Brand name: Nystop
Drug class: Polyenes
VA class: AM700
Molecular formula: C₄₇H₇₅NO₁₇O
CAS number: 1400-61-9

Medically reviewed by Drugs.com on Mar 15, 2024. Written by ASHP.

Introduction

Antifungal; polyene antibiotic.

Uses for Nystatin

Cutaneous Candidiasis

Topical treatment of cutaneous or mucocutaneous infections (e.g., intertriginous candidiasis, candidal diaper rash) caused by Candida albicans and other susceptible Candida.

Topical treatment of candidal diaper dermatitis. Many infants with candidal diaper dermatitis harbor C. albicans in their intestines and infected feces appear to be an important source of the cutaneous infection; however, exact role of GI colonization in development or recurrence of diaper dermatitis unknown. Usually effectively treated with a topical antifungal (e.g., topical nystatin, miconazole, clotrimazole, ciclopirox). Some clinicians recommend that an oral antifungal (e.g., oral nystatin^{† [off-label]}, fluconazole) be used concomitantly to treat possible coexisting intestinal infection (e.g., in those with diaper rash and thrush). Although studies have not provided evidence that concomitant topical and oral therapy is more effective than topical therapy alone, some clinicians suggest that such a strategy may be warranted and is reasonable in severe cases or when patient also has candidal oropharyngeal or GI infection.

Oropharyngeal Candidiasis

Topical treatment of candidiasis of the oral cavity (oropharyngeal candidiasis, thrush).

For mild oropharyngeal candidiasis, IDSA recommends topical treatment with clotrimazole lozenges or miconazole buccal tablets; nystatin (oral suspension) is a recommended alternative. For moderate to severe oropharyngeal candidiasis, IDSA recommends oral fluconazole.

For HIV-infected adults and adolescents with oropharyngeal candidiasis, CDC, NIH, and HIV Medicine Association of IDSA recommend oral fluconazole as drug of choice; if topical treatment used, clotrimazole lozenges, miconazole buccal tablets, or nystatin oral suspension recommended. For HIV-infected children with uncomplicated oropharyngeal candidiasis, topical treatment with clotrimazole lozenges or nystatin oral suspension recommended; oral fluconazole recommended for initial treatment of moderate to severe oropharyngeal candidiasis or when an oral regimen preferred (e.g., in infants).

Nonesophageal Mucous Membrane GI Candidiasis

Oral treatment of mucous membrane (nonesophageal) GI candidiasis.

Esophageal candidiasis requires treatment with a systemic antifungal (not a topical antifungal).

Prevention of Candidiasis in Transplant Recipients, Cancer Patients, or Other Patients at High Risk

Oral nystatin (oral suspension, tablets) has been used in various regimens for prophylaxis against Candida infections^{† [off-label]} during periods of iatrogenic neutropenia in patients receiving immunosuppressive therapy (e.g., patients with malignancies, transplant recipients). Routine primary antifungal prophylaxis against Candida in neutropenic patients not recommended, but may be considered when risk of invasive candidal infection is substantial (e.g., allogeneic hematopoietic stem cell transplant [HSCT] recipients, patients with acute leukemia undergoing intensive remission-induction or salvage-induction chemotherapy). If primary prophylaxis is used to prevent invasive candidiasis in such patients, a systemic azole antifungal (fluconazole, itraconazole, posaconazole, voriconazole) or echinocandin (caspofungin, micafungin) recommended.

Oral nystatin (oral suspension) has been used for prophylaxis to reduce the incidence of invasive candidiasis in low-birthweight neonates at high risk^{† [off-label]}. Antifungal prophylaxis in low-birthweight neonates has been controversial. When such prophylaxis used (e.g., in very low-birthweight neonates weighing <1 kg in nurseries with high rates of neonatal invasive candidiasis), AAP and IDSA recommend fluconazole. IDSA states oral nystatin suspension is an alternative for prophylaxis in low-birthweight neonates weighing <1.5 kg when fluconazole unavailable or should not be used because of concerns related to fluconazole resistance.

Nystatin Dosage and Administration

Administration

Apply topically to the skin as a cream, ointment, or powder.

In fixed combination with a corticosteroid (i.e., triamcinolone acetonide), apply topically to the skin as a cream or ointment.

Administer topically to the oral cavity as an oral suspension.

Administer orally as film-coated tablets.

Has been administered intravaginally; intravaginal preparations no longer commercially available in the US.

Topical Administration

Topical creams, ointments, and powders are for external use only; do not ingest, apply to the eye, or administer intravaginally.

Cream may be preferred instead of ointment in intertriginous areas; powder may be preferred if lesions are very moist.

Cream or Ointment

Apply cream or ointment liberally to affected areas.

If fixed-combination topical cream or ointment containing nystatin and triamcinolone acetonide used, apply to affected areas and gently and thoroughly massage into the skin. Do not use occlusive dressings. (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Powder

Apply powder to affected areas.

For treatment of candidal foot infections, dust powder onto feet and into all footwear (shoes, socks).

