Bromfenac Ophthalmic Solution
(Bromfenac Sodium)Bromfenac Ophthalmic Solution Prescribing Information
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. (
Apply one drop to the affected eye once daily beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 14 days of the postoperative period.
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
The plasma concentration of bromfenac following ocular administration of Bromfenac Ophthalmic Solution 0.07% in humans is unknown. Based on the maximum proposed dose of one drop to each eye (0.035 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.
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
The plasma concentration of bromfenac following ocular administration of Bromfenac Ophthalmic Solution 0.07% in humans is unknown. Based on the maximum proposed dose of one drop to each eye (0.035 mg) and PK information from other routes of administration, the systemic concentration of bromfenac is estimated to be below the limit of quantification (50 ng/mL) at steady-state in humans.
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).
None.
- Sulfite Allergic Reactions ()
5.7 Contact Lens WearBromfenac Ophthalmic Solution should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of Bromfenac Ophthalmic Solution. The preservative in Bromfenac Ophthalmic Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Bromfenac Ophthalmic Solution.
- Slow or Delayed Healing ()
5.7 Contact Lens WearBromfenac Ophthalmic Solution should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of Bromfenac Ophthalmic Solution. The preservative in Bromfenac Ophthalmic Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Bromfenac Ophthalmic Solution.
- Potential for Cross-Sensitivity ()
5.7 Contact Lens WearBromfenac Ophthalmic Solution should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of Bromfenac Ophthalmic Solution. The preservative in Bromfenac Ophthalmic Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Bromfenac Ophthalmic Solution.
- Increased Bleeding Time ()
5.7 Contact Lens WearBromfenac Ophthalmic Solution should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of Bromfenac Ophthalmic Solution. The preservative in Bromfenac Ophthalmic Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Bromfenac Ophthalmic Solution.
- Keratitis and Corneal Reactions ()
5.7 Contact Lens WearBromfenac Ophthalmic Solution should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of Bromfenac Ophthalmic Solution. The preservative in Bromfenac Ophthalmic Solution, benzalkonium chloride, may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Bromfenac Ophthalmic Solution.