FEB 2014

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

Issue link: https://digital.eyeworld.org/i/274531

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Page 34 of 114

32 Boston attractions B o ston boasts a wide range of places to visit and major attractions to see. These include historical sites, famous m useums, and a world-renowned aquarium. Historical sites F reedom Trail www.thefreedomtrail.org 617-357-8300 T he Freedom Trail constitutes a 2.5- mile red path through the heart of downtown Boston, from Boston Common to the USS Constitution in Charlestown. It showcases numerous historic sites that played a key role in the Revolutionary War story on its trail. They include the State House, Park Street Church, Granary B urying Ground, Old Corner Book Store, the Old South Meeting House, and the Old State House. The trail can be explored on your own, with a tour guide, or with an audio guide. It is open year round, but see the website for more details on hours of operation. Faneuil Hall 4 South Market Building 617-523-1300 www.faneuilhallmarketplace.com A marketplace and meeting hall since 1742, Faneuil Hall still serves a role in Boston commerce and his- tory. The hall marketplace offers a multitude of shopping and dining options, as well as special events and street theater. Faneuil Hall Square has daily National Park Service Rangers historic talks every half hour from 9:30 a.m. to 4:30 p.m. daily. Admission is free. The Paul Revere House 19 North Square 617-523-2338 www.paulreverehouse.org Paul Revere, famous for his mid- night ride to warn the American BRIEF SUMMARY OF PRESCRIBING INFORMATION INDICATIONS AND USAGE Ocular Surgery DUREZOL ® a topical corticosteroid, is indicated for the treatment s urgery. Endogenous Anterior Uveitis DUREZOL ® Emulsion is also indicated for the treatment of endogenous anterior uveitis. D OSAGE AND ADMINISTRATION Ocular Surgery eye 4 times daily beginning 24 hours after surgery postoperative period, followed by 2 times daily for a week and then a taper based on the response. Endogenous Anterior Uveitis eye 4 times daily for 14 days followed by tapering as clinically indicated. DOSAGE FORMS AND STRENGTHS DUREZOL ® a sterile preserved emulsion for topical ophthalmic a dministration. CONTRAINDICATIONS The use of DUREZOL ® Emulsion, as with other ophthalmic corticosteroids, is contraindicated in most a ctive viral diseases of the cornea and conjunctiva i ncluding epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures. WARNINGS AND PRECAUTIONS IOP Increase Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects be used with caution in the presence of glaucoma. If this product is used for 10 days or longer, intraocular pressure 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 beyond 28 days should be made by a physician only after examination slit lamp biomicroscopy and, where appropriate, 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. Fungal culture should be taken when appropriate. Topical Ophthalmic Use Only DUREZOL ® E mulsion is not indicated for intraocular administration. 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 D UREZOL ® E mulsion may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of DUREZOL ® E mulsion. ADVERSE REACTIONS A dverse reactions associated with ophthalmic steroids include elevated intraocular pressure, which may be a ssociated with optic nerve damage, visual acuity and secondary ocular infection from pathogens including herpes simplex, and perforation of the globe where t here is thinning of the cornea or sclera. O cular Surgery Ocular adverse reactions occurring in 5-15% of subjects in clinical studies with DUREZOL ® Emulsion i ncluded corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule ocular adverse reactions occurring in 1-5% of subjects i ncluded reduced visual acuity, punctate keratitis, occurring in < 1% of subjects included application site discomfort or irritation, corneal pigmentation and striae, episcleritis, eye pruritis, eyelid irritation and crusting, foreign body sensation, increased lacrimation, macular edema, sclera hyperemia, and uveitis. Most of these reactions may have been the consequence of the surgical procedure. Endogenous Anterior Uveitis A total of 200 subjects participated in the clinical trials for endogenous anterior uveitis, of which 106 were exposed to DUREZOL ® Emulsion. The most common adverse reactions of those exposed to DUREZOL ® Emulsion 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. Adverse reactions occurring in 2-5% of subjects included anterior photophobia, and reduced visual acuity. USE IN SPECIFIC POPULATIONS Pregnancy Teratogenic E shown to be embryotoxic (decrease in embryonic and teratogenic (cleft palate and skeletal) anomalies when administered subcutaneously to rabbits during organogenesis at a dose of 1–10 mcg/kg/day. The to be a teratogenic dose that was concurrently found in the toxic dose range for fetuses and pregnant females. Treatment of rats with 10 mcg/kg/day subcutaneously during organogenesis did not result in any reproductive toxicity, nor was it maternally toxic. At 100 mcg/kg/day after subcutaneous administration in rats, there was a decrease in fetal weights and human doses of DUREZOL ® Emulsion, since DUREZOL ® Emulsion is administered topically with minimal were not measured in the reproductive animal studies. pregnancy has not been evaluated and cannot rule out the possibility of harm, DUREZOL ® Emulsion should Nursing Mothers It is not known whether topical ophthalmic a dministration of corticosteroids could result in quantities in breast milk. Systemically administered corticosteroids appear in human milk and could s uppress growth, interfere with endogenous corticosteroid production, or cause other untoward ® Emulsion is administered to a nursing woman. P ediatric Use Geriatric Use been observed between elderly and younger patients. NONCLINICAL TOXICOLOGY Carcinogenesis, Mutagenesis, and Impairment of Fertility in vitro in the Ames test, and in cultured mammalian cells CHL/IU (a female Chinese hamsters). An in vivo micronucleus Treatment of male and female rats with subcutaneous mating did not impair fertility in either gender. Long term studies have not been conducted to evaluate the Animal Toxicology and/or Pharmacology In multiple studies performed in rodents and n on-rodents, subchronic and chronic toxicity tests as suppression of body weight gain; a decrease in lymphocyte count; atrophy of the lymphatic thinning of the skin; all of which were due to the pharmacologic action of the molecule and are well The NOEL for the subchronic and chronic toxicity tests were consistent between species and ranged from 1–1.25 mcg/kg/day. PATIENT COUNSELING INFORMATION Risk of Contamination This product is sterile when packaged. Patients should be advised not to allow the dropper tip to touch any surface, as this may contaminate the emulsion. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery. Risk of Secondary Infection becomes aggravated, the patient should be advised to consult a physician. Contact Lens Wear DUREZOL ® Emulsion should not be instilled while wearing contact lenses. Patients should be advised to 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. Revised: May 2013 U.S. Patent 6,114,319 DUREZOL ® Emulsion was evaluated in a 3-month, multicenter, double-masked, trial in 79 pediatric patients ( 39 DUREZOL ® Emulsion; 40 prednisolone acetate) 0 to 3 y ears of age for the treatment of infammation following cataract surgery. A similar safety profle was observed in pediatric patients comparing DUREZOL ® Emulsion to prednisolone acetate ophthalmic suspension, 1%. © 2013 Novartis 8/13 DUR13148JAD Manufactured For: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 USA 1-800-757‐9195 Manufactured By: Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, Texas 76134 USA or Catalent Pharma Solutions Woodstock, IL 60098 Source: Greater Boston Convention & Visitors Bureau EW Boston 2014= February 2014 A SCRS•ASOA Preview • A pril 25-29, 2014 26-37 Boston Preview_EW February 2014-DL2_Layout 1 1/30/14 10:14 AM Page 32

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