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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. Keep XENICAL in a tightly closed container.
If a meal is occasionally missed or contains no fat, the dose of XENICAL can be omitted. 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.
HDL ratio, triglycerides, fasting glucose, fasting insulin, diastolic blood pressure, waist circumference, and hip circumference. Patients should also be advised to take multivitamin supplementation at least two hours before or after the administration of XENICAL, or at bedtime . What should I tell my doctor before taking XENICAL? Cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported.
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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 . Pediatric Use Safety and effectiveness in pediatric patients below the age of 12 have not been established. Data from a XENICAL and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when XENICAL was coadministered with cyclosporine. Take XENICAL exactly as your doctor tells you to take it.
Therefore, XENICAL and cyclosporine should not be simultaneously coadministered. For XENICAL, the most common adverse events resulting in discontinuation of treatment were gastrointestinal. XENICAL patients had a normal oral glucose tolerance test while 10. No causal relationship or physiopathological mechanism between pancreatitis and obesity therapy has been definitively established.
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Nursing Mothers It is not known if XENICAL is present in human milk. 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. Your doctor may do certain tests to check your kidney function during treatment with XENICAL. General information about the safe and effective use of XENICAL.
Study 14 161 was conducted with primary care physicians. 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 . HDL ratio and isolated systolic blood pressure were less than that observed in the year one results.
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Based on fecal fat measurements, the effect of XENICAL is seen as soon as 24 to 48 hours after dosing. 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. 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. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese. Clinical signs include palpable purpura, maculopapular lesions, or bullous eruption. Inactive Ingredients : microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, gelatin and titanium dioxide.
The iron balance was decreased by 64. If XENICAL is taken with any one meal very high in fat, the possibility of gastrointestinal effects increases. 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. What are the ingredients in XENICAL?
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However, GI adverse events may occur in some individuals over a period of 6 months or longer. Oily discharge may be clear or have a coloration such as orange or brown. The diet utilized during year 2 was designed for weight maintenance and not weight loss. XENICAL may affect the way other medicines work, and other medicines may affect the way XENICAL works. Take a multivitamin containing vitamins A, D, E, K, and beta-carotene one time each day.
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. Pediatric Patients In clinical trials with XENICAL in adolescent patients ages 12 to 16 years, the profile of adverse reactions was generally similar to that observed in adults. Safely throw away medicine that is out of date or no longer needed.
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Orlistat has no pK within the physiological pH range. If you take a multivitamin, take it at least 2 hours before or after you take XENICAL. For patients receiving both XENICAL and cyclosporine therapy, administer cyclosporine 3 hours after XENICAL. 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.
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. 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. XENICAL is a prescription medicine used with a low calorie diet to increase weight loss in people with obesity. XENICAL and other medicines may affect each other causing side effects. The number where these two meet is your BMI. Statistical significance based on intent-to-treat population, last observation carried forward.
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XENICAL-treated patients and increased by an average of 0. Rare cases of leukocytoclastic vasculitis have been reported. XENICAL should not be used after the given expiration date. Pharmacokinetics Absorption Systemic exposure to orlistat is minimal. 8 lbs in the placebo-treated patients.
In general, the first occurrence of these events was within 3 months of starting therapy. GI adverse events associated with XENICAL treatment lasted for less than 1 week, and a majority lasted for no more than 4 weeks. For patients receiving both XENICAL and levothyroxine therapy, administer levothyroxine and XENICAL at least 4 hours apart. The capsule is imprinted with black. Do not give XENICAL to other people, even if they have the same symptoms that you have. Following one year of treatment, BMI decreased by an average of 0.
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Patients should be advised to adhere to dietary guidelines . Levothyroxine Hypothyroidism has been reported in patients treated concomitantly with XENICAL and levothyroxine postmarketing. 1 Oily discharge may be clear or have an orange or brown color. 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. Rare cases of hypersensitivity have been reported with the use of XENICAL. 2, with black printing ink containing pharmaceutical grade shellac, propylene glycol, strong ammonium solution, potassium hydroxide and black iron oxide.
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. At the end of the study, the mean percent weight loss in the placebo group was -2. XENICAL and placebo treatment groups, respectively. XENICAL is a turquoise, hard-gelatin capsule containing pellets of powder. 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. At the end of year 1, the patients’ diets were reviewed and changed where necessary.
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BMI and body weight after 52 weeks of treatment for the intent-to-treat population are presented in Table 12. INDICATIONS XENICAL is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet. The vitamin supplement should be taken at least 2 hours before or after the administration of XENICAL, such as at bedtime. These are not all the possible side effects of XENICAL. 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.
A Member of the Roche Group, 1 DNA Way, South San Francisco, CA 94080-4990. Take a multivitamin at least 2 hours before or after you take XENICAL, such as at bedtime. Amiodarone A pharmacokinetic study, where amiodarone was orally administered during orlistat treatment, demonstrated a reduction in exposure to amiodarone and its metabolite, desethylamiodarone . Then move across the top row to find the weight closest to your weight.
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They may not work as well while you take XENICAL. Keep XENICAL and all medicines out of the reach of children. 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 . Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours.
Talk to your doctor before you breastfeed and take XENICAL. Postmarketing Experience The following adverse reactions have been identified during postapproval use of XENICAL. In addition, all patients were offered nutritional counseling. 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. XENICAL is available for oral administration as a turquoise hard-gelatin capsule. Based on patients with a baseline and at least one follow-up OGTT measurement, ITT LOCF study population.