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ACULAR LS® (ketorolac tromethamine ophthalmic solution) 0.4%

ACULAR LS® ophthalmic solution is a non-steroidal anti-inflammatory (NSAID) indicated to reduce pain, burning and stinging following corneal refractive surgery. Approved by the U.S. Food and Drug Administration in 2003, the optimized 0.4 percent formulation of ACULAR LS® is clinically proven to block the source of post-corneal refractive surgical eye pain. ACULAR LS® has been shown to achieve significant and rapid pain relief.1

Important Safety Information

ACULAR LS® ophthalmic solution is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation.

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs.

With some nonsteroidal anti-inflammatory drugs there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied NSAIDs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.

All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including ketorolac tromethamine ophthalmic solution, may slow or delay healing.

Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs and should be closely monitored for corneal health.

Postmarketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse events which may become sight threatening.  Topical NSAIDs should be used with caution in these patients.

Postmarketing experience with topical NSAIDs also suggests that use more than 24 hours prior to surgery or use beyond 14 days post-surgery may increase patient risk for the occurrence and severity of corneal adverse events.

It is recommended that ACULAR LS® ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time.

The most frequently reported adverse reactions occurring in approximately 1 to 5 percent of the study population were conjunctival hyperemia, corneal infiltrates, headache, ocular edema and ocular pain.

The most frequent adverse events reported with the use of ketorolac tromethamine ophthalmic solutions have been transient stinging and burning on instillation.  These events were reported by 20 percent – 40 percent of patients participating in these other clinical trials.

  1. Solomon K, Donnenfeld E, Raizman M, et al. Safety and efficacy of Ketorolac tromethamine .04% ophthalmic solution in post-photorefractive Keratectomy patients. J Cataract Refract Surg. 2004; 30:1653-1660.