Натамицин

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Натамицин

Medically reviewed

Marina Burgos

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 Натамицин

Quick Facts

Property Description
Active ingredient Natamycin (Pimaricin)
Form Ophthalmic suspension, Cream, Lozenges
Pharmacological class Polyene Macrolide Antifungal Agent
General purpose Elimination of fungal pathogens
Origin Natural (Derived from Streptomyces natalensis)

Natamycin: Classification and Pharmaceutical Identity

Natamycin (Натамицин) is a highly specific antifungal agent (antimycotic), formally classified as a polyene macrolide antibiotic. This compound is a product of natural origin, biosynthesized during the controlled fermentation process of the bacterium Streptomyces natalensis. The drug's classification as a single-ingredient product is crucial, concentrating its therapeutic profile entirely on eliminating fungal pathogens. Natamycin is an internationally recognized agent, included on the WHO List of Essential Medicines.

Composition and Unique Topical Forms

The sole active ingredient is Natamycin (known historically as Pimaricin), and it is primarily formulated for localized, topical administration, distinguishing it from antifungals administered systemically. While it exists as a cream and lozenges, its most widely recognized form is the ophthalmic suspension or eye drops. Following topical use, Natamycin exhibits low systemic absorption. This low absorption profile is beneficial as it concentrates the therapeutic effect locally while minimizing potential body-wide effects.

General Purpose and Selective Antifungal Action

The overarching general purpose of Natamycin is the definitive elimination of yeasts and filamentous fungi through a fungicidal action. This effect is achieved via selective toxicity, targeting the fungal cell membrane by binding to ergosterol, a sterol molecule essential to the fungal structure but absent in human cells. This targeted approach ensures the drug is highly effective against the intended fungal pathogens while remaining notably inactive against bacteria, preserving the body's necessary bacterial flora.

Regulatory References

  1. WHO List of Essential Medicines

What side effects are possible with Натамицин?

Possible Side Effects and Safety Information

The safety profile of Natamycin (Натамицин), particularly in its ophthalmic suspension form, is defined by localized events, consistent with its low systemic absorption following topical use. Adverse reactions are officially categorized by the system affected.

Officially Documented Adverse Reactions

Adverse reactions are documented in regulatory sources based on surveillance and clinical reports. Frequency classifications are often not defined (Postmarketing Reports), and the events are grouped by the body system involved.

Eye Disorders (Ocular System Effects)

The most commonly observed safety characteristics are localized reactions at the site of administration. These events include eye irritation, eye discomfort, eye pain, eye redness (hyperemia), and the sensation of a foreign body in the eye. Less frequently reported ocular effects include eye edema (swelling) and changes such as corneal opacity or altered vision.

Systemic and Serious Reactions

Less frequent or more severe reactions documented in postmarketing reports affect other systems. These include reactions classified under Immune System Disorders (such as allergic reaction and hypersensitivity), Respiratory Disorders (like dyspnea/shortness of breath), Cardiac Disorders (reports of chest pain), and Nervous System Disorders (reports of paresthesia).

Safety Constraints and Special Population Notes

A history of hypersensitivity to Natamycin or any of its components constitutes an absolute contraindication documented in the regulatory label. A key high-level safety risk involves concomitant use: Natamycin used with topical corticosteroids is associated with the potential for increased spread of the fungal eye infection.

Regarding specific populations, the official safety statement notes that the safety and effectiveness in pediatric patients have not been established. For older adults, no overall differences in safety or effectiveness have been observed compared to younger patients.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory profile for Natamycin overexposure is defined by the drug's limited absorption characteristics. Following topical administration, systemic effects are not expected because Natamycin exhibits negligible systemic absorption, even from the gastrointestinal tract if accidentally swallowed. Consequently, the official prescribing information does not list specific systemic clinical signs or symptom clusters for overdosage.


Required Emergency Actions

Because no specific antidote is known, official regulatory guidance mandates that management relies on immediate professional intervention. The following actions are required:

  • Seek emergency medical attention immediately, or contact a Poison Control center at once if overdosage or accidental ingestion of the ophthalmic suspension is suspected.
  • Professional medical evaluation and monitoring are required to initiate symptomatic and supportive treatment.

