Nystatin Cream

— THERAPEUTIC CATEGORIES —
  • Skin infections (topicals)
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Nystatin Cream Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Nystatin 100000Units/g.

    Pharmacological Class

    Polyene antifungal.

    See Also

    How Supplied

    Contact supplier.

    Storage

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

    Manufacturer

    Various generic manufacturers

    Mechanism of Action

    Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi. 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.

    Nystatin Cream Indications

    Indications

    Cutaneous or mucocutaneous candidiasis.

    Nystatin Cream Dosage and Administration

    Adults and Children

    Apply liberally twice daily.

    Nystatin Cream Contraindications

    Not Applicable

    Nystatin Cream Boxed Warnings

    Not Applicable

    Nystatin Cream Warnings/Precautions

    Warnings/Precautions

    Discontinue if hypersensitivity occurs.

    Warnings/Precautions

    • Do not use nystatin cream for the treatment of systemic, oral, intravaginal, or ophthalmic infections.

    • Discontinue and take appropriate measures as indicated if irritation or sensitization develops.

    • Recommended to use KOH smears, cultures, or other diagnostic method to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

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

    Pregnancy Considerations

    Teratogenic Effects – Category C

    • It is not known whether this cream can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. 

    • Nystatin cream should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

     

    Nursing Mother Considerations

    • It is not known whether nystatin is excreted in human milk. 

    • Use caution when prescribed to a nursing woman.

    Pediatric Considerations

    • Safety and effectiveness have been established in the pediatric population from birth to 16 years. 

    Nystatin Cream Pharmacokinetics

    Elimination

    Fecal.

    Nystatin Cream Interactions

    Not Applicable

    Nystatin Cream Adverse Reactions

    Adverse Reactions

    Irritation (rare).

    Nystatin Cream Clinical Trials

    See Literature

    Nystatin Cream Note

    Notes

    Formerly known under the brand name Mycostatin.

    Nystatin Cream Patient Counseling

    Patient Counseling

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

    • 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.

    • 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.

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

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