BROMFENAC
Generic: BROMFENAC
Basic Information
Manufacturer
Fosun Pharma USA Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
OPHTHALMIC
FDA Set ID
a8f1d85a-5585-4632-bdfa-a54a535b5c17
Indications & Usage
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 ophthalmic solution 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.
Bromfenac ophthalmic solution 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.
Adverse Reactions
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 Fosun Pharma USA Inc.
at 1-866-611-3762 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 to 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) ]
at 1-866-611-3762 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 to 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) ]