What it isTopical ophthalmic NSAID; post-operative inflammation and cystoid macular edema.
Why this oneOnce- or twice-daily dosing, and it controls inflammation without the pressure rise a steroid causes.
What limits itCorneal melting with prolonged use or in a compromised surface, so courses are short and supervised.
FDA-approved for
- postoperative ocular inflammation and pain after cataract surgery (2005)
FDA label
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| FDA dosing | Population | Start | Target | Max |
| Postoperative inflammation and ocular pain after cataract surgery | Adults | 1 drop QD | 1 drop QD | |
Renal Undefined
Hepatic Undefined
Instructions
- Begin 1 day before cataract surgery, continue day of surgery and through 14 days postoperatively
- Space other topical ophthalmic drugs at least 5 minutes apart
- Remove contact lenses before instillation; reinsert 10 minutes after
- Avoid use >24 h before surgery or >14 days postoperatively (corneal risk)
Cautions
- Sulfite allergic reactions (contains sodium sulfite; anaphylaxis/asthmatic episodes)
- Slow or delayed healing; more so with concomitant topical steroids
- Cross-sensitivity to acetylsalicylic acid and other NSAIDs
- Increased ocular bleeding time
- Keratitis and corneal reactions (epithelial breakdown, thinning, ulceration, perforation)
Adverse reactions
- Anterior chamber inflammation
- Foreign body sensation
- Eye pain
- Photophobia
- Blurred vision
Pregnancy No human data; avoid in late pregnancy (NSAID risk of premature ductus arteriosus closure)
Lactation No data; minimal systemic exposure expected after topical ocular use
Principal riskCorneal melting with prolonged use
Cost, est. cash$10–$400/month
Generic entry2011
Classes and tags
Clinical profile
Therapeutic safety burden0 / 4
Overdose danger0 / 4
Weight-gain liability0 / 4
Sedation liability0 / 4
QT / Torsades0 / 4
Direct muscarinic antagonism0 / 4
Embryofetal risk0 / 4
Legacy pregnancy categoryC
Defining liabilityLocal irritation, sensitization or administration-site injury; negligible systemic toxicity at usual use.
Mechanism of action: Bromfenac ballicule
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