VA Class:AM700
VA Class:DE102
VA Class:DE250
Nystatin, a polyene antibiotic, is an antifungal agent.125, 128, 133, 134, 146, 147, 148, 150
Nystatin (cream, ointment, powder) is used for the topical treatment of cutaneous or mucocutaneous infections caused by Candida albicans and other susceptible Candida (e.g., intertriginous candidiasis, candidal diaper rash).128, 133, 147, 148, 150, 292
Fixed combinations containing nystatin and triamcinolone acetonide (cream or ointment) are used for the topical treatment of cutaneous candidiasis.130, 131 There is some evidence from clinical studies in patients with mild to severe manifestations of cutaneous candidiasis that topical treatment with nystatin and triamcinolone acetonide results in faster and more pronounced clearing of erythema and pruritus than treatment with either nystatin or triamcinolone acetonide alone.130, 131 However, because of the risk of adverse effects associated with topical corticosteroids (see Precautions Related to Use of Fixed Combinations Containing Corticosteroids under Cautions: Precautions and Contraindications), some clinicians state that fixed-combination nystatin and triamcinolone acetonide should only be used for short periods of time (i.e., 2 weeks or less) and with close follow-up.162 Alternatively, treatment can be initiated with single-entity topical nystatin in conjunction with a single-entity topical corticosteroid and use of the corticosteroid can be tapered over 1-2 weeks while the topical antifungal is continued until healing is complete.162
Although superficial cutaneous candidiasis rarely causes disseminated infections, candidal skin lesions can occur in patients with invasive disseminated candidiasis.543 Therefore, the Infectious Diseases Society of America (IDSA) recommends that a systemic antifungal (e.g., fluconazole, posaconazole, voriconazole) be used for empiric treatment of cutaneous or mucocutaneous candidiasis in patients with persistent or recurrent episodes of fever and neutropenia.543
Nystatin (cream, ointment, powder) is used for the topical treatment of candidal diaper dermatitis.114, 115, 116, 150, 161 Oral nystatin (oral suspension) has been used as an adjunct to topical nystatin in the treatment of candidal diaper dermatitis†.114, 115, 116, 161
C. albicans is the most common cause of infections associated with diaper dermatitis;161 other Candida (e.g., C. glabrata , C. parapsilosis , C. tropicalis ) also have been reported in such infections.161 Many infants with candidal diaper dermatitis harbor C. albicans in their intestines and infected feces may be an important source of the cutaneous infection;115, 116, 161 however, the exact role of GI colonization with C. albicans in the development or recurrence of diaper dermatitis is unknown.116
Candidal diaper dermatitis usually is effectively treated with a topical antifungal (e.g., topical nystatin, miconazole, clotrimazole, ciclopirox).114, 115, 116, 161, 292 In addition, some clinicians recommend that an oral antifungal (e.g., oral nystatin†, fluconazole) be used concomitantly to treat possible coexisting candidal intestinal infection (e.g., in children with diaper rash and thrush).114, 115, 116 Although results of 2 small studies have not provided evidence that concomitant topical and oral therapy is more effective than topical therapy alone,114, 115 some clinicians suggest that a strategy that includes topical antifungal treatment and adjunctive use of an oral antifungal may be warranted and is reasonable in severe cases or when the patient also has candidal oropharyngeal or GI infection.115, 116, 161
Oral nystatin (oral suspension) is used for the topical treatment of candidiasis of the oral cavity (oropharyngeal candidiasis, thrush).125, 146, 150, 292, 425, 440, 441
For the treatment of mild oropharyngeal candidiasis, IDSA recommends topical treatment with clotrimazole lozenges or miconazole buccal tablets;425 nystatin (oral suspension) is the recommended alternative.425 For moderate to severe oropharyngeal candidiasis, IDSA recommends oral fluconazole.425
For the treatment of oropharyngeal candidiasis in adults and adolescents with human immunodeficiency virus (HIV) infection, the US Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), and HIV Medicine Association of IDSA recommend oral fluconazole as the drug of choice.440 If topical treatment is used in HIV-infected adults and adolescents with oropharyngeal candidiasis, these experts recommend clotrimazole lozenges, miconazole buccal tablets, or nystatin oral suspension.440 In HIV-infected children, CDC, NIH, HIV Medicine Association of IDSA, and American Academy of Pediatrics (AAP) recommend topical treatment with clotrimazole lozenges or nystatin oral suspension for uncomplicated oropharyngeal candidiasis;441 fluconazole is recommended for initial treatment of moderate to severe infections or when an oral regimen is preferred (e.g., in infants).441
