Bromfenac ophthalmic

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

Stop using this medicine and call your doctor at once if you have:

• any change in your vision;
• slow healing after your eye surgery;
• eye redness or bleeding;
• eye pain or swelling; or
• severe eye discomfort, increased tears, crusting or drainage.

Common side effects may include:

• increased sensitivity of your eyes to light;
• mild eye irritation, or feeling like something is in your eye;
• headache; or
• seeing flashes of light or "floaters" in your vision.

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.

You should not use bromfenac ophthalmic if you are allergic to it.

To make sure this medicine is safe for you, tell your doctor if you have:

• asthma or sulfite allergy;

• diabetes;

• rheumatoid arthritis;

• dry eye syndrome;

• an allergy to aspirin or other NSAIDs;

• a bleeding or blood-clotting disorder; or

• more than one eye surgery in a short period of time.

Using bromfenac ophthalmic during the last 3 months of pregnancy may harm the unborn baby.

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

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

Call your doctor for instructions if you miss your first dose, which should be given 1 day before surgery.

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

Stop using this medicine and call your doctor at once if you have:

• any change in your vision;

• slow healing after your eye surgery;

• eye redness or bleeding;

• eye pain or swelling; or

• severe eye discomfort, increased tears, crusting or drainage.

Common side effects may include:

• increased sensitivity of your eyes to light;

• mild eye irritation, or feeling like something is in your eye;

• headache; or

• seeing flashes of light or "floaters" in your vision.

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.

Bromfenac ophthalmic (eye) solution is used to treat pain or swelling of the eye following cataract surgery. bromfenac is a topical nonsteroidal anti-inflammatory drug (NSAID).

bromfenac is available only with your doctor's prescription.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For bromfenac, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to bromfenac or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of bromfenac eye drops in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of bromfenac eye drops in the elderly.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking bromfenac, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using bromfenac with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Ketorolac

Using bromfenac with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abciximab
• Aceclofenac
• Acemetacin
• Acenocoumarol
• Amiloride
• Amineptine
• Amitriptyline
• Amitriptylinoxide
• Amoxapine
• Amtolmetin Guacil
• Anagrelide
• Apixaban
• Ardeparin
• Argatroban
• Aspirin
• Balsalazide
• Bemiparin
• Bendroflumethiazide
• Benzthiazide
• Betamethasone
• Betrixaban
• Bismuth Subsalicylate
• Bivalirudin
• Bromfenac
• Budesonide
• Bufexamac
• Bumetanide
• Cangrelor
• Celecoxib
• Certoparin
• Chlorothiazide
• Chlorthalidone
• Choline Magnesium Trisalicylate
• Choline Salicylate
• Cilostazol
• Citalopram
• Clomipramine
• Clonixin
• Clopamide
• Clopidogrel
• Cortisone
• Cyclopenthiazide
• Cyclosporine
• Dabigatran Etexilate
• Dalteparin
• Danaparoid
• Deflazacort
• Desipramine
• Desirudin
• Desmopressin
• Desvenlafaxine
• Dexamethasone
• Dexibuprofen
• Dexketoprofen
• Diazoxide
• Dibenzepin
• Diclofenac
• Diflunisal
• Digoxin
• Dipyridamole
• Dipyrone
• Dothiepin
• Doxepin
• Droxicam
• Duloxetine
• Edoxaban
• Enoxaparin
• Eplerenone
• Epoprostenol
• Eptifibatide
• Escitalopram
• Ethacrynic Acid
• Etodolac
• Etofenamate
• Etoricoxib
• Felbinac
• Fenoprofen
• Fepradinol
• Feprazone
• Feverfew
• Floctafenine
• Flufenamic Acid
• Fluocortolone
• Fluoxetine
• Flurbiprofen
• Fluvoxamine
• Fondaparinux
• Furosemide
• Ginkgo
• Gossypol
• Heparin
• Hydrochlorothiazide
• Hydrocortisone
• Hydroflumethiazide
• Ibuprofen
• Iloprost
• Imipramine
• Indapamide
• Indomethacin
• Ketoprofen
• Lepirudin
• Levomilnacipran
• Lithium
• Lofepramine
• Lornoxicam
• Loxoprofen
• Lumiracoxib
• Magnesium Salicylate
• Meadowsweet
• Meclofenamate
• Mefenamic Acid
• Melitracen
• Meloxicam
• Mesalamine
• Methotrexate
• Methyclothiazide
• Methylprednisolone
• Metolazone
• Milnacipran
• Morniflumate
• Nabumetone
• Nadroparin
• Naproxen
• Nefazodone
• Nepafenac
• Niflumic Acid
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nortriptyline
• Olsalazine
• Opipramol
• Oxaprozin
• Oxyphenbutazone
• Paramethasone
• Parecoxib
• Parnaparin
• Paroxetine
• Pemetrexed
• Pentosan Polysulfate Sodium
• Pentoxifylline
• Phenindione
• Phenprocoumon
• Phenylbutazone
• Phenyl Salicylate
• Piketoprofen
• Piroxicam
• Polythiazide
• Pralatrexate
• Prasugrel
• Prednisolone
• Prednisone
• Proglumetacin
• Propyphenazone
• Proquazone
• Protein C
• Protriptyline
• Reboxetine
• Reviparin
• Rivaroxaban
• Rofecoxib
• Salicylamide
• Salicylic Acid
• Salsalate
• Sertraline
• Sibutramine
• Sodium Salicylate
• Spironolactone
• Sulfasalazine
• Sulindac
• Tacrolimus
• Tenoxicam
• Tianeptine
• Tiaprofenic Acid
• Ticagrelor
• Ticlopidine
• Tinzaparin
• Tirofiban
• Tolfenamic Acid
• Tolmetin
• Torsemide
• Treprostinil
• Triamterene
• Trichlormethiazide
• Trimipramine
• Trolamine Salicylate
• Valdecoxib
• Venlafaxine
• Vilazodone
• Vorapaxar
• Vortioxetine
• Warfarin
• Xipamide

