NYSTATIN
Clinical safety rating: safe
Animal studies have demonstrated safety
Nystatin binds to sterols in the fungal cell membrane, primarily ergosterol, altering membrane permeability and causing leakage of intracellular components, leading to fungal cell death.
| Metabolism | Nystatin is not absorbed from the gastrointestinal tract, skin, or mucous membranes after topical or oral administration; systemic metabolism is minimal. |
| Excretion | Nystatin is not absorbed from the gastrointestinal tract after oral administration; virtually 100% of the ingested dose is excreted unchanged in the feces. After topical application, systemic absorption is negligible; any absorbed drug is excreted via bile and feces (<1% renal). |
| Half-life | Due to minimal systemic absorption, a terminal elimination half-life is not clinically relevant. In vitro plasma degradation half-life is approximately 1.5 hours, but this is not applicable in vivo. |
| Protein binding | Not clinically relevant due to negligible systemic absorption. In vitro binding to plasma proteins is not typically reported. |
| Volume of Distribution | Not applicable due to lack of systemic absorption. After oral administration, drug remains in GI tract; Vd cannot be determined. |
| Bioavailability | Oral: <1% systemic bioavailability due to poor absorption from GI tract. Topical: Negligible absorption through intact skin or mucous membranes. Vaginal: Minimal systemic absorption. |
| Onset of Action | Oral: Clinical response usually seen within 24 hours. Topical: Relief of symptoms may occur within 24–72 hours. Vaginal tablets: Improvement noted within 48–72 hours. |
| Duration of Action | Oral suspension: Effect persists as long as contact with mucosa; treatment typically continued for 48 hours after resolution of symptoms. Topical creams: Duration depends on continued application; prolonged use (at least 2 weeks) often needed for vaginal candidiasis to prevent relapse. |
Oral: 500,000 to 1,000,000 units (5-10 mL suspension) swish and swallow 3-4 times daily; Vaginal: 1 vaginal tablet (100,000 units) once or twice daily; Topical: Apply cream/ointment 2-3 times daily; duration depends on indication.
| Dosage form | CREAM |
| Renal impairment | No dosage adjustment required for renal impairment. Nystatin is not systemically absorbed. |
| Liver impairment | No dosage adjustment required for hepatic impairment. Nystatin is not systemically absorbed. |
| Pediatric use | Oral suspension: Neonates and infants: 200,000 units (2 mL) four times daily; Children: 500,000 to 1,000,000 units (5-10 mL) four times daily. Topical and vaginal: Use same as adult. |
| Geriatric use | No specific dose adjustment; use caution with oral suspension due to aspiration risk in elderly with dysphagia. Use topical formulations as tolerated. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
No significant drug interactions For topical or oral use only not for systemic use.
| Breastfeeding | Nystatin is not absorbed systemically and is not excreted into breast milk in measurable amounts. It is considered compatible with breastfeeding. No M/P ratio is available due to negligible transfer. |
| Teratogenic Risk | Nystatin is poorly absorbed from the gastrointestinal tract and is not expected to reach significant systemic concentrations. No teratogenic effects have been reported in animal studies. In humans, there is no evidence of fetal harm; it is considered safe for use during all trimesters when administered topically or orally for local antifungal treatment. |
■ FDA Black Box Warning
None
| Common Effects | cutaneous) |
| Serious Effects |
["Hypersensitivity to nystatin or any component of the formulation"]
| Precautions | ["Hypersensitivity reactions including angioedema and rash","Irritation of skin or mucous membranes with prolonged use","Discontinue if irritation or sensitization occurs"] |
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| Fetal Monitoring | No specific maternal or fetal monitoring is required for nystatin use during pregnancy. Standard prenatal care should be continued. |
| Fertility Effects | Systemic exposure is negligible, and no adverse effects on fertility have been reported. Nystatin is not expected to impact reproductive function. |