Eyefen Ophthalmic 5 ml drop

Eyefen Ophthalmic 5 ml drop

DESCRIPTION

Bromfenac 0.09% ophthalmic solution is a sterile, 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.

COMPOSITION

Eyefen Sterile Eye Drops: Each ml contains Bromfenac Sodium

INN equivalent to Bromfenac 0.90 mg. Preservative: Benzalkonium Chloride

Solution BP 0.01%. Vehicle: Povidone (K-17) BP 2.0%.

INDICATIONS

Eyefen Eye Drops 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 Eyefen 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. Or as directed by the physician.

CONTRAINDICATIONS

Eyefen Eye Drops is contraindicated in patients with known hypersensitivity to any ingredient in the formulation.

SIDE EFFECTS

The most common reported adverse experiences 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 Eyefen Eye Drops should be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. Eyefen Eye Drops should not be administered while wearing contact lenses.

PREGNANCY

Pregnancy Category C. There are no adequate and wellcontrolled 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 Eyefen Eye Drops is administered to a nursing woman.

PEDIATRIC USE

Safety and efficacy in pediatric patients have not been established.

DRUG INTERACTIONS

Not known.

SUPPLY

Eyefen Sterile Eye Drops: Each plastic dropper bottle contains 5 ml of Bromfenac 0.09% sterile solution.