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Read this Patient Information before you start taking XENICAL and each time you get a refill. Find the height closest to your height in the left-hand column. What should I tell my doctor before taking XENICAL? Basic Orlistat Precautions To benefit from a Xenical prospect, stay informed with possible contraindications and important precautions.
This medicine must be used together with a reduced-calorie diet and is to used only by adults. 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. If a meal is occasionally missed or contains no fat, the dose of XENICAL can be omitted.
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Talk to your doctor before you breastfeed and take XENICAL. Call your doctor for medical advice about side effects. Patients should also be advised to take multivitamin supplementation at least two hours before or after the administration of XENICAL, or at bedtime .
Talk to your doctor right away if your seizures happen more often or get worse while you take XENICAL. See “What should I tell my doctor before taking XENICAL? Not all possible interactions are listed in this medication guide. Buying drugs in your country requires a prescription. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. For XENICAL, the most common adverse events resulting in discontinuation of treatment were gastrointestinal.
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Antiepileptic Drugs Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs. Medically reviewed on August 12, 2017. XENICAL and placebo treatment groups, respectively.
Do not take XENICAL if you are pregnant or plan to become pregnant. The vitamin supplement should be taken at least 2 hours before or after the administration of XENICAL, such as at bedtime. Most patients are prescribed to take Orlistat 60 mg 3 times a day. Bedtime is a good time to take your multivitamin. Keep XENICAL in a tightly closed container. XENICAL and other medicines may affect each other causing side effects.
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Specific Populations No pharmacokinetic study was conducted for specific populations such as geriatric, different races, and patients with renal and hepatic impairment. Avoid eating high-fat meals or you could have unpleasant side effects on your stomach or intestines. In general, the first occurrence of these events was within 3 months of starting therapy. 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. Doses above 120 mg three times a day have not been shown to provide additional benefit. However, these side effects are rare and most of them are not serious.
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. XENICAL is a turquoise, hard-gelatin capsule containing pellets of powder. 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. Digoxin In 12 normal-weight subjects receiving XENICAL 120 mg three times a day for 6 days, XENICAL did not alter the pharmacokinetics of a single dose of digoxin.
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If it has been more than an hour since your last meal, skip the missed dose and take the medicine at your next regularly scheduled time. 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. Other drugs may interact with orlistat, including prescription and over-the-counter medicines, vitamins, and herbal products. For patients receiving both XENICAL and levothyroxine therapy, administer levothyroxine and XENICAL at least 4 hours apart. 8 lbs in the placebo-treated patients. The effect of XENICAL to delay the onset of type 2 diabetes in obese patients with IGT is presumably due to weight loss, and not to any independent effects of the drug on glucose or insulin metabolism.
If you take a levothyroxine medicine, take XENICAL and levothyroxine at least 4 hours apart. Follow your doctor’s instructions about the type of supplement to use. Do not give alli to anyone under 18 years old. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. What should I avoid while taking Xenical? 1 Oily discharge may be clear or have an orange or brown color.
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A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese. You may take the medicine either with your meal or up to 1 hour after eating. 4 lbs in the patients treated with XENICAL and 5. If your meal doesn’t contain any fat or you want to skip it, don’t take your dose. Do not take extra medicine to make up the missed dose.
Xenical is used to aid in weight loss, or to help reduce the risk of regaining weight already lost. Orlistat is a medicine that may be misused as a weight-loss aid, and you should be aware if anyone is using your medicine improperly or without a prescription. Do not use alli if you have had an organ transplant, if you use cyclosporine, or if you are not overweight. These vitamins are important if you are nursing a baby. Statistical significance based on intent-to-treat population, last observation carried forward.
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If you take a cyclosporine medicine, take XENICAL and cyclosporine at least 3 hours apart. 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. This Patient Information has been approved by the U. Report Problems to the Food and Drug Administration You are encouraged to report negative side effects of prescription drugs to the FDA. Nursing Mothers It is not known if XENICAL is present in human milk. Xenical is only part of a complete program of treatment that also includes diet, exercise, and weight control.
Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Should a significant overdose of XENICAL occur, it is recommended that the patient be observed for 24 hours. XENICAL may affect the way other medicines work, and other medicines may affect the way XENICAL works. BMI and body weight after 52 weeks of treatment for the intent-to-treat population are presented in Table 12. These are signs that the medicine is working properly. Onset of Type 2 Diabetes in Obese Patients In the XENDOS trial, in the overall population, XENICAL delayed the onset of type 2 diabetes such that at the end of four years of treatment the cumulative incidence rate of diabetes was 8.
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Do not use this medicine without a doctor’s advice if you are breast-feeding a baby. In addition, all patients were offered nutritional counseling. XENICAL patients had a normal oral glucose tolerance test while 10. Ethanol does not affect orlistat’s effect on preventing the absorption of fat. 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. Treatment with XENICAL may result in weight loss and improvement in obesity-related risk factors due to weight loss .
XENICAL is available for oral administration as a turquoise hard-gelatin capsule. Ask your doctor or pharmacist if you have any questions. Liver Injury There have been rare postmarketing reports of severe liver injury with hepatocellular necrosis or acute hepatic failure in patients treated with XENICAL, with some of these cases resulting in liver transplant or death. No causal relationship or physiopathological mechanism between pancreatitis and obesity therapy has been definitively established. Taking orlistat can make it harder for your body to absorb certain vitamins. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.
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Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. In addition, all patients were placed on a behavior modification program and offered exercise counseling. 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 . Store at room temperature away from moisture, heat, and light.
National Library of Medicine, Truven Health Analytics and Cerner Multum, Inc. In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed. Geriatric Use Clinical studies of XENICAL did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently from younger patients .
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HDL ratio and isolated systolic blood pressure were less than that observed in the year one results. Buying drugs in your country requires a prescription. Buying drugs in your country requires a prescription. 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. For more information, ask your doctor or pharmacist. Lowered absorption of certain vitamins in your body.
This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Tips on How to Use Orlistat Xenical It’s advisable to take this medication orally, usually with enough liquid and during every meal that contains fats or 1 hour after eating 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. XENICAL 120 mg Capsules: Turquoise, two-piece, No.