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  • CLASSES

    Gynecological Antifungals
    Polyene Antifungals
    Topical Dermatological Antifungals

    DEA CLASS

    Rx

    DESCRIPTION

    Topical polyene antifungal antibiotic.
    Used in the treatment of oropharyngeal, cutaneous, mucocutaneous, and vulvovaginal candidiasis; not useful for systemic fungal infections.
    Adverse events tend to be minimal due to limited systemic absorption.

    COMMON BRAND NAMES

    Bio-Statin, Mycostatin, Nyamyc, Nyata, Nystex, Nystop, Pedi-Dri, Pediaderm AF

    HOW SUPPLIED

    Bio-Statin/Nystatin Oral Cap: 500000U, 1000000U
    Mycostatin/Nyamyc/Nyata/Nystatin/Nystop/Pedi-Dri Topical Pwd: 1g, 100000U
    Mycostatin/Nystatin Oral Tab: 500000U
    Mycostatin/Nystatin/Nystex Oral Susp: 1mL, 5mL, 100000U, 500000U
    Mycostatin/Nystatin/Nystex/Pediaderm AF Topical Cream: 1g, 100000U
    Nystatin/Nystex Topical Ointment: 1g, 100000U

    DOSAGE & INDICATIONS

    For the treatment of cutaneous candidiasis (including adjunctive treatment for candidal diaper dermatitis), mucocutaneous candidiasis (i.e., oropharyngeal candidiasis (thrush), vulvovaginal candidiasis), and intestinal candidiasis (with or without coexisting vulvovaginal candidiasis).
    For the treatment of oropharyngeal candidiasis (thrush).
    Oral dosage (oral suspension)
    Adults, Adolescents, and Children

    400,000 to 600,000 units (4 to 6 mL) per dose PO swished in the mouth 4 times per day. The dose of oral suspension should be divided so that one-half is placed in each side of the mouth. Continue treatment for at least 48 hours after symptoms are resolved. Guidelines recommend treatment for 7 to 14 days.

    Neonates and Infants

    200,000 units (2 mL) per dose PO 4 times daily; each dose is divided so that one-half of each dose is placed in each side of the mouth. Avoid feeding for 5 to 10 minutes. Continue treatment for at least 48 hours after symptoms are resolved. For HIV-infected patients, the HIV guidelines recommend treating for 7 to 14 days.

    Premature Neonates

    100,000 units (1 mL) per dose PO 4 times daily based on limited data in premature and low birth weight neonates; each dose is divided so that one-half of each dose is placed in each side of the mouth. Avoid feeding for 5 to 10 minutes. Continue treatment for at least 48 hours after symptoms are resolved.

    For the treatment of cutaneous candidiasis or mucocutaneous candidiasis, or for adjunctive treatment for candidal diaper dermatitis.
    Topical dosage (cream or ointment)
    Adults, Adolescents, Children, Infants, and Neonates

    Apply to affected area twice daily until complete healing. Cream is preferred to ointment in intertriginous areas.

    Topical dosage (topical powder)
    Adults, Adolescents, Children, Infants, and Neonates

    Apply to affected area 2 to 3 times per day until complete healing. Topical powder is recommended over creams and ointments for very moist lesions.

    For the treatment of vulvovaginal candidiasis (VVC).
    Intravaginal dosage (vaginal tablets)
    Female Adults and Adolescents†

    100,000 units administered intravaginally (PV) once daily for 14 days. According to the CDC,  nystatin is a less effective treatment option than topically applied azole medications.

    For the treatment of intestinal candidiasis (with or without coexisting vulvovaginal candidiasis).
    Oral dosage
    Adults

    The recommended dose is 500,000 to 1 million units PO 3 times daily. Treatment should be continued for at least 48 hours after clinical cure to prevent relapse.

    MAXIMUM DOSAGE

    Adults

    2.4 million units/day PO; 100,000 units/day vaginally; maximum dosage information is not available for topical powder, cream, or ointment.

    Geriatric

    2.4 million units/day PO; 100,000 units/day vaginally; maximum dosage information is not available for topical powder, cream, or ointment.

    Adolescents

    2.4 million units/day PO; maximum dosage information is not available for topical powder, cream, or ointment; safety and efficacy of vaginal products not established, but 100,000 units/day vaginally has been recommended.

    Children

    2.4 million units/day PO; maximum dosage information is not available for topical powder, cream, or ointment; safety and efficacy with vaginal products have not been established.

    Infants

    800,000 units/day PO; maximum dosage information is not available for topical powder, cream, or ointment; safety and efficacy with vaginal products have not been established.

    Neonates

    Neonates: 800,000 units/day PO; maximum dosage information is not available for topical powder, cream, or ointment; safety and efficacy with vaginal products have not been established.
    Premature Neonates: 400,000 units/day PO; maximum dosage information is not available for topical powder, cream, or ointment; safety and efficacy with vaginal products have not been established.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    No dosage adjustment needed.

    Renal Impairment

    No dosage adjustment needed.

    ADMINISTRATION

    Oral Administration
    Oral Liquid Formulations

    For topical, oral administration, use nystatin suspension as a swish and swallow. If using the powder for suspension, prepare only a single dose at a time because it does not contain preservatives.
    Shake the suspension liquid well prior to each adminstration.
    Use the provided dropper or a calibrated oral syringe for accurate dose measurement.
    Administer one half of the dose in each side of the mouth.
    The suspension should be retained in the mouth for as long as possible (e.g., several minutes) before swallowing.

