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Nystatin (topical): Drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Klayesta;
  • Nyamyc;
  • Nystop
Pharmacologic Category
  • Antifungal Agent, Topical
Dosing: Adult
Fungal infections

Fungal infections (cutaneous and mucocutaneous): Topical: Note: Cream is usually preferred to ointment for intertriginous areas; very moist lesions are best treated with topical powder.

Cream, ointment: Apply to the affected areas twice daily or as indicated until healing is complete.

Powder: Apply to the affected areas 2 to 3 times daily until healing is complete.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling. However, dosage adjustment unlikely due to low systemic absorption

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

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

Diaper dermatitis, candidal

Diaper dermatitis, candidal: Limited data available: Infants: Ointment, cream: Topical: Apply 2 to 4 times daily to affected area; most studies have used 4 times daily dosing (Ref).

Mucocutaneous candidal infection

Mucocutaneous candidal infection: Infants, Children, and Adolescents:

Manufacturer's labeling:

Cream/ointment: Topical: Apply to affected area twice daily

Powder: Topical: Apply to affected area 2 to 3 times daily

Alternate dosing: Limited data available: Cream, ointment, powder: Topical: Apply to affected area 2 to 4 times daily (Ref).

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.

Adverse Reactions

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

Frequency not defined: Dermatologic: Contact dermatitis, Stevens-Johnson syndrome

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

Contraindications

Hypersensitivity to nystatin or any component of the formulation

Warnings/Precautions

Concerns related to adverse effects:

• Hypersensitivity: May occur; immediately discontinue if signs of a hypersensitivity reaction occur.

• Irritation: Discontinue if irritation occurs.

Other warnings/precautions:

• Appropriate use: For topical external use only; not for systemic, oral, intravaginal, or ophthalmic use.

Warnings: Additional Pediatric Considerations

Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP, 1997; Shehab, 2009).

Dosage Forms: US

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

Cream, External:

Generic: 100,000 units/g (15 g, 30 g)

Ointment, External:

Generic: 100,000 units/g (15 g, 30 g)

Powder, External:

Klayesta: 100,000 units/g (15 g, 30 g, 60 g)

Nyamyc: 100,000 units/g (15 g, 30 g, 60 g)

Nystop: 100,000 units/g (15 g, 30 g, 60 g)

Generic: 100,000 units/g (15 g, 30 g, 60 g)

Generic Equivalent Available: US

Yes

Pricing: US

Cream (Nystatin External)

100000 units/g (per gram): $1.17

Ointment (Nystatin External)

100000 units/g (per gram): $1.12 - $1.17

Powder (Klayesta External)

100000 units/g (per gram): $1.67

Powder (Nyamyc External)

100000 units/g (per gram): $2.44

Powder (Nystatin External)

100000 units/g (per gram): $0.96 - $1.67

Powder (Nystop External)

100000 units/g (per gram): $1.79

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.

Administration: Adult

For topical external use only; not for systemic, oral, intravaginal, or ophthalmic use. Apply liberally to clean/dry skin. For fungal infection of the feet, the powder should be dusted in all footwear (in addition to application to the feet).

Administration: Pediatric

For topical use only.

Cream or ointment: Gently massage formulation into the skin.

Powder: Dust in shoes, in stockings, and on feet for treatment of candidal infection of the feet; also used on very moist lesions

Use: Labeled Indications

Fungal infections (cutaneous and mucocutaneous): Treatment of cutaneous and mucocutaneous fungal infections caused by Candida albicans and other susceptible Candida species.

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.

Progesterone: Antifungal Agents (Vaginal) may diminish the therapeutic effect of Progesterone. Risk X: Avoid combination

Pregnancy Considerations

Animal reproduction studies have not been conducted. Absorption following oral use is poor and nystatin is not absorbed following application to mucous membranes or intact skin.

Breastfeeding Considerations

It is not known if nystatin is excreted in breast milk; however, absorption following oral use is poor and nystatin is not absorbed following application to mucous membranes or intact skin. The manufacturer recommends that caution be exercised when administering nystatin to nursing women.

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: None through mucous membranes or intact skin

