Макситрол

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Макситрол

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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 Макситрол

Quick Facts

Property Description
Active ingredients Dexamethasone, Neomycin, Polymyxin B
Form Ophthalmic suspension (eye drops) or Ophthalmic ointment
Pharmacological class Ophthalmic steroids with anti-infectives
Common purpose To manage ocular inflammation with co-existing or suspected bacterial infection
Origin Triple fixed-dose combination (synthetic corticosteroid + two antibiotics)

What Type of Combination Medicine is Макситрол?

Макситрол is defined as a specialized, fixed-dose triple combination agent formulated for topical ocular administration, classifying it within the therapeutic group of ophthalmic steroids with anti-infectives. This product is recognized for its integrated approach, which simultaneously addresses two primary issues in the eye: inflammation and the risk of bacterial infection. It is available as either a sterile ophthalmic suspension (eye drops) or an ophthalmic ointment for use on the ocular surface. The combination of a corticosteroid with antimicrobial agents is utilized where a risk of bacterial infection exists.

Composition: The Roles of Dexamethasone, Neomycin, and Polymyxin B

The composition includes three active ingredients: the synthetic glucocorticoid Dexamethasone, which provides the anti-inflammatory action, combined with the antibacterial agents Neomycin (an aminoglycoside) and Polymyxin B (a polypeptide). The combination of these specific antibiotics provides broad-spectrum antibacterial activity suitable for targeting various ocular pathogens, including Staphylococcus aureus. This dual antibiotic approach enhances the medication's defensive profile against common bacterial contaminants. The final preparation is delivered in a sterile base to ensure the highest quality standards for ophthalmic use.

General Purpose of the Dual-Action Ophthalmic Agent

The general purpose of this dual-action agent is to control symptoms associated with steroid-responsive inflammation while simultaneously providing protection against bacterial contamination. The medication's core benefit is its ability to mitigate acute discomfort and pathological processes while ensuring continuous anti-infective protection is delivered. This is particularly relevant in managing inflammation where a secondary bacterial infection is a possibility, providing a singular, comprehensive treatment strategy.

What side effects are possible with Макситрол?

Possible Side Effects and Safety Information

Макситрол is a combination product containing a corticosteroid and two antibiotics, and its safety profile reflects risks associated with each component. Not all side effects are common, but serious adverse reactions are documented, especially with prolonged use.

System Organ Class Common/Uncommon Reactions Serious or Clinically Significant Reactions (Frequency Not Known)
Ocular (Eye) Ocular discomfort, Keratitis, Eye irritation, Eye pruritus (itching) Elevation of intraocular pressure (IOP), Glaucoma (with optic nerve damage), Posterior subcapsular cataract formation, Corneal perforation (in case of thinning), Secondary ocular infection, Stevens-Johnson syndrome
Immune System Hypersensitivity/Allergic sensitization Severe systemic reactions (e.g., anaphylaxis)
Endocrine/Systemic Not commonly reported Cushing's syndrome, Adrenal suppression (with intensive or long-term continuous therapy in predisposed patients)

Key Safety Warnings and Contraindications

  • Duration of Use: Use for 10 days or longer carries an increased risk of elevated IOP and glaucoma. Routine monitoring of IOP is required for extended treatment.
  • Contraindications: The medication is strictly contraindicated in most viral diseases of the cornea and conjunctiva (including herpes simplex keratitis), mycobacterial infection of the eye, fungal diseases of ocular structures, and in individuals with known hypersensitivity to any component (especially Neomycin).
  • Corneal Thinning: Topical steroid use in conditions causing thinning of the cornea or sclera can lead to globe perforation.
  • Secondary Infections: Prolonged use may suppress the body's immune response, increasing the hazard of secondary bacterial or fungal infections of the eye.