Overdose Constraints

The regulatory approach emphasizes the mandatory call for emergency assistance to ensure safety. No differential population-specific overdose severity is documented; however, the instruction to seek immediate help applies critically to all cases, especially concerning the potential for accidental ingestion in children.

Therapeutic Uses of Натамицин

What Натамицин treats: Main Uses and Benefits

Natamycin is generally used for managing conditions characterized by periods of heightened fungal infection symptoms in localized areas. The drug's targeted antifungal action is relevant for managing symptoms associated with the infection. It is formally indicated for the treatment of fungal infections, including Fungal Keratitis, conjunctivitis, blepharitis, and localized Candidiasis.


Localized Eye Infection Management

This domain covers the role of Natamycin in addressing fungal infections of the eye, where it is applied in clinical settings that involve acute or unstable symptom patterns. The medication is used for managing clusters of severe ocular symptoms like intense redness, inflammation, light sensitivity, and eye pain, offering symptomatic relief that is relevant for supporting the structure of the eye and the maintenance of visual clarity.

Relief from Superficial Fungal Symptoms

This area addresses the use of Natamycin's other topical forms for fungal overgrowth on the body's surfaces, primarily in the mouth, throat, or on the skin. It is relevant in situations where symptoms may intensify temporarily, and short-term symptomatic assistance is needed. The treatment is applied in addressing pronounced manifestations like the burning sensation, itching, and visible lesions. By addressing the causative fungi, the treatment provides supportive relief when symptoms interfere with routine activities and assists with maintaining day-to-day comfort during symptomatic periods.


Quick Fact

Property Description
Target Infections Fungal Keratitis, Ocular and Oral Candidiasis
Key Symptoms Addressed Pain, Burning, Redness, and Localized Lesions
Primary Therapeutic Benefit Supports localized infection management and may assist with comfort
Relevance Used in acute fungal symptomatic episodes

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Natamycin — Official Regulatory Information

The eligibility profile for natamycin ophthalmic suspension is strictly defined by regulatory documents, identifying specific populations for whom use is prohibited, conditional, or not established.


Eligibility Scope

Classification Population Eligibility Rule (Regulatory Basis)
Absolute Contraindication Individuals with a history of hypersensitivity to natamycin or any of the product's components.
Established Use Adult patients and older adult (geriatric) patients. No overall difference in safety or effectiveness has been observed in older adults.
Use Not Established Pediatric patients. Safety and effectiveness have not been established in this age group.
Conditional Use (Pregnancy C) Pregnant women. Use is restricted to being administered only if clearly needed.
Conditional Use (Lactation) Nursing women. Caution should be exercised, as it is not known whether the drug is excreted in human milk.

Eligibility-Context Constraints

Official labeling defines a specific constraint for use in patients with active ocular fungal infections: individuals are restricted from wearing contact lenses during the course of treatment. The use of natamycin is established across the adult age spectrum, but remains unestablished in children, emphasizing the regulatory boundaries for its application.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Systemic Interaction Profile

The interaction profile of Natamycin (Pimaricin), particularly the ophthalmic and topical forms, is characterized by a low risk of systemic interaction as documented in regulatory sources. Due to its very poor systemic absorption, no clinically significant systemic drug–drug interactions, such as those mediated by CYP enzymes or drug transporters, are anticipated or officially documented in prescribing information. Consequently, no known systemic interactions with food, alcohol, or herbal products are listed in the official regulatory documents for the topical formulations.


Local Co-administration Restrictions

Interactions are primarily confined to the site of topical application and are governed by co-administration restrictions:

  • Topical Corticosteroids: The concurrent use of Natamycin with topical corticosteroids is restricted or contraindicated in official labels. This is due to the potential risk of locally compromising the antifungal treatment or exacerbating the underlying fungal infection.
  • Other Ophthalmic Medications: Co-administration with other eye drops or ophthalmic solutions requires a mandatory separation interval. A time delay, typically of at least 10 minutes, is necessary to prevent the physical washout of Natamycin from the eye, ensuring that an adequate local concentration is maintained for the intended effect.

Formal Contraindication

Natamycin is formally contraindicated for co-administration in patients with known hypersensitivity to the active ingredient or to any other component of the formulation, as specified in regulatory prescribing information.

