Acular Ls Information
Acular ls (Ketorolac tromethamine) Description
Structural and Molecular Formula:
Acular ls (Ketorolac tromethamine) Clinical Pharmacology
In two double-masked, multi-centered, parallel-group studies, 313 patients who had undergone photorefractive keratectomy received 0.4% or its vehicle QID for up to 4 days. Significant differences favored for the reduction of ocular pain and burning/stinging following photorefractive keratectomy surgery.
Results from clinical studies indicate that ketorolac tromethamine has no significant effect upon intraocular pressure.
The safety and effectiveness of in post-cataract surgery patients has not been established.
Acular ls (Ketorolac tromethamine) Indications And Usage
Acular ls (Ketorolac tromethamine)
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Acular ls (Ketorolac tromethamine) Contraindications
Acular ls (Ketorolac tromethamine)
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Acular ls (Ketorolac tromethamine) Warnings
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 nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery.
Acular ls (Ketorolac tromethamine) Precautions
All topical nonsteroidal anti-inflammatory drugs (NSAIDs), including ketorolac tromethamine ophthalmic solution, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems.
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 ophthalmic solution be used with caution in patients with known bleeding tendencies or who are receiving other medications, which may prolong bleeding time.
Acular ls (Ketorolac tromethamine)
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Ketorolac tromethamine was neither carcinogenic in rats given up to 5 mg/kg/day orally for 24 months (156 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals) nor in mice given 2 mg/kg/day orally for 18 months (62.5 times the maximum recommended human topical ophthalmic dose, on a mg/kg basis, assuming 100% absorption in humans and animals).
Ketorolac tromethamine was not mutagenic in vitro in the Ames assay or in forward mutation assays. Similarly, it did not result in an in vitro increase in unscheduled DNA synthesis or an in vivo increase in chromosome breakage in mice. However, ketorolac tromethamine did result in an increased incidence in chromosomal aberrations in Chinese hamster ovary cells.
Ketorolac tromethamine did not impair fertility when administered orally to male and female rats at doses up to 280 and 499 times the maximum recommended human topical ophthalmic dose, respectively, on a mg/kg basis, assuming 100% absorption in humans and animals.
Acular ls (Ketorolac tromethamine) Adverse Reactions
The most frequently reported adverse reactions for ophthalmic solution occurring in approximately 1 to 5% of the overall 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% - 40% of patients participating in these other clinical trials.
Other adverse events occurring approximately 1% - 10% of the time during treatment with ketorolac tromethamine ophthalmic solutions included allergic reactions, corneal edema, iritis, ocular inflammation, ocular irritation, ocular pain, superficial keratitis, and superficial ocular infections.
Acular ls (Ketorolac tromethamine) Dosage And Administration
The recommended dose of ophthalmic solution is one drop four times a day in the operated eye as needed for pain and burning/stinging for up to 4 days following corneal refractive surgery.
Ketorolac tromethamine ophthalmic solution has been safely administered in conjunction with other ophthalmic medications such as antibiotics, beta blockers, carbonic anhydrase inhibitors, cycloplegics, and mydriatics.
Acular ls (Ketorolac tromethamine) How Supplied
5 mL in 10 mL bottle - NDC 0023-9277-05
© 2011 Allergan, Inc., Irvine, CA 92612, U.S.A. ® marks owned by Allergan, Inc.U.S. Patent 8,008,338Made in the U.S.A.
71654US14C
Acular ls (Ketorolac tromethamine)
Acular ls (Ketorolac tromethamine)
