MYCOSTATIN 100,000 IU/mL Oral Suspension
1. Disclaimer
This information is provided for educational and informational purposes only and is not intended to replace the advice of a qualified physician, dentist, pharmacist, or other healthcare professional. Medication selection, dosing, duration of treatment, and suitability for a particular patient should be determined according to the patient's clinical condition and the currently applicable official product information.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. Readers are responsible for independently verifying the information before relying on it.
Product formulations, excipients, manufacturers, marketing authorisations, indications, and prescribing information may vary between countries and may change over time. The information below therefore distinguishes the documented Egyptian-market presentation from more recent general nystatin labeling where appropriate.
2. Summary
Mycostatin is an oral suspension containing nystatin 100,000 International Units (IU) per mL, a polyene antifungal agent. It is primarily used for the treatment and prevention of Candida infections of the oral cavity, and nystatin oral suspensions are also labeled in some jurisdictions for candidal infections involving the intestinal tract and for prophylaxis of oral candidiasis in certain newborns.
Nystatin acts locally by binding preferentially to ergosterol in fungal cell membranes, increasing membrane permeability and causing leakage of intracellular constituents. Because gastrointestinal absorption is negligible, oral nystatin has very limited systemic exposure and is principally useful for susceptible Candida infections at mucosal or gastrointestinal sites rather than invasive or systemic fungal disease.
The documented Egyptian Mycostatin presentation is a 30 mL oral suspension containing 100,000 IU/mL nystatin and has historically been manufactured by GlaxoSmithKline Egypt for SmithKline Beecham Egypt L.L.C.
3. Brand Name
Mycostatin
Egyptian-market presentation identified:
Mycostatin 100,000 IU/mL Oral Suspension, 30 mL
The product is listed in Egyptian medicine directories under the name Mycostatin 100 000 I.U./mL susp. 30 mL, with nystatin as the active ingredient and GlaxoSmithKline/SmithKline Beecham identified in the manufacturer information. Current online Egyptian listings continue to display this presentation, although such commercial directories should not be regarded as substitutes for a current Egyptian Drug Authority registration record.
4. Category
Pharmacological category: Polyene antifungal.
Pharmacotherapeutic group: Intestinal anti-infectives / polyene antifungal.
ATC classification: A07AA02 – Nystatin.
5. Active Ingredient
Nystatin
Strength: 100,000 IU per mL
Nystatin is a polyene macrolide antifungal obtained from Streptomyces noursei. The activity of nystatin is expressed in antifungal units rather than by mass alone in conventional oral suspension labeling.
Documented excipients of the Egyptian formulation
The documented Egyptian formulation lists:
- Sucrose
- Glycerine
- Sodium saccharin
- Sodium carboxymethylcellulose
- Sodium phosphate
- Methylparaben
- Propylparaben
- Alcohol
- Cherry flavor
- Peppermint oil
- Cinnamic aldehyde
- Hydrochloric acid
- Sodium hydroxide
- Purified water
The exact excipient composition should be confirmed against the package leaflet supplied with the particular Egyptian pack, because nystatin oral suspensions from different manufacturers and jurisdictions do not necessarily contain identical excipients. The modern UK Nystan formulation, for example, contains ethanol, glycerin, sodium carboxymethylcellulose, sodium phosphate, sucrose, parabens, and cherry/peppermint/cinnamic flavoring components, but its formulation is not identical to every other nystatin suspension.
6. Pharmaceutical Form & Strength
Pharmaceutical form: Oral suspension.
Strength: 100,000 IU of nystatin per mL.
The suspension is intended for oral administration and, in the documented formulation, is described as a pale-yellow suspension with a cherry-mint flavor.
The product is a ready-to-use suspension, not a powder requiring reconstitution. The suspension should be adequately mixed before administration. Current nystatin oral-suspension labeling advises shaking well before use, and dilution is not recommended because it may reduce therapeutic efficacy.
7. Manufacturer & Marketing Authorization Holder
Documented Egyptian presentation
The available Egyptian product information identifies:
Manufactured by:
GlaxoSmithKline Egypt
El Salam City, Cairo, Egypt
For:
SmithKline Beecham Egypt L.L.C.
