Label: NYSTATIN- nystatin suspension

  • NDC Code(s): 66689-037-01, 66689-037-50, 66689-037-99
  • Packager: VistaPharm, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 6, 2017

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  • DESCRIPTION

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

    Nystatin Structure

    Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), methylparaben, NF; dibasic sodium phosphate, USP; monobasic sodium phosphate, USP; saccharin sodium, USP; sucrose (50% w/v), NF; glycerin, USP; carboxy-methylcellulose sodium, USP; propylparaben, NF; artificial wild cherry flavor # 14783 and purified water, USP

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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 intra-cellular components. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

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  • INDICATIONS AND USAGE

    Nystatin Oral Suspension is indicated for the treatment of candidiasis in the oral cavity.

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  • CONTRAINDICATIONS

    The preparation is contraindicated in patients with a history of hypersensitivity to any of its 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 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.

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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, broncho-spasm, facial swelling, and non-specific 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

    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: 4-6 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.

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  • HOW SUPPLIED

    Nystatin Oral Suspension, USP, 100,000 USP Nystatin Units per mL, is available as a cherry flavored, light creamy yellow, ready-to-use suspension. It is supplied as follows:
    NDC 66689-037-01. 5 mL unit dose cup.
    NDC 66689-037-50. Case contains 50 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 5 trays of 10 unit dose cups each.
    NDC 66689-037-99. Case contains 100 unit dose cups of 5 mL (NDC 66689-037-01), packaged in 10 trays of 10 unit dose cups each.

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  • Storage

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

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  • SPL UNCLASSIFIED SECTION

    Rx Only

    Manufactured by:

    VistaPharm, Inc.
    Largo, FL 33771

    VP2053R1
    02/17

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  • PRINCIPAL DISPLAY PANEL

    Xact DOSE™

    NYSTATIN
    ORAL SUSPENSION, USP
    500,000 units/ 5 mL

    NDC 66689-037-01

    Alcohol not more than 1% v/v
    SHAKE WELL BEFORE USING
    Protect from freezing
    Store at 20°–25°C (68°–77°F)

    [See USP CONTROLLED RM TEMP]

    Rx Only    This cup delivers 5 mL    VP2052R1

    Manufactured by VistaPharm, Inc.
    Largo, FL 33771

    Dose cup label
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  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin suspension
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:66689-037
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN 100000 [USP'U]  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SUCROSE (UNII: C151H8M554)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    ALCOHOL (UNII: 3K9958V90M)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color YELLOW (Light yellow) Score     
    Shape Size
    Flavor CHERRY Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66689-037-50 5 in 1 CASE 05/10/2010
    1 10 in 1 TRAY
    1 NDC:66689-037-01 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    2 NDC:66689-037-99 10 in 1 CASE 05/10/2010
    2 10 in 1 TRAY
    2 NDC:66689-037-01 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA064142 05/10/2010
    Labeler - VistaPharm, Inc. (116743084)
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