23721 Elestat From Allergan With Epinastine Hydrochloride 0.05% listed at Sex Pills and Drugs
The Ingredients: Epinastine Hydrochloride
Dosage Form and Administration: Solution/drops; Ophthalmic
Drug Trade Name: Elestat
New Drug Application Type: N
The Drug Application Number: 21565
Medicine Product Number: 1
Approval Date: 10/16/2003
Reference Listed Drug: Yes
Applicant Full Name: Allergan Inc
Local Number: 23721
Ophthalmology is the branch of medicine, which deals with the anatomy, physiology and diseases of the eye. The term ophthalmologist refers to a specialist in medical and surgical eye problems. Since ophthalmologists perform operations on eyes, they are both surgical and medical specialists. The eye is a fragile organ, requiring extreme care before, during, and after a surgical procedure. An expert eye surgeon must identify the need for specific procedure and be responsible for conducting the procedure safely. Anesthesia is essential for any eye surgery. Local anesthesia is most commonly used. Retrobulbar and peribulbar techniques for infiltrating the local area surrounding the eye muscle cone are to immobilize the extraocular muscles and eliminate pain sensation. Topical anesthesia using lidocaine topical gel is preferred for quick procedures. In topical anesthesia, patient cooperation is a must for a smooth procedure. General anesthesia is for children, traumatic eye injuries, major orbitotomies, and for apprehensive patients. Cardiovascular monitoring is preferable in local anesthesia and is mandatory in general anesthesia. Proper sterile precautions are used to prepare the area for surgery, including use of antiseptics like povidone-iodine. Sterile drapes, gowns and gloves are necessary. A plastic sheet with a receptacle helps collect the fluids during phacoemulsification. An eye speculum is used to keep the eyes wide open. Although the terms laser eye surgery and refractive surgery are used as if they were interchangeable, this is not the case. Lasers may be used to treat nonrefractive conditions, while radial keratotomy is an example of refractive surgery without the use of a laser. A cataract is an opacification or cloudiness of the eye's crystalline lens due to aging, disease, or trauma that typically prevents light from forming a clear image on the retina. If visual loss is significant, surgical removal of the lens with lost optical power is performed and it is usually replaced with a plastic intraocular lens. Due to the high prevalence of cataracts, cataract extraction is the most common eye surgery. Rest after surgery is necessary. LASIK is Laser-Assisted In Situ Keratomileusis. LASIK is a type of refractive surgery, performed by ophthalmologists using a laser. The operation is with the patient awake and mobile; however, the patient is sometimes given a mild sedative (such as Valium) and anesthetic eye drops. LASIK is in three steps. The first step is to create a flap of corneal tissue. The second step is remodeling of the cornea underneath the flap with the laser. Finally, the flap is repositioned.
Health Risks of Being Overweight
Body Mass Index
Body mass index (BMI) is a tool that determines whether the health of a person is at risk due to his or her weight. BMI is a ratio of weight to height. A BMI of 18.5 to 24.9 is healthy; a BMI of 25 to 29.9 is overweight; and a BMI of 30 or more is obese.
To use the BMI table: Find height in the left-hand column and move across to find weight. The number at the top of the column is the BMI for that height and weight. Pounds have been rounded off.
If a person is overweight, he or she is more likely to develop certain health problems. A person may be able to improve his or her health by losing as little as 10 to 20 pounds. To lose weight and keep it off over time, try to make long term changes in eating and physical activity habits. Choose healthy foods, such as vegetables, fruits, whole grains and low fat meat and dairy products more often. Aim for at least 30 minutes of moderate-intensity physical activity, such as walking, on most or all days of the week.
Waist circumference determines the level of risk the heath of a person is in by measuring his or her waist. Waist measurement does not determine if a person is overweight, but it does indicate if a person has excess fat in the abdomen. This is important because extra fat around the waist may increase health risks even more than fat elsewhere on the body.
Women with a waist measurement of more than 35 inches and men with a waist measurement of more than 40 inches may have an increased risk for diseases related to obesity.
Type 2 Diabetes and Weight
Type 2 diabetes is a disease in which blood sugar levels are above normal. High blood sugar is a major cause of coronary heart disease, kidney disease, stroke, amputation and blindness. In 2002, diabetes was the sixth leading cause of death in the United States.
Type 2 diabetes is the most common type of diabetes in the United States. This form of diabetes is most often associated with old age, obesity, family history of diabetes, previous history of gestational diabetes and physical inactivity. The disease is more common among certain ethnic populations.
More than 85 percent of people with Type 2 diabetes are overweight. Doctors do not know exactly why overweight people are more likely to develop diabetes. Doctors think that being overweight causes cells to change, making them resistant to the hormone insulin. Insulin carries sugar from blood to the cells, where it is used for energy. When a person is insulin resistant, blood sugar cannot be taken up by the cells, resulting in high blood sugar. In addition, the cells that produce insulin must work extra hard to try to keep blood sugar normal. This may cause these cells to gradually fail.
