Label: NYSTATIN - nystatin tablet, coated 

  • NDC Code(s): 23155-051-01
  • Packager: Heritage Pharmaceuticals Inc
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 11/13

If you are a consumer or patient please visit this version.

  • DESCRIPTION

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

    1348d536-figure-01

    C47H75NO17                                           M.W. 926.13

    Nystatin Tablets are for oral administration and contain 500,000 units of nystatin per tablet.

    Nystatin Tablets contain the inactive ingredients: corn starch, confectioner sugar, hydroxypropyl cellulose, dibasic calcium phosphate, microcrystalline cellulose, talc, magnesium stearate, hypromellose, polyethylene glycol, titanium dioxide, FD&C yellow #6, FD&C red #40, FD&C blue # 2 and polysorbate 80.

    Close
  • 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.

    Close
  • INDICATIONS AND USAGE

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

    Close
  • CONTRAINDICATIONS

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

    Close
  • 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.

    Close
  • 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.

    Close
  • 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).

    Close
  • 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.

    Close
  • HOW SUPPLIED

    Nystatin Tablets USP, 500,000 Units are brown, film-coated tablets debossed "HP51" on one side and plain on the other side are packaged in:

    bottles of 100: NDC 23155-051-01

    Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature].

    Manufactured for:
    Heritage Pharmaceuticals Inc.
    Eatontown, NJ 07724
    1.866.901.DRUG (3784)

    Made in India.

    DRUGS/PY/05131523 

    020002332 Revised 10/13

    Close
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Nystatin Tablets USP, 500,000 Units, 100 count bottles

    1348d536-figure-02

    Close
  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin tablet, coated
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:23155-051
    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
    STARCH, CORN  
    SUCROSE  
    HYDROXYPROPYL CELLULOSE  
    ISOPROPYL ALCOHOL  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE  
    CELLULOSE, MICROCRYSTALLINE  
    TALC  
    MAGNESIUM STEARATE  
    HYPROMELLOSE 2910 (6 MPA.S)  
    HYPROMELLOSE 2910 (3 MPA.S)  
    POLYETHYLENE GLYCOL 400  
    POLYETHYLENE GLYCOL 8000  
    TITANIUM DIOXIDE  
    FD&C YELLOW NO. 6  
    FD&C RED NO. 40  
    FD&C BLUE NO. 2  
    POLYSORBATE 80  
    Product Characteristics
    Color BROWN Score no score
    Shape ROUND Size 10mm
    Flavor Imprint Code HP;51
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23155-051-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA062474 10/31/2011
    Labeler - Heritage Pharmaceuticals Inc (780779901)
    Establishment
    Name Address ID/FEI Business Operations
    Shasun Pharmaceuticals Ltd. 915786829 MANUFACTURE(23155-051)
    Close