Cromal Eye Drops, Sodium Cromoglycate/Benzalkonium

Cromal Eye Drops, Sodium Cromoglycate is a mast cell stabilizer, Cromal Eye Drops, Sodium Cromoglycateis used for the treatment of allergic eye disease. Cromal Eye Drops, Sodium Cromoglycate works on the mast cells in the eve to prevent it from releasing substances that can cause red itchy and watery eyes.

Intal Eye Drop

Sodium Cromoglycate/Benzalkonium

Cromal Eye Drop

CIPLA

5 ml

Drop

2%+0.01%w/v

Cromal Eye Drops, Sodium Cromoglycate/Benzalkonium

Introduction

Overview of Cromal Eye Drops as an anti-allergic ophthalmic solution

Cromal Eye Drops are an anti-allergic ophthalmic formulation engineered to quell hypersensitivity of the ocular surface. Designed for patients experiencing recurrent pruritus, tearing, and hyperemia associated with airborne allergens and environmental irritants.

  • Non-steroidal; non-vasoconstrictive
  • Suitable for seasonal and perennial symptom control
  • Intended for regular, preventive use during allergen exposure

Role of sodium cromoglycate as the primary active ingredient

Sodium cromoglycate (cromolyn sodium) functions as a mast-cell stabilizer. It attenuates ocular allergic cascades at the initiation point rather than masking late manifestations.

  • Prevents mast-cell degranulation
  • Mitigates release of histamine, leukotrienes, and other mediators
  • Favors long-term controller therapy in allergic eye disease

mast cell

Purpose of benzalkonium chloride as a preservative

Benzalkonium chloride (BAK) preserves sterility within multi-dose containers. It provides broad antimicrobial protection, yet may interact with the tear film and corneal epithelium in sensitive users.

  • Ensures microbial control after opening
  • Potential to exacerbate dryness with frequent or prolonged use
  • Contact lens compatibility requires caution

Common conditions treated with Cromal Eye Drops

Typical indications include:

  • Allergic conjunctivitis of seasonal or perennial patterns
  • Vernal and atopic keratoconjunctivitis (adjunctive support)
  • Allergen-provoked ocular pruritus, tearing, and redness

Composition

Sodium cromoglycate: concentration and therapeutic function

Formulations commonly contain sodium cromoglycate 2% w/v for ophthalmic use. This concentration optimizes mast-cell stabilization while maintaining excellent tolerability.

  • Controller effect improves with consistent dosing
  • Minimal systemic absorption from topical administration

sodium cromoglycate structure

Benzalkonium chloride: preservative role and potential ocular effects

BAK is included at low microbicidal concentrations to deter contamination.

  • Effective against a range of bacteria and fungi
  • May destabilize lipid layer of the tear film with frequent exposure
  • Advise lens removal prior to instillation (see Administration)

benzalkonium chloride structure

Other inactive ingredients supporting stability and usability

Excipients typically include buffering agents, isotonicity adjusters, and purified water. Their roles are straightforward yet essential.

  • Buffers maintain physiologic pH for comfort
  • Tonicity agents reduce stinging on instillation
  • Packaging: low-squeeze, tamper-evident dropper bottles

How Cromal Eye Drops Work

Mechanism of sodium cromoglycate in stabilizing mast cells

Mast-cell membranes are stabilized, reducing calcium influx and inhibiting degranulation. The upstream blockade restrains both early-phase and late-phase allergic responses.

Prevention of histamine and mediator release during allergic response

By suppressing mediator liberation histamine, prostaglandins, leukotrienes. Cromal diminishes vasodilation, chemosis, and nerve activation that drive itch and redness.

  • Less itch and tearing
  • Reduced conjunctival edema
  • Lower reflex hyperemia

eye edema

Onset of action and duration of relief in ocular conditions

Relief is not instantaneous; benefits accrue with scheduled use. Many patients perceive improvement within several days, with maximal effect after 1-2 weeks of continuous therapy.

  • Best used pre-exposure and throughout allergen season
  • Consistent dosing yields cumulative control

Cromal Eye drops Uses

Cromal Eye drops Uses

Primary Uses

Primary Uses

Allergic conjunctivitis

Reduces itch, tearing, and burning associated with aeroallergens. Appropriate for repeat seasonal flares.

allergic conjunctivitis

Seasonal allergic conjunctivitis (hay fever eyes)

Initiate prior to pollen surges; continue throughout the season to blunt symptom peaks.

allergy to hay fever

Perennial allergic conjunctivitis

Useful for indoor allergen exposure (dust mites, dander). Safe for long-term maintenance.

dust mites

Vernal keratoconjunctivitis

Vernal keratoconjunctivitis

Atopic keratoconjunctivitis

Supportive therapy to mitigate chronic allergic inflammation alongside specialist-directed care.

