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    NYSTATIN-nys Tatin S Us Pens Ion Morton Grove Pharmaceuticals, Inc

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    Zeyad A Abdullah
    Nystatin oral suspension is an antifungal medication used to treat oral candidiasis. It contains 100,000 units of nystatin per mL. Nystatin works by binding to fungal cell membranes and causing leakage. It is generally well tolerated with common side effects including diarrhea and nausea. Nystatin is not absorbed systemically and is used to treat only oral candidiasis.

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    NYSTATIN-nys Tatin S Us Pens Ion Morton Grove Pharmaceuticals, Inc

    Uploaded by

    Zeyad A Abdullah
    29 views5 pages
    Nystatin oral suspension is an antifungal medication used to treat oral candidiasis. It contains 100,000 units of nystatin per mL. Nystatin works by binding to fungal cell membranes and causing leakage. It is generally well tolerated with common side effects including diarrhea and nausea. Nystatin is not absorbed systemically and is used to treat only oral candidiasis.

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    NYSTATIN ORAL SUSPENSION, USP

    Original Title

    20190124_d468395c-0f4c-4503-9a39-ae847524e683

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    Nystatin oral suspension is an antifungal medication used to treat oral candidiasis. It contains 100,000 units of nystatin per mL. Nystatin works by binding to fungal cell membranes and causing leakage. It is generally well tolerated with common side effects including diarrhea and nausea. Nystatin is not absorbed systemically and is used to treat only oral candidiasis.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    29 views5 pages

    NYSTATIN-nys Tatin S Us Pens Ion Morton Grove Pharmaceuticals, Inc

    Uploaded by

    Zeyad A Abdullah
    Nystatin oral suspension is an antifungal medication used to treat oral candidiasis. It contains 100,000 units of nystatin per mL. Nystatin works by binding to fungal cell membranes and causing leakage. It is generally well tolerated with common side effects including diarrhea and nausea. Nystatin is not absorbed systemically and is used to treat only oral candidiasis.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 5

    NYSTATIN- nys tatin s us pens ion

    Morton Grove Pharmaceuticals , Inc.


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    NYSTATIN ORAL
    SUSPENSION, USP
    (100,000 units per mL)
    Rx only

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

    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, potassium 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 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.

    Carcinogenes is , Mutagenes is , 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.

    Nurs ing 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 Us e
    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: 4–6 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.
    60 mL bottles was a calibrated dropper and
    1 Pint (473 mL) bottles (60432-537-16)

    Storage
    Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid freezing
    Rx Only
    Product No.: 8537
    Manufactured For:
    Wockhardt USA, LLC
    Pars ippany, NJ 07054
    Manufactured By:
    Morton Grove Pharmaceuticals , Inc.
    Morton Grove, IL 60053
    A50-8537-16
    REV. 07-18

    PRINCIPAL DISPLAY PANEL Bottle Carton


    MGP
    NDC 60432-537-16
    NYSTATIN ORAL
    SUSPENSION, USP
    (100,000 units
    per mL)
    Fruit Flavored
    SHAKE WELL BEFORE USING
    DO NOT USE IF INNER FOIL SEAL PRINTED "SEALED FOR YOUR PROTECTION" IS
    BROKEN OR MISSING
    Rx Only
    NET: 1 Pint (473 mL)

    Nys tatin Label

    NYSTATIN
    nystatin suspension

    Product Information
    Prod uct T yp e HUMAN PRESCRIPTIO N DRUG Ite m Cod e (S ource ) NDC:6 0 432-537

    Route of Ad minis tration O RAL

    Active Ing redient/Active Moiety


    Ing redient Name Basis o f Streng th Streng th
    NYSTATIN (UNII: BDF1O 1C72E) (NYSTATIN - UNII:BDF1O 1C72E) NYSTATIN 10 0 0 0 0 [USP'U] in 1 mL

    Inactive Ing redients


    Ing redient Name Streng th
    WATER (UNII: 0 59 Q F0 KO 0 R)
    MAGNESIUM ALUMINUM SILICATE (UNII: 6 M3P6 4V0 NC)
    PRO PYLENE GLYCO L (UNII: 6 DC9 Q 16 7V3)
    GLYCERIN (UNII: PDC6 A3C0 O X)
    SUCRO SE (UNII: C151H8 M554)
    PO TASSIUM PHO SPHATE, DIBASIC (UNII: CI71S9 8 N1Z)
    ALCO HO L (UNII: 3K9 9 58 V9 0 M)
    METHYLPARABEN (UNII: A2I8 C7HI9 T)
    PRO PYLPARABEN (UNII: Z8 IX2SC1O H)
    D&C YELLO W NO . 10 (UNII: 35SW5USQ 3G)
    FD&C RED NO . 4 0 (UNII: WZB9 127XO A)
    ANHYDRO US CITRIC ACID (UNII: XF417D3PSL)

    Product Characteristics
    Color YELLO W (Light c re a my ye llo w) S core
    S hap e S iz e
    Flavor FRUIT Imp rint Cod e
    Contains

    Packag ing
    Marketing Start Marketing End
    # Item Co de Packag e Descriptio n
    Date Date
    NDC:6 0 432-537- 6 0 mL in 1 BO TTLE, GLASS; Type 0 : No t a Co mbina tio n
    1 0 4/15/19 9 5
    60 Pro duc t
    NDC:6 0 432-537- 473 mL in 1 BO TTLE, PLASTIC; Type 0 : No t a Co mbina tio n
    2 0 4/15/19 9 5
    16 Pro duc t

    Marketing Information
    Marke ting Cate gory Ap p lication Numb e r or Monograp h Citation Marke ting S tart Date Marke ting End Date
    ANDA ANDA0 6 2512 0 4/15/19 9 5

    Labeler - Morton Grove Pharmaceuticals , Inc. (801897505)

    Registrant - Morton Grove Pharmaceuticals , Inc. (801897505)

    Establishment
    Name Ad d re s s ID/FEI Bus ine s s Op e rations
    Mo rto n Gro ve Pha rma c e utic a ls, Inc . 8 0 18 9 750 5 ANALYSIS(6 0 432-537) , MANUFACTURE(6 0 432-537) , PACK(6 0 432-537)

    Revised: 12/2018 Morton Grove Pharmaceuticals, Inc.

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