Nystatin Evolan
Antifungal oral suspension for oral and intestinal candidiasis
Quick Facts About Nystatin Evolan
Key Takeaways
- Acts locally, not systemically: Nystatin is not absorbed into the bloodstream, which gives it an excellent safety profile with minimal risk of systemic side effects
- Safe for all ages: Can be used in newborns, infants, children, and adults, making it a first-line treatment for oral and intestinal candidiasis across all age groups
- Swish and swallow technique: For oral thrush, hold the suspension in the mouth as long as possible before swallowing to maximize contact time with the infection
- Continue after symptom resolution: Treatment should be continued for 2–3 days after all signs of infection have disappeared to prevent relapse
- Special storage requirements: Unopened bottles must be refrigerated; opened bottles can be stored at room temperature for up to 2 months
What Is Nystatin Evolan and What Is It Used For?
Nystatin Evolan is a polyene antifungal oral suspension containing nystatin (100,000 IU/ml) used to treat fungal infections caused by Candida species in the mouth (oral thrush) and intestines. It acts locally on mucous membranes and is not absorbed into the body.
Nystatin belongs to the polyene class of antifungal medications, one of the oldest and most well-established groups of antifungal drugs. It was first isolated from Streptomyces noursei in 1950 and has been in clinical use for over seven decades. Despite the development of newer antifungal agents, nystatin remains a cornerstone treatment for superficial candidal infections due to its excellent safety profile and targeted local action.
The medicine works by binding to ergosterol, a key component of fungal cell membranes. This binding creates pores in the membrane, causing essential cellular contents to leak out, ultimately leading to fungal cell death. Because human cell membranes contain cholesterol rather than ergosterol, nystatin has a high degree of selectivity for fungal cells over human cells, contributing to its favorable safety profile.
Nystatin Evolan oral suspension is primarily prescribed for two conditions:
- Oral candidiasis (thrush): A fungal infection of the mouth and throat characterized by white, creamy patches on the tongue, inner cheeks, and sometimes the roof of the mouth, gums, and tonsils. It is particularly common in infants, elderly patients, those wearing dentures, people with weakened immune systems, and patients using inhaled corticosteroids.
- Intestinal candidiasis: A fungal overgrowth in the gastrointestinal tract that can cause symptoms such as bloating, abdominal discomfort, diarrhea, and changes in stool consistency. It may occur following antibiotic therapy that disrupts the normal gut flora.
Because nystatin is not absorbed from the gastrointestinal tract, it only works on infections at the site of contact. It is not effective for systemic (bloodstream) fungal infections. For systemic candidiasis, other antifungal medications such as fluconazole or amphotericin B are required.
How does Nystatin Evolan work?
Nystatin exerts its antifungal effect through a direct interaction with the fungal cell membrane. The drug molecule binds specifically to ergosterol, the principal sterol in fungal cell membranes (analogous to cholesterol in human cells). This binding creates transmembrane channels or pores that disrupt the selective permeability of the membrane. As a result, essential intracellular ions such as potassium, as well as sugars and amino acids, leak out of the fungal cell. This loss of cellular contents leads to irreversible cell damage and death.
The selectivity of nystatin for ergosterol over cholesterol means it preferentially targets fungal cells while leaving human cells largely unaffected. However, at very high concentrations, some interaction with cholesterol can occur, which is why systemic use of nystatin is associated with toxicity. Since the oral suspension acts only locally and is not absorbed, this systemic toxicity is not a concern with Nystatin Evolan.
Nystatin is effective against a broad range of Candida species, including Candida albicans (the most common cause of oral thrush), Candida glabrata, Candida tropicalis, and Candida krusei. Clinically significant resistance to nystatin is rare, which is one reason it has remained effective for over 70 years of clinical use.
What Should You Know Before Taking Nystatin Evolan?
Do not use Nystatin Evolan if you are allergic to nystatin or any of its excipients. The medicine contains methylparahydroxybenzoate (E218), which may cause allergic reactions in some people. Consult your doctor before use during pregnancy or breastfeeding.
