Eyeworld

JUN 2015

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

Issue link: https://digital.eyeworld.org/i/526245

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INDICATIONS AND USAGE: DUREZOL® Emulsion is a topical corticosteroid that is indicated for: • The treatment of inflammation and pain associated with ocular surgery. • The treatment of endogenous anterior uveitis. Dosage and Administration • For the treatment of infl ammation and pain associated with ocular surgery instill one drop into the conjunctival sac of the a• ected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response. • For the treatment of endogenous anterior uveitis, instill one drop into the con- junctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated. IMPORTANT SAFETY INFORMATION Contraindications: DUREZOL® Emulsion, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal diseases of ocular structures. Warnings and Precautions • Intraocular pressure (IOP) increase—Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fi elds of vision. If this product is used for 10 days or longer, IOP should be monitored. • Cataracts—Use of corticosteroids may result in posterior subcapsular cataract formation. • Delayed healing—The use of steroids after cataract surgery may delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. The initial prescription and renewal of the medication order be- yond 28 days should be made by a physician only after examination of the patient with the aid of magnification such as slit lamp biomicroscopy and, where appropriate, fluorescein staining. • Bacterial infections—Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. If signs and symptoms fail to improve after 2 days, the patient should be re-evaluated. • Viral infections—Employment of a corticosteroid medication in the treatment of patients with a history of herpes simplex requires great caution. Use of ocular steroids may prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex). • Fungal infections—Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. • Contact lens wear—DUREZOL® Emulsion should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of DUREZOL ® Emulsion. The preservative in DUREZOL® Emulsion may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of DUREZOL ® Emulsion. Most Common Adverse Reactions • Post Operative Ocular Infl ammation and Pain—Ocular adverse reactions occurring in 5-15% of subjects included corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacifi cation, anterior chamber cells, anterior chamber fl are, conjunctival edema, and blepharitis. • In the endogenous anterior uveitis studies, the most common adverse reactions occurring in 5-10% of subjects included blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis, and uveitis. For additional information about DUREZOL® Emulsion, please refer to the brief summary of Prescribing Information on adjacent page. For more resources for eye care professionals, visit MYALCON.COM/DUREZOL. References: 1. DUREZOL (difl uprednate ophthalmic emulsion) [package insert]. Fort Worth, TX: Alcon Laboratories, Inc; Revised May 2013. 2. Korenfeld MS, Silverstein SM, Cooke DL, Vogel R, Crockett RS; Difl uprednate Ophthalmic Emulsion 0.05% (Durezol) Study Group. Difl uprednate ophthalmic emulsion 0.05% for postoperative infl ammation and pain. J Cataract Refract Surg. 2009;35(1):26-34. 3. Fingertip Formulary, November 2014 (estimate derived from information used under license from Fingertip Formulary, LLC, which expressly reserves all rights, including rights of copying, distribution and republication). 4. WellCare. Medication Guide: 2014 WellCare Classic. WellCare website. https://www.wellcarepdp.com/medication_guide/ default. Accessed November 14, 2014. 5. WellCare. Medication Guide: 2015 WellCare Classic and Simple. WellCare website. https://www.wellcarepdp.com/medication_guide/default. Accessed November 14, 2014. 6. Humana. Drug guides for Medicare plans 2014. Humana website. https://www.humana.com/medicare/products-and-services/pharmacy/rx-tools/medicare- drug-list/2014-print. Updated October 30, 2014. Accessed November 14, 2014. 7. Humana. Drug guides for Medicare plans 2015. https://www.humana.com/medicare/products-and-services/pharmacy/rx-tools/medicare-drug-list/2015-print. Updated September 5, 2014. Accessed November 14, 2014. LEARN MORE ABOUT DUREZOL® EMULSION FORMULARY ACCESS IN YOUR AREA AT MYALCON.COM/FORMULARY CORTICOSTEROID COVERAGE IS NOT THE SAME * Pooled data from placebo-controlled trials in patients undergoing cataract surgery; P<0.01 vs placebo. ^ Trademark is the property of its owner. ©2014 Novartis 1/15 DUR14090JAD Post-op relief is a• ordable for your patients 1-3 DON'T LET POSTOPERATIVE INFLAMMATION AND PAIN LEAVE A BAD IMPRESSION more cataract patients achieved zero infl ammation on postoperative Days 8 and 15 vs placebo • 22%* vs 7% on Day 8; 41%* vs 11% on Day 15 1 3 x 2 x Nearly as many cataract patients achieved zero pain on postoperative Days 8 and 15 vs placebo • 58%* vs 27% on Day 8; 63%* vs 35% on Day 15 1 • BETTER or comparable formulary coverage vs generic prednisolone acetate on some Medicare Part D plans 4-7 • NO therapeutic equivalent to DUREZOL® Emulsion WHEN TREATING ENDOGENOUS ANTERIOR UVEITIS, DUREZOL® EMULSION WAS NONINFERIOR TO PRED FORTE^ (DUREZOL® EMULSION 4X DAILY VS PRED FORTE^ 8X DAILY) 1

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