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8 lbs in the placebo-treated patients. Cholelithiasis Substantial weight loss can increase the risk of cholelithiasis. Crystal structure of the thioesterase domain of human fatty acid synthase inhibited by Orlistat”.
GI adverse events associated with XENICAL treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. 3 of the 4 participants who had them. 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.
Read this Patient Information before you start taking XENICAL and each time you get a refill. If you would like more information, talk with your doctor.
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For patients receiving both XENICAL and levothyroxine therapy, administer levothyroxine and XENICAL at least 4 hours apart. If you take a levothyroxine medicine, take XENICAL and levothyroxine at least 4 hours apart. United States Patent and Trademark Office. Oral Contraceptives In 20 normal-weight female subjects, the treatment of XENICAL 120 mg three times a day for 23 days resulted in no changes in the ovulation-suppressing action of oral contraceptives. Its empirical formula is C29H53NO5, and its molecular weight is 495. In Australia and New Zealand, orlistat has been available as a “Pharmacist Only Medicine since 2000.
Inactive Ingredients : microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, gelatin and titanium dioxide. Anticoagulants Including Warfarin Vitamin K absorption may be decreased with XENICAL. Take XENICAL exactly as your doctor tells you to take it. Elimination Following a single oral dose of 360 mg 14C-orlistat in both normal weight and obese subjects, fecal excretion of the unabsorbed drug was found to be the major route of elimination. Keep XENICAL in a tightly closed container.
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Archived from the original on 29 December 2007. Vyfat, Olistat, Obelit, Orlica and Reeshape. Do not give XENICAL to other people, even if they have the same symptoms that you have.
XENICAL and other medicines may affect each other causing side effects. 4 lbs in the patients treated with XENICAL and 5. Orlistat has no pK within the physiological pH range. Based on fecal fat measurements, the effect of XENICAL is seen as soon as 24 to 48 hours after dosing. Weight-Loss Drug to Be Sold Over the Counter”.
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Take XENICAL with your meals or up to one hour after your meal. The diet utilized during year 2 was designed for weight maintenance and not weight loss. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine. In addition, all patients were placed on a behavior modification program and offered exercise counseling. The effect is the percentage of ingested fat excreted, referred to as fecal fat excretion percentage. In addition, all patients were offered nutritional counseling.
A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Patients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function. Find the height closest to your height in the left-hand column. Treatment with XENICAL may result in weight loss and improvement in obesity-related risk factors due to weight loss . Fake Alli diet pills can pose health risks”.
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Do not take XENICAL if you are pregnant or plan to become pregnant. What should I tell my doctor before taking XENICAL? If XENICAL is taken with any one meal very high in fat, the possibility of gastrointestinal effects increases. For more information, ask your doctor or pharmacist. The daily intake of fat should be distributed over three main meals.
At times, such as in spring 2012, orlistat has come into short supply, with consequent price increases because of nonavailability of one of the drug’s components. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to XENICAL exposure. Take a multivitamin at least 2 hours before or after you take XENICAL, such as at bedtime. XENICAL and placebo treatment groups, respectively. One-year Results : Weight Loss, Weight Maintenance, And Risk Factors Pooled data from five clinical trials indicated that the overall mean weight loss from randomization to the end of 1 year of treatment in the intent-to-treat population was 13.
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On 21 January 2009, the European Medicines Agency granted approval for the sale of orlistat without a prescription. Higher doses do not produce more potent effects. 2, with black printing ink containing pharmaceutical grade shellac, propylene glycol, strong ammonium solution, potassium hydroxide and black iron oxide. Table 4 illustrates the percentage of adult patients on XENICAL and placebo who developed a low vitamin level on two or more consecutive visits during 1 and 2 years of therapy in studies in which patients were not previously receiving vitamin supplementation. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese.
Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours. All studies, with the exception of 14 161, were conducted at centers specialized in treating obesity and complications of obesity. In several studies of up to 6-weeks duration, the effects of therapeutic doses of XENICAL on gastrointestinal and systemic physiological processes were assessed in normal weight and obese subjects. Caution should be exercised when XENICAL is administered to a nursing woman. Then move across the top row to find the weight closest to your weight.
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Acute oxalate nephropathy after treatment with XENICAL has been reported in patients with or at risk for renal disease . 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. Cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported. During the study, all patients were instructed to take a multivitamin containing fat-soluble vitamins at least 2 hours before or after ingestion of XENICAL.
The diet utilized during year 1 was a reduced-calorie diet. INDICATIONS XENICAL is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. XENICAL inhibited absorption of a vitamin E acetate supplement. 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. However, GI adverse events may occur in some individuals over a period of 6 months or longer. Drug Patent Expirations in June 2009″.
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1 year in five large multicenter studies for the intent-to-treat populations are presented in Table 6. Study 14 161 was conducted with primary care physicians. Ethanol does not affect orlistat’s effect on preventing the absorption of fat. 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 . Food and Drug Administration issued an alert stating that some counterfeit versions of Alli sold over the Internet contain no orlistat, and instead contain the weight-loss drug sibutramine.
Clinical signs include palpable purpura, maculopapular lesions, or bullous eruption. This information does not take the place of talking to your doctor about your medical condition or your treatment. Do not use XENICAL for a condition for which it was not prescribed. The effectiveness of orlistat in promoting weight loss is definite but modest. Each capsule contains a pellet formulation consisting of 120 mg of the active ingredient, orlistat, as well as the inactive ingredients microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, and talc. Long-term effects of weight-reducing drugs in hypertensive patients”.
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This suggests that the observed increased risks of liver injury linked to the start of treatment may reflect changes in health status associated with the decision to begin treatment rather than any causal effect of the drug. In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed. FDA OKs First Nonprescription Diet Pill”. On 23 January 2006, a U.
XENICAL is available for oral administration as a turquoise hard-gelatin capsule. Neither study showed embryotoxicity or teratogenicity. Weight-loss may affect glycemic control in patients with diabetes mellitus. XENICAL may affect the way other medicines work, and other medicines may affect the way XENICAL works. A reduced therapeutic effect of amiodarone is possible.
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Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Your doctor may do certain tests to check your kidney function during treatment with XENICAL. You can ask your pharmacist or doctor for information about XENICAL that is written for health professionals. 1 Oily discharge may be clear or have an orange or brown color.
Nursing Mothers It is not known if XENICAL is present in human milk. The diet prescribed in the second year was designed to maintain patient’s current weight. At the end of year 1, the patients’ diets were reviewed and changed where necessary. Orlistat is used for the treatment of obesity. Patients should be strongly encouraged to take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and beta-carotene .