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(bromfenac) Ophthalmic Solution 0.09% Sterile
- Patient Information:
Details with Side Effects
XIBROM (bromfenac ophthalmic solution) 0.09% is a sterile, topical, nonsteroidal antiinflammatory drug (NSAID) for ophthalmic use. Each mL of Xibrom contains 1.035 mg bromfenac sodium 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 formula of bromfenac sodium is:
Bromfenac sodium is a yellow to orange crystalline powder. The molecular weight of bromfenac sodium is 383.17. XIBROM (bromfenac ophthalmic solution ) ophthalmic solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of XIBROM (bromfenac ophthalmic solution ) ophthalmic solution is approximately 300 mOsmol/kg. Each mL of XIBROM ophthalmic solution contains: Active: bromfenac sodium hydrate 0.1035%. Inactives: benzalkonium chloride (0.05 mg/mL), 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 the pH, and water for injection, USP.
What are the possible side effects of bromfenac ophthalmic (Xibrom)?
Stop using bromfenac ophthalmic 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 bromfenac ophthalmic 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
This is not a complete list of side effects and others may occur. Tell your doctor...
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: 6/23/2009
This monograph has been modified to include the generic and brand name in many instances.
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