Romfen

• Ophthalmic Use:
• Treatment of inflammation and reduction of ocular pain following cataract surgery.
• Management of postoperative ocular inflammation.
• Relief of pain and inflammation associated with ocular surgeries and conditions.
• Off-label Uses:
• May be used for various inflammatory ocular conditions as determined by ophthalmologists, including postoperative inflammation after refractive surgery or corneal injuries.

• Route: Ophthalmic solution (eye drops).
• Adults:
• Typical dose: One drop in the affected eye(s) twice daily, starting 1 day before cataract surgery, on the day of surgery, and continuing for up to 2 weeks postoperatively.
• Pediatrics:
• Safety and efficacy have not been established. Use only if clearly indicated by a specialist.
• Elderly:
• No specific dose adjustment required; monitor for ocular tolerance.
• Administration Instructions:
• Instill drops into the conjunctival sac.
• Avoid contamination of the dropper tip.
• Wait at least 5 minutes before instilling other ophthalmic preparations.

Bromfenac sodium is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits the cyclooxygenase (COX) enzymes COX-1 and COX-2, leading to decreased synthesis of prostaglandins. By reducing prostaglandin production, bromfenac diminishes inflammation, pain, and edema in ocular tissues following surgery or injury. Its high lipophilicity allows good corneal penetration and sustained intraocular concentrations for effective anti-inflammatory action.

• Absorption:
• Following ophthalmic administration, bromfenac penetrates the cornea and reaches therapeutic levels in the aqueous humor.
• Distribution:
• Concentrates primarily in ocular tissues; systemic absorption is minimal.
• Metabolism:
• Systemic metabolism involves hepatic pathways, including CYP2C9-mediated oxidation.
• Elimination:
• Systemically absorbed portion is excreted mainly via renal routes.
• Half-life:
• Ocular half-life supports twice-daily dosing; systemic half-life is approximately 12 hours but systemic exposure is low.

• Pregnancy:
• FDA Category C: Animal reproduction studies have shown adverse effects on the fetus; no adequate human studies. Use only if the potential benefit justifies the risk.
• Lactation:
• It is unknown whether bromfenac is excreted in human milk; caution is advised during breastfeeding.

• Primary Class: Nonsteroidal Anti-inflammatory Drug (NSAID)
• Subclass: Ophthalmic NSAID

• Known hypersensitivity to bromfenac, other NSAIDs, or any formulation excipients.
• Active corneal epithelial defects or ocular infections.
• History of bronchospasm or allergic-type reactions following NSAID use.

• Risk of corneal adverse reactions including thinning, erosion, or ulceration, especially in patients with compromised corneas.
• Use with caution in patients with history of ocular herpes simplex or other infections.
• Discontinue if eye pain, redness, or visual disturbances occur.
• Avoid contact lens use during treatment unless otherwise directed.
• Patients with asthma or NSAID hypersensitivity should be monitored for hypersensitivity reactions.
• Use caution in patients with bleeding disorders due to NSAID effects on platelet function.

Common:

• Eye discomfort or pain at instillation site
• Conjunctival hyperemia (redness)
• Dry eyes
• Blurred vision
• Headache

Less Common / Rare:

• Corneal epithelial defects or erosions
• Eye swelling or irritation
• Photophobia
• Allergic reactions such as eyelid edema or rash

• No significant systemic drug interactions reported due to minimal systemic absorption.
• Caution when used concomitantly with other topical ophthalmic drugs; space dosing by at least 5 minutes.
• Use with other NSAIDs or corticosteroids may increase risk of ocular adverse effects.
• Avoid concomitant use with contact lenses without medical advice.

• Recent ophthalmology guidelines endorse bromfenac as an effective NSAID for postoperative ocular inflammation and pain control with a favorable safety profile.
• Label updates include enhanced warnings regarding corneal adverse events and recommendations for careful patient selection and monitoring.
• Dosing schedules updated to twice daily for improved compliance and reduced ocular irritation.

• Store at 20°C to 25°C (68°F to 77°F).
• Protect from freezing and light.
• Keep container tightly closed when not in use.
• Discard any unused portion after the recommended duration of use.