This preparation is indicated for the treatment of ocular conditions requiring anti-inflammatory therapy where bacterial infection caused by organisms sensitive to neomycin and/or polymyxin B is present or may be a potential risk. Such conditions include non-purulent conjunctivitis and blepharitis, scleritis, non-herpetic keratitis, dacryocystitis, and for prophylactic use following ocular surgery, foreign body removal, chemical or thermal burns, abrasions, lacerations, or other eye injuries.

Each mL contains:

• Prednisolone acetate 5 mg
• Neomycin sulfate (equivalent to 3.5 mg neomycin base) 5 mg
• Polymyxin B sulfate 10,000 units

To treat the eye: 1 drop every 3 to 4 hours, or more frequently as required.

To treat the lids: instill 1 drop in the eye every 3 to 4 hours, close the eye and rub the excess on the lids and lid margins.

To treat the surrounding skin areas: where the eye or lid inflammation co-exists with surrounding skin involvement, drops may be spread liberally on the area and allowed to dry.

Pediatric Use: Safety and effectiveness in children have not been evaluated.

Synergistic effects may occur with penicillins. Additive toxicity may be seen with drugs that are neurotoxic, ototoxic, or nephrotoxic. This medicine may reduce the absorption of digoxin and methotrexate, and may increase the effect of oral anticoagulants.

Acute herpes simplex (dendritic keratitis), vaccinia, varicella, and other viral infections of the cornea and conjunctiva. Ocular tuberculosis, fungal eye infections, and hypersensitivity to any component of the formulation.

May cause increased intraocular pressure (IOP) with possible development of glaucoma and, rarely, optic nerve damage. Posterior subcapsular cataract formation and delayed wound healing may also occur.

Corneal fungal and viral infections may develop during prolonged use of topical steroids.

The safety of topical corticosteroid use during pregnancy has not been established. Use only if clearly needed under medical supervision.

In infections caused by microorganisms, steroid use may mask, worsen, or activate the infection. Prolonged use may increase intraocular pressure leading to glaucoma, optic nerve damage, reduced visual acuity, visual field defects, and posterior subcapsular cataracts. Intraocular pressure should be monitored regularly. Long-term corticosteroid use may cause thinning of the cornea or sclera, increasing the risk of perforation. It may also delay wound healing and promote overgrowth of non-susceptible organisms. If superinfection occurs, discontinue and start appropriate treatment. Persistent inflammation after long-term steroid use may indicate fungal infection of the cornea. Caution is required in patients with a history of herpes simplex infection. In acute purulent eye infections, steroids may mask or worsen infection. Neomycin sulfate may cause allergic skin sensitization, although the exact frequency is unknown.

Ophthalmic steroid–antibiotic combination preparations

Store at 15°C–25°C. Do not freeze. Store in upright position. Prescription only. Keep out of reach of children. Shake well before use.