Ocufen (Flurbiprofen Sodium Ophthalmic Solution)
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Ocufen (Flurbiprofen Sodium Ophthalmic Solution)

OCUFEN®
(flurbiprofen sodium) Ophthalmic Solution, USP 0.03% sterile

DRUG DESCRIPTION

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.

Structural Formula

OCUFEN® (flurbiprofen sodium) Structural Formula Illustration

C15H12FNaO2•2H2O      Mol. Wt. 302.27

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 pH. The pH of OCUFEN® ophthalmic solution is 6.0 to 7.0. It has an osmolality of 260 - 330 mOsm/kg.

What are the possible side effects of flurbiprofen ophthalmic (Ocufen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • eye pain or redness;
  • vision changes; or
  • severe burning, stinging, or itching of your eyes.

Less serious side effects may include mild burning, stinging, or itching of your eyes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects....

Read All Potential Side Effects and See Pictures of Ocufen »

What are the precautions when taking flurbiprofen sodium ophthalmic solution (Ocufen)?

Before using flurbiprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like thimerosal), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), other types of asthma, growths in the nose (nasal polyps), bleeding or clotting problems, other eye problems (such as cornea problems, dry eye syndrome, past eye surgeries), diabetes, rheumatoid...

Read All Potential Precautions of Ocufen »

Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

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

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

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 5 mL bottle - NDC 11980-801-03

Storage

Store at 15°-25°C (59°-77°F). Rx only

Revised: 06 2012. Allergan, Inc. Irvine, CA 92612, U.S.A.

Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

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, hyphema, miosis, mydriasis, and ocular hyperemia.

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

Read the Ocufen (flurbiprofen sodium ophthalmic solution) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

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.

Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.

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 OCUFEN® 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 non-steroidal 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 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 300 times the human daily topical dose) and above.

There are no adequate and well-controlled studies in pregnant women. OCUFEN® 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.

Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

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

CONTRAINDICATIONS

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

Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.

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, OCUFEN® 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.

Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

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.

Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

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.

Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Ocufen Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

FLURBIPROFEN - OPHTHALMIC

(flewr-BIH-pro-fen)

COMMON BRAND NAME(S): Ocufen

USES: This medication is used before certain types of eye surgery (such as cataract removal). It prevents the pupil of the eye from narrowing. This effect makes it easier for the doctor to examine the inside of the eye, to remove the cataract, and to replace it with a new lens. Flurbiprofen belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs).

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 after eye surgery to treat pain, swelling, and redness.

HOW TO USE: Apply the eye drops before surgery to the affected eye, usually every 30 minutes starting 2 hours before surgery (for a total of 4 drops), or as directed by your doctor. If you are directed to use this medication after eye surgery, follow your doctor's instructions.

Do not wear contact lenses while you are using this medicine. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again.

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.

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 1 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.

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

If you are using another kind of eye medication (for example, other 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.

This medication is intended for short-term use only. Do not use this medication more often or for longer than prescribed because doing so may increase your risk of serious side effects.

Do not use this product if it becomes contaminated (for example, drops turn cloudy or a dark color). Use of contaminated eye medication can cause infection, serious damage to the eye, and loss of vision. Contact your doctor or pharmacist for more information.

If you are instructed to use this medication after eye surgery, tell your doctor if your symptoms persist or worsen.

Disclaimer

Ocufen Consumer (continued)

SIDE EFFECTS: Stinging/burning of the eyes for 1 to 2 minutes may occur when you apply this medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

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 any of these rare but serious side effects occur: eye pain, decreased vision, bleeding in the eye (increased redness 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 (especially of the face/tongue/throat), 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.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Ocufen (flurbiprofen sodium ophthalmic solution) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using flurbiprofen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like thimerosal), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), other types of asthma, growths in the nose (nasal polyps), bleeding or clotting problems, other eye problems (such as cornea problems, dry eye syndrome, past eye surgeries), diabetes, rheumatoid arthritis.