Off-label Uses

Contact lens-related allergic eye irritation

May diminish lens-associated papillary responses when paired with lens hygiene optimization.

contact lens on finger

Ocular mastocytosis-related symptoms

Stabilization of mast-cell activity can moderate pruritus and redness in select cases.

Preventive management before seasonal triggers

Pre-season initiation establishes mast-cell stability, reducing the intensity of first exposures.

flower field and pollens

Adjunctive therapy in dry eye with allergic components

When allergy coexists with evaporative or aqueous-deficient dry eye, cromoglycate may attenuate allergic drivers of surface irritation.

Dosage and Administration

Typical regimen: 1-2 drops in the affected eye(s) four times daily, or as directed by an eye-care professional. Pediatric dosing generally mirrors adult schedules when indicated.

putting eye drops in right eye

Frequency of instillation and typical duration of treatment

Administer at evenly spaced intervals. Continue throughout allergen exposure; reassess if symptoms persist beyond expected periods.

Step-by-step administration technique

  • Wash hands thoroughly.
  • Shake gently if labeled to do so.
  • Tilt head back; pull down the lower lid to create a conjunctival pocket.
  • Instill a single drop without touching the tip to any surface.
  • Close eye gently; perform nasolacrimal occlusion for 1-2 minutes to limit systemic absorption.

Use with or without contact lenses

Remove soft contact lenses prior to dosing; wait at least 15 minutes before reinsertion due to BAK interaction with lens materials. Consider preservative-free periods on heavy dosing days.

Adjustments for long-term use or chronic conditions

For chronic disease, evaluate surface health and tear dynamics at intervals. Step down frequency when allergen load diminishes; escalate temporally during spikes.

Side Effects

Common Side Effects

Mild eye irritation or stinging sensation

Transient tingling on instillation that resolves quickly.

Transient blurred vision

Momentary blur due to drop viscosity or reflex tearing; avoid immediate driving post-dose.

Watery eyes or redness

Usually self-limited as the ocular surface acclimates.

watery eyes

Unusual taste after administration

Nasolacrimal drainage may cause a brief bitter or metallic taste.

Less Common but Notable Side Effects

Swelling of eyelids

Report persistent edema for evaluation of hypersensitivity.

Persistent eye discomfort

Continuous burning or pain warrants reassessment of formulation tolerance.

Dryness of ocular surface due to benzalkonium

BAK exposure may exacerbate dryness with frequent dosing; consider dosing intervals or alternative preservatives if required.

dry red eyes

Rare allergic reactions to preservatives

Hyperemia, pruritus, or dermatitis around the lids suggests preservative sensitivity.

Warnings and Important Precautions

Need for regular ophthalmic monitoring with prolonged use

Chronic users benefit from periodic ocular surface examinations, tear-film assessment, and review of concomitant therapies.

warning sign

Avoiding contamination of dropper tip

Do not touch the tip to the eye, skin, or any surface. Recap securely after each use to preserve sterility.

Precaution with contact lens wearers (benzalkonium chloride interaction)

BAK can bind to soft lenses and irritate the cornea. Remove lenses prior to instillation and delay reinsertion; consider daily disposables during high-frequency use.

Risk of rebound irritation with improper use

Inconsistent dosing or over-frequent instillation may aggravate symptoms. Adhere to prescribed schedules and avoid self-escalation without professional guidance.

Contraindications

Hypersensitivity to sodium cromoglycate or benzalkonium chloride

Individuals with a documented hypersensitivity to either sodium cromoglycate or benzalkonium chloride should avoid the use of this formulation. Even small exposures may provoke immediate ocular irritation, swelling, or dermatological manifestations around the eyelids.

Known intolerance to preservatives in ophthalmic solutions

Some patients experience chronic intolerance to ophthalmic preservatives, particularly benzalkonium chloride. This intolerance can manifest as persistent dryness, conjunctival inflammation, or corneal epithelial damage with prolonged exposure.

History of allergic reaction to cromoglycate formulations

A history of allergic responses to cromoglycate-containing eye drops warrants complete avoidance. Manifestations may include intense redness, periorbital swelling, and pruritus that do not resolve with standard symptomatic care.

Careful Administration in Special Populations

Elderly Patients

Age-related alterations in tear film stability and ocular surface physiology demand cautious administration.

