Class: Polyenes
VA Class: AM700
CAS Number: 1400-61-9
Brands: Mycostatin, Mykacet, Nystat-Rx, Nystop, Pedi-Dri
Introduction
Antifungal; polyene antibiotic.128 129 130 131 133 134 150
Uses for Nystatin
Cutaneous and Mucocutaneous Candidiasis
Treatment of cutaneous infections caused by Candida,128 130 133 147 148 149 including perlèche, intertriginous candidiasis, and paronychia.e Used topically alone128 133 147 149 or in fixed combination with a corticosteroid (triamcinolone acetonide).130
Treatment of candidal diaper dermatitis.114 115 149 150 Treatment of choice is a topical antifungal (e.g., nystatin, clotrimazole, miconazole);115 may be used in conjunction with a topical corticosteroid.130 e 149 The majority of 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 Some clinicians recommend that an oral antifungal agent (e.g., oral nystatin) be administered concomitantly to treat the intestinal infection,115 but studies have not provided evidence that concomitant oral and topical therapy is more effective than topical therapy alone.114 115
Oropharyngeal Candidiasis
Treatment of oropharyngeal candidiasis (thrush).111 126 131 146 149
Uncomplicated oropharyngeal candidiasis usually can be treated using oral topical therapy (clotrimazole lozenge or nystatin oral suspension); systemic oral antifungals (fluconazole, itraconazole, ketoconazole) usually are reserved for treatment of oropharyngeal candidiasis unresponsive to oral topical antifungals or for severe oropharyngeal candidiasis with esophageal involvement.111 126 Some clinicians prefer to use systemic oral azole antifungals for initial therapy of oropharyngeal candidiasis in HIV-infected individuals.111 112
Nystatin is ineffective for treatment of esophageal candidiasis in HIV-infected individuals.111 112
Intestinal Candidiasis
Oral treatment of mucous membrane (nonesophageal) GI candidiasis.131 134
Has been used orally in conjunction with an intravaginal antifungal to treat coexisting intestinal candidiasis and vulvovaginal candidiasis.100 101 (See Vulvovaginal Candidiasis under Uses.)
Vulvovaginal Candidiasis
Treatment of vulvovaginal candidiasis.102 108 119 122 129 CDC and other clinicians recommend that uncomplicated vulvovaginal candidiasis (defined as vulvovaginal candidiasis that is mild to moderate, sporadic or infrequent, most likely caused by C. albicans, or occurring in immunocompetent women) be treated with an intravaginal azole antifungal (e.g., butoconazole, clotrimazole, miconazole, terconazole, tioconazole) or, alternatively, oral fluconazole.102 108 116 118 119 122 123 127 Intravaginal nystatin can be used for uncomplicated vulvovaginal candidiasis,102 108 127 but generally is less effective than intravaginal azole antifungals.102 127
Has been used orally in conjunction with an intravaginal antifungal to treat coexisting intestinal candidiasis and vulvovaginal candidiasis.100 101 While early studies provided some limited evidence that reducing intestinal candidal colonization could improve the mycologic response and reduce the recurrence rate of vulvovaginal candidiasis,100 101 most evidence suggests that combined oral and intravaginal therapy does not substantially reduce the risk of recurrence compared with intravaginal therapy alone.103 104 105 106
Topical treatment of male sexual partners of women with recurrent vulvovaginal candidiasis who have symptomatic balanitis or penile dermatitis.102 Routine treatment of asymptomatic male sexual partners of women with recurrent vulvovaginal candidiasis is not recommended but may be considered when the woman has recurrent infections.102 120 124
Prevention of Candida Infections
Oral nystatin has been used for prevention of initial or recurrent mucocutaneous candidiasis (including oropharyngeal candidiasis) in HIV-infected individuals†,110 but is no longer included in the prophylaxis guidelines of the Prevention of Opportunistic Infections Working Group of the US Public Health Service and Infectious Diseases Society of America (USPHS/IDSA).109 If prophylaxis of mucocutaneous candidiasis is indicated in HIV-infected individuals with history of frequent or severe episodes of oropharyngeal, esophageal, or vaginal candidiasis, USPHS/IDSA recommends fluconazole or, alternatively, itraconazole.109
