Flarex (Fluorometholone Acetate Ophthalmic) - Description and Clinical Pharmacology

DESCRIPTION

FLAREX® (fluorometholone acetate) 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%. Inactive: sodium chloride, monobasic sodium phosphate, edetate disodium, hydroxyethyl cellulose, tyloxapol, hydrochloric acid and/or sodium hydroxide (to adjust pH), and purified water. DM-00

CLINICAL PHARMACOLOGY

Corticosteroids suppress the inflammatory response to inciting agents of mechanical, chemical or immunological nature. No generally accepted explanation of this steroid property has been advanced. Clinical studies demonstrate that Fluorometholone Acetate is significantly more efficacious than Fluorometholone for the treatment of external ocular inflammation.¹ Corticosteroids cause a rise in intraocular pressure in susceptible individuals. In a small study, FLAREX Ophthalmic Suspension demonstrated a significantly longer average time to produce a rise in intraocular pressure than did dexamethasone phosphate; however, the ultimate magnitude of the rise was equivalent for both drugs and in a small percentage of individuals a significant rise in intraocular pressure occurred within three days.²