Lecrolyn

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Lecrolyn

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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 Lecrolyn

What is Lecrolyn?

Lecrolyn is an ophthalmic solution used for the management of allergic eye symptoms. It belongs to a group of medications known as mast cell stabilizers. The active ingredient in this medication is sodium cromoglicate.

Mechanism of Action

The active substance works by preventing the release of natural substances, such as histamine, from specific cells in the eye called mast cells. In individuals with allergies, these mast cells can become unstable and release inflammatory mediators when exposed to allergens like pollen, dust mites, or animal dander. By stabilizing the cell membrane, Lecrolyn helps to reduce the underlying cause of allergic inflammation.

Therapeutic Use

Lecrolyn is primarily used to alleviate the symptoms associated with various forms of allergic conjunctivitis. These symptoms typically include:

  • Redness of the eyes
  • Itching or burning sensations
  • Watery discharge
  • Swelling of the eyelids or the conjunctiva

It is often utilized for both seasonal allergic conjunctivitis, which occurs at specific times of the year, and perennial allergic conjunctivitis, which can persist year-round due to indoor allergens.

What side effects are possible with Lecrolyn?

Possible Side Effects and Safety Information

The safety profile for Lecrolyn (sodium cromoglicate ophthalmic solution) is characterized by a low incidence of adverse reactions, primarily local ocular irritation, due to the drug's minimal systemic absorption. Safety data is established via regulatory reviews from authorities such as the EMA and FDA (for the active substance).

Adverse Reactions Summary

Classification (Frequency) Adverse Reaction Scope
Common (Less than 1 in 10) Transient stinging or burning sensation upon instillation.
Rare (Less than 1 in 1,000) Other local irritation symptoms (e.g., dryness, puffiness, eye irritation).
Extremely Rare (Less than 1 in 10,000) Hypersensitivity reactions (severe allergic reactions, including swelling, rash, or breathing difficulties).

Serious Adverse Reactions: Although classified as extremely rare, hypersensitivity reactions to the active substance or excipients are considered clinically significant and require immediate attention.

Safety Restrictions and Population Considerations

Contraindication: Lecrolyn is contraindicated in patients with known hypersensitivity to sodium cromoglicate or any of the product's excipients.

Preservative Caution: Formulations containing the preservative benzalkonium chloride have specific limitations. This preservative may be absorbed by and discolor soft contact lenses; therefore, lenses must be removed before use and reinserted after at least 15 minutes. Benzalkonium chloride may also cause or exacerbate eye irritation and symptoms of dry eyes, especially with prolonged use or in patients with corneal disorders.

Driving and Machinery: The drops may cause a transient blurring of vision immediately following instillation. Patients are advised not to drive or operate machinery until vision is completely clear.

Pregnancy and Lactation: As systemic absorption is very low (typically less than 0.07%), adverse effects on the fetus or breastfed infant are considered unlikely. However, as with all medications, caution is advised, and use during pregnancy, especially the first trimester, should only be when there is a clear medical need.

Overdose and Emergency Response

Overdose and When to Seek Help

The active ingredient in Lecrolyn ophthalmic solution, cromoglicic acid, is generally known to have low potential for acute systemic toxicity, even when ingested in larger-than-normal quantities. The poor systemic absorption of the drug from the eye further limits the risk of a serious reaction following typical accidental overdose or misuse.

Documented Overdose Profile

Official regulatory sources indicate that symptoms of overdosage, if they occur, are typically mild and non-serious.

  • Acute Non-Serious Symptoms: These may include general discomfort such as nausea, vomiting, upper abdominal pain, headache, cough, sneezing, or wheezing. These effects are usually transient and manageable with supportive measures.
  • Serious Complications: Due to the drug's low toxicity profile, serious or life-threatening systemic complications are not commonly documented in regulatory safety summaries.

