Romfen0.09%

Bromfenac sodium ophthalmic solution is a topical nonsteroidal anti-inflammatory drug (NSAID) used for the treatment of postoperative inflammation and the reduction of ocular pain in patients who have undergone cataract surgery. Bromfenac is marketed in more than one strength (for example, some products are 0.07% dosed once daily, others 0.075% dosed twice daily, and others 0.09% dosed once daily); the generic name alone does not identify which specific strength and regimen a given product uses.

Contains Romfen 0.09% as the active ingredient in a sterile ophthalmic solution. Marketed strengths include 0.07%, 0.075%, and 0.09% bromfenac (expressed as bromfenac free acid), each with a different labeled dosing regimen. The generic name alone does not identify a single specific strength; always confirm the exact concentration on the specific product's own label, since the correct dosing frequency depends on which strength is dispensed.

Bromfenac sodium is a topical nonsteroidal anti-inflammatory eye drop used to reduce inflammation and pain following cataract surgery. It works by blocking the production of prostaglandins, chemical messengers that contribute to inflammation, swelling, and pain in the eye after surgery. It is for ophthalmic use only and is available in more than one strength, each with its own labeled dosing schedule.

Therapeutic Class: Ophthalmic Nonsteroidal Anti-inflammatory Drug (NSAID)

Bromfenac inhibits both cyclooxygenase-1 and cyclooxygenase-2 (COX-1 and COX-2) enzymes, blocking the synthesis of prostaglandins, which are mediators of intraocular inflammation, vasodilation, increased vascular permeability, and increased intraocular pressure in some contexts. After topical ocular administration, plasma concentrations of bromfenac are generally low, reflecting limited systemic absorption from properly administered eye drops.

• Wash hands before use
• Tilt the head back, gently pull down the lower eyelid to form a pocket, and instill the prescribed number of drops
• Avoid touching the dropper tip to the eye or any surface to prevent contamination
• If using other topical ophthalmic medicines at the same time (such as antibiotics, mydriatics, or other eye drops), space administration at least 5 minutes apart
• Remove contact lenses before instillation, if applicable, per your doctor's advice

Bromfenac may be used together with other topical ophthalmic medications, such as alpha agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics, with doses spaced at least 5 minutes apart. Because topical NSAIDs may slow or delay healing, concomitant use with topical corticosteroids may further increase the potential for wound-healing problems, and should be assessed by the treating ophthalmologist. Systemic drug interactions are uncommon with normal topical ocular use, given generally limited systemic absorption.

Common side effects

• Eye irritation, stinging, or burning on instillation
• Eye pain or a foreign body sensation
• Eye redness
• Itching around the eye

Serious side effects (seek medical attention)

• Corneal problems, including thinning, erosion, or, rarely, corneal perforation, particularly with prolonged use or in susceptible patients (such as those with pre-existing corneal disease)
• Delayed or slowed wound healing, especially if used together with topical corticosteroids
• Signs of an allergic reaction, including in sulfite-sensitive patients: swelling, rash, or difficulty breathing

Patients with evidence of corneal epithelial breakdown should stop using bromfenac and any other topical NSAID immediately and seek prompt medical evaluation.

Pregnancy

Because of the known effects of prostaglandin-inhibiting drugs on the fetal cardiovascular system (closure of the ductus arteriosus), use of bromfenac ophthalmic solution should be avoided during late pregnancy. Use earlier in pregnancy should only occur if a doctor considers it clinically necessary.

Breastfeeding

There is limited specific data on bromfenac use during breastfeeding; given generally low systemic absorption from topical ocular use, it is often considered acceptable under medical guidance, but should be discussed with a healthcare professional.

• Use with caution in patients with known bleeding tendencies, or those receiving other medications that may prolong bleeding time, as topical NSAIDs may increase bleeding of ocular tissue during surgery.
• Topical NSAIDs, including bromfenac, may slow or delay wound healing; concomitant use with topical corticosteroids may further increase this risk.
• Some formulations contain sodium sulfite, which can rarely cause allergic-type reactions, including anaphylaxis or asthmatic episodes, in susceptible individuals, more common in people with asthma.
• Continued use of topical NSAIDs in susceptible patients may lead to corneal epithelial breakdown, thinning, erosion, ulceration, or, rarely, perforation, which can be sight-threatening; discontinue immediately if this occurs.
• Bromfenac may be used in conjunction with other topical ophthalmic medications, with dosing spaced at least 5 minutes apart.

Topical ophthalmic overdose is uncommon with normal use, but excessive use may increase local irritation or the risk of corneal problems described above. If the product is accidentally swallowed or a large amount is applied, seek medical advice. Stop use and consult a doctor if eye pain, redness, or vision changes worsen.

Store as directed on the product label, typically at controlled room temperature, protected from light, and tightly closed between uses. Do not use after the labeled expiry date, and discard any unused portion after the manufacturer's specified in-use period following opening, as this may vary by product.

• Elderly: No specific dose adjustment is generally required for topical ophthalmic use.
• Renal or hepatic impairment: Systemic absorption from topical ophthalmic use is generally limited, so specific dose adjustment is not typically required, though caution is reasonable in patients with significant systemic disease.

Treatment typically begins about 1 day before cataract surgery, continues on the day of surgery, and is generally continued through a defined postoperative period (commonly around 2 weeks), as specified on the individual product's labeling; the treating ophthalmologist determines the exact duration based on the specific product and the patient's recovery.

Drug Class: Topical ophthalmic NSAID (cyclooxygenase inhibitor)

Bromfenac works by blocking cyclooxygenase enzymes in ocular tissue, which reduces the production of prostaglandins responsible for postoperative inflammation, swelling, and pain in the eye following cataract surgery. This helps ease discomfort and supports a smoother recovery after the procedure.

Bromfenac ophthalmic solution is used primarily in adults undergoing cataract surgery; specific pediatric dosing recommendations are generally not established, and use in children should be guided by an ophthalmologist.