Eyeworld

September 2011 S everal members of ASCRS said they were happy to be involved with the fly-in. After the legislators' talks, Sandra Yeh, M.D., Springfield, Ill., said she was fired up to talk to Wis- consin legislators about the Al- liance's agenda. "There are lawmakers who are making decisions about physicians and about Medicare who are not properly educated," she said. "It be- hooves us to come here and educate them. It really does. They are inter- ested in hearing our perspective." ©2005, 2007 Alcon, Inc. 3/11 NPF11500JAD NEVANAC® (nepafenac ophthalmic suspension) 0.1%, topical ophthalmic Initial U.S. Approval: 2005 Revised: 9/2007 BRIEF SUMMARY 1 INDICATIONS AND USAGE NEVANAC® ophthalmic suspension is indicated for the treatment of pain and inammation associated with cataract surgery. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing One drop of NEVANAC® should be applied to the aected eye(s) three-times-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the rst 2 weeks of the postoperative period. 2.2 Use with Other Topical Ophthalmic Medications NEVANAC® may be administered in conjunction with other topical ophthalmic medications such as beta-blockers, carbonic anhydrase inhibitors, alp ha-agonists, cycloplegics, and mydriatics. 3 DOSAGE FORMS AND STRENGTHS Sterile ophthalmic suspension: 0.1% 3 mL in a 4 mL bottle 4 CONTRAINDICATIONS NEVANAC® is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other NSAID. 5 WARNINGS AND PRECAUTIONS 5.1 Increased Bleeding Time With some nonsteroidal anti-inammatory drugs including NEVANAC®, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation. There have been reports that ocularly applied nonsteroidal anti-inammatory drugs may cause increased bleeding of ocular tissues (including hyphemas) in conjunction with ocular surgery. It is recommended that NEVANAC® ophthalmic suspension be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time. 5.2 Delayed Healing Topical nonsteroidal anti-inammatory drugs (NSAIDs) including NEVANAC®, 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. 5.3 Corneal Eects 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 including NEVANAC® 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 1 day prior to surgery or use beyond 14 days post surgery may increase patient risk and severity of corneal adverse events. 5.4 Contact Lens Wear NEVANAC® should not be administered while using contact lenses. 6 ADVERSE REACTIONS Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reect the rates observed in practice. 6.1 Ocular Adverse Reactions The most frequently reported ocular adverse reactions following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. These events occurred in approximately 5 to 10% of patients. Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment. Some of these events may be the consequence of the cataract surgical procedure. 6.2 Non-Ocular Adverse Reactions Non-ocular adverse reactions reported at an incidence of 1 to 4% included headache, hypertension, nausea/vomiting, and sinusitis. See full prescribing information for NEVANAC®. ALCON LABORATORIES, INC. Fort Worth, Texas 76134 USA Doctors fly in to interact with Congress Senator Sherrod Brown (D-OH) continued on page 10 From left front row: Kenneth Rosenthal, M.D., Sharon Richens, M.D., Sandra Yeh, M.D., ASCRS Director of Government Relations Nancey McCann, Stephen Lane, M.D., Marc Michelson, M.D., and Paul Arnold, M.D. From left back row: David Davidorf, M.D., R. Doyle Stulting, M.D., Ed Holland, M.D., Parag Parekh, M.D., Chair of the Government Relations Committee Brock Bakewell, M.D., James Bryan, M.D., and ASCRS Executive Director David Karcher

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