Label: NYSTATIN suspension

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 9, 2019

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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

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

    Chemical Structure

    C47H75NO17      MW 926.13

    C47H75NO17      MW 926.13

    Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL.

    Inactive ingredients: alcohol (≤ 1% v/v), artificial wild cherry flavor, banana flavor, D&C yellow # 10, FD&C red # 40, glycerin, USP, magnesium aluminum silicate, methylparaben, NF, potas-sium phosphate dibasic, USP, propylene glycol, USP, propylparaben, NF, purified water, USP and sucrose 33.5%. May also contain citric acid, USP for pH adjustment.

  • 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 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 com-ponents.

  • 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 preg-nant 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 very rarely. Stevens-Johnson syndrome has been reported very rarely.

    Other: Tachycardia, bronchospasm, facial swelling, and non-specific myalgia have also been rarely reported.

  • OVERDOSAGE

    Oral doses of nystatin in excess of five million units daily have caused nausea and gastrointesti-nal upset. There have been no reports of serious toxic effects of 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

    4-6 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 USP Nystatin Units per mL, is available as a fruit flavored, light creamy yellow, ready-to-use suspension.

    Available overbagged with 5 x 5 mL Unit dose cups per bag, NDC 55154-1578-5

    SHAKE CUPS WELL BEFORE USING

    STORAGE

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

  • SPL UNCLASSIFIED SECTION

    Rx Only

    Manufactured By:
    Morton Grove Pharmaceuticals, Inc.
    Morton Grove, IL 60053

    Manufactured For:
    Wockhardt USA, LLC.
    Parsippany, NJ 07054

    Packaged By:
    Precision Dose, Inc.
    S. Beloit, IL 61080

    Distributed By:

    Cardinal Health

    Dublin, OH 43017

    L37411960719

    LI825

    Rev. 07/10

  • PRINCIPAL DISPLAY PANEL - Bag

    Nystatin Oral Suspension, USP

    500,000 units per 5 ml

    5 Unit Dose Cups

    Bag Label
  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55154-1578(NDC:68094-599)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Nystatin (UNII: BDF1O1C72E) (Nystatin - UNII:BDF1O1C72E) Nystatin500000 [USP'U]  in 5 mL
    Product Characteristics
    ColorYELLOWScore    
    ShapeSize
    FlavorFRUITImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55154-1578-55 in 1 BAG12/15/2005
    15 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06251212/15/2005
    Labeler - Cardinal Health (603638201)