Drug Uses

Xenical is used to help obese people who fit certain weight and height requirements lose weight and maintain weight loss. Xenical works in your intestines, where it blocks some of the fat you eat from being absorbed. This undigested fat is then eliminated in your bowel movements. Use Xenical together with a reduced-calorie diet. The weight management effects of Xenical continue only as long as you are taking it.

How Taken

Xenical comes in a capsule to take it orally. It is usually taken tree times a day with food. Take Xenical exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Xenical should be given with meals. A diet consisting of daily intake of fat (30% of total calories), carbohydrates, and protein should be distributed evenly over 3 main meals.

Warnings/Precautions

Do not take Xenical without first talking to your doctor if you have a chronic malabsorption syndrome, or gallbladder problems. You may not be able to take Xenical if you have any of the conditions listed above. Before taking Xenical, talk to your doctor if you have a history of kidney stones, have diabetes, have anorexia or bulimia, take any other weight-loss medicine, or take cyclosporine. You may not be able to take Xenical, or you may require a dosage adjustment or special monitoring during your treatment if you have any of the conditions listed above. Xenical is in the FDA pregnancy category B. This means that it is not expected to harm an unborn baby. Do not take Xenical without first talking to your doctor if you are pregnant. It is not known whether Xenical passes into breast milk. Do not take Xenical without first talking to your doctor if you are breast-feeding a baby.

Missed Dose

If you miss a dose resume taking Xenical at the next meal. Do not try to make up the loss with a double dose. The extra drug will not help.

Possible Side Effects

Stop taking Xenical and seek emergency medical attention if you experience a rare allergic reaction including shortness of breath; closing of your throat; swelling of your lips, tongue, or face; or hives. Other, less serious side effects are more likely to occur. Continue to take Xenical and talk to your doctor if you experience oily spotting, gas with discharge, an urgent need to go to the bathroom, oily or fatty stools, an oily discharge, an increased number of bowel movements, an inability to control bowel movements, or orange or brown colored oil in your stool. The bowel changes listed above are a natural effect of blocking fat and indicate that Xenical is working. They generally occur early in treatment, particularly after meals containing higher amounts of fat than are recommended. These symptoms are usually temporary and lessen or disappear as you continue treatment and keep to your recommended diet of meals containing 30% fat. Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Storage

Store this medication at room temperature and out of the reach of children. Protect from moisture. Keep container tightly closed. Throw away any unused medicine after the expiration date.

Overdose

Seek emergency medical attention. Symptoms of a Xenical overdose are not known.

More Information

Xenical may decrease your body's absorption of some fat-soluble vitamins. To ensure adequate nutrition, your doctor may recommend taking a multivitamin that contain vitamins D, E, K, and beta-carotene. Take your vitamin supplement once a day, at least 2 hours before or after a dose of Xenical. Each time you take Xenical, your meal should contain no more than about 30% of calories from fat. Evenly divide your daily intake of fat, carbohydrates, and protein over three main meals a day. Talk to your doctor about following a healthy eating plan.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

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Only weight loss medication whose benefits have been studied in adolescents Roche announced today that its leading weight loss medicine Xenical (orlistat) has received European approval to include clinical, safety and efficacy data in the label on the use in obese adolescents aged 12 years or over. The label change has been approved following the results of a major study that shows Xenical to be highly effective in helping obese young people to lose weight. As a result of this change, physicians may now consider Xenical as an effective option in the management of obesity in adolescents. In Europe in the last few years there has been a significant increase in obesity in children and adolescents, with as many as one in four affected in some regions. Obese children tend to become obese adults, and they carry a high risk of acute and chronic diseases, leading to reduced life expectancy. Treatment and prevention of childhood obesity has been identified as a healthcare priority in Europe. “This is a further example of Roche's continuing commitment to tackling the growing epidemic of obesity. By studying the use of Xenical in obese adolescents aged 12 and over, we have now shown that the drug can benefit young people as much as adults. Xenical is now the only weight loss treatment in the US and EU that provides guidance from clinical trials in its label on use in this population,” said William M. Burns, CEO Roche Pharma. The label change is based on data from a large study (recently published in JAMA1) in which 539 obese adolescent patients received either 120 mg Xenical or placebo three times daily, alongside a reduced-calorie diet and exercise for 1 year. Weight loss was tracked using changes in the adolescents’ Body Mass Index (BMI), a measure that takes into account not only the changes in body weight but also the changes in height which occur in growing adolescents. Study results were consistent with those seen in adults and showed at the end of treatment: • Adolescents treated with Xenical had a significantly reduced BMI (decrease of 0.55 kg/m2 compared to an increase of 0.31 kg/m2 in the placebo group). • Almost twice as many adolescents treated with Xenical reduced by =5% their BMI (26.5% vs 15.7%) and their body weight (19% vs 11.7%) • Adolescents treated with Xenical had a greater decrease in body fat (2.4kg vs 0.4kg) • Waist circumference decreased significantly in Xenical recipients, but increased in placebo recipients (–1.33 cm vs +0.12 cm). • Adolescents who responded to treatment (=5% weight loss at 12 weeks) had a reduction in body weight of 7.6 kg and a BMI decrease of 3.7 kg/m2. • Treatment was well tolerated, with adverse events generally similar to those observed in adults. These data, from the largest and longest study of a weight loss medication in adolescents, add to the extensive evidence base including safety, and clinical experience gained with Xenical since it was first marketed in 1998. “Access to pharmacotherapy such as orlistat to complement diet and exercise will be important for physicians and patients trying to combat the growing trend of adolescent obesity. It means that the medical profession will have a new weapon to help adolescents lose weight, and stop them progressing to become overweight adults with the associated health complications” commented lead investigator Professor Prof. Jean-Pierre Chanoine, Endocrinology and Diabetes Unit, British Columbia Children's Hospital, Vancouver, Canada. About Xenical Xenical is the number one prescription weight loss medication, approved for use in adults in over 50 countries worldwide. Xenical has a unique mode of action, it works locally in the gut to prevent dietary fat absorption by around 30 percent and effectively promotes weight loss. It is the most extensively studied pharmacological weight management treatment to date, with over 30,000 overweight or obese patients participating in clinical trials with Xenical, including the 4 year landmark XENDOS study. It is an effective therapy that not only helps patients lose weight, but also helps them maintain their weight loss. Xenical was approved in December 2003 for use in adolescents 12 years and above in the US. About Roche Headquartered in Basel, Switzerland, Roche is one of the world’s leading research-focused healthcare groups in the fields of pharmaceuticals and diagnostics. As a supplier of innovative products and services for the early detection, prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people’s health and quality of life. Roche is a world leader in diagnostics, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2004 sales by the Pharmaceuticals Division totalled 21.7 billion Swiss francs, while the Diagnostics Division posted sales of 7.8 billion Swiss francs. Roche employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai.

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