Oral Administration

Oral Suspension

Administer undiluted using calibrated dropper or dosing cup provided by manufacturer.

Shake suspension well before using.

Place one-half of the dose in each side of the mouth (use a dropper in infants and young children) and retain in the mouth as long as possible before swallowing.

Do not feed infants for 5–10 minutes after the dose.

Dosage

Dosage of nystatin is expressed in terms of USP nystatin units.

Pediatric Patients

Cutaneous Candidiasis

Topical

Cream, ointment, or powder (100,000 units/g): Apply to affected areas 2 or 3 times daily until healing is complete.

Treatment duration of 7–10 days usually effective. Although symptomatic relief may be apparent within 24–72 hours, complete full course of treatment. If no response obtained, perform appropriate laboratory testing. (See Selection and Use of Antifungals under Cautions.)

Fixed-combination cream or ointment (nystatin 100,000 units/g and triamcinolone acetonide 0.1%): Apply to affected areas twice daily (morning and evening). Use lowest effective dosage. Some clinicians state do not exceed treatment duration of 2 weeks. Manufacturers state discontinue if signs and symptoms persist after 25 days of treatment. (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Candidal Diaper Dermatitis

Topical

Cream, ointment, or powder (100,000 units/g): Apply to affected areas 3 or 4 times daily for 7–10 days.

Oral

Oral suspension (100,000 units/mL): As an adjunct to topical nystatin^{† [off-label]}, 100,000 units 3 or 4 times daily has been used.

Oropharyngeal Candidiasis

Oral Topical

Oral suspension (100,000 units/mL): 200,000 units 4 times daily in infants and 400,000–600,000 units 4 times daily in children. Limited data indicate that 100,000 units 4 times daily is effective in premature and low-birthweight infants.

Oral suspension (100,000 units/mL) in HIV-infected pediatric patients: 400,000–600,000 units 4 times daily in children and 400,000–600,000 units 4 or 5 times daily in adolescents.

Treatment duration of 7–14 days usually recommended. Manufacturers recommend continuing treatment for at least 48 hours after perioral symptoms subside and cultures are negative for C. albicans.

Prevention of Candidiasis in Low-birthweight Neonates† [off-label]

Oral Topical

Oral suspension (100,000 units/mL): If used as an alternative in low-birthweight neonates (<1.5 kg) at high risk, IDSA recommends 100,000 units 3 times daily for 6 weeks.

Adults

Cutaneous Candidiasis

Topical

Cream, ointment, or powder (100,000 units/g): Apply to affected areas 2 or 3 times daily.

Treatment duration of 7–10 days usually effective. Although symptomatic relief may be apparent within 24–72 hours, complete full course of treatment. If no response obtained, perform appropriate laboratory testing. (See Selection and Use of Antifungals under Cautions.)

Fixed-combination cream or ointment (nystatin 100,000 units/g and triamcinolone acetonide 0.1%): Apply to affected areas twice daily (morning and evening). Some clinicians state do not exceed treatment duration of 2 weeks. Manufacturers state discontinue if signs and symptoms persist after 25 days of treatment. (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Oropharyngeal Candidiasis

Oral Topical

Oral suspension (100,000 units/mL): 400,000–600,000 units 4 times daily.

Oral suspension (100,000 units/ml) in HIV-infected adults: 400,000–600,000 units 4 or 5 times daily.

Treatment duration of 7–14 days usually recommended. Manufacturers recommend continuing treatment for at least 48 hours after perioral symptoms subside and cultures are negative for C. albicans.

Nonesophageal Mucous Membrane GI Candidiasis

Oral

Film-coated tablets (500,000 units): 500,000 units to 1 million units 3 times daily; continue for ≥48 hours after clinical cure.

Cautions for Nystatin

Contraindications

• Hypersensitivity to nystatin or any ingredient in the formulation.

Warnings/Precautions

Sensitivity Reactions

Irritation or sensitization may occur. Rash, urticaria, and Stevens-Johnson syndrome reported rarely.

Discontinue if irritation or sensitization occurs.

Selection and Use of Antifungals

Nystatin topical creams, ointments, or powders: For external use only; do not use for treatment of systemic, oral, ophthalmic, or intravaginal infections.

Nystatin oral suspension and film-coated oral tablets: Do not use for treatment of systemic fungal infections.

Prior to initiation of topical treatment of cutaneous or mucocutaneous Candida infections, confirm diagnosis using appropriate laboratory testing (e.g., potassium hydroxide [KOH] smears, cultures, other diagnostic methods). If there is no response to topical treatment, repeat appropriate laboratory testing to confirm the diagnosis.

Use of Fixed Combinations Containing Corticosteroids

When fixed-combination topical preparations containing nystatin and triamcinolone acetonide used, consider cautions, precautions, and contraindications associated with topical corticosteroid therapy.

Fixed-combination topical cream or ointment containing nystatin and triamcinolone acetonide: For external use only; do not use for ophthalmic infections.

