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Classification   |    Detailed evidence-based information

Substances Included Synonyms

Therapeutic Toxic Class

    A) Nystatin is a polyene antifungal derivative of Streptomyces noursei. Its potency is expressed in units, where 1 mg is equivalent to greater than 2000 units (USP).

Specific Substances

    1) Biofanal
    2) Candio-hermal
    3) Diastatin
    4) Fungicidin
    5) Moronal
    6) Mycostatin
    7) Mycostatin 20
    8) Nilstat
    9) Nistatina
    10) Nyotran
    11) Nystan
    12) Nystatine
    13) Nystatinum
    14) Nystavescent
    15) O-V Statin
    16) Stamycin
    17) CAS 1400-61-9

Available Forms Sources

    A) FORMS
    1) Nystatin is available in the United States in the following formulations:
    a) Topical powder: 100,000 Units/g (Prod Info NYAMYC(TM) topical powder, 2005)
    b) Oral suspension: 100,000 Units/mL (Prod Info nystatin oral suspension, 2006)
    c) Oral tablet: 500,000 Units (Prod Info nystatin oral tablets, 2009)
    d) Topical cream: 100,000 Units/g (Prod Info nystatin topical cream, 2006)
    e) Topical ointment: 100,000 Units/g (Prod Info nystatin topical ointment, 2006)
    f) Vaginal tablet: 100,000 Units (Prod Info nystatin vaginal tablets, 2000)
    2) The nystatin oral pastilles (lozenges; Mycostatin(R)) are no longer marketed in the United States.
    B) USES
    1) Nystatin is a polyene antifungal agent used to treat candidal vulvovaginitis, candidiasis of skin, cutaneous and mucocutaneous infections, non-esophageal gastrointestinal candidiasis, and oropharyngeal candidiasis (Prod Info nystatin oral tablets, 2009; Prod Info nystatin topical ointment, 2006; Prod Info nystatin topical cream, 2006; Prod Info NYAMYC(TM) topical powder, 2005; Prod Info nystatin oral tablets, 2003; Prod Info nystatin vaginal tablets, 2000).

Overview

Life Support

    A) This overview assumes that basic life support measures have been instituted.

Clinical Effects

    0.2.1) SUMMARY OF EXPOSURE
    A) USES: Nystatin is a polyene antifungal agent used to treat candidal vulvovaginitis, candidiasis of skin, cutaneous and mucocutaneous infections, non-esophageal gastrointestinal candidiasis, and oropharyngeal candidiasis.
    B) PHARMACOLOGY: Nystatin binds to sterols in the fungal cell membrane, resulting in the cell membrane's inability to function as a selective barrier, thus allowing loss of essential cellular constituents.
    C) EPIDEMIOLOGY: Overdose is rare.
    D) WITH THERAPEUTIC USE
    1) Toxicity from orally administered nystatin is extremely low. Nausea, vomiting, diarrhea, and oral irritation have been reported with oral nystatin therapy. RARE: Acute allergic reaction, tachycardia, bronchospasm, facial swelling, skin rash, urticaria, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and nonspecific myalgia have rarely been reported. Severe vulvovaginitis has been reported following intravaginal nystatin therapy.
    E) WITH POISONING/EXPOSURE
    1) Overdose data are limited. Overdose effects are anticipated to be an extension of adverse effects observed following therapeutic doses. Patients given doses greater than 5 million units daily developed only nausea and gastrointestinal upset.
    0.2.20) REPRODUCTIVE
    A) Nystatin is classified as pregnancy risk category B.

Laboratory Monitoring

    A) No specific laboratory tests are necessary unless otherwise clinically indicated.
    B) Monitor serum electrolytes in patients with significant vomiting and/or diarrhea.