Required Emergency Actions

In the event of an overdose, the general regulatory guidance is to administer symptomatic and supportive treatment. There is no specific antidote for cromoglicic acid. Treatment focuses on managing any reported symptoms until they resolve.

When to Seek Immediate Medical Help

While an overdose of the eye solution is not generally expected to be life-threatening, you should seek immediate medical attention if severe or unusual symptoms develop, or if you are concerned about a very large ingestion. Always contact a poison control center or emergency services for guidance based on the specific circumstances.

Therapeutic Uses of Lecrolyn

What Lecrolyn treats: main uses and benefits

The therapeutic focus is relevant for the management of symptoms associated with allergic eye conditions. This medication is commonly used across conditions presenting with episodic or recurrent manifestations, such as seasonal (hay fever) and perennial allergic conjunctivitis. It is applied across therapeutic domains involving symptoms related to inflammatory or irritative states linked to environmental triggers.

Lecrolyn helps address symptom clusters that may become intense or disruptive, such as pruritus (itching), burning sensation, watering, and redness. Applied in scenarios where additional management of discomfort is required, this therapy assists in easing the overall symptom load and supports the management of symptoms that interfere with daily comfort. The medication's prophylactic value may be part of symptomatic management, commonly used in settings where short-term symptom stabilization is important.

Quick Fact: Symptom Support for Ocular Pruritus and Redness

Eligibility and Restrictions for Use

The eligibility profile for Lecrolyn (Sodium Cromoglycate Ophthalmic Solution) is defined strictly by regulatory guidelines concerning patient characteristics and pre-existing conditions. Use is permitted only when these official eligibility criteria are met.

Contraindications and Prohibitions

Non-Eligibility Criterion Regulatory Status
Hypersensitivity to sodium cromoglycate or excipients Contraindicated (Absolute prohibition)
Children under 2 years of age Contraindicated (Specific EU/UK labeling)
Use while wearing soft contact lenses Prohibited (Must remove lenses before use)

Conditional and Age-Based Eligibility

Population Group Regulatory Status
Adults and Older Adults Allowed (No dosage adjustment required)
Children 4 years and older Established (US FDA labeling)
Children below 4 years of age Safety and effectiveness Not Established
Pregnancy (FDA Category B) Use Only If Clearly Needed
Lactation (Nursing Mothers) Caution is advised
Dry Eye / Compromised Cornea Use with Caution

These regulations establish clear boundaries for appropriate use, defining non-eligible populations by absolute contraindications and minimum age thresholds. Eligibility is further made conditional based on concurrent practices like contact lens wear and physiological states such as pregnancy or lactation.

What should I know about interactions with other medicines?

Regulatory information for sodium cromoglicate (the active substance in Lecrolyn ophthalmic solution) indicates a limited profile for drug-drug interactions.

General Interaction Profile

Official regulatory documents state that no harmful interactions with other systemic medicines are known to occur. This is attributed to the drug’s pharmacological properties, including its poor systemic absorption following topical application to the eye. In human volunteers, only trace amounts of the drug are absorbed into the systemic circulation.

Specific Interaction Statements

While general use is associated with a low interaction risk, some regulatory documents mention a single, specific interaction observed in animal studies. This was noted in pregnant mice where a high subcutaneous dose of sodium cromoglicate, when combined with isoproterenol, resulted in an increased incidence of major fetal malformations compared to the drug alone. This finding has not been observed in rats or rabbits and does not constitute a clinical restriction for the ophthalmic formulation in humans.

Other concurrent therapies, such as other ophthalmic solutions (e.g., steroids or antibiotics), have been used in association with sodium cromoglicate in studies with no observed drug-drug interactions in animal eyes.

Mechanism of Action

Inhibition of Mast Cell Degranulation

This domain covers the primary biological target and molecular interaction of Sodium Cromoglycate. The compound acts at the surface of the mast cell, a specialized immune cell, to inhibit the process of degranulation. Its action involves modulating the flux of calcium ions ( Ca^2+) across the cell membrane, which is the essential molecular signal required to trigger secretion. By inhibiting this key step, the compound functionally stabilizes the cell and interferes with the stimulus-secretion coupling necessary for the acute immune cascade.

