Nystatyna Teva

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Nystatyna Teva

Treatment option: Infection, Oral Cavity

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Nystatyna Teva

Quick Facts

Property Description
Active ingredient Nystatin (INN)
Form Tablets, Oral Suspension, Vaginal Globules
Pharmacological class Antifungal Agent, Polyene Macrolide Antibiotic
Common use Localized fungal infections (Candidiasis)
Origin Biosynthetic (from Streptomyces noursei)

What Type of Medicine is Nystatyna Teva?

Nystatyna Teva is a specific pharmaceutical preparation containing the active ingredient Nystatin, which is a highly effective antifungal agent. It is classified within the pharmacological class of polyene macrolide antibiotics, a type of compound clinically recognized for its potent activity against yeasts and fungi. This classification confirms that the medicine’s primary purpose is to control infections caused by susceptible fungi, such as common forms of candidiasis, in a targeted manner.

Nystatin: Composition and Origin

The Nystatin compound is known for its biosynthetic origin, as it is naturally produced by the soil-dwelling bacterium Streptomyces noursei. This natural derivation gives it a unique structure. Nystatyna Teva is manufactured in various dosage forms, including film-coated tablets and oral suspension, designed for local action. Crucially, the drug exhibits minimal systemic absorption from the gastrointestinal tract, meaning its therapeutic effect is confined mainly to the localized site of application, such as the mouth or intestinal lining.

General Purpose and Forms

The general purpose of the medicine is to exert a direct, concentrated antimycotic effect against pathogens where the infection is present. It achieves this by selectively binding to ergosterol, a sterol component unique to the fungal cell membrane, which rapidly disrupts the cell’s structural integrity. This potent action against the fungal pathogen results in effective fungicidal or fungistatic activity that stops the proliferation of the infection.

Regulatory References

  1. MedlinePlus Drug Information

What side effects are possible with Nystatyna Teva?

Possible Side Effects and Safety Information

Nystatyna Teva's safety profile is characterized by the negligible systemic absorption of its active substance, Nystatin, from the gastrointestinal tract. Consequently, the officially documented adverse reactions are primarily confined to local effects and the gastrointestinal system.

Classification Organ System Documented Adverse Reactions
Uncommon Gastrointestinal Disorders Diarrhoea, abdominal discomfort, nausea, vomiting
Rare Immune System Disorders, Skin Hypersensitivity, Angioedema (including facial oedema), Urticaria, Rash
Very Rare Skin and Subcutaneous Tissue Stevens-Johnson Syndrome (SJS)

Serious Adverse Reactions and Safety Restrictions

Regulatory documentation highlights the risk of severe hypersensitivity reactions, including Angioedema, and the very rare occurrence of Stevens-Johnson Syndrome (SJS). The medicine is contraindicated in individuals with a known hypersensitivity to Nystatin or any formulation excipients. Furthermore, due to its poor absorption, it is not indicated for the treatment of systemic mycoses (deep, internal fungal infections).

If irritation or sensitization develops during the course of treatment, official labeling mandates discontinuation of the medicine. In terms of exposure patterns, Nystatin is generally documented as being well tolerated even during prolonged use.

Population-Specific Safety Considerations

For pregnancy and lactation, the safety profile reflects the minimal absorption of Nystatin. While the exact fetal exposure is not fully known, the negligible systemic uptake is often noted, and the medicine is generally reserved for use when the potential benefit is judged to outweigh the possible risk. No specific precautions are detailed in the official labeling for older adults or individuals with renal impairment.

This structure reflects how government authorities classify side effects by frequency and system to define the medicine's overall risk profile, emphasizing local effects and specific, low-frequency systemic risks.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Nystatin (the active ingredient in Nystatyna Teva) emphasizes that due to its property of negligible absorption from the gastrointestinal tract, systemic toxicity is not anticipated following an oral overdose. The documented effects are therefore highly localized to the digestive system.

Documented Overdose Manifestations

The chief effects of overdosage are confined to the digestive system. Regulatory labels state that oral doses in excess of five million units daily have been associated with the following manifestations:

Manifestation Type Description
Gastrointestinal Nausea, vomiting, diarrhea, and general gastrointestinal upset or distress.
Systemic Risk No serious toxic effects are expected, and the risk of systemic toxicity is not anticipated.

Emergency Action Requirements

In the event of a suspected or known overdose, immediate professional assistance is required, as outlined by regulatory authorities.

