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
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
ActionsActions
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.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Solution | 0.09% (of bromfenac) | Xibrom (with benzalkonium chloride, povidone, and sodium sulfite) | ISTA |
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions May 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.
More Xibrom resources
- Xibrom Side Effects (in more detail)
- Xibrom Dosage
- Xibrom Use in Pregnancy & Breastfeeding
- Xibrom Drug Interactions
- Xibrom Support Group
- 0 Reviews for Xibrom - Add your own review/rating
- Xibrom Prescribing Information (FDA)
- Xibrom Advanced Consumer (Micromedex) - Includes Dosage Information
- Xibrom MedFacts Consumer Leaflet (Wolters Kluwer)
- Xibrom Consumer Overview
- Bromday Prescribing Information (FDA)
- Bromday Consumer Overview
Compare Xibrom with other medications
- Postoperative Ocular Inflammation
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