Before starting treatment with Nystatin Evolan, it is important to understand the conditions under which the medicine should not be used, as well as any precautions that may apply. While nystatin is generally considered one of the safest antifungal medications due to its lack of systemic absorption, certain individuals may still need to exercise caution.
Contraindications
The only absolute contraindication for Nystatin Evolan is a known hypersensitivity (allergy) to nystatin or any of the other ingredients in the formulation. If you have previously experienced an allergic reaction to a nystatin-containing product, you should not use Nystatin Evolan. Allergic reactions to nystatin are rare but can include skin rash, itching, swelling, and in very rare cases, more severe reactions such as angioedema (swelling of the face and throat).
The excipients in Nystatin Evolan include xylitol, carmellose sodium, methylparahydroxybenzoate (E218), spearmint flavoring, and purified water. If you have a known allergy to any of these substances, particularly methylparahydroxybenzoate (a preservative also known as methylparaben), you should inform your doctor before starting treatment.
Warnings and Precautions
Speak with your doctor, pharmacist, or nurse before using Nystatin Evolan if you have any concerns about your medical condition. While nystatin is generally well tolerated, there are a few considerations to keep in mind:
- Methylparahydroxybenzoate (E218): This preservative can cause allergic reactions, which may sometimes be delayed. If you notice any signs of an allergic reaction such as skin rash, hives, or itching after starting treatment, stop using the medicine and contact your healthcare provider.
- Sodium content: Nystatin Evolan contains 0.5 mg sodium per ml of oral suspension. This is less than 23 mg per dose and is essentially sodium-free. Patients on strict sodium-restricted diets should be reassured that the sodium content is negligible.
- Persistent or recurrent infections: If your symptoms do not improve after the expected treatment period, or if they recur shortly after treatment ends, consult your doctor. Persistent oral thrush may be a sign of an underlying condition such as diabetes, immune deficiency, or nutritional deficiency that requires further investigation.
- Xylitol content: The oral suspension is sweetened with xylitol rather than sucrose, making it suitable for patients who need to avoid sugar. Xylitol does not promote dental caries.
Pregnancy and Breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before using Nystatin Evolan.
Pregnancy: While nystatin is not absorbed systemically and therefore has a very low theoretical risk to the developing fetus, you should only use this medicine during pregnancy if your doctor considers the benefit to outweigh any potential risk. Your doctor will make this assessment based on the severity of your infection and the stage of your pregnancy. International guidelines generally consider topical nystatin preparations to be compatible with pregnancy for the treatment of oral and intestinal candidiasis.
Breastfeeding: It is not known whether nystatin passes into breast milk. However, since nystatin is not absorbed from the gastrointestinal tract, systemic exposure is essentially nil, making it unlikely that clinically significant amounts would reach breast milk. Nevertheless, you should consult your doctor before using this medicine while breastfeeding. Nystatin is frequently used to treat oral thrush in nursing infants, which provides further reassurance about its safety profile.
Driving and Using Machines
Nystatin has no known effect on the ability to drive or operate machinery. You may continue your normal activities while using this medicine. You are, however, always responsible for assessing your own fitness to drive or perform tasks requiring concentration. If you experience any unexpected symptoms, discuss them with your doctor.
How Does Nystatin Evolan Interact with Other Drugs?
Nystatin Evolan has no known clinically significant drug interactions because it is not absorbed into the bloodstream. Tell your doctor about all medications you are taking, as this is always good practice for comprehensive medication management.
One of the major advantages of nystatin compared to many other antifungal medications is its excellent drug interaction profile. Because nystatin is not absorbed from the gastrointestinal tract and acts entirely locally, it does not enter the systemic circulation. This means it does not undergo hepatic metabolism and does not affect cytochrome P450 enzymes, which are the primary pathway through which most drug interactions occur.
