NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]

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NYSTATIN SUSPENSION [ATLANTIC BIOLOGICALS CORP.]
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NDC 17856-0811-1, 17856-0811-2, 17856-0811-3, 17856-0811-4, 17856-0811-5
Set ID 378c70ef-0fbc-4f0d-89c6-200735282fd7
Category HUMAN PRESCRIPTION DRUG LABEL
Packager ATLANTIC BIOLOGICALS CORP.
Generic Name
Product Class
Product Number
Application Number ANDA203621
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  • SPL UNCLASSIFIED SECTION

    Rx Only

  • DESCRIPTION

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

    nystatin chemical structure

    C 47H 75NO 17     MW 926.13

    Nystatin Oral Suspension USP, for oral administration, contains 100,000 USP Nystatin Units per mL. Inactive ingredients: alcohol (≤ 1% v/v), artificial peppermint flavor, cherry flavor, citric acid, D&C Yellow No. 10, FD&C Red No. 40, glycerin, magnesium aluminum silicate, methylparaben, potassium phosphate dibasic, propylene glycol, propylparaben, purified water and sucrose.

  • 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 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 non-specific 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 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 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 USP Nystatin Units per mL, is available in a cherry, peppermint flavored, light creamy yellow, ready-to-use suspension, supplied in the following oral dosage forms:

    NDC 17856-0811-01 NYSTATIN 100,000 UNITS/ML 0.5ML ENFIT SYRINGE 120 ct UD 

    NDC 17856-0811-02 NYSTATIN 100,000 UNITS/ML 1ML ENFIT SYRINGE 120 ct UD

    NDC 17856-0811-03 NYSTATIN 100,000 UNITS/ML 2ML ENFIT SYRINGE 120 ct UD

    NDC 17856-0811-04 NYSTATIN 100,000 UNITS/ML 5ML ENFIT SYRINGE 48 ct UD

    NDC 17856-0811-05 NYSTATIN 100,000 UNITS/ML 5ML CUP 72 ct UD 

    Storage

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

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:

    ATLANTIC BIOLOGICALS CORP

    20101 N.E 16TH PLACE 

    MIAMI, FL 33179

  • PRINCIPAL DISPLAY PANEL

    NDC 17856-0811

    NYSTATIN
    ORAL
    SUSPENSION, USP

    [100,000 units per mL]

    Alcohol ≤ 1% v/v SHAKE WELL

    Rx ONLY

    FOR INSTITUTIONAL USE ONLY

    SEE INSERT

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  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin suspension
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:17856-0811(NDC:0121-0810)
    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)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM PHOSPHATE, DIBASIC (UNII: CI71S98N1Z)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SUCROSE (UNII: C151H8M554)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    Product Characteristics
    Coloryellow (Light - Creamy) Score    
    ShapeSize
    FlavorCHERRY (w/Peppermint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:17856-0811-1120 in 1 BOX, UNIT-DOSE01/26/2021
    10.5 mL in 1 SYRINGE; Type 0: Not a Combination Product
    2NDC:17856-0811-2120 in 1 BOX, UNIT-DOSE01/26/2021
    21 mL in 1 SYRINGE; Type 0: Not a Combination Product
    3NDC:17856-0811-3120 in 1 BOX, UNIT-DOSE01/26/2021
    32 mL in 1 SYRINGE; Type 0: Not a Combination Product
    4NDC:17856-0811-448 in 1 BOX, UNIT-DOSE01/26/2021
    45 mL in 1 SYRINGE; Type 0: Not a Combination Product
    5NDC:17856-0811-572 in 1 BOX, UNIT-DOSE01/26/2021
    55 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    6NDC:17856-0811-6120 in 1 BOX, UNIT-DOSE01/26/2021
    61 mL in 1 SYRINGE; Type 0: Not a Combination Product
    7NDC:17856-0811-7120 in 1 BOX, UNIT-DOSE01/26/2021
    72 mL in 1 SYRINGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20362105/07/2019
    Labeler - ATLANTIC BIOLOGICALS CORP. (047437707)
    Establishment
    NameAddressID/FEIBusiness Operations
    ATLANTIC BIOLOGICALS CORP.047437707relabel(17856-0811) , repack(17856-0811)
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