Nonesophageal Mucous Membrane GI Candidiasis
Oral nystatin (tablets) is used for the treatment of mucous membrane (nonesophageal) GI candidiasis.134
Esophageal candidiasis requires treatment with a systemic antifungal (e.g., fluconazole, echinocandin, amphotericin B).425, 440, 441
Prevention of Candidiasis in Transplant Recipients, Cancer Patients, or Other Patients at High Risk
Transplant Recipients and Patients with Cancer
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) with variable results.105, 106, 107, 108, 111, 135, 136, 137, 138, 139, 140, 143, 144 Use of primary antifungal prophylaxis against Candida infections in neutropenic cancer or transplant patients or nonneutropenic patients has been controversial, particularly since such prophylaxis may predispose the patient to colonization with resistant fungi and/or result in the emergence of highly resistant organisms.142, 144, 145, 422
While there is some limited evidence that oral nystatin prophylaxis may reduce the incidence of mucocutaneous candidiasis in some neutropenic patients, it is unlikely that the drug would decrease the frequency of invasive candidiasis.144 In addition, there is some evidence that oral fluconazole is more effective than oral nystatin for prophylaxis against Candida infections in immunocompromised patients.140, 143 In one study in adult and pediatric liver transplant patients randomized to receive antifungal prophylaxis with nystatin oral suspension or oral fluconazole, Candida infections developed in 27% of those receiving nystatin and 12% of those receiving fluconazole (intent-to-treat analysis).140 Superficial Candida infections or documented systemic invasive Candida infections developed in 25.3 or 6%, respectively, of those receiving nystatin and in 10.5 or 1.3%, respectively, of those receiving fluconazole.140
If primary prophylaxis against Candida infections is indicated in neutropenic patients when the 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), IDSA recommends a systemic regimen with an azole antifungal (fluconazole, itraconazole, posaconazole, voriconazole) or echinocandin (caspofungin, micafungin).422, 425 These experts state that antifungal prophylaxis is not recommended if the anticipated duration of neutropenia is less than 7 days.422 If primary prophylaxis is used to prevent invasive candidiasis in high-risk adults in intensive care units (ICUs), IDSA recommends fluconazole as the drug of choice and echinocandins (anidulafungin, caspofungin, micafungin) as alternatives.425 (See Uses: Prevention of Candidiasis in Transplant Recipients, Cancer Patients, or Other Patients at High Risk, in Fluconazole 8:14.08.)
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 There is some evidence that nystatin prophylaxis can decrease the risk of colonization and reduce the incidence of invasive candidiasis in low-birthweight neonates149, 155, 156, 157, 158, 160 if initiated within 48 hours of birth;149, 155, 156, 157, 158 however, some studies indicate that nystatin is less effective than fluconazole for such prophylaxis.156
Although antifungal prophylaxis in low-birthweight neonates has been controversial,160, 292, 425 AAP and IDSA recommend IV or oral fluconazole when such prophylaxis is used (e.g., in very low-birthweight neonates weighing less than 1 kg in nurseries that have high rates of neonatal invasive candidiasis).292, 425 (See Uses: Prevention of Candidiasis in Transplant Recipients, Cancer Patients, or Other Patients at High Risk, in Fluconazole 8:14.08.) IDSA recommends oral nystatin suspension as an alternative for prophylaxis in low-birthweight neonates weighing less than 1.5 kg when fluconazole is unavailable or should not be used because of concerns related to fluconazole resistance.425
Nystatin is applied topically to the skin as a cream,147 ointment,148 or powder.128, 133 Nystatin also is commercially available in fixed combination with a corticosteroid (i.e., triamcinolone acetonide) for topical application to the skin as a cream or ointment.130, 131
Nystatin is applied topically to the oral cavity as an oral suspension125, 146 and is administered orally as film-coated tablets.134
Although nystatin has been administered intravaginally,118, 129 intravaginal preparations of the drug are no longer commercially available in the US.