Treatment Overview

    0.4.2) ORAL/PARENTERAL EXPOSURE
    A) MANAGEMENT OF MILD TO MODERATE TOXICITY
    1) Treatment is symptomatic and supportive. Correct any significant fluid and/or electrolyte abnormalities in patients with severe diarrhea and/or vomiting.
    B) MANAGEMENT OF SEVERE TOXICITY
    1) Treatment is symptomatic and supportive. Significant toxicity is not expected after nystatin overdose.
    C) DECONTAMINATION
    1) PREHOSPITAL: Nystatin is minimally absorbed in the gastrointestinal tract. Toxicity after acute ingestion is unlikely. Gastrointestinal decontamination is generally unnecessary.
    2) HOSPITAL: Toxicity after acute ingestion is unlikely. Gastrointestinal decontamination is generally unnecessary. Consider activated charcoal only if coingestants with significant toxicity are involved.
    D) AIRWAY MANAGEMENT
    1) Should not be required in these cases. Endotracheal intubation and mechanical ventilation may be required in patients with severe allergic reaction.
    E) ANTIDOTE
    1) None.
    F) ACUTE ALLERGIC REACTION
    1) MILD to MODERATE effects: Monitor airway. Administer antihistamines with or without inhaled beta agonists, corticosteroids, or epinephrine. SEVERE Effects: Administer oxygen; aggressive airway management may be necessary. Administer antihistamines, epinephrine, corticosteroids as needed. Treatment includes IV fluids and ECG monitoring.
    G) ENHANCED ELIMINATION PROCEDURE
    1) Hemodialysis is not recommended given the minimal systemic absorption and low toxicity of nystatin.
    H) PATIENT DISPOSITION
    1) HOME CRITERIA: A patient with an inadvertent exposure, that remains asymptomatic can be managed at home.
    2) OBSERVATION CRITERIA: Patients with a deliberate overdose, and those who are symptomatic, need to be monitored for several hours to assess electrolyte and fluid balance and gastrointestinal function. Patients that remain asymptomatic can be discharged.
    3) ADMISSION CRITERIA: Hospital admission is rarely necessary. Patients should be admitted for severe vomiting, profuse diarrhea, severe abdominal pain, dehydration, and electrolyte abnormalities.
    4) CONSULT CRITERIA: Consult a poison center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the diagnosis is not clear.
    I) PITFALLS
    1) If significant toxicity develops other causes should be sought. When managing a suspected nystatin overdose, the possibility of multidrug involvement should be considered.
    J) PHARMACOKINETICS
    1) ABSORPTION: Oral: negligible. Topical: minimal.
    K) DIFFERENTIAL DIAGNOSIS
    1) Patients with underlying cardiac dysrhythmias or electrolyte imbalance may develop more severe symptoms.

Range Of Toxicity

    A) TOXICITY: A minimum toxic dose has not been established, and significant toxicity is not expected after overdose. Patients given doses greater than 5 million units daily developed only nausea and gastrointestinal upset.
    B) THERAPEUTIC DOSE: ADULTS: ORAL TABLET: 1 to 2 tablets (500,000 to 1,000,000 units) orally 3 times per day. ORAL SUSPENSION: 4 to 6 mL (400,000 to 600,000 units) orally (retained in mouth as long as possible prior to swallowing) 4 times daily. VAGINAL TABLETS: 1 tablet (100,000 units) intravaginally daily for 2 weeks. TOPICAL OINTMENT, CREAM, OR POWDER: apply topically 2 to 3 times daily. CHILDREN: ORAL SUSPENSION: infants; 2 mL (200,000 units) orally 4 times/day; continue treatment for at least 48 hr after perioral symptoms disappear; children; 4 to 6 mL (400,000 to 600,000 units) ORALLY (retained in mouth as long as possible prior to swallowing) 4 times daily; continue treatment for at least 48 hr after perioral symptoms disappear. TOPICAL OINTMENT, CREAM, OR POWDER: apply topically 2 to 3 times daily.

Clinical Effects

Summary Of Exposure

    A) USES: Nystatin is a polyene antifungal agent used to treat candidal vulvovaginitis, candidiasis of skin, cutaneous and mucocutaneous infections, non-esophageal gastrointestinal candidiasis, and oropharyngeal candidiasis.
    B) PHARMACOLOGY: Nystatin binds to sterols in the fungal cell membrane, resulting in the cell membrane's inability to function as a selective barrier, thus allowing loss of essential cellular constituents.
    C) EPIDEMIOLOGY: Overdose is rare.
    D) WITH THERAPEUTIC USE
    1) Toxicity from orally administered nystatin is extremely low. Nausea, vomiting, diarrhea, and oral irritation have been reported with oral nystatin therapy. RARE: Acute allergic reaction, tachycardia, bronchospasm, facial swelling, skin rash, urticaria, acute generalized exanthematous pustulosis, Stevens-Johnson syndrome, and nonspecific myalgia have rarely been reported. Severe vulvovaginitis has been reported following intravaginal nystatin therapy.
    E) WITH POISONING/EXPOSURE
    1) Overdose data are limited. Overdose effects are anticipated to be an extension of adverse effects observed following therapeutic doses. Patients given doses greater than 5 million units daily developed only nausea and gastrointestinal upset.

