AFM Ophthalmic Solution

Fluorometholone Acetate ophthalmic suspension is indicated for the treatment of-

• Acute and chronic non-infectious conjunctivitis and keratitis of allergic origin.
• Non-infectious inflammation of the anterior chamber of the eye (including anterior uveitis, episcleritis and scleritis).
• Post-operative irritative conditions after strabismus, cataract and glaucoma surgery.

Fluorometholone is a corticosteroid with an excellent anti-inflammatory action with no significant influence on the intraocular pressure. The anti-inflammatory activity of Fluorometholone is at least 40 times stronger than that of Hydrocortisone. Corticosteroids are thought to act by the introduction of phospholipase A2 inhibitory proteins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandin and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. In comparison with other corticosteroids Fluorometholone is more rapidly degraded in tissue and therefore has less effect on the intraocular pressure. The immunosuppressive action of Fluorometholone is less pronounced than that of Dexamethasone.

1 drop instilled into the conjunctival sac 2-4 times daily. During the initial 24 to 48 hours the dosage may be safely increased to 1 drop every hour. Care should be taken not to discontinue therapy prematurely. Shake well before use.

Specific drug interaction studies have not been conducted with Fluorometholone ophthalmic suspension.

• Hypersensitivity to any ingredient of the formulation.
• Infectious conjunctivitis or keratitis.
• Injuries and ulcerous processes of cornea, especially infections caused by virus, bacteria and fungi.
• Dry eyes, especially keratoconjunctivitis sicca.
• Glaucoma.

Glaucoma with optic nerve damage, visual acuity or field defects, cataract formation, secondary ocular infection following suppression of host immunity, perforation of the globe.

Safety of the use of topical steroids during pregnancy and lactation has not been established. Fluorometholone ophthalmic suspension should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Shake well before using. If this product is used for 10 days or longer, intraocular pressure should be monitored.

Ophthalmic Steroid preparations

Store in a cool, dry place and protected from light. Keep out of the reach of children. Discard the container 4 weeks after opening.