Nystatin topical cream, ointment, or powder are for external use only and should not be ingested, applied to the eye, or administered intravaginally.128, 130, 131, 133, 147, 148
The cream may be preferred instead of the ointment in intertriginous areas;147 the powder may be preferred if lesions are very moist.128, 133, 147
Nystatin cream or ointment should be applied liberally to affected areas.147, 148
Alternatively, the powder may be applied to affected areas.128, 133 For the treatment of candidal foot infections, the powder should be dusted onto the feet and into all footwear (shoes, socks).128, 133
Fixed-combination topical preparations containing nystatin and triamcinolone acetonide are for external use only and contact with the eyes should be avoided.130, 131 The fixed-combination cream or ointment should be applied to affected areas130, 131 and gently and thoroughly massaged into the skin.130 Occlusive dressings should not be used.130, 131 (See Precautions Related to Use of Fixed Combinations Containing Corticosteroids under Cautions: Precautions and Contraindications.)
Commercially available nystatin oral suspension is administered undiluted using the calibrated dropper or dosing cup provided by the manufacturer.125, 146 The oral suspension should be shaken well prior to administration.125, 146
One-half of the dose of oral suspension should be placed in each side of the mouth (use a dropper in infants and young children) and retained in the mouth for as long as possible before swallowing.125, 146 Infants should not be fed for 5-10 minutes after the dose.125, 146
Dosage of nystatin is expressed in terms of USP nystatin units.125, 128, 133, 146, 147, 148
For the topical treatment of cutaneous or mucocutaneous candidiasis in neonates, infants, and children, nystatin cream, ointment, or powder containing 100,000 units/g should be applied to affected areas 2 or 3 times daily until healing is complete.128, 133, 147, 148 A treatment duration of 7-10 days usually is effective.150 Although symptomatic relief may be apparent within 24-72 hours after initiation of topical treatment,147, 148, 150 the full course of treatment should be completed.128, 133 If no response is obtained, appropriate laboratory testing should be performed.128, 133 (See Selection and Use of Antifungals under Cautions: Precautions and Contraindications.)
If a fixed combination containing nystatin and triamcinolone acetonide (nystatin 100,000 units/g and triamcinolone acetonide 0.1%) is used for the topical treatment of cutaneous candidiasis in pediatric patients, the cream or ointment should be applied to affected areas twice daily (morning and evening).130, 131 When used in pediatric patients, the lowest effective dosage should be used.131 Some clinicians state that the treatment duration generally should not exceed 2 weeks.162, 292 The manufacturers state that the fixed combination should be discontinued if signs and symptoms persist after 25 days of treatment.130, 131 (See Precautions Related to Use of Fixed Combinations Containing Corticosteroids under Cautions: Precautions and Contraindications.)
