penal complex Smartphones, Tablets Sabotaging Teens' Sleep understand

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divulge to (*this news item will not be available after 01/18/2018) By Mary Elizabeth Dallas Friday, October 20, 2017 FRIDAY, Oct. 20, 2017 (HealthDay News) -- Teens sleep less than they used to, sacrificing shuteye to spend more time on their phones and tablets. Experts say teens need at least nine hours of sleep a night to be engaged and productive during the day. Anything less can cause daytime sleepiness and interfere with school or daily activities. Faced with an array of tempting distractions, how much sleep are today's teens actually getting? To find out, researchers analyzed a pair of long-term, national surveys of more than 360,000 eighth- through 12th-graders. One survey asked eighth-, 10th- and 12th-graders how often they got at least seven hours of shuteye. The other asked high school students how long they slept on a typical school night. In 2015, 4 out of 10 teens slept less than seven hours a night. That's up 58 percent since 1991 and 17 percent more than in 2009 when smartphone use became more mainstream, the researchers said. "Teens' sleep began to shorten just as the majority started using smartphones. It's a very suspicious pattern," said study leader Jean Twenge, a psychology professor at San Diego State University. The more time students reported spending online, the less sleep they got, according to the study published Oct. 19 in the journal Sleep Medicine . Those who were online five hours a day were 50 percent more likely to be sleep-deprived than classmates who limited their daily time online to an hour. Studies have shown that light from smartphones and tablets can disrupt the body's natural sleep-wake cycle. "Our body is going to try to meet its sleep needs, which means sleep is going to interfere or shove its nose in other spheres of our lives," said study co-author Zlatan Krizan, an associate professor of psychology at Iowa State University. "Teens may catch up with naps on the weekend or they may start falling asleep at school." Though smartphones, tablets and other electronic devices are often an essential part of life, the researchers said moderation is key. Everyone -- young and old alike -- should limit use to two hours each day, they advised in a San Diego State University news release. "Given the importance of sleep for both physical and mental health, both teens and adults should consider whether their smartphone use is interfering with their sleep," Twenge said. "It's particularly important not to use screen devices right before bed, as they might interfere with falling asleep." SOURCE: San Diego State University, news release, Oct. 19, 2017 HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Sleep Disorders Teen Health Recent Health News taking into consideration


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most beautiful (*this news item will not be available after 01/18/2018) Friday, October 20, 2017 FRIDAY, Oct. 20, 2017 (HealthDay News) -- Smoking and oral sex may be a deadly combo that raises a man's risk for head and neck cancer, a new study suggests. The key factor is transmission of oral strains of the cancer-linked human papillomavirus (HPV), which can be passed through oral sex. In fact, men who smoke and have five or more partners with whom they've had oral sex -- in this study, that typically meant cunnilingus -- have the highest risk of developing a type of head and neck cancer known as oropharyngeal cancer. Dr. Otis Brawley is chief medical officer at the American Cancer Society. Reviewing the new study, he noted that "the incidence of oral HPV infection seems to be rising among white men in their 50s and 60s," perhaps due to increasing acceptance of oral sex. Still, for most people, the risk of contracting an HPV-linked head-and-neck cancer remains very low, said lead researcher Amber D'Souza. She is an associate professor of epidemiology at Johns Hopkins Bloomberg School of Public Health in Baltimore. D'Souza added that the risk is far lower among women and nonsmokers, and people who have few oral sex partners. The new findings "should reassure people that cancer-causing oral HPV prevalence is low among most groups," D'Souza said. But certain groups do have higher risk. One recent study found that 11 million American men are infected with oral HPV. That means one in nine U.S. males aged 18 to 69 is infected. Brawley said that the increase is partly a result of the sexual revolution in the 1960s and 1970s. "The increase in oral sex led to the increased number of people with [oral] HPV," he said. For the new study, D'Souza's team reviewed data on more than 13,000 people, aged 20 to 69, who took part in a major federal government survey and had been tested for oral HPV infection. This survey is a nationally representative group, so it's likely that the vast majority of male participants who said they were the active partner in oral sex were heterosexual men engaging in cunnilingus. To predict the risk of cancer from oral HPV infection, the researchers used the numbers of oropharyngeal cancer cases and deaths from U.S. cancer registries. The investigators found that men and women who had one or no oral sex partners had the lowest prevalence of cancer-causing oral HPV. Rates of HPV infection went up in smokers, however, and the rate also went up when men and women had two or more oral sex partners, though the rates were still low. The risk increased dramatically -- to 7 percent -- among men who smoked and had two to four oral sex partners. The risk rose to nearly 7.5 percent among men who didn't smoke but who had five or more oral sex partners, D'Souza's team found. And the greatest risk (nearly 15 percent) was seen among men who smoked and who also had five or more oral sex partners, the findings showed. More than 100 types of HPV exist, but only a few cause cancer, including cervical cancer, D'Souza noted. Most people who contract oral HPV rid themselves of it naturally within about nine months, Brawley noted. "But there are a group of people who get the infection and keep the infection for 20 or 30 years. Those are the people who end up getting head or neck or cervical cancer," he said. Each year in the United States, about 16,500 cases of oropharyngeal cancer are diagnosed. Of these, 11,500 (70 percent) are related to HPV infection, D'Souza said. Screening for oral HPV infection probably isn't the answer, D'Souza said, because the cancers are so rare. "Current tests might identify who has an oral HPV, but do not predict future cancer risk well," she explained. Brawley suggested that there is one easily available prevention: the HPV vaccine. Given early in life, it protects against cervical cancer and anal cancer, and most likely protects against head and neck cancer, too, he said. The hope is that over time as more kids are vaccinated, cancers caused by HPV will greatly diminish, Brawley said. Patti Gravitt is a professor in the department of global health at George Washington University in Washington, D.C. She said the connection between oral HPV and smoking isn't clear. "We also see a connection between smoking and cervical cancer, so it's likely that smoking and HPV interact in some way to increase the risk of cancer," Gravitt said. The report was published Oct. 20 in the Annals of Oncology . SOURCES: Amber D'Souza, Ph.D., M.P.H., associate professor, epidemiology, Johns Hopkins Bloomberg School of Public Health, Baltimore; Otis Brawley, M.D., chief medical officer, American Cancer Society; Patti Gravitt, Ph.D., professor, department of global health, George Washington University, Washington, D.C.; Oct. 20, 2017, Annals of Oncology HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on HPV Men's Health Smoking Recent Health News for boosting


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is in general Kidney Failure Can Isolate Young Patients remedies

is in general Kidney Failure Can Isolate Young Patients remedies

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that offer (*this news item will not be available after 01/18/2018) By Robert Preidt Friday, October 20, 2017 FRIDAY, Oct. 20, 2017 (HealthDay News) -- Kidney failure takes an especially tough toll on young adults, affecting their employment and relationships, researchers report. Young people with kidney failure are less likely to have jobs or be in long-term relationships than others their age, according to a new British research review. "It is vital to understand how kidney failure affects social goals, because by defining these we can seek interventions to improve areas of deficit," said Dr. Alexander Hamilton, of the University of Bristol in England. His team analyzed 60 published studies that included nearly 16,000 kidney failure patients aged 16 to 30. They were either on dialysis or had received a kidney transplant. Compared to their healthy peers, these young people had a worse quality of life and were more likely to be unemployed and to live in their parents' home, the study found. They also were less likely to be married or have a romantic partner. These social, employment and lifestyle issues were worse among those on dialysis than among those who'd had a kidney transplant, the researchers said. There were no differences between kidney failure patients and their healthy peers in terms of education levels or rates of smoking and drinking. The study was published in the Oct. 19 issue of the Clinical Journal of the American Society of Nephrology . "We know that most young people with end-stage kidney disease have a kidney transplant, but they are high-risk for the transplanted kidney to fail," Hamilton said in a journal news release. While much attention has been paid to the transition between pediatric and adult care for kidney patients, he said it's also essential to look at the social ramifications among this younger adult age group. "These areas really matter to patients," Hamilton said. SOURCE: Clinical Journal of the American Society of Nephrology , news release, Oct. 19, 2017 HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Kidney Failure Mental Health Recent Health News geared toward


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day by day Pollution Tied to 9 Million Deaths Worldwide in 2015 latest

day by day Pollution Tied to 9 Million Deaths Worldwide in 2015 latest

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a method (*this news item will not be available after 01/18/2018) By Robert Preidt Friday, October 20, 2017 FRIDAY, Oct. 20, 2017 (HealthDay News) -- Pollution led to more than 9 million deaths worldwide in 2015, or 1 in 6 deaths that year, a new report reveals. Air pollution, the worst culprit, was linked to 6.5 million heart- and lung-related deaths, The Lancet Commission on Pollution and Health said. Water pollution was tied to 1.8 million deaths, mostly from gastrointestinal and parasitic infections. And workplace-related pollution and lead pollution also played a role, contributing to 800,000 deaths and 500,000 deaths, respectively. "Pollution is much more than an environmental challenge -- it is a profound and pervasive threat that affects many aspects of human health and well-being," said Dr. Philip Landrigan, co-lead of the commission. "It deserves the full attention of international leaders, civil society, health professionals, and people around the world," added Landrigan, a professor at the Icahn School of Medicine at Mount Sinai in New York City. The report is published in the Oct. 20 online issue of The Lancet . Two years in the making, it involved more than 40 international health and environmental authors. Air pollution-related deaths were attributed to heart disease, stroke, lung cancer and chronic obstructive pulmonary disease (COPD), the report said. Occupational pollution led to deadly diseases such as pneumoconiosis (a lung disease caused by inhaling irritants) in coal workers; bladder cancer in dye workers; and asbestosis, lung cancer, mesothelioma and other cancers in workers exposed to asbestos, according to the report. Meanwhile, high blood pressure, kidney failure and heart disease contributed to deaths related to lead pollution. "Our goal is to raise global awareness of the importance of pollution, and mobilize the political will needed to tackle it, by providing the most in-depth estimates of pollution and health available," Landrigan said in a journal news release. Nearly all pollution-linked deaths (92 percent) were in low- and middle-income countries. In rapidly industrializing countries -- such as Bangladesh, China, India, Pakistan, Kenya and Madagascar -- pollution-linked deaths accounted for up to 1 in 4 of all fatalities, the report said. China and India suffered the most pollution-linked deaths -- 4.3 million between them. The report authors said many emerging chemical pollutants remain unidentified, so the report likely underestimates the true extent of pollution-related disease and death. Richard Fuller, who also led the commission, said the way to tackle pollution is to make it a priority in terms of planning, research and finding. He is a founder of Pure Earth, a nonprofit group involved in pollution cleanup and prevention. "Pollution can be eliminated, and pollution prevention can be highly cost-effective -- helping to improve health and extend life span, while boosting the economy," said Fuller. This has been seen in richer countries where legislation has helped to curb the most flagrant forms of pollution, he added. The result has been cleaner air and water, lower blood lead concentrations, removal of hazardous waste sites, and less polluted and more livable cities, Fuller said. SOURCE: The Lancet , news release, Oct. 19, 2017 HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Air Pollution Environmental Health Water Pollution Recent Health News a very


