NYSTOP

General Administration Information
For storage information, see the specific product information within the How Supplied section.

Route-Specific Administration

Oral Administration
-To prevent relapse, treatment is generally continued for at least 48 hours after clinical cure (i.e., symptoms disappear and culture demonstrate fungal eradication).
Oral Liquid Formulations
-Shake the suspension well prior to each administration.
-Use the provided dropper or a calibrated oral syringe for accurate dose measurement.
-Administer one-half of the dose in each side of the mouth.
-Retain the solution in the mouth for as long as possible before swallowing.
-Avoid food or feeding for 5 to 10 minutes after each dose.



Topical Administration
-Topical nystatin is not for ophthalmic use.
-Instruct patients to discontinue treatment and seek medical attention if symptoms of irritation or sensitization develop.
Cream/Ointment/Lotion Formulations
-Apply liberally to the affected skin area(s) until healing is complete.

Other Topical Formulations
Topical Powder
-Very moist lesions are best treated with the topical dusting powder.
-For the treatment of the feet, dust the powder on the feet as well as in all footwear.
-Apply to lesions until healing is complete.

Oral nystatin is generally well tolerated. Nausea, vomiting, diarrhea (including a case of bloody diarrhea), and gastrointestinal upset (dyspepsia) or disturbances have been reported with oral nystatin in the general population. Oral irritation and sensitization have also been reported with oral nystatin.

Oral nystatin is generally well tolerated. Bronchospasm, facial swelling, nonspecific myalgia, and sinus tachycardia have been reported with oral nystatin in the general population.

Dermatologic adverse events reported in less than 0.1% of persons in the general population using topical nystatin include allergic reactions, burning, eczema, pruritus, rash, and pain on application. Rash, including urticaria, has been reported rarely with oral nystatin; Stevens-Johnson syndrome has been reported very rarely with oral nystatin.

Nystatin is contraindicated in persons with a history of hypersensitivity to any of its components.

Description: Nystatin is an oral and topical polyene antifungal indicated for the treatment of oropharyngeal, cutaneous, and mucocutaneous candidiasis. Nystatin is not indicated for the treatment of invasive candidiasis due to negligible absorption from the gastrointestinal tract. Nystatin possesses fungistatic and fungicidal activity against a wide variety of yeast and yeast-like fungi. The nystatin oral suspension and topical preparations are FDA approved in pediatric patients as young as neonates.

Per the manufacturer, this drug has been shown to be active against most strains of the following microorganisms either in vitro and/or in clinical infections: Candida albicans, Candida glabrata, Candida guilliermondii, Candida krusei, Candida parapsilosis, Candida pseudotropicalis, Candida sp., Candida tropicalis, Trichophyton mentagrophytes, Trichophyton rubrum
NOTE: The safety and effectiveness in treating clinical infections due to organisms with in vitro data only have not been established in adequate and well-controlled clinical trials.

For the treatment of cutaneous and mucocutaneous candidiasis, including candidal diaper dermatitis:
Topical dosage (cream or ointment):
Neonates: Apply liberally to the affected skin area(s) twice daily until healing is complete.
Infants, Children, and Adolescents: Apply liberally to the affected skin area(s) twice daily until healing is complete.
Topical dosage (powder):
Neonates: Apply a dusting to the affected skin area(s) 2 to 3 times daily until healing is complete. For fungal infection of the feet, dust the powder on the feet as well as in all footwear. Very moist lesions are best treated with the topical dusting powder.
Infants, Children, Adolescents: Apply a dusting to the affected skin area(s) 2 to 3 times daily until healing is complete. For fungal infection of the feet, dust the powder on the feet as well as in all footwear. Very moist lesions are best treated with the topical dusting powder.

For the treatment of oropharyngeal candidiasis (thrush):
Oral dosage (suspension):
Premature Neonates: 100,000 units PO 4 times daily for at least 48 hours after clinical cure based on limited data in premature and low birth weight neonates; place one-half of the dose in each side of the mouth.
Neonates: 200,000 units PO 4 times daily for 7 to 14 days; place one-half of the dose in each side of the mouth. The FDA-approved duration is for at least 48 hours after clinical cure.
Infants: 200,000 units PO 4 times daily for 7 to 14 days; place one-half of the dose in each side of the mouth. The FDA-approved duration is for at least 48 hours after clinical cure.
Children and Adolescents: 400,000 to 600,000 units PO 4 times daily for 7 to 14 days; place one-half of the dose in each side of the mouth. The FDA-approved duration is for at least 48 hours after clinical cure.

For candidiasis prophylaxis* in high-risk premature neonates:
Oral dosage (suspension):
Premature Neonates: 100,000 units PO 3 times daily for 6 weeks is recommended as an alternative therapy in premature neonates weighing less than 1,500 g in cases where resistance or availability preclude the use of fluconazole. 100,000 units 3 to 4 times daily has reduced invasive candidiasis in studies of high-risk patients. Doses were either administered as one-half the dose placed in each side of the mouth or instilled into the stomach via oro/nasogastric tube. One study coated the mouth with 50,000 units and administered the remainder by orogastric tube. Duration of prophylaxis has varied.

Maximum Dosage Limits:
-Neonates
Premature Neonates: 400,000 units/day PO; safety and efficacy have not been established for topical cream, ointment, or powder.
Neonates: 800,000 units/day PO; 2 applications/day topically for cream or ointment; 2 to 3 applications/day topically for powder.
-Infants
800,000 units/day PO; 2 applications/day topically for cream or ointment; 2 to 3 applications/day topically for powder.
-Children
2.4 million units/day PO; 2 applications/day topically for cream or ointment; 2 to 3 applications/day topically for powder.
-Adolescents
2.4 million units/day PO; 2 applications/day topically for cream or ointment; 2 to 3 applications/day topically for powder.

Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

*non-FDA-approved indication

Monograph content under development

Mechanism of Action: Nystatin is a polyene antifungal that acts by binding to sterols in the cell membranes of both fungal and human cells, which results in a change in membrane permeability allowing leakage of intracellular components with subsequent cell death. Nystatin has greater affinity for ergosterol, the sterol found in fungal cell membranes, than for cholesterol, the sterol found in human cell membranes; however, nystatin is too toxic to be used parenterally. Nystatin is both fungistatic and fungicidal.

Pharmacokinetics: Nystatin is administered orally and topically.

Affected cytochrome P450 isoenzymes and drug transporters: none


-Route-Specific Pharmacokinetics
Oral Route
Gastrointestinal absorption of nystatin is insignificant. Most orally administered nystatin is excreted in feces as unchanged drug.

Topical Route
Nystatin is not absorbed from intact skin or mucous membranes.


-Special Populations
Renal Impairment
In persons with renal insufficiency receiving oral nystatin, significant plasma concentrations of nystatin may occasionally occur.