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Nystatin (oral): Drug information

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

For abbreviations, symbols, and age group definitions 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.

Peritonitis, secondary prevention

Peritonitis, secondary prevention (peritoneal dialysis):

Note: To prevent development of fungal peritonitis in patients on peritoneal dialysis who require antibiotics (Ref).

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

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: Oral: No dosage adjustment necessary for any degree of kidney impairment (limited systemic absorption) (Ref).

Hemodialysis, intermittent (thrice weekly): Oral: No supplemental dose or dosage adjustment necessary (Ref).

Peritoneal dialysis: Oral: No dosage adjustment necessary (Ref).

CRRT: Oral: No dosage adjustment necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration): Oral: No dosage adjustment necessary (Ref).

Dosing: Liver 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: Liver Impairment: Pediatric

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

Adverse Reactions

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

Postmarketing:

Cardiovascular: Tachycardia

Dermatologic: Acute generalized exanthematous pustulosis (Ocerin-Guerra 2012), skin rash (Sahu 2019), Stevens-Johnson syndrome, urticaria

Gastrointestinal: Diarrhea (including bloody diarrhea), gastrointestinal distress, nausea, oral irritation, vomiting

Hypersensitivity: Facial swelling, hypersensitivity reaction (oral sensitization)

Neuromuscular & skeletal: Myalgia

Respiratory: Bronchospasm

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): $0.29 - $22.90

Tablets (Nystatin Oral)

500000 unit (per each): $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

Peritonitis, secondary prevention (peritoneal dialysis)

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 drug interactions program by clicking on the “Launch drug interactions program” link above.

Saccharomyces boulardii: Antifungal Agents (Systemic and Oral [Non-Absorbable]) may decrease therapeutic effects of Saccharomyces boulardii. Risk X: Avoid

Pregnancy Considerations

Animal reproduction studies have not been conducted. Outcome data following maternal use of oral nystatin during pregnancy are available (Czeizel 2003; Heinonen 1977; Mayrogenis 2014). Absorption following oral use is poor.

Local topical treatment of oropharyngeal candidiasis is preferred during pregnancy (HHS [OI adult 2024]).

Breastfeeding Considerations

The presence of nystatin in 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: Multilind | 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 | Nystatin stada;
  • (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 | Nystamysyn/farmasyn;
  • (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 biomep | Nistatina brissa | Nistatina bruluagsa | Nistatina GI | Nistatina Iqfa | Nizin v | Parastina;
  • (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 | Niosta | Rianest;
  • (SA) Saudi Arabia: Mikostat | Mycosat | Mycostatin | Rianest | Sinaten;
  • (SE) Sweden: Mycostatin | Nystafox | Nystatin abacus medicine | Nystatin orifarm | Nystimex;
  • (SG) Singapore: Candistatin;
  • (SI) Slovenia: Mycostatin | Nistatin;
  • (SK) Slovakia: Fungicidin;
  • (SL) Sierra Leone: Nyska;
  • (SR) Suriname: Mycostatin | Nystatine | Nystatine labaz;
  • (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: Dawastin | 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: Cantidan | Nystatab;
  • (ZA) South Africa: Candacide | Canstat | Mycostatin | Nystacid;
  • (ZM) Zambia: Fungistin | Neovag | Nystaleb;
  • (ZW) Zimbabwe: Nystatin dome
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