FLUCA EYE DROPS 5ML

Indications

Approved Uses

Steroid-responsive inflammatory conditions of the anterior segment where an allergic component is present (e.g., allergic conjunctivitis including seasonal/perennial forms, and vernal keratoconjunctivitis/keratoconjunctivitis with significant inflammation).

Dosage & Administration

Dosing by Condition

Allergic conjunctivitis/vernal keratoconjunctivitis with significant inflammation: instill 1-2 drops into affected eye(s) 2-4 times daily; in more severe inflammation, dosing may be increased temporarily (e.g., up to every 2 hours initially) then tapered as control is achieved per prescriber.

Initial Dose

1-2 drops in the affected eye(s) 2-4 times daily. During the first 24 to 48 hours, the frequency may be increased to every 4 hours as directed by a doctor.

Maintenance Dose

1-2 drops into affected eye(s) 4 times daily

Maximum Dose

Typical: 1-2 drops in affected eye(s) 2-4 times daily; in severe inflammation may be increased (e.g., every hour initially) under ophthalmologist supervision, then taper to the lowest effective frequency

Dose Adjustment Notes

If used frequently or for more than a short course, taper by gradually reducing dosing frequency as signs/symptoms improve; avoid abrupt discontinuation after prolonged corticosteroid use.

How to Take

Shake well before each use. Instill the prescribed number of drops into the conjunctival sac (pull down lower lid), then close the eye gently for 1-2 minutes and apply nasolacrimal occlusion. Avoid touching the dropper tip to the eye/skin/surfaces. If using other eye medicines, separate by 5-10 minutes (apply drops before ointments). Remove contact lenses before use and reinsert after at least 15 minutes (and avoid lenses if the eye is acutely inflamed unless advised).

How to Prepare

Shake well before each use to resuspend the suspension uniformly.

Side Effects

Common Side Effects

Transient burning/stinging on instillation, eye irritation/foreign-body sensation, temporary blurred vision, and watering/tearing.

Side Effect Frequency

Common: transient burning/stinging/irritation and temporary blurred vision. Less common/with prolonged use: increased intraocular pressure, cataract formation, delayed healing, and secondary infection; hypersensitivity reactions can occur.

Safety & Warnings

Contraindications

Hypersensitivity to components; epithelial herpes simplex keratitis (dendritic keratitis); vaccinia/varicella and other viral diseases of cornea/conjunctiva; mycobacterial ocular infection; fungal diseases of ocular structures

Warnings & Precautions

Monitor IOP if treatment exceeds ~10 days or in glaucoma risk; prolonged use increases risk of glaucoma/optic nerve damage and cataract; may mask/worsen infection-avoid use in active ocular infection unless appropriately treated; caution with history of herpes simplex; avoid contaminating dropper tip; remove soft contact lenses (benzalkonium chloride preservative) and wait ~15 minutes before reinsertion; not for injection

Driving Warning

Avoid Driving

Drug Interactions

Food Interaction

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

Special Populations

Pregnancy

Consult Doctor

Breastfeeding

Caution

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Preparation Instructions

Shake well before each use to resuspend the suspension uniformly.

Missed Dose

Use the missed dose as soon as remembered; if it is close to the next scheduled dose, skip the missed dose and resume the regular schedule-do not double doses.

Stopping the Medicine

Do not stop abruptly after prolonged/frequent use; taper frequency as directed to prevent rebound inflammation

Overdose

Topical overdose: rinse/flush the eye with water or saline if excessive instillation; ingestion of a small bottle is unlikely to cause serious toxicity-observe/supportive care and seek medical advice/poison center if symptomatic or in children

Patient Counseling

Shake well before each use (suspension). Instill as prescribed; avoid touching the dropper tip to the eye/skin/surfaces. Remove contact lenses before use and wait at least 15 minutes before reinsertion (especially soft lenses). Temporary blurred vision may occur-wait until vision clears before driving/operating machinery. Use only for the prescribed duration; prolonged corticosteroid use can raise intraocular pressure and increase cataract/infection risk-seek care for eye pain, worsening redness, discharge, or vision changes. Do not share; prescription-only product. Discard after 28 days from first opening (unless local label states otherwise).

Monitoring Requirements

If used for ≥10 days or repeatedly/prolonged: monitor intraocular pressure; consider slit-lamp/corneal evaluation and lens assessment for cataract with longer courses, and monitor for infection or delayed healing.

Pharmacology

Mechanism of Action

Fluorometholone is a corticosteroid that suppresses ocular inflammation by downregulating inflammatory mediator production (e.g., prostaglandins/leukotrienes) and cytokine activity; sodium cromoglicate stabilizes mast cells to prevent degranulation and release of histamine and other mediators, reducing allergic responses.

Half-Life

Not well characterized for this ophthalmic combination; systemic half-life is not clinically meaningful because systemic absorption is minimal (cromoglicate systemic t1/2 is ~1-2 hours when absorbed).

Bioavailability

Minimal systemic absorption after topical ophthalmic administration; systemic bioavailability is very low for both components.

Excretion

Sodium cromoglicate: excreted largely unchanged in urine and bile; Fluorometholone: any systemically absorbed fraction is metabolized and eliminated mainly via renal and biliary/fecal routes as metabolites (systemic exposure is minimal).

Protein Binding

Not reliably established for this ophthalmic product; systemic protein-binding values are not clinically relevant given minimal systemic absorption.

Product Information

Available Dosage Forms

Eye drops, suspension (ophthalmic suspension).

Composition per Dose

Each 1ml of suspension contains: 1mg Fluorometholone and 20mg Sodium Cromoglicate.

OTC Alternatives

OTC options for mild allergic conjunctivitis may include antihistamine/mast-cell stabilizer eye drops (e.g., ketotifen) and, in some markets, sodium cromoglicate alone; however, this product is prescription (SFDA) and steroid-containing alternatives are not OTC.

Target Organ

Eye

Preservative Free

No

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