Nyamyc

• Upsher-Smith Laboratories, Inc.

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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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.

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei.

Nyamyc® (Nystatin Topical Powder, USP) is for dermatologic use.

Nyamyc® (Nystatin Topical Powder, USP) contains 100,000 USP nystatin units per gram dispersed in talc.

General

Nyamyc® (Nystatin Topical Powder, USP) should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

INFORMATION FOR THE PATIENT

Patients using this medication should receive the following information and instructions:

1. The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed.
2. Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.
3. If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

Laboratory Tests

If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.

Pregnancy

Category C

Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether theses preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nyamyc® (Nystatin Topical Powder, USP) should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Pediatric Use

Safety and effectiveness have been established in the pediatric population from birth to 16 years. (see DOSAGE AND ADMINISTRATION).

Geriatric Use

Clinical studies with nystatin topical powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

Very moist lesions are best treated with the topical dusting powder.

Adults and Pediatric Patients (Neonates and Older)

Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

Applies to nystatin topical: vaginal cream, vaginal tablet

Other dosage forms:

• topical cream, topical ointment, topical powder

Along with its needed effects, nystatin topical (the active ingredient contained in Nyamyc) 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 as soon as possible if any of the following side effects occur while taking nystatin topical:

• Vaginal burning or itching not present before use of this medicine