Urgent Medical Help is Required When: Official guidance instructs that emergency services must be contacted if the affected individual exhibits severe, life-threatening clinical signs. These signs include collapse, experiencing a seizure, having trouble breathing, or being unable to be awakened. For other non-life-threatening concerns, individuals must contact a Poison Control Center immediately for advice.

Supportive Management: Medical management is focused on providing relief for the documented symptoms. No specific antidote is documented for Nystatin overdosage. Treatment involves symptomatic and supportive therapy, and routine measures such as gastric lavage may be performed to address the unabsorbed quantity of medicine.

Therapeutic Uses of Nystatyna Teva

What Nystatyna Teva Treats: Main Uses and Benefits

This medicine is relevant in contexts marked by increased discomfort or tension due to specific fungal infections. It is generally applied across therapeutic domains where short-term symptomatic support is needed to address localized issues caused by fungal organisms.


Relief for Symptoms of Oral and Gastrointestinal Candidiasis

Nystatyna Teva is used for managing symptoms related to physical discomfort that interfere with daily functioning, such as those associated with oral thrush and candidiasis in the intestines. This medicine is commonly used across conditions presenting with systemic or localized discomfort caused by recurrent or episodic manifestations.

“Nystatyna Teva provides supportive relief when symptoms interfere with routine activities, helping to improve day-to-day comfort during symptomatic periods.”

This medicine is considered relevant for conditions characterized by periods of heightened symptoms or those where symptoms may intensify temporarily, such as in patients taking certain medications. Applied in these contexts, Nystatyna Teva assists with maintaining functional stability by offering symptomatic relief that helps patients cope more steadily with symptom fluctuations. It contributes to easing the overall symptom load and supports the patient during difficult episodes by easing distress.


Quick Fact: Relief for Physical Discomfort

Eligibility and Restrictions for Use

Who Can and Cannot Use Nystatyna Teva?

Absolute Contraindications and Restrictions

Nystatyna Teva must not be used by individuals with a known history of hypersensitivity to the active substance Nystatin or any of its components. Regulatory documents state that the medicine is contraindicated for treating systemic mycoses (internal body fungal infections), as Nystatin exhibits insignificant systemic absorption and is intended only for localized treatment.

Age-Group and Conditional Eligibility

Use is generally established across adults, children, and infants, with the oral suspension being the appropriate form for younger pediatric populations. For pregnant women, the FDA classifies Nystatin as Category C, meaning it should only be administered if clearly needed, due to insufficient human data. Caution is warranted during breastfeeding, as it is unknown whether the substance is excreted in human milk.

Special consideration is also required for patients with renal insufficiency, where regulatory documents note that increased plasma concentrations may occasionally occur during oral therapy. Additionally, certain formulations are restricted for patients with rare hereditary sugar intolerances (e.g., fructose intolerance) if the product contains specific excipients like sucrose.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section outlines the officially documented interaction patterns for the active ingredient Nystatin (Nystatyna Teva) as reported in government regulatory documents.

Interaction Scope

The interaction profile of Nystatin is overwhelmingly determined by its characteristic minimal systemic absorption from the gastrointestinal tract and local mode of action.

Interaction Category Official Regulatory Statement
Systemic Drug-Drug Interactions None documented. The negligible systemic absorption means Nystatin does not reach plasma concentrations sufficient to interfere with the metabolism of co-administered systemic medicines.
Metabolic/Transporter Interactions None documented. The product does not interact with CYP450 enzymes or major drug transporters (like P-gp) on a systemic level.
Contraindicated Combinations None listed based on systemic drug-drug interaction risk.

Timing-Based Interaction Rules

Classification Official Regulatory Statement
Food/Drink Separation For the oral suspension form, administration may require separation from food and drink. This is a timing constraint intended to maximize the local contact time of the product with the oral mucosa to treat localized candidiasis.
Population-Specific Notes None documented for interaction severity changes in specific populations, such as those with hepatic or renal impairment.

Regulatory documents consistently confirm that the product's interaction structure is defined by the absence of systemic risk, eliminating the need for warnings related to systemic metabolic or pharmacodynamic interactions.

Mechanism of Action

The action of Nystatyna Teva is driven entirely by the active component, Nystatin, which mediates a direct fungicidal mechanism through physical destruction of the target cell.