Overdose and Emergency Response

Overdose Manifestations and Immediate Actions

Acute overdose resulting from excessive topical application of the ophthalmic product may lead to localized signs such as punctuate keratitis, erythema, increased lacrimation, and lid itching. In such instances of acute local excess, official regulatory instructions state that the eye(s) may be flushed with lukewarm or warm water as a supportive measure.

The accidental oral ingestion of the product is generally not expected to produce acute toxic effects from the quantity in a single container. However, regulatory authorities mandate that if the medication is accidentally swallowed, individuals must seek emergency medical attention or call the Poison Help line immediately, to ensure appropriate observation is undertaken.

Risks from Excessive Exposure

The most significant outcomes associated with use in excess of listed dosing instructions are linked to the systemic absorption of the Dexamethasone component. This excessive exposure carries a risk of severe endocrine effects, including Cushing's syndrome and adrenal suppression. Regulatory labeling notes that children and patients taking CYP3A4 inhibitors are particularly predisposed to these systemic risks.

Monitoring of intraocular pressure (IOP) is required if the product is used for 10 days or longer, as increased IOP is a documented complication of prolonged exposure to the corticosteroid. No specific antidote is formally documented in the official prescribing information.

Therapeutic Uses of Макситрол

Quick Facts: Uses of Макситрол

  • Ocular Inflammation: Helps manage inflammatory conditions of the external eye structures, including the conjunctiva, cornea, and anterior globe segment.
  • Bacterial Infection Risk: Indicated when a corticosteroid is needed and a bacterial infection exists or there is a risk of a bacterial ocular infection.
  • Injury Management: May be used to help address inflammation resulting from corneal injury caused by chemical, radiation, or thermal burns, or from the penetration of foreign bodies.

What Макситрол Treats: Main Uses and Benefits

Макситрол (Neomycin and Polymyxin B Sulfates and Dexamethasone ophthalmic) is a combination product used to help treat certain conditions affecting the eye. The primary therapeutic use is for steroid-responsive inflammatory ocular conditions when a concurrent bacterial infection is present or where the risk of such an infection is considered high.

The medication is utilized to help achieve a diminution in edema and inflammation in the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye. This includes help managing inflammation associated with chronic anterior uveitis. Additionally, it may be indicated for reducing inflammatory reactions that may follow a corneal injury, such as those caused by chemical, radiation, or thermal burns.

The inclusion of an antimicrobial component is intended to help reduce the risk of secondary bacterial ocular infection in susceptible patients. This treatment approach is guided by the established need for both an anti-inflammatory agent and an anti-infective agent within the context of the condition being managed.

Eligibility and Restrictions for Use

Eligibility Map: Who can and cannot use Макситрол — official regulatory information

Category Official Regulatory Statement
Populations for whom use is allowed Adults, including the geriatric population [2.1, 2.8]. Children aged ge 2 years [2.2, 2.4]. Patients with steroid-responsive inflammatory ocular conditions when a concurrent bacterial infection or risk of infection exists [1.1, 1.2].
Populations for whom use is contraindicated Individuals with known or suspected hypersensitivity to Dexamethasone, Neomycin, Polymyxin B, or any component [1.1, 1.2]. Patients with Viral diseases of the cornea and conjunctiva, including Epithelial Herpes Simplex Keratitis, Vaccinia, or Varicella [1.1, 1.2]. Patients with Fungal or Mycobacterial infection of the ocular structures [1.1, 1.2].
Age-related eligibility rules Safety and effectiveness have not been established in children younger than 2 years of age [2.2, 2.4]. No overall differences in safety or effectiveness have been observed in older adults; no dose adjustment is required [2.1, 2.8].
Condition-specific eligibility rules Patients with Hepatic or Renal Impairment have not been studied; however, dose adjustment is considered unnecessary [2.1]. Patients with a history of diabetes have an increased risk of corticosteroid-induced raised intraocular pressure [2.1].
Pregnancy and lactation eligibility status Pregnancy (Category C - US FDA): Use should occur only if the potential benefit justifies the potential risk to the fetus or embryo [1.1, 1.2]. Lactation: Caution should be exercised; use is dependent on a risk-benefit assessment [1.2].
Eligibility-related restrictions Use with caution in patients with diseases causing thinning of the cornea or sclera due to perforation risk [1.1, 1.2]. Contact lens wear is generally discouraged during treatment [2.1].

