bromfenac sodium sesquihydrate: clinical use

Prescribing considerations

• Licensed for postoperative ocular inflammation after cataract extraction in adults.
• Safety and efficacy are not established in children or adolescents.
• Use cautiously after complicated or repeated ocular surgery and in corneal denervation, epithelial defects, diabetes, dry eye, rheumatoid arthritis or other ocular-surface disease.
• Topical anti-inflammatory treatment may mask acute ocular infection.
• Review bleeding tendencies and medicines that prolong bleeding time.

Contraindications and cautions

• Hypersensitivity to bromfenac, an excipient or another NSAID.
• Previous asthma, urticaria or acute rhinitis precipitated by aspirin or another prostaglandin-synthesis inhibitor.

Monitoring

• Assess promptly for epithelial breakdown, corneal thinning, erosion, ulceration or perforation; discontinue bromfenac if epithelial breakdown develops.
• Monitor corneal health closely in susceptible patients, especially when an ophthalmic corticosteroid is also used.
• Review worsening inflammation or visual symptoms after withdrawal, including possible macular oedema.

Clinical pharmacology

Bromfenac is an ophthalmic NSAID that mainly inhibits COX-2 and prostaglandin synthesis. It penetrates the cornea and ocular tissues; plasma concentrations were not quantifiable following topical ocular administration in product studies.

Formulation and product differences

• The selected product is a preserved, clear yellow multidose solution in an LDPE bottle.
• It contains benzalkonium chloride, which may irritate dry or compromised eyes and can be absorbed by soft contact lenses.
• It also contains sodium sulphite. The opened bottle has a 28-day in-use shelf life and requires no special storage conditions.

Eye drops

Route: Ophthalmic

Strengths: 0.9 mg/mL