For the topical treatment of candidal diaper dermatitis, nystatin cream, ointment, or powder containing 100,000 units/g has been applied to affected areas 3 or 4 times daily for 7-10 days.114, 150
When nystatin oral suspension has been used as an adjunct to topical nystatin for the treatment of candidal diaper rash†, the oral suspension containing 100,000 units/mL has been given in a dosage of 100,000 units 3 or 4 times daily.115, 150, 161
If nystatin oral suspension containing 100,000 units/mL is used for the topical treatment of candidiasis of the oral cavity (oropharyngeal candidiasis, thrush), the recommended dosage in children is 400,000-600,000 units 4 times daily.125, 146, 425 Infants may receive nystatin oral suspension in a dosage of 200,000 units 4 times daily;125, 146 results of limited studies indicate that premature and low-birthweight infants may receive 100,000 units 4 times daily.125, 146 A treatment duration of 7-14 days usually is recommended.425 The manufacturers recommend that treatment be continued for at least 48 hours after perioral symptoms have subsided and cultures are negative for Candida albicans .125, 146
If nystatin oral suspension is used for the topical treatment of oropharyngeal candidiasis in pediatric patients with human immunodeficiency virus (HIV) infection, the US Centers for Disease Control and Prevention (CDC), National Institutes of Health (NIH), HIV Medicine Association of the Infectious Diseases Society of America (IDSA), and American Academy of Pediatrics (AAP) recommend a dosage of 400,000-600,000 units 4 times daily in HIV-infected children441 and a dosage of 400,000-600,000 units 4-5 times daily in HIV-infected adolescents.440 A treatment duration of 7-14 days usually is recommended.440, 441
Prevention of Candidiasis in Low-birthweight Neonates
If nystatin oral suspension containing 100,000 units/mL is used as an alternative for prophylaxis to reduce the incidence of invasive candidiasis in low-birthweight neonates weighing less than 1.5 kg at high risk†, IDSA recommends a dosage of 100,000 units 3 times daily for 6 weeks.425
For the topical treatment of cutaneous or mucocutaneous candidiasis in adults, nystatin cream, ointment, or powder containing 100,000 units/g should be applied to affected areas 2 or 3 times daily until healing is complete.128, 133, 147, 148 A treatment duration of 7-10 days usually is effective.150 Although symptomatic relief may be apparent within 24-72 hours after initiation of topical treatment,147, 148, 150 the full course of treatment should be completed.128, 133 If no response is obtained, appropriate laboratory testing should be performed.128, 133 (See Selection and Use of Antifungals under Cautions: Precautions and Contraindications.)
If a fixed combination containing nystatin and triamcinolone acetonide (nystatin 100,000 units/g and triamcinolone acetonide 0.1%) is used for the topical treatment of cutaneous candidiasis in adults, the cream or ointment should be applied to affected areas twice daily (morning and evening).130, 131 Some clinicians state that the treatment duration generally should not exceed 2 weeks.162, 292 The manufacturers state that the fixed combination should be discontinued if signs and symptoms persist after 25 days of treatment.130, 131 (See Precautions Related to Use of Fixed Combinations Containing Corticosteroids under Cautions: Precautions and Contraindications.)
If nystatin oral suspension containing 100,000 units/mL is used for the topical treatment of candidiasis of the oral cavity (oropharyngeal candidiasis, thrush), the recommended dosage in adults is 400,000-600,000 units 4 times daily.125, 146, 425 A treatment duration of 7-14 days usually is recommended.425 The manufacturers recommend that treatment be continued for at least 48 hours after perioral symptoms have subsided and cultures are negative for C. albicans .125, 146
If nystatin oral suspension is used for the topical treatment of oropharyngeal candidiasis in HIV-infected adults, CDC, NIH, and HIV Medicine Association of IDSA recommend a dosage of 400,000-600,000 units 4 or 5 times daily.440 A treatment duration of 7-14 days usually is recommended.440
Nonesophageal Mucous Membrane GI Candidiasis
If nystatin tablets containing 500,000 units are used for the topical treatment of nonesophageal mucous membrane GI candidiasis, a dosage of 500,000 units to 1 million units 3 times daily is recommended.134 Treatment with the oral tablets generally should be continued for at least 48 hours after clinical cure.134
Nystatin administered topically or orally generally is well tolerated, even during prolonged use.125, 130, 131, 134, 146, 147, 148
The most common adverse effects reported with topical nystatin are allergic reactions, including burning, itching, rash, eczema, and application site pain.128, 133
Fixed-combination topical preparations containing nystatin and triamcinolone acetonide may rarely cause irritation.130, 131 An acneiform eruption was reported in at least one patient receiving a topical fixed combination containing nystatin and triamcinolone acetonide.130, 131 Adverse local reactions reported infrequently with topical preparations containing corticosteroids include burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, and miliaria.130, 131