Mechanism of Action

How Натамицин Works

Selective Targeting of Fungal Sterols

Natamycin (Pimaricin) operates through a target-specific pharmacodynamic mechanism that is dependent on the unique composition of the fungal cell membrane. Its primary biological target is ergosterol, the principal sterol molecule integral to the fungal plasma membrane structure but absent in mammalian cells. The drug functions as a specific binder, engaging in a high-affinity binding and sequestration process that physically removes functional ergosterol from the lipid bilayer pool. This demonstrates selective toxicity due to the structural difference between fungal ergosterol and mammalian cholesterol.

Disruption of Fungal Cellular Dynamics

The depletion of functional ergosterol disrupts the fungus's ability to maintain structural integrity and functional dynamics. This molecular action interferes with essential cellular processes, including nutrient uptake via membrane transport proteins and necessary membrane-dependent events like vesicle trafficking. The consequent halt in metabolism and structural stability prevents the continuation of fungal life processes, leading directly to the fungicidal outcome.

Dosage and Administration Information

Natamycin is administered exclusively via the topical ophthalmic route using the 5% suspension for the treatment of susceptible fungal infections of the eye. The product is not indicated for injection and is for external application only. The official instructions mandate that the suspension must be shaken well immediately prior to use to ensure the correct concentration of the active ingredient is delivered in each drop.


The treatment protocol for fungal keratitis typically follows a two-phase schedule. Initially, one drop of the 5% suspension is instilled into the conjunctival sac at high frequency, specifically at hourly or two-hourly intervals. This intensive regimen is maintained for the first three to four days, after which the frequency is generally reduced to a maintenance dose of one drop 6 to 8 times daily. For less severe infections, such as fungal blepharitis and conjunctivitis, administration of one drop 4 to 6 times daily may be sufficient.


The total duration of therapy is generally continued for 14 to 21 days or until the active infection has resolved. The dosage should be reduced gradually at 4 to 7 day intervals to complete the full therapeutic course. If other topical ophthalmic medications are being used concurrently, they must be separated by a minimum of 5 minutes. Official labeling notes that the safety and effectiveness of Natamycin have not been established for pediatric patients.

Recent Clinical Evidence

Overview of Clinical Research

Natamycin is an antifungal agent primarily studied and used in the treatment of specific fungal infections of the eye, such as fungal keratitis (a corneal infection). It is one of the few topical agents approved by major regulatory bodies for this specific ophthalmic use. Recent clinical evidence has focused largely on its comparison to other antifungal therapies and advancements in its formulation.


Comparative Efficacy and Formulation Studies

Multiple randomized controlled trials (RCTs) have evaluated natamycin 5% ophthalmic suspension against other treatments, particularly voriconazole and chlorhexidine, for managing filamentous fungal keratitis (caused by fungi like Fusarium and Aspergillus).

Research from the Mycotic Ulcer Topical Treatment Trial (MUTT I) and subsequent analyses suggested that natamycin 5% was associated with improved clinical outcomes compared to voriconazole 1%, particularly in cases involving Fusarium species. Conversely, some smaller studies and pilot trials have compared natamycin to chlorhexidine, with findings that necessitated further large-scale, comprehensive RCTs to establish a clearer comparative benefit.

Further research has focused on new formulations, such as aqueous or solubilized natamycin, due to the limited corneal penetration of the conventional suspension. Studies exploring these newer formulations suggest they may offer a potential alternative, with some showing a trend toward more rapid re-epithelialization in patients with mild-to-moderate fungal keratitis. These studies are ongoing and are aimed at improving drug delivery to the deeper ocular tissues.

Frequently Asked Questions (FAQ)

Common questions about Натамицин (FAQ)

Q: Does Натамицин cream work for skin fungus?

A: Official FDA labeling indicates Natamycin is primarily used for ophthalmic (eye) fungal infections, such as keratitis, conjunctivitis, and blepharitis. While Natamycin may be available in other topical forms, like creams, in different regions of the world, its use for specific skin fungus is not included in the official FDA-approved labeling for the eye suspension.


Q: Can children safely use Натамицин?

A: According to the official prescribing information, the safety and effectiveness of Natamycin ophthalmic suspension have not been established in pediatric patients. Regulatory documents state that the safety and effectiveness have not been established in this age group.


