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In a 4 year clinical trial, the general pattern of adverse event distribution was similar to that reported for the 1 and 2 year studies with the total incidence of gastrointestinal related adverse events occurring in year 1 decreasing year on year over the four year period. Increase in liver transaminases and in alkaline phosphatase.
To reduce the chance of a drug-drug interaction, cyclosporine should be taken at least 3 hours before or after XENICAL in patients taking both drugs. Buying drugs in your country requires a prescription. XENDOS study than in the five 2-year studies. Statistical significance based on intent-to-treat population, last observation carried forward.
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. The majority of orlistat overdose cases received during post-marketing reported either no adverse events or adverse events that are similar to those reported with recommended dose. Your doctor will tell you how much XENICAL to take and when to take it.
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Find the height closest to your height in the left-hand column. 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. Single doses of 800 mg orlistat and multiple doses of up to 400 mg three times daily for 15 days have been studied in normal weight and obese subjects without significant adverse findings.
Antidiabetic medicinal product treatment may have to be closely monitored when taking orlistat. At the end of year 1, the patients’ diets were reviewed and changed where necessary. Buying drugs in your country requires a prescription. They may not work as well while you take XENICAL. 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.
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Therefore orlistat treatment should only be initiated after careful consideration of the possible impact in these patients. However, orlistat may indirectly reduce the availability of oral contraceptives and lead to unexpected pregnancies in some individual cases. Weight-loss may affect glycemic control in patients with diabetes mellitus. For XENICAL, the most common adverse events resulting in discontinuation of treatment were gastrointestinal. In clinical trials, the decrease in bodyweight with orlistat treatment was less in type II diabetic patients than in non-diabetic patients.
GI adverse events associated with XENICAL treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. XENICAL may affect the way other medicines work, and other medicines may affect the way XENICAL works. The active ingredient in Xenical, orlistat, is an anti-obesity medicine, which does not affect appetite. Potential Risks And Benefits Patients should be informed of potential risks which include lowered absorption of fat-soluble vitamins and potential liver injury, increases in urinary oxalate, and cholelithiasis . In a clinical trial of XENICAL for the prevention of type 2 diabetes, the rates of cholelithiasis as an adverse event were 2.
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Use of XENICAL in this age group is supported by evidence from adequate and well-controlled studies of XENICAL in adults with additional data from a 54-week efficacy and safety study and a 21- day mineral balance study in obese adolescent patients aged 12 to 16 years. XENICAL discontinued treatment due to adverse events, compared with 5. Following one year of treatment, BMI decreased by an average of 0. See “What should I tell my doctor before taking XENICAL? XENICAL is a prescription medicine used with a low calorie diet to increase weight loss in people with obesity.
Specific Populations No pharmacokinetic study was conducted for specific populations such as geriatric, different races, and patients with renal and hepatic impairment. Patients should also be advised to take multivitamin supplementation at least two hours before or after the administration of XENICAL, or at bedtime . This Patient Information has been approved by the U.
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If a meal is occasionally missed or contains no fat, the dose of XENICAL can be omitted. Rare cases of leukocytoclastic vasculitis have been reported. For patients receiving both XENICAL and cyclosporine therapy, administer cyclosporine 3 hours after XENICAL. Orlistat is a white to off-white crystalline powder.
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. What is a Patient Information Leaflet and why is it useful? The use of orlistat may be associated with hyperoxaluria and oxalate nephropathy leading sometimes to renal failure. The iron balance was decreased by 64. Population With Abnormal Risk Factors at Randomization The relative differences in risk factors between treatment with XENICAL and placebo were similar to the results following 1 year of therapy for LDL- and HDL-cholesterol, triglycerides, fasting insulin, diastolic blood pressure, and waist circumference.
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6 kg between the two groups. 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 . Buying drugs in your country requires a prescription. This can lead to a decrease of immunosuppressive efficacy. 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 . Upon discontinuation of therapy, faecal fat content usually returns to pre-treatment levels, within 48 to 72 hours.
A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. 06 kg and the mean difference from placebo in HbA1c reduction was 0. All studies, with the exception of 14 161, were conducted at centers specialized in treating obesity and complications of obesity. OVERDOSE Single doses of 800 mg XENICAL and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings.
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Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours. Neither study showed embryotoxicity or teratogenicity. What benefits has it shown during the studies? In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed.
The effects of Xenical were first tested in experimental models before being studied in humans. If a meal is missed or contains no fat, the dose of orlistat should be omitted. Its empirical formula is C29H53NO5, and its molecular weight is 495. Buying drugs in your country requires a prescription.
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Take XENICAL with your meals or up to one hour after your meal. Do not give XENICAL to other people, even if they have the same symptoms that you have. What are the ingredients in XENICAL? Keep the container tightly closed in order to protect from moisture. You may report side effects to FDA at 1-800-FDA-1088.
CLINICAL PHARMACOLOGY Mechanism Of Action Orlistat is a reversible inhibitor of gastrointestinal lipases. Acute oxalate nephropathy after treatment with XENICAL has been reported in patients with or at risk for renal disease . For patients receiving both XENICAL and levothyroxine therapy, administer levothyroxine and XENICAL at least 4 hours apart. Take XENICAL exactly as your doctor tells you to take it. The number where these two meet is your BMI.
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Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established. Cholelithiasis Substantial weight loss can increase the risk of cholelithiasis. The vast majority of patients receiving up to four full years of treatment with orlistat in clinical studies had vitamin A, D, E and K and beta-carotene levels that stayed within normal range. If you would like more information, talk with your doctor.
A reduced therapeutic effect of amiodarone is possible. In general, the first occurrence of these events was within 3 months of starting therapy. 2, with black printing ink containing pharmaceutical grade shellac, propylene glycol, strong ammonium solution, potassium hydroxide and black iron oxide.
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Call your doctor for medical advice about side effects. Your doctor may do certain tests to check your kidney function during treatment with XENICAL. Rare cases of hypersensitivity have been reported with the use of XENICAL. XENICAL is available for oral administration as a turquoise hard-gelatin capsule.
Postmarketing Experience The following adverse reactions have been identified during postapproval use of XENICAL. For orlistat no clinical data on exposed pregnancies are available. Orlistat is practically insoluble in water, freely soluble in chloroform, and very soluble in methanol and ethanol. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine site of the gastric and pancreatic lipases. Xenical has been studied in seven main studies involving over 3,000 overweight or obese patients.