Oral nystatin 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).135 136 137 138 139 140 144 Routine primary antifungal prophylaxis in neutropenic patients is not recommended, but may be considered in certain carefully selected high-risk patients (e.g., solid organ transplant recipients, patients in institutions that have a high incidence of fungal infections).141 143 145 If primary prophylaxis against candida infections is used in cancer or transplant recipients, many clinicians recommend oral fluconazole.141 143
Nystatin Dosage and Administration
Administration
Apply topically to the skin as a cream, ointment, or powder.128 130 133 147 148 Administer topically to the oral cavity as an oral suspension.131 146 Administer intravaginally as a vaginal tablet.129 Administer orally as film-coated tablets.134
Topical creams, ointments, or powders should not be ingested, applied to the eye, or administered intravaginally.128 130 133 e
Topical Administration
When treating cutaneous candidiasis, use proper hygiene and skin care measures to prevent spread of infection and reinfection; keep affected areas dry and exposed to air if possible.e
Cream may be preferred instead of ointment in intertriginous areas; powder may be preferred if lesions are very moist.147
Avoid occlusive dressings.e
Cream or Ointment
Apply cream or ointment to affected area and gently and thoroughly massage into the skin.128 130 147 148
Powder
Apply powder to affected areas.133
For treatment of candidal foot infections, dust powder onto feet and into shoes and stockings.128 133
Oral Topical Administration
For Oral Suspension
The powder for oral suspension is used by the patient to extemporaneously prepare each individual dose at the time of administration.131 Add the appropriate dose of powder (units of nystatin) to the volume of water recommended by the manufacturer (e.g., 118–177 mL) and stir well until suspended.131
Place one-half of the oral suspension in one side of the mouth and retain in the mouth for as long as possible before swallowing.131 Repeat using the remainder of the oral suspension in the other side of the mouth.131
Suspension
Shake suspension well before using.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.146 Do not feed infants for 5–10 minutes after the dose.146
Intravaginal Topical Administration
Insert vaginal tablet high in the vagina using the applicator provided by the manufacturer.129
Continue intravaginal nystatin during menstruation.129 Cleansing douches may be used by nonpregnant patients; adjunctive anti-infective douches are unnecessary.129
Dosage
Pediatric Patients
Cutaneous Candidiasis
Topical
Cream, ointment, or powder: Apply to affected areas 2 or 3 times daily for ≥2 weeks.128 133 147 148 e
Candidal Diaper Dermatitis
Topical
Cream, ointment, or powder: Apply to affected areas several times daily for 7–10 days.114 150
Fixed-combination cream or ointment containing nystatin and triamcinolone acetonide: Apply to affected area in the morning and evening.130 e
Oral
Oral suspension: As an adjunct to topical nystatin, some clinicians recommend oral administration of 100,000 units of nystatin 4 times daily.e 132
Oropharyngeal Candidiasis
Oral Topical
Oral suspension: 200,000 units 4 times daily in infants or 400,000–600,000 units 4 times daily in children.131 146 Limited data indicate that 100,000 units 4 times daily is effective in premature and low birthweight infants.146
Continue treatment for 14 days or for ≥48 hours after perioral symptoms have disappeared and cultures have returned to normal.131 146 If symptoms persist, confirm the diagnosis of candidiasis and rule out other pathogens before initiating another course of nystatin therapy.131
Adults
Cutaneous Candidiasis
Topical
Cream, ointment, or powder: Apply to affected areas 2 or 3 times daily for ≥2 weeks.128 133 147 148 e
Fixed combination cream or ointment containing nystatin and triamcinolone acetonide: Apply to affected area in the morning and evening.130
Symptomatic improvement of cutaneous or mucocutaneous candidal infections usually occurs within 1–3 days; however, continue therapy for ≥2 weeks.e Discontinue therapy only after 2 successive negative tests for Candida.e
Clinical and mycologic cure for chronic paronychia may require several months of therapy.e
Oropharyngeal Candidiasis
Oral Topical
Oral suspension: 400,000 to 600,000 units 4 times daily.131 146 In HIV-infected individuals, 500,000 to 1,000,000 units 3–5 times daily.111
Continue treatment for 14 days or for ≥48 hours after perioral symptoms have disappeared and cultures have returned to normal.131 If symptoms persist, confirm the diagnosis of candidiasis and rule out other pathogens before initiating another course of nystatin therapy.131