A person may lower his or her risk for developing Type 2 diabetes by losing weight and increasing the amount of physical activity he or she does. If a person has Type 2 diabetes, losing weight and becoming more physically active can help him or her control blood sugar levels and prevent or delay complications. Losing weight and exercising more may also allow a person to reduce the amount of diabetes medication he or she takes. The Diabetes Prevention Program, a large clinical study sponsored by the National Institutes of Health, found that losing just five to seven percent of body weight and doing moderate-intensity exercise for 30 minutes a day, 5 days a week, may prevent or delay the onset of Type 2 diabetes.
Coronary Heart Disease and Stroke and Weight
Coronary heart disease means that the heart and circulation blood flow are not functioning normally. Often, the arteries have become hardened and narrowed. If a person has coronary heart disease, he or she may suffer from a heart attack, congestive heart failure, sudden cardiac death, angina chest pain or abnormal heart rhythm. In a heart attack, a disruption in the flow of blood and oxygen to the heart damages portions of the heart muscle. During a stroke, blood and oxygen do not flow normally to the brain, possibly causing paralysis or death. Coronary heart disease is the leading cause of death in the United States and stroke is the third leading cause.
Overweight people are more likely to develop high blood pressure, high levels of triglycerides blood fats and LDL cholesterol, which is a fat-like substance often called bad cholesterol, and low levels of HDL cholesterol, also known as good cholesterol. High blood pressure and cholesterol are risk factors for heart disease and stroke. In addition, excess body fat may produce substances that cause inflammation. Inflammation in blood vessels and throughout the body may raise heart disease risk.
When a person loses 5 to 10 percent of his or her weight, he or she has a lower chance for developing coronary heart disease or having a stroke. If a person weighs 200 pounds, this means losing as little as 10 pounds. Weight loss may improve blood pressure, triglyceride and cholesterol levels; improve heart function and blood flow; and decrease inflammation throughout the body.
Metabolic Syndrome and Weight
The metabolic syndrome is a group of risk factors related to obesity for coronary heart disease and diabetes. A person has the metabolic syndrome if he or she has three or more of the following risk factors: A large waistline. For men, this means a waist measurement of 40 inches or more and for women, it means a waist measurement of 35 inches or more; high triglycerides or taking medication to treat high triglycerides. A triglyceride level of 150 mg/dL or higher is high; Low levels of HDL good cholesterol or taking medications to treat low HDL. For men, low HDL cholesterol is below 40 mg/dL. For women, it is below 50 mg/dL; High blood pressure or taking medications to treat high blood pressure. High blood pressure is 130 mm Hg or higher for systolic blood pressure the top number or 85 mm Hg or higher for diastolic blood pressure the bottom number; High fasting blood glucose sugar or taking medications to treat high blood sugar. This means a fasting blood sugar of 100 mg/dL or higher.
A person with metabolic syndrome has approximately twice the risk for coronary heart disease and five times the risk for Type 2 diabetes. It is estimated that 27 percent of American adults have the metabolic syndrome.
The metabolic syndrome relates to obesity, especially abdominal obesity. Other risk factors that affect metabolic syndrome are physical inactivity, insulin resistance, genetics and old age.
Obesity is a risk factor for the metabolic syndrome because it raises blood pressure and triglycerides, lowers good cholesterol and contributes to insulin resistance. Excess fat around the abdomen carries even higher risks.
It may be possible to prevent the metabolic syndrome with weight management and physical activity. For patients who already have the syndrome, losing weight and being physically active may help prevent or delay the development of diabetes, coronary heart disease or other complications.
Individuals who are overweight or obese and who have the metabolic syndrome should aim to lose 10 percent of their body weight and do at least 30 minutes of moderate-intensity physical activity every day. Doctors also advise that people quit smoking, eat healthfully and take prescription medications for conditions such as high blood pressure or low HDL cholesterol.
Cancer and Weight
Cancer occurs when cells in one part of the body, such as the colon, grow abnormally or out of control. The cancerous cells sometimes spread to other parts of the body, such as the liver. Cancer is the second leading cause of death in the United States.
Being overweight may increase the risk of developing several types of cancer, including cancers of the colon, esophagus and kidney. Overweight women may also have to deal with uterine and postmenopausal breast cancer. Gaining weight during adult life increases the risk for several of these cancers, even if the weight gain does not result in overweight or obesity.
Doctors are unsure how being overweight increases the risk of cancer. It may be that fat cells release hormones that affect cell growth, leading to cancer. In addition, eating or physical activity habits that may lead to being overweight may also contribute to cancer risk. Avoiding weight gain may prevent a rise in cancer risk. Healthy eating and physical activity habits may lower cancer risk. Weight loss may also lower the risk, although studies are inconclusive.
