Eyeworld

Ophthalmology's continued from page 97 September 2011 the professions may vary but the personalities as a whole really don't. Everyone is a Type A personality and not necessarily in a bad way. The goals that allow you to succeed pro- fessionally are the same goals that put you into the endurance sports because you're pushing your limits." Both Drs. Stager and Wilson are goal-oriented people with a never- say-die attitude who thrive off dou- ble-dog daring themselves to tackle daunting challenges. Both doctors ran marathons in the past and felt like they accomplished everything they wanted to there. But whereas Dr. Stager got involved in the sport through cycling, Dr. Wilson was a competitive swimmer. "It's been an evolving process," he said. "I've always been more of a distance individual. I went from swimming to marathons to triathlons to the long-course triathlons. At that point in time, having the image of Julie Moss crawling across the finish line [in the 1982 Hawaii Ironman Triathlon] somehow seemed attractive." As much exercising as Drs. Stager and Wilson do, both stress the importance of not doing it as well. Triathletes have to take a break from training, which can be the hardest part of the preparation process for these ambitious individu- als. "There's always a chance when you're getting in shape that you'll do more harm than good," cau- tioned Dr. Gills. "You can get hurt running too far. You have to do enough stretching and take enough time off." "Doing the exercising is not the problem," said Dr. Stager. "Most peo- ple will find the time and then overdo it. The problem is you have to take the time to recover. You have to allow your body to rest. A lot of people will get injured because their body is overtrained, and they'll de- velop knee problems and a variety of different aliments." RESTASIS ® (cyclosporine ophthalmic emulsion) 0.05% Sterile, Preservative-Free INDICATIONS AND USAGE RESTASIS ® ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not seen in patients currently taking topical anti- inflammatory drugs or using punctal plugs. CONTRAINDICATIONS RESTASIS ® is contraindicated in patients with active ocular infections and in patients with known or suspected hypersensitivity to any of the ingredients in the formulation. WARNING RESTASIS ® ophthalmic emulsion has not been studied in patients with a history of herpes keratitis. PRECAUTIONS General: For ophthalmic use only. Information for Patients The emulsion from one individual single-use vial is to be used immediately after opening for administration to one or both eyes, and the remaining contents should be discarded immediately after administration. Do not allow the tip of the vial to touch the eye or any surface, as this may contaminate the emulsion. RESTASIS ® should not be administered while wearing contact lenses. Patients with decreased tear produc tion typically should not wear contact lenses. If contact lenses are worn, they should be removed prior to the administration of the emulsion. Lenses may be reinserted 15 minutes following administration of RESTASIS ® ophthalmic emulsion. Carcinogenesis, Mutagenesis, and Impairment of Fertility Systemic carcinogenicity studies were carried out in male and female mice and rats. In the 78-week oral (diet) mouse study, at doses of 1, 4, and 16 mg/kg/day, evidence of a statistically significant trend was found for lymphocytic lymphomas in females, and the incidence of hepatocellular carcinomas in mid-dose males significantly exceeded the control value. In the 24-month oral (diet) rat study, conducted at 0.5, 2, and 8 mg/kg/ day, pancreatic islet cell adenomas significantly exceeded the control rate in the low dose level. The hepatocellular carcinomas and pancreatic islet cell adenomas were not dose related. The low doses in mice and rats are approximately 1000 and 500 times greater, respectively, than the daily human dose of one drop (28 µL) of 0.05% RESTASIS ® BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. Cyclosporine has not been found mutagenic/genotoxic in the Ames Test, the V79-HGPRT Test, the micronu cleus test in mice and Chinese hamsters, the chromosome-aberration tests in Chinese hamster bone-marrow, the mouse dominant lethal assay, and the DNA-repair test in sperm from treated mice. A study analyzing sister chromatid exchange (SCE) induction by cyclosporine using human lymphocytes in vitro gave indication of a positive effect (i.e., induction of SCE). No impairment in fertility was demonstrated in studies in male and female rats receiving oral doses of cyclosporine up to 15 mg/kg/day (approximately 15,000 times the human daily dose of 0.001 mg/kg/day) for 9 weeks (male) and 2 weeks (female) prior to mating. Pregnancy-Teratogenic Effects Pregnancy category C. Teratogenic Effects: No evidence of teratogenicity was observed in rats or rabbits receiving oral doses of cyclosporine up to 300 mg/ kg/day during organogenesis. These doses in rats and rabbits are approximately 300,000 times greater than the daily human dose of one drop (28 µL) 0.05% RESTASIS ® BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. Non-Teratogenic Effects: Adverse effects