Postoperative inflammation and ocular pain after cataract surgery
One drop QD to the affected eye starting 1 day before surgery, on the day of surgery, and through the first 14 days postoperatively.
Anterior chamber cells reach zero-to-trace in 80% by day 15, with separation from placebo by day 3.
Contraindications
None listed on the FDA label.
Available Forms
0.07% ophthalmic solution, 3 mL in a 7.5 mL dropper bottle
Mechanism of Action
Nonsteroidal anti-inflammatory drug; inhibits cyclooxygenase 1 and 2 and so blocks the prostaglandin synthesis that drives postoperative intraocular inflammation. In animal eyes prostaglandins disrupt the blood-aqueous barrier and produce vasodilation, increased vascular permeability, leukocytosis, and raised intraocular pressure.
Warnings & Precautions
Keratitis and corneal reactions: Topical NSAIDs may cause keratitis, and continued use in susceptible patients may progress to epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration, or corneal perforation, any of which may be sight threatening. Discontinue immediately on evidence of corneal epithelial breakdown and monitor corneal health closely.
Higher-risk corneas: Complicated ocular surgery, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease such as dry eye, rheumatoid arthritis, and repeat ocular surgery within a short period raise the risk of sight-threatening corneal events.
Extended perioperative use: Dosing more than 24 hours before surgery or beyond 14 days after surgery may increase the occurrence and severity of corneal adverse events.
Sulfite allergic reactions: Contains sodium sulfite, which may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people; sulfite sensitivity is seen more frequently in asthmatic than in non-asthmatic people.
Slow or delayed healing: All topical NSAIDs may slow or delay healing, as do topical corticosteroids, and concomitant use may increase the potential for healing problems.
Cross-sensitivity: Potential cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs; use caution in patients who have previously reacted to these drugs.
Increased bleeding time: NSAIDs can interfere with platelet aggregation, and ocularly applied NSAIDs have been reported to increase bleeding of ocular tissues, including hyphema, in conjunction with ocular surgery. Use caution with known bleeding tendencies or drugs that prolong bleeding time.
Contact lens wear: Not to be instilled while wearing contact lenses. Remove lenses before instillation; the benzalkonium chloride preservative may be absorbed by soft lenses, which may be reinserted 10 minutes after dosing.
Common Side Effects
Ocular, 3% to 8%: Anterior chamber inflammation, foreign body sensation, eye pain, photophobia, blurred vision.
Pregnancy & Lactation
Pregnancy: No data in pregnant women. Systemic exposure after topical ocular dosing is expected to be minimal, but avoid use in late pregnancy because prostaglandin synthesis inhibitors can close the fetal ductus arteriosus. Oral dosing through organogenesis produced embryo-fetal lethality and maternal toxicity in rats and rabbits at 90 and 150 times the predicted human Cmax at the recommended ophthalmic dose; rats also showed delayed parturition at 30 times and dystocia, increased neonatal mortality, and reduced postnatal growth at 90 times.
Lactation: No data on presence in human milk, effects on the breastfed infant, or effects on milk production; systemic exposure from ocular dosing is expected to be minimal, though harm to the infant cannot be ruled out.
Pediatric Use
Safety and effectiveness not established in pediatric patients.
Available Forms
Mechanism of Action
Pregnancy & Lactation
Pediatric Use