Current Egyptian online medicine listings continue to identify the product as GlaxoSmithKline > SmithKline Beecham.
Because a current publicly accessible Egyptian regulatory record was not identified, the present-day legal marketing-authorisation status and corporate identity should be confirmed from the current package labeling or the Egyptian Drug Authority when legally relevant. Historical manufacturer/MAH information should not automatically be assumed to represent the current corporate registration.
8. Mechanism of Action
Nystatin is a polyene antifungal that binds to sterols, particularly ergosterol, in susceptible fungal cell membranes. This interaction alters membrane permeability and promotes the formation of membrane channels or pores through which intracellular electrolytes and other cellular components leak. The resulting disruption of membrane integrity can lead to fungal cell death.
Nystatin has a much greater affinity for fungal ergosterol than for mammalian cholesterol, which contributes to its selective antifungal activity.
9. Spectrum of Activity
Nystatin is active against susceptible yeasts and yeast-like fungi, particularly species of Candida. Candida albicans is a principal target organism. Nystatin may be fungistatic or fungicidal depending on concentration and organism susceptibility.
Its activity is not directed against bacteria or viruses, and it should not be used as a substitute for antibacterial, antiviral, or systemic antifungal therapy when these are clinically indicated.
Nystatin's lack of meaningful systemic absorption is important to its clinical use: it is suitable mainly for superficial or mucosal candidiasis and is not appropriate treatment for invasive or systemic fungal infections.
10. Pharmacokinetics
Absorption
Orally administered nystatin is negligibly absorbed from the gastrointestinal tract. Current product information describes gastrointestinal absorption as insignificant, with most orally administered nystatin passing through the gastrointestinal tract unchanged.
Distribution and systemic exposure
Because systemic absorption is minimal, systemic exposure after conventional oral administration is generally low. However, significant plasma concentrations may occasionally occur in patients with renal insufficiency receiving oral nystatin in conventional dosage forms.
Metabolism and elimination
Most orally administered nystatin is eliminated unchanged in the feces.
Clinical significance
The minimal gastrointestinal absorption explains why oral nystatin is useful for local treatment of candidal infection in the mouth and gastrointestinal tract but is not effective therapy for systemic or invasive candidiasis.
11. Indications
For the documented nystatin oral-suspension labeling, indications include:
- Treatment and prevention of candidal infections of the oral cavity.
- Treatment of intestinal candidiasis in accordance with the applicable product labeling.
- Prevention and treatment of oral candidiasis (thrush) in infants and children.
- In certain product labeling, prophylaxis of oral candidiasis in newborns, particularly newborns born to mothers with documented vaginal candidiasis.
Important clinical distinction regarding oesophageal candidiasis
Some product information, including the documented Nystan formulation, lists oesophageal candidiasis among its indications. However, nystatin acts locally and should not be assumed to provide adequate systemic treatment for established oesophageal candidiasis. Contemporary candidiasis guidance recommends systemic antifungal treatment, such as fluconazole when appropriate, for oesophageal candidiasis because systemic therapy is required for effective treatment.
Therefore, the presence of oesophageal candidiasis in some product labeling should not be interpreted as evidence that oral nystatin suspension is an adequate treatment for all cases of oesophageal candidiasis.
12. Administration
Route: Oral.
The suspension is administered directly into the mouth and swallowed. For oral candidiasis, the suspension should be distributed over the affected areas and retained in the mouth for as long as reasonably possible before swallowing, because local contact is an important part of its therapeutic effect.
Dosing
Dosing depends on age, indication, severity, and the specific approved product information.
For the documented formulation, a traditional labeled regimen for oral candidiasis is:
Adults:
1 mL (100,000 IU) four times daily, with the suspension retained in the mouth as long as possible before swallowing.
Infants and children:
1 mL (100,000 IU) four times daily for treatment in the documented product information.
Newborn prophylaxis:
1 mL once daily has been specified in the historical product information for prophylaxis.
