Label: NYSTATIN- nystatin suspension

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 10/12

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  • DESCRIPTION

    Nystatin is obtained from Streptomyces noursei. It is known to be a mixture, but the composition has not been completely elucidated. Nystatin A is closely related to amphotericin B. Each is a macro-cyclic lactone containing a ketal ring, an all-trans polyene system, and a mycosamine (3-amino-3-deoxyrhamose) moiety.

    Its structural formula is:

    Image of Structural Formula

    C47H75NO17 M.W. 926.13

    Nystatin oral suspension, USP is a cherry-mint flavored, ready-to-use suspension. Each mL of nystatin oral suspension, USP contains 100,000 units of nystatin in a vehicle containing 50% w/v sucrose with the following inactive ingredients: alcohol (less than 1% v/v), carboxymethylcellulose sodium, cherry flavor, citric acid, glycerin, peppermint flavor, purified water, and sodium citrate. Citric acid and/or sodium hydroxide may be used to adjust pH (5.3-7.5).

    PRESERVATIVES ADDED: Methylparaben 0.12%, Propylparaben 0.03%

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  • CLINICAL PHARMACOLOGY

    Nystatin acts by binding to sterols in the cell membrane of the fungus with a resultant change in membrane permeability allowing leakage of intracellular components. Nystatin is absorbed very sparingly following oral administration, with no detectable blood levels when given in the recommended doses.

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  • INDICATIONS AND USAGE

    Nystatin oral suspension, USP is indicated for the treatment of infections of the oral cavity caused by Candida albicans.

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  • CONTRAINDICATIONS

    Nystatin is contraindicated in patients with a history of hypersensitivity to nystatin or any of the suspension components.

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  • PRECAUTIONS

    General

    Discontinue treatment with nystatin if sensitization or irritation is reported during use.

    Nystatin is not effective in the treatment of systemic mycoses since it is not significantly absorbed from the gastrointestinal tract.

    Information for Patients

    Patient should be advised to retain nystatin in the mouth as long as possible and to continue its use for at least 2 days after symptoms have subsided.

    There should be no interruption or discontinuation of the medication until the prescribed course of treatment is completed, even though symptomatic relief may occur within a few days.

    If symptoms of local irritation develop, the physician should be notified immediately.

    Laboratory Tests

    If there is a lack of therapeutic response, appropriate microbiological studies (e .g., KOH smears and/or cultures) should be repeated to confirm the diagnosis of candidiasis and rule out other pathogens before instituting another course of therapy.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

    No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. In mice exposed to nystatin 50 mg/kg by injection, an increased incidence of chromosomal aberrations, consisting primarily of chromatid breaks, was observed in bone marrow cells. However, there have been no studies to determine the mutagenicity of orally-administered nystatin or its effects on fertility in males or females.

    Pregnancy

    Teratogenic Effects

    Pregnancy Category C

    Teratogenicity studies have not been conducted with nystatin. It is also not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin should be given to a pregnant woman only if clearly needed.

    Nonteratogenic Effects

    In one rat reproductive study, nystatin was administered orally to pregnant rats in single doses of 100, 500, or 3000 mg/kg on the ninth day of gestation, or as multiple doses of 500 mg/kg/day on gestation days 1-20, 1-4, 7-10, 11-14, or 15-18. It was found that nystatin had a slight abortive effect when used during the whole period of pregnancy. No abnormalities were seen in surviving fetuses. Although no adverse effects or complications have been attributed to the use of intra-vaginal nystatin in neonates born to women treated during pregnancy, no similar studies evaluating complications of oral nystatin have been conducted.

    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 section for pediatric dosing recommendations.

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  • ADVERSE REACTIONS

    To report SUSPECTED ADVERSE REACTIONS, contact Hi-Tech Pharmacal Co., Inc. at 1-800-262-9010 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    Gastrointestinal symptoms including diarrhea, gastrointestinal distress, nausea, vomiting and burning of the mouth have been reported. Hypersensitivity reactions including rash, pruritus, and anaphylactoid reaction have also been reported.

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  • OVERDOSAGE

    Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointestinal upset.

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  • DOSAGE AND ADMINISTRATION

    Infants: 2 mL (200,000 units) four times daily (1 mL in each side of mouth).

    Pediatric patients and adults: 4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth).

    NOTE: Limited clinical studies in neonates, including premature and low-birth weight neonates, indicate that 1 mL (100,000 units) four times daily is effective.

    Local treatment should be continued at least 48 hours after perioral symptoms have disappeared and/or cultures returned to normal. It is recommended that the drug be retained in the mouth as long as possible before swallowing.

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  • HOW SUPPLIED

    Nystatin Oral Suspension USP, 100,000 units per mL, is available as a yellow, milky, ready-to-use suspension with a cherry-mint flavor in the following sizes:

    60 mL bottles (with child-resistant calibrated dropper)

    SHAKE WELL BEFORE USING.

    Storage: Store between 15°-30°C (59°-86°F). PROTECT FROM FREEZING.

    Dispense in a tight, light resistant container when dispensing from the original container.

    KEEP OUT OF REACH OF CHILDREN.

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  • PRINCIPAL DISPLAY PANEL
  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin suspension
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42254-322(NDC:50383-587)
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NYSTATIN (NYSTATIN) NYSTATIN 100000 [USP'U]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    SUCROSE  
    ALCOHOL  
    CARBOXYMETHYLCELLULOSE SODIUM  
    ANHYDROUS CITRIC ACID  
    GLYCERIN  
    WATER  
    SODIUM CITRATE  
    SODIUM HYDROXIDE  
    METHYLPARABEN  
    PROPYLPARABEN  
    Product Characteristics
    Color YELLOW (yellow, milky) Score     
    Shape Size
    Flavor CHERRY, PEPPERMINT Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42254-322-60 1 in 1 CARTON
    1 60 mL in 1 BOTTLE, DROPPER
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA064042 01/27/2012
    Labeler - Rebel Distributors Corp (118802834)
    Registrant - PSS World Medical, Inc. (101822862)
    Establishment
    Name Address ID/FEI Business Operations
    PSS World Medical, Inc. 791528623 REPACK(42254-322)
    Establishment
    Name Address ID/FEI Business Operations
    STAT RX USA LLC 786036330 REPACK(42254-322)
    Establishment
    Name Address ID/FEI Business Operations
    Dispensing Solutions, Inc. 066070785 RELABEL(42254-322), REPACK(42254-322)
    Establishment
    Name Address ID/FEI Business Operations
    SCRIPT PAK 964420108 RELABEL(42254-322), REPACK(42254-322)
    Establishment
    Name Address ID/FEI Business Operations
    Keltman Pharmaceuticals, Inc. 362861077 REPACK(42254-322)
    Establishment
    Name Address ID/FEI Business Operations
    Rebel Distirbutors Corp. 118802834 RELABEL(42254-322), REPACK(42254-322)
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