Polcrom 2%

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

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 Polcrom 2%

What is Polcrom 2%?

Polcrom 2% is a medicinal product in the form of eye drops, primarily used to alleviate symptoms associated with allergic inflammation of the eyes. The active substance in this preparation is sodium cromoglicate.

Mechanism of Action

Sodium cromoglicate belongs to a group of medications known as mast cell stabilizers. Mast cells are a type of white blood cell that play a significant role in the body's immune response. During an allergic reaction, these cells release various chemical mediators, such as histamine, which lead to common allergy symptoms including redness, itching, and swelling.

Polcrom 2% works by stabilizing the membranes of these mast cells. By preventing the release of histamine and other inflammatory substances, the medication helps to manage the underlying cause of allergic discomfort rather than just masking the symptoms.

Therapeutic Use

This medication is typically utilized for the following conditions:

  • Allergic Conjunctivitis: Inflammation of the conjunctiva caused by allergens such as pollen, pet dander, or dust mites.
  • Seasonal and Perennial Allergies: Management of eye symptoms that occur during specific seasons (hay fever) or throughout the year.

Because of its mechanism of action, Polcrom 2% is often most effective when used consistently. It is designed to act locally on the surface of the eye to provide targeted relief from allergic reactions.

Regulatory References

  1. anti-allergic agents
  2. histamine

What side effects are possible with Polcrom 2%?

Possible Side Effects and Safety Information

The safety characteristics of topical Sodium Cromoglycate (Polcrom 2%) are classified by regulatory authorities based primarily on the localized effects at the site of administration, with systemic reactions being rare due to limited absorption.

Adverse Reaction Classification

Adverse reactions are grouped into System-Organ Classes (SOC) and assigned a frequency, with the most common effects being localized and transient:

  • Eye Disorders: The most frequently reported effect upon instillation of the eye drops is transient stinging or burning. Less common ocular effects documented in regulatory labeling include eye itching, dryness, watering, or conjunctival injection (redness).
  • Respiratory Disorders: Use of the intranasal solution may be followed by transient nasal stinging, burning, or increased sneezing.
  • Immune System Disorders: Rare but clinically significant reactions documented in official labeling include immediate hypersensitivity reactions (such as generalized rash or swelling) and, very rarely, anaphylaxis.

Safety Considerations and Restrictions

Official regulatory documents contain specific safety notes and restrictions:

  • Population Notes: Safety and effectiveness of the ophthalmic product have not been established for children under 4 years of age. Use during the first trimester of pregnancy requires explicit professional assessment, though systemic risk is considered low.
  • Excipient Restriction: The ophthalmic formulation contains Benzalkonium Chloride, which is noted in regulatory text for its potential to cause irritation and the risk of absorption by soft contact lenses.
  • Driving: Patients are advised against driving or operating machinery immediately following administration if they experience transient blurring of vision until normal vision is restored.

The official safety profile is characterized by classifying most adverse effects as localized and transient, while specifying constraints regarding pediatric use and highlighting the need to monitor for rare, immediate hypersensitivity reactions.

Overdose and Emergency Response

Overdose and When to Seek Help

Official regulatory information for Polcrom 2% (sodium cromoglicate) indicates a low risk for severe systemic effects due to its limited absorption when used correctly. The official overdose profile focuses on potential clinical manifestations that may require professional assessment.

Documented Overdose Indications

While Polcrom 2% is generally considered to have a low potential for causing an adverse systemic reaction following an overdose, the drug's properties suggest a risk for certain physical signs based on its chemical class. The documented clinical manifestations associated with an overdose situation, which necessitate medical observation, include:

  • Dry mouth
  • Visual accommodation disorder (difficulty focusing the eyes)
  • Tachycardia (abnormally rapid heart rate)

Required Emergency Action

Immediate professional medical help should be sought if an overdose is suspected and these signs or any other concerning symptoms appear. Overdose management for products containing sodium cromoglicate is typically symptomatic and supportive, meaning care is focused on managing the physical effects experienced. Official labeling and regulatory guidance often recommend contacting a regional Poison Control Centre or seeking emergency medical services immediately for advice and management of a suspected drug overdose. Continued medical observation may be necessary, even if initial symptoms appear mild.

Therapeutic Uses of Polcrom 2%

Polcrom 2% (Sodium Cromoglycate topical solution) is commonly used to help manage symptoms associated with allergic reactions in the eyes and nose. This medication is applied across therapeutic domains involving distressing symptoms of acute and recurrent allergic episodes.

The medicine is used in conditions characterized by periods of heightened symptoms, focusing on symptoms related to inflammatory or irritative states. Key indications include Seasonal Allergic Conjunctivitis and Perennial Allergic Rhinitis. This application is often relevant when supportive symptom management is appropriate, such as during phases when symptoms become more noticeable.

Polcrom 2% helps address symptom clusters that may appear suddenly, providing support that helps ease the overall symptom load. It is applied to assist with managing major ocular symptoms like intense itching and tearing, alongside key nasal manifestations such as frequent sneezing, watery rhinorrhea, and nasal congestion simultaneously. This application may help patients cope more steadily with difficult episodes.