    Topical Administration

    Topical preparations should not be applied to the eye.

    Cream/Ointment/Lotion Formulations

    Rub ointment or cream gently into the skin of the affected area.

    Other Topical Formulations

    Topical Powder
    For the treatment of candidal infection of the feet, the powder should be dusted in shoes and socks, as well as on the feet.

    Intravaginal Administration

    Use vaginal applicators supplied by the manufacturer.
    Instruct patient on proper administration.

    STORAGE

    Generic:
    - Protect from freezing
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Bio-Statin :
    - Refrigerate (between 36 and 46 degrees F)
    Mycostatin:
    - Do not freeze
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Nyamyc:
    - Avoid excessive heat (above 104 degrees F)
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Nyata:
    - Avoid excessive heat (above 104 degrees F)
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Nystex:
    - Do not freeze
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Nystop:
    - Avoid excessive heat (above 104 degrees F)
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Pediaderm AF:
    - Do not freeze
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Pedi-Dri:
    - Avoid excessive heat (above 104 degrees F)
    - Store at controlled room temperature (between 68 and 77 degrees F)

    CONTRAINDICATIONS / PRECAUTIONS

    Paraben hypersensitivity

    Some formulations of nystatin, such as the nystatin oral suspension and the topical cream, contain methylparaben and propylparaben. These products should be used with caution in patients with paraben hypersensitivity.

    Pregnancy

    Most formulations of nystatin are classified as FDA pregnancy risk category C. Nystatin vaginal inserts are classified as FDA pregnancy risk category A. The effects on the fetus from administration during pregnancy are unknown. Nystatin should be used during pregnancy only when clearly needed.

    Breast-feeding

    The use of topical nystatin is not a problem during breast-feeding; topical nystatin is commonly used as a first line therapy on affected areas of the breast when thrush (C. albicans) infection in the neonate gets transferred to the maternal breast tissue. It is not known whether orally-administered nystatin is excreted in human breast milk; the manufacturer recommends caution when nystatin is used in breast-feeding women. However, nystatin is poorly absorbed systemically ; therefore, minimal serum and milk concentrations would be expected.

    Diabetes mellitus

    Because nystatin suspension contains significant amounts of sucrose, it should be used cautiously in patients with diabetes mellitus.

    ADVERSE REACTIONS

    Severe

    Stevens-Johnson syndrome / Delayed / 0-0.1
    eczema vaccinatum / Delayed / 0-0.1
    bronchospasm / Rapid / Incidence not known
    angioedema / Rapid / Incidence not known

    Moderate

    hyperglycemia / Delayed / Incidence not known
    sinus tachycardia / Rapid / Incidence not known

    Mild

    diarrhea / Early / 1.0-10.0
    vomiting / Early / 1.0-10.0
    dyspepsia / Early / 1.0-10.0
    nausea / Early / 1.0-10.0
    urticaria / Rapid / 0-1.0
    skin irritation / Early / 0-1.0
    rash (unspecified) / Early / 0-1.0
    pruritus / Rapid / 0-0.1
    myalgia / Early / Incidence not known

    DRUG INTERACTIONS

    Econazole: (Moderate) The combination of econazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
    Ketoconazole: (Moderate) The combination of ketoconazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
    Miconazole: (Moderate) The combination of miconazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
    Miconazole; Petrolatum; Zinc Oxide: (Moderate) The combination of miconazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
    Oxiconazole: (Moderate) The combination of oxiconazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
    Sertaconazole: (Moderate) The combination of sertaconazole and nystatin represent duplication of therapy whenever the drugs are used by similar route, and is usually avoided.
    Sulconazole: (Moderate) The combination of sulconazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.

    PREGNANCY AND LACTATION

    Pregnancy

    Most formulations of nystatin are classified as FDA pregnancy risk category C. Nystatin vaginal inserts are classified as FDA pregnancy risk category A. The effects on the fetus from administration during pregnancy are unknown. Nystatin should be used during pregnancy only when clearly needed.

    The use of topical nystatin is not a problem during breast-feeding; topical nystatin is commonly used as a first line therapy on affected areas of the breast when thrush (C. albicans) infection in the neonate gets transferred to the maternal breast tissue. It is not known whether orally-administered nystatin is excreted in human breast milk; the manufacturer recommends caution when nystatin is used in breast-feeding women. However, nystatin is poorly absorbed systemically ; therefore, minimal serum and milk concentrations would be expected.

    MECHANISM OF ACTION

    Nystatin is a polyene antifungal that binds to sterols in the cell membranes of both fungal and human cells. Nystatin is usually fungistatic in vivo but may have fungicidal activity at high concentrations or against extremely susceptible organisms. Nystatin has greater affinity for ergosterol, the sterol found in fungal cell membranes, than for cholesterol, the sterol found in human cell membranes; however, nystatin is too toxic to be used systemically. As a result of this binding, membrane integrity of both fungal cells and human cells is impaired, causing the loss of intracellular potassium and other cellular contents. Because bacteria do not contain sterols in their cell membranes, nystatin is ineffective against this class of organisms. Nystatin is also ineffective against protozoa, trichomonads, and viruses.

    PHARMACOKINETICS

    Nystatin is administered orally, topically, and intravaginally.

    Oral Route

    Although nystatin is used orally, it is poorly absorbed from the GI tract. After oral administration, nystatin is almost entirely excreted in feces as unchanged drug.

    Topical Route

    Nystatin is not absorbed from intact skin or mucous membranes.