Medically reviewed on Dec 29, 2018
(nye STAT in)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Capsule, Oral [preservative free]:
Bio-Statin: 500,000 units, 1,000,000 units [dye free]
Bio-Statin: (1 ea)
Generic: (1 ea [DSC])
Generic: 100,000 units/mL (5 mL, 60 mL, 473 mL, 480 mL)
Generic: 500,000 units
Brand Names: U.S.
- Antifungal Agent, Oral Nonabsorbed/Partially Absorbed
Binds to sterols in fungal cell membrane, changing the cell wall permeability allowing for leakage of cellular contents
Feces (as unchanged drug)
Onset of Action
Symptomatic relief from candidiasis: 24-72 hours
Use: Labeled Indications
Treatment of susceptible cutaneous, mucocutaneous, and oral cavity fungal infections normally caused by the Candida species
Hypersensitivity to nystatin or any component of the formulation
Oral candidiasis: Suspension (swish and swallow): 400,000-600,000 units 4 times/day; swish in the mouth and retain for as long as possible (several minutes) before swallowing
Intestinal infections: Oral tablets: 500,000-1,000,000 units every 8 hours
Note: Powder for compounding: 1/8 teaspoon (500,000 units) to equal approximately 1/2 cup of water; give 4 times/day
Refer to adult dosing.
Oral candidiasis: Oral suspension:
Infants: Oral: 200,000 to 400,000 units 4 times daily or 100,000 units to each side of mouth 4 times daily; one study of 14 patients (neonates and infants) found higher cure rates using 400,000 units/dose 4 times daily (Hoppe 1997)
Children and Adolescents: Oral: 400,000 to 600,000 units 4 times daily; administer half of dose to each side of mouth; swish and retain in the mouth for as long as possible before swallowing.
Peritonitis (Peritoneal dialysis), prophylaxis for high risk situations (eg, during antibiotic therapy or PEG placement): Oral Suspension: Infants, Children, and Adolescents: 10,000 units/kg once daily (Warady [ISPD] 2012)
Suspension: Shake well before using. Should be swished about the mouth and retained in the mouth for as long as possible (several minutes) before swallowing. For neonates and infants, paint nystatin suspension into recesses of the mouth.
Tablet and suspension: Store at controlled room temperature of 15°C to 25°C (59°F to 77°F).
Powder for suspension: Store under refrigeration at 2°C to 8°C (36°F to 46°F).
Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the therapeutic effect of Saccharomyces boulardii. Avoid combination
1% to 10%: Gastrointestinal: Diarrhea, nausea, stomach pain, vomiting
<1%, postmarketing, and/or case reports: Hypersensitivity reaction
Pregnancy Risk Factor
Animal reproduction studies have not been conducted. Adverse events in the fetus or newborn have not been reported following maternal use of vaginal nystatin during pregnancy. Absorption following oral use is poor.
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience abdominal pain, nausea, vomiting, or diarrhea. Have patient report immediately to prescriber mouth irritation (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: mouth and throat products