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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. The safety and efficacy of XENICAL have been evaluated in obese adolescent patients aged 12 to 16 years. Common Xenical side effects are caused by orlistat’s fat-blocking action.
Rare cases of leukocytoclastic vasculitis have been reported. XENICAL and other medicines may affect each other causing side effects. XENICAL 120 mg three times a day and with an incidence that was greater than placebo during year 1 and year 2, regardless of relationship to study medication.
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Further information Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Xenical only for the indication prescribed. Its empirical formula is C29H53NO5, and its molecular weight is 495. CLINICAL PHARMACOLOGY Mechanism Of Action Orlistat is a reversible inhibitor of gastrointestinal lipases. Xenical is only part of a complete program of treatment that also includes diet, exercise, and weight control. INDICATIONS XENICAL is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet.
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. Buying drugs in your country requires a prescription. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Your doctor may do certain tests to check your kidney function during treatment with XENICAL. Take a multivitamin at least 2 hours before or after you take XENICAL, such as at bedtime. See “What should I tell my doctor before taking XENICAL?
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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. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Data from a XENICAL and cyclosporine drug interaction study indicate a reduction in cyclosporine plasma levels when XENICAL was coadministered with cyclosporine. Doses above 120 mg three times a day have not been shown to provide additional benefit. 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 .
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Cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported. XENICAL and cyclosporine should not be simultaneously coadministered. Pharmacokinetics Absorption Systemic exposure to orlistat is minimal. 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. The daily intake of fat should be distributed over three main meals. It is not known if XENICAL is safe and effective in children under 12 years old.
Stop taking orlistat and tell your doctor right away if you become pregnant. The number where these two meet is your BMI. Patients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function. 24,000 prescription drugs, over-the-counter medicines and natural products. The dose may be taken during the meal or within 1 hour of completing the meal. Medically reviewed on January 2, 2018.
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Orlistat has no pK within the physiological pH range. In addition, all patients were offered nutritional counseling. Weight loss is not recommended during pregnancy. Find the height closest to your height in the left-hand column.
Call your doctor for medical advice about side effects. Read this Patient Information before you start taking XENICAL and each time you get a refill. Doses above 120 mg three times a day have not been shown to provide additional benefit.
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The diet utilized during year 2 was designed for weight maintenance and not weight loss. 4 hours before or 4 hours after you take Xenical. Xenical is used to aid in weight loss, or to help reduce the risk of regaining weight already lost. Buying drugs in your country requires a prescription. Available for Android and iOS devices. Buying drugs in your country requires a prescription.
What are the ingredients in XENICAL? Following one year of treatment, BMI decreased by an average of 0. 2, with black printing ink containing pharmaceutical grade shellac, propylene glycol, strong ammonium solution, potassium hydroxide and black iron oxide. Your doctor will tell you how much XENICAL to take and when to take it.
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In clinical trials in obese diabetic patients, hypoglycemia and abdominal distension were also observed. The daily intake of fat, carbohydrate, and protein should be distributed over three main meals. General information about the safe and effective use of XENICAL. 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. High-fat meals taken in combination with Xenical can increase your risk of unpleasant side effects on your stomach or intestines.
These are signs that the medicine is working properly. 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. 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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Do not give alli to anyone under 18 years old. Take the supplement at bedtime, or at least 2 hours before or after you take orlistat. 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. 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.
Cholelithiasis Substantial weight loss can increase the risk of cholelithiasis. The vitamin supplement should be taken at least 2 hours before or after the administration of XENICAL, such as at bedtime. Safely throw away medicine that is out of date or no longer needed. Caution should be exercised when XENICAL is administered to a nursing woman.
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At the end of the study, the mean percent weight loss in the placebo group was -2. Levothyroxine Hypothyroidism has been reported in patients treated concomitantly with XENICAL and levothyroxine postmarketing. The BMI is calculated by dividing weight in kilograms by height in meters squared. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records.
Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48 to 72 hours. Ask your doctor or pharmacist if you have any questions. Based on fecal fat measurements, the effect of XENICAL is seen as soon as 24 to 48 hours after dosing. This Patient Information has been approved by the U. 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. Keep XENICAL and all medicines out of the reach of children.
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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. HDL ratio and isolated systolic blood pressure were less than that observed in the year one results. Call your doctor for medical advice about side effects.
Buying drugs in your country requires a prescription. This medicine must be used together with a reduced-calorie diet and is to used only by adults. 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. 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 take XENICAL if you are pregnant or plan to become pregnant. Buying drugs in your country requires a prescription.