Therapy should generally be continued for at least 48 hours after clinical symptoms have resolved in order to reduce the risk of recurrence. Current product information also advises reassessment when symptoms worsen or persist beyond approximately 14 days rather than simply continuing treatment indefinitely.
Contemporary treatment guidance
Doses for adult oropharyngeal candidiasis vary according to guideline, patient population, and clinical setting. For example, the IDSA guideline lists nystatin suspension 100,000 U/mL at 4–6 mL four times daily for 7–14 days as an alternative treatment for mild oropharyngeal candidiasis. This demonstrates why the dosage prescribed by the clinician and the official labeling of the particular product should take precedence over automatically applying a dose from a different formulation or jurisdiction.
13. Method of Preparation
No reconstitution is required. Mycostatin oral suspension is supplied as a ready-to-use liquid suspension.
Before administration
- Shake the bottle well before use.
- Measure the prescribed volume accurately using the supplied measuring device or an appropriate oral syringe/dropper.
- For oral candidiasis, place the suspension in the mouth and allow it to remain in contact with the affected areas for as long as practicable before swallowing.
- Do not dilute the suspension unless specifically directed by a healthcare professional, because dilution may reduce therapeutic efficacy.
The product should not be used if there is visible evidence of significant deterioration, contamination, or an abnormal change in the preparation.
14. Contraindications
The principal established contraindication is:
- Hypersensitivity to nystatin or to any component of the formulation.
Liver disease
Liver disease is not an established contraindication to nystatin oral suspension merely because the formulation contains sodium saccharin. The claim that sodium saccharin requires the product to be avoided in patients with liver disease is not supported by the current product information reviewed for nystatin oral suspension.
Nystatin itself has not been convincingly linked to clinically apparent drug-induced liver injury, and its negligible oral absorption further limits systemic exposure.
Patients with significant liver disease should nevertheless receive individualized medical advice when any medication is being considered.
15. Warnings & Precautions
Hypersensitivity and irritation
Treatment should be discontinued if significant irritation, sensitization, hypersensitivity, or another clinically important allergic reaction develops. Rare hypersensitivity reactions and angioedema have been reported.
Systemic fungal infections
Oral nystatin suspension should not be used to treat systemic or invasive mycoses. Such infections require antifungal therapy capable of achieving effective systemic concentrations.
Sucrose
The documented formulation contains sucrose. It should therefore be used with particular attention in patients with rare hereditary disorders such as:
- hereditary fructose intolerance,
- glucose-galactose malabsorption, or
- sucrase-isomaltase insufficiency.
Such patients should not take formulations containing clinically relevant amounts of sucrose.
Ethanol
The formulation contains a small amount of ethanol. The exact quantity depends on the product formulation. Current nystatin oral-suspension labeling identifies ethanol as an excipient and provides the amount per dose for the relevant formulation.
Parabens
The documented formulation contains methylparaben and propylparaben, which may cause allergic reactions, including delayed hypersensitivity reactions.
Persistence or worsening of symptoms
If symptoms worsen, fail to improve, or persist despite appropriate treatment, the diagnosis should be reassessed rather than extending therapy indefinitely. Current product information advises clinical reassessment when symptoms persist beyond 14 days.
Simultaneous treatment of other Candida sites
When clinically appropriate, recognized or symptomatic candidal infection at other sites may require simultaneous management to reduce persistence or reinfection.
16. Drug Interactions
No clinically significant drug interactions are established for nystatin oral suspension in current product information. The current UK SmPC states that there are no known interactions.
This should not be interpreted as proof that interaction is impossible with every medicine under every circumstance. The low systemic absorption of oral nystatin substantially limits its potential for pharmacokinetic drug interactions compared with systemically absorbed antifungal agents.
17. Side Effects
Nystatin oral suspension is generally well tolerated, including during relatively prolonged treatment. Reported adverse effects include:
Gastrointestinal disorders
- Nausea
- Diarrhea
- Abdominal discomfort
- Vomiting
- Gastrointestinal upset, particularly with large oral doses.