Using bromfenac with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acebutolol
• Alacepril
• Anisindione
• Atenolol
• Azilsartan
• Azilsartan Medoxomil
• Benazepril
• Betaxolol
• Bisoprolol
• Candesartan
• Captopril
• Carteolol
• Carvedilol
• Celiprolol
• Cilazapril
• Delapril
• Dicumarol
• Enalapril
• Enalaprilat
• Eprosartan
• Esmolol
• Fosinopril
• Imidapril
• Irbesartan
• Labetalol
• Levobunolol
• Lisinopril
• Losartan
• Metipranolol
• Metoprolol
• Moexipril
• Nadolol
• Nebivolol
• Olmesartan
• Oxprenolol
• Penbutolol
• Pentopril
• Perindopril
• Pindolol
• Practolol
• Propranolol
• Quinapril
• Ramipril
• Sotalol
• Spirapril
• Telmisartan
• Temocapril
• Timolol
• Trandolapril
• Valsartan
• Zofenopril

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of bromfenac. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to aspirin, phenylacetic acid, and other NSAIDs (eg, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Voltaren®), history of or
• Bleeding problems—Use with caution. May make these conditions worse.

• Asthma or
• Sulfite allergy—Use with caution. bromfenac contains sodium sulfite which may cause an allergic reaction in patients with these conditions.

• Corneal (front part of the eye) denervation or
• Corneal (front part of the eye) epithelial defects or
• Diabetes or
• Ocular (eye) surface diseases (eg, dry eye syndrome) or
• Ocular (eye) surgeries, complicated or
• Ocular (eye) surgeries, multiple within a short period of time or
• Rheumatoid arthritis—Use with caution. May increase the risk of experiencing corneal problems.

This medication is used to treat swelling (inflammation) and pain in the eye after a certain type of eye surgery (cataract surgery). Bromfenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking the effects of certain natural substances (prostaglandins) that cause pain and inflammation.

How to use Bromfenac SODIUM Drops

Your doctor may direct you to start using this medication the day before or the day after your surgery. Place 1 drop into the affected eye as directed by your doctor, usually once or twice a day for 2 weeks. Carefully follow your doctor's specific directions.

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.

This medication should not be used while wearing contact lenses. Consult your doctor or pharmacist for details.

If you are wearing contact lenses, remove them before using eye drops. 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 (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.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day. Continue using it for the full time prescribed.

Do not apply this medication more often than prescribed or continue using it for longer than directed by your doctor. Prolonged use of bromfenac eye drops may increase the risk of very serious side effects of the eye.

Temporary irritation/burning/stinging of the eye, temporary blurred vision, watery eyes, or headache may occur. 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 right away if any of these unlikely but serious side effects occur: severe pain/redness in the eye, sensitivity of the eyes to light (photophobia), eye discharge, blurry/abnormal vision, feeling as if something is in the eye, itching/redness/pain around the eyes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

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 or at www.fda.gov/medwatch.

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

Before using bromfenac, 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. This product may contain inactive ingredients (such as sulfites), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding disorders, other eye problems (e.g., dry eye syndrome, corneal problems), diabetes, rheumatoid arthritis, asthma, growths in the nose (nasal polyps).

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). 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.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center 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. Do not store in the bathroom. 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 2016. Copyright(c) 2016 First Databank, Inc.