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dependancy Drug OD Rate Now Higher in Rural U.S. Than Cities: CDC among the finest

dependancy Drug OD Rate Now Higher in Rural U.S. Than Cities: CDC among the finest

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and mock (*this news item will not be available after 01/18/2018) By Robert Preidt Friday, October 20, 2017 FRIDAY, Oct. 20, 2017 (HealthDay News) -- Drug overdose death rates in rural areas of the United States are now higher than in cities, a trend that worries federal health officials. In 2015, drug overdose was the leading cause of injury-related death in the United States -- with 52,000 fatalities attributed to opioid painkillers, heroin and other potentially deadly drugs, researchers said in a new report. U.S. Centers for Disease Control and Prevention Director Dr. Brenda Fitzgerald said rising overdose death rates outside metropolitan areas warrant attention. "We need to understand why this is happening so that our work with states and communities can help stop illicit drug use and overdose deaths in America," Fitzgerald said in an agency news release. In 1999, drug overdose death rates were 6.4 per 100,000 in urban regions and 4 per 100,000 in rural areas. But the gap gradually disappeared. By 2015, the rate was 17 per 100,000 in rural areas and 16.2 per 100,000 in cities, the study findings showed. The researchers assessed illicit drug use and disorders from 2003 to 2014, and drug overdose deaths from 1999 to 2015 in urban and rural areas. The investigators were led by Karin Mack of the CDC's National Center for Injury Prevention and Control. Although the percentage of people reporting illegal drug use is actually lower in rural areas, the effects appear to be greater, the researchers noted. Overall, "most overdose deaths occurred in homes, where rescue efforts may fall to relatives who have limited knowledge of or access to life-saving treatment and overdose follow-up care," the authors explained in the news release. Looking at where drug users live and where they die from overdoses might lead to better preventive measures, the team pointed out. Some other findings in the report: Rising rates of drug overdose deaths nationwide between 1999 and 2015 were consistent across gender, race and intent (unintentional, suicide, homicide or undetermined). The actual number of drug overdose deaths remains much higher in cities. In 2015, about six times as many drug overdose deaths occurred in urban areas (45,059) as in rural areas (7,345). The percentage of people reporting use of illicit drugs in the past month fell among those aged 12 to 17 over a 10-year period, but rose sharply in other age groups. On a positive note, past-year illicit drug use disorders declined during 2003-2014. "On the one hand, the decline in illicit drug use by youth and the lower prevalence of illicit drug use disorders are encouraging signs," Mack's team wrote. "On the other hand, the increasing rate of drug overdose deaths in rural areas, which surpassed rates in urban areas, is cause for concern." Since rural residents are less likely to have access to substance abuse treatment services, the findings point to a need to beef up such services outside cities, the authors of the report said. Moreover, doctors should be updated on guidelines for prescribing opioids for chronic pain. And communities with high opioid-use disorder rates might benefit from greater access to addiction/overdose treatments such as methadone, buprenorphine or naltrexone, Mack and colleagues concluded. The findings were published in the Oct. 20 issue of the CDC's Morbidity and Mortality Weekly Report . SOURCES: U.S. Centers for Disease Control and Prevention, news release, Oct. 19, 2017; Oct. 20, 2017, Morbidity and Mortality Weekly Report HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Drug Abuse Health Statistics Opioid Abuse and Addiction Recent Health News it also includes


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a quirky Tighter Rules on Arsenic in Water Saved Lives: Study do not forget that

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final result (*this news item will not be available after 01/21/2018) By Robert Preidt Monday, October 23, 2017 MONDAY, Oct. 23, 2017 (HealthDay News) -- U.S. government limits on arsenic in drinking water has likely averted hundreds of cases of lung and bladder cancer annually, a new study suggests. After the Environmental Protection Agency introduced tighter limits on arsenic in public drinking water in 2006, there was a 17 percent decrease in levels of arsenic in the urine of people served by public water systems that complied with the rule, the researchers found. Not only that, but there were an estimated 200 fewer cases of lung and bladder cancer a year after the tougher rules were put in place. Levels of arsenic in the urine of people who used private wells did not change, according to the study published Oct. 23 in The Lancet Public Health journal. Arsenic is a carcinogen that naturally occurs in drinking water across the United States. The study findings highlight the important role that government drinking water regulations play in reducing toxic exposures and protecting health, the researchers said. "EPA regulation was associated with a significant decrease in urinary arsenic concentrations among Americans who use public water systems," said study author Anne Nigra, from the Columbia University Mailman School of Public Health in New York City. However, private wells are not subject to regulation by the EPA. "Levels of arsenic in private wells, estimated to provide water to roughly 45.5 million Americans, vary significantly throughout the U.S.A. Because of the cost of testing and treating contaminated water, private well water users remain inadequately protected against arsenic exposure in drinking water, especially residents of lower socioeconomic status," Nigra said in a journal news release. In fact, a government study published just last week estimated that 2 million private well users may be exposed to high levels of arsenic in their drinking water. High levels of arsenic have been linked to an increased risk for a broad range of cancers, including skin, lung, bladder, kidney and liver cancers, the researchers noted. It can also threaten the nervous system, respiratory function, heart health and the immune system. "The findings are consistent with data from previous studies of the health benefits of reducing arsenic concentrations in drinking water," Dr. Philip Landrigan, a professor at the Icahn School of Medicine at Mount Sinai in New York City, wrote in an editorial that accompanied the latest study. "They are also concordant with analyses of the benefits of interventions against air pollution, which have been shown produced major gains both for human health and the economy," he wrote. SOURCE: The Lancet Public Health , news release, Oct. 22, 2017 HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Drinking Water Recent Health News currently


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plow through Poverty Does No Favors for Health widespread

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enchanting (*this news item will not be available after 01/21/2018) Monday, October 23, 2017 MONDAY, Oct. 23, 2017 (HealthDay News) -- Being in relatively poor financial health when middle-aged or older appears to significantly increase the risk for developing a disability or dying early. The observation stems from an analysis of data from the United States and England that drew links between wealth and health among almost 20,000 people aged 54 to 76. For example, over a 10-year period, Americans aged 54 to 64 who were in the lowest wealth bracket (with financial holdings of $39,000 or less) faced a 48 percent risk for developing a disability and 17 percent risk for dying prematurely, the investigators found. By comparison, their peers in the highest bracket (with holdings equaling $560,000 or more) had a 15 percent disability risk and 5 percent premature death risk. The fact that people in England are guaranteed cradle-to-grave government-run health care coverage, while Americans are not, did not seem to have much effect. "We saw similar relationships in both the United States and England, which are two countries with very different health and social safety-net systems," explained Dr. Lena Makaroun, the study's lead author. "We also saw the same pattern for older adults, both above and below age 65," she said. Makaroun noted that in the United States, Medicare becomes available at age 65, and both countries also start dispensing retirement benefits in the form of U.S. Social Security and the State Pension in England around that age. "Seeing similar results in both countries, and in both age groups, suggests that [additional] health care or [additional] financial benefits later in life may not be enough" when it comes to trying to improve the health prospects of people who enter their later years in poor financial shape, said Makaroun. She is a research fellow with the VA Puget Sound Health Care System and the division of gerontology and geriatric medicine at the University of Washington in Seattle. For the study, the researchers focused on two groups of study participants -- those aged 54 to 64 ("middle aged"), and those aged 66 to 76. Each person's wealth status was calculated based on their total assets -- including real estate, vehicles, retirement savings and investment accounts -- minus their total debts. Disability status was assessed on the basis of whether participants could, on their own, get dressed, bathe, eat, get in and out of bed, and use the bathroom. The researchers determined that, in both countries, the poorest people in their mid-50s or older faced a "high" absolute risk for becoming disabled or dying early. That absolute risk did rise among the older group, relative to the middle-aged group. But in relative terms, the link between being in the poorest financial health and the poorest physical health, compared with the richest individuals, held steady across the 54-and-up age spectrum in both countries. Still, the study team also observed that even those who were only slightly better off than the poorest participants saw their health prognosis markedly improve. Makaroun stressed that the study could not prove that poverty actually causes early death or disability. But she suggested that main stressors associated with poverty -- such as unstable housing, trauma and sleep problems -- may take a toll. "And from our study it does not seem that universal health care alone can eliminate the inequalities in health outcomes for low-wealth individuals that we see," she said. Co-author of an accompanying editorial, Dr. Martin McKee, a professor of European public health with the London School of Hygiene & Tropical Medicine, suggested that the connection between higher wealth and better health could have a lot to do with empowerment. "Most poor people know what they should do to stay healthy," he explained. "However, if they are struggling with trying to hold down several poorly paid jobs, lack of child care, and debt, it is unrealistic to expect them to travel further and pay higher prices for healthy foods, to go to the gym, and the like." Having resources also "seems to give people a more positive outlook on life, seeing the value of investing in their future through healthy activities," McKee added. "Essentially, they see a point in investing for the long term, while those who see the future as just more pain, worry and misery don't." The study was published online Oct. 23 in JAMA Internal Medicine . SOURCES: Lena K. Makaroun, M.D., research fellow, VA Health Services Research & Development, VA Puget Sound Health Care System, division of gerontology and geriatric medicine, University of Washington, Seattle Martin McKee, M.D., D.Sc., professor, London School of Hygiene & Tropical Medicine, London, England Oct. 23, 2017, JAMA Internal Medicine , online HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Health Disparities Seniors' Health Recent Health News special