Connection to the overall eligibility profile: Official regulatory documents define eligibility for Макситрол by establishing absolute contraindications that prohibit use in patients with specific ocular infections or component allergies. Eligibility is further restricted by age, with use not established for children under two years old, and by physiological status, with conditional use applied to pregnant and nursing women. These constraints ensure the combination agent is reserved for the approved population where the dual action is appropriate according to label requirements.

What should I know about interactions with other medicines?

The official regulatory profile for this medicine documents specific interaction patterns concerning systemic exposure, additive risks, and administration timing.

Systemic Exposure-Altering Agents

Co-administration with certain agents classified as CYP3A4 inhibitors, including specific medicines like ritonavir and cobicistat, may interfere with the body's breakdown of the Dexamethasone component. This pharmacokinetic interaction reduces Dexamethasone clearance, resulting in increased systemic exposure. Regulatory labeling advises that this combination should be avoided unless the therapeutic benefit is deemed to outweigh the increased risk of systemic corticosteroid side-effects, such as adrenal suppression.

Additive Risks and Pharmacodynamic Effects

An additive toxicity risk is officially documented with the antibiotic components. Concomitant or sequential use with systemic, oral, or topical drugs that have neurotoxic, ototoxic, or nephrotoxic effects should be avoided whenever possible, to prevent compounding these documented risks. Furthermore, the combination of the topical steroid with other topical Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) may increase the documented potential for corneal healing problems.

Administration Timing and Cautions

A mandatory timing rule applies to ocular administration: when using any other topical ophthalmic medicinal product, the preparations must be administered at least 5 minutes apart, with any ointments applied last. Official labeling also advises caution for patients with a personal or family history of diabetes due to the possibility of reduced glucose tolerance related to topical corticosteroid exposure.

Mechanism of Action

Modulating the Ocular Inflammatory Cascade

This domain describes how the corticosteroid component, dexamethasone, acts as a glucocorticoid agonist. It engages intracellular glucocorticoid receptors to inhibit the transcription of pro-inflammatory genes and enzymes like phospholipase A2. This fundamental action results in decreased production of pro-inflammatory mediators, which alters subsequent pathway activity and microvascular permeability.


Dual Action Against Bacterial Cell Systems

This domain covers the combined antibacterial mechanism provided by neomycin and polymyxin B. Neomycin targets the bacterial 30S ribosomal subunit, disrupting protein synthesis, while polymyxin B disrupts the integrity of the bacterial cell membrane. This combined assault on the internal protein-making machinery and the external cell structure results in bacterial cell death, leading to cellular lysis and subsequent disruption of bacterial colony formation.

Dosage and Administration Information

How to Use Макситрол: Administration Guidelines

Макситрол (Neomycin and Polymyxin B Sulfates and Dexamethasone ophthalmic) is administered through the topical ocular route—applied directly to the eye or into the conjunctival sac. The medication is available in two sterile forms: an ophthalmic suspension (eye drops) and an ophthalmic ointment.


Dosing and Frequency

The usage protocol is typically short-term and relies on a titrated dosing schedule that is adjusted as the clinical condition improves. For the suspension in acute, severe inflammation, the frequency may be as often as one to two drops every hour. As favorable response is observed, the frequency is typically gradually reduced to one drop every four to six hours.

