Prescription Drugs

CLINICAL PHARMACOLOGY Pharmacokinetics Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is passed unchanged in the stool. In patients with renal insufficiency receiving oral therapy with conventional dosage forms, significant plasma concentrations of nystatin may occasionally occur. Microbiology Nystatin is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. Candida albicans demonstrates no significant resistance to nystatin in vitro on repeated subculture in increasing levels of nystatin; other Candida species become quite resistant. Generally, resistance does not develop in vivo. Nystatin acts by binding to sterols in the cell membrane of susceptible Candida species with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

CLINICAL PHARMACOLOGY Pharmacokinetics Nystatin is not absorbed from intact skin or mucous membrane. Microbiology Nystatin is an antibiotic which is both fungistatic and fungicidalin vitro against a wide variety of yeasts and yeast-like fungi, including Candida 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 albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (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, or viruses.

Nystatin (nystatin) Oral Suspension, USPDESCRIPTION Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Structural formula: Nystatin Oral Suspension is a cherry-mint flavored suspension for oral administration. It contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol ( ≤ 1% v/v), carboxymethylcellulose sodium, flavor, glycerin, methylparaben, propylparaben, purified water, saccharin sodium, sodium citrate, and sucrose (50% w/v). May also contain citric acid for pH adjustment.

Find Lowest Prices on MYCOSTATIN (nystatin) Cream MYCOSTATIN (nystatin) Powder FOR TOPICAL USE ONLY • NOT FOR OPHTHALMIC USE DESCRIPTION Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. Structural formula: Mycostatin® Cream (Nystatin Cream) and Mycostatin® Topical Powder (Nystatin Topical Powder) are for dermatologic use. MYCOSTATIN® (Nystatin) Cream for topical use, contains 100,000 USP nystatin units per gram. Inactive ingredients: aluminum hydroxide concentrated wet gel, titanium dioxide, propylene glycol, cetearyl alcohol (and) ceteareth-20, white petrolatum, sorbitol solution, glyceryl monostearate, polyethylene glycol monostearate, sorbic acid and simethicone. MYCOSTATIN® (Nystatin) Topical Powder contains 100,000 USP nystatin units per gram dispersed in talc.

INDICATIONS Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity. DOSAGE AND ADMINISTRATION Infants: 2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes). NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective. Children and Adults: 4–6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing. Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans. HOW SUPPLIED Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a cherry-mint flavored, light creamy yellow, ready-to-use suspension in 60 mL bottles with calibrated dropper and 473 mL bottles. Storage Store at 20°-25°C (68°-77°F) with excursions permitted between 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]; avoid freezing. Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811. Revised: Apr 2015

INDICATIONS 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. DOSAGE AND ADMINISTRATION 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. HOW SUPPLIED 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.

PATIENT INFORMATION No information provided. Please refer to the PRECAUTIONS section.

OVERDOSE Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset. There have been no reports of serious toxic effects or superinfections (See CLINICAL PHARMACOLOGY: Pharmacokinetics ). CONTRAINDICATIONS The preparation is contraindicated in patients with a history of hypersensitivity to any of its components.

OVERDOSE No information provided. CONTRAINDICATIONS Nystatin topical preparations are contraindicated in patients with a history of hypersensitivity to any of their components.

SIDE EFFECTS Nystatin is well tolerated even with prolonged therapy. Oral irritation and sensitization have been reported (See PRECAUTIONS: General). Gastrointestinal Diarrhea (including one case of bloody diarrhea), nausea, vomiting, gastrointestinal upset/disturbances. Dermatologic Rash, including urticaria has been reported rarely. Stevens-Johnson syndrome has been reported very rarely. Other Tachycardia, bronchospasm, facial swelling, and nonspecific myalgia have also been reported. DRUG INTERACTIONS No information provided.

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.

WARNINGS No information provided. PRECAUTIONS General This medication is not to be used for the treatment of systemic mycoses. Discontinue treatment if sensitization or irritation is reported during use. Carcinogenesis, Mutagenesis, Impairment Of Fertility No long-term animal studies have been performed to evaluate carcinogenic potential. There also have been no studies to determine mutagenicity or whether this medication affects fertility in males or females. Pregnancy Teratogenic Effects - Category C Animal reproduction studies have not been conducted with nystatin oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension should be given to a pregnant woman only if clearly needed. Nursing Mothers It is not known whether nystatin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when nystatin is administered to a nursing woman. Pediatric Use See DOSAGE AND ADMINISTRATION.

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.