In clinical practice, nystatin oral suspension can generally be used safely alongside virtually any other medication. This is particularly important for patients who are already taking multiple medications, such as elderly patients or those with chronic conditions, where the risk of drug interactions with systemically absorbed antifungals like fluconazole or itraconazole would be a significant concern.
| Drug Category | Interaction Risk | Clinical Significance | Recommendation |
|---|---|---|---|
| Antibiotics | None known | No systemic absorption | Safe to use together |
| Oral contraceptives | None known | No effect on absorption | Safe to use together |
| Immunosuppressants | None known | No enzyme inhibition | Safe to use together |
| Anticoagulants (e.g., warfarin) | None known | No hepatic metabolism | Safe to use together |
| Other antifungals (systemic) | None known | Different mechanisms | May be combined if indicated |
Despite the excellent safety profile, it is always good medical practice to inform your doctor or pharmacist about all medications you are currently taking, have recently taken, or plan to take. This includes prescription medicines, over-the-counter products, herbal remedies, and dietary supplements. While no interactions are expected with nystatin, a comprehensive medication review helps ensure optimal therapeutic outcomes.
Unlike fluconazole and itraconazole, which are absorbed systemically and can interact with many commonly used medications (including warfarin, certain statins, and immunosuppressants), nystatin's purely local action eliminates concerns about drug interactions. This makes it an ideal choice for patients on complex medication regimens.
What Is the Correct Dosage of Nystatin Evolan?
For oral thrush, the standard adult dose is 1 ml four times daily after meals, held in the mouth as long as possible before swallowing. For intestinal candidiasis, adults take 5 ml three times daily. Children and infants receive 1 ml four times daily for both conditions. Always follow your doctor's specific instructions.
The dosage of Nystatin Evolan depends on the type and location of the infection being treated. Your doctor or dentist will determine the appropriate dose and adjust it individually based on your condition. It is important to always shake the bottle well before each use, as the active ingredient may settle during storage.
Adults
Oral Candidiasis (Thrush) — Adults
Dose: 1 ml (100,000 IU) four times daily
Administration: Take after meals. Hold the suspension in your mouth as long as possible (ideally 1–2 minutes), swishing it around to cover all affected areas, then swallow. This “swish and swallow” technique maximizes the contact time between the medicine and the infected mucosal surfaces.
Intestinal Candidiasis — Adults
Dose: 5 ml (500,000 IU) three times daily
Administration: Swallow the suspension directly. Unlike oral thrush treatment, there is no need to hold the medicine in the mouth. The higher dose is necessary to achieve adequate concentrations throughout the gastrointestinal tract.
Children
Oral Candidiasis (Thrush) — Children, Infants, and Newborns
Dose: 1 ml (100,000 IU) four times daily
Age range: From birth (including newborns, infants from 1 month to 2 years, and children over 2 years)
Administration: Take after meals. Hold in the mouth as long as possible before swallowing. For infants and newborns, the suspension can be given drop by drop or diluted with a small amount of water and applied directly inside the mouth using a cotton swab or clean finger.
Intestinal Candidiasis — Children and Infants
Dose: 1 ml (100,000 IU) four times daily (for children over 2 years and infants from 1 month to 2 years)
Administration: Swallow the suspension directly.
| Patient Group | Condition | Dose | Frequency | Method |
|---|---|---|---|---|
| Adults | Oral thrush | 1 ml (100,000 IU) | 4 times daily | Swish and swallow |
| Adults | Intestinal candidiasis | 5 ml (500,000 IU) | 3 times daily | Swallow directly |
| Children (>2 years) | Oral thrush | 1 ml (100,000 IU) | 4 times daily | Swish and swallow |
| Infants (1 month–2 years) | Oral thrush | 1 ml (100,000 IU) | 4 times daily | Drop by drop / apply in mouth |
| Newborns (birth–1 month) | Oral thrush | 1 ml (100,000 IU) | 4 times daily | Drop by drop / apply in mouth |
| Children & Infants | Intestinal candidiasis | 1 ml (100,000 IU) | 4 times daily | Swallow directly |
Elderly
No specific dose adjustment is necessary for elderly patients. The standard adult dosing regimen applies. Since nystatin is not absorbed systemically, age-related changes in kidney or liver function do not affect the drug's pharmacokinetics. Elderly patients, particularly those wearing dentures, are at increased risk for oral candidiasis and may benefit from good denture hygiene practices alongside antifungal treatment.
Missed Dose
If you forget to take a dose of Nystatin Evolan, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a forgotten dose. Consistency in dosing is important for treatment effectiveness, so try to take the medicine at approximately the same times each day.