Skin and hypersensitivity reactions
- Rash
- Urticaria
- Hypersensitivity reactions
- Angioedema, including facial oedema.
Serious skin reactions
Stevens–Johnson syndrome has been reported very rarely.
Local effects
- Irritation
- Sensitization
If a significant allergic or irritating reaction develops, treatment should be stopped and medical advice obtained.
18. Use in Special Populations
Infants and children
Nystatin oral suspension is widely used for oral candidiasis in infants and children, and the documented product labeling includes pediatric therapeutic and newborn prophylactic regimens. Accurate measurement is particularly important in young children.
Newborns
Historical labeling for the product specifies 1 mL once daily for prophylaxis of oral candidiasis in newborns under the stated clinical circumstances. Treatment regimens for an established neonatal infection may differ and should follow the clinician's instructions and the applicable pediatric/neonatal guideline.
Pregnancy
The formal product information is conservative: animal reproductive studies have not been conducted, and because the risk to the fetus cannot be absolutely excluded from clinical labeling, nystatin should be used during pregnancy when the expected benefit outweighs potential risk. Gastrointestinal absorption is negligible.
Current NHS information is more reassuring and states that nystatin can be used during pregnancy, reflecting its long clinical experience and minimal systemic absorption.
Breastfeeding
The product information notes that it is not established whether nystatin is excreted into human milk, while gastrointestinal absorption is insignificant.
Current NHS guidance states that nystatin can be used during breastfeeding and that it is not thought to pass into breast milk in clinically significant amounts.
Elderly patients
No specific dosage adjustment or additional precaution is generally required solely on the basis of age.
Renal impairment
No specific dosage adjustment is established in the product information. However, significant plasma concentrations of nystatin may occasionally occur in patients with renal insufficiency receiving oral therapy with conventional dosage forms. Clinical judgment should therefore be used in patients with significant renal impairment.
Hepatic impairment
A specific dose adjustment is generally not expected solely because of hepatic impairment, given the negligible gastrointestinal absorption. Importantly, hepatic disease should not be described as a contraindication solely because of the presence of sodium saccharin in the formulation.
Ability to drive or operate machinery
No clinically relevant effect on the ability to drive or operate machinery is expected from nystatin oral suspension.
19. Storage Conditions
For the documented Egyptian product information, the storage instruction is:
Store below 30°C.
Storage instructions can differ between manufacturers and updated formulations. For example, the current UK ready-mixed nystatin formulation specifies do not store above 25°C. Therefore, the storage temperature printed on the package supplied to the patient should take precedence over a generic nystatin storage recommendation.
Keep the medicine out of the reach and sight of children.
20. Additional Sections
Overdose
Because gastrointestinal absorption is negligible, accidental ingestion or overdose is unlikely to cause clinically important systemic toxicity. However, very large oral doses have been associated with nausea and gastrointestinal disturbance; the product information reports such effects with oral doses exceeding approximately 5 million units per day.
Clinical pharmacology
Nystatin is a locally acting polyene antifungal whose principal activity is against susceptible Candida species. Its pharmacological profile is characterized by strong local antifungal activity and minimal systemic absorption.
Pharmaceutical characteristics
The documented Egyptian product is a 30 mL bottle of oral suspension supplied with a dosing device, with the bottle packaged in a carton with a leaflet.
Incompatibilities
No clinically relevant incompatibilities are identified in current ready-mixed nystatin oral-suspension product information.
Important clinical limitation
Nystatin suspension is a local/topical oral antifungal treatment, not a systemic antifungal. Consequently, failure to improve may indicate an incorrect diagnosis, resistant or unusually severe disease, inadequate local exposure, an underlying predisposing condition, or a site of infection for which nystatin is not appropriate.
21. Frequently Asked Questions (FAQ)
What is Mycostatin oral suspension used for?
Mycostatin contains nystatin and is primarily used to treat Candida infections of the mouth (oral thrush). Product labeling also includes intestinal candidiasis and, in certain circumstances, prevention of oral candidiasis in newborns.
