Rx only

FOR OPHTHALMIC USE ONLY

Flurbiprofen sodium ophthalmic solution USP, 0.03% is a sterile topical nonsteroidal anti-inflammatory product for ophthalmic use.

Chemical Name:

Sodium (±)-2-(2-fluoro-4-biphenylyl)propionate dihydrate.

Structural Formula:

Each mL contains:

Active: flurbiprofen sodium 0.03%.

Inactives: citric acid, edetate disodium, polyvinyl alcohol 1.4%, potassium chloride, purified water, sodium chloride, sodium citrate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH (6.0 – 7.0).

Preservative: thimerosal 0.005%.

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, 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.

Flurbiprofen sodium ophthalmic solution is indicated for the inhibition of intraoperative miosis.

Flurbiprofen sodium ophthalmic solution is contraindicated in individuals who are hypersensitive to any components of the medication.

With some nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that flurbiprofen sodium ophthalmic solution may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

There is the potential for cross-sensitivity to acetylsalicylic acid and other nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

Transient burning and stinging upon instillation and other minor symptoms of ocular irritation have been reported with the use of flurbiprofen sodium ophthalmic solution. Other adverse reactions reported with the use of flurbiprofen sodium ophthalmic solution include: fibrosis, hyphema, miosis, mydriasis, and ocular hyperemia.

Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported [see Warnings].

To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage will not ordinarily cause acute problems. If accidentally ingested, drink fluids to dilute.

A total of four (4) drops of flurbiprofen sodium ophthalmic solution should be administered by instilling one (1) drop approximately every 1/2 hour beginning 2 hours before surgery.

Flurbiprofen sodium ophthalmic solution USP, 0.03% is supplied in a plastic bottle with a controlled drop tip in the following size:

2.5 mL - NDC 24208-314-25

Store at 15°C to 25°C (59°F to 77°F).

Distributed by:

Bausch & Lomb Americas Inc.

Bridgewater, NJ 08807 USA

Manufactured by:

Bausch & Lomb Incorporated

Tampa, FL 33637 USA

© 2022 Bausch & Lomb Incorporated or its affiliates



Revised: September 2022

9100605 (Folded)

9100705 (Flat)

NDC 24208-314-25

Flurbiprofen

Sodium

Ophthalmic

Solution, USP

0.03%

(Sterile)

FOR OPHTHALMIC

USE ONLY

Rx only

2.5 mL

BAUSCH + LOMB

9540401

AB31404