APICROM 2% EYE DROPS

Indications

Approved Uses

Treatment and prevention of allergic conjunctivitis, vernal keratoconjunctivitis, vernal conjunctivitis, and vernal keratitis.

Off-Label Uses

Off-label: giant papillary conjunctivitis (contact lens-related) and atopic keratoconjunctivitis (adjunct/prophylaxis).

Dosage & Administration

Dosing by Condition

Allergic conjunctivitis: 1-2 drops in each affected eye 4-6 times daily at regular intervals. Vernal keratoconjunctivitis: 1-2 drops in each affected eye 4-6 times daily

Initial Dose

1-2 drops in each affected eye 4 times daily

Maintenance Dose

1-2 drops in each affected eye 4-6 times daily

Maximum Dose

1-2 drops in each eye 4-6 times/day at regular intervals

Children's Dosage

Children 4 years and older: same as adult dosing (1-2 drops in each affected eye 4-6 times daily)

Dose Adjustment Notes

No renal or hepatic dose adjustment is generally required because systemic absorption from ophthalmic use is minimal; use regularly throughout allergen exposure for best effect.

How to Take

Wash hands. Tilt head back, pull down the lower eyelid to form a pocket, instill 1-2 drops into the conjunctival sac. Close the eye gently for 1-2 minutes; avoid blinking hard. Do not touch the dropper tip to the eye/skin/any surface. Optional: apply nasolacrimal occlusion (gentle pressure at the inner corner) for ~1 minute to reduce systemic absorption.

Side Effects

Common Side Effects

Transient ocular burning/stinging, eye irritation/foreign-body sensation, conjunctival hyperemia (redness), tearing (watery eyes), and transient blurred vision.

Side Effect Frequency

Most common: transient ocular burning/stinging on instillation; other reported effects include conjunctival hyperemia, tearing/watery eyes, transient blurred vision, itching/irritation, eyelid edema/puffiness; hypersensitivity reactions are rare.

Safety & Warnings

Contraindications

Hypersensitivity to cromolyn sodium or any component of the formulation.

Warnings & Precautions

For ophthalmic use only; avoid contaminating dropper tip; remove contact lenses and wait at least 15 minutes before reinsertion (benzalkonium chloride may be absorbed by soft lenses); not for immediate relief of acute allergic symptoms-requires regular use; discontinue and seek care if hypersensitivity occurs.

Age Restriction

Safety and efficacy not established in children <4 years; use in <4 years only on clinician advice.

Drug Interactions

Drug Interactions

No significant drug interactions established; clinically relevant systemic interactions are unlikely due to minimal absorption.

Interaction Severity

No clinically significant drug interactions are expected/known with ophthalmic cromolyn sodium.

Food Interaction

No known food interactions (not applicable for ophthalmic administration).

Special Populations

Pregnancy

Caution

Breastfeeding

Caution

Children

Children 4 years and older: same as adult dosing (1-2 drops in each affected eye 4-6 times daily)

Elderly

Standard adult dosing.

Kidney Impairment

No adjustment needed.

Liver Impairment

No adjustment needed.

Storage & Patient Advice

Stopping the Medicine

Continue for as long as allergen exposure/symptoms persist; symptoms may recur if stopped-can stop when no longer needed (no taper required).

Overdose

Overdose is unlikely with ophthalmic use; if excessive instillation, rinse with water/normal saline; if ingested, manage symptomatically and seek medical advice/poison center.

Patient Counseling

Use regularly as directed (works best preventively, not for instant relief). Remove contact lenses before use and wait at least 15 minutes before reinserting (especially soft lenses). Avoid touching the dropper tip; do not share the bottle. Expect possible brief stinging/blurred vision after instillation. Seek medical advice if symptoms persist/worsen or if no meaningful improvement after ~2 weeks of regular use; follow local guidance on discard-after-opening (commonly 4 weeks unless the product label states otherwise).

Monitoring Requirements

No routine monitoring required. Regular eye examinations are recommended.

Pharmacology

Mechanism of Action

Mast cell stabilizer: inhibits antigen-triggered mast cell degranulation (via reduced calcium-dependent mediator release), decreasing release of histamine and other inflammatory mediators.

Onset of Action

Some symptom relief may occur within hours to a few days; full benefit may require 1-2 weeks of regular use.

Bioavailability

Systemic absorption after ophthalmic administration is minimal/negligible (commonly cited as <1%; specific percentages vary by source).

Metabolism

Not metabolized; excreted unchanged.

Product Information

Available Dosage Forms

Eye drops (ophthalmic solution) only for this product (APICROM 2% Eye Drops).

Composition per Dose

Each mL: 20 mg cromolyn sodium (2%)

Generic Availability

Yes

Target Organ

Eye

Preservative Free

No

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