  • Monitor closely for preservative-induced ocular surface dryness.
  • Evaluate periodically for corneal epithelial fragility.

old eyes

Pregnant Women and Nursing Mothers

Sodium cromoglycate demonstrates minimal systemic absorption, suggesting a favorable safety profile during pregnancy and lactation. However, prudent medical supervision remains essential.

  • Use only under physician-guided risk-benefit assessment.
  • Breastfeeding mothers should be counseled regarding negligible transfer into breast milk.

Children

The safety and efficacy of sodium cromoglycate are established in pediatric allergic conjunctivitis, but specific precautions are required.

  • Dosage typically mirrors adult recommendations, though compliance challenges may arise.
  • Careful monitoring for ocular irritation in younger children is necessary.

Drug Interactions

Drug interactions with ophthalmic preparations are generally minor but clinically relevant if not managed appropriately.

  • When multiple eye drops are prescribed, instill each medication at least 5-10 minutes apart to avoid dilution or washout.
  • Concurrent use with topical antihistamine drops may reduce perceived efficacy due to overlapping mechanisms or altered absorption.
  • Contact lens cleaning and disinfecting solutions containing preservatives may amplify surface irritation when combined with benzalkonium chloride exposure.

Overdosage

Symptoms of accidental excessive instillation

Excessive use may result in transient ocular burning, watering, or blurred vision. Severe complications are exceedingly rare due to minimal systemic absorption.

Management of local irritation or discomfort

Flushing the eye gently with sterile saline or clean water is often sufficient. Persistent discomfort requires ophthalmic evaluation.

Guidance in case of oral ingestion by children

If the solution is accidentally ingested, gastrointestinal irritation such as nausea or abdominal discomfort may occur. Seek prompt medical advice for supportive management.

Storage and Handling Precautions

Optimal storage conditions (temperature, light protection)

Store at controlled room temperature, away from direct sunlight and excessive humidity. Do not freeze the solution.

Shelf life and expiry after opening

Eye drops should be discarded within four weeks of opening to avoid contamination, regardless of the printed expiry date.

Safe handling to avoid microbial contamination

Keep the dropper tip sterile by avoiding contact with the eye, fingers, or external surfaces. Always close the cap tightly after each use.

Proper disposal of unused solution

Dispose of unused or expired eye drops according to local pharmaceutical waste guidelines. Avoid discarding in household waste or wastewater to minimize environmental impact.

Conclusion

Cromal Eye Drops, combining sodium cromoglycate with benzalkonium chloride, play a pivotal role in the long-term management of allergic eye disorders. Their efficacy depends on adherence to prescribed schedules, awareness of contraindications, and proper administration techniques. Safe usage supported by professional monitoring and patient education ensures sustained symptom control and protects ocular health. For persistent or severe manifestations, consultation with an ophthalmologist is essential to guide ongoing therapy and adjust treatment strategies.

Cromal Eye Drops, Sodium Cromoglycate/Benzalkonium FAQ

What is the use of cromal eye drops?

Cromal Eye Drop is a medication designed to address allergic eye conditions. It effectively alleviates allergy symptoms like inflammation (redness and swelling), itchiness, and watery eyes.

What is sodium cromoglycate eye drops used for?

To address allergic conjunctivitis, a condition caused by hay fever, dust mites, and various other allergens.

What is the role of benzalkonium chloride in eye drops?

Benzalkonium chloride is the most widely utilized preservative in eye drops.

How many times a day can you use sodium cromoglicate eye drops?

4

Is benzalkonium safe for eyes?

Benzalkonium chloride has been noted to induce eye irritation, resulting in dry eye symptoms and potentially impacting the tear film and corneal surface.

What are the side effects of sodium cromoglycate eye drops?

  • Dry eyes
  • Allergic reactions
  • Dizziness

What age can you use sodium cromoglycate eye drops?

6 years and up

How long does it take for sodium cromoglicate eye drops to work?

2 weeks

Is benzalkonium a steroid?

No

Is sodium cromoglicate good for eyes?

Sodium Cromoglicate Eye Drops are designed to relieve red, watery, and itchy eyes resulting from allergies like hay fever, dust mites, and pet dander.

What are the benefits of sodium cromoglycate?

Sodium cromoglicate eye drops function by preventing the release of natural substances (such as histamine) in your body that trigger allergic reactions.

Is benzalkonium an anti-fungal?

Benzalkonium chloride is a chlorine-derived chemical compound known for its effective antimicrobial properties against bacteria, viruses, and fungi

Can you be allergic to benzalkonium?

Yes

How do benzalkonium chloride eye drops work?

It works by breaking down bacterial cell membranes and is present in over half of all topical ophthalmic medications

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