Bromfenac

Bromfenac ophthalmic solution, 0.075% is indicated for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery.

Instill one drop of bromfenac ophthalmic solution to the affected eye twice daily (morning and evening) beginning 1 day prior to surgery, the day of surgery, and 14 days postsurgery. (

Topical ophthalmic solution: bromfenac 0.075%.

There are no adequate and well-controlled studies in pregnant women to inform any drug associated risks.  Treatment of pregnant rats and rabbits with oral bromfenac did not produce teratogenic effects at clinically relevant doses.

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

Treatment of rats with bromfenac at oral doses up to 0.9 mg/kg/day (195 times a unilateral daily human ophthalmic dose on a mg/m² basis, assuming 100% absorbed) and rabbits at oral doses up to 7.5 mg/kg/day (3243 times a unilateral daily dose on a mg/m² basis) produced no structural teratogenicity in reproduction studies. However, embryo-fetal lethality, neonatal mortality and reduced postnatal growth were produced in rats at 0.9 mg/kg/day, and embryo-fetal lethality was produced in rabbits at 7.5 mg/kg/day.

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.

• Slow or Delayed Healing (
  5.1 Slow or Delayed Healing

  All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac ophthalmic solution, 0.075%, 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.
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• Potential for Cross-Sensitivity (
  5.2 Potential for Cross-Sensitivity

  There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs, including bromfenac ophthalmic solution, 0.075%. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
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• Increased Bleeding Time of Ocular Tissue (
  5.3 Increased Bleeding Time of Ocular Tissue

  With some NSAIDs, including bromfenac ophthalmic solution, 0.075%, 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.

  It is recommended that bromfenac ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
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• Keratitis and Corneal Effects (
  5.4 Keratitis and Corneal Reactions

  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, including bromfenac ophthalmic solution, 0.075%, 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 postsurgery may increase patient risk for the occurrence and severity of corneal adverse events.
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• Contact Lens Wear (
  5.5 Contact Lens Wear

  Bromfenac ophthalmic solution should not be administered while wearing contact lenses. The preservative in Bromfenac ophthalmic solution, benzalkonium chloride, may be absorbed by soft contact lenses.
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