"The U.S. Food and Drug Administration today warned five eye care providers to stop the misleading advertising and promotion of refractive lasers used in eye surgery procedures such as LASIK. The FDA found that the providers’ advertisements "...
(bromfenac) Ophthalmic Solution
Xibrom (bromfenac ophthalmic solution) 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of Xibrom contains 1.035 mg bromfenac sodium sesquihydrate (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodium is designated chemically as sodium 2-amino-3(4-bromobenzoyl) phenylacetate sesquihydrate, with an empirical formula of C15H11BrNNaO3• 1½H2O. The structural structure for bromfenac sodium is:
Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.17. Xibrom ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of Xibrom ophthalmic solution is approximately 300 mOsmol/kg.
Each mL of Xibrom ophthalmic solution contains
Active: bromfenac sodium sesquihydrate 0.1035% equivalent to 0.9 mg bromfenac free acid
Preservative: benzalkonium chloride (0.05 mg/mL)
Inactives: boric acid, disodium edetate (0.2 mg/mL), polysorbate 80 (1.5 mg/mL), povidone (20 mg/mL), sodium borate, sodium sulfite anhydrous (2 mg/mL), sodium hydroxide to adjust pH and water for injection, USP.
What are the possible side effects of bromfenac ophthalmic (Bromday, Xibrom)?
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 bromfenac ophthalmic and call your doctor at once if you have a serious side effect such as:
- any change in your vision;
- slow healing after your eye surgery;
- eye redness or bleeding;
- eye pain or swelling, increased sensitivity to light;
- feeling like something is in your eye; or
- severe eye discomfort, increased tears, crusting or...
What are the precautions when taking bromfenac ophthalmic solution (Xibrom)?
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...
Last reviewed on RxList: 2/7/2014
This monograph has been modified to include the generic and brand name in many instances.
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