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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A 60 mg low-dose version of the prescription weight-loss medication orlistat (marketed by GlaxoSmithKline as Xenical(R) 120 mg) was found to be safe, effective and tolerable in overweight individuals, according to new data presented today at the 2005 Annual Meeting of NAASO, The Obesity Society in Vancouver, British Columbia. The study, which compared orlistat 60 mg plus diet to placebo plus diet in patients with a body mass index (BMI) of 25 to 28, demonstrates a statistically significant difference in weight loss. Orlistat patients who completed the four-month treatment period lost 5 percent of their baseline weight and diet alone lost 3.3 percent. The randomized, placebo-controlled, 16-week study was conducted in a primary care setting, offered minimal intervention and was largely self-instructional. Approximately 36 percent of orlistat users and 28 percent of the placebo group (who used diet modifications alone) lost more than five percent of their initial body weight. Approximately 57 percent of orlistat users, compared to 42 percent of the placebo group, lost more than three percent of their initial body weight. Orlistat patients also demonstrated significant decreases in total cholesterol, LDL cholesterol, systolic and diastolic blood pressure. Safety and tolerability of 60 mg orlistat in this population was similar to that observed in previous studies in a more overweight population. "Prescription orlistat has been used successfully for years to help obese individuals lose weight and improve their health, so it's exciting to find that a lower dose of orlistat can help those who are overweight with their weight loss efforts," said lead investigator Dr. James Anderson, Professor of Medicine and Clinical Nutrition at the University of Kentucky. "The number of overweight individuals in this country continues to increase each year, and the risk of these folks progressing to obesity - and the resulting more serious medical problems - is significant." About Orlistat Prescription orlistat is marketed by GlaxoSmithKline (GSK) as Xenical(R). It is supported by more than 100 clinical studies conducted in more than 30 countries, including a four-year study, the longest study ever of a weight-loss drug. More than 21 million people in 145 countries have used orlistat safely, and it is available without a prescription in several countries. GSK provides the following information about the drug: Xenical(R) (orlistat 120 mg) is non-systemic, and works in the gut by inhibiting the absorption of dietary fat. Non-absorbed fat can lead to some changes in bowel habits. These changes are minimal if the dietary recommendations are followed and generally occur in the first weeks of treatment; however, for some people they may continue for 6 months or longer while on Xenical(R). Patients considering taking Xenical(R) should tell their doctor if they are pregnant, nursing, taking cyclosporine, have food absorption problems or reduced bile flow. A daily multivitamin is recommended because Xenical(R) can reduce the absorption of fat-soluble vitamins. Currently available in 120 mg dose capsules via prescription, GlaxoSmithKline Consumer Healthcare has submitted a New Drug Application to the U.S. Food and Drug Administration seeking approval to market orlistat at the lower 60 mg dose over-the-counter as a weight loss aid. About Overweight Currently 65 percent, or approximately 130 million, U.S. adults are overweight or obese. Overweight is defined as having a body mass index (BMI) ranging from 25.0 to 29.9, and obesity is the diagnosis in individuals with a BMI greater than or equal to 30. Body mass index can be used to screen for both overweight and obesity in adults and is a non-gender specific calculation based on height and weight. Factors that can contribute to overweight include an abundance of high-calorie foods, low levels of physical activity, behavior, environment, and genetics. Overweight can be associated with an increased risk of developing health problems such as hypertension, type 2 diabetes and heart disease.

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