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every time More Evidence That Depression Shortens Lives provides you with

every time More Evidence That Depression Shortens Lives provides you with

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is very important (*this news item will not be available after 01/21/2018) Monday, October 23, 2017 MONDAY, Oct. 23, 2017 (HealthDay News) -- People with depression tend to die earlier than expected -- a pattern that has grown stronger among women in recent years, new research finds. The study followed thousands of Canadian adults between 1952 and 2011. Overall, it found people with depression had a higher death rate versus those without the mood disorder. The link only emerged among women starting in the 1990s. Yet by the end of the study, depression was affecting men's and women's longevity equally. The findings do not prove that depression itself shaves years off people's lives, said lead researcher Stephen Gilman. The study could not account for the effects of physical health conditions, for example. "So one explanation could be that people with depression were more likely to have a chronic condition," said Gilman, of the U.S. National Institute of Child Health and Human Development. But even if that were true, he added, it would not mean that depression bears no blame -- because depression can take a toll on physical health. "Many studies have found that people with depression have higher risks of heart disease and stroke, for example," Gilman said. The findings are based on 3,410 Canadian adults who were followed for up to several decades. The first wave of participants was interviewed in 1952, the next in 1970, and the final in 1992. At each wave, roughly 6 percent of adults had depression, based on a standard evaluation. And on average, those people had a shorter life span. For example, a 25-year-old man who was depressed in 1952 could expect to live another 39 years, on average. That compared with 51 years for a man without depression. Men with depression at any point had a higher risk of dying over the coming years, versus those free of the disorder. The picture was different for women, though. The connection between depression and mortality only surfaced in the 1990s. Women with depression at that point were 51 percent more likely to die by 2011, compared with other women. That brought their risk on par with depressed men. The reasons are unclear. "Why would depression be less toxic to women at one time point than another?" Gilman said. He speculated that societal shifts have some role. Women in recent decades have been much more likely to juggle work and home life, or be single mothers, for example. Another possibility, Gilman said, is that women tend to suffer more severe depression these days. There was some evidence that the impact of depression lessened over time. Men with depression in 1952 no longer showed a higher death risk after 1968, for example -- unless they also had depression at the later interviews, too. As for causes of death, there was no evidence that suicides explained the risks among people with depression. "There were actually few suicides," Gilman said. "People with depression died of the same causes that other people did -- like cardiovascular disease and cancer." Dr. Aaron Pinkhasov is chairman of behavioral health at NYU Winthrop Hospital in Mineola, N.Y. He said depression can indirectly shorten life span in a number of ways. Depressed people are less able to maintain a healthy lifestyle, and are more vulnerable to smoking and drinking. They may also be less equipped to manage any physical health conditions. "Once depression sets in, you may not have the motivation or energy," said Pinkhasov, who was not involved with the research. Gilman said his study can't say whether treating depression erases the higher death risk associated with it. But, Pinkhasov said, there is evidence that depression treatment can help people better control high blood pressure and diabetes, for example. He stressed that there are various effective treatments -- from "talk therapy" to medication. "Don't blame yourself for being 'weak,' or tell yourself you should just snap out of it," Pinkhasov said. John Hamilton, a counselor at Mountainside Treatment Center in Canaan, Conn., agreed. He said that women, in particular, can have a "sense of shame" over mental health symptoms in part because they feel they need to be the rock of the family. "They might even have people around them saying, 'Snap out of it, you have kids,'" said Hamilton, who also had no role in the study. "But depression is no different from any other chronic disease," he said. "We need to have a compassionate, nonjudgmental approach to it." The results were published Oct. 23 in the journal CMAJ . SOURCES: Stephen Gilman, Sc.D., acting chief, health behavior branch, U.S. National Institute of Child Health and Human Development, Bethesda, Md.; Aaron Pinkhasov, M.D., chairman, behavioral health, NYU Winthrop Hospital, Mineola, N.Y., and associate professor, clinical psychiatry, Stony Brook University School of Medicine, Stony Brook, N.Y.; John Hamilton, L.M.F.T., L.A.D.C., chief clinical outreach officer, Mountainside Treatment Center, Canaan, Conn.; Oct. 23, 2017, CMAJ , online HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Depression Recent Health News to the doorstep


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before Sivextro Tablets Generic Name: Tedizolid Tablets (ted-eye-ZOE-lid) Brand Name: Sivextro Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Pricing & Coupons Uses of Sivextro: It is used to treat bacterial infections. What do I need to tell my doctor BEFORE I take Sivextro? If you have an allergy to Sivextro (tedizolid tablets) or any part of this medicine. If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs. If you have a low white blood cell count. This is not a list of all drugs or health problems that interact with Sivextro. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. Slideshow Flagyl Side Effects and What You Can Do About Them What are some things I need to know or do while I take Sivextro? Tell all of your health care providers that you take Sivextro. This includes your doctors, nurses, pharmacists, and dentists. Do not use longer than you have been told. A second infection may happen. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby. How is this medicine (Sivextro) best taken? Use Sivextro as ordered by your doctor. Read all information given to you. Follow all instructions closely. Take with or without food. To gain the most benefit, do not miss doses. Keep taking this medicine as you have been told by your doctor or other health care provider, even if you feel well. What do I do if I miss a dose? Take a missed dose as soon as you think about it. If it is less than 8 hours until your next dose, skip the missed dose and go back to your normal time. Do not take 2 doses at the same time or extra doses. Dosage Information (comprehensive) What are some side effects that I need to call my doctor about right away? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. It is common to have diarrhea when taking Sivextro. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff) associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking this medicine or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor. What are some other side effects of Sivextro? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Loose stools (diarrhea). Dizziness. Headache. Upset stomach or throwing up. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. Side Effects (complete list) If OVERDOSE is suspected: If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. How do I store and/or throw out Sivextro? Store at room temperature. Store in a dry place. Do not store in a bathroom. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Check with your pharmacist about how to throw out unused drugs. Consumer Information Use and Disclaimer If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor. Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Sivextro, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sivextro. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Sivextro (tedizolid tablets). Review Date: November 1, 2017 Next Side Effects Print this page Add to My Med List More about Sivextro (tedizolid) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Espaรฑol 0 Reviews Add your own review/rating Drug class: oxazolidinone antibiotics Consumer resources Sivextro Sivextro oral/injection Sivextro (Tedizolid Injection) Sivextro (Advanced Reading) Sivextro Intravenous (Advanced Reading) Professional resources Sivextro (AHFS Monograph) Sivextro (FDA) Sivextro tablet, film coated; lyophilized powder for injection (FDA) Related treatment guides Skin and Structure Infection Bacterial Infection Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug 3 years Approval History FDA approved 2014 Sivextro Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Manufacturer Merck & Co., Inc. Drug Class Oxazolidinone antibiotics Related Drugs Skin and Structure Infection ciprofloxacin , azithromycin , Augmentin , Zithromax , cefdinir , ceftriaxone , cefuroxime , mupirocin topical , Rocephin , Bactroban , Ceftin , More... Bacterial Infection ciprofloxacin , amoxicillin , azithromycin , doxycycline , cephalexin , metronidazole , Augmentin , Zithromax , Levaquin , Keflex , levofloxacin , More... borderless


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nevertheless (*this news item will not be available after 01/21/2018) Monday, October 23, 2017 MONDAY, Oct. 23, 2017 (HealthDay News) -- Medical marijuana appears to hold only limited promise for sick children and teenagers, a new review suggests. It can help kids fighting cancer with chemotherapy-related nausea and vomiting, and it can control seizures somewhat in children with epilepsy, said study author Dr. Shane Shucheng Wong. He is a psychiatrist with Massachusetts General Hospital, in Boston. But there's not enough evidence to say that medical marijuana can help kids with any other medical conditions, such as neuropathic pain, post-traumatic stress disorder (PTSD) or Tourette's syndrome, Wong added. Medical marijuana is now legal in 29 states and the District of Columbia, making it potentially available as a medication for kids. "Children and adolescents can legally access medical cannabis if they have certification from a doctor and from their legal guardian," Wong said. "As a result, doctors and families really need to understand what we know and what we don't yet know about medical cannabis to make the best decision for the child's health." A review of medical literature revealed 21 studies directly examining the potential benefits of medical pot for children and teens, the researchers said. These included six studies on the impact pot has on chemotherapy-induced nausea and vomiting, and 11 studies on epilepsy. Studies involving pot's usefulness in controlling chemotherapy side effects -- four of which were randomized, controlled trials -- found that medical cannabis was significantly better than anti-nausea drugs, according to the review. The active intoxicating ingredient in pot, THC, appears to reduce nausea and vomiting in these young patients, the trials showed. Since 1985, there have been two drugs approved by the U.S. Food and Drug Administration to treat chemo side effects that are forms of synthetic THC, Wong said. The drugs are dronabinol (Marinol) and nabilone (Cesamet). The epilepsy studies, which included one randomized trial, showed that another chemical compound in pot called cannabidiol (CBD) appears to reduce the frequency of seizures in children and teens. CBD does not cause intoxication. An epilepsy drug based on CBD, Epidiolex, is currently in fast-track phase 3 trials "to try to show enough scientific evidence to support its use for potential [FDA] approval," Wong said. "It certainly is promising." Research is lacking on any other uses for medical marijuana in children and teenagers, the researchers concluded. Studies to see whether medical pot could help treat other conditions all lacked control groups and other gold-standard research procedures, "so they were at very high risk of bias," Wong explained. Even though there seem to be some good uses for medical pot, doctors and families need to weigh potential negative effects in treating children and teens with marijuana, Wong noted. "Particularly frequent use of high-potency THC over extended periods of time suggests negative effects on learning, memory, attention and problem-solving ability," Wong said. "Children's brains are really actively developing, and so they seem to be much more vulnerable to the potential negative effects of cannabis for cognition than adults." Other side effects can include drowsiness, dizziness, changes in mood and appetite, diarrhea and, in some cases, actually causing seizures to grow worse, Wong said. And, according to Dr. Kashmira Rustomji, there's also some concern that kids who use medical pot might feel more comfortable later using it to get high. Rustomji is an assistant professor of pediatrics and psychiatry with the Icahn School of Medicine at Mount Sinai in New York City. "The danger in legalizing marijuana and making it available to kids is that the perspective from young people might be, 'It's medically OK to use, so it should be OK to use it recreationally as well,' " she said. "My perspective is that there is some good evidence for some medical uses of marijuana, but we don't have enough pediatric data," Rustomji continued. "We still need to do a lot of other pediatric studies and randomized controlled studies to see where there is good long-term data for these uses." The review was published online Oct. 23 in the journal Pediatrics . SOURCES: Shane Shucheng Wong, M.D., a psychiatrist, Massachusetts General Hospital, Boston; Kashmira Rustomji, M.D., MPH, assistant professor, pediatrics and psychiatry, Icahn School of Medicine at Mount Sinai, New York City; Oct. 23, 2017, Pediatrics , online HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Children's Health Marijuana Recent Health News most useful


