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 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  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. 

Last updated on RxList: 6/23/2009

XIBROM ophthalmic solution is indicated for the treatment of postoperative inflammation in patients who have undergone cataract extraction.

For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of XIBROM ophthalmic solution should be applied to the affected eye(s) two times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.

XIBROM™ (bromfenac ophthalmic solution) 0.09% is supplied in a white LDPE plastic squeeze bottle with a 15 mm LDPE white dropper-tip and 15 mm polypropylene gray cap as follows: 

NDC 67425-004-50    5 mL in 10 mL container 
NDC 67425-004-12    2.5 mL in 7.5 mL container

Storage 

Store at 15-25 °C (59-77 °F)

Manufactured for : ISTA Pharmaceuticals, Inc. Irvine, CA 92618. By: Bausch & Lomb Incorporated Tampa, FL 33637,  Under license from:  Senju Pharmaceutical Co., Ltd. Osaka, Japan 541-0046, Revised December 2008.

Last updated on RxList: 6/23/2009

The most commonly reported adverse experiences reported following use of XIBROM after cataract surgery include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis. These events were reported in 2-7% of patients.

Clinical Practice

The following events have been identified during postmarketing use of bromfenac ophthalmic solution 0.09% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09%, or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown (see PRECAUTIONS, General). 

No information provided.

Last updated on RxList: 6/23/2009

Contains sodium sulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people. 

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. 

With some NSAIDs, there exists the potential for increased bleeding time due to interference with platelet aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. 

General

All topical nonsteroidal anti-inflammatory drugs (NSAIDs) may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. 

Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health. 

Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. 

Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for the occurrence and severity of corneal adverse events.

It is recommended that XIBROM ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. 

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term carcinogenicity studies in rats and mice given oral doses of bromfenac up to 0.6 mg/kg/day (360 times the recommended human ophthalmic dose [RHOD] of 1.67 μg/kg in 60 kg person on a mg/kg/basis, assuming 100% absorbed) and 5.0 mg/kg/day (3000 times RHOD), respectively revealed no significant increases in tumor incidence. 

Bromfenac did not show mutagenic potential in various mutagenicity studies, including the reverse mutation, chromosomal aberration, and micronucleus tests. 

Bromfenac did not impair fertility when administered orally to male and female rats at doses up to 0.9 mg/kg/day and 0.3 mg/kg/day, respectively (540 and 180 times RHOD, respectively). 

Pregnancy

Teratogenic Effects

Pregnancy Category C

Reproduction studies performed in rats at oral doses up to 0.9 mg/kg/day (540 times RHOD) and in rabbits at oral doses up to 7.5 mg/kg/day (4500 times RHOD) revealed no evidence of teratogenicity due to bromfenac. However, 0.9mg/kg/day in rats caused embryo-fetal lethality, increased neonatal mortality, and reduced postnatal growth. Pregnant rabbits treated with 7.5 mg/kg/day caused increased post-implantation loss. 

There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. 

Non-Teratogenic Effects

Because of the known effects of prostaglandin biosynthesis-inhibiting drugs on the fetal cardiovascular system (closure of ductus arteriosus), the use of XIBROM ophthalmic solution during late pregnancy should be avoided.

Nursing Mothers

Caution should be exercised when XIBROM ophthalmic solution is administered to a nursing woman. 

Pediatric Use

Safety and efficacy in pediatric patients below the age of 18 have not been established. 

Geriatric Use

There is no evidence that the efficacy or safety profiles for XIBROM differ in patients 65 years of age and older compared to younger adult patients. 

Last updated on RxList: 6/23/2009

No information provided.

XIBROM ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredient in the formulation. 

Last updated on RxList: 6/23/2009

Mechanism of Action

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory activity. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.

Prostaglandins have been shown in many animal models to be mediators of certain kinds of intraocular inflammation. In studies performed in animal eyes, prostaglandins have been shown to produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.  