Oral irritation and sensitization have been reported with nystatin oral suspension or tablets.125, 134, 146 Rash, urticaria, and Stevens-Johnson syndrome have been reported rarely.125, 134, 146
Diarrhea (including a case of bloody diarrhea), nausea, vomiting, and GI upset/disturbances have been reported with oral nystatin.125, 134, 146
Other adverse effects reported rarely include tachycardia, bronchospasm, facial swelling, and nonspecific myalgia.125, 134, 146
Precautions and Contraindications
Nystatin and fixed combinations containing nystatin and triamcinolone acetonide are contraindicated in individuals hypersensitive to nystatin or any ingredient in the formulation.125, 128, 130, 131, 133, 134, 146, 147, 148
If irritation or hypersensitivity occurs during treatment with nystatin or fixed-combination nystatin and triamcinolone acetonide, the drug should be discontinued immediately and appropriate measures taken.128, 130, 131, 133, 134, 146, 147, 148
Selection and Use of Antifungals
Nystatin topical cream, ointment, or powder are for external use only and should not be used for the treatment of systemic, oral, ophthalmic, or intravaginal infections.128, 133, 147, 148
Nystatin oral suspension and film-coated tablets should not be used for the treatment of systemic fungal infections.134, 146
Prior to initiation of topical treatment of cutaneous or mucocutaneous candidiasis, the diagnosis should be confirmed using appropriate laboratory testing (e.g., potassium hydroxide [KOH] smears, cultures, other diagnostic methods).128, 133 If there is no response to topical treatment, appropriate laboratory testing should be repeated to confirm the diagnosis.128, 133
Patients should be informed of the importance of completing the full course of treatment, even if symptomatic relief occurs within the first few days.128, 133
Patients should be advised to discontinue the drug and notify a clinician if irritation or hypersensitivity occurs.128, 130, 131, 133
Precautions Related to Use of Fixed Combinations Containing Corticosteroids
When a fixed-combination topical preparation containing nystatin and triamcinolone acetonide is used, the usual cautions, precautions, and contraindications associated with topical corticosteroids also should be considered.130, 131
Fixed-combination nystatin and triamcinolone acetonide topical cream and ointment are for external use only and should not be used for ophthalmic infections.130, 131
Patients being treated with fixed-combination topical preparations containing nystatin and triamcinolone acetonide should be informed that occlusive dressings (e.g., bandages or other coverings or wraps) should not be used on the treated site since this may increase systemic absorption of the corticosteroid.130, 131 In pediatric patients being treated in the diaper area, parents should be advised that tight-fitting diapers or plastic pants should be avoided since these items would constitute occlusive dressings.116, 130, 131 Some clinicians state that fixed-combination topical preparations containing an antifungal and a corticosteroid should not be used in the diaper area.116 (See Cautions: Pediatric Precautions.)
The manufacturers recommend discontinuing fixed-combination topical preparations containing nystatin and triamcinolone acetonide if signs and symptoms persist after 25 days of treatment.130, 131 When fixed combinations containing a corticosteroid are used, some clinicians state that the treatment duration should not exceed 2 weeks,162 especially in pediatric patients.292
Clinicians should 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 have been reported in some patients receiving a topical corticosteroid.130, 131 (See Cautions in the Topical Corticosteroids General Statement 84:06.08.)
Nystatin topical cream and ointment may be used in pediatric patients and usually are well tolerated, including when used in debilitated infants.147, 148
Safety and efficacy of topical nystatin powder have been established in pediatric patients, including neonates and infants.128, 133
Safety and efficacy of nystatin oral suspension have been established in pediatric patients, including infants and young children.125, 146
Fixed-combination topical cream containing nystatin and triamcinolone acetonide has been used effectively for the topical treatment of cutaneous candidiasis in a limited number of infants and children 2 months to 12 years of age in clinical studies.130, 131 Clinicians should consider that pediatric patients may be more susceptible to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature individuals because of the greater skin surface area-to-body weight ratio.130, 131 In addition, chronic corticosteroid therapy may interfere with the growth and development of children.130, 131 If a fixed-combination topical cream or ointment containing nystatin and triamcinolone acetonide is used in pediatric patients, the lowest effective dosage should be used131, 292 and some clinicians state that the maximum duration of treatment with such fixed combinations should be 2 weeks.162, 292 (See Cautions: Pediatric Precautions, in the Topical Corticosteroids General Statement 84:06.08.)