Targeted Membrane Perforation

Nystatin belongs to the polyene macrolide class, which is mechanistically defined by its ability to bind selectively to ergosterol, a crucial sterol molecule found only in the fungal plasma membrane. The drug then facilitates the self-assembly of multiple Nystatin molecules into a transmembrane aqueous channel or pore. This mechanism is highly specific because Nystatin exhibits a much greater affinity for fungal ergosterol than for cholesterol, the sterol found in human cell membranes. This targeted action initiates the rapid structural compromise of the pathogen's membrane.

Collapse of Cellular Homeostasis

The formation of these pores allows the rapid, uncontrolled efflux of monovalent cations, particularly potassium ions ( K^+), out of the fungal cell cytoplasm. This leakage immediately disrupts the cell's vital electrochemical gradient and osmotic balance. This direct mechanism dismantles the homeostatic conditions necessary for fungal metabolism and survival, resulting in irreversible cellular failure and fungal cell lysis (a fungicidal consequence).

Dosage and Administration Information

The administration of Nystatyna Teva is structured by strict, form-specific instructions detailed in product labeling to ensure concentrated localized action. The medicine is administered through two official routes: orally, using the film-coated tablets or the 100,000 units/mL oral suspension, and intra-vaginally, using the 100,000 unit vaginal inserts.

Standard adult dosing for intestinal use is typically 500,000 to 1,000,000 units of the oral tablet, taken three times a day. For oral candidiasis, the suspension is dosed at 400,000 to 600,000 units per dose, administered four times daily. A key procedural requirement is that the suspension must be shaken well before use and retained in the mouth for as long as possible before swallowing to maximize contact time.

Specific rules exist for certain populations: the pediatric dose for infants (e.g., 200,000 units four times daily) requires avoiding feeding for 5 to 10 minutes afterward. The treatment course is time-bound. For oral use, Nystatin therapy should continue for a minimum of 48 hours after the disappearance of symptoms or clinical cure to prevent relapse. For vaginal candidiasis, the insert is typically used once daily, preferably at bedtime, for a standard duration of 14 consecutive days. If a dose is missed, general guidance advises taking it as soon as remembered, unless it is close to the next scheduled dose, in which case the missed dose should be skipped to resume the regular schedule.

Recent Clinical Evidence

Research evidence / Overview of studies for Nystatyna Teva


Evidence for Use in Localized Fungal Infections (Candidiasis)

Studies have evaluated Nystatin (the active ingredient in Nystatyna Teva) in individuals with fungal infections of the mouth and mucosal linings. Researchers have conducted Randomized Controlled Trials (RCTs) and Systematic Reviews to investigate the drug's properties. The studies were used in research exploring how symptoms change over time; outcomes monitored included the Clinical Cure Rate, a metric assessing the visual status of lesions in trials, and the Mycological Cure Rate, which monitored fungal metrics using lab tests.

Studies explored the use of Nystatin in conditions characterized by fluctuating or episodic manifestations. Findings were examined where Nystatin was compared to other antifungals; some studies described patterns that indicated a difference in measured outcomes when compared to other types of agents in certain patient groups.


Evidence for Use in Preventing Fungal Colonization

Research has also evaluated Nystatin in scenarios involving a potential for fungal colonization in specific high-risk settings. Randomized Controlled Trials (RCTs) were conducted to examine fungal overgrowth in the gastrointestinal and oral tracts. Studies monitored the incidence of Fungal Colonization using swabs and, in some research, the incidence of Invasive Fungal Infection.

The research examined use in critically ill adults and Very Low Birth Weight (VLBW) infants in the intensive care setting. Findings describe patterns observed in these studies, where Nystatin use was observed in some studies to correlate with reduced fungal colonization measurements in VLBW infants. Conversely, in studies focusing on patients receiving cancer treatment, data show patterns related to Nystatin not appearing to influence the outcome of oral candidiasis when compared to absorbed antifungal drugs.


Research in Specific Populations and Patient Groups

Research was observed in infants and children, allowing researchers to track outcomes related to physical discomfort and fungal clearance in these younger age groups. Research examined Nystatin’s role in adults who have specific risk factors for localized candidiasis, such as those who use dentures, as well as immunocompromised patients. Results apply only to the populations studied. Research does not determine whether an individual will respond similarly across different age groups; the findings related to fungal burden in infants, for example, reflect only the specific conditions under which they were conducted.


