IMPORTANT RISK INFORMATION

 

Indications and Usage

BromSite (bromfenac ophthalmic solution) 0.075% is a nonsteroidal anti-inflammatory drug (NSAID) eyedrop for the treatment of inflammation and prevention of pain in patients undergoing cataract surgery.

Important Risk Information

All NSAID eyedrops, including BromSite, may slow or delay healing after cataract surgery. Use of NSAID and steroid eyedrops at the same time may increase the potential for healing problems.

Before you use BromSite, tell your doctor about all your medical conditions you have and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. In addition, tell your doctor:

  • If you have ever experienced allergic reactions to any medicines, especially to aspirin or other NSAID medicines
  • If you have a tendency to bleed or are taking any medicines that may prolong the time it takes you to stop bleeding (e.g., aspirin). With some NSAIDs, including BromSite, the potential exists for increased bleeding time.
  • If you have had complicated or repeated eye surgeries within a short period of time, or if you have been diagnosed with corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease (e.g., dry eye syndrome), or rheumatoid arthritis. Patients with these conditions may be at increased risk for keratitis (inflammation of the cornea) and other potentially sight-threatening corneal side effects that may result from the use of NSAID eyedrops.

You should not wear contact lenses while using BromSite. The preservative in BromSite, benzalkonium chloride, may be absorbed by soft contact lenses.

In clinical trials, the most common side effects of BromSite were inflammation of the inner eye, headache, eye floaters, iritis, eye pain and high eye pressure.

You are encouraged to report negative side effects of prescription drugs to the FDA.Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

For additional information about BromSite, please click here for the full Prescribing Information.