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Generic Name: Bromfenac Sodium
Class: Nonsteroidal Anti-inflammatory Agents
VA Class: CN104
Chemical Name: 2-amino-3-(4-bromobenzoyl)benzeneacetic acid sesquihydrate monosodium salt
Molecular Formula: C15H11BrNNaO3
CAS Number: 120638-55-3


Prototypical NSAIA.1

Uses for Xibrom

Postoperative Ocular Inflammation and Pain

Management of ocular inflammation and pain associated with cataract extraction.1

Xibrom Dosage and Administration


Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.1

Avoid contamination of the solution container.2

Do not administer while wearing contact lenses.1 (See Advice to Patients.)


Available as bromfenac sodium sesquihydrate; dosage expressed in terms of bromfenac.1


Postoperative Ocular Inflammation and Pain

1 drop of a 0.09% solution in the affected eye(s) twice daily, beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period.1

Cautions for Xibrom


  • Known hypersensitivity to bromfenac sodium or any ingredient in the formulation.1




May inhibit platelet aggregation and prolong bleeding time.1

May cause increased bleeding of ocular tissues (including hyphemas) when used in conjunction with ocular surgery.1

Use with caution in patients with underlying bleeding tendencies or in those receiving drugs known to prolong bleeding time.1

Sensitivity Reactions

Hypersensitivity Reactions

Possible cross-sensitivity with aspirin, phenylacetic acid derivatives, and other NSAIAs.1 Use with caution in patients with history of hypersensitivity to these drugs.1

Sulfite Sensitivity

Formulation contains sodium sulfite, which may cause allergic-type reactions (including anaphylaxis and life-threatening or less severe asthmatic episodes) in certain susceptible individuals.1

General Precautions

Wound-healing Complications

May slow or delay wound healing.1 (See Specific Drugs under Interactions.)

Ocular Effects

Use may result in keratitis.1 In some susceptible patients, continued use may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation; these events may be sight-threatening.1 If manifestations of corneal epithelial breakdown occur, discontinue therapy immediately and monitor for corneal health.1

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 developing adverse corneal effects that may become sight-threatening.1 Use with caution in these patients.1

Use >24 hours prior to surgery or use beyond 14 days postoperatively may precipitate or exacerbate adverse corneal effects.1

Specific Populations


Category C.1

Avoid use in late pregnancy (i.e., third trimester) because of known effects on the fetal cardiovascular system (possible premature closure of the ductus arteriosus).1 2


Not known whether distributed into milk following ophthalmic administration.2 Use with caution.1

Pediatric Use

Safety and efficacy not established in children <18 years of age.1

Geriatric Use

No substantial differences in safety and efficacy relative to younger adults.1

Common Adverse Effects

Abnormal ocular sensation, conjunctival hyperemia, ocular redness or irritation (e.g., pruritus, burning, stinging, pain), headache, iritis.1

Interactions for Xibrom

No formal drug interaction studies to date.3

Specific Drugs




Corticosteroids, topical

Increased potential for wound-healing complications1


Xibrom Pharmacokinetics



Systemic concentration at steady state in humans estimated to be below limit of quantification (50 ng/mL).1







  • Inhibits synthesis of prostaglandins in body tissues by inhibiting cyclooxygenase (COX), including both COX-1 and COX-2 isoenzymes.1

  • Ocular effects associated principally with inhibition of ocular prostaglandin synthesis.1 2

Advice to Patients

  • Risk of ocular bleeding.1 Risk of anaphylactoid and other sensitivity reactions.1

  • Importance of learning and adhering to proper administration techniques to avoid contamination of the ophthalmic solution with common bacteria that can cause ocular infections.2

  • Importance of removing contact lenses before administration.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1 Risk of use during late pregnancy.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses.1

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Bromfenac Sodium


Dosage Forms


Brand Names




0.09% (of bromfenac)

Xibrom (with benzalkonium chloride, povidone, and sodium sulfite)


AHFS DI Essentials. © Copyright, 2016, American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

Date published: May 01, 2006
Last reviewed: May 01, 2006
Date modified: February 08, 2016


1. ISTA Pharmaceuticals, Inc. Xibrom (bromfenac ophthalmic solution) 0.09% prescribing information. Irvine, CA; 2006 Feb.

2. ISTA Pharmaceuticals, Inc., Irvine, CA: Personal communication.

3. ISTA Pharmaceuticals, Inc. Xibrom (bromfenac ophthalmic solution 0.09%) formulary submission dossier. Irvine, CA; 2005.