Do not use occlusive dressings (e.g., bandages or other coverings or wraps) on treatment site since this may increase systemic absorption of the corticosteroid. Because tight-fitting diapers or plastic pants can be occlusive, avoid these in pediatric patients being treated in the diaper area. Some clinicians state fixed-combination topical preparations containing an antifungal and a corticosteroid should not be used in the diaper area. (See Pediatric Use under Cautions.)

Manufacturers recommend discontinuing if signs and symptoms persist after 25 days of topical treatment. Some clinicians state do not exceed treatment duration of 2 weeks, especially in pediatric patients.

Consider that topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria reported in some patients receiving a topical corticosteroid.

Specific Populations

Pregnancy

Animal reproduction studies not performed using topical or oral nystatin. Not known whether nystatin can cause fetal harm or affect reproduction capacity.

Topical nystatin: Use during pregnancy only if potential benefits outweigh potential risks to the fetus.

Oral nystatin (oral suspension, tablets): Use during pregnancy only if clearly needed.

Fixed-combination topical preparations containing nystatin and triamcinolone acetonide: Use during pregnancy only if potential benefits outweigh potential risks to the fetus. Do not use topical preparations containing corticosteroids extensively, in large amounts, or for prolonged periods during pregnancy.

Lactation

Not known whether nystatin distributed into milk.

Use nystatin and fixed-combinations containing nystatin and triamcinolone acetonide with caution in nursing women.

Pediatric Use

Topical cream and ointment: May be used in pediatric patients; usually well tolerated, including in debilitated infants.

Topical powder: Safety and efficacy established in pediatric patients, including neonates and infants.

Oral suspension: Safety and efficacy established in pediatric patients, including infants and young children.

Fixed-combination topical cream and ointment containing nystatin and triamcinolone acetonide: The cream has been used effectively for topical treatment of cutaneous candidiasis in a limited number of infants and children 2 months to 12 years of age. When using the cream or ointment, consider that pediatric patients may be more susceptible to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature individuals because of greater skin surface area-to-body weight ratio. Chronic corticosteroid therapy may interfere with growth and development of children. Use lowest effective dosage in pediatric patients; some clinicians state do not exceed treatment duration of 2 weeks. (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Geriatric Use

Insufficient experience in clinical studies in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults. Other clinical experience has not revealed age-related differences in response, but greater sensitivity of some geriatric individuals cannot be ruled out.

Common Adverse Effects

Topical creams, ointments, or powders: Hypersensitivity reactions (burning, itching, rash, eczema, application site pain).

Oral suspension or film-coated tablets: Oral irritation and sensitization; GI effects (nausea, vomiting, diarrhea, GI distress).

Nystatin Pharmacokinetics

Absorption

Bioavailability

Not absorbed following topical application to intact skin or mucous membranes.

Only very limited absorption following oral administration. Usually undetectable in plasma when given in usual oral dosages; may be detected in plasma following oral administration in patients with renal impairment.

Elimination

Elimination Route

Following oral administration, almost entirely excreted unchanged in feces.

Stability

Storage

Topical

Cream

15–30°C; avoid excessive heat (40°C).

Fixed combination of nystatin and triamcinolone acetonide: 20–25°C; avoid freezing.

Ointment

15–30°C; do not freeze.

Fixed combination of nystatin and triamcinolone acetonide: 20–25°C; avoid freezing.

Powder

Depending on manufacturer, tight container at 20–25°C or 15–30°C; avoid excessive heat (40°C).

Oral

Oral Suspension

20–25°C (may be exposed to 15–30°C); avoid freezing.

Tablets, Film-coated

20–25°C.

Actions and Spectrum

• Polyene antifungal.

• Fungistatic or fungicidal in action.

• Binds to sterols in the fungal cell membrane, which no longer functions as a selective barrier and allows loss of potassium and other cellular constituents.

• Active against a variety of yeasts and yeast-like fungi. Inactive against bacteria, protozoa, and viruses.

• Candida: Active against C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. pseudotropicalis, C. guilliermondi, and C. tropicalis.

• C. albicans resistant to nystatin can be produced in vitro, and resistance has been reported in clinical isolates of C. albicans, C. glabrata, C. guilliermondi, C. krusei, C. lipolytica, C. lusitaniae, and C. tropicalis.

• Candida resistant to nystatin may be cross-resistant to other polyene antifungals (e.g., amphotericin B, natamycin).

Advice to Patients

• Importance of not interrupting or discontinuing treatment until prescribed regimen is completed, even if symptomatic relief occurs within the first few days after initiation of treatment.

• Importance of discontinuing treatment and notifying clinician if irritation or hypersensitivity occurs.

• If using fixed-combination topical preparations containing nystatin and triamcinolone acetonide, advise patients that occlusive dressings (e.g., bandages or other coverings or wraps) should not be used on treated sites. If prescribed for topical treatment in the diaper area, advise parents that tight-fitting diapers or plastic pants should be avoided since these would constitute occlusive dressings.

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.

• Importance of advising patients of other important precautionary information. (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

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