Sleep apnea is a condition in which a person stops breathing for short periods during the night. A person who has sleep apnea may suffer from daytime sleepiness, difficulty concentrating and even heart failure.
The risk for sleep apnea is higher for overweight people. An overweight person may have more fat stored around his or her neck. This may make the airway smaller. A smaller airway can make breathing difficult, loud, cause snoring or stop altogether. In addition, fat stored in the neck and throughout the body may produce substances that cause inflammation. Inflammation in the neck is a risk factor for sleep apnea.
Weight loss usually improves sleep apnea. Weight loss may help to decrease neck size and lessen inflammation.
Osteoarthritis is a common joint disorder that causes the joint bone and cartilage tissue that protects joints to wear away. Osteoarthritis most often affects the joints of the knees, hips and lower back.
Extra weight may place extra pressure on joints and cartilage, causing them to wear away. In addition, people with more body fat may have higher blood levels of substances that cause inflammation. Inflammation at the joints may raise the risk for osteoarthritis.
Weight loss of at least five percent of body weight may decrease stress on the knees, hips and lower back, and lessen inflammation in the body. If a person has osteoarthritis, losing weight may help improve these symptoms.
Gallbladder disease includes gallstones and inflammation or infection of the gallbladder. Gallstones are clusters of solid material that form in the gallbladder. These clusters consist of mostly of cholesterol and can cause abdominal pain, especially after consuming fatty foods. The pain may be sharp or dull.
Overweight people have a higher risk for developing gallbladder disease. Overweight people may produce more cholesterol, a fatty substance found in the body, and heighten the risk for gallstones. Sometimes overweight people may have an enlarged gallbladder, which may not work properly.
Fast weight loss of more than three pounds per week or large weight loss can actually increase the chance of developing gallstones. Modest, slow weight loss of about one half to two pounds a week is less likely to cause gallstones. Achieving a healthy weight may lower the risk for developing gallstones.
Fatty Liver Disease
Fatty liver disease occurs when fat builds up in the liver cells and causes injury and inflammation in the liver. Fat build up can sometimes lead to severe liver damage, cirrhosis, a build up of scar tissue that blocks proper blood flow in the liver or even liver failure. Fatty liver disease is like alcoholic liver damage and can occur in people who drink little or no alcohol.
People who have diabetes or pre-diabetes, which is when blood sugar levels are higher than normal but not yet in the diabetic range, are more likely to have fatty liver disease than people without these conditions. Overweight people are more likely to develop diabetes. Doctors do not know why some people who are overweight or diabetic get fatty liver disease and others do not.
Losing weight and being physically active can help control the blood sugar levels in the body. Losing weight can also reduce the build up of fat in the liver and prevent further injury. People with fatty liver disease should avoid drinking alcohol.
Overweight and obesity raise the risk of pregnancy complications for both mother and baby. Pregnant women who are overweight or obese may have an increased risk for: Gestational diabetes high blood sugar during pregnancy; Pre-eclampsia, which is high blood pressure during pregnancy that can cause severe problems for both mother and baby if left untreated; and Cesarean delivery or complications with cesarean delivery.
Babies of overweight or obese mothers have an increased risk of neural tube defects of the brain and spinal cord, stillbirth, prematurity and being large for gestational age.
Pregnant women who are overweight are more likely to develop insulin resistance, high blood sugar and high blood pressure. Insulin resistance is when cells do not respond properly to the hormone insulin, which carries blood sugar to cells for energy. Insulin resistance may result in high levels of blood sugar. Being overweight also increases risks associated with surgery and anesthesia and severe obesity increases operative time and blood loss.
Some studies have shown that gaining excess weight during pregnancy, even without becoming obese, may increase risks. It is important to consult with an obstetrician or other health care provider about how much weight to gain during pregnancy.
Women who are overweight or obese and who would like to become pregnant should speak with a health care provider about losing weight before becoming pregnant. Pre-pregnancy weight loss significantly reduces pregnancy complications. Pregnant women who are overweight or obese should speak with a health care provider about limiting gestational weight gain and being physically active during pregnancy.
Losing excess weight after delivery may help women reduce their health risks. If a woman developed gestational diabetes, losing weight will lower her risk of developing diabetes later in life.
If a person is overweight, losing as little as five percent of body weight may lower the risk for several diseases, including coronary heart disease and Type 2 diabetes. If a person weighs 200 pounds, this means losing 10 pounds. Slow and steady weight loss of one-half to two pounds per week and not more than three pounds per week is the safest way to lose weight.
To lose weight and keep it off over time, try to make long term changes in eating habits and physical activity. Choose healthy foods, such as vegetables, fruits, whole grains and low fat meat and dairy products more often. Eat just enough food to satisfy the hunger. Aim for at least 30 minutes of moderate-intensity physical activity, such as walking, on most or all days of the week. To lose weight or to maintain weight loss, many people need to do more than 30 minutes of moderate physical activity daily.
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