Description
Bromfenac ophthalmic (eye) solution is used to treat pain or swelling of the eye following cataract surgery. This medicine is a topical nonsteroidal anti-inflammatory drug (NSAID).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Solution
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Drug Interactions
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 this medicine, 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 this medicine 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 this medicine 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
- Bemetizide
- Bemiparin
- Bendroflumethiazide
- Benzthiazide
- Betrixaban
- Bismuth Subsalicylate
- Bivalirudin
- Budesonide
- Bufexamac
- Bumetanide
- Cangrelor
- Celecoxib
- Certoparin
- Chlorothiazide
- Chlorthalidone
- Choline Magnesium Trisalicylate
- Choline Salicylate
- Cilostazol
- Citalopram
- Clomipramine
- Clonixin
- Clopamide
- Clopidogrel
- Cyclopenthiazide
Using this medicine 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
- Anisindione
- Atenolol
- Azilsartan
- Azilsartan Medoxomil
- Benazepril
- Betaxolol
- Bisoprolol
- Candesartan
- Captopril
- Carteolol
- Carvedilol
- Celiprolol
- Dicumarol
- Enalapril
- Enalaprilat
- Eprosartan
- Esmolol
- Fosinopril
- Irbesartan
- Labetalol
- Levobunolol
- Lisinopril
- Losartan
- Metipranolol
- Metoprolol
- Moexipril
- Nadolol
- Nebivolol
- Olmesartan
- Oxprenolol
- Penbutolol
- Perindopril
- Pindolol
- Propranolol
- Quinapril
- Ramipril
- Sotalol
- Spirapril
- Telmisartan
Other Interactions
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 this medicine. 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. This medicine 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.
Proper Use
Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects. This medicine is not for long-term use.
Keep using this medicine for at least 2 weeks unless your doctor tells you otherwise.
This medicine can be used with other ophthalmic (eye) medicines. Wait at least 5 minutes before using another eye medicine.
Remove contact lenses before you use the eye drops. Wait for at least 10 minutes before putting the contact lenses back in.
To use the eye drops:
- Wash your hands with soap and water before and after you use this medicine.
- Tilt the head back. Press your finger gently on the skin just beneath the lower eyelid and pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
- To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye drops.
If you are using more than one eye product, apply these medicines at least 5 minutes apart.
Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
- For ophthalmic dosage form (eye drops):
- For eye pain or swelling following cataract surgery:
- Adults—
- Bromsite™: Use one drop in the affected area two times a day (morning and evening) starting 1 day before cataract surgery, continued on the day of surgery, and for 14 days after the surgery.
- Prolensa® and Bromday®: Use one drop in the affected eye once a day starting 1 day before cataract surgery, continued on the day of surgery, and for 14 days after the surgery.
- Children—Use and dose must be determined by your doctor.
- Adults—
- For eye pain or swelling following cataract surgery:
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
Precautions
It is very important that your eye doctor (ophthalmologist) check your progress at regular visits to make sure this medicine is working properly and to check for unwanted effects.
If your symptoms do not improve within a few days or if they become worse, check with your doctor.
This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, shortness of breath, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
Slow or delayed healing may occur while you are using this medicine. Ask your doctor before using this medicine together with a topical corticosteroid (eg, betamethasone, clobetasol, hydrocortisone, Lotrisone®).
Using this medicine may increase risk of having keratitis and corneal problems. Check with your eye doctor right away if you have blurred vision, changes in vision, or eye redness, irritation, or pain while using this medicine.
While applying the medicine, your eyes will probably sting or burn for a short time. This is to be expected.
Do not use other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
More common
- Blurred vision
- change in color vision
- decreased vision or other changes in vision
- difficulty seeing at night
- eye pain
- red, sore eyes
- sensitivity to light
- tearing
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
- Abnormal sensation in the eye
- burning or stinging of the eye
- feeling of having something in the eye
- headache
- itching of the eyes
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
DRG-20062377
