Xibrom Information
Xibrom (Bromfenac)
Xibrom (Bromfenac) Description
Xibrom (Bromfenac) (bromfenac ophthalmic solution) 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of Xibrom (Bromfenac) 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 CHBrNNaO • 1½HO. 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 is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of Xibrom (Bromfenac) ophthalmic solution is approximately 300 mOsmol/kg. Each mL of Xibrom (Bromfenac) ophthalmic solution contains: bromfenac sodium hydrate 0.1035%. 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.
Xibrom (Bromfenac) Clinical Pharmacology
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.
Xibrom (Bromfenac) Indications And Usage
Xibrom (Bromfenac) ophthalmic solution is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.
Xibrom (Bromfenac) Contraindications
Xibrom (Bromfenac) ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredient in the formulation.
Xibrom (Bromfenac) Warnings
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.
Xibrom (Bromfenac) Precautions
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 (Bromfenac) ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
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).
Xibrom (Bromfenac) Adverse Reactions
The most commonly reported adverse experiences reported following use of Xibrom (Bromfenac) 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.
Xibrom (Bromfenac) Dosage And Administration
For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of Xibrom (Bromfenac) 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) How Supplied
Xibrom (Bromfenac) ™ (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 cc container
NDC 67425-004-12
2.5 mL in 7.5 cc container
Xibrom (Bromfenac)
Xibrom (Bromfenac) Principal Display Panel
NDC 67425-004-12
Sterile 2.5 mLRx onlyTwice Daily
Each mL of Xibrom (Bromfenac) ophthalmic solution contains:
This product is sterile when manufactured and should be dispensed in the original unopened container. Instruct patient on precautions to avoid contamination.
Store at 15-25°C (59-77°F).
