Bromday

Generic Name: bromfenac (ophthalmic)
Date of Approval: October 16, 2010
Company: ISTA Pharmaceuticals, Inc.

Treatment for: Swelling and Pain Caused by Cataract Surgery

FDA Approves Bromday

The U.S. Food and Drug Administration (FDA) approved Bromday (bromfenac ophthalmic solution) 0.09% as a once-daily prescription eye drop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

What is Bromday?

Bromday is a non-steroidal anti-inflammatory drug (NSAID).

Bromday is used to treat swelling and pain caused by cataract surgery.

Bromday may also be used for other purposes not listed here.

What is the most important information I should know about Bromday?

Use this medication exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.

Before using this medication, tell your doctor if you are pregnant or breast-feeding.

If you miss a dose, use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

Before using bromfenac tell your doctor if you are using a steroid such as prednisone, dexamethasone, or others. You may not be able to use Bromday or you may need dosage adjustments or special tests during treatment.

Stop using this medication and get emergency medical help if you think you have used too much medicine, or if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Less serious side effects are more likely, and you may have none at all. Talk to your doctor about any side effect that seems unusual or is especially bothersome. Common side effects may include: eye redness, eye irritation, eye pain, unusual sensation in the eye, and headache.

What should I discuss with my healthcare provider before using Bromday?

You should not use this medication if you have ever had an allergic reaction to bromfenac.

Before using Bromday, tell your doctor if you have:

• asthma
• sulfite allergy
• diabetes
• rheumatoid arthritis
• dry eye syndrome
• corneal conditions of he eye
• any drug allergy; especially an allergy to aspirin, phenylacetic acid or NSAIDs
• a bleeding disorder; or are taking another drug that may increase your risk for bleeding
• more than one eye surgery in a short period of time
• slow or delayed healing

If you have any of these conditions, you may need a dose adjustment or special tests to safely use Bromday.

FDA Pregnancy Category C: This medication may be harmful to an unborn baby. It is especially important avoid this drug during the last trimester of pregnancy. Do not use bromfenac without telling your doctor if you are pregnant. Tell your doctor if you become pregnant during treatment.

See also: Bromday pregnancy and breastfeeding warnings (in more detail)

Nursing Mothers: It is not known if Bromday passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Bromday?

Use Bromday exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.

Wash your hands before using the eye drops.

Contact lenses should not be worn during treatment with Bromday.

To apply the eye drops:

• Tilt your head back slightly and pull down on the lower eyelid to create a small pocket. Hold the dropper above the eye with the dropper tip down. Look up and away from the dropper. Squeeze out a drop and close your eye. Gently press your finger to the inside corner of the eye (near the nose) for about 1 minute to keep the liquid from draining into your tear duct.

Bromday is usually used once a day beginning one day prior to cataract surgery and continuing through the next 14 days after surgery. Follow your doctor's directions.

If you have been prescribed more than one ophthalmic preparation, the medicines should be administered at least 5 minutes apart.

Do not touch the dropper to any surface, including the eyes or hands. If the dropper becomes contaminated, it could cause an infection in your eye.

Store the drops at room temperature away from heat and moisture. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine, or if anyone has accidentally swallowed it. An overdose of this medication is unlikely to be harmful.

What should I avoid while taking Bromday?

Bromday can cause side effects that may impair your vision. Be careful if you drive or do anything that requires you to be able to see clearly. Avoid using other medications in your eyes during treatment with Bromday unless your doctor has told you to.

Bromday side effects

Stop using Bromday and 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. Stop using Bromday and call your doctor at once if you have any change in your vision.

Other less serious side effects are more likely to occur, such as:

• feeling like something is in your eye;
• eye pain, itching, or redness; or
• headache.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Bromday side effects (in more detail)

Bromday Dosing Information

Usual Adult Dose for Postoperative Ocular Inflammation:

Instill 1 drop in affected eye(s) once a day beginning 24 hours before cataract surgery and continuing throughout the first 2 weeks of the postoperative period.

Bromday, like most topical nonsteroidal anti-inflammatory agents may increase the risk for the occurrence and severity of corneal adverse events if instilled more than 24 hours prior to and longer than 2 weeks following cataract surgery.

What other drugs will affect Bromday?

Before using bromfenac tell your doctor if you are using a steroid such as prednisone, dexamethasone, and others.

This list is not complete and there may be other drugs that can interact with Bromday Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about Bromday.

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.