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footslogging away Sivextro (Injection) Generic Name: Tedizolid Injection (ted-eye-ZOE-lid) Brand Name: Sivextro Overview Side Effects Dosage Professional Interactions More Pregnancy Warnings User Reviews Support Group Q & A Pricing & Coupons Uses of Sivextro: It is used to treat bacterial infections. What do I need to tell my doctor BEFORE I take Sivextro? If you have an allergy to Sivextro (tedizolid injection) or any part of this medicine. If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs. If you have a low white blood cell count. This is not a list of all drugs or health problems that interact with Sivextro. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. Slideshow Think Before You Ink: Health Risks Associated With Tattoos What are some things I need to know or do while I take Sivextro? Tell all of your health care providers that you take Sivextro. This includes your doctors, nurses, pharmacists, and dentists. Do not use longer than you have been told. A second infection may happen. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby. How is this medicine (Sivextro) best taken? Use Sivextro as ordered by your doctor. Read all information given to you. Follow all instructions closely. It is given as an infusion into a vein over a period of time. What do I do if I miss a dose? Call your doctor to find out what to do. Dosage Information (comprehensive) What are some side effects that I need to call my doctor about right away? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. It is common to have diarrhea when taking this medicine. Rarely, a very bad form of diarrhea called Clostridium difficile (C diff) associated diarrhea (CDAD) may occur. Sometimes, this has led to a deadly bowel problem (colitis). CDAD may happen while you are taking Sivextro or within a few months after you stop taking it. Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat loose stools without first checking with your doctor. What are some other side effects of Sivextro? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Loose stools (diarrhea). Dizziness. Headache. Upset stomach or throwing up. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. Side Effects (complete list) If OVERDOSE is suspected: If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. How do I store and/or throw out Sivextro? If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it. Consumer Information Use and Disclaimer If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor. Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Check with your pharmacist about how to throw out unused drugs. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Sivextro, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Sivextro. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Sivextro (tedizolid injection). Review Date: November 1, 2017 Next Side Effects Print this page Add to My Med List More about Sivextro (tedizolid) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Espaรฑol 0 Reviews Add your own review/rating Drug class: oxazolidinone antibiotics Consumer resources Sivextro Sivextro oral/injection Sivextro (Tedizolid Tablets) Sivextro (Advanced Reading) Sivextro Intravenous (Advanced Reading) Professional resources Sivextro (AHFS Monograph) Sivextro (FDA) Sivextro tablet, film coated; lyophilized powder for injection (FDA) Related treatment guides Skin and Structure Infection Bacterial Infection Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Sivextro Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Manufacturer Merck & Co., Inc. Drug Class Oxazolidinone antibiotics Related Drugs Skin and Structure Infection ciprofloxacin , azithromycin , Augmentin , Zithromax , cefdinir , ceftriaxone , cefuroxime , mupirocin topical , Rocephin , Bactroban , Ceftin , More... Bacterial Infection ciprofloxacin , amoxicillin , azithromycin , doxycycline , cephalexin , metronidazole , Augmentin , Zithromax , Levaquin , Keflex , levofloxacin , More... top-rated


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the medication (*this news item will not be available after 01/21/2018) By Robert Preidt Monday, October 23, 2017 MONDAY, Oct. 23, 2017 (HealthDay News) -- A single company dominates the health insurance market in many U.S. cities -- and that dangerous trend is increasing, according to a new American Medical Association (AMA) report. Analyzing 2016 data, researchers found that in 43 percent of 389 cities, just one health insurer had at least a 50 percent share of the market. That compares with 40 percent of cities in 2014. Moreover, 69 percent of health insurance markets in those 389 cities were "highly concentrated" in 2016, meaning there was a significant lack of competition. Anthem commanded the market in 82 of the cities examined, followed by Health Care Service Corp. (42 cities) and UnitedHealth Group (26 cities). Highly concentrated health insurance markets lead to higher patient premiums, according to the AMA. The report aims to draw the attention of policymakers and regulators to specific markets where lack of competition may harm patients and the doctors treating them. "After years of largely unchallenged consolidation in the health insurance industry, a few recent attempts to consolidate have received closer scrutiny than in the past, including the proposed mergers of Anthem and Cigna, as well as Aetna and Humana," said AMA President Dr. David Barbe. "Previous versions of the AMA study played a key role in efforts to block the proposed mega-mergers by helping federal and state antitrust regulators identify markets where those mergers would cause anti-competitive harm," Barbe noted in an AMA news release. In the current report, the 10 states with the least competitive commercial health insurance markets are: Alabama, Delaware, Hawaii, South Carolina, Louisiana, Michigan, Kentucky, Vermont, Alaska and Illinois. In 27 states, the commercial health insurance market became more concentrated between 2014 and 2016. The 10 states with the largest increases in market concentration during that time were: Kentucky, Alaska, South Carolina, Mississippi, South Dakota, Oklahoma, Vermont, Arkansas, Nevada and New Mexico. SOURCE: American Medical Association, news release, Oct. 23, 2017 HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Health Insurance Recent Health News persistent


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they bring about Skeeter Stik Generic Name: Benzocaine and Menthol Topical Liquid (BEN zoe kane & MEN thole) Brand Name: Skeeter Stik Overview Side Effects Interactions Reviews Q & A More Uses of Skeeter Stik: It is used to relieve itching and pain from insect bites or skin irritation. Slideshow Sore Throat Remedies And Treatments What do I need to tell my doctor BEFORE I take Skeeter Stik? If you have an allergy to Skeeter Stik (benzocaine and menthol topical liquid) or any part of this medicine. If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs. This medicine may interact with other drugs or health problems. Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Skeeter Stik with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. What are some things I need to know or do while I take Skeeter Stik? Tell all of your health care providers that you take this medicine. This includes your doctors, nurses, pharmacists, and dentists. This medicine may cause harm if swallowed. If Skeeter Stik is swallowed, call a doctor or poison control center right away. Different brands of this medicine may be for use in different ages of children. Talk with the doctor before giving Skeeter Stik to a child. Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant. Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby. How is this medicine (Skeeter Stik) best taken? Use Skeeter Stik as ordered by your doctor. Read all information given to you. Follow all instructions closely. Follow how to use as you have been told by the doctor or read the package insert. Do not take this medicine by mouth. Use on your skin only. Keep out of your mouth, nose, ears, and eyes (may burn). Do not use large amounts of Skeeter Stik. Do not use over a large area, raw skin, or blisters. Talk with the doctor. Wash hands before and after use. Clean affected part before use. Make sure to dry well. Put a thin layer on the affected skin and rub in gently. What do I do if I miss a dose? If you use this medicine on a regular basis, put on a missed dose as soon as you think about it. If it is close to the time for your next dose, skip the missed dose and go back to your normal time. Do not put on 2 doses at the same time or extra doses. Many times Skeeter Stik is used on an as needed basis. Do not use more often than told by the doctor. What are some side effects that I need to call my doctor about right away? WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect: Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat. Very bad skin irritation. What are some other side effects of Skeeter Stik? All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away: Skin irritation. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch. Side Effects (complete list) If OVERDOSE is suspected: If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. How do I store and/or throw out Skeeter Stik? Store at room temperature. Store in a dry place. Do not store in a bathroom. Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets. Check with your pharmacist about how to throw out unused drugs. Consumer Information Use and Disclaimer If your symptoms or health problems do not get better or if they become worse, call your doctor. Do not share your drugs with others and do not take anyone else's drugs. Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor. Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins. Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened. This information should not be used to decide whether or not to take Skeeter Stik (benzocaine and menthol topical liquid) or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Skeeter Stik. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine. Review Date: November 1, 2017 Next Side Effects Print this page Add to My Med List More about benzocaine/menthol topical Side Effects Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: mouth and throat products Consumer resources Benzocaine and Menthol Aerosol Benzocaine and Menthol Pads and Swabs Benzocaine and Menthol Strips Benzocaine and Menthol Topical Liquid Benzocaine/Menthol Lozenges Other brands: Cepacol Sore Throat , Chloraseptic Sore Throat Lozenges Related treatment guides Sore Throat Tonsillitis/Pharyngitis Drug Status OTC Availability Over the counter N Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Benzocaine / menthol topical Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! Drug Class Mouth and throat products Related Drugs Sore Throat menthol topical , benzocaine topical , Cepacol Sore Throat , phenol topical , Chloraseptic Sore Throat Spray , Cepacol Ultra , Chloraseptic Sore Throat Lozenges , Trocaine , dyclonine topical , Assure Sore Throat , Vicks Cough Drops , More... Tonsillitis / Pharyngitis amoxicillin , azithromycin , Zithromax , cefdinir , cefuroxime , Ceftin , clarithromycin , Amoxil , Biaxin , Omnicef , Penicillin VK , More... Related: Sore Throat (Pharyngitis) superior