Cardiovascular

    3.5.2) CLINICAL EFFECTS
    A) TACHYCARDIA
    1) WITH THERAPEUTIC USE
    a) Tachycardia has rarely been reported with nystatin oral use (Prod Info nystatin oral tablets, 2009; Prod Info nystatin oral suspension, 2007).

Respiratory

    3.6.2) CLINICAL EFFECTS
    A) BRONCHOSPASM
    1) WITH THERAPEUTIC USE
    a) Bronchospasm has been reported rarely with nystatin use (Prod Info nystatin oral tablets, 2009; Prod Info nystatin oral suspension, 2007).

Gastrointestinal

    3.8.2) CLINICAL EFFECTS
    A) GASTROENTERITIS
    1) WITH THERAPEUTIC USE
    a) Nausea, vomiting, and diarrhea (including one case of bloody diarrhea) has been reported with nystatin use (Prod Info nystatin oral tablets, 2009; Prod Info nystatin oral suspension, 2007).
    2) WITH POISONING/EXPOSURE
    a) Patients given doses greater than 5 million units daily developed only nausea and gastrointestinal upset (Prod Info nystatin oral tablets, 2009).
    B) ORAL IRRITATION
    1) WITH THERAPEUTIC USE
    a) Oral irritation and sensitization have been reported with use of nystatin (Prod Info nystatin oral tablets, 2009; Prod Info nystatin oral suspension, 2007).

Genitourinary

    3.10.2) CLINICAL EFFECTS
    A) VULVOVAGINITIS
    1) WITH THERAPEUTIC USE
    a) CASE REPORT: A 64-year-old woman developed severe vulvovaginitis after using intravaginal nystatin therapy for 10 days for Candida glabrata infection (Dan, 2001).

Dermatologic

    3.14.2) CLINICAL EFFECTS
    A) CONTACT DERMATITIS
    1) WITH THERAPEUTIC USE
    a) Allergic contact dermatitis to nystatin is quite rare, but has been reported (Wasilewski, 1970). Nystatin is not irritating to the skin (Fed Reg, 1982).
    B) ERUPTION
    1) WITH THERAPEUTIC USE
    a) Skin rash including urticaria has been reported with nystatin use (Prod Info nystatin oral tablets, 2009; Prod Info nystatin oral suspension, 2007; Prod Info nystatin topical powder, 2006).
    b) Acute generalized exanthematous pustulosis was reported in 3 patients following oral nystatin therapy. Sensitivity testing revealed delayed type hypersensitivity to nystatin (Kuchler et al, 1997).
    c) One patient developed a transient exanthema after oral and vaginal use of nystatin (Mick et al, 1975).
    C) STEVENS-JOHNSON SYNDROME
    1) WITH THERAPEUTIC USE
    a) Stevens-Johnson syndrome has rarely been reported in patients receiving nystatin (Prod Info nystatin oral tablets, 2009; Prod Info nystatin oral suspension, 2007).
    b) CASE REPORT: A case of Stevens-Johnson syndrome was reported in a 14-month-old child following the application of nystatin ointment. Maculopapular eruptions appeared on the patient after the administration of nystatin oral suspension for the treatment of thrush on previous occasions. Despite this apparent allergy, nystatin ointment was applied to these macular eruptions, and within 90 minutes, Stevens-Johnson syndrome developed (Garty, 1991).

Musculoskeletal

    3.15.2) CLINICAL EFFECTS
    A) MUSCLE PAIN
    1) WITH THERAPEUTIC USE
    a) Nonspecific myalgia has rarely been reported with nystatin oral use (Prod Info nystatin oral tablets, 2009; Prod Info nystatin oral suspension, 2007).

Immunologic

    3.19.2) CLINICAL EFFECTS
    A) ACUTE ALLERGIC REACTION
    1) WITH THERAPEUTIC USE
    a) Allergic reactions have been reported with nystatin use (Prod Info nystatin topical powder, 2006).
    b) Acute generalized exanthematous pustulosis was reported in 3 patients following oral nystatin therapy. Sensitivity testing revealed delayed-type hypersensitivity to nystatin (Kuchler et al, 1997).

Reproductive

    3.20.1) SUMMARY
    A) Nystatin is classified as pregnancy risk category B.
    3.20.3) EFFECTS IN PREGNANCY
    A) PREGNANCY CATEGORY
    NYSTATINB
    Reference: Briggs et al, 1998

Laboratory Monitoring

Monitoring Parameters Levels

    4.1.1) SUMMARY
    A) No specific laboratory tests are necessary unless otherwise clinically indicated.
    B) Monitor serum electrolytes in patients with significant vomiting and/or diarrhea.