Intestinal Candidiasis
Oral
Oral suspension prepared using the powder for oral suspension: 500,000 to 1 million units 3 times daily for ≥48 hours after clinical cure.131
Film-coated tablets: 2 tablets (500,000 to 1 million units) 3 times daily for ≥48 hours after clinical cure.131
Vulvovaginal Candidiasis
Intravaginal
Vaginal tablet: 1 tablet (100,000 units) once daily for 14 days.102 129
Cautions for Nystatin
Contraindications
Hypersensitivity to nystatin or any ingredient in the formulation.128 129 130 131 133 134 146 147 148
Warnings/Precautions
Sensitivity Reactions
Hypersensitivity Reactions
Irritation or sensitization may occur.129 Rash, urticaria, and Stevens-Johnson syndrome reported rarely.128 133 134
Discontinue therapy if irritation or sensitization occurs.128 129 131 133 134 146 147 148
General Precautions
Selection and Use of Antifungals
Nystatin topical creams, ointments, or powders should not be used for treatment of systemic, oral, ophthalmic, or intravaginal infections.128 133
Nystatin oral suspension or film-coated oral tablets should not be used for treatment of systemic fungal infections.134 146
Prior to use of topical nystatin for treatment of cutaneous or mucocutaneous Candida infections128 133 and prior to use of intravaginal nystatin tablets for treatment of vulvovaginal candidiasis, diagnosis should be confirmed by microscopic examination (saline or potassium hydroxide [KOH] wet mount or Gram stain) and/or culture.102 119 128 129 133
If symptoms persist after initial treatment, confirm the diagnosis and rule out other pathogens before initiating another course of nystatin.128 130 133
Use of Fixed Combinations Containing Corticosteroids
When nystatin is used in fixed combination with a corticosteroid, consider the cautions, precautions, and contraindications associated with topical corticosteroid therapy.130 e i
Specific Populations
Pregnancy
Category A (vaginal tablets).129
Category C (topical creams, ointments, and powders).128 133
Category C (oral suspension and film-coated oral tablets).134 146
Category C (topical creams containing fixed combination of nystatin and triamcinolone acetonide).130
Lactation
Not known whether nystatin distributed into milk; use with caution.128 130 133 134 146
Not known whether triamcinolone acetonide distributed into milk; use fixed-combination preparations containing nystatin and triamcinolone acetonide with caution.130
Pediatric Use
Topical cream and topical powder may be used in pediatric patients, including neonates.128 133
Safety and efficacy of vaginal tablets not established in pediatric patients.129
Fixed-combination preparations containing nystatin and triamcinolone acetonide have been used effectively for treatment of cutaneous candidiasis in a limited number of children 2 months to 12 years of age.130 Pediatric patients may be more susceptible to topical corticosteroid-induced hypothalamic-pituitary-adrenal (HPA) axis suppression and Cushing’s syndrome than mature individuals because of the greater skin surface area-to-body weight ratio.130 134 e
Common Adverse Effects
Topical creams, ointments, or powders: Hypersensitivity reactions (burning, itching, rash, eczema, pain).128 133
Oral suspension or film-coated oral tablets: Mild and transitory GI effects (nausea, vomiting, diarrhea, GI distress); hypersensitivity reactions.131 146
Nystatin Pharmacokinetics
Absorption
Bioavailability
Not absorbed following topical application to intact skin or mucous membranes.128 129 130 133
Insignificant absorption occurs in most patients following oral administration.131 134 146 Usually undetectable in plasma when given in usual oral doses,131 but clinically important plasma concentrations may occur occasionally in patients with renal impairment.134 146
Elimination
Elimination Route
Following oral administration, majority of nystatin dose is excreted unchanged in feces.131 134 146
Stability
Storage
Topical
Cream or Ointment
15–30°C; avoid freezing and excessive heat (40°C).128 133 147 148
Powder
Tight container at 15–30°C; avoid excessive heat (40°C).128 133
Oral Topical
Powder For Oral Suspension
Tight, light resistant container at 2–8°C.131 Potency of the powder can only be assured for up to 90 days after the container is first opened.131
Contains no preservative; use oral suspension immediately after the powder is mixed in water.131
Suspension
15–30°C; avoid freezing.146
Oral
Tablets, Film-coated
15–30°C.134
