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.^{125 128 133 134 146 147 148 150}

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.^{116 128 133 147 148 150 292}

Topical treatment of candidal diaper dermatitis.^{114 115 116 150 161} 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;^{115 116 161} however, exact role of GI colonization in development or recurrence of diaper dermatitis unknown.¹¹⁶ Usually effectively treated with a topical antifungal (e.g., topical nystatin, miconazole, clotrimazole, ciclopirox).^{114 115 116 161 292} 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).^{114 115 116} Although studies have not provided evidence that concomitant topical and oral therapy is more effective than topical therapy alone,^{114 115} 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.^{115 116 161}

Oropharyngeal Candidiasis

Topical treatment of candidiasis of the oral cavity (oropharyngeal candidiasis, thrush).^{125 146 150 292 425 440 441}

For mild oropharyngeal candidiasis, IDSA recommends topical treatment with clotrimazole lozenges or miconazole buccal tablets;⁴²⁵ nystatin (oral suspension) is a recommended alternative.⁴²⁵ For moderate to severe oropharyngeal candidiasis, IDSA recommends oral fluconazole.⁴²⁵

For HIV-infected adults and adolescents with oropharyngeal candidiasis, CDC, NIH, and HIV Medicine Association of IDSA recommend oral fluconazole as drug of choice;⁴⁴⁰ if topical treatment used, clotrimazole lozenges, miconazole buccal tablets, or nystatin oral suspension recommended.⁴⁴⁰ For HIV-infected children with uncomplicated oropharyngeal candidiasis, topical treatment with clotrimazole lozenges or nystatin oral suspension recommended;⁴⁴¹ oral fluconazole recommended for initial treatment of moderate to severe oropharyngeal candidiasis or when an oral regimen preferred (e.g., in infants).⁴⁴¹

Nonesophageal Mucous Membrane GI Candidiasis

Oral treatment of mucous membrane (nonesophageal) GI candidiasis.¹³⁴

Esophageal candidiasis requires treatment with a systemic antifungal (not a topical antifungal).^{425 440 441}

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).^{105 106 107 108 111 135 136 137 138 139 140 143 144} 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).^{422 425} 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.^{422 425}

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]}.^{141 154 155 156 157 158 159 160 425} Antifungal prophylaxis in low-birthweight neonates has been controversial.^{160 292 425} 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.^{292 425} 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.⁴²⁵

Nystatin Dosage and Administration

Administration

Apply topically to the skin as a cream,¹⁴⁷ ointment,¹⁴⁸ or powder.^{128 133}

In fixed combination with a corticosteroid (i.e., triamcinolone acetonide), apply topically to the skin as a cream or ointment.^{130 131}

Administer topically to the oral cavity as an oral suspension.^{125 146}

Administer orally as film-coated tablets.¹³⁴

Has been administered intravaginally;^{118 129} 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.^{128 130 131 133 147 148}

Cream may be preferred instead of ointment in intertriginous areas;¹⁴⁷ powder may be preferred if lesions are very moist.^{128 133 147}

Cream or Ointment

Apply cream or ointment liberally to affected areas.^{147 148}

If fixed-combination topical cream or ointment containing nystatin and triamcinolone acetonide used, apply to affected areas^{130 131} and gently and thoroughly massage into the skin.¹³⁰ Do not use occlusive dressings.^{130 131} (See Use of Fixed Combinations Containing Corticosteroids under Cautions.)

Powder

Apply powder to affected areas.^{128 133}

For treatment of candidal foot infections, dust powder onto feet and into all footwear (shoes, socks).^{128 133}

Oral Administration

Oral Suspension

Administer undiluted using calibrated dropper or dosing cup provided by manufacturer.^{125 146}

Shake suspension well before using.^{125 146}

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.^{125 146}

Do not feed infants for 5–10 minutes after the dose.^{125 146}

Dosage

Dosage of nystatin is expressed in terms of USP nystatin units.^{125 128 133 146 147 148}

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.^{128 133 147 148}

Treatment duration of 7–10 days usually effective.¹⁵⁰ Although symptomatic relief may be apparent within 24–72 hours,^{147 148 150} complete full course of treatment.^{128 133} If no response obtained, perform appropriate laboratory testing.^{128 133} (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).^{130 131} Use lowest effective dosage.¹³¹ Some clinicians state do not exceed treatment duration of 2 weeks.^{162 292} Manufacturers state discontinue if signs and symptoms persist after 25 days of treatment.^{130 131} (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.^{114 150}