Treatment

Life Support

    A) Support respiratory and cardiovascular function.

Patient Disposition

    6.3.1) DISPOSITION/ORAL EXPOSURE
    6.3.1.1) ADMISSION CRITERIA/ORAL
    A) Hospital admission is rarely necessary. Patients should be admitted for severe vomiting, profuse diarrhea, severe abdominal pain, dehydration, and electrolyte abnormalities.
    6.3.1.2) HOME CRITERIA/ORAL
    A) A patient with an inadvertent exposure, that remains asymptomatic can be managed at home.
    6.3.1.3) CONSULT CRITERIA/ORAL
    A) Consult a poison center or medical toxicologist for assistance in managing patients with severe toxicity or in whom the diagnosis is not clear.
    6.3.1.5) OBSERVATION CRITERIA/ORAL
    A) Patients with a deliberate overdose, and those who are symptomatic, need to be monitored for several hours to assess electrolyte and fluid balance and gastrointestinal function. Patients that remain asymptomatic can be discharged.

Monitoring

    A) No specific laboratory tests are necessary unless otherwise clinically indicated.
    B) Monitor serum electrolytes in patients with significant vomiting and/or diarrhea.

Oral Exposure

    6.5.1) PREVENTION OF ABSORPTION/PREHOSPITAL
    A) Nystatin is minimally absorbed in the gastrointestinal tract. Toxicity after acute ingestion is unlikely. Gastrointestinal decontamination is generally unnecessary.
    6.5.3) TREATMENT
    A) MONITORING OF PATIENT
    1) No specific laboratory tests are necessary unless otherwise clinically indicated.
    2) Monitor serum electrolytes in patients with significant vomiting and/or diarrhea.
    B) ACUTE ALLERGIC REACTION
    1) SUMMARY
    a) Mild to moderate allergic reactions may be treated with antihistamines with or without inhaled beta adrenergic agonists, corticosteroids or epinephrine. Treatment of severe anaphylaxis also includes oxygen supplementation, aggressive airway management, epinephrine, ECG monitoring, and IV fluids.
    2) BRONCHOSPASM
    a) ALBUTEROL
    1) ADULT: 2.5 to 5 milligrams in 2 to 4.5 milliliters of normal saline delivered per nebulizer every 20 minutes up to 3 doses. If incomplete response administer 2.5 to 10 mg every 1 to 4 hours as needed, or 10 to 15 mg/hr by continuous nebulization as needed (National Heart,Lung,and Blood Institute, 2007). CHILD: 0.15 milligram/kilogram (minimum 2.5 milligrams) per nebulizer every 20 minutes up to 3 doses. If incomplete response administer 0.15 to 0.3 mg/kg (up to 10 mg) every 1 to 4 hours as needed, or 0.5 mg/kg/hr by continuous nebulization (National Heart,Lung,and Blood Institute, 2007).
    3) CORTICOSTEROIDS
    a) Consider systemic corticosteroids in patients with significant bronchospasm.
    b) PREDNISONE: ADULT: 40 to 80 milligrams/day. CHILD: 1 to 2 milligrams/kilogram/day (maximum 60 mg) in 1 to 2 divided doses divided twice daily (National Heart,Lung,and Blood Institute, 2007).
    4) MILD CASES
    a) DIPHENHYDRAMINE
    1) SUMMARY: Oral diphenhydramine, as well as other H1 antihistamines can be used as indicated (Lieberman et al, 2010).
    2) ADULT: 50 milligrams orally, or 10 to 50 mg intravenously at a rate not to exceed 25 mg/min or may be given by deep intramuscular injection. A total of 100 mg may be administered if needed. Maximum daily dosage is 400 mg (Prod Info diphenhydramine HCl intravenous injection solution, intramuscular injection solution, 2013).
    3) CHILD: 5 mg/kg/24 hours or 150 mg/m(2)/24 hours. Divided into 4 doses, administered intravenously at a rate not exceeding 25 mg/min or by deep intramuscular injection. Maximum daily dosage is 300 mg (Prod Info diphenhydramine HCl intravenous injection solution, intramuscular injection solution, 2013).
    5) MODERATE CASES
    a) EPINEPHRINE: INJECTABLE SOLUTION: It should be administered early in patients by IM injection. Using a 1:1000 (1 mg/mL) solution of epinephrine. Initial Dose: 0.01 mg/kg intramuscularly with a maximum dose of 0.5 mg in adults and 0.3 mg in children. The dose may be repeated every 5 to 15 minutes, if no clinical improvement. Most patients respond to 1 or 2 doses (Nowak & Macias, 2014).
    6) SEVERE CASES
    a) EPINEPHRINE
    1) INTRAVENOUS BOLUS: ADULT: 1 mg intravenously as a 1:10,000 (0.1 mg/mL) solution; CHILD: 0.01 mL/kg intravenously to a maximum single dose of 1 mg given as a 1:10,000 (0.1 mg/mL) solution. It can be repeated every 3 to 5 minutes as needed. The dose can also be given by the intraosseous route if IV access cannot be established (Lieberman et al, 2015). ALTERNATIVE ROUTE: ENDOTRACHEAL ADMINISTRATION: If IV/IO access is unavailable. DOSE: ADULT: Administer 2 to 2.5 mg of 1:1000 (1 mg/mL) solution diluted in 5 to 10 mL of sterile water via endotracheal tube. CHILD: DOSE: 0.1 mg/kg to a maximum of 2.5 mg administered as a 1:1000 (1 mg/mL) solution diluted in 5 to 10 mL of sterile water via endotracheal tube (Lieberman et al, 2015).