Can Mycostatin be used for oral thrush in babies?
Yes. Nystatin oral suspension is an established treatment for oral candidiasis in infants and children. The dose should follow the current product labeling and the healthcare professional's instructions.
Should the suspension be swallowed immediately?
For oral candidiasis, it is preferable to keep the suspension in contact with the affected oral surfaces for as long as reasonably possible before swallowing, because local contact contributes to its therapeutic action.
Does Mycostatin treat fungal infections throughout the body?
No. Oral nystatin has negligible gastrointestinal absorption and is not suitable for systemic or invasive fungal infections.
Does nystatin treat oesophageal candidiasis?
Some product information lists oesophageal candidiasis among its indications. However, established oesophageal candidiasis generally requires a systemically active antifungal, and oral nystatin suspension should not be assumed to provide adequate treatment for this condition.
Can Mycostatin be taken during pregnancy?
Nystatin has minimal systemic absorption. Current NHS guidance states that nystatin can be used during pregnancy, while formal product information uses a more conservative risk-benefit wording. The prescribing decision should therefore follow the current official local product information and the clinician's assessment.
Can nystatin be used during breastfeeding?
Current NHS guidance considers nystatin compatible with breastfeeding, while formal labeling notes that breast-milk excretion has not been established but systemic absorption is insignificant.
Does liver disease contraindicate Mycostatin?
No. Liver disease should not be listed as a contraindication simply because the formulation contains sodium saccharin. Nystatin itself is minimally absorbed orally and has not been convincingly associated with clinically apparent drug-induced liver injury.
Are there known drug interactions?
No clinically significant drug interactions are listed for nystatin oral suspension in the current product information reviewed.
How should the bottle be prepared before each dose?
It is a ready-to-use suspension. Shake well before use and measure the prescribed dose accurately. Dilution is generally not recommended.
How long should treatment continue?
The duration depends on the indication and the patient's response. Product information recommends continuing treatment for at least 48 hours after symptoms disappear and reassessing patients whose symptoms worsen or persist beyond approximately 14 days.
22. References
- Nystan 100,000 units/ml Oral Suspension (Ready-Mixed) – Summary of Product Characteristics. Electronic Medicines Compendium (emc). Current product information, including composition, indications, dosing, contraindications, precautions, adverse effects, pharmacokinetics, interactions, and storage.
- Nystatin 100,000 unit/ml Oral suspension (Ready Mixed) – Summary of Product Characteristics. Electronic Medicines Compendium (emc), updated April 2025.
- Nystatin Oral Suspension USP [100,000 units per mL] – DailyMed/FDA labeling. Current U.S. labeling, updated February 6, 2026, confirming the 100,000 units/mL strength, negligible gastrointestinal absorption, occasional significant plasma concentrations in renal insufficiency, and current product information.
- Pappas PG, et al. Clinical Practice Guideline for the Management of Candidiasis: 2016 Update by the Infectious Diseases Society of America. Clinical Infectious Diseases. Recommendations concerning oropharyngeal and oesophageal candidiasis.
- Nystatin – LiverTox. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), NCBI Bookshelf. Information concerning absorption, mechanism, uses, and hepatic safety.
- NHS. Nystatin – pregnancy, breastfeeding and fertility. Current clinical information regarding use during pregnancy and breastfeeding.
- Historical Egyptian Mycostatin product information, Version 02, dated 26 September 2013. Information reproduced from the documented Egyptian product leaflet, including the Egyptian presentation, historical manufacturer information, excipients, dosing, storage, and package details.
- Egyptian medicine listings for Mycostatin 100,000 IU/mL suspension, 30 mL. Current online Egyptian listings identifying the product presentation, nystatin as the active ingredient, and the GlaxoSmithKline/SmithKline Beecham manufacturing attribution. These commercial directories are supplementary evidence and should not replace the current official Egyptian regulatory record.
- Nystatin oral suspension – systematic review and meta-analysis of efficacy and safety in oral candidiasis. Evidence regarding treatment protocols and comparative efficacy of nystatin suspension in oral candidiasis.