Pronunciation:

BROME-fen-ak

Brand Names:

• Xibrom

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Anti-Inflammatory

Pharmacologic—

NSAID

Chemical—

Acetic Acid (class)

Uses of This Medicine:

Bromfenac is a drug used to treat inflammation of the eye following cataract surgery.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

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.

Children—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of ophthalmic bromfenac in children with use in other age groups.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of ophthalmic bromfenac in the elderly with use in other age groups, this medicine has been used mostly in elderly patients and is not expected to cause different side effects or problems than it does in younger adults.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

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.

• Ardeparin
• Certoparin
• Dalteparin
• Danaparoid
• Enoxaparin
• Nadroparin
• Parnaparin
• Reviparin
• Tacrolimus
• Tinzaparin

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:

• Bleeding problems of the eye—May be worsened by bromfenac

• Corneal denervation or
• Corneal epithelial defects or
• Diabetes mellitus or
• Ocular surface diseases (e.g., dry eyes) or
• Ocular surgeries, complicated or
• Ocular surgeries, multiple within a short period of time or
• Rheumatoid arthritis—May increase the risk of experiencing corneal problems

• Allergy to sulfites—May cause allergic-type reactions

Proper Use of This Medicine:

To use:

• The bottle is only partially full to provide proper drop control.
• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath 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
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• 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.

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 (solution):
  • For eye inflammation following cataract surgery:
    • Adults—1 drop to the problem eye 2 times a day; treatment should start 24 hours after surgery and continue for 2 weeks
    • Children—Use and dose must be determined by your doctor.

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.

Precautions While Using This Medicine:

If your symptoms do not improve within a few days or if they become worse, check with your doctor.

While applying the medicine, your eyes will probably sting or burn for a short time. This is to be expected.

Side Effects of This Medicine:

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.

Incidence not determined

(observed during clinical practice, estimates of frequency can not be determined)

Vision changes

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 eye

burning or stinging of the eye

eye irritation

eye pain

eye redness

headache

increase in blood flow to the whites of the eyes

itching of the eyes

sensitivity to light

tearing

throbbing pain

Incidence not determined

(observed during clinical practice, estimates of frequency can not be determined)

Blurred vision or other changes in vision