    2) INTRAVENOUS INFUSION: Intravenous administration may be considered in patients poorly responsive to IM or SubQ epinephrine. An epinephrine infusion may be prepared by adding 1 mg (1 mL of 1:1000 (1 mg/mL) solution) to 250 mL D5W, yielding a concentration of 4 mcg/mL, and infuse this solution IV at a rate of 1 mcg/min to 10 mcg/min (maximum rate). CHILD: A dosage of 0.01 mg/kg (0.1 mL/kg of a 1:10,000 (0.1 mg/mL) solution up to 10 mcg/min (maximum dose 0.3 mg) is recommended for children (Lieberman et al, 2010). Careful titration of a continuous infusion of IV epinephrine, based on the severity of the reaction, along with a crystalloid infusion can be considered in the treatment of anaphylactic shock. It appears to be a reasonable alternative to IV boluses, if the patient is not in cardiac arrest (Vanden Hoek,TL,et al).
    7) AIRWAY MANAGEMENT
    a) OXYGEN: 5 to 10 liters/minute via high flow mask.
    b) INTUBATION: Perform early if any stridor or signs of airway obstruction.
    c) CRICOTHYROTOMY: Use if unable to intubate with complete airway obstruction (Vanden Hoek,TL,et al).
    d) BRONCHODILATORS are recommended for mild to severe bronchospasm.
    e) ALBUTEROL: ADULT: 2.5 to 5 milligrams in 2 to 4.5 milliliters of normal saline delivered per nebulizer every 20 minutes up to 3 doses. If incomplete response administer 2.5 to 10 mg every 1 to 4 hours as needed, or 10 to 15 mg/hr by continuous nebulization as needed (National Heart,Lung,and Blood Institute, 2007).
    f) ALBUTEROL: CHILD: 0.15 milligram/kilogram (minimum 2.5 milligrams) per nebulizer every 20 minutes up to 3 doses. If incomplete response administer 0.15 to 0.3 milligram/kilogram (maximum 10 milligrams) every 1 to 4 hours as needed OR administer 0.5 mg/kg/hr by continuous nebulization (National Heart,Lung,and Blood Institute, 2007).
    8) MONITORING
    a) CARDIAC MONITOR: All complicated cases.
    b) IV ACCESS: Routine in all complicated cases.
    9) HYPOTENSION
    a) If hypotensive give 500 to 2000 milliliters crystalloid initially (20 milliliters/kilogram in children) and titrate to desired effect (stabilization of vital signs, mentation, urine output); adults may require up to 6 to 10 L/24 hours. Central venous or pulmonary artery pressure monitoring is recommended in patients with persistent hypotension.
    1) VASOPRESSORS: Should be used in refractory cases unresponsive to repeated doses of epinephrine and after vigorous intravenous crystalloid rehydration (Lieberman et al, 2010).
    2) DOPAMINE: Initial Dose: 2 to 20 micrograms/kilogram/minute intravenously; titrate to maintain systolic blood pressure greater than 90 mm Hg (Lieberman et al, 2010).
    10) H1 and H2 ANTIHISTAMINES
    a) SUMMARY: Antihistamines are second-line therapy and are used as supportive therapy and should not be used in place of epinephrine (Lieberman et al, 2010).
    1) DIPHENHYDRAMINE: ADULT: 25 to 50 milligrams via a slow intravenous infusion or IM. PEDIATRIC: 1 milligram/kilogram via slow intravenous infusion or IM up to 50 mg in children (Lieberman et al, 2010).
    b) RANITIDINE: ADULT: 1 mg/kg parenterally; CHILD: 12.5 to 50 mg parenterally. If the intravenous route is used, ranitidine should be infused over 10 to 15 minutes or diluted in 5% dextrose to a volume of 20 mL and injected over 5 minutes (Lieberman et al, 2010).
    c) Oral diphenhydramine, as well as other H1 antihistamines, can also be used as indicated (Lieberman et al, 2010).
    11) DYSRHYTHMIAS
    a) Dysrhythmias and cardiac dysfunction may occur primarily or iatrogenically as a result of pharmacologic treatment (epinephrine) (Vanden Hoek,TL,et al). Monitor and correct serum electrolytes, oxygenation and tissue perfusion. Treat with antiarrhythmic agents as indicated.
    12) OTHER THERAPIES
    a) There have been a few reports of patients with anaphylaxis, with or without cardiac arrest, that have responded to vasopressin therapy that did not respond to standard therapy. Although there are no randomized controlled trials, other alternative vasoactive therapies (ie, vasopressin, norepinephrine, methoxamine, and metaraminol) may be considered in patients in cardiac arrest secondary to anaphylaxis that do not respond to epinephrine (Vanden Hoek,TL,et al).

