Bromfenac Ophthalmic Solution - Bromfenac Sodium solution/ Drops

Bromfenac Ophthalmic Solution 0.07% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Instill one drop into the affected eye once daily beginning 1 day prior to surgery, continued on the day of surgery, and through the first 14 days postsurgery. (

Ophthalmic solution: bromfenac 0.07%

There are no available data on Bromfenac Ophthalmic Solution use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes.

The systemic exposure to bromfenac following topical ocular administration is low

However, 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.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Premature closure of the ductus arteriosus in the fetus has occurred with third trimester use of oral and injectable NSAIDs. Measurable maternal and fetal plasma drug levels are available with oral and injectable routes of NSAID administration. The maternal plasma level of Bromfenac Ophthalmic Solution following ocular administration is unknown

Embryo-fetal lethality and maternal toxicity were produced in rats and rabbits treated with bromfenac during the period of organogenesis at oral doses up to 0.9 mg/kg/day and 7.5 mg/kg/day, respectively. These doses corresponded to a Cmax 90- and 150- times the predicted Cmax at the recommended human ophthalmic dose (RHOD), respectively. In rats, bromfenac treatment caused delayed parturition at 0.3 mg/kg/day (30 times the predicted human Cmax at the RHOD), and caused dystocia, increased neonatal mortality, and reduced postnatal growth at 0.9 mg/kg/day (90 times the predicted human Cmax at the RHOD).

• Sulfite Allergic Reactions (
  
  
  5.1 Sulfite Allergic Reactions

  Bromfenac Ophthalmic Solution 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 non-asthmatic people.
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• Slow or Delayed Healing (
  
  
  5.2 Slow or Delayed Healing

  All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including bromfenac, 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 (
  
  
  5.3 Potential for Cross-Sensitivity

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

  With some NSAIDs, including bromfenac, 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 Reactions (
  
  
  5.5 Keratitis and Corneal Reactions

  Use of topical NSAIDs, including bromfenac, 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, 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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