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Prof. Dr. Mustafa Özdoğan · Medical Oncologist

What Is Mikostatin (Nystatin), and Why Is It Used in Cancer Patients?

What Is Mikostatin (Nystatin), and Why Is It Used in Cancer Patients?
In this article

Quick Summary

  • Mikostatincontains nystatin , a polyeneantifungal that binds to ergosterol and forms pores in the fungal cell membrane. It acts mainly against Candida species. Systemic absorption is negligible with oral/topical use.
  • In oncology, it is used particularly for chemotherapy/radiotherapy-related oral candidiasis (thrush), providing treatment and local control; it is among the topical antifungal options in supportive care.
  • Turkey: The product is licensed to a domestic company and supplied as a 100,000 IU/ml oral suspension. It is covered by SGK reimbursement.
  • ADME: Following oral administration, absorption is negligible; there is no substantial systemic distribution/biotransformation; fecal excretion (mostly unchanged).
  • Side Effects: Generally well tolerated; rarely nausea, diarrhea, rash or hypersensitivity; very rarely severe skin reactions. Consider sugar and paraben content.

 What Is Mikostatin?

Mikostatinis supplied with a dropper and contains, in every 1 mL, 100,000 units of nystatin . It is licensed for Candida infections of the mouth and gastrointestinal tract, for both prevention and treatment , as an oral suspension. Indications include oral, esophageal and intestinal candidiasis.

Mechanism of Action 

1️⃣ Action at the Cell Membrane

Nystatin binds to the sterol ergosterol in the fungal cell membrane, causing pores to form. Intracellular electrolytes then leak out and the fungal cell dies.

2️⃣ Local Action, No Systemic Absorption

The oral suspension acts locally on the oral mucosa and is not absorbed into the systemic circulation. This allows safe use in cancer patients without burdening the kidneys or liver.

  • Rapid Symptom Relief: Oral burning, white plaques and taste changes rapidly improve.
  • Low Resistance Development: Candida resistance to nystatin is less common than resistance to other antifungals.
  • Compatible with Combination Treatments: Can be safely used alongside chemotherapy, antibiotics or radiotherapy.

Why Is It Used in Cancer Patients? 

In cancer patients, chemotherapy, radiotherapy or corticosteroids can cause immunosuppression, making fungal colonization of the oral flora common. Mikostatin has an important role in both treatment and prophylaxis (prevention) in this setting.

  • Immunosuppression: In patients with neutropenia and mucositis (https://www.drozdogan.com/agiz-yaralari/), Candida albicans proliferates. Mikostatin provides local control.
  • Chemotherapy-Induced Mucositis: Reduces secondary fungal infection risk in damaged mucosa.
  • After Radiotherapy: Prevents fungal infections caused by dry mouth and pH changes in patients receiving head-and-neck irradiation.
  • Long-Term Antibiotic Use: Disrupts oral flora balance; Mikostatin helps restore it.

Turkish Licensing, Manufacturer and SGK Reimbursement

Product Name: 100,000 IU/ml oral suspension (dropper bottle)

Active Ingredient: Nystatin

Marketing Authorization Holder: Deva Holding A.Ş.

Indication: Prevention and treatment of oral/esophageal/intestinal candidiasis

SGK: Covered by reimbursement.

Price: 132.81 TL. 

 Administration and Dosage

  • General Principle: Divide doses evenly throughout the day; continue for at least 48 hours after symptoms disappear.
  • Adult Oral Candidiasis: Approximately 1 mL of suspension, 4 times daily; maximize contact with affected areas by holding it in the mouth before swallowing.
  • Children/Infants: Approximately 1 mL, 4 times daily; for neonatal prophylaxis, 1 mL 1 time daily.
  • Administration: Shake the bottle; measure with the dropper; if possible, keep in the mouth for several minutes before swallowing.
  • Special Populations: No specific dosing data for kidney/liver impairment (systemic absorption is low).
  • Esophageal/Gastrointestinal Involvement: Systemic azoles are more effective in most cases; consult infectious diseases for refractory or deep involvement.

 Absorption, Distribution, Metabolism and Excretion

Parameter Summary
Absorption Systemic absorption from oral/topical formulations is negligible; action is local.
Distribution No substantial tissue distribution is expected because there is no meaningful systemic exposure.
Metabolism No major metabolic pathway has been described because systemic exposure is low.
Excretion The swallowed portion is excreted mostly unchanged in feces.

 Side Effect Profile and Safety

  • General Tolerability is good; rare nausea, gastrointestinal discomfort or diarrhea; infrequent urticaria/rash; very rare severe skin reactions.
  • Pregnancy/Breastfeeding: Category C; avoid unless necessary. A benefit–risk assessment is required despite low systemic absorption.
  • Important Warning: Nystatin oral/topical formulations must not be used for systemic fungal infections .
  • Excipients: Formulations may contain sucrose, small amounts of ethanol and methyl/propylparaben → use caution with fructose intolerance/sucrase-isomaltase deficiency, hyperglycemia/tooth decay risk or paraben allergy.
  • Drug Interactions: Clinically significant interactions are not expected because systemic absorption is low.

 Special Situations Requiring Attention

  • Severe immunosuppression or recurrent/refractory oral candidiasis warrants consideration of systemic treatment (e.g. fluconazole); seek infectious diseases advice for esophageal/deep tissue involvement.
  • Sugar/Paraben Content: Use caution in diabetes, children and patients with an allergy history.
  • Denture Stomatitis: Prolong drug contact with denture-bearing areas; optimize denture hygiene.
  • Dry Mouth (Xerostomia): Lozenges may be unsuitable in severe xerostomia; suspension is preferred.

Importance in Oncology Practice

During chemotherapy/radiotherapy with damaged mucosa, oral candidiasis increases morbidity through pain, altered taste, eating difficulties and poor treatment adherence. Topical Mikostatin may help control symptoms; prophylaxis depends on the protocol and risk level. Topical antifungals are supported in suitable cases; severe spread primarily requires systemic treatment.

 Practical Administration Tips

  1. Holding in the Mouth: Prolonged contact between the suspension and lesions before swallowing improves efficacy.
  2. The 48-Hour Rule: Continue for at least 48 hours after symptoms disappear.
  3. Resistance/Inadequate Response: If symptoms have not improved within 14 days, consider alternatives such as fluconazole; obtain cultures/susceptibility tests if needed.
  4. Hygiene and Care: Combine with denture cleaning and gentle oral care; avoid irritating solutions.

📚 References 

  1. Mikostatin (Nistatin) 100.000 IU/mL Oral Süspansiyon — Summary of Product Characteristics and Patient Information Leaflet, Turkish versions.
  2. Nystatin drug monographs — pharmacodynamic and pharmacokinetic summaries in standard reference databases.
  3. NIH safety reviews — safety profiles of nystatin and related antifungals.
  4. MASCC/ISOO oral care and oral infection management guidelines and clinical practice statements (2014, 2020, 2024 updates).
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