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Nystex
Classes
Gynecological Antifungals
Polyene Antifungals
Topical Dermatological Antifungals
Administration
For topical, oral administration, use nystatin suspension as a swish and swallow. If using the powder for suspension, prepare only a single dose at a time because it does not contain preservatives.
Shake the suspension liquid well prior to each adminstration.
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.
The suspension should be retained in the mouth for as long as possible (e.g., several minutes) before swallowing.
Topical preparations should not be applied to the eye.
Rub ointment or cream gently into the skin of the affected area.
Topical Powder
For the treatment of candidal infection of the feet, the powder should be dusted in shoes and socks, as well as on the feet.
Use vaginal applicators supplied by the manufacturer.
Instruct patient on proper administration.
Adverse Reactions
Stevens-Johnson syndrome / Delayed / 0-0.1
eczema vaccinatum / Delayed / 0-0.1
bronchospasm / Rapid / Incidence not known
angioedema / Rapid / Incidence not known
hyperglycemia / Delayed / Incidence not known
sinus tachycardia / Rapid / Incidence not known
diarrhea / Early / 1.0-10.0
vomiting / Early / 1.0-10.0
dyspepsia / Early / 1.0-10.0
nausea / Early / 1.0-10.0
urticaria / Rapid / 0-1.0
skin irritation / Early / 0-1.0
rash / Early / 0-1.0
pruritus / Rapid / 0-0.1
myalgia / Early / Incidence not known
Common Brand Names
Bio-Statin, Mycostatin, Nyamyc, Nyata, Nystex, Nystop, Pedi-Dri, Pediaderm AF
Dea Class
Rx
Description
Topical polyene antifungal antibiotic.
Used in the treatment of oropharyngeal, cutaneous, mucocutaneous, and vulvovaginal candidiasis; not useful for systemic fungal infections.
Adverse events tend to be minimal due to limited systemic absorption.
Dosage And Indications
500,000 to 1,000,000 units PO 3 times daily for at least 48 hours after clinical cure to prevent relapse.
Apply to affected area(s) twice daily until healing is complete.
Apply to affected area(s) twice daily until healing is complete.
Apply to affected area(s) twice daily until healing is complete.
Apply to affected area(s) 2 to 3 times daily until healing is complete. For infections of the feet, also dust powder in footwear. Topical powder is recommended over creams and ointments for very moist lesions.
Apply to affected area(s) 2 to 3 times daily until healing is complete. For infections of the feet, also dust powder in footwear. Topical powder is recommended over creams and ointments for very moist lesions.
Apply to affected area(s) 2 to 3 times daily until healing is complete. For infections of the feet, also dust powder in footwear. Topical powder is recommended over creams and ointments for very moist lesions.
400,000 to 600,000 units (4 to 6 mL) PO 4 times daily for 7 to 14 days; divide dose so that one-half of each dose is placed in each side of the mouth. The FDA-approved duration is for at least 48 hours after clinical cure.
400,000 to 600,000 units (4 to 6 mL) PO 4 times daily for 7 to 14 days; divide dose so that one-half of each dose is placed in each side of the mouth. The FDA-approved duration is for at least 48 hours after clinical cure.
200,000 units (2 mL) PO 4 times daily for 7 to 14 days; divide dose so that one-half of each dose is placed in each side of the mouth. Avoid feeding for 5 to 10 minutes. The FDA-approved duration is for at least 48 hours after clinical cure.
200,000 units (2 mL) PO 4 times daily for 7 to 14 days; divide dose so that one-half of each dose is placed in each side of the mouth. Avoid feeding for 5 to 10 minutes. The FDA-approved duration is for at least 48 hours after clinical cure.
100,000 units (1 mL) PO 4 times daily for at least 48 hours after clinical cure based on limited data in premature and low birth weight neonates; divide each dose so that one-half of each dose is placed in each side of the mouth. Avoid feeding for 5 to 10 minutes.
