NYSTATIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]

NYSTATIN TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]
PDF | XML

NDC 53489-400-01, 53489-400-02, 53489-400-03, 53489-400-05, 53489-400-10
Set ID b70731df-fead-4f40-941e-7889a9c5d800
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Sun Pharmaceutical Industries, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA062838
  • SPL UNCLASSIFIED SECTION

    Rx only

  • 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, D&C Yellow No. 10 Aluminum Lake, 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.

  • 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.

  • INDICATIONS AND USAGE

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

  • CONTRAINDICATIONS

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

  • 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.

  • 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.

  • 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).

  • 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.

  • 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.

  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Sun Pharmaceutical Industries, Inc.
    Cranbury, NJ 08512

    Rev 02, November 2014

  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    NystatinTablets USP (oral)- 100 tablets

    Principal Display Panel - 100 Tablets
  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin tablet, film coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:53489-400
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    nystatin (UNII: BDF1O1C72E) (nystatin - UNII:BDF1O1C72E) nystatin500000 [USP'U]
    Inactive Ingredients
    Ingredient NameStrength
    anhydrous lactose (UNII: 3SY5LH9PMK)  
    carnauba wax (UNII: R12CBM0EIZ)  
    starch, corn (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    HYDROXYPROPYL CELLULOSE (120000 MW) (UNII: UKE75GEA7F)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    magnesium stearate (UNII: 70097M6I30)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
    starch, potato (UNII: 8I089SAH3T)  
    stearic acid (UNII: 4ELV7Z65AP)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    D&C yellow no. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code MP;83
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53489-400-0250 in 1 BOTTLE; Type 0: Not a Combination Product12/22/1988
    2NDC:53489-400-01100 in 1 BOTTLE; Type 0: Not a Combination Product12/22/1988
    3NDC:53489-400-03250 in 1 BOTTLE; Type 0: Not a Combination Product12/22/1988
    4NDC:53489-400-05500 in 1 BOTTLE; Type 0: Not a Combination Product12/22/1988
    5NDC:53489-400-101000 in 1 BOTTLE; Type 0: Not a Combination Product12/22/1988
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06283812/22/1988
    Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Frontida BioPharm Inc.080243260MANUFACTURE(53489-400) , ANALYSIS(53489-400) , PACK(53489-400)