FLURBIPROFEN SODIUM- flurbiprofen sodium solution/ drops 
Bausch & Lomb Incorporated

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Flurbiprofen Sodium Ophthalmic Solution USP, 0.03% (Sterile)

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:

Flurbiprofen sodium structural formula

C15H12 FNaO2 •2H2O         Mol. Wt. 302.27

Each mL Contains:

 ACTIVE: Flurbiprofen sodium 0.03% (0.3 mg/mL).

INACTIVES: Citric Acid, Edetate Disodium, Polyvinyl Alcohol 1.4%, Potassium Chloride, Purified Water, Sodium Chloride, and Sodium Citrate. Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (6.0 – 7.0).

PRESERVATIVE ADDED: Thimerosal 0.005%.

CLINICAL PHARMACOLOGY

Flurbiprofen sodium is one of a series of phenylalkanoic acids that have shown analgesic antipyretic, and antiinflammatory 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 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

General:

Topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.

It is recommended that 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.

Information for Patients:

Patients should be instructed to avoid allowing the tip of the bottle to contact the eye or surrounding structures because this could cause the tip to become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.

To avoid the potential for cross-contamination, the patient should be advised to use one bottle for each eye with bilateral ocular surgery. The use of the same bottle of eye drops for both eyes is not recommended with ocular surgery.

Drug Interactions:

Interaction of 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 flurbiprofen sodium ophthalmic solution.

Carcinogenesis, Mutagenesis, Impairment of Fertility:

Long-term studies in mice and/or rats have shown no evidence of carcinogenicity with flurbiprofen.

Long-term mutagenicity studies in animals have not been performed.

Pregnancy:

Pregnancy Category C. Flurbiprofen has been shown to be embryocidal, delay parturition, prolong gestation, reduce weight, and/or slightly retard growth of fetuses when given to rats in daily oral doses of 0.4 mg/kg (approximately 300 times the human daily topical dose) and above. There are no adequate and well-controlled studies in pregnant women. Flurbiprofen sodium ophthalmic solution should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from flurbiprofen sodium, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

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 hyeremia.

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

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 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 symbol IS NOT INTACT.

Storage:

Store at 15°–25°C (59°–77°F).

Revised: November 2012

Bausch & Lomb Incorporated
Tampa, Florida 33637
©Bausch & Lomb Incorporated

Principal Display Panel

2.5 mL carton

NDC 24208-314-25

Bausch & Lomb

Flurbiprofen Sodium Ophthalmic Solution USP, 0.03% (Sterile)

Rx only

[icon- eye] [icon- 0.03%] [icon- solution] [icon- 2.5 mL]

FLURBIPROFEN SODIUM 
flurbiprofen sodium solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:24208-314
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FLURBIPROFEN SODIUM (FLURBIPROFEN) FLURBIPROFEN SODIUM0.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
EDETATE DISODIUM 
HYDROCHLORIC ACID 
POLYVINYL ALCOHOL 
POTASSIUM CHLORIDE 
WATER 
SODIUM CHLORIDE 
SODIUM CITRATE 
SODIUM HYDROXIDE 
THIMEROSAL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24208-314-251 in 1 CARTON
12.5 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07444701/04/1995
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated807927397MANUFACTURE(24208-314)

Revised: 12/2012
Document Id: 8d90b181-36aa-4c80-8e43-ba6239d07c8e
Set id: 11db354f-caf9-4567-811e-6c9beb1330c7
Version: 3
Effective Time: 20121218
 
Bausch & Lomb Incorporated