Description:

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

Composition:

Each ml contains 1.035 mg Bromfenac sodium equivalent to 0.9 mg Bromfenac free acid.

Pharmacology:

Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID) that has anti-inflammatory potency higher than diclofenac. The mechanism of its action is thought to be due to its ability to block prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2.

Indications:

Bromfenac ophthalmic solution is indicated for – treatment of postoperative inflammation and pain in patients who have undergone cataract extraction, prevention of miosis in cataract surgery, treatment of pseudophakic cystoid macular edema (CME), treatment of external or anterior ocular inflammatory diseases such as blepharitis, conjunctivitis & scleritis

Dosage and Administration:

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(s) two times daily beginning 24 hours after cataract surgery and continuing through the first 2 weeks of the postoperative period. Prevention of miosis in cataract surgery: Beginning 1 hour prior to surgery, instill Bromfenac every 30 minutes. Treatment of pseudophakic cystoid macular edema (CME): 1 drop 2 times daily for 3 months. Other indications: 1 drop 2 times daily.

Contraindications:

Bromfenac ophthalmic solution is contraindicated in patients with known hypersensitivity to any ingredient in the formulation.

Side Effects:

The most commonly reported adverse experiences following use of Bromfenac include: abnormal sensation in eye, conjunctival hyperemia, eye irritation (including burning/stinging), eye pain, eye pruritus, eye redness, headache, and iritis.

Precautions:

Use of topical NSAIDs in patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening. Topical NSAIDs should be used with caution in these patients. It is recommended that Bromfenac ophthalmic solution should 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.

Pregnancy:

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers:

Caution should be exercised when Bromfenac ophthalmic solution is administered to a nursing woman.

Pediatric Use:

Safety and efficacy in pediatric patients have not been established.

Drug Interactions:

None known.

Storage:  

Store at 15-25⁰ C. Close the bottle immediately after use. The solution should be used within one month after first opening of the bottle. Keep out of the reach of children.

Packing:

Plastic dropper bottle containing 5 ml Eye Drops.