Enhanced Elimination

    A) HEMODIALYSIS
    1) Hemodialysis is not recommended given the minimal systemic absorption and low toxicity of nystatin.

Range Of Toxicity

Summary

    A) TOXICITY: A minimum toxic dose has not been established, and significant toxicity is not expected after overdose. Patients given doses greater than 5 million units daily developed only nausea and gastrointestinal upset.
    B) THERAPEUTIC DOSE: ADULTS: ORAL TABLET: 1 to 2 tablets (500,000 to 1,000,000 units) orally 3 times per day. ORAL SUSPENSION: 4 to 6 mL (400,000 to 600,000 units) orally (retained in mouth as long as possible prior to swallowing) 4 times daily. VAGINAL TABLETS: 1 tablet (100,000 units) intravaginally daily for 2 weeks. TOPICAL OINTMENT, CREAM, OR POWDER: apply topically 2 to 3 times daily. CHILDREN: ORAL SUSPENSION: infants; 2 mL (200,000 units) orally 4 times/day; continue treatment for at least 48 hr after perioral symptoms disappear; children; 4 to 6 mL (400,000 to 600,000 units) ORALLY (retained in mouth as long as possible prior to swallowing) 4 times daily; continue treatment for at least 48 hr after perioral symptoms disappear. TOPICAL OINTMENT, CREAM, OR POWDER: apply topically 2 to 3 times daily.

Therapeutic Dose

    7.2.1) ADULT
    A) CANDIDIASIS
    1) ORAL
    a) TABLET: Recommended dose is 1 to 2 tablets (500,000 to 1,000,000 units) orally 3 times per day. Treatment should be continued for at least 48 hours after clinical cure to prevent relapse (Prod Info nystatin oral film coated tablets, 2014).
    b) SUSPENSION: Recommended dose is 4 to 6 mL (400,000 to 600,000 units) orally 4 times daily. Continue treatment until perioral symptoms are resolved and for at least 48 hours after resolution of Candida albicans (Prod Info nystatin oral suspension, 2013).
    B) CUTANEOUS OR MUCOCUTANEOUS MYCOTIC INFECTIONS (CANDIDA ALBICANS AND OTHER SUSCEPTIBLE CANDIDA SPECIES)
    1) TOPICAL
    a) CREAM, OINTMENT, OR POWDER: Apply to affected area topically (100,000 units nystatin (ointment or cream) per gram) 2 to 3 times per day (Prod Info nystatin topical cream, 2013; Prod Info nystatin topical ointment, 2012; Prod Info Nyamyc(TM) topical powder, 2007).
    C) VULVOVAGINAL CANDIDIASIS
    1) VAGINAL
    a) TABLETS: Recommended dose is 1 tablet (100,000 units) intravaginally daily for 2 weeks (Prod Info nystatin vaginal tablets, 2000).
    7.2.2) PEDIATRIC
    A) CANDIDIASIS
    1) ORAL
    a) INFANTS: SUSPENSION: Recommended dose is 2 mL (200,000 units) orally 4 times daily (Prod Info nystatin oral suspension, 2013).
    b) CHILDREN: SUSPENSION: Recommended dose is 4 to 6 mL (400,000 to 600,000 units) orally 4 times daily. Continue treatment until perioral symptoms are resolved and for at least 48 hours after resolution of Candida albicans (Prod Info nystatin oral suspension, 2013).
    B) CUTANEOUS OR MUCOCUTANEOUS MYCOTIC INFECTIONS (CANDIDA ALBICANS AND OTHER SUSCEPTIBLE CANDIDA SPECIES)
    1) TOPICAL
    a) NEONATES AND OLDER: CREAM, OINTMENT, OR POWDER: Apply to affected area topically (100,000 units nystatin (ointment, cream or powder) per gram) 2 to 3 times per day (Prod Info nystatin topical cream, 2013; Prod Info nystatin topical ointment, 2012; Prod Info Nyamyc(TM) topical powder, 2007).

