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It is not known if XENICAL passes into your breast milk. Buying drugs in your country requires a prescription.
Rare cases of hypersensitivity have been reported with the use of XENICAL. Avoid eating high-fat meals or you could have unpleasant side effects on your stomach or intestines. 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. XENICAL is a prescription medicine used with a low calorie diet to increase weight loss in people with obesity.
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In a clinical trial of XENICAL for the prevention of type 2 diabetes, the rates of cholelithiasis as an adverse event were 2. 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. If you take a multivitamin, take it at least 2 hours before or after you take XENICAL.
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 . Xenical is not approved for use by anyone younger than 12 years old. Talk to your doctor right away if your seizures happen more often or get worse while you take XENICAL. 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.
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Rare cases of increase in transaminases and in alkaline phosphatase and hepatitis that may be serious have been reported. Buying drugs in your country requires a prescription. Postmarketing Experience The following adverse reactions have been identified during postapproval use of XENICAL. Stop taking this medicine and tell your doctor right away if you become pregnant. Because XENICAL has been shown to reduce the absorption of some fat-soluble vitamins and betacarotene, patients should be counseled to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition .
Antiepileptic Drugs Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs. 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 . Keep XENICAL in a tightly closed container. Weight loss is not recommended during pregnancy. 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 . Do not use in larger or smaller amounts or for longer than recommended.
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Subscribe to receive email notifications whenever new articles are published. 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. Common orlistat side effects are caused by its fat-blocking action. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Buying drugs in your country requires a prescription. The relative changes in risk factors associated with obesity following 2 years of therapy were also assessed in the population as a whole and the population with abnormal risk factors at randomization.
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. 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. Patients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function. Xenical is the prescription-strength form of orlistat.
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General information about the safe and effective use of XENICAL. 4 hours before or 4 hours after you take orlistat. Rare cases of leukocytoclastic vasculitis have been reported. XENICAL and other medicines may affect each other causing side effects. Orlistat blocks some of the fat that you eat, keeping it from being absorbed by your body. The diet prescribed in the second year was designed to maintain patient’s current weight.
Pancreatitis has been reported with the use of XENICAL in postmarketing surveillance. XENICAL may affect the way other medicines work, and other medicines may affect the way XENICAL works. Its empirical formula is C29H53NO5, and its molecular weight is 495.
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This medicine may be misused as a weight-loss aid, and you should be aware if anyone is using your medicine improperly or without a prescription. At the end of year 1, the patients’ diets were reviewed and changed where necessary. Find out everything you need to know about weight loss drugs in our prescription weight loss pill guide. You may report side effects to FDA at 1-800-FDA-1088. 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. If you skip a meal or you eat a meal that does not contain any fat, skip your dose for that meal.
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. Do not take XENICAL if you are pregnant or plan to become pregnant. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese. What other drugs will affect orlistat? No causal relationship or physiopathological mechanism between pancreatitis and obesity therapy has been definitively established.
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A reduced therapeutic effect of amiodarone is possible. Do not use XENICAL for a condition for which it was not prescribed. Your doctor may do certain tests to check your kidney function during treatment with XENICAL.
XENICAL-treated patients and increased by an average of 0. For patients receiving both XENICAL and levothyroxine therapy, administer levothyroxine and XENICAL at least 4 hours apart. This medicine must be used together with a reduced-calorie diet. Войдите, чтобы связаться с Orlistat 120mg Manaus-AM. Based on patients with a baseline and at least one follow-up OGTT measurement, ITT LOCF study population. 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.
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HDL ratio and isolated systolic blood pressure were less than that observed in the year one results. Further information Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use orlistat only for the indication prescribed. If you also take cyclosporine, do not take it within 3 hours before or 3 hours after you take orlistat.
This Patient Information has been approved by the U. The effect is the percentage of ingested fat excreted, referred to as fecal fat excretion percentage. Report Problems to the Food and Drug Administration You are encouraged to report negative side effects of prescription drugs to the FDA. Clinical Studies The long-term effects of XENICAL on morbidity and mortality associated with obesity have not been established. Fat-soluble Vitamin Supplements And Analogues Data from a pharmacokinetic interaction study showed that the absorption of beta-carotene supplement is reduced when concomitantly administered with XENICAL.
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DRUG INTERACTIONS Cyclosporine Data from a XENICAL and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when XENICAL was coadministered with cyclosporine. XENICAL patients had a normal oral glucose tolerance test while 10. Treatment with XENICAL may result in weight loss and improvement in obesity-related risk factors due to weight loss . 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. Other drugs may interact with orlistat, including prescription and over-the-counter medicines, vitamins, and herbal products.
It is a single diastereomeric molecule that contains four chiral centers, with a negative optical rotation in ethanol at 529 nm. Store at room temperature away from moisture, heat, and light. Avoid a diet that is high in fat. Dosing Instructions Patients should be counseled to take XENICAL as directed with meals or up to one hour after a meal. Throw away any unused orlistat after the expiration date on the medicine label has passed.
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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. 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. These are not all the possible side effects of XENICAL. In addition, all patients were offered nutritional counseling. Amiodarone A pharmacokinetic study, where amiodarone was orally administered during orlistat treatment, demonstrated a reduction in exposure to amiodarone and its metabolite, desethylamiodarone .
Do not use alli if you have had an organ transplant, if you use cyclosporine, or if you are not overweight. 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. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours.