Xibrom

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

Introduction

Prototypical NSAIA.1

Uses for Xibrom

Postoperative Ocular Inflammation and Pain

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

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Xibrom Dosage and Administration

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.)

Dosage

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

Adults

Postoperative Ocular Inflammation and Pain
Ophthalmic

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

Contraindications

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

Warnings/Precautions

Warnings

Bleeding

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

Pregnancy

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

Lactation

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

Drug

Interaction

Comments

Corticosteroids, topical

Increased potential for wound-healing complications1

 

Xibrom Pharmacokinetics

Absorption

Bioavailability

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

Stability

Storage

Ophthalmic

Solution

15–25°C.1

Actions

  • 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.)

Preparations

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

Bromfenac Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.09% (of bromfenac)

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

ISTA

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Bromday 0.09% Solution (ISTA PHARMACEUTICALS): 2/$179.99 or 5/$505.96

Bromfenac Sodium 0.09% Solution (MYLAN): 3/$129.98 or 8/$380.96

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions May 1, 2006. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

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.

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