Your vision may be temporarily blurred or unstable after applying eye drops. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

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

Disclaimer

Ocufen Consumer (continued)

DRUG INTERACTIONS: The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this drug include: drugs that can cause bleeding (antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin/heparin).

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as ibuprofen or naproxen). These drugs are similar to flurbiprofen and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.

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.

This medication has been prescribed for your current condition only. Do not use it later for another eye condition unless told to do so by your doctor. A different medication may be necessary in that case.

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 59-86 degrees F (15-30 degrees C) away from light. Do not store in the bathroom. Keep the bottle tightly closed when not in use. 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 February 2012. Copyright(c) 2012 First Databank, Inc.

Ocufen Patient Information Including Side Effects

Brand Names: Ocufen

Generic Name: flurbiprofen ophthalmic (Pronunciation: FLUR bi PROE fen)

What is flurbiprofen ophthalmic (Ocufen)?

Flurbiprofen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Flurbiprofen works by reducing hormones that cause inflammation and pain in the body.

Flurbiprofen ophthalmic (for the eye) is used to prevent your pupil from constricting, or narrowing, during eye surgery.

Flurbiprofen ophthalmic may also be used for purposes not listed in this medication guide.

What are the possible side effects of flurbiprofen ophthalmic (Ocufen)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • eye pain or redness;
  • vision changes; or
  • severe burning, stinging, or itching of your eyes.

Less serious side effects may include mild burning, stinging, or itching of your eyes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Ocufen (flurbiprofen sodium ophthalmic solution) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about flurbiprofen ophthalmic (Ocufen)?

You should not use this medication if you are allergic to flurbiprofen.

Before you receive flurbiprofen ophthalmic, tell your doctor if you are allergic to any medications, or if you have a bleeding or blood-clotting disorder or take a blood thinner such as warfarin (Coumadin).

Do not wear any contact lens that has not been approved by your doctor.

Do not use other eye medications during treatment with flurbiprofen ophthalmic unless your doctor tells you to.

Side Effects Centers

Ocufen Patient Information including How Should I Take

What should I discuss with my healthcare provider before I receive flurbiprofen ophthalmic (Ocufen)?

You should not use this medication if you are allergic to flurbiprofen.

To make sure you can safely use flurbiprofen ophthalmic, tell your doctor if you have a bleeding or blood-clotting disorder.

FDA pregnancy category C. It is not known whether flurbiprofen ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether flurbiprofen ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I use flurbiprofen ophthalmic (Ocufen)?

Use exactly as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Flurbiprofen ophthalmic is usually given every 30 minutes beginning 2 hours before your surgery. If you receive this medication at the surgery center, the eye drops will be given by a healthcare professional.

If you have been given the medication to start using your drops at home on the day of your surgery, follow the instructions below.

Wash your hands before using the eye drops.

To apply the eye drops:

  • Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper as you squeeze out a drop, then close your eye.
  • Gently press your finger to the inside corner of the eye (near your nose) for about 1 minute to keep the liquid from draining into your tear duct.
  • Use the eye drops only in the eye you are having surgery on.
  • Do not allow the dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

If you use this medication at home, try not to miss any doses.

If you store the drops at home, keep them at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

Side Effects Centers

Ocufen Patient Information including If I Miss a Dose

What happens if I miss a dose (Ocufen)?

Call your doctor if you miss a dose of this medication. The timing of your doses in relation to your surgery is very important for the medication to be effective.

What happens if I overdose (Ocufen)?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid after I receive flurbiprofen ophthalmic (Ocufen)?

Do not wear any contact lens that has not been approved by your doctor.

Do not use other eye medications during treatment with flurbiprofen ophthalmic unless your doctor tells you to.

What other drugs will affect flurbiprofen ophthalmic (Ocufen)?

Tell your doctor about all other medications you use, especially a blood thinner such as warfarin (Coumadin).

This list is not complete and other drugs may interact with flurbiprofen ophthalmic. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about flurbiprofen ophthalmic.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.08. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

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Side Effects Centers

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