Clinical studies of nystatin topical powder did not include sufficient numbers of patients 65 years of age or older to determine whether they respond differently than younger patients.128 Other reported clinical experience has not identified differences in responses between geriatric and younger patients, but greater sensitivity of some geriatric individuals cannot be ruled out.128
Mutagenicity and Carcinogenicity
Studies have not been conducted to date to assess the mutagenic or carcinogenic potential of nystatin in humans or animals.125, 128, 133, 134, 146
Animal reproduction studies have not been performed using topical or oral nystatin.125, 128, 133, 134, 146 It is not known whether nystatin can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity.125, 128, 133, 134, 146
Topical nystatin should be used during pregnancy only if potential benefits outweigh potential risks to the fetus.128, 133
Oral nystatin (oral suspension, tablets) should be used during pregnancy only if clearly needed.125, 134, 146
Fixed-combination topical preparations containing nystatin and triamcinolone acetonide should be used during pregnancy only if potential benefits outweigh potential risks to the fetus.130, 131 Topical preparations containing corticosteroids should not be used extensively, in large amounts, or for prolonged periods during pregnancy.130, 131
It is not known whether nystatin is distributed into human milk.125, 128, 133, 134, 146
Nystatin and fixed combinations containing nystatin and triamcinolone acetonide should be used with caution in nursing women.125, 128, 130, 131, 133, 134, 146
Nystatin exerts its antifungal activity by binding to sterols in the fungal cell membrane.125, 128, 133, 134, 146, 147, 148, 150 As a result of this binding, the membrane is no longer able to function as a selective barrier and allows loss of potassium and other cellular constituents.125, 128, 133, 134, 146, 147, 148, 150
Nystatin has fungistatic or fungicidal activity against a variety of yeasts and yeast-like fungi.125, 128, 133, 134, 146, 147, 148
Nystatin is active against Candida albicans ,128, 133, 146, 150 C. glabrata ,128, 133, 150 C. krusei ,128, 133 C. parapsilosis ,128, 133 C. pseudotropicalis ,128, 133 C. guilliermondii ,128, 133 and C. tropicalis .128, 133 In vitro, nystatin concentrations of 0.5-2 mcg/mL inhibit C. albicans and C. glabrata .150
Nystatin is not active against bacteria, protozoa, or viruses.125, 128, 133, 134, 146, 147, 148
Candida resistant to nystatin can be produced in vitro,150 and resistance has been reported in clinical isolates of Candida albicans ,150 C. glabrata ,150 C. guilliermondii ,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
Nystatin is not absorbed from intact skin or mucous membranes.128, 130, 133
Only very limited amounts of nystatin are absorbed from the GI tract.125, 134, 146 Plasma concentrations of nystatin usually are undetectable following oral administration of usual dosages of the drug; however, oral administration in patients with renal impairment may result in detectable plasma concentrations of the drug.125, 134, 146 Orally administered nystatin is excreted almost entirely in feces as unchanged drug.125, 134, 146
Nystatin is a polyene antifungal antibiotic produced by Streptomyces noursei 125, 128, 133, 134, 146, 147, 148, 150 and is a mixture of closely related compounds.102, 150 Nystatin occurs as a yellow to light tan powder with a cereal-like odor and is very slightly soluble in water and slightly to sparingly soluble in alcohol.130, 131 Potency of nystatin is expressed in terms of UPS nystatin units;125, 128, 133, 134, 146, 147, 148 each mg of nystatin contains not less than 4400 USP nystatin units.102
Nystatin is commercially available as a cream,147 ointment,148 or powder for topical application to the skin.128, 133 The drug also is commercially available in fixed combination with triamcinolone acetonide as a cream130 or ointment131 for topical application to the skin.130, 131
For topical oral application, nystatin is commercially available as an oral suspension125, 146 or film-coated tablets.134
Nystatin topical cream should be stored at 15-30°C and protected from excessive heat (40°C).147 Nystatin topical ointment should be stored at 15-30°C and should not be frozen.148
Depending on the manufacturer, nystatin topical powder should be stored in a tight container at 20-25°C128 or 15-30°C133 and should be protected from excessive heat (40°C).128, 133
Commercially available nystatin oral suspension should be stored at 20-25°C,125, 146 but may be exposed to temperatures ranging from 15-30°C.125 Freezing should be avoided.146
Nystatin film-coated tablets should be stored at 20-25°C.134
Fixed-combination topical cream or ointment containing nystatin and triamcinolone acetonide should be stored at 20-25°C and freezing should be avoided.130, 131
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.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Suspension | 100,000 units per mL* | Nystatin Oral Suspension | |
Tablets, film-coated | 500,000 units* | Nystatin Tablets | ||
Topical | Cream | 100,000 units per g* | Nystatin Cream | |
Ointment | 100,000 units per g* | Nystatin Ointment | ||
Powder | 100,000 units per g* | Nystatin Topical Powder | ||
Nystop® | Paddock |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Cream | Nystatin 100,000 units per g and Triamcinolone Acetonide 0.1%* | Nystatin and Triamcinolone Acetonide Cream | |
Ointment | Nystatin 100,000 units per g and Triamcinolone Acetonide 0.1%* | Nystatin and Triamcinolone Acetonide Ointment |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Only references cited for selected revisions after 1984 are available electronically.
