Nystatin Cream

DESCRIPTION

Nystatin is a polyeneantifungalantibioticobtained fromStreptomyces nursei. Structural formula:

Nystatin Cream, USP is for dermatologic use.

Nystatin cream for topical use, contains 100,000 USP nystatin units per gram in a cream base containing aluminum hydroxide gel, ceteareth-15, glyceryl monostearate, polyethylene glycol 400 monostearate, propylene glycol, purified water, simethicone emulsion, sorbitol solution, titanium dioxide, white petrolatum, methylparaben, propylparaben, and sodium hydroxide.

INDICATIONS

Nystatin Cream, USP is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused byCandida albicans和other susceptibleCandidaspecies.

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

DOSAGE AND ADMINISTRATION

成人和儿科患者(新生儿及以上)

Apply liberally to affected areas twice daily or as indicated until healing is complete.

HOW SUPPLIED

Nystatin Cream, USPis a smooth yellow cream.

Nystatin Cream, USP is supplied in 15 g (NDC0713-0678-15) and 30 g (NDC0713-0678-31)tubesproviding 100,000 USP Nystatin units pergram.

Store at 20° to 25°C (68° to 77°F) [seeUSP Controlled Room Temperature]. Avoid freezing.

Manufactured by: G&W Laboratories, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. Revised: Aug 2015

SIDE EFFECTS

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. (SeePRECAUTIONS:General.)

To report SUSPECTED ADVERSE REACTIONS, contact G&W Laboratories , Inc. at 1-800- 922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

None provided.

WARNINGS

Please refer to thePRECAUTIONSsection.

PRECAUTIONS

General

Nystatin cream 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 ofcutaneousor mucocutaneouscandidiasis和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, And Impairment Of Fertility

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

Pregnancy

Teratogenic Effects

C类

Animal reproduction studies have not been conducted with any nystatin cream. It also is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin cream 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. (SeeDOSAGE AND ADMINISTRATION.)

Geriatric Use

Clinical studies with nystatin cream 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.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Nystatin cream is contraindicated in patients with a history of hypersensitivity to any of its components.

CLINICAL PHARMACOLOGY

Pharmacokinetics

Nystatin is not absorbed from intact skin ormucousmembrane.

Microbiology

Nystatin is an antibiotic which is bothfungistatic和真菌的in vitroagainst a wide variety of yeasts andyeast-like fungi, includingCandida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes. Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin,Candida albicansdoes not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species ofCandida(C.tropicalis, C. guilliermondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria,protozoa, orviruses.

PATIENT INFORMATION

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

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.

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.

If symptoms of irritation develop, the patient should be advised to notify the physician promptly.