FML 0.1% EYE DROPS 5ML

Indications

Approved Uses

Treatment of corticosteroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.

Dosage & Administration

Dosing by Condition

Steroid-responsive ocular inflammation: Instill 1-2 drops into the affected eye(s) 2-4 times daily; during the initial 24-48 hours, dosing may be increased (e.g., every 4 hours or more frequently per severity) then reduce to the lowest effective frequency as improvement occurs.

Initial Dose

1-2 drops into the affected eye(s) every 4 hours; may increase to every 1-2 hours in the first 24-48 hours for severe inflammation

Maintenance Dose

1-2 drops two to four times daily, gradually tapered to discontinue.

Maximum Dose

Acute inflammation: 1-2 drops into the affected eye(s) every 1-2 hours initially, then reduce frequency as improvement occurs; continued high-frequency use requires close ophthalmic monitoring.

Children's Dosage

Children 2 years and older: same as adult dosing (1-2 drops every 4 hours); Not recommended in children under 2 years

Dose Adjustment Notes

No renal/hepatic dose adjustment is generally required for ophthalmic use; if therapy is prolonged or high-frequency, taper by gradually reducing dosing frequency rather than stopping abruptly to avoid rebound inflammation.

How to Take

Shake well before each use (suspension). Wash hands. Instill the prescribed number of drops into the lower conjunctival sac without touching the dropper tip to the eye/skin/surfaces. Close the eye gently and perform nasolacrimal occlusion (press inner corner) for 1-2 minutes to reduce systemic absorption. If using other eye meds, separate by 5-10 minutes. Remove soft contact lenses before use and wait at least 15 minutes before reinserting (preservative-related lens issues).

How to Prepare

Shake well before use.

Side Effects

Common Side Effects

Transient burning/stinging, eye irritation/discomfort, blurred vision, foreign body sensation; with continued/prolonged use: increased intraocular pressure and risk of cataract formation; less commonly: tearing/itching/redness.

Side Effect Frequency

Frequency not reliably quantifiable; commonly reported reactions include transient burning/stinging/irritation, blurred vision, and increased intraocular pressure; with prolonged use: cataract and secondary infection risk.

Safety & Warnings

Contraindications

Contraindicated in: most viral diseases of the cornea and conjunctiva (including epithelial herpes simplex keratitis/dendritic keratitis, vaccinia, varicella), mycobacterial ocular infection, fungal diseases of ocular structures, and hypersensitivity to fluorometholone or any component; avoid use in untreated purulent ocular infections.

Warnings & Precautions

Prolonged use may raise IOP and cause glaucoma-monitor IOP if used ≥10 days; may cause posterior subcapsular cataract; may mask/worsen infections-avoid in active viral/fungal/mycobacterial disease and use cautiously if bacterial infection is present; may delay corneal healing and increase risk of perforation in corneal/scleral thinning; remove contact lenses before use and reinsert after ~15 minutes if preservative-containing; pediatric safety <2 years not established.

Age Restriction

Safety and effectiveness in pediatric patients below 2 years of age have not been established (use only if clearly needed under specialist supervision).

Driving Warning

Avoid Driving

Drug Interactions

Drug Interactions

Clinically significant systemic drug interactions are unlikely, but strong CYP3A inhibitors (e.g., ritonavir/cobicistat) may increase systemic corticosteroid effects; additive IOP elevation may occur with other ocular steroids and infection risk may increase with immunosuppressants.

Interaction Severity

Clinically relevant interactions are mainly additive ocular adverse effects with other topical agents that can delay corneal healing (e.g., ophthalmic NSAIDs) and additive IOP elevation with other corticosteroids; systemic CYP3A inhibitor interactions are possible but generally low-likelihood with ophthalmic use, though caution is reasonable with strong inhibitors and prolonged/high-dose use.

Food Interaction

No restriction

Alcohol Interaction

Safe

Special Populations

Pregnancy

Category C

Breastfeeding

Caution

Children

Children 2 years and older: same as adult dosing (1-2 drops every 4 hours); Not recommended in children under 2 years

Elderly

Standard adult dosing; monitor intraocular pressure as elderly patients may be more susceptible to corticosteroid-induced IOP elevation

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Storage Conditions

Store below 30°C; do not freeze; keep container tightly closed. Discard after ~28 days (4 weeks) from first opening (per local policy/label where applicable).

Preparation Instructions

Shake well before use.

Stopping the Medicine

Do not stop abruptly after prolonged/frequent use; taper by gradually reducing dosing frequency as inflammation improves.

Patient Counseling

Shake well before each use; wash hands; avoid touching the dropper tip; instill into the lower eyelid pocket; close eye and press the inner corner for 1-2 minutes. Remove soft contact lenses and wait at least 15 minutes before reinserting. Space other eye drops by 5-10 minutes. Temporary blurred vision/stinging can occur-avoid driving until vision clears. Use only as prescribed and do not stop abruptly if used for an extended period (taper per prescriber). Seek care urgently for eye pain, vision changes, worsening redness/discharge, or no improvement within ~48 hours; prolonged use can increase eye pressure and cataract risk. Store below 30°C (verified API).

Monitoring Requirements

Monitor intraocular pressure if used for 10 days or longer; with prolonged/repeated courses, perform slit-lamp examination to assess for cataract formation, corneal thinning/ulceration, and superinfection; reassess if not improving within ~48 hours.

Pharmacology

Mechanism of Action

Synthetic corticosteroid (glucocorticoid receptor agonist) that suppresses ocular inflammation by altering gene transcription, including induction of phospholipase A2 inhibitory proteins (lipocortins), reducing prostaglandin/leukotriene and other inflammatory mediator production.

Onset of Action

Symptomatic anti-inflammatory benefit may begin within hours, with noticeable clinical improvement often within 1-2 days if the condition is steroid-responsive.

Duration of Effect

Not well-defined as a fixed per-dose duration; dosing is guided by clinical response and typically ranges from 2-4 times daily with possible short-term increased frequency.

Half-Life

Unknown (not established for ophthalmic administration).

Bioavailability

Minimal systemic absorption / low systemic bioavailability after ophthalmic administration.

Metabolism

Unknown / not well characterized for ophthalmic fluorometholone; any absorbed drug is expected to undergo hepatic metabolism typical of corticosteroids.

Protein Binding

Unknown (not established for ophthalmic fluorometholone).

Product Information

Available Dosage Forms

Ophthalmic suspension (eye drops).

Composition per Dose

Each mL of suspension: fluorometholone 1 mg (0.1%); excipients include benzalkonium chloride 0.004% (preservative), polyvinyl alcohol, sodium chloride, sodium phosphate dibasic, sodium phosphate monobasic, polysorbate 80, edetate disodium, purified water; pH adjusted with sodium hydroxide and/or hydrochloric acid

Generic Availability

Yes

OTC Alternatives

No OTC alternative for prescription-strength ophthalmic corticosteroids; OTC antihistamine eye drops (e.g., ketotifen) for allergic conjunctivitis only

Target Organ

Eye

Preservative Free

No

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