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benefiting from (*this news item will not be available after 01/21/2018) By Robert Preidt Monday, October 23, 2017 MONDAY, Oct. 23, 2017 (HealthDay News) -- Avoid the stuffed animals at your pediatrician's office. Or better yet, take your own playthings when your child has a doctor's appointment. That's one of the tips in updated guidelines from the American Academy of Pediatrics (AAP) to prevent the spread of germs in doctors' offices. The guidelines say waiting rooms should not have plush toys, which can harbor germs and are difficult to clean. Instead, parents should bring toys from home for their children. Infection control in doctors' offices or other outpatient locations should be as strict as in hospitals, according to the academy. Cough and sneeze etiquette and hand hygiene are key measures for curbing infections. Pediatricians should post visual reminders for people to cover their nose and mouth with their elbows rather than their hands when coughing and sneezing, and to properly dispose of tissues, the AAP advises. Also, waiting rooms should contain alcohol-based sanitizers and masks. The group also recommends required annual flu vaccination for doctors' office personnel. And employees should provide documentation of immunity or immunization against other vaccine-preventable infections, including whooping cough, measles, mumps, rubella, chickenpox and hepatitis B. In addition, special precautions should be taken for cystic fibrosis patients, the academy said. Because their lungs are especially vulnerable to drug-resistant bacterial infections, they should be taken directly into an exam room and not left in the waiting room. The guidelines were published online Oct. 23 in the journal Pediatrics . SOURCE: American Academy of Pediatrics, news release, Oct. 23, 2017 HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Children's Health Health Facilities Recent Health News workers


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prescription drugs (*this news item will not be available after 01/21/2018) By Robert Preidt Monday, October 23, 2017 MONDAY, Oct. 23, 2017 (HealthDay News) -- Teens who vape e-cigarettes with higher nicotine levels are more likely to start smoking conventional cigarettes soon after, new research shows. "We know that teens who vape e-cigarettes are much more likely to become conventional cigarette smokers," said study lead researcher Adam Leventhal. "Our study suggests that the nicotine in e-cigarettes may be a key reason why teens who vape progress to more frequent smoking." Leventhal directs the University of Southern California Health, Emotion and Addiction Laboratory at the Keck School of Medicine in Los Angeles. E-cigarettes are sold with nicotine levels ranging from zero to more than 25 milligrams of nicotine per milliliter (mg/mL). In this study, a high-nicotine device was defined as having levels at or above 18 mg/mL. Leventhal's team tracked outcomes for 181 grade-10 students from high schools in the Los Angeles area. All of the teens said they had used e-cigarettes within the past month, and they provided data on nicotine levels in the devices they used. Six months later, those who used higher nicotine levels in their e-cigarettes were more likely to report use of both e-cigarettes and regular cigarettes within the past month. These teens also reported vaping and/or smoking more intensely. While 43 percent of the students who'd used high-nicotine e-cigarettes said they were "frequent smokers" of traditional cigarettes six months later, that was true for only 10 percent of those who'd vaped using lower-nicotine devices, Leventhal's group found. And teens who vaped using high-nicotine e-cigarettes smoked an average of 14 times as many "regular" cigarettes per day six months later compared to those who'd tried nicotine-free versions of the devices, the findings showed. More kids are trying high-nicotine e-cigarettes nowadays, Leventhal noted. "While previous research reported that most adolescents were using nicotine-free e-cigarettes, results from our survey and other soon-to-be published studies show that many more teens are vaping e-cigarettes with nicotine than we originally thought," he said in a university news release. Two anti-smoking advocates weren't surprised by the findings. "Vaping nicotine through e-cigarettes -- especially at higher concentrations -- is associated with continued vaping and with smoking traditional cigarettes," said Dr. Len Horovitz, a pulmonary specialist at Lenox Hill Hospital in New York City. Patricia Folan is a nurse who directs the Center for Tobacco Control at Northwell Health in Great Neck, N.Y. She said that this, and other research, "highlights the imperative for the U.S. Food and Drug Administration to regulate these devices, including the amount of nicotine in these products and proper labeling of their content." Folan warned that "vaping has the potential to addict a new generation, which might not otherwise have experimented with traditional cigarettes, to nicotine. If these devices are not regulated and this trend goes unchecked, we will most likely see an increase in smoking rates among youth." E-cigarettes are available in a wide variety of nicotine concentrations. Recently, the FDA was given regulatory power over e-cigarette solutions containing nicotine. The study was published Oct. 23 in the journal JAMA Pediatrics . SOURCES: Len Horovitz, M.D., pulmonary specialist, Lenox Hill Hospital, New York City; Patricia Folan, R.N., DNP, director, Center for Tobacco Control, Northwell Health, Great Neck, N.Y.; University of Southern California, news release, Oct. 23, 2017 HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on E-Cigarettes Smoking and Youth Recent Health News most effective


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hit upon 11th ed. CLSI document M2 A11 (ISBN 1-56238-781-2 [Print]; ISBN 1-56238-782-0 [Electronic]). Clinical and Laboratory Standards Institute is attempting

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cashing in on Keeping Your Driving Teen Focused on the Road cures

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political views (*this news item will not be available after 01/22/2018) Tuesday, October 24, 2017 TUESDAY, Oct. 24, 2017 (HealthDay News) -- A 17-year-old Minnesota teen runs a red light, killing a father and his 10-year-old daughter. A 16-year-old Missouri girl -- her driver's license only days old -- dies when she turns onto a road and is slammed by a tractor-trailer. A 16-year-old Maine teen breaks her neck after crashing her vehicle. What do all of these recent tragedies have in common? The young drivers had all been suspected of texting while behind the wheel. The problem of distracted driving among teens continues, with public service campaigns aiming a spotlight on the issue to raise awareness among teenagers and their parents. "Distraction is really something that's no surprise, since teens are connected to their cellphones," said Rich Romer. He's state relations manager for the American Automobile Association in Washington, D.C. "But we've found that while only 6 percent of teens ages 16 to 18 say it's acceptable to text or email while driving ... 34 percent have sent one while driving in the last month," Romer added. "This 'do-as-I-say, not-as-I-do' culture permeates all the way down to our youth." Motor vehicle crashes are the leading cause of death among teenagers in the United States, according to the U.S. National Highway Traffic Safety Administration (NHTSA). Distracted driving claimed 3,450 lives in 2016 alone, with teen drivers accounting for the highest percentage of all drivers reported as distracted at the time of the fatal crash. Another 400,000 people were injured in distracted driving incidents in 2015. Other startling statistics: According to TeenSafe, a smartphone control and monitoring service for parents, texting while driving raises a teenager's risk for having an auto accident by 400 percent. And 40 percent of teens have said they were passengers in a car while the driver -- who may have included their own parent -- was using his or her smartphone. But a 2016 AAA Foundation for Traffic Safety study revealed that the top distraction for teen drivers isn't their cellphone, but the presence of other passengers, who often are teenage friends. Other passengers accounted for 15 percent of teen driver accidents, according to the research, while 12 percent stemmed from texting or talking on a smartphone. "All distractions aren't electronic," said Russ Martin, director of government relations for the Governors Highway Safety Association in Washington, D.C. "Distraction comes in many forms." Texting is considered especially perilous because it involves using the eyes, hands and brain at the same time. Drivers who send and receive text messages take their eyes off the road for about five seconds. At 55 miles per hour, that's equivalent to driving the length of a football field with eyes closed, according to the NHTSA. "We have to imagine that the amount of attention we're bringing to this issue is getting through to some teenagers, [but] the problem is it's hard to accurately measure," Martin said. "It's very difficult to get the data. Drivers don't always admit they're distracted, there may not be witnesses, and sometimes there's no evidence to clue a police officer into it." One anti-distraction measure some parents employ includes pay-for-service apps that help monitor teen driver activities or shut down cellphone use while driving. TeenSafe produced the iPhone TeenSafe Control App, which pauses and schedules app, data and phone use to protect teens against distracted driving. Similar smartphone apps include Canary, which notifies parents of unsafe driving practices; DriveSmart, which mutes incoming texts and sends calls directly to voicemail; and DriveScribe, which monitors teen driving and rewards safe driving habits. But Romer cautioned parents against relying solely on apps and other technological solutions to protect their children. "They may be of some assistance, but really, the best countermeasure we would recommend are involved parents," he said. "Research has shown that involved parents who do supervised practice driving, sign a parent-teen agreement [detailing driving rules], and parents who set good examples can really reduce crashes and violations among teen drivers," Romer added. Romer, Martin, the NHTSA and TeenSafe offered these tips to parents to help their teen drivers avoid distractions: Talk to your teen about the responsibility of safe driving, impressing upon him or her that the odds are against teen drivers surviving a crash when driving while distracted. Put your own phone down while driving, especially when your teen is in the car and watching you. Turn off the radio when teen drivers are first learning how to drive. Loud music can be very distracting while learning the basics. Set specific consequences if a teen driver doesn't follow the rules. SOURCES: Rich Romer, state relations manager, American Automobile Association, Washington, D.C.; Russ Martin, director, government relations, Governors Highway Safety Association, Washington, D.C. HealthDay Copyright (c) 2017 HealthDay . All rights reserved. News stories are written and provided by HealthDay and do not reflect federal policy, the views of MedlinePlus, the National Library of Medicine, the National Institutes of Health, or the U.S. Department of Health and Human Services. More Health News on Impaired Driving Motor Vehicle Safety Teen Health Recent Health News sensible


