvovaginitis while receiving intravaginal nystatin therapy for Candida glabrata infection. She was administered nystatin vaginal tablets, 100,000 units twice daily for 14 days. She returned immediately after having completed the course complaining of intense skin rash in the vulvar area accompanied by severe irritation, burning, and itching. Therapy with a hydrocortisone cream and intramuscular betamethasone dipropionate was initiated. A week later, she had marked improvement with clearing of the vulvovaginal erythema and edema.[Ref]

Hypersensitivity

Hypersensitivity side effects associated with nystatin topical (the active ingredient contained in Pediaderm AF) powder, cream, and ointment have included allergic reactions and allergic contact dermatitis in less than 0.1% of patients. Stevens-Johnson syndrome has also been reported.

Some side effects of Pediaderm AF may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.