Quick Fact: Support for Localized Discomfort
This medication is primarily used in a preventative (prophylactic) manner to assist with easing the impact of symptoms before they become temporarily overwhelming.

Eligibility and Restrictions for Use

Who can and cannot use Polcrom 2%? — Official Regulatory Information

The eligibility profile for Polcrom 2% (Sodium Cromoglycate 2% Eye Drops) is defined by established approvals, restrictions, and absolute contraindications found in government regulatory documents.

Category Official Regulatory Status
Populations for whom use is allowed Adults and Older Adults are approved for use, with no evidence suggesting required dosage alteration.
Populations for whom use is contraindicated Patients with known hypersensitivity to the active substance, Sodium Cromoglycate, or any of the product's excipients.
Age-related eligibility rules Use in children is established, but effectiveness is not established below the age of 4 or 5 years (depending on the authority). Some labels may contraindicate use in children under two years of age.

Pregnancy and Lactation Eligibility

Use in pregnancy is not recommended unless there is a clear medical need, with caution advised, especially during the first trimester. It is not known whether Sodium Cromoglycate is excreted in human breast milk; thus, caution should be exercised during lactation.

Eligibility-related restrictions

Soft contact lens wearers must not wear their lenses during treatment. Lenses must be removed before instillation and not reinserted for at least 15 minutes due to the presence of the preservative, Benzalkonium Chloride.

This structure reflects the regulatory requirement to define who is formally permitted, restricted, or excluded from using the medicine under its labeled conditions.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Polcrom 2% (Sodium Cromoglycate topical solution) has a focused interaction profile largely defined by its limited systemic absorption, as noted in authoritative government regulatory documents.

Systemic Drug-Drug Interactions

Due to the minimal systemic absorption of Sodium Cromoglycate following topical administration (ophthalmic or intranasal), the medicine is not documented to participate in clinically significant systemic pharmacokinetic interactions. Official regulatory labeling confirms that Polcrom 2% is not expected to inhibit or induce major metabolic enzymes, such as the Cytochrome P450 (CYP) system, nor is it documented to alter the plasma concentration ( C max or AUC) of other systemically administered medicinal products.

Specific interacting medicines are typically not listed for systemic metabolic or transporter-based interactions because of this low exposure. The use of Polcrom 2% may be permitted concomitantly with other anti-allergic treatments, including topical or systemic corticosteroids, without documented negative pharmacodynamic interactions.

Procedural and Local Constraints

The primary interaction-related restriction is a mandatory procedural constraint involving the excipient Benzalkonium Chloride, which is commonly used as a preservative in ophthalmic formulations. For the eye solution, users are restricted from wearing soft contact lenses during administration, as the lenses may absorb the preservative. This is a local interaction constraint rather than a traditional drug-drug interaction.

Regulatory documents state that caution may be warranted in patients with impaired renal or hepatic function, although this consideration is not tied to a specific documented interaction outcome.

Mechanism of Action

Polcrom 2% is classified as a mast cell stabilizer. Its primary mechanism of action involves inhibiting the rapid influx of calcium ions ( Ca^2+) into the mast cell cytoplasm following antigen-induced activation. This specific action contributes to maintaining the integrity of the mast cell membrane, which subsequently inhibits the release of inflammatory vesicles (degranulation). This is an essential step in regulating the immediate hypersensitivity response. By inhibiting degranulation, the compound restricts the local accumulation of potent preformed inflammatory mediators, including histamine, as well as newly synthesized eicosanoids such as leukotrienes. Furthermore, the compound exhibits no significant affinity for H1 receptors.

Dosage and Administration Information

How to Use Polcrom 2%

The administration of Polcrom 2% (Sodium Cromoglycate topical solution) is based on the principles of prophylactic timing and sustained, fixed frequency. The medication is used to establish protection before allergen exposure occurs.

Administration Routes and Dosing

Polcrom 2% is designated for topical use and is administered via two primary routes depending on the specific formulation:

Route of Administration Standard Dosing Regimen Frequency and Interval
Intranasal (Spray) One standardized dose into each nostril. Typically four to six times daily at regular, fixed intervals.
Ophthalmic (Drops) One to two drops into each eye (conjunctival sac). Typically four to six times daily at regular, fixed intervals.

Usage Protocol and Timing Constraints

The usage protocol is defined by its preventive nature. Treatment must be initiated prior to contact with the known allergen, often starting up to one week before the anticipated period of exposure. Once initiated, the medication must be continued daily throughout the entire duration of allergen presence. The fixed, frequent dosing schedule is important; the product is not intended for use on an as-needed basis, and the maximum recommended frequency should not be exceeded.

Procedural and Population Rules

Labeling for the intranasal spray approves use in children aged 2 years and older. For proper administration, users must clear the nasal passages before intranasal application. Guidelines stipulate that the bottle or container is not to be shared between patients. If a dose is missed, it should be applied as soon as possible, but without doubling the dose.

