Medically reviewed by Drugs.com. Last updated on Jun 20, 2020.
(nye STAT in)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral [preservative free]:
Bio-Statin: 500,000 units, 1,000,000 units [dye free]
Bio-Statin: (1 ea)
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
Intestinal infections: Oral tablets: 500,000-1,000,000 units every 8 hours
Oral candidiasis, mild disease (alternative agent): 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 (HHS [adult OI] 2020; IDSA [Pappas 2016]).
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.
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
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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.
What is this drug used for?
• It is used to treat many fungal infections.
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
• Abdominal pain
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
• Mouth irritation
• Fast heartbeat
• Muscle pain
• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Note: This is not a comprehensive list of all side effects. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a limited summary of general information about the medicine's uses from the patient education leaflet and is not intended to be comprehensive. This limited summary does NOT include all information available about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not intended to provide medical advice, diagnosis or treatment and does not replace information you receive from the healthcare provider. For a more detailed summary of information about the risks and benefits of using this medicine, please speak with your healthcare provider and review the entire patient education leaflet.
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