Pharmacokinetics

The plasma concentration of bromfenac following ocular administration of 0.09% XIBROM (bromfenac ophthalmic solution) in humans is unknown. Based on the maximum proposed dose of one drop to each eye (0.09mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans. 

Clinical Trials

Clinical efficacy was evaluated in two randomized, double-masked, placebo-controlled U.S. trials in which subjects with a summed ocular inflammation score  3 after cataract surgery were assigned to XIBROM or placebo in a 2:1 ratio following surgery. One drop of XIBROM or vehicle was self-instilled in the study eye twice a day for 14 days, beginning the day after surgery. The primary endpoint was reduction of ocular inflammation (to trace inflammation or clearing) assessed 14 days post-surgery using a slit lamp binocular microscope. In the intent-to­treat analyses of both studies, a significant effect of XIBROM on ocular inflammation after cataract surgery was demonstrated (62-66% vs. 40-48%). 

Last updated on RxList: 6/23/2009

XIBROM ophthalmic solution should not be administered while wearing contact lenses. 

Last updated on RxList: 6/23/2009

IMPORTANT NOTE: This is a summary and does not contain all possible information about this product. For complete information about this product or your specific health needs, ask your health care professional. Always seek the advice of your health care professional if you have any questions about this product or your medical condition. This information is not intended as individual medical advice and does not substitute for the knowledge and judgment of your health care professional. This information does not contain any assurances that this product is safe, effective, or appropriate for you.

BROMFENAC - OPHTHALMIC

(BROM-fen-ack)

COMMON BRAND NAME(S): Xibrom

USES: This medication is used to treat swelling (inflammation) and pain in the eye after a certain type of eye surgery (cataract surgery). Bromfenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking the effects of certain natural substances (prostaglandins) that cause pain and inflammation.

HOW TO USE: This drug is usually started 24 hours after surgery and continued for 2 weeks after surgery. Place 1 drop into the affected eye, usually 2 times daily or as directed by your doctor.

To apply eye drops, wash your hands first. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

This medication should not be used while wearing contact lenses. Consult your doctor or pharmacist for details.

If you are wearing contact lenses, remove them before using eye drops. Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps if your dose is for more than 1 drop and for your other eye if so directed.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same times each day. Continue using it for the full time prescribed.

Do not apply this medication more often than prescribed or continue using it for longer than directed by your doctor. Prolonged use of bromfenac eye drops may increase the risk of very serious side effects of the eye.

SIDE EFFECTS: Temporary irritation/burning/stinging of the eye, temporary blurred vision, watery eyes, or headache may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: severe pain/redness in the eye, sensitivity of the eyes to light (photophobia), eye discharge, blurry/abnormal vision, feeling as if something is in the eye, itching/redness/pain around the eyes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

If you notice other effects not listed above, contact your doctor or pharmacist.

Contact your doctor for medical advice about side effects. The following numbers do not provide medical advice, but in the US you may report side effects to the Food and Drug Administration (FDA) at 1-800-FDA-1088. In Canada, you may call Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 to sulfites; or if you have any other allergies.

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 problems), diabetes, rheumatoid arthritis, asthma, growths in the nose (nasal polyps).

After you apply this drug, your vision may become temporarily blurred. Use caution while driving, using machinery, or doing any other activity that requires clear vision.

During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to an unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anti-platelet medications (e.g., clopidogrel), other NSAID medications (e.g., aspirin, ibuprofen), blood thinners (e.g., warfarin, heparin), other eye medications.

If your doctor has directed you to take low doses of aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue to take the aspirin. Consult your doctor or pharmacist for more details.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

OVERDOSE: This medicine may be harmful if swallowed. If swallowing or overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

MISSED DOSE: If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE: Store at room temperature between 59-77 degrees F (15-25 degrees C) away from heat and light. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised July 2008 Copyright(c) 2008 First DataBank, Inc.