Recent Clinical Evidence

Research Evidence / Overview of Studies for Polcrom 2%

Evidence for Use in Seasonal Allergic Conjunctivitis

Research primarily involves short-term Randomized Controlled Trials (RCTs) and subsequent analysis, such as Systematic Reviews, for topical Sodium Cromoglycate (ophthalmic solution). These studies have primarily studied Seasonal Allergic Conjunctivitis, a condition marked by episodic manifestations (such as hay fever or temporary airborne allergies).

Researchers in these settings focused on outcomes describing episodic or acute changes, primarily by monitoring patient-reported outcomes describing perceived discomfort, such as changes in the intensity of ocular symptoms like itching, redness, and tearing. Some trials described patterns related to the measured changes in objective signs, such as conjunctival redness, when compared to the reference group.

Evidence for Managing Perennial and Severe Allergic Eye Conditions

Research has also explored the use of the ophthalmic solution in conditions involving periods of heightened symptoms but with a chronic nature, such as Perennial Allergic Conjunctivitis. Studies have examined Sodium Cromoglycate in relation to Vernal Keratoconjunctivitis (VKC), a less common but more severe condition. These studies primarily involved controlled comparative studies.

Evidence for Use in Allergic Rhinitis

Topical Sodium Cromoglycate (intranasal solution) was evaluated in studies relevant in trials assessing short-term or episodic symptom patterns related to Allergic Rhinitis (hay fever or nose allergies). The research examined outcomes capturing phases of heightened symptom activity, such as sneezing frequency and nasal congestion. Studies monitored that the time frame necessary to observe the measured changes was noted to be up to several weeks of consistent use.

Research Gaps and Uncertainties in the Evidence Base

The evidence base for Polcrom 2% is classified as having moderate certainty, according to scientific reviews. Key limitations include that the sample sizes were modest in some of the older, foundational studies, and the evidence quality varies across studies due to differences in research methods. There is limited information for long-term outcomes and the effect of usage spanning multiple years. The results apply only to the populations studied, and researchers note ongoing uncertainty regarding the findings for certain subgroups.

Frequently Asked Questions (FAQ)

Common questions about Polcrom 2% (FAQ)

Q: How quickly does the 2% concentration start working after the first dose?

Official product information describes Polcrom 2% as a prophylactic treatment. This means it works by preventing allergic symptoms, not by offering immediate relief. For the full anti-allergic effect to be established, consistent use over several days or even weeks may be necessary, depending on the condition being treated.

Q: What is the duration of the effect after a single dose of the eye drops?

The medication is not designed for single-dose relief or to be used on an as-needed basis. Official administration protocols indicate the eye drops are to be administered in regularly spaced doses to maintain continuous protection. This frequent, fixed schedule is necessary to maintain the stabilizing effect of the medicine.

Q: Why do the drops sometimes sting or burn upon application?

Official regulatory documents list a transient stinging or burning sensation as the most frequently reported side effect upon applying the eye drops. This effect is temporary and generally fades shortly after administration.

Q: What is considered a severe adverse reaction that requires immediate medical attention?

While very rare, severe allergic reactions have been reported in official documents following cromoglycate administration. Official warnings advise seeking immediate medical assistance if signs such as difficulty breathing, or sudden swelling of the face, lips, or eyelids are experienced. This is classified as an immediate hypersensitivity reaction.

Q: Does it work for animal dander allergies?

The eye drops are indicated for the treatment of general allergic conjunctivitis. This condition is known to be caused by various common environmental allergens, including pollen, dust, and allergens related to animal hair.

Q: Is there any danger if the drops are accidentally swallowed or enter the mouth or ear?

Official regulatory data indicates that the active ingredient, Sodium Cromoglycate, is poorly absorbed from the gastrointestinal tract when swallowed. In the event of accidental ingestion, official guidelines typically recommend only symptomatic treatment.

Q: Is it safe to use if I have glaucoma?

According to official product information, glaucoma is not listed as a contraindication or specific special precaution for this medicine.

Q: Is there a strong regulatory emphasis on handwashing before application?

Regulatory documents contain instructions that the dropper tip should not touch the eye, fingers, or any other surface. This process is intended to prevent contamination and reduce the risk of serious eye damage or infection.

Q: What is the recommended waiting period between applying different eye drops?

If you are using multiple different ophthalmic products, official guidance suggests administering them at separate times. Official guidance generally suggests administering different ophthalmic products at least five to ten minutes apart to allow for proper absorption of the medication.

How should Polcrom 2% be stored and disposed of?

Official Storage and Disposal Instructions

Regulatory documentation defines strict environmental and time-related controls for storing and discarding Polcrom 2% (Sodium Cromoglycate) solution.

Storage Category Official Regulatory Requirement
Temperature Store at a temperature not higher than 25 C (below 77 F) and keep from freezing.
Protection Protect from light and moisture. Store in the original outer packaging with the container tightly closed.
Stability Discard four weeks after first opening the bottle (for eye drops). Do not use the medicine after the expiration date.
Child Safety Keep out of the sight and reach of children.

For disposal, unused or expired Polcrom 2% must not be thrown into wastewater or household waste. The official procedure requires that you ask a pharmacist how to properly dispose of the medicine to protect the environment.

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

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