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.^{115 150 161}

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.¹⁴⁶ Limited data indicate that 100,000 units 4 times daily is effective in premature and low-birthweight infants.¹⁴⁶

Oral suspension (100,000 units/mL) in HIV-infected pediatric patients: 400,000–600,000 units 4 times daily in children⁴⁴¹ and 400,000–600,000 units 4 or 5 times daily in adolescents.⁴⁴⁰

Treatment duration of 7–14 days usually recommended.^{425 440 441} Manufacturers recommend continuing treatment for at least 48 hours after perioral symptoms subside and cultures are negative for C. albicans.^{125 146}

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.⁴²⁵

Adults

Cutaneous Candidiasis

Topical

Cream, ointment, or powder (100,000 units/g): Apply to affected areas 2 or 3 times daily.^{128 133 147 148}

Treatment duration of 7–10 days usually effective.¹⁵⁰ Although symptomatic relief may be apparent within 24–72 hours,^{147 148 150} complete full course of treatment.^{128 133} If no response obtained, perform appropriate laboratory testing.^{128 133} (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).^{130 131} Some clinicians state do not exceed treatment duration of 2 weeks.¹⁶² Manufacturers state discontinue if signs and symptoms persist after 25 days of treatment.^{130 131} (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.^{125 146}

Oral suspension (100,000 units/ml) in HIV-infected adults: 400,000–600,000 units 4 or 5 times daily.⁴⁴⁰

Treatment duration of 7–14 days usually recommended.^{425 440} Manufacturers recommend continuing treatment for at least 48 hours after perioral symptoms subside and cultures are negative for C. albicans.^{125 146}

Nonesophageal Mucous Membrane GI Candidiasis

Oral

Film-coated tablets (500,000 units): 500,000 units to 1 million units 3 times daily;¹³⁴ continue for ≥48 hours after clinical cure.¹³⁴

Cautions for Nystatin

Contraindications

• Hypersensitivity to nystatin or any ingredient in the formulation.^{125 128 130 131 133 134 146 147 148}

Warnings/Precautions

Sensitivity Reactions

Irritation or sensitization may occur.^{128 133 134} Rash, urticaria, and Stevens-Johnson syndrome reported rarely.^{128 133 134}

Discontinue if irritation or sensitization occurs.^{128 131 133 134 146 147 148}

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.^{128 133 147 148}

Nystatin oral suspension and film-coated oral tablets: Do not use for treatment of systemic fungal infections.^{134 146}

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).^{128 133} If there is no response to topical treatment, repeat appropriate laboratory testing to confirm the diagnosis.^{128 133}

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.^{130 131}

Fixed-combination topical cream or ointment containing nystatin and triamcinolone acetonide: For external use only; do not use for ophthalmic infections.^{130 131}

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.^{130 131} Because tight-fitting diapers or plastic pants can be occlusive, avoid these in pediatric patients being treated in the diaper area.^{116 130 131} Some clinicians state fixed-combination topical preparations containing an antifungal and a corticosteroid should not be used in the diaper area.¹¹⁶ (See Pediatric Use under Cautions.)

Manufacturers recommend discontinuing if signs and symptoms persist after 25 days of topical treatment.^{130 131} Some clinicians state do not exceed treatment duration of 2 weeks,¹⁶² especially in pediatric patients.²⁹²

Consider that topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects.^{130 131} Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia, and glucosuria reported in some patients receiving a topical corticosteroid.^{130 131}

Specific Populations

Pregnancy

Animal reproduction studies not performed using topical or oral nystatin.^{125 128 133 134 146} Not known whether nystatin can cause fetal harm or affect reproduction capacity.^{125 128 133 134 146}

Topical nystatin: Use during pregnancy only if potential benefits outweigh potential risks to the fetus.^{128 133}

Oral nystatin (oral suspension, tablets): Use during pregnancy only if clearly needed.^{125 134 146}

Fixed-combination topical preparations containing nystatin and triamcinolone acetonide: Use during pregnancy only if potential benefits outweigh potential risks to the fetus.^{130 131} Do not use topical preparations containing corticosteroids extensively, in large amounts, or for prolonged periods during pregnancy.^{130 131}