Feature Detail
Suspension Initial Dose One to two drops per application
Ointment Dose Approximately 1/2 inch ribbon per application
Ointment Frequency Typically applied three or four times daily
Course Duration Limited, generally up to 10 days

Administration Requirements

The ophthalmic suspension must be shaken well before each use to ensure proper dispersion of the active ingredients. A critical constraint during the course of treatment is that contact lenses should not be worn. Furthermore, special care must be maintained to avoid contaminating the applicator tip of the bottle or tube during application to preserve sterility. The medication is indicated for use in children two years of age and older, with no specific dosage adjustments typically required for older adults due to its topical application.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Макситрол

Evidence for Steroid-Responsive Ocular Inflammation with Infection Risk

The research describing the regulatory context of this triple-combination product (Dexamethasone, Neomycin, Polymyxin B) primarily relies on the historical evidence of combining these components for eye conditions where both inflammation and a risk of bacterial contamination are present. The evidence base was built upon historical clinical experience with the combination's components and regulatory findings that described the clinical contexts where the product was evaluated in relation to inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior globe segment.

Regulatory research has focused on comparative bioequivalence studies, which monitor how the active ingredients behave and are absorbed, mainly in adult patients. Other research included in vitro studies where the antimicrobial components was observed in tests against specific common bacterial eye pathogens. This research described the spectrum of bacterial susceptibility studied, including organisms such as Staphylococcus aureus and Pseudomonas aeruginosa.


Study Outcomes and What Researchers Examined

The primary focus of the regulatory evidence and supporting research was on outcomes linked to inflammatory or irritative states and the measurement of changes in the microbiological environment. Researchers explored the use of the formulation, examining outcomes related to edema and inflammation within the affected areas of the eye. Evidence also involves monitoring the microbiological environment to understand the scope of susceptibility patterns associated with Neomycin and Polymyxin B against pathogens studied. Related research further contributes to the broader evidence landscape by monitoring functional outcomes like visual acuity over defined time intervals. The findings describe patterns observed in these studies, but research does not determine whether an individual will respond similarly.


Evidence in Specific Patient Groups

Studies have explored how different groups of people were monitored to understand if patient characteristics were associated with patterns related to the outcomes.

  • Older Adults: Studies have been observed in regulatory reviews; these findings did not indicate patterns related to geriatric-specific differences in the populations studied when compared to other adult patients. Findings describe group patterns related to general adult use.
  • Pediatric Populations: The evidence remains limited for pediatric use. Effectiveness has not been established in children, particularly for those younger than 2 years of age. The research provides context on the adult population, but data for certain groups remain insufficient.
  • Pregnancy and Lactation: There are no adequate or well-controlled studies in pregnant women. Research in animals was observed in some studies to inform the lack of certainty in humans, and therefore, long-term effects are not fully established. It is unknown whether the components are excreted in human milk after topical ophthalmic use.

What is Still Uncertain About the Research for Макситрол

There are specific areas where the research base is limited. The data for certain groups remain insufficient, especially for pediatric patients under the age of two. Additionally, long-term effects are not fully established through specific dedicated trials, particularly concerning potential changes that may occur with extended observation periods. While the combination is included in regulatory documentation, comparative evidence is lacking from modern, large-scale studies directly comparing this specific triple combination against the individual components or other regimens for every indication.

Key Studies & References

  1. Dexamethasone, Topical Ophthalmic - MedlinePlus Drug Information

Frequently Asked Questions (FAQ)

Common questions about Макситрол (FAQ)


Q: What should be done if vision becomes slightly blurred after using Макситрол? (Что делать, если после Макситрола зрение стало немного расплывчатым?)

It is officially documented that your vision may be temporarily blurred following the administration of the eye suspension or ointment. Because of this known temporary effect, official information advises exercising caution when driving a motor vehicle or operating heavy machinery immediately after using the product. Concerns about vision changes should be discussed with a healthcare professional.


Q: What are the most common side effects that occur when using Макситрол? (Какие побочные эффекты чаще всего возникают при использовании Макситрола?)

