Postoperative inflammation after cataract extraction
1 drop QID beginning 24 hours after surgery, continuing through the first 2 postoperative weeks
Pain and photophobia after corneal refractive surgery
1 to 2 drops within the hour before surgery, 1 to 2 drops within 15 minutes after surgery, then QID for up to 3 days
Contraindications
Hypersensitivity to any component of the formulation.
Available Forms
0.1% (1 mg/mL) sterile solution, 5 mL fill in a 10 mL bottle
Mechanism of Action
Phenylacetic acid NSAID that inhibits cyclooxygenase and thereby prostaglandin synthesis. Prostaglandins mediate intraocular inflammation by disrupting the blood-aqueous barrier and increasing vascular permeability, so suppressing them limits postoperative anterior chamber cell and flare.
Warnings & Precautions
Corneal adverse events: All topical NSAIDs may slow or delay healing, and in susceptible patients continued use can produce epithelial breakdown, corneal thinning, infiltrates, erosion, ulceration and perforation, which may be sight-threatening. Discontinue immediately at any evidence of corneal epithelial breakdown and monitor corneal health closely.
Historical melt cases: An 11-case review of corneal melts on topical diclofenac, prompted by 1999 ASCRS member reports, attributed 7 to a generic formulation (Falcon) and 4 to the brand, with onset from 6 days to 17 months; the author concluded that coexistent factors rather than dose alone were implicated. Note that those 7 were a different manufacturer's product, not this one, and that the paper states all 11 followed 0.5% diclofenac ophthalmic solution, a strength not marketed ophthalmically.
Higher-risk patients: Complicated ocular surgery, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease such as dry eye, rheumatoid arthritis, or repeat ocular surgery within a short period raise the risk of sight-threatening corneal events.
Treatment duration: Use more than 24 hours before surgery or beyond 14 days after surgery may increase the occurrence and severity of corneal adverse events.
Concomitant topical steroids: Steroids also slow or delay healing, so combined use with a topical NSAID increases the potential for healing problems.
Bleeding risk: Interference with thrombocyte aggregation may prolong bleeding time, and ocularly applied NSAIDs have been reported to increase bleeding of ocular tissues including hyphema in conjunction with ocular surgery; caution with known bleeding tendencies or other agents that prolong bleeding time.
Cross-sensitivity: Potential cross-reactivity with acetylsalicylic acid, phenylacetic acid derivatives and other NSAIDs; caution in patients who have previously reacted to these drugs.
Refractive stability: Not established in patients treated after corneal refractive procedures; monitor for one year following use in that setting.
Soft contact lenses: Not for use in current soft lens wearers, except a bandage hydrogel lens during the first 3 days after refractive surgery.
Shared bottle: Use of one bottle for both eyes is not recommended for drops used in association with surgery.
Common Side Effects
Ocular, across studies: Transient burning and stinging approximately 15%.
Ocular, cataract surgery: Keratitis up to 28%, though in many of those cases keratitis was noted before treatment began.
Ocular, refractive surgery: Lacrimation complaints approximately 30% after incisional procedures.
Ocular, IOP: Elevated IOP after cataract surgery approximately 15%; clinical studies showed no significant drug effect on IOP.
Ocular, 10% or less: Acute IOP elevation, blurred or abnormal vision, corneal edema, corneal deposits, corneal opacity or lesions, iritis, conjunctivitis, eye pain, redness, itching, eyelid swelling, ocular allergy.
Ocular, postmarketing: Corneal erosion, infiltrates, thinning, ulceration, perforation and epithelial breakdown; frequency cannot be estimated.
Pregnancy: Category C. No adequate, well-controlled studies in pregnant women; no teratogenicity in mice at oral doses up to 5,000 times, or in rats and rabbits up to 2,500 times, the human topical dose, despite maternal and fetal toxicity. Avoid in late pregnancy, since prostaglandin synthesis inhibitors can close the fetal ductus arteriosus.
Lactation: Unknown whether topical ophthalmic use produces detectable quantities in human milk; weigh continued nursing against the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients not established.
Available Forms
Mechanism of Action
Pregnancy & Lactation
Pediatric Use