Q: Is it normal to feel a stinging sensation after applying Натамицин?

A: Yes, localized sensations at the application site are common. Official documents report adverse reactions including eye irritation, eye discomfort, and eye pain. These general descriptions cover the sensation often described as stinging.


Q: Can Натамицин be used during pregnancy?

A: Natamycin is classified by the FDA as Pregnancy Category C. This means it should be administered to pregnant women only if clearly needed. The official labeling indicates it is not known whether the drug can cause fetal harm or affect reproductive capacity.


Q: What should I do if I miss a dose of Натамицин?

A: Official patient information often includes guidance that if a dose is missed, it should be applied as soon as it is remembered. However, if it is almost time for the next dose, the missed dose is typically skipped, and the patient returns to the regular dosing schedule. Patients are generally instructed not to use double or extra doses.


Q: Does storing Натамицин in the fridge make it last longer?

A: Official storage instructions specify keeping the product at room temperature, generally between 36°F and 75°F (2°C and 24°C). The product should be protected from light and should not be frozen. Storage outside the recommended temperature range is not advised by the manufacturer.


Q: Can I use makeup while I'm on a course of Натамицин treatment?

A: Official labeling advises against wearing contact lenses if there are signs of an active eye infection. This warning regarding contact lenses suggests caution with other items that contact the eye or dropper tip, though makeup itself is not explicitly prohibited in regulatory documents.


Q: What happens in my body when Натамицин is absorbed?

A: Natamycin has very poor systemic absorption when applied topically as an eye drop. This means only a very small amount, if any, enters the bloodstream. The vast majority of its therapeutic effect remains localized in the eye.


Q: Is it normal for my symptoms to get slightly worse before they improve with Натамицин?

A: Official warnings note that if there is a failure of improvement after 7 to 10 days of administration, the infection may not be susceptible to the drug. It is recommended that any new or worsening symptoms be reported to a healthcare provider for proper evaluation.


Q: What are the most common side effects of Натамицин?

A: The most frequently reported adverse reactions are localized to the eye. These typically include eye irritation, eye discomfort, eye pain, redness (hyperemia), and the sensation of a foreign body in the eye.


Q: Are there any severe side effects I should watch out for with Натамицин?

A: Postmarketing reports document severe or less frequent systemic reactions, such as signs of an allergic reaction (like difficulty breathing or swelling of the face) and chest pain. If severe symptoms are experienced, seeking immediate medical attention is necessary.


Q: What happens if I stop using Натамицин too early?

A: Official warnings emphasize the importance of completing the full prescribed course. Prematurely stopping treatment has been associated with an increased risk of infection recurrence or the development of resistance.


Q: Is there a generic version of Натамицин available?

A: Yes, according to the U.S. FDA’s regulatory listings, Natamycin ophthalmic suspension is available in generic versions.


Q: Is Натамицин effective against all types of fungus?

A: Natamycin is known to be effective against a broad spectrum of yeasts and filamentous fungi, including species such as Candida, Aspergillus, Fusarium, and Penicillium. However, official information notes that it is not effective against all fungal species.


Q: Is it possible to be resistant to the effects of Натамицин?

A: Official warnings state that failure to improve after 7 to 10 days of treatment may suggest the infection is caused by a microorganism that is not susceptible to natamycin. Inadequate treatment or skipping doses can also increase the risk of an infection becoming resistant.


Q: Can I use expired Натамицин if it looks okay?

A: Official patient information advises that medication that is outdated should not be kept or used. It should be disposed of following the instructions on the label and local regulations.

How should Натамицин be stored and disposed of?

Storage and Disposal of Natamycin

Natamycin must be stored under specific, officially documented conditions to maintain product stability and integrity.

Required Storage Conditions

Condition Requirement
Temperature Store at room temperature, specifically between 2°C and 24°C (36°F and 75°F).
Protection Protect from light; keep the container tightly closed.
Prohibition Do not freeze the medicine; avoid excessive heat.
Child Safety Keep out of the reach of children.

Disposal Instructions

Unused or outdated Natamycin must be disposed of according to local regulations. The product should not be flushed down a toilet or poured down a sink unless an official drug take-back program specifically advises this method. Disposal procedures are designed to follow approved pharmaceutical waste handling standards.

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

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