According to clinical trial data, the most frequently reported adverse reactions are ocular discomfort, eye irritation, and inflammation of the cornea (keratitis). These effects are generally uncommon, typically occurring in less than 1% of patients studied. Detailed information about side effects is provided in the official product labeling.


Q: Can Макситрол cause redness or burning in the eyes? (Может ли Макситрол вызвать покраснение или жжение в глазах?)

Yes, official safety information indicates that eye redness (ocular hyperemia), eye irritation, and a burning sensation may occur, although they are uncommon. Any severe or persistent symptoms should be discussed with a healthcare provider.


Q: Is Макситрол sold by prescription or can it be purchased freely? (Макситрол продается по рецепту или его можно купить свободно?)

Макситрол is classified as a prescription-only medicine in official regulatory markets. This means it requires a valid medical prescription from an authorized healthcare professional.


Q: What is “dry eye syndrome” after prolonged use of Макситрол? (Что такое «синдром сухого глаза» после длительного применения Макситрола?)

The product contains benzalkonium chloride, a preservative, which regulatory warnings state may cause eye irritation. This is especially true for individuals who already have dry eyes or existing disorders of the cornea. Patients with a history of dry eye syndrome may wish to consult a healthcare professional regarding the use of this product.


Q: Why might Макситрол not be helping in my case (general question about ineffectiveness)? (Почему Макситрол не помогает в моем случае (общий вопрос о неэффективности)?)

According to official warnings, a lack of improvement could be due to several factors. Prolonged use of the antibiotic components may sometimes lead to the overgrowth of non-susceptible organisms, such as fungi. Additionally, the steroid component may sometimes mask the clinical signs of an underlying infection, requiring further evaluation by a healthcare professional.


Q: What is in Макситрол besides the antibiotics? (Что входит в состав Макситрола кроме антибиотиков?)

In addition to the three active ingredients—dexamethasone (the steroid), neomycin, and polymyxin B (the antibiotics)—the suspension contains other components known as excipients. These include a preservative called benzalkonium chloride and other agents, such as hypromellose, which stabilize the formulation.


Q: Can the use of Макситрол affect blood test results? (Может ли применение Макситрола повлиять на результаты анализа крови?)

Although Макситрол is applied topically to the eye, there is a recognized risk of some systemic exposure, particularly with prolonged or very intensive use. This potential systemic absorption may, in susceptible individuals, lead to systemic effects of the corticosteroid component, such as adrenal suppression. It is important for patients to inform their healthcare providers about all medications they are taking.


Q: How does Макситрол differ from Dexamethasone? (Чем отличается Макситрол от Дексаметазона?)

Dexamethasone is the name of the steroid component alone, which provides the anti-inflammatory action. Макситрол is a fixed-dose combination product. It combines dexamethasone with two antibiotics, neomycin and polymyxin B, making it a dual-action treatment that addresses both inflammation and bacterial infection risk.


Q: Can Макситрол be used simultaneously with other systemic antibiotics? (Можно ли использовать Макситрол одновременно с другими системными антибиотиками?)

Caution is advised when Макситрол is used alongside other systemic medications that belong to the same drug classes as its antibiotic components (aminoglycosides or polymyxin B). Regulatory information warns that combining these may increase the risk of serious side effects, such as neurotoxicity, ototoxicity (hearing damage), and nephrotoxicity (kidney damage), which are associated with the systemic use of those agents.


Q: What precautions should be observed when using Макситрол? (Какие меры предосторожности нужно соблюдать при использовании Макситрола?)

Key precautions detailed in official documents include avoiding the use of contact lenses during treatment. If the product is used for ten days or longer, routine monitoring of the internal eye pressure is required. Users must also be aware of the small, known risk of secondary infections and the potential for corneal or scleral thinning.


Q: Does Макситрол affect the effectiveness of other medications being taken (systemic)? (Влияет ли Макситрол на эффект от других принимаемых лекарств (системных)?)