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

  • (AE) United Arab Emirates: Mikostat | Mycostatin | Nilstat;
  • (AR) Argentina: Candermil | Micostatin | Micostyl | Neostatin | Nistat | Nistatina | Nistatina denver farma | Nistatina lafedar | Nistatina sintesina;
  • (AT) Austria: Candio hermal | Mycostatin | Nystaderm;
  • (AU) Australia: Mycostatin | Nilstat;
  • (BD) Bangladesh: Costatin | Nystat | Nystin;
  • (BE) Belgium: Nilstat | Nystatine;
  • (BG) Bulgaria: Nystatin abr;
  • (BR) Brazil: Aftoderm | Albistin | Candistatin | Canditrat | Furp nistatina | Kandistat | Kolpazol | Miconastin | Micostal | Micostalab | Micostatin | Neo mistatin | Neostatin | Nicostat | Nidazolin | Nistagyn | Nistatec | Nistatin | Nistatina | Nistaval | Nistax | Nistomic | Nistrazin | Sifnistina | Tricocet | Vagistatina;
  • (CH) Switzerland: Mycostatin;
  • (CL) Chile: Micostatin | Nistatina;
  • (CO) Colombia: Micostatin | Nistatina | Nistavon | Tisat;
  • (CZ) Czech Republic: Fungicidin;
  • (DE) Germany: Adiclair | Biofanal | Candio hermal | Cordes nystatin | Fungireduct | Lederlind | Moronal | Mykoderm | Mykundex | Nystaderm | Nystapaed | Nystatin acis | Nystatin holsten;
  • (DO) Dominican Republic: Candistatin | Karynistin | Micostatin | Nistan | Nistatina;
  • (EC) Ecuador: Micostatin;
  • (EE) Estonia: Adiclair;
  • (EG) Egypt: Mycostatin;
  • (ES) Spain: Mycostatin;
  • (FI) Finland: Mycostatin | Stereomycin;
  • (FR) France: Mycostatine;
  • (GB) United Kingdom: Nystan | Nystatin dome;
  • (GR) Greece: Mycostatin | Nystamysyn;
  • (HK) Hong Kong: Mycostatin | Nyderma;
  • (HR) Croatia: Nistatin Pliva;
  • (ID) Indonesia: Mycostatin | Nistina;
  • (IE) Ireland: Mycostatin | Nystaderm;
  • (IL) Israel: Mycostatin;
  • (IN) India: Mycostatin | Nistin;
  • (IQ) Iraq: Mycodad | Mycodin;
  • (IT) Italy: Mycostatin;
  • (JO) Jordan: Mycophil | Mycostatin;
  • (JP) Japan: Mycostatin;
  • (KE) Kenya: Nelstat | Nycostat;
  • (KR) Korea, Republic of: Mycostatin | Stadin;
  • (KW) Kuwait: Mikostat | Mycostatin;
  • (LB) Lebanon: Mycostatin;
  • (LT) Lithuania: Fungicidin;
  • (LU) Luxembourg: Candio hermal | Nilstat | Nystatine;
  • (LV) Latvia: Adiclair | Fungicidin | Nystatin acis;
  • (MA) Morocco: Mycostatine;
  • (MX) Mexico: Micostatin | Micostatin v | Nistaquim;
  • (MY) Malaysia: Candistatin | Mycostatin | Uphastatin;
  • (NG) Nigeria: Linkabs nystatin;
  • (NL) Netherlands: Nystatine | Nystatine labaz;
  • (NO) Norway: Mycostatin | Nystatin acis;
  • (NZ) New Zealand: Mycostatin | Nilstat;
  • (PE) Peru: Fungofen | Fungostatin | Micostatin | Nistatina;
  • (PH) Philippines: Mycostatin;
  • (PK) Pakistan: Nilstat;
  • (PL) Poland: Fungicidin | Nystatyna;
  • (PR) Puerto Rico: Mycostatin | Nilstat | Nystex | Nystop | Pedi-Dri | Pediaderm AF;
  • (PT) Portugal: Mycostatin;
  • (QA) Qatar: Rianest;
  • (SA) Saudi Arabia: Mikostat | Mycostat | Mycostatin | Rianest;
  • (SE) Sweden: Mycostatin;
  • (SG) Singapore: Candistatin;
  • (SI) Slovenia: Nistatin;
  • (SK) Slovakia: Fungicidin;
  • (TH) Thailand: Mycostatin;
  • (TR) Turkey: Mikostatin;
  • (TW) Taiwan: Mycostatin | Mycostatin Baby | Nadostine;
  • (UG) Uganda: Candistatin;
  • (UY) Uruguay: Micostatin;
  • (VE) Venezuela, Bolivarian Republic of: Micostatin | Nistatina | Romalina;
  • (ZA) South Africa: Canstat | Mycostatin | Nystacid;
  • (ZM) Zambia: Neovag;
  • (ZW) Zimbabwe: Nystacid
  1. American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. [PubMed 9024461]
  2. Bradley JS, Nelson JD, Cantery JB, et al, eds. Nelson's Pediatric Microbial Therapy. 21st ed. American Academy of Pediatrics; 2015.
  3. Hoppe JE, "Treatment of Oropharyngeal Candidiasis and Candidal Diaper Dermatitis in Neonates and Infants: Review and Reappraisal," Pediatr Infect Dis J, 1997, 16(9):885-94. [PubMed 9306485]
  4. Munz D, Powell KR, Pai CH. Treatment of candidal diaper dermatitis: a double-blind placebo-controlled comparison of topical nystatin with topical plus oral nystatin. J Pediatr. 1982;101(6):1022-1025. [PubMed 6754898]
  5. Nyamyc (nystatin) [prescribing information]. Maple Grove, MN: Upsher-Smith Laboratories; June 2020.
  6. Nystatin Cream USP [prescribing information]. Levittown, PA: Torrent Pharma Inc; October 2021.
  7. Nystatin Ointment USP [prescribing information]. Princeton, NJ: Macleods Pharma USA Inc; February 2021.
  8. Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]
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