Acular®
Ketorolac 0.5% · ophthalmic solution
NSAID
Approved uses
Ocular itching due to seasonal allergic conjunctivitis
One drop QID to the affected eye(s).
Inflammation following cataract surgery
One drop QID to the affected eye starting 24 hours after surgery, continuing through the first 2 weeks postoperatively.
OFF-LABELNot in the FDA label for this product
Acute pseudophakic cystoid macular edema
One drop QID, alone or combined with prednisolone acetate 1% QID, continued until the edema resolves or for 3 months, then tapered over 3 weeks.
RCT · n=28 · underpowered
Small randomized double-masked trial, 28 patients enrolled and 26 completed, CME developing 21 to 90 days after cataract extraction. A gain of 2 or more Snellen lines occurred in 6 of 9 on ketorolac alone, 8 of 9 on ketorolac plus prednisolone, and 4 of 8 on prednisolone alone; only the combination reached a mean 2-line gain, and it beat prednisolone monotherapy at every visit. Responders on ketorolac improved at a mean 1.43 months versus 2.75 months on prednisolone. Underpowered single trial, so treat as supportive rather than definitive.
Contraindications
Hypersensitivity to any component of the formulation.
Available Forms0.5% (5 mg/mL) solution, 5 mL fill in a 10 mL dropper bottle
Mechanism of ActionNonsteroidal anti-inflammatory drug of the pyrrolo-pyrrole class; inhibits prostaglandin biosynthesis by blocking cyclooxygenase. Lowering prostaglandin production blunts the itch, hyperemia, and vascular permeability of allergic conjunctivitis and the anterior segment inflammation that follows 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: Bottle tip contact with the eye or surrounding structures can contaminate the solution and cause serious ocular infection and vision loss.
Common Side Effects
- Ocular, most frequent: Transient stinging and burning on instillation, reported by up to 40% of patients in clinical trials.
- Ocular, 1% to 10%: Allergic reactions including eye swelling, hyperemia, and pruritus; corneal edema; iritis; ocular inflammation; ocular irritation; ocular pain; superficial keratitis; superficial ocular infections.
- Ocular, rare: Corneal infiltrates, corneal ulcer, eye dryness, blurred vision.
- Ocular, postmarketing: Corneal erosion, corneal thinning, corneal perforation, epithelial breakdown.
- Systemic: Headache, reported rarely; bronchospasm or 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. Avoid in late pregnancy because prostaglandin-inhibiting drugs can close the fetal ductus arteriosus.
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.