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there isn't [1000:<75% (> <50% for absolute neutrophil count) of lower limit of normal (LLN) for values normal at baseline Represents lowest abnormal post-baseline value through the last dose of active drug Number of patients with non-missing laboratory values Hemoglobin (> <10.1 g/dL [M]) (> <9 g/dL [F]) 3.1% 3.7% Platelet count (> <112 10 3 /mm 3 ) 2.3% 4.9% Absolute neutrophil count (> <0.8 10 3 /mm 3 ) 0.5% 0.6% Myelosuppression Phase 1 studies conducted in healthy adults exposed to Sivextro for 21 days showed a possible dose and duration effect on hematologic parameters beyond 6 days of treatment. In the Phase 3 trials, clinically significant changes in these parameters were generally similar for both treatment arms (see Table 3 ). Peripheral and Optic Neuropathy Peripheral and optic neuropathy have been described in patients treated with another member of the oxazolidinone class for longer than 28 days. In Phase 3 trials, reported adverse reactions for peripheral neuropathy and optic nerve disorders were similar between both treatment arms (peripheral neuropathy 1.2% vs. 0.6% for tedizolid phosphate and linezolid, respectively; optic nerve disorders 0.3% vs. 0.2%, respectively). No data are available for patients exposed to Sivextro for longer than 6 days. Drug Interactions Orally administered Sivextro inhibits Breast Cancer Resistance Protein (BCRP) in the intestine, which can increase the plasma concentrations of orally administered BCRP substrates, and the potential for adverse reactions. If possible, an interruption in the treatment of the co-administered BCRP substrate medicinal product should be considered during treatment with Sivextro, especially for BCRP substrates with a narrow therapeutic index (e.g., methotrexate or topotecan). If coadministration cannot be avoided, monitor for adverse reactions related to the concomitantly administered BCRP substrates, including rosuvastatin. [ See Clinical Pharmacology (12.3) . ] USE IN SPECIFIC POPULATIONS Pregnancy Pregnancy Category C There are no adequate and well-controlled studies of Sivextro in pregnant women. Sivextro should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. In embryo-fetal studies, tedizolid phosphate was shown to produce fetal developmental toxicities in mice, rats, and rabbits. Fetal developmental effects occurring in mice in the absence of maternal toxicity included reduced fetal weights and an increased incidence of costal cartilage anomalies at the high dose of 25 mg/kg/day (4-fold the estimated human exposure level based on AUCs). In rats, decreased fetal weights and increased skeletal variations including reduced ossification of the sternebrae, vertebrae, and skull were observed at the high dose of 15 mg/kg/day (6-fold the estimated human exposure based on AUCs) and were associated with maternal toxicity (reduced maternal body weights). In rabbits, reduced fetal weights but no malformations or variations were observed at doses associated with maternal toxicity. The no observed adverse effect levels (NOAELs) for fetal toxicity in mice (5 mg/kg/day), maternal and fetal toxicity in rats (2.5 mg/kg/day), and rabbits (1 mg/kg/day) were associated with tedizolid plasma area under the curve (AUC) values approximately equivalent to (mice and rats) or 0.04-fold (rabbit) the tedizolid AUC value associated with the oral human therapeutic dose. In a pre-postnatal study, there were no adverse maternal or offspring effects when female rats were treated during pregnancy and lactation with tedizolid phosphate at the highest tested dose of 3.75 mg/kg/day, with plasma tedizolid exposure (AUC) approximately equivalent to the human plasma AUC exposure at the clinical dose of 200 mg/day. Nursing Mothers Tedizolid is excreted in the breast milk of rats. It is not known whether tedizolid is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sivextro is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients below the age of 18 have not been established. Geriatric Use Clinical studies of Sivextro did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No overall differences in pharmacokinetics were observed between elderly subjects and younger subjects. Overdosage In the event of overdosage, Sivextro should be discontinued and general supportive treatment given. Hemodialysis does not result in meaningful removal of tedizolid from systemic circulation. Sivextro Description Sivextro (tedizolid phosphate), a phosphate prodrug, is converted to tedizolid in the presence of phosphatases. Tedizolid phosphate has the chemical name [(5 R )-(3-3-Fluoro-4-[6-(2-methyl-2 H -tetrazol- 5-yl) pyridin-3-yl]phenyl-2-oxooxazolidin- 5-yl]methyl hydrogen phosphate. Its empirical formula is C 17 H 16 FN 6 O 6 P and its molecular weight is 450.32. Its structural formula is: Tedizolid phosphate is a white to yellow solid and is administered orally or by intravenous infusion. The pharmacologically active moiety, tedizolid, is an antibacterial agent of the oxazolidinone class. Sivextro tablets contain 200 mg of tedizolid phosphate, and the following inactive ingredients: microcrystalline cellulose, mannitol, crospovidone, povidone, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol/macrogol, talc, and yellow iron oxide. Sivextro for injection is a sterile, white to off-white sterile lyophilized powder for injection in single-use vials of 200 mg. The inactive ingredients are mannitol (105 mg), sodium hydroxide, and hydrochloric acid, which is used in minimal quantities for pH adjustment. Sivextro - Clinical Pharmacology Mechanism of Action Tedizolid phosphate is the prodrug of tedizolid, an antibacterial agent [ see Clinical Pharmacology (12.3) , (12.4) ]. Pharmacodynamics The AUC/minimum inhibitory concentration (MIC) was shown to best correlate with tedizolid activity in animal infection models. In the mouse thigh infection model of S. aureus , antistaphylococcal killing activity was impacted by the presence of granulocytes. In granulocytopenic mice (neutrophil count> <100 cells/mL), bacterial stasis was achieved at a human-equivalent dose of approximately 2000 mg/day; whereas, in non-granulocytopenic animals, stasis was achieved at a human-equivalent dose of approximately 100 mg/day. The safety and efficacy of Sivextro for the treatment of neutropenic patients (neutrophil counts> <1000 cells/mm 3 ) have not been evaluated. Cardiac Electrophysiology In a randomized, positive- and placebo-controlled crossover thorough QTc study, 48 enrolled subjects were administered a single oral dose of Sivextro at a therapeutic dose of 200 mg, Sivextro at a supratherapeutic dose of 1200 mg, placebo, and a positive control; no significant effects of Sivextro on heart rate, electrocardiogram morphology, PR, QRS, or QT interval were detected. Therefore, Sivextro does not affect cardiac repolarization. Pharmacokinetics Tedizolid phosphate is a prodrug that is converted by phosphatases to tedizolid, the microbiologically active moiety, following oral and intravenous administration. Only the pharmacokinetic profile of tedizolid is discussed further due to negligible systemic exposure of tedizolid phosphate following oral and intravenous administration. Following multiple once-daily oral or intravenous administration, steady-state concentrations are achieved within approximately three days with tedizolid accumulation of approximately 30% (tedizolid half-life of approximately 12 hours). Pharmacokinetic (PK) parameters of tedizolid following oral and intravenous administration of 200 mg once daily tedizolid phosphate are shown in Table 4. Table 4: Mean (Standard Deviation) Tedizolid Pharmacokinetic Parameters Following Single and Multiple Oral and Intravenous Administration of 200 mg Once-Daily Tedizolid Phosphate Pharmacokinetic Parameters of Tedizolid * Oral Intravenous Single Dose Steady State Single Dose Steady State * C max , maximum concentration; T max , time to reach C max ; AUC, area under the concentration-time curve; CL, systemic clearance; CL/F, apparent oral clearance Median (range) AUC is AUC 0- (AUC from time 0 to infinity) for single-dose administration and AUC 0-24 (AUC from time 0 to 24 hours) for multiple-dose administration C max (mcg/mL) 2.0 (0.7) 2.2 (0.6) 2.3 (0.6) 3.0 (0.7) T max (hr) 2.5 (1.0 - 8.0) 3.5 (1.0 - 6.0) 1.1 (0.9 - 1.5) 1.2 (0.9 - 1.5) AUC (mcg hr/mL) 23.8 (6.8) 25.6 (8.4) 26.6 (5.2) 29.2 (6.2) CL or CL/F (L/hr) 6.9 (1.7) 8.4 (2.1) 6.4 (1.2) 5.9 (1.4) Absorption Peak plasma tedizolid concentrations are achieved within approximately 3 hours following oral administration under fasting conditions or at the end of the 1 hour intravenous infusion of tedizolid phosphate. The absolute bioavailability is approximately 91% and no dosage adjustment is necessary between intravenous and oral administration. Tedizolid phosphate (oral) may be administered with or without food as total systemic exposure (AUC 0- ) is unchanged between fasted and fed (high-fat, high-calorie) conditions. Distribution Protein binding of tedizolid to human plasma proteins is approximately 70 to 90%. The mean steady state volume of distribution of tedizolid in healthy adults following a single intravenous dose of tedizolid phosphate 200 mg ranged from 67 to 80 L (approximately twice total body water). Tedizolid penetrates into the interstitial space fluid of adipose and skeletal muscle tissue with exposure similar to free drug exposure in plasma. Metabolism Other than tedizolid, which accounts for approximately 95% of the total radiocarbon AUC in plasma, there are no other significant circulating metabolites in humans. There was no degradation of tedizolid in human liver microsomes indicating tedizolid is unlikely to be a substrate for hepatic CYP450 enzymes. In vitro studies showed that conjugation of tedizolid is mediated via multiple sulfotransferase (SULT) isoforms (SULT1A1, SULT1A2, and SULT2A1). Excretion Following single oral administration of 14 C-labeled tedizolid phosphate under fasted conditions, the majority of elimination occurred via the liver, with 82% of the radioactive dose recovered in feces and 18% in urine, primarily as a non-circulating and microbiologically inactive sulfate conjugate. Most of the elimination of tedizolid (> 85%) occurs within 96 hours. Less than 3% of the tedizolid phosphate-administered dose is excreted in feces and urine as unchanged tedizolid. Specific Populations Based on the population pharmacokinetic analysis, there are no clinically relevant demographic or clinical patient factors (including age, gender, race, ethnicity, weight, body mass index, and measures of renal