Blockade of the Acute Mediator Cascade

This domain explains the resulting pathway effects and physiological consequences. The cellular stabilization mechanism directly blocks the release of potent, pre-formed chemical signals, primarily histamine, as well as newly synthesized mediators like leukotrienes, into the local tissue. This pharmacological intervention blocks the mediator release that drives increased vascular permeability and nerve activation in the conjunctiva. The mechanism is dependent on the compound's presence prior to allergen exposure to achieve maximal cellular stabilization.

Dosage and Administration Information

How to Use Lecrolyn: Administration Guidelines

Lecrolyn (Sodium Cromoglycate ophthalmic solution) is administered via the topical ocular route, meaning it is applied directly to the conjunctival sac of the eye. Its effectiveness depends on consistent and regular dosing throughout the exposure period to allergens.


Dosage and Frequency

The standard regimen is 1 or 2 drops instilled into each affected eye. The typical dosing frequency is four times a day (QID) at regular intervals.

Population Standard Dosing
Adults and Elderly 1 or 2 drops per eye, 4 times daily.
Children 1 or 2 drops per eye, 4 times daily (typically over 4 years of age).

For a missed dose, patients should skip the forgotten dose and resume the normal schedule, without using a double dose to compensate. Therapy should be continued for as long as required to sustain improvement, often throughout the entire allergen season.


Procedural Instructions

Proper technique is required to maintain the sterility of the solution and ensure correct delivery.

  • Sterility: The dropper tip must not touch the eye, eyelid, fingers, or any other surface during application.
  • Contact Lenses: Soft contact lenses must be removed prior to instillation of the eye drops and can only be reinserted 15 minutes afterwards.
  • Co-Administration: If other topical eye preparations are used, a minimum interval of 15 minutes must be observed between the application of the products.
  • Container Life: Multi-dose solutions must be discarded after four weeks of first opening.

Standardizing the procedure for using the medicine emphasizes the regimen and technique used to support the protective action.

Recent Clinical Evidence

Lecrolyn: Recent Clinical Evidence

Clinical research has investigated Lecrolyn (sodium cromoglicate) as a topical treatment for various allergic eye conditions, including seasonal allergic conjunctivitis (SAC) and vernal keratoconjunctivitis (VKC).


Primary Research Focus

Lecrolyn belongs to a class of medications known as mast cell stabilizers. Studies have explored whether the active substance, sodium cromoglicate, prevents certain cells in the eye from releasing histamine and other inflammatory mediators that are associated with allergic symptoms like itching, redness, and tearing.

Key Findings from Clinical Trials

Numerous double-blind, placebo-controlled trials and systematic reviews have evaluated the use of sodium cromoglicate ophthalmic solution in adults and children (typically aged 4 and older):

  • Symptom Relief: A meta-analysis of multiple trials suggested that participants using topical sodium cromoglicate were more likely to perceive benefit in reducing symptoms compared with those using a placebo.
  • Onset of Action: Unlike some other topical allergy treatments, sodium cromoglicate is studied as a prophylactic (preventative) agent. Study results indicate that symptomatic improvement is often observed within a few days, but consistent use over several weeks may be required to achieve its full potential, suggesting a slow onset of action.
  • Comparative Studies: Some studies have investigated the outcomes associated with sodium cromoglicate when compared to other ocular anti-allergy agents, such as nedocromil sodium. These comparative analyses reported differing results on the degree and speed of symptom reduction.

Safety and Tolerability

Across clinical studies, sodium cromoglicate ophthalmic solutions were generally observed to be well-tolerated. The most frequently reported adverse event was transient local stinging or burning upon application. Due to minimal systemic absorption from the eye, the risk of non-ocular side effects was considered low in the populations studied.