102. The United States Pharmacopeia, 41st rev, and The National Formulary, 35th ed. From USP website. Accessed 2018 July 17. [Web]
105. Hann IM, Prentice HG, Corringham R et al. Ketoconazole versus nystatin plus amphotericin B for fungal prophylaxis in severely immunocompromised patients. Lancet . 1982; 1:826-9. [PubMed 6122057]
106. DeGregorio MW, Lee WMF, Ries CA. Candida infections in patients with acute leukemia: ineffectiveness of nystatin prophylaxis and relationship between oropharyngeal and systemic candidiasis. Cancer . 1982; 50:2780-4. [PubMed 6958353]
107. Kay HEM, Watson JG, Jameson B et al. Infection after bone marrow transplantation using cyclosporine. Transplantation . 1983; 36:491-5. [PubMed 6314614]
108. Jones PG, Kauffman CA, McAuliffe LS et al. Efficacy of ketoconazole v nystatin in prevention of fungal infections in neutropenic patients. Arch Intern Med . 1984; 144:549-51. [PubMed 6322710]
111. Bodey GP, Keating MJ, McCredie KB et al. Prospective randomized trial of antibiotic prophylaxis in acute leukemia. Am J Med . 1985; 78:407-16. [PubMed 3919579]
114. Munz D, Powell KR, Pai CH. Treatment of candidal diaper dermatitis: a double-blind placebo-controlled comparison of topical nystatin with topical plus oral nystatin. J Pediatr . 1982; 101:1022-5. [PubMed 6754898]
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125. E. Fougera & Co. Nystatin oral suspension, USP 100,000 USP nystatin units/mL prescribing information. Melville, NY; 2007 Nov.
128. Mayne Pharma Inc. Nystatin topical powder, USP prescribing information. Greenville, NC; 2015 May.
129. Odyssey Pharmaceuticals. Nystatin vaginal tablets USP 100,000 units prescribing information. East Hanover, NJ. 2003 March.
130. Perrigo. Nystatin and triamcinolone acetonide cream, USP prescribing information. Allergan, MI; 2017 Apr.
131. Actavis Pharma, Inc. Nystatin and triamcinolone acetonide ointment, USP prescribing information. Parsippany, NJ; 2015 May.
133. Paddock Laborotories, LLC. Nystop® (nystatin) topical powder, USP prescribing information. Minneapolis, MN; 2012 Sep
134. Heritage Pharmaceuticals, Inc. Nystatin tablet, USP, coated for oral use prescribing information. East Brunswick, NJ; May 2018.
135. Williams C, Whitehouse JM, Lister TA et al. Oral anticandidal prophylaxis in patients undergoing chemotherapy for acute leukemia. Med Pediatr Oncol . 1977; 3:275-80. [PubMed 311410]
136. Carpentieri U, Haggard ME, Lockhart LH et al. Clinical experience in prevention of candidiasis by nystatin in children with acute lymphocytic leukemia. J Pediatr . 1978; 92:593-5. [PubMed 273087]
137. Pizzuto J, Conte G, Ambriz R et al. Nystatin prophylaxis in leukemia and lymphoma. N Engl J Med . 1978; 298:279-80. [PubMed 619271]
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