Overdose
If you or someone else has taken too much Nystatin Evolan, or if a child has accidentally ingested the medicine, contact your doctor, hospital, or poison control center for assessment and advice. Because nystatin is not absorbed from the gastrointestinal tract, overdose is unlikely to cause systemic toxicity. However, ingestion of very large amounts may lead to gastrointestinal symptoms such as nausea, vomiting, and diarrhea.
To prevent the infection from returning, continue treatment for 2–3 days after all visible signs of infection have disappeared. Stopping treatment too early is a common cause of recurrent candidiasis. Your doctor will advise you on the appropriate total treatment duration based on your individual situation.
What Are the Side Effects of Nystatin Evolan?
Nystatin Evolan is generally well tolerated due to its lack of systemic absorption. Uncommon side effects include allergic skin reactions and gastrointestinal symptoms at high doses. Rare but serious reactions such as Stevens-Johnson syndrome and angioedema have been reported. Stop use and seek immediate medical attention for severe skin or allergic reactions.
Like all medicines, Nystatin Evolan can cause side effects, although not everybody experiences them. Because nystatin acts locally and is not absorbed into the bloodstream, side effects are generally mild and infrequent compared to systemically absorbed antifungal medications. Most patients complete their course of treatment without experiencing any adverse effects.
Severe skin and mucous membrane changes (Stevens-Johnson syndrome), hypersensitivity reactions with swelling of the face and throat (angioedema), or widespread red, scaly rash with bumps under the skin and blisters accompanied by fever (acute generalized exanthematous pustulosis, AGEP).
Rare
- Stevens-Johnson syndrome (severe skin and mucous membrane reaction)
Uncommon
- Allergic skin reactions (rash, itching, hives)
- Nausea (typically at high doses)
- Vomiting (typically at high doses)
- Diarrhea (typically at high doses)
Very Rare
- Hypersensitivity reactions
- Angioedema (swelling of face, lips, tongue, or throat)
Frequency Not Known
- Acute generalized exanthematous pustulosis (AGEP) — widespread red, scaly rash with bumps under the skin and blisters, usually appearing at the start of treatment
The gastrointestinal side effects (nausea, vomiting, diarrhea) are dose-dependent and most commonly occur when using the higher doses prescribed for intestinal candidiasis (5 ml three times daily). These symptoms are usually mild and resolve spontaneously without the need to discontinue treatment. If they become troublesome, your doctor may adjust the dosing regimen.
Allergic skin reactions, while uncommon, may be related to nystatin itself or to the methylparahydroxybenzoate preservative in the formulation. If you develop any new skin symptoms during treatment, inform your healthcare provider promptly. In most cases, these reactions are mild and self-limiting.
When to seek urgent medical help
While serious adverse reactions to nystatin are extremely rare, you should seek immediate medical attention if you experience any of the following:
- Sudden difficulty breathing or swallowing
- Rapid swelling of the face, lips, tongue, or throat
- Severe, widespread skin rash with blistering
- High fever accompanied by a widespread rash
- Any symptoms suggesting a severe allergic reaction
Reporting side effects
If you experience any side effects, including those not listed in this guide, report them to your healthcare provider. Reporting suspected adverse reactions helps regulatory authorities continuously monitor the benefit-risk balance of medicines. You can also report side effects directly to your national medicines regulatory authority.
How Should You Store Nystatin Evolan?
Store unopened bottles in the refrigerator (2–8°C). Once opened, store at room temperature (up to 25°C) and use within 2 months. Keep out of reach of children. Do not use after the expiry date. Dispose of unused medicine through your pharmacy, not via household waste.
Proper storage of Nystatin Evolan is essential to ensure the medicine remains effective throughout its use. Nystatin is a biological molecule that can degrade under inappropriate conditions, so following the storage instructions carefully will help maintain the potency and safety of your medicine.
- Unopened bottles: Store in the refrigerator at 2–8°C (36–46°F). This temperature range helps preserve the activity of the nystatin molecule and the stability of the suspension.
- Opened bottles: Once opened, the bottle can be stored at room temperature, up to 25°C (77°F), for a maximum of 2 months. Write the date you first open the bottle on the label or carton so you can track the expiry of the opened product.
