Mycostatin

MYCOSTATIN® Cream: 100,000 units nystatin per gram in an aqueous, perfumed vanishing cream base, in 30 g (NDC 0003-0579-31) tubes.

MYCOSTATIN® Topical Powder: 100,000 units nystatin per gram in 15 g (NDC 0003-0593-20) plastic squeeze bottles.

ALSO AVAILABLE

MYCOSTATIN® (Nystatin) is also available as vaginal tablets and in oral formulations (pastilles, suspension, tablets). See package inserts for complete prescribing information.

Storage

MYCOSTATIN (nystatin) ® Cream: Store at room temperature, avoid freezing.

MYCOSTATIN (nystatin) ® Topical Powder: Store at room temperature, avoid excessive heat (40° C/104° F). Keep tightly closed.

Westwood-Squibb Pharmaceuticals, Inc., A Bristol-Myers Squibb Company, Princeton, NJ 08543 USA.

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

These preparations are not indicated for systemic, oral, intravaginal or ophthalmic use.

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

MYCOSTATIN (nystatin) ® Cream

Adults and Pediatric Patients (Neonates and Older): Apply liberally to affected areas twice daily or as indicated until healing is complete.

MYCOSTATIN (nystatin) ® Topical 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.

Nystatin topical preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

WARNINGS

No information provided.

PRECAUTIONS

General

Nystatin, topical preparations 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.

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: Teratogenic Effects

Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations 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 MYCOSTATIN (Nystatin) Cream and MYCOSTATIN (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.

SIDE EFFECTS

The frequency of adverse events reported in patients using Mycostatin (nystatin) ® preparations 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.)

DRUG INTERACTIONS

No information provided.

The frequency of adverse events reported in patients using Mycostatin (nystatin) ® preparations 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.)

No information provided.

Nystatin is not absorbed from intact skin or mucous membrane.