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Nystatin (oral): Drug information

Nystatin (oral): Drug information
(For additional information see "Nystatin (oral): Patient drug information" and see "Nystatin (oral): Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: Canada
  • JAMP-Nystatin;
  • PMS-Nystatin;
  • TEVA-Nystatin
Pharmacologic Category
  • Antifungal Agent, Oral Nonabsorbed/Partially Absorbed
Dosing: Adult
Candidiasis, oropharyngeal, mild disease

Candidiasis, oropharyngeal, mild disease (alternative agent): Oral: Suspension (swish and swallow): 400,000 to 600,000 units 4 times daily; swish in the mouth and retain for as long as possible (several minutes) before swallowing. Duration is for 7 to 14 days (Ref).

Note: Powder for compounding: 1/8 teaspoon (500,000 units) to equal approximately 1/2 cup of water; give 4 times/day.

Peritoneal dialysis-associated infection, prevention of secondary fungal infection

Peritoneal dialysis-associated infection (concurrently treated with antibacterials), prevention of secondary fungal infection: Oral: 500,000 units 3 or 4 times daily for the duration of antibacterial therapy; may extend nystatin duration for an additional 3 days after the last dose of an aminoglycoside or an additional 7 days after the last dose of vancomycin (Ref).

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Nystatin (oral): Pediatric drug information")

Candidiasis, oropharyngeal, treatment

Candidiasis, oropharyngeal (mild), treatment: Note: Treat for 7 to 14 days (Ref).

Infants: Oral suspension: Oral: 200,000 units 4 times daily; administer half of dose to each side of mouth (Ref).

Children and Adolescents: Oral suspension: Oral: 400,000 to 600,000 units 4 times daily; administer half of dose to each side of mouth; swish and retain in the mouth for as long as possible before swallowing (Ref).

Peritonitis, prophylaxis for high-risk situations

Peritonitis (peritoneal dialysis), prophylaxis for high-risk situations (eg, during antibiotic therapy or percutaneous endoscopic gastrostomy [PEG] placement): Infants, Children, and Adolescents: Oral suspension: Oral: 10,000 units/kg/dose once daily (Ref).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

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

<1%, postmarketing, and/or case reports: Hypersensitivity reaction

Contraindications

Hypersensitivity to nystatin or any component of the formulation

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Suspension, Mouth/Throat:

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

Tablet, Oral:

Generic: 500,000 units

Generic Equivalent Available: US

Yes

Pricing: US

Suspension (Nystatin Mouth/Throat)

100000 units/mL (per mL): $0.20 - $1.01

Tablets (Nystatin Oral)

500000 unit (per each): $1.31 - $1.42

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Suspension, Mouth/Throat:

Generic: 100,000 units/mL (5 mL, 24 mL, 48 mL, 100 mL, 500 mL, 1000 mL)

Administration: Adult

Oral: Suspension: Shake well before using. For treatment of oropharyngeal candidiasis, should be swished about the mouth and retained in the mouth for as long as possible (several minutes) before swallowing.

Administration: Pediatric

Oral: Suspension: Shake suspension well before use.

Oropharyngeal candidiasis treatment: Swish suspension about the mouth and retain in the mouth for as long as possible (several minutes) before swallowing. For neonates and infants, paint nystatin suspension into recesses of the mouth. To allow adequate contact time with site of infection, it is recommended to avoid feedings for 5 to 10 minutes following administration or to administer after meals (Ref).

Use: Labeled Indications

Treatment of candidiasis in the oral cavity.

Use: Off-Label: Adult

Peritoneal dialysis-associated infection (concurrently treated with antibacterials), prevention of secondary fungal infection

Medication Safety Issues
Sound-alike/look-alike issues:

Nystatin may be confused with HMG-CoA reductase inhibitors (also known as "statins"; eg, atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, simvastatin), Nitrostat.

Metabolism/Transport Effects

None known.

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may diminish the therapeutic effect of Saccharomyces boulardii. Risk X: Avoid combination

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.

Breastfeeding Considerations

Excretion into breast milk is not known; however, absorption following oral use is poor.

Mechanism of Action

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

Pharmacokinetics (Adult Data Unless Noted)

Onset of action: Symptomatic relief from candidiasis: 24 to 72 hours.

