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Four-year Results : Long-term Weight Control And Risk Factors In the 4-year double-blind, placebo-controlled XENDOS study, the effects of XENICAL in delaying the onset of type 2 diabetes and on body weight were compared to placebo in 3304 obese patients who had either normal or impaired glucose tolerance at baseline. WARNINGS Included as part of the PRECAUTIONS section.
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The safety and efficacy of XENICAL have been evaluated in obese adolescent patients aged 12 to 16 years. Facts Even if you think you’re getting enough fruits and vegetables per day, how can you be sure?
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Surprising Health Benefits of Sex How would you like a stronger immune system or better sleep? XENICAL-treated patients and increased by an average of 0. Concomitant Medications Patients should be asked if they are taking cyclosporine, beta carotene or vitamin E supplements, levothyroxine, warfarin, antiepileptic drugs, amiodarone, or antiretroviral drugs due to potential interactions .
Orlistat is combined with a reduced-calorie diet to promote weight loss. If a meal is occasionally missed or contains no fat, the dose of XENICAL can be omitted. Superfoods – Are you eating enough?
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CLINICAL PHARMACOLOGY Mechanism Of Action Orlistat is a reversible inhibitor of gastrointestinal lipases. If you take too much XENICAL call your doctor or go to the nearest hospital emergency room right away. Liver failure has been reported in patients treated with orlistat.
Weight Control and Smoking Cessation One concern smokers have when considering quitting smoking is weight gain. All studies, with the exception of 14 161, were conducted at centers specialized in treating obesity and complications of obesity. Data from a XENICAL and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when XENICAL was coadministered with cyclosporine.
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You may report side effects to FDA at 1-800-FDA-1088. Phenytoin In 12 normal-weight subjects receiving XENICAL 120 mg three times a day for 7 days, XENICAL did not alter the pharmacokinetics of a single 300-mg dose of phenytoin. Antiepileptic Drugs Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs. Safe use of orlistat during pregnancy has not been established. Buying drugs in your country requires a prescription.
Study 14 161 was conducted with primary care physicians. The No-Diet Approach Lose weight without dieting! Pravastatin In a 2-way crossover study of 24 normal-weight, mildly hypercholesterolemic patients receiving XENICAL 120 mg three times a day for 6 days, XENICAL did not affect the pharmacokinetics of pravastatin. Take the Food Portion Distortion Quiz to find out how and why gigantic portions trick you into eating more than reasonable amounts of food! Orlistat also may be used to prevent weight gain after weight has been lost.
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Patients should not take XENICAL if they are pregnant, have chronic malabsorption syndrome, cholestasis or hypersensitivity to XENICAL or to any component of this product . Cholelithiasis Substantial weight loss can increase the risk of cholelithiasis. Use In Specific Populations Pregnancy Pregnancy Category X XENICAL is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm. Buying drugs in your country requires a prescription.
Call your doctor for medical advice about side effects. Table 5 illustrates the percentage of adolescent patients on XENICAL and placebo who developed a low vitamin level on two or more consecutive visits during the 1-year study. There have been reports of hepatic failure observed with the use of XENICAL in postmarketing surveillance, with some of these cases resulting in liver transplant or death . Based on fecal fat measurements, the effect of XENICAL is seen as soon as 24 to 48 hours after dosing. Orlistat has no pK within the physiological pH range.
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In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed. Rare cases of leukocytoclastic vasculitis have been reported. Are There Prescription Drugs That Help with Weight Loss? If you take a cyclosporine medicine, take XENICAL and cyclosporine at least 3 hours apart. Safely throw away medicine that is out of date or no longer needed.
In a clinical trial of XENICAL for the prevention of type 2 diabetes, the rates of cholelithiasis as an adverse event were 2. Do I need a prescription for orlistat? XENICAL may affect the way other medicines work, and other medicines may affect the way XENICAL works. Based on patients with a baseline and at least one follow-up OGTT measurement, ITT LOCF study population. 2, with black printing ink containing pharmaceutical grade shellac, propylene glycol, strong ammonium solution, potassium hydroxide and black iron oxide.
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Take a multivitamin at least 2 hours before or after you take XENICAL, such as at bedtime. Report Problems to the Food and Drug Administration You are encouraged to report negative side effects of prescription drugs to the FDA. 10 Tips for a Healthier Fast Food Diet Losing weight is tough on the road. High protein diets let you snack on protein-rich foods you love, but what are the downsides? Nursing Mothers It is not known if XENICAL is present in human milk. SIDE EFFECTS Clinical Trials Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in patients.
What preparations of orlistat are available? Lower gastrointestinal bleeding has been reported in patients treated with XENICAL. Vitamin D: How Much is Enough? 4 lbs in the patients treated with XENICAL and 5.
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Low-Carb Snacks in Pictures Interested in low-carb snacking? XENICAL is a prescription medicine used with a low calorie diet to increase weight loss in people with obesity. Orlistat is practically insoluble in water, freely soluble in chloroform, and very soluble in methanol and ethanol. For example, a person who weighs 180 lbs and is 5’5″ has a BMI of 30. The daily intake of fat, carbohydrate, and protein should be distributed over three main meals.
These are not all the possible side effects of XENICAL. Only a maximum of three capsules of either Xenical or Alli should be taken daily. Healthy Dieting Myths and Facts Learn about healthy dieting myths and facts. Cyclosporine should be administered 3 hours after the administration of XENICAL . The number where these two meet is your BMI.
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Pediatric Patients In clinical trials with XENICAL in adolescent patients ages 12 to 16 years, the profile of adverse reactions was generally similar to that observed in adults. Anticoagulants Including Warfarin Vitamin K absorption may be decreased with XENICAL. What should I tell my doctor before taking XENICAL? 13 Easy Ways to Eat More Greens Learn 13 easy ways to add more greens to your diet. Can I give orlistat to my obese teenager? At the end of year 1, the patients’ diets were reviewed and changed where necessary.
In patients found to have an impaired OGTT at randomization, the percent of patients improving to normal or deteriorating to diabetic status following 1 and 2 years of treatment with XENICAL compared to placebo are presented. Do not give XENICAL to other people, even if they have the same symptoms that you have. Buying drugs in your country requires a prescription.
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XENICAL inhibited absorption of a vitamin E acetate supplement. Weight Loss – The Basics There are lots of reasons for people who are overweight or obese to lose weight. Its empirical formula is C29H53NO5, and its molecular weight is 495. Talk to your doctor right away if your seizures happen more often or get worse while you take XENICAL.
A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese. XENICAL 120 mg three times a day and with an incidence that was greater than placebo during year 1 and year 2, regardless of relationship to study medication. Rare cases of hypersensitivity have been reported with the use of XENICAL. Top Diets: The Best Dieting Tips Ever for Weight Loss What separates good diets from the best diets? What are the uses for orlistat?