Adult: For the treatment of inflammation and reduction of pain in patients undergoing cataract surgery: As 0.07% or 0.09% (once-daily formulation) ophthalmic solution: Instil 1 drop into the affected eye(s) once daily beginning 1 day before surgery, continued on the day of surgery, and for the 1st 2 weeks of the postoperative period. As 0.075% ophthalmic solution: Instil 1 drop into the affected eye(s) bid beginning 1 day prior to surgery, continued on the day of surgery, and for the 1st 2 weeks of the postoperative period. As 0.09% (twice-daily formulation) ophthalmic solution: Instil 1 drop into the affected eye(s) bid, beginning the next day after surgery and continued for the 1st 2 weeks of the postoperative period.
Contraindications
Hypersensitivity to bromfenac or other NSAIDs. Patients in whom attacks of asthma, acute rhinitis, or urticaria are precipitated by aspirin or other agents with prostaglandin synthetase inhibiting activity.
Special Precautions
Patient with complicated ocular surgeries, corneal epithelial defects, corneal denervation, ocular surface diseases (e.g. dry eye syndrome), repeated ocular surgeries within a short period of time; diabetes mellitus, rheumatoid arthritis, predisposition to bleeding (e.g. known bleeding tendencies, receiving medicines which interfere with coagulation). May mask signs of acute ocular infection. Pregnancy and lactation.
Adverse Reactions
Significant: Corneal effects, including keratitis, epithelial breakdown, corneal thinning, erosion, perforation, or ulceration which may lead to loss of vision; increased intraocular bleeding (including hyphaema), delayed or slowed healing. Eye disorders: Blurred vision, eye pain, eye irritation (including stinging/burning sensation), foreign body sensation in eyes, eye pruritus, eye redness, decreased visual acuity, corneal or eyelid oedema, photophobia, retinal exudates, iritis, ocular hypertension. Nervous system disorders: Headache.
This drug may cause temporary blurring of vision, if affected, do not drive or operate machinery. Do not wear contact lenses during treatment.
Monitoring Parameters
Evaluate the patient’s allergy history with aspirin or other NSAIDs. Monitor for intraocular bleeding.
Drug Interactions
Concomitant use with ophthalmic corticosteroids may delay the healing of ophthalmic tissue and increase the risk of corneal adverse effects. May increase the risk of bleeding with drugs that prolong bleeding time.
Action
Description: Mechanism of Action: Bromfenac is a phenylacetic acid derivative NSAID. It inhibits prostaglandin synthesis in body tissues by reducing the activity of cyclooxygenase (COX) 1 and 2, thereby resulting in decreased formation of prostaglandin precursors. Pharmacokinetics: Absorption: Permeates efficiently into the cornea of cataract patients. Distribution: Plasma protein binding: 99.8%. Excretion: Elimination half-life: 1.4 hours (aqueous humour).