Kenyan Health Patient Information Leaflet
Therapeutic agent (verify pharmacological class)
1 INDICATIONS AND USAGE Bromfenac Ophthalmic Solution 0.09% is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction (1) .
2 DOSAGE AND ADMINISTRATION 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 post-surgery (2.1) . 2.1 Recommended Dosing For the treatment of postoperative inflammation in patients who have undergone cataract extraction, one drop of bromfenac ophthalmic solution should be applied 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. 2.2 Use with Other Topical Ophthalmic Medications Bromfenac ophthalmic solution may be administered in conjunction with other topical ophthalmic medications such as alpha-agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics. Drops should be administered at least 5 minutes apart.
6 ADVERSE REACTIONS The most commonly reported adverse reactions in 2-7% of patients were abnormal sensation in eye, conjunctival hyperemia and eye irritation (including burning/stinging) (6.1) . To report SUSPECTED ADVERSE REACTIONS, contact Sentiss at 1-855-473-6847 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience The most commonly reported adverse experiences reported 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. 6.2 Post-Marketing Experience The following events have been identified during post-marketing use of bromfenac ophthalmic solution 0.09% in clinical practice. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The events, which have been chosen for inclusion due to either their seriousness, frequency of reporting, possible causal connection to topical bromfenac ophthalmic solution 0.09% or a combination of these factors, include corneal erosion, corneal perforation, corneal thinning, and epithelial breakdown. [see Warnings and Precautions (5) ]
16 HOW SUPPLIED/STORAGE AND HANDLING Bromfenac Ophthalmic Solution 0.09% is supplied in a white LDPE plastic squeeze bottle with a LDPE white dropper-tip and polypropylene gray cap as follows: 1.7 mL in 6 mL container - 72485-649-71 STORAGE Store at 20º - 25ºC (68º - 77ºF) [see USP Controlled Room Temperature].