100,000 units (1 mL) 3 times daily for 6 weeks is recommended by guidelines as an alternative therapy in premature neonates weighing less than 1500 g in cases where resistance or availability preclude the use of fluconazole. 100,000 units (1 mL) 3 to 4 times daily has reduced invasive candidiasis in studies of high-risk patients. Doses were either administered as 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 0.5 mL of nystatin and then gave the rest via orogastric tube. Duration of prophylaxis has varied. Avoid feeding for 5 to 10 minutes after a dose.
†Indicates off-label use
Dosing Considerations
No dosage adjustment needed.
No dosage adjustment needed.
Drug Interactions
Econazole: (Moderate) The combination of econazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
Ketoconazole: (Moderate) The combination of ketoconazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
Miconazole: (Moderate) The combination of miconazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
Miconazole; Petrolatum; Zinc Oxide: (Moderate) The combination of miconazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
Oxiconazole: (Moderate) The combination of oxiconazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
Sertaconazole: (Moderate) The combination of sertaconazole and nystatin represent duplication of therapy whenever the drugs are used by similar route, and is usually avoided.
Sulconazole: (Moderate) The combination of sulconazole and nystatin represents duplication of therapy whenever the drugs are used by similar routes and are usually avoided.
How Supplied
Bio-Statin/Nystatin Oral Cap: 500000U, 1000000U
Mycostatin/Nyamyc/Nyata/Nystatin/Nystop/Pedi-Dri Topical Pwd: 1g, 100000U
Mycostatin/Nystatin Oral Tab: 500000U
Mycostatin/Nystatin/Nystex Oral Susp: 1mL, 5mL, 100000U, 500000U
Mycostatin/Nystatin/Nystex/Pediaderm AF Topical Cream: 1g, 100000U
Nystatin/Nystex Topical Ointment: 1g, 100000U
Maximum Dosage
2.4 million units/day PO; maximum dosage information is not available for topical powder, cream, or ointment.
2.4 million units/day PO; maximum dosage information is not available for topical powder, cream, or ointment.
2.4 million units/day PO; maximum dosage information is not available for topical powder, cream, or ointment.
2.4 million units/day PO; maximum dosage information is not available for topical powder, cream, or ointment.
800,000 units/day PO; maximum dosage information is not available for topical powder, cream, or ointment.
Neonates: 800,000 units/day PO; maximum dosage information is not available for topical powder, cream, or ointment.
Premature Neonates: 400,000 units/day PO; maximum dosage information is not available for topical powder, cream, or ointment.
Mechanism Of Action
Nystatin is a polyene antifungal that binds to sterols in the cell membranes of both fungal and human cells. Nystatin is usually fungistatic in vivo but may have fungicidal activity at high concentrations or against extremely susceptible organisms. 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 systemically. As a result of this binding, membrane integrity of both fungal cells and human cells is impaired, causing the loss of intracellular potassium and other cellular contents. Because bacteria do not contain sterols in their cell membranes, nystatin is ineffective against this class of organisms. Nystatin is also ineffective against protozoa, trichomonads, and viruses.
Pharmacokinetics
Nystatin is administered orally, topically, and intravaginally.
Although nystatin is used orally, it is poorly absorbed from the GI tract. After oral administration, nystatin is almost entirely excreted in feces as unchanged drug.
Nystatin is not absorbed from intact skin or mucous membranes.
Pregnancy And Lactation
Animal reproduction studies have not been conducted with any oral or topical nystatin preparation. It also is not known whether these preparations can cause fetal harm when used during human pregnancy or can affect reproductive capacity. However, gastrointestinal absorption of oral nystatin is insignificant and systemic absorption is minimal. Topical nystatin products are not absorbed from intact skin or mucous membranes. Nystatin should be used during pregnancy only when clearly needed.
It is unknown whether oral nystatin is excreted in human milk. However, gastrointestinal absorption of oral nystatin is insignificant; therefore, minimal serum and milk concentrations would be expected. Topical nystatin products are not absorbed from intact skin or mucous membranes. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.