Maximum Tolerated Exposure

    A) Patients given doses greater than 5 million units daily developed only nausea and gastrointestinal upset (Prod Info nystatin oral tablets, 2009).

Serum Plasma Blood Concentrations

    7.5.2) TOXIC CONCENTRATIONS
    A) TOXIC CONCENTRATION LEVELS
    1) CONCENTRATION LEVEL
    a) Doses of 8,000,000 units resulted in plasma levels of 1 to 2.5 micrograms/milliliter in a patient with normal renal function. A dose of 2,700,000 units/kilogram yielded a plasma level of 9.8 units/milliliter (Fed Reg, 1982).

Toxicity Information

    7.7.1) TOXICITY VALUES
    A) ANIMAL DATA
    1) LD50- (INTRAPERITONEAL)MOUSE:
    a) 4400 mcg/kg (RTECS , 2001a)
    2) LD50- (ORAL)MOUSE:
    a) 8 g/kg (RTECS , 2001a)
    3) LD50- (INTRAPERITONEAL)RAT:
    a) 24305 mcg/kg (RTECS , 2001a)
    4) LD50- (ORAL)RAT:
    a) 10 g/kg (RTECS , 2001a)

Pharmacology Toxicology

Pharmacologic Mechanism

    A) Nystatin is a polyene antifungal with a large conjugate, double-bond ring system linked to an amine sugar. It has both a hydrophillic and hydrophobic portion.
    B) Antifungal inhibitory concentrations range from 1.5 to 6.5 mcg/mL.
    C) Nystatin interacts with sterols in the cell walls of fungi, producing channels or pores which increase cell permeability and leakage (Gilman et al, 1985).

Physicochemical

Physical Characteristics

    A) The odor resembles cereal (Fed Reg, 1982).

Molecular Weight

    A) Nystatin A1: 938.30 (RTECS , 2001)