- Expiry date: Do not use after the expiry date printed on the packaging (after “EXP”). The expiry date refers to the last day of that month.
- Keep out of sight and reach of children.
- Disposal: Do not dispose of medicines via wastewater or household waste. Return unused medicine to your pharmacy for proper disposal. This helps protect the environment.
When you remove the bottle from the refrigerator for first use, it is helpful to immediately write the opening date on the label. Set a reminder for 2 months later to discard any remaining suspension. Always shake the bottle well before each use, as the active ingredient may settle during storage.
What Does Nystatin Evolan Contain?
Each ml of Nystatin Evolan contains 100,000 International Units (IU) of nystatin as the active ingredient. Inactive ingredients include xylitol, carmellose sodium, methylparahydroxybenzoate (E218), spearmint flavoring, and purified water. The suspension is sweetened with xylitol instead of sugar.
Understanding the full composition of your medicine can help you identify potential allergens and make informed decisions about your treatment. Here is a detailed breakdown of all ingredients in Nystatin Evolan oral suspension:
Active ingredient
Nystatin: 100,000 IU per ml of oral suspension. Nystatin is a polyene macrolide antifungal antibiotic produced by Streptomyces noursei. It is measured in International Units (IU) rather than milligrams because its potency is defined by biological activity against standard fungal preparations.
Inactive ingredients (excipients)
- Xylitol: A sugar alcohol used as a sweetener. Unlike sucrose, xylitol does not promote dental caries and has a negligible effect on blood sugar levels, making the formulation suitable for diabetic patients. Xylitol may also have mild antimicrobial properties against certain oral bacteria.
- Carmellose sodium: A thickening and stabilizing agent that helps maintain the uniform suspension of nystatin particles in the liquid. It ensures consistent dosing with each measured use.
- Methylparahydroxybenzoate (E218): A preservative that prevents microbial contamination of the suspension. Note that this ingredient may cause allergic reactions in some individuals, potentially with a delayed onset.
- Spearmint flavoring: Added to improve the taste of the suspension and enhance patient acceptability, particularly important for children and infants.
- Purified water: The liquid base of the suspension.
Physical appearance
Nystatin Evolan oral suspension is an opaque, light yellow to light brown liquid with a mint flavor. It is supplied in amber glass bottles with plastic closures in pack sizes of 100 ml or 140 ml. Not all pack sizes may be marketed in all countries.
Frequently Asked Questions About Nystatin Evolan
Medical References
This article is based on evidence-based medical information from the following international sources:
- European Medicines Agency (EMA). Nystatin — Summary of Product Characteristics. Available at: www.ema.europa.eu
- World Health Organization (WHO). WHO Model List of Essential Medicines, 23rd List (2023). Nystatin listed as an essential antifungal medicine. Available at: www.who.int
- British National Formulary (BNF). Nystatin — Indications, dose, contra-indications, side-effects. National Institute for Health and Care Excellence (NICE). Available at: bnf.nice.org.uk
- Pappas PG, Kauffman CA, Andes DR, et al. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America (IDSA). Clinical Infectious Diseases. 2016;62(4):e1–e50. doi:10.1093/cid/civ933
- Millsop JW, Fazel N. Oral candidiasis. Clinics in Dermatology. 2016;34(4):487–494. doi:10.1016/j.clindermatol.2016.02.022
- Williams DW, Kuriyama T, Silva S, Malic S, Lewis MAO. Candida biofilms and oral candidosis: treatment and prevention. Periodontology 2000. 2011;55(1):250–265. doi:10.1111/j.1600-0757.2009.00338.x
- Lyu X, Zhao C, Yan ZM, Hua H. Efficacy of nystatin for the treatment of oral candidiasis: a systematic review and meta-analysis. Drug Design, Development and Therapy. 2016;10:1161–1171. doi:10.2147/DDDT.S100795
- Garcia-Cuesta C, Sarrion-Perez MG, Bagan JV. Current treatment of oral candidiasis: A literature review. Journal of Clinical and Experimental Dentistry. 2014;6(5):e576–e582. doi:10.4317/jced.51798
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