Ocufen (Flurbiprofen sodium) (flurbiprofen sodium ophthalmic solution, USP) 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use.
Sodium (±)-2-(2-fluoro-4-biphenylyl)-propionate dihydrate.
Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic, antipyretic, and anti-inflammatory activity in animal inflammatory diseases. Its mechanism of action is believed to be through inhibition of the cyclo-oxygenase enzyme that is essential in the biosynthesis of prostaglandins.
Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed on animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilatation, increased vascular permeability, leukocytosis, and increased intraocular pressure.
Prostaglandins also appear to play a role in the miotic response produced during ocular surgery by constricting the iris sphincter independently of cholinergic mechanisms. In clinical studies, Ocufen (Flurbiprofen sodium) ophthalmic solution has been shown to inhibit the miosis induced during the course of cataract surgery. Results from clinical studies indicate that flurbiprofen sodium has no significant effect upon intraocular pressure.
With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference with thrombocyte aggregation. There have been reports that Ocufen (Flurbiprofen sodium) ophthalmic solution may cause increased bleeding of ocular tissues including hyphemas in conjunction with ocular surgery.
There exists the potential for cross-sensitivity to acetylsalicylic acid and other non-steroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Wound healing may be delayed with the use of Ocufen (Flurbiprofen sodium) (flurbiprofen sodium ophthalmic solution, USP) 0.03%.
It is recommended that Ocufen (Flurbiprofen sodium) ophthalmic solution be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
Interaction of Ocufen (Flurbiprofen sodium) ophthalmic solution with other topical ophthalmic medications has not been fully investigated.
Although clinical studies with acetylcholine chloride and animal studies with acetylcholine chloride or carbachol revealed no interference, and there is no known pharmacological basis for an interaction, there have been reports that acetylcholine chloride and carbachol have been ineffective when used in patients treated with Ocufen (Flurbiprofen sodium) ophthalmic solution.
Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of Ocufen (Flurbiprofen sodium) ophthalmic solution. Other adverse reactions reported with the use of Ocufen (Flurbiprofen sodium) ophthalmic solution include: fibrosis, miosis, and mydriasis.
Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported.
Ocufen (Flurbiprofen sodium) (flurbiprofen sodium ophthalmic solution, USP) is available for topical ophthalmic administration as a 0.03% sterile solution, and is supplied in a white opaque low density polyethylene bottle with a controlled dropper tip and a gray high impact polystyrene cap in the following size:
Revised May 2004© 2004 Allergan, Inc.Irvine, CA 92612, U.S.A.® Marks owned by Allergan, Inc.
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