Label: NYSTATIN tablet, coated

  • NDC Code(s): 23155-051-01
  • Packager: Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL

Drug Label Information

Updated August 9, 2023

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  • DESCRIPTION

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

    Image

    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, dibasic calcium phosphate, FD&C yellow #6, FD&C red #40, FD&C blue # 2, hydroxypropyl cellulose, hypromellose, microcrystalline cellulose, magnesium stearate, polyethylene glycol, polysorbate 80, talc 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.

    To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc. at 1-866-901-DRUG (3784) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

  • 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 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 by:

    Strides Pharma Science Limited

    Puducherry- 605 014, India.

    PON/DRUGS/16 13 4193

    Distributed by:

    Avet Pharmaceuticals Inc.

    East Brunswick, NJ 08816

    1.866.901.DRUG (3784)

    logo

    1041073

    Rev: 06/2020

    OR

    Manufactured by:

    Vivimed Life Sciences Private Limited

    Alathur, Kanchipuram – 603 110, Tamilnadu, India.

    M.L. No.: TN00002327

    Manufactured for:

    Avet Pharmaceuticals Inc.

    East Brunswick, NJ 08816

    1.866.901.DRUG(3784)

    Avet logo

    1043190

    Revised: 08/2021

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

    500,000 Units, 100 ct 500,000 Units, 100 ct

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

    label

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  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin tablet, coated
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:23155-051
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN500000 [USP'U]
    Inactive Ingredients
    Ingredient NameStrength
    STARCH, CORN (UNII: O8232NY3SJ)  
    SUCROSE (UNII: C151H8M554)  
    HYDROXYPROPYL CELLULOSE (90000 WAMW) (UNII: UKE75GEA7F)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    TALC (UNII: 7SEV7J4R1U)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)  
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    Product Characteristics
    ColorBROWNScoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code HP;51
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:23155-051-01100 in 1 BOTTLE; Type 0: Not a Combination Product10/31/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06247410/31/2011
    Labeler - Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)
    Registrant - Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. (780779901)
    Establishment
    NameAddressID/FEIBusiness Operations
    Strides Pharma Science Limited871402375MANUFACTURE(23155-051) , ANALYSIS(23155-051) , PACK(23155-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vivimed Life Sciences Private Limited860477684ANALYSIS(23155-051) , MANUFACTURE(23155-051) , PACK(23155-051)
    Establishment
    NameAddressID/FEIBusiness Operations
    Capua Bioservices S.p.A.447961004ANALYSIS(23155-051) , API MANUFACTURE(23155-051)
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