Flurbiprofen Sodium Ophthalmic Solution .03% 2.5 ml

Rx only

FOR OPHTHALMIC USE ONLY

DESCRIPTION

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:

C15H12 FNaO2 •2H2O         Mol. Wt. 302.27

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%.

CLINICAL PHARMACOLOGY

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.

INDICATIONS AND USAGE

Flurbiprofen Sodium Ophthalmic Solution is indicated for the inhibition of intraoperative miosis.

CONTRAINDICATIONS

Flurbiprofen Sodium Ophthalmic Solution is contraindicated in individuals who are hypersensitive to any components of the medication.

WARNINGS

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.

PRECAUTIONS

ADVERSE REACTIONS

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, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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

DO NOT USE IF IMPRINTED “Protective Seal” WITH YELLOW IS NOT INTACT.

Storage:

Store at 15°–25°C (59°–77°F).

Bausch + Lomb, a division of Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA
©Bausch & Lomb Incorporated

Revised: July 2016