PRED FORTE 1% EYE DROPS 5ML

Indications

Approved Uses

Steroid-responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye (e.g., allergic conjunctivitis, keratitis, iritis/uveitis anterior, cyclitis).

Dosage & Administration

Dosing by Condition

Ocular inflammation: 1-2 drops into the conjunctival sac 2-4 times daily; in the first 24-48 hours, frequency may be increased (e.g., up to hourly in severe inflammation) then taper as response occurs.

Initial Dose

1-2 drops every hour during the day and every two hours at night for the first 24-48 hours in severe cases, then reduced.

Maintenance Dose

1-2 drops 2-4 times daily as inflammation responds to treatment

Maximum Dose

During the initial 24 to 48 hours, the dosing frequency may be increased if necessary; then 1-2 drops 2-4 times daily.

Children's Dosage

Safety and efficacy in pediatric patients have been established; use same as adult dosing.

Dose Adjustment Notes

Taper frequency gradually as inflammation improves, especially if used for more than a few days; avoid abrupt discontinuation after prolonged/frequent dosing to reduce rebound inflammation. No renal/hepatic dose adjustment is generally required for ophthalmic use.

How to Take

Shake well before each use (ophthalmic suspension). Wash hands. Tilt head back, pull down lower eyelid, instill 1 drop into the conjunctival sac (or as prescribed), then close eye gently 1-2 minutes and perform nasolacrimal occlusion for ~1 minute. Avoid touching the dropper tip. Remove contact lenses before use and wait at least 15 minutes before reinserting.

How to Prepare

Shake well before each use (ophthalmic suspension) to ensure uniform resuspension; avoid touching the dropper tip to the eye or surfaces.

Side Effects

Common Side Effects

Transient burning or stinging upon instillation, temporary blurred vision, eye irritation, foreign body sensation, increased intraocular pressure.

Side Effect Frequency

Common: transient burning/stinging and blurred vision/temporary visual disturbance; Important risks with prolonged/frequent use: increased intraocular pressure/glaucoma, posterior subcapsular cataract, delayed wound healing, and secondary ocular infection (frequencies often not precisely quantified in labeling).

Safety & Warnings

Contraindications

Viral diseases of the cornea and conjunctiva (including epithelial herpes simplex keratitis, vaccinia, varicella), mycobacterial ocular infections, fungal diseases of ocular structures, acute purulent untreated bacterial infections, hypersensitivity to prednisolone or any component of the formulation

Warnings & Precautions

Monitor intraocular pressure if treatment exceeds ~10 days; prolonged use increases risk of glaucoma and posterior subcapsular cataract; may mask or worsen infection-avoid/stop if infection suspected and treat appropriately; use caution with corneal/scleral thinning (perforation risk) and after ocular surgery (delayed healing); not for injection; if preservative-containing, remove soft contact lenses and reinsert after ~15 minutes; separate from other eye meds by 5-10 minutes.

Age Restriction

Safety and effectiveness in pediatric patients have been established; no specific minimum age restriction.

Special Populations

Pregnancy

Use during pregnancy only if potential benefit justifies potential risk to fetus (animal teratogenicity data).

Breastfeeding

Caution

Children

Safety and efficacy in pediatric patients have been established; use same as adult dosing.

Elderly

Standard adult dosing; monitor intraocular pressure closely as elderly patients may be more susceptible to steroid-induced glaucoma

Kidney Impairment

No adjustment needed

Liver Impairment

No adjustment needed

Storage & Patient Advice

Preparation Instructions

Shake well before each use (ophthalmic suspension) to ensure uniform resuspension; avoid touching the dropper tip to the eye or surfaces.

Stopping the Medicine

Do not stop abruptly after prolonged use - taper the dose gradually under ophthalmologist guidance to avoid rebound inflammation

Overdose

Ocular overdose: rinse/flush the eye with water or saline; ingestion of a small bottle is unlikely to cause serious toxicity but seek medical advice/poison center guidance, especially for children, and provide supportive care.

Patient Counseling

Shake well before each use; wash hands; avoid touching the dropper tip; remove contact lenses and wait at least 15 minutes before reinserting; close eye gently and consider nasolacrimal occlusion for ~1 minute; use exactly as prescribed and do not stop abruptly if used frequently/prolonged-taper per prescriber; report worsening pain, vision changes, or signs of infection; attend follow-up for eye-pressure checks if used ≥10 days; store below 25°C.

Monitoring Requirements

Monitor intraocular pressure if used for 10 days or longer; with prolonged/repeated courses, periodic slit-lamp examination for cataract formation and assessment of corneal integrity/infection is recommended.

Pharmacology

Metabolism

Prednisolone (systemically absorbed) undergoes hepatic metabolism (reduction/oxidation and conjugation); prednisolone acetate is hydrolyzed by ocular esterases to prednisolone in ocular tissues.

Product Information

Available Dosage Forms

Eye drops, suspension (ophthalmic).

Composition per Dose

Each mL: 10 mg prednisolone acetate (1%) in ophthalmic suspension with benzalkonium chloride as preservative

Generic Availability

Yes

OTC Alternatives

No OTC alternative for prescription-strength ophthalmic corticosteroid; OTC lubricant eye drops for symptomatic relief only

Target Organ

Eye

Preservative Free

No

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