Bromfenic ophthalmic solution (XIbrom)

Bromfenac ophthalmic solution) 0.09% is a sterile, topical, nonsteroidal anti-inflammatory drug (NSAID) for ophthalmic use.

Each mL contains 1.035 mg bromfenac sodium (equivalent to 0.9 mg bromfenac free acid).

A nonsteroidal anti-inflammatory drug (NSAID).

The mechanism of its action due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.

Prostaglandins in many animal models are mediators of intraocular inflammation and can produce disruption of the blood-aqueous humor barrier, vasodilation, increased vascular permeability, leukocytosis, and increased intraocular pressure.

The plasma concentration of bromfenac following ocular administration is estimated to be below the limit of quantification at steady-state in humans.

Reduces inflammation after cataract surgery and is indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.

Contains sodium sulfite, that may cause allergic-type reactions in susceptible people.

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs and should be used when treating individuals who have previously exhibited sensitivities to these drugs.

There exists the potential for increased bleeding time due to interference with platelet aggregation. with NSAIDs.

May slow or delay healing, keratitis, epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation which may be sight threatening.

Topical NSAIDs used in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases, rheumatoid arthritis, repeat ocular surgeries may be at increased risk for corneal adverse events which may become sight threatening.

Topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post surgery may increase patient risk for corneal adverse events.

Because of the known effects of prostaglandin biosynthesis use during pregnancy should be avoided.

Adverse reactions include: abnormal sensation in eye, conjunctival hyperemia, eye irritation, eye pain, eye pruritus, eye redness, headache, and iritis occurring in 2-7% of patients.

Usual adult dosage is one drop in the affected eye(s) two times daily.

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