Evidence Gaps and Areas of Research Uncertainty

Key limitations exist in the available data. The majority of clinical studies that examined Nystatin focused on short-term symptom changes and typically have follow-up durations that were limited, meaning long-term outcomes regarding the durability of fungal clearance and relapse rates are not fully established in the research. Evidence quality varies across studies, with a significant number of supporting trials being older, which affects how confidently modern clinical quality assessments can be made.

Frequently Asked Questions (FAQ)

Common questions about Nystatyna Teva (FAQ)


Q: How long does Nystatyna Teva stay in your system after you stop using it?

A: According to official product information, systemic absorption of Nystatin is minimal following oral use, meaning very little of the drug actually enters the bloodstream. Most of the medication is eliminated unchanged in the feces. Due to its mechanism, Nystatin is not expected to remain in the main body system for an extended period following oral use.

Q: Is Nystatyna Teva safe to use if I am pregnant?

A: Official regulatory documents classify Nystatin as FDA Pregnancy Category C. This classification indicates that while animal studies showed adverse effects, there are no adequate studies in humans. The FDA classification suggests the drug may be used when the potential benefit is judged to outweigh the possible risk, and its administration is reserved for when clearly needed.

Q: Can Nystatyna Teva be used by children, and what are the general considerations?

A: Use of Nystatin is established in pediatric patients, including infants. A key consideration noted in official documents is that certain solid forms, such as film-coated tablets, may not be suitable for very young children. In such cases, the oral suspension is typically the dosage form utilized for younger patients.

Q: What should I know about the ingredients in Nystatyna Teva besides the main drug?

A: Inactive ingredients (excipients) vary depending on the specific formulation, but examples often found on official labels include common components like sucrose, lactose, starches, and coloring agents. Official labeling notes that patients with known allergies or sugar intolerances may need to check the full list of inactive ingredients for their specific product.

Q: How long until I should notice an improvement in my symptoms from Nystatyna Teva?

A: Official drug references indicate that for oral candidiasis, patients typically report the onset of symptom relief within 24 to 72 hours after beginning therapy. However, it is important that any prescribed treatment course duration is completed, even after initial symptom improvement.

Q: Is Nystatyna Teva the same as other brands containing nystatin?

A: Nystatin is the generic name for the active ingredient and is available under many different brands, including Nystatyna Teva. While these products contain the same active medicine, the inactive ingredients (excipients) can vary between manufacturers. These differences may be a factor for patients with certain allergies or specific intolerances.

Q: Why do some people say Nystatyna Teva tastes bad?

A: Some oral formulations include additives like artificial fruit flavors to enhance palatability. Despite this, patient experiences suggest that the active ingredient, Nystatin, imparts a metallic or otherwise unpleasant taste that may vary between individuals.

Q: Can Nystatyna Teva make existing skin conditions worse?

A: If irritation or sensitization (such as a rash or inflammation) develops during the course of treatment, official labeling mandates discontinuation of the medicine. This is a general caution related to any localized adverse reaction that may arise.

Q: Does using Nystatyna Teva affect birth control pills?

A: Regulatory documents state that due to Nystatin’s negligible systemic absorption, no systemic drug-drug interactions are known. The drug is not expected to reach the bloodstream in concentrations sufficient to interfere with the metabolism or effectiveness of oral contraceptive medications.

Q: Is Nystatyna Teva generally considered safe for elderly patients?

A: Official regulatory labeling does not specify any special dosage recommendations or precautions uniquely required for the elderly population. The safety profile, which is primarily local due to poor systemic absorption, suggests the medicine is typically used in older adults with the same general considerations as other adult patients.

Q: Does Nystatyna Teva interact with alcohol?

A: Because Nystatin has minimal systemic absorption, no systemic interaction with orally consumed alcohol is documented in official sources. However, some oral liquid formulations do contain small amounts of ethanol (alcohol) as an inactive ingredient, which may be a consideration.

Q: What common medicines should not be taken near the time of using Nystatyna Teva?

A: Since Nystatin has negligible systemic absorption, no systemic drug-drug interactions are documented. The only notable regulatory constraint is that the oral suspension form may require separation from food and drink to maximize the local contact time of the product with the infected area. This constraint is related to timing, not chemical interaction.

Q: What type of research has shown Nystatyna Teva to be useful?

A: Studies supporting the medicine's use include Randomized Controlled Trials (RCTs) and Systematic Reviews. These studies evaluated its use in treating localized fungal infections and in preventing fungal colonization in high-risk groups. Outcomes monitored in this research typically include the Clinical Cure Rate.