References

General Bibliography

    1) Boutati EI, Maltezou HC, Lopez-Berestein G, et al: Phase I study of maximum tolerated dose of intravenous liposomal nystatin (L-NYST) for the treatment of refractory febrile neutropenia (RFN) in patients with hematological malignancies (abstract LM22), Presented at the 35th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, 1995, pp 330.
    2) Dan M: Severe vulvovaginitis associated with intravaginal nystatin therapy. Am J Obstet Gynecol 2001; 185:254-255.
    3) Garty BZ: Stevens-Johnson syndrome associated with nystatin treatment (letter). Arch Dermatol 1991; 127:741-742.
    4) Gilman AG, Goodman LS, & Rall TW: The Pharmacological Basis of Therapeutics, 7th ed, Macmillan Publishing Co, New York, NY, 1985.
    5) Kuchler A, Hamm H, & Weidenthaler-Barth B: Acute generalized exanthematous pustulosis following oral nystatin therapy: a report of three cases. Br J Dermatol 1997; 137:808-11.
    6) Lieberman P, Nicklas R, Randolph C, et al: Anaphylaxis-a practice parameter update 2015. Ann Allergy Asthma Immunol 2015; 115(5):341-384.
    7) Lieberman P, Nicklas RA, Oppenheimer J, et al: The diagnosis and management of anaphylaxis practice parameter: 2010 update. J Allergy Clin Immunol 2010; 126(3):477-480.
    8) Mick R, Muller-Tyl E, & Neufeld T: Comparison of the effectiveness of nystatin and amphotericin b in the therapy of female genital mycoses (German). Wien Med Wochenschr 1975; 125:131-135.
    9) National Heart,Lung,and Blood Institute: Expert panel report 3: guidelines for the diagnosis and management of asthma. National Heart,Lung,and Blood Institute. Bethesda, MD. 2007. Available from URL: http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf.
    10) Nowak RM & Macias CG : Anaphylaxis on the other front line: perspectives from the emergency department. Am J Med 2014; 127(1 Suppl):S34-S44.
    11) Powles R, Mawhorter S, & Williams T: Liposomal nystatin (Nyotran) vs. amphotericin B (Fungizone) in empiric treatment of presumed fungal infection in neutropenic patients (abstract LB-4), Presented at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy (addendum), San Francisco, CA, 1999, pp 14.
    12) Product Information: NYAMYC(TM) topical powder, nystatin topical powder. Upsher Smith Laboratories, Minneapolis, MN, 2005.
    13) Product Information: Nyamyc(TM) topical powder, nystatin topical powder. Upsher-Smith Laboratories Inc. (per DailyMed), Minneapolis, MN, 2007.
    14) Product Information: diphenhydramine HCl intravenous injection solution, intramuscular injection solution, diphenhydramine HCl intravenous injection solution, intramuscular injection solution. Hospira, Inc. (per DailyMed), Lake Forest, IL, 2013.
    15) Product Information: nystatin oral film coated tablets, nystatin oral film coated tablets. AvKARE, Inc. (per DailyMed), Pulaski, TN, 2014.
    16) Product Information: nystatin oral suspension, nystatin oral suspension. E. Fougera & Co, Melville, NY, 2007.
    17) Product Information: nystatin oral suspension, nystatin oral suspension. Lehigh Valley Technologies, Inc. (per DailyMed), Allentown, PA, 2013.
    18) Product Information: nystatin oral suspension, nystatin oral suspension. Taro Pharmaceuticals,Inc, Hawthorne, NY, 2006.
    19) Product Information: nystatin oral tablets, nystatin oral tablets. Mutual Pharmaceutical Company, Inc, Philadelphia, PA, 2009.
    20) Product Information: nystatin oral tablets, nystatin oral tablets. Teva Pharmaceuticals USA, Sellersville, PA, 2003.
    21) Product Information: nystatin topical cream, nystatin topical cream. Actavis MidAtlantic,LLC, Lincolnton, NC, 2006.
    22) Product Information: nystatin topical cream, nystatin topical cream. Perrigo (per DailyMed), Allegan, MI, 2013.
    23) Product Information: nystatin topical ointment, nystatin topical ointment. Actavis MidAtlantic,LLC, Lincolnton, NC, 2006.
    24) Product Information: nystatin topical ointment, nystatin topical ointment. Perrigo (per DailyMed), Allegan, MI, 2012.
    25) Product Information: nystatin topical powder, nystatin topical powder. Ethex Corporation, St. Louis, MO, 2006.
    26) Product Information: nystatin vaginal tablets, nystatin vaginal tablets. Odyssey Pharmameuticals,Inc, East Hanover, NJ, 2000.
    27) RTECS : Registry of Toxic Effects of Chemical Substances. National Institute for Occupational Safety and Health. Cincinnati, OH (Internet Version). Edition expires 2001; provided by Truven Health Analytics Inc., Greenwood Village, CO.
    28) RTECS : Registry of Toxic Effects of Chemical Substances. National Institute for Occupational Safety and Health. Cincinnati, OH (Internet Version). Edition expires July/31/2001a; provided by Truven Health Analytics Inc., Greenwood Village, CO.
    29) Vanden Hoek,TL; Morrison LJ; Shuster M; et al: Part 12: Cardiac Arrest in Special Situations 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. American Heart Association. Dallas, TX. 2010. Available from URL: http://circ.ahajournals.org/cgi/reprint/122/18_suppl_3/S829. As accessed 2010-10-21.
    30) Wasilewski C: Allergic contact dermatitis from nystatin. Arch Dermatol 1970; 102:216-217.
    31) Williams AH & Moore JE: Multicenter study to evaluate the safety and efficacy of various doses of liposome-encapsulated nystatin in nonneutropenic patients with candidemia (abstract 1420), Presented at the 39th Interscience Conference on Antimicrobial Agents and Chemotherapy, San Francisco, CA, 1999, pp 567.