or liver function) that impact the pharmacokinetics of tedizolid. Hepatic Impairment Following administration of a single 200 mg oral dose of Sivextro, no clinically meaningful changes in mean tedizolid C max and AUC 0- were observed in patients with moderate (n=8) or severe (n=8) hepatic impairment (Child-Pugh Class B and C) compared to 8 matched healthy control subjects. No dose adjustment is necessary for patients with hepatic impairment. Renal Impairment Following administration of a single 200 mg intravenous dose of Sivextro to 8 subjects with severe renal impairment defined as eGFR <30 mL/min/1.73 m 2 , the C max was essentially unchanged and AUC 0- was decreased by less than 10% compared to 8 matched healthy control subjects. Hemodialysis does not result in meaningful removal of tedizolid from systemic circulation, as assessed in subjects with end-stage renal disease (eGFR> <15 mL/min/1.73 m 2 ). No dosage adjustment is necessary in patients with renal impairment or patients on hemodialysis. Geriatric Patients The pharmacokinetics of tedizolid were evaluated in a Phase 1 study conducted in elderly healthy volunteers (age 65 years and older, with at least 5 subjects at least 75 years old; n=14) compared to younger control subjects (25 to 45 years old; n=14) following administration of a single oral dose of Sivextro 200 mg. There were no clinically meaningful differences in tedizolid C max and AUC 0- between elderly subjects and younger control subjects. No dosage adjustment of Sivextro is necessary in elderly patients. Gender The impact of gender on the pharmacokinetics of Sivextro was evaluated in clinical trials of healthy males and females and in a population pharmacokinetics analysis. The pharmacokinetics of tedizolid were similar in males and females. No dosage adjustment of Sivextro is necessary based on gender. Drug Interaction Studies Drug Metabolizing Enzymes Transformation via Phase 1 hepatic oxidative metabolism is not a significant pathway for elimination of Sivextro. Neither Sivextro nor tedizolid detectably inhibited or induced the metabolism of selected CYP enzyme substrates, suggesting that drug-drug interactions based on oxidative metabolism are unlikely. Membrane Transporters The potential for tedizolid or tedizolid phosphate to inhibit transport of probe substrates of important drug uptake (OAT1, OAT3, OATP1B1, OATP1B3, OCT1, and OCT2) and efflux transporters (P-gp and BCRP) was tested in vitro . No clinically relevant interactions are expected to occur with these transporters except BCRP. Coadministration of multiple oral doses of Sivextro (200 mg once daily) increased the Cmax and AUC of rosuvastatin (10 mg single oral dose), a known BCRP substrate, by approximately 55% and 70%, respectively, in healthy subjects [ see Drug Interactions (7) ]. Monoamine Oxidase Inhibition Tedizolid is a reversible inhibitor of monoamine oxidase (MAO) in vitro . The interaction with MAO inhibitors could not be evaluated in Phase 2 and 3 trials, as subjects taking such medications were excluded from the trials. Adrenergic Agents Two placebo-controlled crossover studies were conducted to assess the potential of 200 mg oral Sivextro at steady state to enhance pressor responses to pseudoephedrine and tyramine in healthy individuals. No meaningful changes in blood pressure or heart rate were seen with pseudoephedrine. The median tyramine dose required to cause an increase in systolic blood pressure of 30 mmHg from pre-dose baseline was 325 mg with Sivextro compared to 425 mg with placebo. Palpitations were reported in 21/29 (72.4%) subjects exposed to Sivextro compared to 13/28 (46.4%) exposed to placebo in the tyramine challenge study. Serotonergic Agents Serotonergic effects at doses of tedizolid phosphate up to 30-fold above the human equivalent dose did not differ from vehicle control in a mouse model that predicts serotonergic activity. In Phase 3 trials, subjects taking serotonergic agents including antidepressants such as selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, and serotonin 5-hydroxytryptamine (5-HT1) receptor agonists (triptans), meperidine, or buspirone were excluded. Microbiology Tedizolid belongs to the oxazolidinone class of antibacterial drugs. Mechanism of Action The antibacterial activity of tedizolid is mediated by binding to the 50S subunit of the bacterial ribosome resulting in inhibition of protein synthesis. Tedizolid inhibits bacterial protein synthesis through a mechanism of action different from that of other non-oxazolidinone class antibacterial drugs; therefore, cross-resistance between tedizolid and other classes of antibacterial drugs is unlikely. The results of in vitro time-kill studies show that tedizolid is bacteriostatic against enterococci, staphylococci, and streptococci. Mechanism of Resistance Organisms resistant to oxazolidinones via mutations in chromosomal genes encoding 23S rRNA or ribosomal proteins (L3 and L4) are generally cross-resistant to tedizolid. In the limited number of Staphylococcus aureus strains tested, the presence of the chloramphenicol-florfenicol resistance ( cfr ) gene did not result in resistance to tedizolid in the absence of chromosomal mutations. Frequency of Resistance Spontaneous mutations conferring reduced susceptibility to tedizolid occur in vitro at a frequency rate of approximately 10 -10 . Interaction with Other Antimicrobial Drugs In vitro drug combination studies with tedizolid and aztreonam, ceftriaxone, ceftazidime, imipenem, rifampin, trimethoprim/sulfamethoxazole, minocycline, clindamycin, ciprofloxacin, daptomycin, vancomycin, gentamicin, amphotericin B, ketoconazole, and terbinafine demonstrate neither synergy nor antagonism. Spectrum of Activity Tedizolid has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections, as described in Indications and Usage (1) . Aerobic and Facultative Gram-positive Bacteria Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates) Streptococcus pyogenes Streptococcus agalactiae Streptococcus anginosus Group (including S. anginosus , S. intermedius , and S. constellatus ) Enterococcus faecalis The following in vitro data are available, but their clinical significance has not been established. At least 90% of the following microorganisms exhibit an in vitro minimum inhibitory concentration (MIC) less than or equal to 0.5 mcg/mL for tedizolid. However, the safety and effectiveness of Sivextro in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials. Aerobic and Facultative Anaerobic Gram-positive Bacteria Staphylococcus epidermidis (including methicillin-susceptible and methicillin-resistant isolates) Staphylococcus haemolyticus Staphylococcus lugdunensis Enterococcus faecium Susceptibility Test Methods When available, the clinical microbiology laboratory should provide cumulative results of the in vitro susceptibility test results for antimicrobial drugs used in local hospitals and practice areas to the physician as periodic reports that describe the susceptibility profile of nosocomial and community-acquired pathogens. These reports should aid the physician in selecting an effective antibacterial drug for treatment. Dilution Techniques Quantitative methods are used to determine antimicrobial minimum inhibitory concentrations (MICs). These MIC values provide estimates of the susceptibility of bacteria to antimicrobial compounds. The MIC values should be determined using a standardized procedure based on dilution methods (broth, agar, or microdilution) or equivalent using standardized inoculum and concentrations of tedizolid. 1, 3 The MIC values should be interpreted according to the criteria provided in Table 5. Table 5: Susceptibility Test Interpretive Criteria for Sivextro Pathogen Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion Zone Diameter (mm) S I R S I R S=susceptible, I=intermediate, R=resistant * Includes S. anginosus , S. intermedius , S. constellatus Staphylococcus aureus (methicillin-resistant and methicillin-susceptible isolates) 0.5 1 2 19 16 - 18 15 Streptococcus pyogenes 0.5 - - 18 - - Streptococcus agalactiae 0.5 - - 18 - - Streptococcu s anginosus Group * 0.25 - - 17 - - Enterococcus faecalis 0.5 - - 19 - - Diffusion techniques Quantitative methods that require measurement of zone diameters also provide reproducible estimates of the susceptibility of bacteria to antimicrobial compounds. The standardized procedure requires the use of standardized inoculum concentrations. 2, 3 This procedure uses paper disks impregnated with 20 mcg tedizolid to test the susceptibility of microorganisms to tedizolid. Reports from the laboratory providing results of the standard single-disk susceptibility test with a 20 mcg tedizolid disk should be interpreted according to the criteria in Table 5. A report of "Susceptible" indicates that the antimicrobial drug is likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentration usually achievable at the site of infection. A report of "Intermediate" indicates that the result should be considered equivocal, and if the microorganism is not fully susceptible to alternative drugs, the test should be repeated. This category implies possible clinical efficacy in body sites where the drug is physiologically concentrated. This category also provides a buffer zone that prevents small uncontrolled technical factors from causing major discrepancies in interpretation. A report of "Resistant" indicates that the antimicrobial drug is not likely to inhibit growth of the pathogen if the antimicrobial drug reaches the concentrations usually achievable at the infection site; other therapy should be selected. Quality Control Standardized susceptibility test procedures require the use of laboratory control microorganisms to monitor and ensure the accuracy and precision of supplies and reagents used in the assay, and the techniques of the individuals performing the test. 1, 2, 3 Standardized tedizolid powder should provide the following range of MIC values noted in Table 6. For the diffusion technique using the 20 mcg tedizolid disk, results within the ranges specified in Table 6 should be observed. Table 6: Acceptable Quality Control Ranges for Susceptibility Testing Quality Control Organism Minimum Inhibitory Concentrations (mcg/mL) Disk Diffusion (zone diameter in mm) Staphylococcus aureus ATCC 29213 0.25 - 1 Not Applicable Staphylococcus aureus ATCC 25923 Not Applicable 22 - 29 Enterococcus faecalis ATCC 29212 0.25 - 1 Not Applicable Streptococcus pneumoniae ATCC 49619 0.12 - 0.5 24 - 30 Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term carcinogenicity studies have not been conducted with tedizolid