Q: What happens if someone takes too much Nystatyna Teva?

A: Official regulatory documents state that no reports of serious toxic effects have followed overdosage of Nystatin. However, official documentation notes that doses exceeding recommended amounts have been associated with nausea, vomiting, and general gastrointestinal upset.

Q: How long does the protective effect of Nystatyna Teva last after completing the course?

A: Official documentation notes a key limitation in available data, which often focuses on short-term symptom changes. Studies typically have limited follow-up durations, meaning that long-term outcomes regarding the durability of fungal clearance and relapse rates are not fully established in the research.

Q: Why is Nystatyna Teva usually only available with a prescription?

A: Nystatin is generally classified as a prescription-only (Rx) human drug. This status ensures that a qualified healthcare professional first makes a correct diagnosis of a localized fungal infection. It also serves to rule out the possibility of a systemic mycosis (deep, internal infection), which the drug cannot treat due to its minimal absorption.

Q: What official warnings are associated with Nystatyna Teva?

A: Official labeling carries warnings about the potential for severe hypersensitivity reactions, such as Angioedema. It also lists the risk of the very rare but serious skin condition known as Stevens-Johnson Syndrome (SJS). Furthermore, the drug is officially warned as not indicated for systemic fungal infections.

Q: Can Nystatyna Teva affect my sleep or cause insomnia?

A: Insomnia or other sleep-related disorders are not listed among the most commonly documented adverse reactions in official regulatory documents for Nystatin. Adverse events for this medicine are primarily confined to the gastrointestinal system and local allergic reactions.

Q: Can Nystatyna Teva be used on other parts of the body if the instructions are for oral use?

A: The oral suspension and tablets are specifically indicated for the local treatment of oral, pharyngeal, or intestinal candidiasis. Due to its mechanism, the medicine is not indicated for treating systemic or deep-seated mycoses. Use is restricted to the specific sites of infection where the particular formulation is intended to be applied.

Q: Is Nystatyna Teva a generic or a brand-name drug?

A: Nystatin is the generic name for the active ingredient. It is an off-patent medication that is included on the World Health Organization's List of Essential Medicines. Nystatyna Teva is one of many preparations containing this generic ingredient.

Q: Are there different formulations of Nystatyna Teva for different types of fungal infections?

A: The different formulations (tablets, oral suspension, vaginal inserts) are used to treat localized infections caused by Candida species, which is the primary target. The varying forms are designed to target different sites of candidiasis, such as the mouth, intestines, or vaginal area, to ensure direct, concentrated action.

Q: What happens if Nystatyna Teva comes into contact with the eyes?

A: The official guidance notes that nystatin preparations are not intended for use in the eyes. For accidental exposure, seeking guidance based on general safety protocols is appropriate.

Q: Can Nystatyna Teva be used by people with a history of heart conditions?

A: Official regulatory documents do not list a history of heart conditions as a specific contraindication for use. However, tachycardia (a fast heartbeat) has been rarely reported as an adverse reaction in some official product information.

Q: How does Nystatyna Teva compare to Fluconazole (non-comparative comparison, focus on difference in type)?

A: The two medicines belong to different classes of antifungals with different mechanisms of action. Nystatin is a polyene macrolide that works by binding directly to ergosterol to cause pore formation. Fluconazole is an azole antifungal that works by inhibiting the synthesis of ergosterol within the fungal cell.

Q: What other ingredients are listed in Nystatyna Teva besides the drug itself?

A: The inactive ingredients listed on official labels vary by product (e.g., tablet vs. suspension). Examples found in the drug description section include common pharmaceutical components such as anhydrous lactose, carnauba wax, corn starch, microcrystalline cellulose, and polyethylene glycol.

How should Nystatyna Teva be stored and disposed of?

Storage and Disposal of Nystatin Oral Suspension

Official regulatory labeling dictates specific conditions to maintain the stability of Nystatin Oral Suspension:


  • Temperature: Store at controlled room temperature, generally 20 C to 25 C (68 F to 77 F). The product must avoid freezing.
  • Protection: Keep the container tightly closed and protect from light.
  • Child Safety: It is mandatory to keep this medication out of the sight and reach of children.

Disposal Instructions

  • Unused or expired product must be disposed of properly. Patients are advised to check with a pharmacist regarding local drug take-back programs.
  • Do not flush unused Nystatin down a toilet or drain unless explicitly instructed to do so by regulatory guidance.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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