OCUFEN® (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.

Contains: Active: flurbiprofen sodium 0.03% (0.3 mg/mL). Preservative: thimerosal 0.005%. Inactives: citric acid; edetate disodium; polyvinyl alcohol 1.4%; potassium chloride; purified water; sodium chloride; and sodium citrate. May also contain hydrochloric acid and/or sodium hydroxide to adjust the pH. The pH of OCUFEN® ophthalmic solution is 6.0 to 7.0. It has an osmolality of 260-330 mOsm/kg.

OCUFEN® ophthalmic solution is indicated for the inhibition of intraoperative miosis.

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

OCUFEN® (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: 2.5 mL in 6 mL bottle - NDC 11980-801-03

Note: Store between 15 – 25°C (59 – 79°F).

Revised February 2003. Allergan, Inc., Irvine, California 92612, U.S.A. FDA revision date: 8/25/2003

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

Increased bleeding tendency of ocular tissues in conjunction with ocular surgery has also been reported.

Interaction of OCUFEN® 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® ophthalmic solution.

With nonsteroidal anti-inflammatory drugs, there exists the potential for increased bleeding due to interference with thrombocyte aggregation. There have been reports that OCUFEN® 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 nonsteroidal anti-inflammatory drugs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

General

Wound healing may be delayed with the use of OCUFEN® (flurbiprofen sodium ophthalmic solution, USP) 0.03%.

It is recommended that OCUFEN® ophthalmic solution be used with caution in surgical patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.

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 333 times the human daily topical dose) and above.

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.

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

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

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® 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.

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

FLURBIPROFEN - OPHTHALMIC

(flewr-BIH-pro-fen)

COMMON BRAND NAME(S): Ocufen

USES: This medication is used to stop the pupil of the eye from narrowing during eye surgery. Flurbiprofen belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by stopping the release and effects of certain natural substances (prostaglandins) that cause narrowing of the pupil.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat swelling and redness caused by certain eye conditions.

HOW TO USE: For use in surgery, one drop is placed into the eye every 30 minutes beginning 2 hours before surgery (4 drops total) or as directed by your doctor.

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

If you are wearing contact lenses, remove them before using eye drops. Discuss with your doctor when to replace your contact lenses.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed or if your dose is for more than 1 drop.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

SIDE EFFECTS: Temporary irritation/burning/stinging of the eye or temporary blurred vision may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. (See also Precautions section.) Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if this unlikely but serious side effect occurs: severe eye pain.

Tell your doctor immediately if this rare but very serious side effect occurs: bleeding in the eye.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching, swelling, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking flurbiprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., naproxen, celecoxib); or if you have any other allergies.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders, a certain virus infection of the eye (herpes simplex keratitis), certain eye problems (corneal erosion, corneal ulceration), asthma, diabetes, kidney disease, rheumatoid arthritis, asthma, growths in the nose (nasal polyps).

Vision may be temporarily blurred or unstable after applying eye drops. Use caution while driving, using machinery, or doing any activity that requires clear vision. Limit alcoholic beverages.

During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to an unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

This drug should not be used with the following medication because very serious interactions may occur: cidofovir.

If you are currently using this medication listed above, tell your doctor or pharmacist before starting flurbiprofen.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: other NSAID medications (e.g., aspirin, ibuprofen), blood thinners (e.g., warfarin, heparin), other eye medications.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If overdose or swallowing is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C) away from heat and light. Discard this medication if it turns brown or cloudy or contains particles. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.