Nyamyc

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Nyamyc

Classes

Gynecological Antifungals
Polyene Antifungals
Topical Dermatological Antifungals

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.

Adverse Reactions
Severe

bronchospasm / Rapid / Incidence not known
Stevens-Johnson syndrome / Delayed / Incidence not known

Moderate

sinus tachycardia / Rapid / Incidence not known

Mild

pruritus / Rapid / 0-0.1
diarrhea / Early / Incidence not known
dyspepsia / Early / Incidence not known
nausea / Early / Incidence not known
vomiting / Early / Incidence not known
myalgia / Early / Incidence not known
skin irritation / Early / Incidence not known
urticaria / Rapid / Incidence not known
rash / Early / Incidence not known

Common Brand Names

KLAYESTA, Mycostatin, Nyamyc, Nyata, Nystex, Nystop, Pedi-Dri, Pediaderm AF

Dea Class

Rx

Description

Oral and topical, polyene antifungal
Used for the treatment of oropharyngeal, gastrointestinal, cutaneous, and mucocutaneous candidiasis
Fungistatic and fungicidal activity against a wide variety of yeast and yeast-like fungi

Dosage And Indications
For the treatment of candidiasis, including gastrointestinal candidiasis and cutaneous and mucocutaneous candidiasis, including candidal diaper dermatitis. For the treatment of gastrointestinal candidiasis. Oral dosage (tablets) Adults

500,000 to 1,000,000 units PO 3 times daily for at least 48 hours after clinical cure to prevent relapse.

For the treatment of cutaneous and mucocutaneous candidiasis, including candidal diaper dermatitis. Topical dosage (cream or ointment) Adults

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.

Neonates

Apply liberally to the affected skin area(s) twice daily until healing is complete.

Topical dosage (powder) Adults

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, and 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.

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.

For the treatment of oropharyngeal candidiasis (thrush). Oral dosage (suspension) Adults

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.

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.

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.

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.

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.

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.

†Indicates off-label use

Dosing Considerations
Hepatic Impairment

Specific dosing recommendations in persons with hepatic impairment are not available; it appears no dosage adjustment is needed.

Renal Impairment

Specific dosing recommendations in persons with renal impairment are not available; it appears no dosage adjustment is 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

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
Adults

3 million units/day PO; 2 applications/day topically for cream or ointment; 2 to 3 applications/day topically for powder.

Geriatric

3 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.

Children

2.4 million 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.

Neonates

Neonates: 800,000 units/day PO; 2 applications/day topically for cream or ointment; 2 to 3 applications/day topically for powder.
Premature Neonates: 400,000 units/day PO; safety and efficacy have not been established for topical cream, ointment, or powder.

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

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.

Pregnancy And Lactation
Pregnancy

Use nystatin during pregnancy only if the potential benefit to the mother outweighs the potential risk to the fetus. It is not known whether nystatin can cause fetal harm when used during pregnancy or can affect reproductive capacity. Animal reproduction studies have not been conducted with nystatin. However, gastrointestinal absorption of oral nystatin is insignificant. Topical nystatin products are not absorbed from intact skin or mucous membranes.

Use nystatin with caution during breast-feeding. It is unknown whether nystatin is excreted in human milk. However, gastrointestinal absorption of oral nystatin is insignificant. Topical nystatin products are not absorbed from intact skin or mucous membranes.