Date: PRO PHARMA TECHNOLOGY TOOLBOX Generic: Ketorolac trimethamine Brand: ACUVAIL OPHTHALMIC SOLUTION Strengths: 0.45% 1 INDICATION1 Acuvail is a preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug, and is indicated for the treatment of pain and inflammation following cataract surgery. Incidence/Prevalence10 Prevalance: 5,500,000 people have a cataract interfering with their vision in the US (Research to Prevent Blindness, NISE, NSF) or approx 1 in 49 or 2.02% Incidence: 400,000 new cases of cataract occur each year in the US (Research to Prevent Blindness, NISE, NSF) or approx 1 in 679 or 0.15% 2 DOSAGE AND ADMINISTRATION1 One drop of Acuvail should be applied to the affected eye twice daily, beginning one day prior to cataract surgery, continued on the day of surgery, and through the first two weeks of the postoperative period. 3 MECHANISM OF ACTION1 Acuvail is formulated at pH 6.8, enabling deionized drug delivery on the corneal surface. It also contains carboxymethylcellulose, a viscous molecule that enables the drug to adhere to the ocular surface and to enhance patient comfort. Ketorolac inhibits the COX-1 and COX-2 enzymes, that must be blocked in order to inhibit the development of prostaglandins, which are considered to be the primary sources of pain and inflammation following cataract surgery. Drug Structure1,2 4 ADVERSE REACTION/SIDE EFFECTS 1,3,4 The most common side effects were reported in 1-6% of patients and included increased intraocular pressure, conjunctival hyperemia and/or hemorrhage, corneal edema, ocular pain, headache, tearing, and blurred vision. Some of these events are thought to be due to the surgical procedure itself, and not the drug. P.O. BOX 280130 • NORTHRIDGE, CA 91328-0130 • (818) 701-5438 • FAX (818) 701-0249 Date: severe burning, stinging, or itching of your eyes; eye pain, redness, or watering; vision changes, increased sensitivity to light; white patches on your eyes; or crusting or drainage from your eyes. Less serious side effects may include: mild burning, stinging, or itching of your eyes; swollen or puffy eyelids; or headache. 5 TREATMENT GUIDELINES3, 4, 7 Given for post-operative inflammation following cataract extraction. 6 PRICING (relative)5 Acuvail is priced at $130 per 30ml bottle. 7 Drug Comparison1,3, 6, 8, 11 The standard recommended dose of diclofenac (VOLTAREN) eye drops for use after cataract surgery is one drop in the affected eye four times daily (versus twice daily), starting 24 hours after surgery and continuing for two weeks. The recommended dose of ACULARophthalmic solution (preservative-free ketorolac) is one drop (0.25 mg) four times a day for relief of ocular itching due to seasonal allergic conjunctivitis. “We conclude that ketorolac is as safe as ketoprofen and diclofenac for the treatment of pain after major surgery.” -E. Heitlinger14 Ketorolac, diclofenac, and ketoprofen are equally safe for pain relief after major surgery British Journal of Anaesthesia, 2002, Vol. 88, No. 2 227-233 Primary advantage of this drug is twice daily dosing. Voltaren (diclofenac) and Acular (ketorolac) are four-times daily. 1. Drugs@FDA : http://www.accessdata.fda.gov/Scripts/cder/DrugsatFDA/ 2. DrugBank: http://www.drugbank.ca/ 3. Dipiro: USC Pharmacology Website 4. WebMD: http://www.webmd.com/ 5. DrugStore: http://www.drugstore.com/ 6. Rxfiles: http://www.rxfiles.ca/rxfiles/modules/druginfoindex/druginfo.aspx 7. Rphworld: http://www.rphworld.com/pharmacist/link-347.html 8. Rphworld: http://www.rphworld.com/pharmacist/viewlink-25534.html 9. CenterWatch: http://www.centerwatch.com/drug-information/index.htm 10. Wrong Diagnosis: http://www.wrongdiagnosis.com 11. British Medical Journal Clinical Evidence: http://clinicalevidence.bmj.com.libproxy.usc.edu/ceweb/index.jsp P.O. BOX 280130 • NORTHRIDGE, CA 91328-0130 • (818) 701-5438 • FAX (818) 701-0249