NYSTATIN SUSPENSION [VISTAPHARM, INC.]

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NYSTATIN SUSPENSION [VISTAPHARM, INC.]
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NDC 66689-008-02, 66689-008-08, 66689-008-16
Set ID 3651ad5b-436c-4ae9-9ab1-80b6ac8ae0a8
Category HUMAN PRESCRIPTION DRUG LABEL
Packager VistaPharm, Inc.
Generic Name
Product Class
Product Number
Application Number ANDA065422
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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

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

    Chemical Structure

    Nystatin Oral Suspension, USP, for oral administration contains 100,000 Nystatin units per mL. In addition, the yellow opaque suspension contains the following inactive ingredients : Alcohol (0.5% v/v), USP, Alcohol free Bubble Gum Flavoring, Carboxymethylcellulose Sodium, USP, Dibasic Sodium Phosphate, USP, Glycerin Natural 99.5%, USP, Methylparaben, NF, (Preservative), Monobasic Sodium Phosphate, USP, Propylparaben, NF, (Preservative), Purified Water, USP, Saccharin Sodium, USP, and Sucrose, NF.

  • 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 Oral Suspension, USP, is indicated for the treatment of candidiasis in the oral cavity.

  • CONTRAINDICATIONS

    The preparation is contraindicated in patients with a history of hypersensitivity to any of its 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 oral suspension. It is also not known whether nystatin oral suspension can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Nystatin oral suspension 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.

    Pediatric Use

    See DOSAGE AND ADMINISTRATION.

  • 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 EVENTS, contact FDA at 1-800-FDA-1088 or www.fda.gov.

  • 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 or superinfections (see CLINICAL PHARMACOLOGY: Pharmacokinetics).

  • DOSAGE AND ADMINISTRATION

    Infants

    2 mL (200,000 units) four times daily (in infants and young children, use dropper to place one-half of dose in each side of mouth and avoid feeding for 5 to 10 minutes).

    NOTE: Limited clinical studies in premature and low birth weight infants indicate that 1 mL four times daily is effective.

    Children and Adults

    4 to 6 mL (400,000 to 600,000 units) four times daily (one-half of dose in each side of mouth). The preparation should be retained in the mouth as long as possible before swallowing.

    Continue treatment for at least 48 hours after perioral symptoms have disappeared and cultures demonstrate eradication of Candida albicans.

  • HOW SUPPLIED

    Nystatin Oral Suspension, USP, 100,000 Nystatin units per mL, is available as a bubble gum flavored, yellow opaque, ready-to-use suspension.

    Nystatin Oral Suspension, USP, is available as follows:

    NDC 66689-008-02: 2 fl. oz. bottle (60 mL): supplied in individual carton with calibrated dropper;

    NDC 66689-008-08: 8 fl. oz. bottle (237 mL);

    NDC 66689-008-16: 16 fl. oz. bottle (480 mL).

    Storage

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

    AVOID FREEZING

  • SPL UNCLASSIFIED SECTION

    Rx Only

    Manufactured By:
    VistaPharm®
    Largo, FL 33771

    VP1086R2
    06/19

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle

    NDC 66689-008-02

    NYSTATIN ORAL

    SUSPENSION, USP

    100,000 units per mL

    Contains: Alcohol 0.5% v/v

    (Bubblegum Flavored)

    SHAKE WELL BEFORE USING

    At The Time Of Dispensing Replace

    Cap with Safety Cap Dropper

    2 fl. oz.

    (60 mL)

    Rx only

    VistaPharm®

    container-label
  • PRINCIPAL DISPLAY PANEL - 60 mL Carton

    NDC 66689-008-02

    NYSTATIN ORAL

    SUSPENSION, USP

    100,000 units per mL

    (Bubblegum Flavored)

    Contains: Alcohol 0.5% v/v

    SHAKE WELL BEFORE USING

    2 fl. oz.

    (60 mL)

    with calibrated dropper 

    Rx only

    VistaPharm®

    Carton Label-60mL
  • PRINCIPAL DISPLAY PANEL - 480 mL Bottle

    NDC 66689-008-16

    NYSTATIN ORAL

    SUSPENSION, USP

    100,000 units per mL

    Contains: Alcohol 0.5% v/v

    (Bubblegum Flavored)

    SHAKE WELL BEFORE USING

    16 fl. oz.

    (480 mL)

    Rx only

    VistaPharm®

    Bottle Label
  • PRINCIPAL DISPLAY PANEL - 480 mL Carton

    NDC 66689-008-16

    NYSTATIN ORAL

    SUSPENSION, USP

    100,000 units per mL

    (Bubblegum Flavored)

    Contains: Alcohol 0.5% v/v

    SHAKE WELL BEFORE USING

    16 fl. oz.

    (480 mL)

    Rx only

    VistaPharm®

    Carton-Label
  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:66689-008
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN100000 [USP'U]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorYELLOW (Light yellow) Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66689-008-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2012
    2NDC:66689-008-08237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2012
    3NDC:66689-008-16480 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06542205/01/2012
    Labeler - VistaPharm, Inc. (116743084)
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