FOR TOPICAL OPHTHALMIC USE ONLY. NOT FOR INJECTION. Use in the treatment of herpes simplex infection requires great caution. Prolonged use may result in glaucoma, damage to the optic nerve, defect in visual acuity and visual field, cataract formation and/or may aid in the establishment of secondary ocular infections from pathogens due to suppression of host response. Acute purulent infections of the eye may be masked or exacerbated by presence of steroid medication. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with chronic use of topical steroids. It is advisable that the intraocular pressure be checked frequently.
There is currently no manufacturer warning information available for this drug.
FLAREX® (fluorometholone acetate ophthalmic suspension) is indicated for use in the treatment of steroid responsive inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the eye.
FLAREX® (fluorometholone acetate ophthalmic suspension) is a corticosteroid prepared as a sterile topical ophthalmic suspension. The active ingredient, fluorometholone acetate, is a white to creamy white powder with an empirical formula of C24H31FO5 and a molecular weight of 418.5. Its chemical name is 9-fluoro-11β, 17-dihydroxy-6α-methylpregna-1, 4-diene-3, 20-dione 17-acetate. The chemical structure of Fluorometholone Acetate is presented below:
Each mL contains: Active: fluorometholone acetate 1 mg (0.1%). Preservative: benzalkonium chloride 0.01%. Inactives: sodium chloride, monobasic sodium phosphate, edetate disodium, hydroxyethyl cellulose, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water. The pH of the suspension is approximately 7.3, with an osmolality of approximately 300 mOsm/kg.