For the treatment of corticosteroid-responsive ophthalmic disorders including allergic conjunctivitis, ocular burns or trauma due to corneal injury resulting from chemical, thermal or penetration trauma, giant papillary conjunctivitis (GPC), keratitis, postoperative ocular inflammation, vernal keratoconjunctivitis.
Ophthalmic corticosteroid
Fluorometholone Acetate is a corticosteroid with an excellent anti-inflammatory action to inciting agents of mechanical, chemical or immunological in nature. Fluorometholone is thought to act by the induction of phospholipase A2 inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A2. In clinical studies on patient's eyes treated with both Dexamethasone and Fluorometholone suspensions, Fluorometholone demonstrated a lower propensity to increase intraocular pressure than did Dexamethasone.
OPHTHALMIC Allergic & inflammatory conditions of the eye: Adult: As 0.1% ointment: Apply ½ inch ribbon to the conjunctival sac 1-3 times daily. As 0.1% solution: Instil 1-2 drops into the conjunctival sac 2-4 times daily. Dosage may be increased to every 4 hr in severe cases during the initial 24-48 hr. Re-evaluate if no signs of improvement after 48 hr of treatment. Child: >2 yr: As 0.1% ointment: Apply ½ inch ribbon to the conjunctival sac 1-3 times daily. As 0.1% solution: Instil 1-2 drops into the conjunctival sac 2-4 times daily. Dosage may be increased to every 4 hr in severe cases during the initial 24-48 hr. Re-evaluate if no signs of improvement after 48 hr of treatment.
Specific drug interaction studies have not been conducted with Fluorometholone ophthalmic suspension.
Viral diseases of the cornea & conjunctiva, including epithelial herpes simplex keratitis (dend ritic keratitis), Vaccinia & Varicella, mycobacterial eye infection, ocular fungal infections, untreated eye infections; hypersensitivity. Glaucoma (check lOP periodically), history of herpes simplex fungal or bacterial infections. Not to be used in mustard gas keratitis & Sjogren’s keratoconj unctivitis. May cause corneal & scleral thinning which may lead to perforation in serious cases. Use of steroids after cataract surgery may prolong healing time & increase bleb formation. Pregnancy, lactation; child <2 yr.
Elevated intraocular pressure, optic nerve damage, postsubcapsular cataract formation, delayed wound healing, uveitis, perforation of the globe, keratitis, conjunctivitis, corneal ulcers, loss of accommodation, secondary ocular infections, rarely systemic hypercorticoidism.
Use is not recommended during pregnancy. A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Store in a dry place and away from light. Keep out of reach of children. To prevent contamination of the dropper tip and suspension, care should be taken, not to touch the eyelids, surrounding areas, finger or other surfaces with the dropper tip of the bottle. The bottle should be tightly closed when not in use. Do not use after 4 weeks of first opening.