Bromfenac Ophthlamic Solution

Bromfenac Ophthalmic Solution, 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use. Each mL of Bromfenac Ophthalmic Solution, 0.09% contains 1.035 mg bromfenac sodium sesquihydrate (equivalent to 0.9 mg bromfenac free acid). Bromfenac sodium sesquihydrate is designated chemically as sodium 2-amino-3-(4-bromobenzoyl) phenyl acetate sesquihydrate, with an empirical formula of C15H11BrNNaO3• 3/2 H2O. The structural structure for bromfenac sodium sesquihydrate is:

Bromfenac sodium sesquihydrate is a yellow or orange yellow crystalline powder. The molecular weight of bromfenac sodium sesquihydrate is 383.17. Bromfenac Ophthalmic Solution is supplied as a sterile aqueous 0.09% solution, with a pH of 8.3. The osmolality of Bromfenac Ophthalmic Solution is approximately 300 mOsmol/kg.

Each mL of Bromfenac Ophthalmic Solution contains:

Active: bromfenac sodium sesquihydrate 0.1035%

Preservative: benzalkonium chloride (0.05 mg/mL)

Inactives: boric acid, edetate disodium dihydrate, polysorbate 80, povidone, sodium borate, sodium sulfite anhydrous, sodium hydroxide to adjust pH and water for injection.