FLAREX Eye drops, suspension Ref.[10812] Active ingredients: Fluorometholone

Source: FDA, National Drug Code (US)  Revision Year: 2019 

2. 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. Corticosteroids cause a rise in intraocular pressure in susceptible individuals. In a small study, FLAREX (fluorometholone acetate 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.

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.

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