Postoperative inflammation and prevention of ocular pain after cataract surgery
One drop BID, morning and evening, to the affected eye starting 1 day before surgery, on the day of surgery, and for 14 days after surgery.
Left 77% pain-free by day 1 and cleared anterior chamber cells in 57% by day 15.
Contraindications
None listed on the FDA label.
Available Forms
0.075% ophthalmic solution, 5 mL in a 7.5 mL dropper bottle, foil pouch
Mechanism of Action
Nonsteroidal anti-inflammatory drug that blocks prostaglandin synthesis by inhibiting cyclooxygenase 1 and 2, formulated in a viscous polycarbophil vehicle (DuraSite). Prostaglandins mediate intraocular inflammation, disrupting the blood-aqueous barrier and producing vasodilation, increased vascular permeability, leukocytosis, and raised intraocular pressure in animal eyes.
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.
Delayed healing: All topical NSAIDs may slow or delay healing, and concomitant topical steroids compound the risk.
Cross-sensitivity: Potential cross-reactivity with acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs; use caution in patients who have 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 administered while wearing contact lenses; the benzalkonium chloride preservative may be absorbed by soft lenses.
Pregnancy: No adequate and well-controlled studies in pregnant women; avoid during late pregnancy because prostaglandin synthesis inhibitors can close the fetal ductus arteriosus. Oral dosing in rats and rabbits produced no structural teratogenicity at clinically relevant doses, though embryo-fetal lethality occurred in both species at the highest doses tested.
Lactation: No data on presence in human milk, effects on the breastfed infant, or effects on milk production; systemic exposure from ocular dosing is low.