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Nystatin (Oral)

Pronunciation

Pronunciation

(nye STAT in)

Dosage Forms

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]

Powder, Oral:

Bio-Statin: (1 ea)

Generic: (1 ea)

Suspension, Mouth/Throat:

Generic: 100,000 units/mL (5 mL, 60 mL, 473 mL, 480 mL)

Tablet, Oral:

Generic: 500,000 units

Brand Names: U.S.

  • Bio-Statin

Pharmacologic Category

  • Antifungal Agent, Oral Nonabsorbed/Partially Absorbed

Pharmacology

Binds to sterols in fungal cell membrane, changing the cell wall permeability allowing for leakage of cellular contents

Absorption

Poorly absorbed

Excretion

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

Contraindications

Hypersensitivity to nystatin or any component of the formulation

Dosing: Adult

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

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

Oral candidiasis:

Suspension:

Premature infants: 100,000 units 4 times/day; paint suspension into recesses of the mouth

Infants: 200,000 units 4 times/day or 100,000 units to each side of mouth 4 times/day; paint suspension into recesses of the mouth

Children: 400,000-600,000 units 4 times/day; swish in the mouth and retain for as long as possible (several minutes) before swallowing

Powder for compounding: Children: Refer to adult dosing.

Dosing: Renal Impairment

No dosage adjustment provided in manufacturer’s labeling.

Dosing: Hepatic Impairment

No dosage adjustment provided in manufacturer’s labeling.

Administration

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.

Storage

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).

Drug Interactions

Saccharomyces boulardii: Antifungal Agents (Systemic, Oral) may diminish the therapeutic effect of Saccharomyces boulardii. Avoid combination

Adverse Reactions

1% to 10%: Gastrointestinal: Diarrhea, nausea, stomach pain, vomiting

<1% (Limited to important or life-threatening): Hypersensitivity reactions

Pregnancy Risk Factor

C

Pregnancy Considerations

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.

Patient Education

• 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 severe dysphagia or severe mouth pain or 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.

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