Yes, regulatory documents describe a potential interaction with certain systemic medicines classified as CYP3A4 inhibitors (for example, ritonavir or cobicistat). The combined use of these drugs can reduce the body’s breakdown of the steroid component, potentially increasing the risk of systemic corticosteroid side-effects.


Q: If a dose of Макситрол is missed, what should be done next? (Если пропустил одно закапывание Макситрола, что делать дальше?)

Regulatory patient information often suggests that if a dose is missed, it should be used as soon as it is remembered. However, if the time is very close to your next scheduled dose, you should skip the missed dose entirely. It is generally cautioned not to double the dose to make up for a missed application.


Q: Can Макситрол be used for prevention after eye surgery? (Можно ли использовать Макситрол для профилактики после операции на глазу?)

Official indications state that the product is suitable for steroid-responsive inflammatory ocular conditions where a bacterial infection or risk of infection exists. The application of this medication in the post-operative setting is determined by a healthcare professional.


Q: How can one tell that the infection has completely passed after using Макситрол? (Как узнать, что инфекция полностью прошла после применения Макситрола?)

Official guidance advises that a healthcare professional should be consulted if inflammation or pain persists longer than 48 hours or becomes aggravated. Even if your symptoms improve quickly, it is generally recommended to continue using the medication for the full time prescribed to ensure the infection is completely cleared.


Q: Should Макситрол be stopped if the eyes feel better? (Нужно ли прекращать прием Макситрола, если глазам стало лучше?)

Patient information generally indicates that continued use for the full prescribed duration is important, even if symptoms improve quickly. Stopping the medication too early can lead to the infection returning or the bacteria developing resistance to the antibiotics.


Q: What are the most serious but rare side effects of Макситрол? (Каковы самые серьезные, но редкие побочные эффекты Макситрола?)

Serious reactions that have been reported include the potential for anaphylaxis (severe allergic reaction), Stevens-Johnson syndrome, and an increase in intraocular pressure (IOP) that could potentially lead to glaucoma. Any experience of severe or sudden symptoms should prompt immediate discussion with a healthcare provider.


Q: Does Макситрол affect the healing of the cornea? (Влияет ли Макситрол на заживление роговицы?)

Yes, regulatory documents indicate that the steroid component, dexamethasone, has the potential to delay or slow the normal process of wound healing in the eye. The use of the steroid after certain surgical procedures, such as cataract surgery, may be associated with delayed healing.


Q: What is the difference between Макситрол (drops) and other popular antibiotic eye drops? (В чем разница между Макситролом (капли) и другими популярными глазными каплями с антибиотиком?)

The key difference is that Макситрол is a triple-combination product. It provides a unique dual action by combining a potent anti-inflammatory steroid (dexamethasone) with two different anti-infective agents (neomycin and polymyxin B), whereas some other common eye drops may contain only a single antibiotic.


Q: Does Макситрол affect the operation of machinery? (Влияет ли Макситрол на управление механизмами?)

Official information explicitly states that due to the potential for temporary blurred vision immediately following application, caution should be exercised. It is advised not to operate machinery or drive a motor vehicle until your vision has completely cleared.

How should Макситрол be stored and disposed of?

Official Storage and Disposal Requirements

Storage and handling instructions for Maxitrol (Макситрол) are provided on the regulatory label and must be followed to maintain product stability and safety.

Requirement Area Official Instructions
Temperature & Protection Store at or below 25^circmathrmC (77^circmathrmF). Do not refrigerate the ophthalmic ointment or suspension. Keep away from direct sunlight and store the suspension upright in its original container.
In-Use Stability The medicine must be discarded 28 days (one month) after the container is first opened, regardless of the amount of product remaining.
Child Safety Always keep Maxitrol out of the reach and sight of children.
Disposal Rules To protect the environment, do not dispose of this medicine in household trash or pour it into wastewater. Unused or expired medication should be returned to a pharmacist or local disposal program as directed by official regulations.

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

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