Acuvail®
Ketorolac 0.45% · ophthalmic solution
NSAID
Approved uses
Pain and inflammation following cataract surgery
One drop BID to the affected eye starting 1 day before surgery, on the day of surgery, and through the first 2 weeks postoperatively.
Median time to pain resolution is 1 day, with most patients pain free by postoperative day 1.
Contraindications
Hypersensitivity to any component of the formulation.
Available Forms0.45% (4.5 mg/mL) preservative-free solution, 0.4 mL single-dose vials, carton of 30 vials in 3 pouches of 10
Mechanism of ActionNonsteroidal anti-inflammatory drug of the pyrrolo-pyrrole class; inhibits prostaglandin biosynthesis by blocking cyclooxygenase. Lowering prostaglandin production reduces the anterior chamber cell and flare and the ocular pain that follow cataract extraction.
Warnings & Precautions
- Delayed healing: Topical NSAIDs may slow or delay healing; concomitant topical steroids compound the risk.
- Cross-sensitivity: Potential cross-reactivity with acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs. Bronchospasm and exacerbation of asthma have been reported in patients with aspirin or NSAID hypersensitivity or a past history of asthma.
- Increased bleeding time: Interference with thrombocyte aggregation. Ocularly applied NSAIDs have been reported to increase bleeding of ocular tissues, including hyphema, in conjunction with surgery. Use caution with known bleeding tendencies or concomitant drugs that prolong bleeding time.
- Corneal effects: Keratitis can occur, and continued use in susceptible patients may progress to epithelial breakdown, corneal thinning, erosion, ulceration, or perforation, which may be sight threatening. Discontinue immediately on corneal epithelial breakdown and monitor corneal health closely.
- Higher-risk corneas: Complicated or repeat ocular surgery, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease such as dry eye, and rheumatoid arthritis raise the risk of sight-threatening corneal events.
- Extended perioperative use: Dosing more than 1 day before surgery or beyond 14 days after surgery increases the occurrence and severity of corneal adverse events.
- Contact lens wear: Not to be administered while wearing contact lenses.
- Contamination risk: Vial tip contact with the eye or surrounding structures can contaminate the solution or injure the eye, with serious ocular infection and vision loss possible.
Common Side Effects
- Ocular, 1% to 6%: Increased intraocular pressure, conjunctival hyperemia or hemorrhage, corneal edema, ocular pain, tearing, blurred vision. Some may be consequences of the surgery itself.
- Ocular, class-wide: Allergic reactions including eye swelling, hyperemia, and pruritus.
- Ocular, postmarketing: Corneal erosion, corneal thinning, corneal melt, corneal perforation, epithelial breakdown, ulcerative keratitis.
- Systemic: Headache in 1% to 6%; bronchospasm and exacerbation of asthma reported postmarketing.
Pregnancy & LactationPregnancy: No adequate and well-controlled studies in pregnant women; no teratogenicity seen in rats or rabbits at clinically relevant doses.
Lactation: Presence in human milk after topical dosing is unknown; use caution in a nursing woman.
Pediatric UseSafety and effectiveness not established below age 2.