Absorption: Poorly absorbed.

Excretion: Feces (as unchanged drug).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Candistatin | Mikostat | Mycosat | Mycostatin | Nilstat | Rianest;
  • (AR) Argentina: Candermil | Dipni | Micostatin | Micostyl | Nistagrand | Nistat | Nistatina | Nistatina denver farma | Nistatina lafedar | Nistatina sintesina;
  • (AT) Austria: Mycostatin;
  • (AU) Australia: Mycostatin | Nilstat;
  • (BD) Bangladesh: Candex | Canstat | Costatin | Enystin | Fefun | Fungistin | Mycocin | Mycostatin | Naf | Nistatin | Nycotin | Nysol | Nyst | Nystanon | Nystat | Nystin | Ornys | Restin;
  • (BE) Belgium: Nilstat | Nystatine;
  • (BF) Burkina Faso: Nystatine;
  • (BG) Bulgaria: Fungostatin;
  • (BR) Brazil: Aftoderm | Albistin | Candistatin | Canditrat | Copazol | Fungistatina | Kolpazol | Micostal | Micostalab | Micostatin | Neo mistatin | Neostatin | Nicostat | Nidazolin | Nistamax | Nistatina | Nistaval | Nistax | Sifnistina | Tricocet | Vagistatina;
  • (CH) Switzerland: Mycostatin;
  • (CI) Côte d'Ivoire: Nystasha;
  • (CL) Chile: Micostatin | Nistatina | Nistoral;
  • (CN) China: Mycostatin | Nysfungin | Nystatin co.;
  • (CO) Colombia: Hongistina | Micostatin | Nistafar | Nistapen | Nistatina | Nistavon | Normafem | Tain;
  • (DE) Germany: Adiclair | Biofanal | Candida lokalicid | Candio hermal | Moronal | Mykundex | Nystaderm | Nystatin acis;
  • (DO) Dominican Republic: Acronistina | Alfanisten | Ameristina | Candistatin | Fratina | Karynistin | Micostatin | Nistatina;
  • (EC) Ecuador: Acronistina | Micostatin | Nistat | Nistatina;
  • (EE) Estonia: Biofanal | Nystatin holsten;
  • (EG) Egypt: Antimycot | Fungistatin | Mycostatin | Orastatin;
  • (ES) Spain: Mycostatin;
  • (ET) Ethiopia: Nystaleb;
  • (FI) Finland: Mycostatin | Nystacid | Nystatin orifarm | Nystimex | Stereomycin;
  • (FR) France: Mycostatine;
  • (GB) United Kingdom: Infestat | Nystamont | Nystan | Nystatin dome | Nystatin kent | Nystatin sandoz;
  • (GR) Greece: Mycostatin | Nystamont | Nystamysyn;
  • (HK) Hong Kong: Christatin | Lystin | Mycostatin | Nystacid | Nystates | Nystatets | Pms-nystatin | Saturcon | Statin;
  • (ID) Indonesia: Candigal | Constantia | Fungatin | Kandistatin | Mycostatin | Nymiko | Nyndia | Nystin;
  • (IE) Ireland: Mycostatin;
  • (IL) Israel: Mycostatin | Nystatin ready mix;
  • (IN) India: Alstatin | Mycostatin;
  • (IQ) Iraq: Jastateen | Kindistatin | Nystadad | Nystarx | Nystatin j | Nystatin mdi;
  • (IT) Italy: Mycostatin;
  • (JO) Jordan: Mycophil | Mycosat | Mycostatin | Rianest;
  • (JP) Japan: Mycostatin | Nystatin meiji;
  • (KE) Kenya: Femin p | Fungistin | Gynostat | Labstatin | Nycodeal | Nycostat | Nystalite | Ristatin;
  • (KR) Korea, Republic of: Candacin | Mycostatin | Stadin;
  • (KW) Kuwait: Mikostat | Mycostatin | Rianest;
  • (LB) Lebanon: Medistan | Mycophil | Mycostatin | Rivostatin;
  • (LT) Lithuania: Adiclair | Fungicidin;
  • (LU) Luxembourg: Candio hermal | Nilstat | Nystatine;
  • (LV) Latvia: Fungicidin | Nystaderm | Nystatin acis | Nystatin actavis | Nystatin stada;