Frequently Asked Questions (FAQ)

Common questions about Lecrolyn (FAQ)

Q: Are there any long-term safety concerns from using Lecrolyn for many months?

Lecrolyn is sometimes used consistently over an extended period, such as throughout an allergen season, to achieve its full effect. However, for formulations that contain the preservative benzalkonium chloride, regulatory documents indicate that the use of such products should be approached with caution and may require monitoring. Specifically, patients with dry eyes or corneal disorders are generally advised to discuss prolonged use with a healthcare professional.

Q: Do I need a prescription to get Lecrolyn?

The regulatory status of eye drop formulations containing sodium cromoglicate can vary depending on the country or region. In some markets, the product may be legally classified as an over-the-counter (OTC) medicine available without a prescription. In other markets, the medicine remains a prescription product requiring authorization from a doctor.

Q: Can Lecrolyn be used for eye redness that is NOT caused by allergies?

Official regulatory documents indicate that Lecrolyn is specifically intended only for the treatment of allergic disorders of the eye, such as allergic conjunctivitis. Therefore, its use for redness or irritation that is not caused by an allergic reaction is not indicated in the official product information.

Q: What should I do if I accidentally put too many drops of Lecrolyn in my eye?

The drug has minimal absorption into the body after being applied to the eye, meaning the risk of serious systemic side effects from acute over-instillation is considered low. According to official guidance, medical observation is recommended in the event that more drops than recommended are put in, and the normal dosing regimen should be continued thereafter.

Q: Are there known risks associated with mixing Lecrolyn and alcohol consumption?

Official regulatory documents state that no harmful interactions with alcohol consumption are known to occur when using the ophthalmic solution. This profile is consistent with the drug’s pharmacological properties, which show poor systemic absorption following topical application to the eye.

Q: Can I use Lecrolyn for eye irritation from wind or dust?

The official therapeutic use of Lecrolyn is strictly limited to treating symptoms that result from allergic conditions. Use for general eye irritation caused by factors like wind or dust—which are not allergic in nature—is not indicated in the official product information.

Q: Is it normal to see some discharge or crusting after using Lecrolyn?

Official summaries of adverse effects generally do not list discharge or crusting as either a common or rare side effect. Most frequently reported adverse effects are limited to transient local irritation, such as a temporary stinging sensation or burning immediately upon application.

Q: Can I use Lecrolyn if I have had eye surgery recently?

Official regulatory warnings suggest that if an intercurrent ocular condition occurs, such as recent eye surgery or trauma, patients should consult with a physician regarding the continued use of the multi-dose container. This consultation helps ensure that the continued use remains appropriate.

Q: Is it true that Lecrolyn is a non-steroidal anti-inflammatory drug (NSAID)?

No, this is not the case. The active ingredient in Lecrolyn, sodium cromoglicate, is officially classified as a mast cell stabilizer. It belongs to the anti-allergic agent class, which operates through a mechanism distinct from that of non-steroidal anti-inflammatory drugs (NSAIDs).

How should Lecrolyn be stored and disposed of?

How to Store and Dispose of Lecrolyn?

The storage and disposal of Lecrolyn (Sodium Cromoglycate eye drops) must follow strict official regulatory guidelines to maintain stability and ensure safety.

Storage Conditions

Mandatory Storage: The medicine must be stored at a temperature at or below 25 °C or 30 °C (varies by product label) and must not be frozen. It must be kept out of the sight and reach of children and protected from light by storing it in its original outer carton.

Stability Limits: Multi-dose bottles must be kept tightly closed and discarded four weeks (one month) after first opening. Single-dose units must be used immediately after opening and the remainder discarded.

Disposal Instructions

Lecrolyn must not be thrown away via household waste or flushed down the toilet. All unused or expired product must be returned to a pharmacist for safe disposal in accordance with local environmental regulations.

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

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