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The diet prescribed in the second year was designed to maintain patient’s current weight. If you take a levothyroxine medicine, take XENICAL and levothyroxine at least 4 hours apart. 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. 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 .
Talk to your doctor before you breastfeed and take XENICAL. XENICAL discontinued treatment due to adverse events, compared with 5. Based on patients with a baseline and at least one follow-up OGTT measurement, ITT LOCF study population. What should I tell my doctor before taking XENICAL?
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. In a clinical trial of XENICAL for the prevention of type 2 diabetes, the rates of cholelithiasis as an adverse event were 2. It is a single diastereomeric molecule that contains four chiral centers, with a negative optical rotation in ethanol at 529 nm. The BMI is calculated by dividing weight in kilograms by height in meters squared.
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For example, a person who weighs 180 lbs and is 5’5″ has a BMI of 30. Lower gastrointestinal bleeding has been reported in patients treated with XENICAL. 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. 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.
Report Problems to the Food and Drug Administration You are encouraged to report negative side effects of prescription drugs to the FDA. Find the height closest to your height in the left-hand column. Anticoagulants Including Warfarin Vitamin K absorption may be decreased with XENICAL. The diet utilized during year 2 was designed for weight maintenance and not weight loss. 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. Buying drugs in your country requires a prescription.
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Should a significant overdose of XENICAL occur, it is recommended that the patient be observed for 24 hours. Buying drugs in your country requires a prescription. This information does not take the place of talking to your doctor about your medical condition or your treatment. Nursing Mothers It is not known if XENICAL is present in human milk. They may not work as well while you take XENICAL. XENICAL is available for oral administration as a turquoise hard-gelatin capsule.
2 years of the same therapy. For more information, ask your doctor or pharmacist. It is not known if XENICAL is safe and effective in children under 12 years old. Caution should be exercised when XENICAL is administered to a nursing woman. 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. WARNINGS Included as part of the PRECAUTIONS section.
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The capsule is imprinted with black. Lowered absorption of certain vitamins in your body. 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. Buying drugs in your country requires a prescription. It is not known if XENICAL passes into your breast milk.
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 . HDL ratio, triglycerides, fasting glucose, fasting insulin, diastolic blood pressure, waist circumference, and hip circumference. If XENICAL is taken with any one meal very high in fat, the possibility of gastrointestinal effects increases.
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Buying drugs in your country requires a prescription. XENICAL patients had a normal oral glucose tolerance test while 10. The effect is the percentage of ingested fat excreted, referred to as fecal fat excretion percentage.
Neither study showed embryotoxicity or teratogenicity. If you take a cyclosporine medicine, take XENICAL and cyclosporine at least 3 hours apart. 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.
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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 . Then move across the top row to find the weight closest to your weight. For XENICAL, the most common adverse events resulting in discontinuation of treatment were gastrointestinal.
If you take a multivitamin, take it at least 2 hours before or after you take XENICAL. In the 4-year XENDOS study, the general pattern of adverse events 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 each year over the 4-year period. Specific Populations No pharmacokinetic study was conducted for specific populations such as geriatric, different races, and patients with renal and hepatic impairment. Buying drugs in your country requires a prescription.
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Bedtime is a good time to take your multivitamin. Buying drugs in your country requires a prescription. In addition, all patients were offered nutritional counseling. Read this Patient Information before you start taking XENICAL and each time you get a refill. 2, with black printing ink containing pharmaceutical grade shellac, propylene glycol, strong ammonium solution, potassium hydroxide and black iron oxide. XENICAL is a turquoise, hard-gelatin capsule containing pellets of powder.
Weight-loss may affect glycemic control in patients with diabetes mellitus. The effect of commencing orlistat treatment in patients on stable amiodarone therapy has not been studied. Keep XENICAL in a tightly closed container.
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Dosing Instructions Patients should be counseled to take XENICAL as directed with meals or up to one hour after a 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. If you take too much XENICAL call your doctor or go to the nearest hospital emergency room right away. 1 year in five large multicenter studies for the intent-to-treat populations are presented in Table 6. 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.
Antiepileptic Drugs Convulsions have been reported in patients treated concomitantly with orlistat and antiepileptic drugs. Levothyroxine Hypothyroidism has been reported in patients treated concomitantly with XENICAL and levothyroxine postmarketing. HDL ratio and isolated systolic blood pressure were less than that observed in the year one results.
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Buying drugs in your country requires a prescription. Statistical significance based on intent-to-treat population, last observation carried forward. Pancreatitis has been reported with the use of XENICAL in postmarketing surveillance.
XENICAL and cyclosporine should not be simultaneously coadministered. The relative changes in risk factors associated with obesity following 1 year of therapy with XENICAL and placebo are presented for the population as a whole and for the population with abnormal values at randomization. Rare cases of leukocytoclastic vasculitis have been reported.
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Your doctor may do certain tests to check your kidney function during treatment with XENICAL. Buying drugs in your country requires a prescription. XENICAL inhibited absorption of a vitamin E acetate supplement. XENICAL should not be used after the given expiration date. Postmarketing Experience The following adverse reactions have been identified during postapproval use of XENICAL. A reduced therapeutic effect of amiodarone is possible.
After 1 year of treatment, 45. Pharmacokinetics Absorption Systemic exposure to orlistat is minimal. 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. Acute oxalate nephropathy after treatment with XENICAL has been reported in patients with or at risk for renal disease . Do not give XENICAL to other people, even if they have the same symptoms that you have. Patients should also be advised to take multivitamin supplementation at least two hours before or after the administration of XENICAL, or at bedtime .