phosphate. Tedizolid phosphate was negative for genotoxicity in all in vitro assays (bacterial reverse mutation (Ames), Chinese hamster lung (CHL) cell chromosomal aberration) and in all in vivo tests (mouse bone marrow micronucleus, rat liver unscheduled DNA synthesis). Tedizolid, generated from tedizolid phosphate after metabolic activation ( in vitro and in vivo ), was also tested for genotoxicity. Tedizolid was positive in an in vitro CHL cell chromosomal aberration assay, but negative for genotoxicity in other in vitro assays (Ames, mouse lymphoma mutagenicity) and in vivo in a mouse bone marrow micronucleus assay. In a fertility study, oral tedizolid phosphate had no adverse effects on the fertility or reproductive performance, including spermatogenesis, of male rats at the maximum tested dose (50 mg/kg/day) with a plasma tedizolid AUC approximately 5-fold greater than the plasma AUC value in humans at the oral therapeutic dose. Tedizolid phosphate also had no adverse effects on the fertility or reproductive performance of adult female rats at doses up to the maximum tested (15 mg/kg/day). Plasma tedizolid exposure (AUC) at this NOAEL in female rats was approximately 4-fold higher than that in humans at the oral therapeutic dose. Animal Toxicology and/or Pharmacology Repeated-oral and intravenous dosing of tedizolid phosphate in rats in 1-month and 3-month toxicology studies produced dose- and time-dependent bone marrow hypocellularity (myeloid, erythroid, and megakaryocyte), with associated reduction in circulating RBCs, WBCs, and platelets. These effects showed evidence of reversibility and occurred at plasma tedizolid exposure levels (AUC) 6-fold greater than the plasma exposure associated with the human therapeutic dose. In a 1-month immunotoxicology study in rats, repeated oral dosing of tedizolid phosphate was shown to significantly reduce splenic B cells and T cells and reduce plasma IgG titers. These effects occurred at plasma tedizolid exposure levels (AUC) 3-fold greater than the expected human plasma exposure associated with the therapeutic dose. Clinical Studies Acute Bacterial Skin and Skin Structure Infections A total of 1333 adults with acute bacterial skin and skin structure infections (ABSSSI) were randomized in two multicenter, multinational, double-blind, non-inferiority trials. Both trials compared Sivextro 200 mg once daily for 6 days versus linezolid 600 mg every 12 hours for 10 days. In Trial 1, patients were treated with oral therapy, while in Trial 2, patients could receive oral therapy after a minimum of one day of intravenous therapy. Patients with cellulitis/erysipelas, major cutaneous abscess, or wound infection were enrolled in the trials. Patients with wound infections could have received aztreonam and/or metronidazole as adjunctive therapy for gram-negative bacterial coverage, if needed. The intent-to-treat (ITT) patient population included all randomized patients. In Trial 1, 332 patients with ABSSSI were randomized to Sivextro and 335 patients were randomized to linezolid. The majority (91%) of patients treated with Sivextro in Trial 1 were less than 65 years old with a median age of 43 years (range: 18 to 86 years). Patients treated with Sivextro were predominantly male (61%) and White (84%); 13% had BMI 35 kg/m 2 , 8% had diabetes mellitus, 35% were current or recent intravenous drug users, and 2% had moderate to severe renal impairment. The overall median surface area of infection was 188 cm 2 . The types of ABSSSI included were cellulitis/erysipelas (41%), wound infection (29%), and major cutaneous abscess (30%). In addition to local signs and symptoms of infection, patients were also required to have at least one regional or systemic sign of infection at baseline, defined as lymphadenopathy (87% of patients), temperature 38 C or higher (16% of patients), white blood cell count greater than 10,000 cells/mm 3 or less than 4000 cells/mm 3 (42%), or 10% or more band forms on white blood cell differential (4%). The primary endpoint in Trial 1 was early clinical response defined as no increase from baseline lesion area at 48-72 hours after the first dose and oral temperature of 37.6 C, confirmed by a second temperature measurement within 24 hours in the ITT population. In Trial 2, 332 patients with ABSSSI were randomized to Sivextro and 334 patients were randomized to linezolid. The majority (87%) of patients treated with Sivextro in Trial 2 were less than 65 years old with a median age of 46 years (range: 17 to 86 years). Patients treated with Sivextro were predominantly male (68%) and White (86%); 16% had BMI 35 kg/m 2 , 10% had diabetes mellitus, 20% were current or recent intravenous drug users, and 4% had moderate to severe renal impairment. The overall median surface area of infection was 231 cm 2 . The types of ABSSSI included were cellulitis/erysipelas (50%), wound infection (30%), and major cutaneous abscess (20%). In addition to local signs and symptoms of infection, patients were also required to have at least one regional or systemic sign of infection at baseline, defined as lymphadenopathy (71% of patients), temperature 38 C or higher (31% of patients), white blood cell count greater than 10,000 cells/mm 3 or less than 4000 cells/mm 3 (53%), or 10% or more band forms on white blood cell differential (16%). The primary endpoint in Trial 2 was early clinical response defined as at least a 20% decrease from baseline lesion area at 48-72 hours after the first dose in the ITT population (Table 7). Table 7: Early Clinical Response in the ITT Patient Population Sivextro (200 mg) Linezolid (1200 mg) Treatment Difference (2-sided 95% CI) CI=confidence interval * Primary endpoint for Trial 1; sensitivity analysis for Trial 2 Primary endpoint for Trial 2; sensitivity analysis for Trial 1 No increase in lesion surface area from baseline and oral temperature of 37.6 C, confirmed by a second temperature measurement within 24 hours at 48-72 hours * Trial 1, N 332 335 Responder, n (%) 264 (79.5) 266 (79.4) 0.1 (-6.1, 6.2) Trial 2, N 332 334 Responder, n (%) 286 (86.1) 281 (84.1) 2.0 (-3.5, 7.3) At least a 20% decrease from baseline in lesion area at 48-72 hours Trial 1, N 332 335 Responder, n (%) 259 (78.0) 255 (76.1) 1.9 (-4.5, 8.3) Trial 2, N 332 334 Responder, n (%) 283 (85.2) 276 (82.6) 2.6 (-3.0, 8.2) An investigator assessment of clinical response was made at the post-therapy evaluation (PTE) (7 - 14 days after the end of therapy) in the ITT and CE (Clinically Evaluable) populations. Clinical success was defined as resolution or near resolution of most disease-specific signs and symptoms, absence or near resolution of systemic signs of infection if present at baseline (lymphadenopathy, fever,> 10% immature neutrophils, abnormal WBC count), and no new signs, symptoms, or complications attributable to the ABSSSI requiring further treatment of the primary lesion (Table 8). Table 8: Investigator-Assessed Clinical Response at Post-therapy Evaluation in ITT and CE Patient Populations from Two Phase 3 ABSSSI Trials Sivextro (200 mg) n/N (%) Linezolid (1200 mg) n/N (%) Treatment Difference (2-sided 95% CI) CI=confidence interval; ITT=intent-to-treat; CE=clinically evaluable Trial 1 ITT 284/332 (85.5) 288/335 (86.0) -0.5 (-5.8, 4.9) CE 264/279 (94.6) 267/280 (95.4) -0.8 (-4.6, 3.0) Trial 2 ITT 292/332 (88.0) 293/334 (87.7) 0.3 (-4.8, 5.3) CE 268/290 (92.4) 269/280 (96.1) -3.7 (-7.7, 0.2) Clinical success by baseline pathogens from the primary infection site or blood cultures for the microbiological intent-to-treat (MITT) patient population for two integrated Phase 3 ABSSSI studies are presented in Table 9 and Table 10. Table 9: Early Clinical Response by Baseline Pathogen from Two Phase 3 ABSSSI Trials (MITT Population) Pathogen No increase in lesion surface area from baseline and oral temperature of 37.6 C * At least a 20% decrease from baseline in lesion area Sivextro (200 mg) n/N (%) Linezolid (1200 mg) n/N (%) Sivextro (200 mg) n/N (%) Linezolid (1200 mg) n/N (%) Pooled analysis; n=number of patients in the specific category; N=Number of patients with the specific pathogen isolated from the ABSSSI * Primary endpoint of Trial 1 Primary endpoint of Trial 2 Staphylococcus aureus 276/329 (83.9) 278/342 (81.3) 280/329 (85.1) 276/342 (80.7) Methicillin-resistant S. aureus 112/141 (79.4) 113/146 (77.4) 114/141 (80.9) 111/146 (76.0) Methicillin-susceptible S. aureus 164/188 (87.2) 167/198 (84.3) 166/188 (88.3) 167/198 (84.3) Streptococcus pyogenes 27/33 (81.8) 18/20 (90.0) 25/33 (75.8) 16/20 (80.0) Streptococcus anginosus Group 22/30 (73.3) 26/28 (92.9) 22/30 (73.3) 25/28 (89.3) Streptococcus agalactiae 6/9 (66.7) 8/10 (80.0) 6/9 (66.7) 7/10 (70.0) Enterococcus faecalis 7/10 (70.0) 3/4 (75.0) 6/10 (60.0) 1/4 (24.0) Baseline bacteremia in the tedizolid arm with relevant pathogens included two subjects with MRSA, four subjects with MSSA, two subjects with S. pyogenes , one subject with S. agalactiae , and one subject with S. constellatus. All of these subjects were Responders at the 48-72 hour evaluation. At the Post-therapy Evaluation (PTE), 8 of 10 subjects were considered clinical successes. Table 10: Clinical Response at PTE by Baseline Pathogen from Two Phase 3 ABSSSI Trials (MITT Population) Pathogen Clinical Response at PTE Sivextro (200 mg) n/N (%) Linezolid (1200 mg) n/N (%) Pooled analysis; n=number of patients in the specific category; N=Number of patients with the specific pathogen isolated from the ABSSSI Staphylococcus aureus 291/329 (88.5) 303/342 (88.6) Methicillin-resistant S. aureus 118/141 (83.7) 119/146 (81.5) Methicillin-susceptible S. aureus 173/188 (92.0) 186/198 (93.9) Streptococcus pyogenes 30/33 (90.9) 19/20 (95.0) Streptococcus anginosus Group 21/30 (70.0) 25/28 (89.3) Streptococcus agalactiae 8/9 (88.9) 8/10 (80.0) Enterococcus faecalis 7/10 (70.0) 4/4 (100.0) Baseline bacteremia in the tedizolid arm with relevant pathogens included two subjects with MRSA, four subjects with MSSA, two subjects with S. pyogenes , one subject with S. agalactiae , and one subject with S. constellatus. All of these subjects were Responders at the 48-72 hour evaluation. At the Post-therapy Evaluation (PTE) 8 of 10 subjects were considered clinical successes. REFERENCES Clinical and Laboratory Standards Institute (CLSI). Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard 9th ed., CLSI document M7 A9. Wayne, PA: Clinical and Laboratory Standards Institute; 2012. Clinical and Laboratory Standards Institute (CLSI). Performance Standards for Antimicrobial Disk Susceptibility Tests, Approved Standard good sized


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