NYSTATIN SUSPENSION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]

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NYSTATIN SUSPENSION [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]
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NDC 0168-0037-60
Set ID 855277ef-d6ad-4582-a289-c8c739bf675b
Category HUMAN PRESCRIPTION DRUG LABEL
Packager E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Generic Name
Product Class
Product Number
Application Number ANDA062517
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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

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

    Structural Formula

    Molecular Formula: C47 H75 NO17      Molecular Weight: 926.13

    Nystatin Oral Suspension, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol USP (not more than 1% by volume), mint blend flavoring, dibasic sodium phosphate USP, glycerin USP, purified water USP, colloidal silicon dioxide, sucrose NF (50%), methylparaben NF (0.12%) and propylparaben NF (0.03%) as preservatives.

  • 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 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–Pregnancy 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.

  • 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 (approximately 1/2 teaspoon)(200,000 units) four times daily 1 mL (approximately 1/4/ teaspoon) (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 (approximately 1 teaspoon)(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 mint-flavored, light yellow, ready-to-use suspension in the following sizes:

    NDC 0168-0037-60       60 mL bottle (with a calibrated dosing cup)
    NDC 0168-0037-61       60 mL bottle (with a calibrated dropper)
    NDC 0168-0037-74       1 Pint bottle

    Shake well before using. Wash cup before and after each use.
    Before dispensing, replace cap with safety cap dropper.

    Store at 20°-25°C (68°-77°F); excursions permitted between 15°-30°C (59°-86°F)
    [see USP Controlled Room Temperature].

    WARNING: Keep out of reach of children.

    This product sealed for your protection. If the seal is missing or broken return to place of purchase.

    E. FOUGERA & CO.
    A division of Nycomed US Inc.
    Melville, New York 11747

    I237C/IF237E
    R11/07
    #276

  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60ML CONTAINER

    NDC 0168-0037-60

    FOUGERA®

    NYSTATIN ORAL

    SUSPENSION USP

    100,000 USP Nystatin Units per mL

    Rx only

    60mL

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60ML CONTAINER
  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60ML CARTON

    NDC 0168-0037-60

    FOUGERA®

    NYSTATIN ORAL

    SUSPENSION USP

    100,000 USP

    Nystatin Units per mL

    Rx only

    60mL

    with Dose

    Measuring Cup

    Shake well before using.

    Wash cup before

    and after use.

    WARNING: Keep out

    of reach of children.

    PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60ML CARTON
  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0168-0037
    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)  
    sodium phosphate, dibasic (UNII: GR686LBA74)  
    glycerin (UNII: PDC6A3C0OX)  
    water (UNII: 059QF0KO0R)  
    silicon dioxide (UNII: ETJ7Z6XBU4)  
    sucrose (UNII: C151H8M554)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0168-0037-601 in 1 CARTON
    160 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA06251706/07/1984
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fougera Pharmaceuticals Inc.043838424ANALYSIS(0168-0037)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fougera Pharmaceuticals Inc.174491316MANUFACTURE(0168-0037)
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