Intravaginal
Tablets
15–30°C.129
Actions and SpectrumActions
Fungistatic or fungicidal in action.128 129 133 134 146
Binds to sterols in the fungal cell membrane, which no longer functions as a selective barrier and allows the loss of potassium and other cellular constituents.128 129 130 131 133 134 146 150
Active against a variety of pathogenic and nonpathogenic yeasts and fungi.128 129 133 134 146 Inactive against organisms that do not contain sterols in their cell membrane (e.g., bacteria, protozoa, viruses).128 129 133 134 146
Candida: Active against C. albicans, C. glabrata, C. krusei, C. parapsilosis, C. pseudotropicalis, C. guilliermondi, and C. tropicalis.128 133 e
Dermatophytes: Active against Trichophyton rubrum and T. mentagrophytes.128 133
Nystatin resistance has been reported in some strains of C. albicans, C. glabrata, C. guilliermondi, C. krusei, and C. tropicalis.128 133 134 150 e
Advice to Patients
Importance of not interrupting or discontinuing oral or topical nystatin therapy until the prescribed regimen is completed even though symptomatic relief may occur within a few days.128 133 e
Importance of not interrupting or discontinuing vaginal nystatin therapy during a prescribed regimen, even during menstruation or if symptomatic relief occurs after only a few days of therapy, unless otherwise instructed by clinician.129
Importance of discontinuing treatment and consulting clinician if irritation or sensitization (redness, itching, burning, blistering, swelling, oozing) occurs at the treatment site.128 129 133 e
Advise patients of preventive measures to prevent reinfection.130
Importance of instructing patient on proper preparation and use of extemporaneous oral suspensions prepared from powder for oral suspension.131 Advise patient that extemporaneously prepared oral suspensions do not contain a preservative and should be used immediately after preparation and should not be stored.131
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.e
Preparations
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | For suspension | 50 million units* | Nystatin Powder | Paddock |
Nystat-Rx | X-GEN | |||
150 million units* | Nystatin Powder | Paddock | ||
Nystat-Rx | X-GEN | |||
500 million units* | Nystatin Powder | Paddock | ||
Nystat-Rx | X-GEN | |||
1 billion units | Nystat-Rx | X-GEN | ||
2 billion units* | Nystatin Powder | Paddock | ||
Nystat-Rx | X-GEN | |||
Suspension | 100,000 units/mL* | Nystatin Suspension (with ≤1% alcohol parabens and sucrose 50%) | Actavis, Fougera, Morton Grove, Taro | |
Tablets, film-coated | 500,000 units* | Nystatin Tablets | Teva, United Research Laboratories | |
Topical | Cream | 100,000 units/g* | Mycostatin (with propylene glycol) | Bristol-Myers Squibb |
Nystatin Cream | Actavis, Fougera, Perrigo, Taro | |||
Ointment | 100,000 units/g* | Nystatin Ointment | Actavis, Fougera, Perrigo | |
Powder | 100,000 units/g* | Mycostatin (dispersed in talc) | Bristol-Myers Squibb | |
Nystatin Topical Powder (dispersed in talc) | Par, Upsher-Smith | |||
Nystop (dispersed in talc) | Paddock | |||
Pedi-Dri (dispersed in talc) | Pedinol | |||
Vaginal | Tablets | 100,000 units* | Nystatin Vaginal Tablets (available with applicator) | Odyssey |
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Topical | Cream | 100,000 units/g with Triamcinolone Acetonide 0.1%* | Mykacet | Actavis |
Nystatin and Triamcinolone Acetonide Cream | Fougera, Taro | |||
Ointment | 100,000 units/g with Triamcinolone Acetonide 0.1%* | Mykacet | Actavis | |
Nystatin and Triamcinolone Acetonide Ointment | Fougera, Taro |
Comparative Pricing
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Nystatin-Triamcinolone 100000-0.1UNIT/GM-% Cream (TARO): 60/$14.99 or 120/$19.98
Nystatin-Triamcinolone 100000-0.1UNIT/GM-% Cream (FOUGERA): 30/$13.99 or 60/$20.98
Nystatin-Triamcinolone 100000-0.1UNIT/GM-% Cream (FOUGERA): 15/$12.99 or 45/$20.99
Nystatin-Triamcinolone 100000-0.1UNIT/GM-% Ointment (TARO): 15/$17.77 or 45/$32.29
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, 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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131. Paddock Laborotories, Inc. Nystatin USP for extemporaneous preparation of oral suspension prescribing information. Minneapolis, MN.
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148. Alpharma. Nystatin ointment, USP (100,000 units/g) prescribing information. Baltimore, MD. 2000 Nov.
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