Label: NYSTATIN- nystatin tablet, film coated 

  • Label RSS
  • NDC Code(s): 53489-400-01, 53489-400-02, 53489-400-03, 53489-400-05, view more
    53489-400-10
  • Packager: Mutual Pharmaceutical Company, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 11/09

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  • SPL UNCLASSIFIED SECTION

    Rx only

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  • DESCRIPTION

    Nystatin is an antimycotic polyene antibiotic obtained from Streptomyces noursei. Its structural formula:

    Chemical Structure

    Nystatin tablets are provided for oral administration as coated tablets containing 500,000 units nystatin.

    Inactive ingredients: anhydrous lactose, carnauba wax, corn starch, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, stearic acid, and titanium dioxide.

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  • 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.

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  • INDICATIONS AND USAGE

    Nystatin tablets are intended for the treatment of non-esophageal mucus membrane gastrointestinal candidiasis.

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  • CONTRAINDICATIONS

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

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  • 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. 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.

    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.

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  • ADVERSE REACTIONS

    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 rarely reported.

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  • OVERDOSAGE

    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 of superinfections (see CLINICAL PHARMACOLOGY, Pharmacokinetics).

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  • DOSAGE AND ADMINISTRATION

    The usual therapeutic dosage is one to two tablets (500,000 to 1,000,000 units nystatin) three times daily. Treatment should generally be continued for at least 48 hours after clinical cure to prevent relapse.

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  • HOW SUPPLIED

    Nystatin tablets, USP 500,000 units, are round, brown, film coated, debossed MP 83. Available as follows:

    Bottles of 50 NDC 53489-400-02
    Bottles of 100 NDC 53489-400-01
    Bottles of 250 NDC 53489-400-03
    Bottles of 500 NDC 53489-400-05
    Bottles of 1000 NDC 53489-400-10

    Store at 20° to 25°C (68° to 77°F).

    [See USP Controlled Room Temperature]

    DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.

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  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    MUTUAL PHARMACEUTICAL COMPANY, INC.
    Philadelphia, PA 19124 USA

    Rev 01, July 2009

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  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle

    MP

    NDC 53489-400-01

    NYSTATIN TABLETS USP
    (ORAL)

    500,000 units

    100 TABLETS
    Rx only

    MUTUAL PHARMACEUTICAL CO., INC.
    PHILADELPHIA, PA 19124 USA

    Principal Display Panel - 100 Tablet Bottle
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  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin tablet, film coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53489-400
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    nystatin (nystatin) nystatin 500000 [USP'U]
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous lactose  
    carnauba wax  
    starch, corn  
    FD&C BLUE NO. 2  
    FD&C RED NO. 40  
    hydroxypropyl cellulose  
    hypromellose  
    magnesium stearate  
    cellulose, microcrystalline  
    polyethylene glycol  
    povidone  
    starch, potato  
    stearic acid  
    titanium dioxide  
    Product Characteristics
    Color BROWN Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code MP;83
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53489-400-02 50 in 1 BOTTLE
    2 NDC:53489-400-01 100 in 1 BOTTLE
    3 NDC:53489-400-03 250 in 1 BOTTLE
    4 NDC:53489-400-05 500 in 1 BOTTLE
    5 NDC:53489-400-10 1000 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA062838 12/22/1988
    Labeler - Mutual Pharmaceutical Company, Inc. (121735955)
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