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Nystatin

Class: Polyenes
VA Class: AM700
Molecular Formula: C47H75NO17O
CAS Number: 1400-61-9
Brands: Nystop

Medically reviewed by Drugs.com. Last updated on Mar 25, 2019.

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, 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 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.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 areas130 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, 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
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

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°C125 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

Nystatin

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Suspension

100,000 units/mL*

Nystatin Suspension

Tablets, film-coated

500,000 units*

Nystatin Tablets

Topical

Cream

100,000 units/g*

Nystatin Cream

Ointment

100,000 units/g*

Nystatin Ointment

Powder

100,000 units/g*

Nystatin Topical Powder

Nystop

Paddock

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

Nystatin and Triamcinolone Acetonide

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Topical

Cream

100,000 units per g with Triamcinolone Acetonide 0.1%*

Nystatin and Triamcinolone Acetonide Cream

Ointment

100,000 units per g with Triamcinolone Acetonide 0.1%*

Nystatin and Triamcinolone Acetonide Ointment

AHFS DI Essentials™. © Copyright 2019, Selected Revisions March 25, 2019. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

Only references cited for selected revisions after 1984 are available electronically.

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