Label: NYSTATIN- nystatin powder

  • NDC Code(s): 42543-052-61, 42543-052-62, 42543-052-63
  • Packager: Vensun Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 31, 2014

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  • DESCRIPTION

    Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for nystatin is C47H75NO17.
    The molecular weight of nystatin is 926.1.  

    structural formula

    structural formula

    Nystatin Topical Powder, USP is for dermatologic use.

    Nystatin Topical Powder, USP, contains 100,000 USP nystatin units per gram dispersed in talc.

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  • CLINICAL PHARMACOLOGY

    Pharmacokinetics

     Nystatin is not absorbed from intact skin or mucous membrane.

    Microbiology

    Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida
     albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T.
    mentagrophytes.

    Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the
    subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not
    develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C.
    tropicalis, C. guilliermondi, C.
    krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become
    cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed.

    Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

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  • INDICATIONS AND USAGE

    Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans
    and other susceptible Candida species.

    This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.

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  • CONTRAINDICATIONS

     Nystatin Topical Powder is contraindicated in patients with a history of hypersensitivity to any of its components.

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  • PRECAUTIONS

    General

    Nystatin Topical Powder should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.

    If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended
    that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and
    to rule out infection caused by other pathogens.

    INFORMATION FOR THE PATIENT

    Patients using this medication should receive the following information and instructions:

    1.       The patient should be instructed to use this medication as directed (including the replacement of missed doses).
    This medication is not for any disorder other than that for which it is prescribed.

    2.       Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt
    or discontinue therapy until the prescribed course of treatment is completed.

    3.       If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

    Laboratory Tests

     If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

    Carcinogenesis, Mutagenesis, Impairment of Fertility

     No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed
    to determine the mutagenicity of nystatin or its effects on male or female fertility.

    Pregnancy: Teratogenic Effects

     Category C: Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these
    preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should
    be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

    Nursing Mothers

     It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

    Pediatric Use

     Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION).

    Geriatric Use

    Clinical studies with nystatin topical powder did not include sufficient numbers of subjects aged 65 years and older to determine whether they respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.

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  • ADVERSE REACTIONS

     The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General)

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  • DOSAGE AND ADMINISTRATION

    Very moist lesions are best treated with the topical dusting powder.

    Adults and Pediatric Patients (Neonates and Older):

    Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

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  • HOW SUPPLIED

     Nystatin Topical Powder, USP is supplied as 100,000 units nystatin per gram in 15 g, 30 g and 60 g plastic squeeze bottles.

    NDC 42543-052-61 for 15 g.

    NDC 42543-052-62 for 30 g.

    NDC 42543-052-63 for 60 g.

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  • STORAGE

    Store at 20º to 25ºC (68º to 77ºF) and excursions permitted to 15º to 30ºC (59º to 86ºF)  [See USP Controlled Room Temperature]. Avoid excessive heat (40ºC/104ºF).

    Keep tightly closed.

     Keep out of reach of children.

     

    Manufactured for
    Vensun Pharmaceuticals, Inc.
    790 Township Line Rd.
    Yardley, PA 19067

    Rev 00, May 2014

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  • PRINCIPAL DISPLAY PANEL

    15g Presentation

    NDC42543-052-61
    Nystatin Topical Powder, USP
    100,000 USP units per gram
    15 grams
    FOR TOPICAL USE ONLY
    Not for Ophthalmic Use
    Rx Only
     Vensun Pharmaceuticals, Inc. 

    15g

    15g

     

    30g Presentation

    NDC42543-052-62
    Nystatin Topical Powder, USP
    100,000 USP units per gram
    30 grams
    FOR TOPICAL USE ONLY
    Not for Ophthalmic Use
    Rx Only
     Vensun Pharmaceuticals, Inc. 

     30g

    30g

    60g Presentation

    NDC42543-052-63
    Nystatin Topical Powder, USP
    100,000 USP units per gram
    60 grams
    FOR TOPICAL USE ONLY
    Not for Ophthalmic Use
    Rx Only
     Vensun Pharmaceuticals, Inc. 

     60g

    60g

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  • INGREDIENTS AND APPEARANCE
    NYSTATIN 
    nystatin powder
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:42543-052
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    NYSTATIN (UNII: BDF1O1C72E) (NYSTATIN - UNII:BDF1O1C72E) NYSTATIN 100000 [USP'U]  in 1 g
    Inactive Ingredients
    Ingredient Name Strength
    TALC (UNII: 7SEV7J4R1U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42543-052-61 15 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2 NDC:42543-052-62 30 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    3 NDC:42543-052-63 60 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA065175 09/01/2014
    Labeler - Vensun Pharmaceuticals, Inc. (078310501)
    Registrant - X-Gen Pharmaceuticals, Inc. (790169531)
    Establishment
    Name Address ID/FEI Business Operations
    Pharmaceutics International, Inc. 878265586 MANUFACTURE(42543-052)
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