Bromfenac 0.07% Ophthalmic Solution 3mL

NDC: 82260-602-03

Bromfenac Ophthalmic Solution 0.07%, 3 mL — Bausch & Lomb

Active ingredient	Bromfenac sodium sesquihydrate 0.0805% (equivalent to bromfenac free acid 0.07%)
Dosage form	Ophthalmic solution, sterile, single-patient-use dropper bottle (contains sodium sulfite; preserved with benzalkonium chloride 0.005%)
Route	Ophthalmic (topical)
Size	3 mL dropper bottle
Manufacturer	Bausch & Lomb Americas Inc.
NDC	82260-602-03

Indications and Usage

Indicated for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery.

Dosage and Administration

Instill one drop into the affected eye once daily, beginning 1 day prior to cataract surgery, continued on the day of surgery, and through the first 14 days postsurgery. May be administered with other topical ophthalmic medications (e.g., alpha agonists, beta-blockers, carbonic anhydrase inhibitors, cycloplegics, mydriatics); space applications at least 5 minutes apart.

Warnings and Precautions

• Contains sodium sulfite, which may cause allergic-type reactions, including anaphylactic symptoms and asthmatic episodes, in susceptible individuals
• May slow or delay healing; concomitant use with topical corticosteroids may further increase this risk
• Potential for cross-sensitivity in patients with known sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, or other NSAIDs
• May increase bleeding time due to interference with platelet aggregation; use with caution in patients with bleeding tendencies or on medications that prolong bleeding time
• May cause keratitis; in susceptible patients, continued use may result in corneal epithelial breakdown, thinning, erosion, ulceration, or perforation — discontinue immediately if signs of corneal breakdown occur
• Should not be instilled while wearing contact lenses; remove lenses prior to use and wait at least 10 minutes before reinsertion
• Avoid touching dropper tip to the eye, eyelids, or any surface to prevent contamination

Contraindications

None.

Adverse Reactions

Most commonly reported reactions (3–8% of patients) include anterior chamber inflammation, foreign body sensation, eye pain, photophobia, and blurred vision.

Storage and Handling

Store at 15°C to 25°C (59°F to 77°F). After opening, may be used until the expiration date printed on the bottle.

How Supplied

Supplied as a 3 mL fill in a 7.5 mL white LDPE plastic squeeze bottle with white LDPE dropper tip and gray polypropylene cap.

Professional use only. Clinical information summarized from FDA-approved prescribing information (Structured Product Labeling); refer to the full prescribing information via DailyMed for complete details.