were seen in reproduction studies in rats and rabbits only at dose levels toxic to dams. At toxic doses (rats at 30 mg/kg/day and rabbits at 100 mg/kg/day), cyclosporine oral solution, USP, was embryo- and fetotoxic as indicated by increased pre- and postnatal mortality and reduced fetal weight together with related skeletal retardations. These doses are 30,000 and 100,000 times greater, respectively than the daily human dose of one-drop (28 µL) of 0.05% RESTASIS ® BID into each eye of a 60 kg person (0.001 mg/kg/day), assuming that the entire dose is absorbed. No evidence of embryofetal tox icity was observed in rats or rabbits receiving cyclosporine at oral doses up to 17 mg/kg/day or 30 mg/kg/day, respectively, during organogenesis. These doses in rats and rabbits are approximately 17,000 and 30,000 times greater, respectively, than the daily human dose. Offspring of rats receiving a 45 mg/kg/day oral dose of cyclosporine from Day 15 of pregnancy until Day 21 post partum, a maternally toxic level, exhibited an increase in postnatal mortality; this dose is 45,000 times greater than the daily human topical dose, 0.001 mg/kg/day, assuming that the entire dose is absorbed. No adverse events were observed at oral doses up to 15 mg/kg/day (15,000 times greater than the daily human dose). There are no adequate and well-controlled studies of RESTASIS ® in pregnant women. RESTASIS ® should be administered to a pregnant woman only if clearly needed. Nursing Mothers Cyclosporine is known to be excreted in human milk following systemic administration but excretion in human milk after topical treatment has not been investigated. Although blood concentrations are undetectable after topical administration of RESTASIS ® ophthalmic emulsion, caution should be exercised when RESTASIS ® is administered to a nursing woman. Pediatric Use The safety and efficacy of RESTASIS ® ophthalmic emulsion have not been established in pediatric patients below the age of 16. Geriatric Use No overall difference in safety or effectiveness has been observed between elderly and younger patients. ADVERSE REACTIONS The most common adverse event following the use of RESTASIS ® was ocular burning (17%). Other events reported in 1% to 5% of patients included conjunctival hyperemia, discharge, epiphora, eye pain, foreign body sensation, pruritus, stinging, and visual disturbance (most often blurring). Rx Only Based on package insert 71876US14B Revised February 2010 ©2010 Allergan, Inc. Irvine, CA 92612, U.S.A. ® marks owned by Allergan, Inc. APC80OW11 U.S. Patent 5,474,979 Made in the U.S.A. 315-25995 Bleed: XX.XX" x XX.XX" Trim: 2.125" x 12.5" Live: XX.XX" x XX.XX" CLIENT NAME: Abelson Taylor JOB#: VW120 DESC: Restasis OPERATOR: DL ROUND: 1 DATE: 02/14/2011 FILE NAME: VW120_b01.indd QC Check __________ __________ __________ "You get into the mindset that if you can do more, you'll be better, which is not necessarily true," said Dr. Wilson. "It's about being more focused and targeted with the work- outs, hitting particular points and goals so there is more purpose to the workout than just being out there." As for their individual goals, Dr. Wilson is currently training for his 20th Ironman. His best time is 10 hours and 22 seconds, but he's not out to beat it, at least not right now. "This next race is a rebuilding process, and I'm trying to take goals off the table," he said. "I'm trying to get back to less burnout and more enjoyment. When you get side- tracked with family, work, and everything else, you still enjoy it, but don't necessarily have the focus you did when you first got into it." Dr. Stager, being relatively new to the sport, is still setting personal goals and enjoying crossing the fin- ish line. "After finishing the full Iron- man, I almost collapsed," he said. "We had a big cookout and I think I lasted 30 minutes and then I was in bed. I was wiped out, but I was so happy. I put so much work into it. It was a wonderful feeling and sense of accomplishment." His ultimate goal is to qualify for the Ironman World Champi- onship in Hawaii. "In my age group, I'd have to do better than 10:30 hours to place, which means shaving an hour off my time," he said. "It's not impossi- ble. I don't know if I'll ever qualify, but I hold it out there as a goal." For these guys, that's what it's all about. "At the end of the day, it's all about a challenge," said Dr. Wilson. "If you look at people who are goal driven, the process of getting to the race is the reward. The euphoria is during the race, not necessarily after, because the race is what you worked toward. Everyone walks into every race with a different goal in his or her mind." "Make it fun," said Dr. Gills. "Make sure you can do it in a way that doesn't interfere with your lifestyle and relationships. Make sure the Ironman balances out your life." EW Editors' note: The physicians mentioned have no financial interests related to their comments. Contact information Gills: jgills@stlukeseye.com Stager: stagerdr@aol.com Wilson: mwilson5@uthsc.edu Dr. Stager's friends and family show their support In the final stretch ... Finish time of 11 hours, 55 minutes, and 12 seconds

• Cover