IBN SINA PHARMACEUTICALS LTD.
Bromfenac is indicated for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract extraction
Ophthalmic Non-Steroid drugs
Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID). The mechanism of anti-inflammatory activity 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.
Adults: 1 drop to the problem eye 2 times a day; treatment should start 24 hours after surgery and should continue for 2 weeks Children: Use and dose must be determined by the doctor. Pediatric Use: Safety and efficacy in pediatric patients below the age of 18 have not been established yet.
Bromfenac ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredients of the formulation.
The most commonly reported adverse reactions following use of 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
Pregnancy Category C. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Caution should be exercised when Bromfenac ophthalmic solution is administered to a nursing mother.
All topical 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. 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. Bromfenac ophthalmic solution should not be administered while wearing contact lenses. Bromfenac ophthalmic solution contains Sodium Sulfite, a compound 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. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.
Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light. Do not use more than 4 weeks after opening.