  • (MA) Morocco: Mycostatine;
  • (MX) Mexico: Aponistan | Bistatin f | Bistatin v | Mersatin v | Mibesan s | Micostatin | Nistan v | Nistaquim | Nistatina | Nistatina bayer | Nistatina biomep | Nistatina brissa | Nistatina bruluagsa | Nistatina GI | Nistatina Iqfa | Nizin v | Parastina | Zinagen;
  • (MY) Malaysia: Candistatin | Mikostat | Mycostatin | Tystatin;
  • (NG) Nigeria: Biomestatine | Donystatin | Emek jiors nystatin | Jimstatin | Kenstatin | Krishat nystatin | Trust time nystatin;
  • (NL) Netherlands: Nystatine | Nystatine bmodesto | Nystatine eureco pharma | Nystatine labaz | Nystatine rph;
  • (NO) Norway: Biofanal | Mycostatin | Nystatin orifarm | Nystatin stada | Nystimex;
  • (NZ) New Zealand: M nystatin | Mycostatin | Nilstat;
  • (PE) Peru: Fungostatin | Gynostatin | Micoflam | Micostatin | Nistatina;
  • (PH) Philippines: Afunginal | Fungistat | Maicostat | Mycostatin | Mycosyl | Mystin | Nocan | Nysaph | Nyst | Nyszac | Orastin | Stanys;
  • (PK) Pakistan: Myconil | Nilstat;
  • (PL) Poland: Fungicidin | Nyscandin | Nystapol | Nystatin tzf | Nystatina | Nystatyna | Nystvagin;
  • (PR) Puerto Rico: Mycostatin | Nilstat | Nystex;
  • (PT) Portugal: Mycostatin;
  • (PY) Paraguay: Micad | Nista t;
  • (QA) Qatar: Mycosat | Rianest;
  • (SA) Saudi Arabia: Mikostat | Mycosat | Mycostatin | Rianest | Sinaten;
  • (SE) Sweden: Mycostatin | Nystatin orifarm | Nystimex;
  • (SG) Singapore: Candistatin;
  • (SI) Slovenia: Mycostatin | Nistatin;
  • (SK) Slovakia: Fungicidin;
  • (SL) Sierra Leone: Nyska;
  • (SV) El Salvador: Candiprin;
  • (TH) Thailand: Gynetin | Gynova | Lystin | Mycostatin | Mycotin | Nagena | Nystin | Tystatin | Vagena;
  • (TN) Tunisia: Mikostat | Mycostatine | Nystatine;
  • (TR) Turkey: Fungostatin | Mikostatin | Niosta | Nistatin;
  • (TW) Taiwan: Marnycin | Mycocide | Mycostatin | Nadostine | Sanitatin | Scanytin | Statin;
  • (UA) Ukraine: Nystatin zdorovje;
  • (UG) Uganda: Femin p | Fungistin | Labstatin | Mycoren | Nycostat | Nyska p | Nystago | Nystaleb | Nytin;
  • (UY) Uruguay: Micostatin | Nistat;
  • (VE) Venezuela, Bolivarian Republic of: Micostatin | Nistat | Nistatina | Romalina;
  • (VN) Viet Nam: Nystatab;
  • (ZA) South Africa: Candacide | Canstat | Mycostatin | Nystacid;
  • (ZM) Zambia: Fungistin | Neovag | Nystaleb;
  • (ZW) Zimbabwe: Nystatin dome
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  13. Nystatin oral suspension [prescribing information]. Greenville, SC: PAI Pharmaceutical Associates Inc; January 2020.
  14. Nystatin oral suspension [prescribing information]. Philadelphia, PA: Lannett Company, Inc; September 2019.
  15. Nystatin tablets [prescribing information]. East Brunswick, NJ: Avet Pharmaceuticals Inc; June 2020.
  16. Nystatin tablets [prescribing information]. North Wales, PA: Teva Pharmaceuticals USA Inc; February 2016.
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  18. Refer to manufacturer's labeling.
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