CROMA EYE DROPS 15ML

Indications

Approved Uses

Allergic conjunctivitis (seasonal/perennial) with symptomatic relief of itching/watering and associated conjunctival redness (hyperemia).

Off-Label Uses

Adjunctive use in other allergic ocular conditions such as vernal keratoconjunctivitis or giant papillary conjunctivitis may be used in practice, but this combination is primarily intended for allergic conjunctivitis and redness relief.

Dosage & Administration

Dosing by Condition

Allergic conjunctivitis: Instill 1-2 drops in affected eye(s) 4 times daily (some references allow 3-4 times daily); use regularly and, for seasonal symptoms, start before/at allergen exposure and continue through the season as directed.

Maximum Dose

1-2 drops in the affected eye(s) up to 4 times daily; avoid use beyond 72 hours (3 days) without medical advice

Children's Dosage

Children ≥5 years: 1-2 drops into affected eye(s) 4 times daily (same as adult dosing). Not recommended in children under 5 years.

Dose Adjustment Notes

No renal/hepatic dose adjustment is generally required due to minimal systemic absorption; avoid prolonged/frequent use of the tetrahydrozoline-containing product (typically limit decongestant use to ≤3-5 days) to reduce rebound hyperemia and systemic sympathomimetic risk.

How to Take

For ophthalmic use only. Wash hands. Tilt head back, pull down lower eyelid, instill 1-2 drops into the conjunctival sac of affected eye(s). Avoid touching the dropper tip to the eye/skin/surfaces. Close the eye gently and apply nasolacrimal occlusion (press inner corner) for ~1 minute. If using other eye medicines, separate by 5-10 minutes. Remove contact lenses before use and reinsert after at least 15 minutes (especially with preserved products).

Side Effects

Common Side Effects

Transient burning/stinging on instillation, eye irritation, blurred vision, lacrimation; conjunctival hyperemia or rebound redness with excessive/prolonged use; rarely mydriasis.

Side Effect Frequency

Common: transient ocular burning/stinging/irritation and temporary blurred vision; Uncommon/Rare: mydriasis and rebound hyperemia with overuse (tetrahydrozoline), hypersensitivity reactions; Rare systemic sympathomimetic effects (e.g., headache, palpitations, hypertension) can occur especially with excessive use or in children.

Safety & Warnings

Contraindications

Hypersensitivity to sodium cromoglicate, tetrahydrozoline, or any excipient; narrow-angle (angle-closure) glaucoma

Warnings & Precautions

Do not use while wearing soft contact lenses; remove lenses and wait at least 15 minutes before reinsertion. Avoid prolonged/frequent use (limit to ≤72 hours without medical advice) due to rebound hyperemia. Use with caution in cardiovascular disease, hypertension, hyperthyroidism, or diabetes; avoid in/seek advice for glaucoma risk; discontinue and seek care if pain, vision changes, or hypersensitivity occur; for ophthalmic use only

Age Restriction

Not recommended under 5 years of age

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Use with caution with MAO inhibitors and tricyclic antidepressants (may potentiate pressor/sympathomimetic effects of tetrahydrozoline); caution with other sympathomimetics

Interaction Severity

MAO inhibitors and tricyclic antidepressants: potentially significant interaction (treat as major/clinically important) due to possible potentiation of systemic pressor effects if absorbed; other interactions are generally low relevance with correct ophthalmic use.

Food Interaction

No clinically relevant food interactions (not applicable for ophthalmic administration).

Special Populations

Breastfeeding

Consult Doctor

Children

Children ≥5 years: 1-2 drops into affected eye(s) 4 times daily (same as adult dosing). Not recommended in children under 5 years.

Elderly

Standard adult dosing; use with caution in elderly patients with cardiovascular disease or hypertension due to tetrahydrozoline component

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Stopping the Medicine

Do not use the tetrahydrozoline-containing product for more than 72 hours (3 days) without medical advice; stopping may lead to return of allergy symptoms and prolonged use can cause rebound redness

Overdose

Topical overdose: unlikely; irrigate/flush the eye with water or saline if excessive instillation. Accidental oral ingestion (especially in children) can cause serious systemic toxicity (CNS depression, bradycardia, hypotension, hypothermia, respiratory depression); seek urgent medical care and provide supportive treatment

Patient Counseling

Use exactly as prescribed for ophthalmic use. Avoid contaminating the tip. Expect brief stinging/blurred vision; avoid driving until clear. Remove contact lenses and reinsert after ≥15 minutes. Do not use the decongestant-containing drops continuously for more than ~3-5 days without medical advice due to rebound redness. Seek care urgently for severe eye pain, vision changes, marked swelling, or worsening symptoms. Store below 30°C (per SFDA) and keep out of children’s reach; discard after the in-use period stated on the product leaflet (commonly ~28 days if specified).

Pharmacology

Mechanism of Action

Sodium cromoglicate stabilizes mast cells and inhibits mediator release (e.g., histamine) to prevent allergic inflammation; tetrahydrozoline is an alpha-adrenergic agonist causing conjunctival vasoconstriction to reduce redness.

Onset of Action

Tetrahydrozoline (decongestant): within minutes. Sodium cromoglicate (anti-allergic): several days to weeks for full prophylactic effect

Duration of Effect

Tetrahydrozoline decongestant effect typically lasts about 4-6 hours (may extend up to ~8 hours in some patients); cromoglicate is preventive and requires regular dosing rather than providing a single-dose duration.

Half-Life

Sodium cromoglicate: no clinically meaningful systemic half-life after ophthalmic use (systemic absorption is minimal); Tetrahydrozoline: systemic half-life is not well-established/variable and is not reliably cited for ophthalmic use (avoid quoting a single definitive value).

Bioavailability

Sodium cromoglicate: very low systemic absorption after ophthalmic use (generally <1%); tetrahydrozoline: minimal systemic absorption with correct use, but systemic effects are possible especially with overuse or in children.

Metabolism

Sodium cromoglicate: not metabolized (excreted unchanged); Tetrahydrozoline: limited/partial hepatic metabolism may occur, with overall elimination mainly renal.

Excretion

Sodium cromoglicate: any systemically absorbed fraction is excreted unchanged in urine and bile; Tetrahydrozoline: systemically absorbed drug (and metabolites) are eliminated primarily via the urine.

Protein Binding

Sodium cromoglicate: protein binding not reliably established for clinical use (often reported variably; do not fix at 65%); Tetrahydrozoline: not well-characterized/unknown.

Product Information

Available Dosage Forms

Ophthalmic solution (eye drops)

Composition per Dose

Each 1ml of ophthalmic solution contains: 40mg Sodium Cromoglicate and 0.5mg Tetrahydrozoline Hydrochloride.

Target Organ

Eye

Preservative Free

No

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