Lactation

Not known whether nystatin distributed into milk.^{125 128 133 134 146}

Use nystatin and fixed-combinations containing nystatin and triamcinolone acetonide with caution in nursing women.^{125 128 130 131 133 134 146}

Pediatric Use

Topical cream and ointment: May be used in pediatric patients; usually well tolerated, including in debilitated infants.^{147 148}

Topical powder: Safety and efficacy established in pediatric patients, including neonates and infants.^{128 133}

Oral suspension: Safety and efficacy established in pediatric patients, including infants and young children.^{125 146}

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.^{130 131} 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.^{130 131} Chronic corticosteroid therapy may interfere with growth and development of children.^{130 131} Use lowest effective dosage in pediatric patients;^{130 131 292} some clinicians state do not exceed treatment duration of 2 weeks.²⁹² (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.¹²⁸ Other clinical experience has not revealed age-related differences in response, but greater sensitivity of some geriatric individuals cannot be ruled out.¹²⁸

Common Adverse Effects

Topical creams, ointments, or powders: Hypersensitivity reactions (burning, itching, rash, eczema, application site pain).^{128 133}

Oral suspension or film-coated tablets: Oral irritation and sensitization;^{125 134 146} GI effects (nausea, vomiting, diarrhea, GI distress).^{125 134 146}

Nystatin Pharmacokinetics

Absorption

Bioavailability

Not absorbed following topical application to intact skin or mucous membranes.^{128 130 133}

Only very limited absorption following oral administration.^{125 134 146} Usually undetectable in plasma when given in usual oral dosages; may be detected in plasma following oral administration in patients with renal impairment.^{125 134 146}

Elimination

Elimination Route

Following oral administration, almost entirely excreted unchanged in feces.^{125 134 146}

Stability

Storage

Topical

Cream

15–30°C; avoid excessive heat (40°C).¹⁴⁷

Fixed combination of nystatin and triamcinolone acetonide: 20–25°C; avoid freezing.¹³⁰

Ointment

15–30°C; do not freeze.¹⁴⁸

Fixed combination of nystatin and triamcinolone acetonide: 20–25°C; avoid freezing.¹³¹

Powder

Depending on manufacturer, tight container at 20–25°C¹²⁸ or 15–30°C;¹³³ avoid excessive heat (40°C).^{128 133}

Oral

Oral Suspension

20–25°C^{125 146} (may be exposed to 15–30°C);¹²⁵ avoid freezing.¹⁴⁶

Tablets, Film-coated

20–25°C.¹³⁴

Actions and Spectrum

• Polyene antifungal.^{125 128 133 134 146 147 148 150}

• Fungistatic or fungicidal in action.^{125 128 133 134 146 147 148}

• 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.^{125 128 133 134 146 147 148 150}

• Active against a variety of yeasts and yeast-like fungi.^{125 128 133 134 146 147 148} Inactive against bacteria, protozoa, and viruses.^{125 128 133 134 146 147 148}

• Candida: Active against C. albicans,^{128 133 146 150} C. glabrata,^{128 133 150} C. krusei,^{128 133} C. parapsilosis,^{128 133} C. pseudotropicalis,^{128 133} C. guilliermondi,^{128 133} and C. tropicalis.^{128 133}

• C. albicans resistant to nystatin can be produced in vitro,¹⁵⁰ and resistance has been reported in clinical isolates of C. albicans, ¹⁵⁰ C. glabrata,¹⁵⁰ C. guilliermondi,^{128 133 150} C. krusei,^{128 133} C. lipolytica,¹⁵⁰ C. lusitaniae,¹⁵⁰ and C. tropicalis.^{128 133 150}

• Candida resistant to nystatin may be cross-resistant to other polyene antifungals (e.g., amphotericin B, natamycin).¹⁵⁰

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.^{128 133}

• Importance of discontinuing treatment and notifying clinician if irritation or hypersensitivity occurs.^{128 130 131 133}

• 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.^{130 131} 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.^{116 130 131}

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, and any concomitant illnesses.^{125 128 130 131 133 134 146 147 148}

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.^{125 128 130 131 133 134 146 147 148}

• Importance of advising patients of other important precautionary information.^{125 128 130 131 133 134 146 147 148} (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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