Orlistat: Uses, Dosage & Side Effects. Generic Name: orlistat (OR li stat)Brand Names: alli, Xenical. What is orlistat? Orlistat blocks some of the fat that you eat, keeping it from being absorbed by your body. Orlistat side effects. Get emergency medical help if you have any signs of an allergic reaction to orlistat: hives; difficult breathing; swelling of your face, lips. Amsa Fast 42 Capsules Orlistat 120 mg Price $49.99 Free Shipping on Orders of $75 or More. What is Amsa Fast? Amsa fast is a fat blocker which main ingredient is. XENICAL (orlistat) Capsules. DESCRIPTION. XENICAL (orlistat) is a gastrointestinal lipase inhibitor for obesity management that acts by inhibiting the absorption of. Orlistat is used to aid in weight loss, or to help reduce the risk of regaining weight already lost. This medicine must be used together with a reduced- calorie diet. Orlistat is for use only in adults. It is dangerous to purchase orlistat on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of . For more information, contact the U. S. Food and Drug Administration (FDA) or visit www. Important information. Do not take orlistat if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight or obese. You should not take orlistat if you have gallbladder problems or chronic malabsorption syndrome (an inability to absorb food and nutrients properly). Before taking orlistat, tell your doctor if you have an underactive thyroid, a history of gallstones or pancreatitis, type 1 or type 2 diabetes, an eating disorder, liver disease, or if you take other weight- loss medications (prescription or over- the- counter). Do not give the over- the- counter brand (alli) to a child younger than 1. Prescription orlistat (Xenical) should not be used by anyone age 1. This medication should be used only by the person it was prescribed or recommended for and should never be shared with another person, especially someone who has a history of eating disorder. Keep the medication in a place where others cannot get to it. Orlistat 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. Follow your diet, medication, and exercise routines very closely. Avoid a diet that is high in fat. High- fat meals taken in combination with orlistat can increase your risk of unpleasant side effects on your stomach or intestines. Before taking this medicine. WebMD explains how the weight loss drug orlistat, marketed as Alli and Xenical, works, and its possible side effects. Pictures of Xenical (Orlistat 120 mg), drug imprint information, side effects for the patient. For the Consumer. Applies to orlistat: oral capsule. As well as its needed effects, orlistat may cause unwanted side effects that require medical attention. You should not take orlistat if you are allergic to it, or if you have: gallbladder problems; chronic malabsorption syndrome (an inability to absorb food and nutrients properly); orif you are pregnant. Ask a doctor or pharmacist if it is safe for you to use orlistat if you have other medical conditions, especially: liver disease; kidney disease; a history of gallstones or kidney stones; underactive thyroid; a history of pancreatitis; type 1 or type 2 diabetes; an eating disorder (anorexia or bulimia); orif you take any other weight- loss medications (prescription or over- the- counter). Do not use orlistat if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight or obese. Stop taking this medicine and tell your doctor right away if you become pregnant. Taking orlistat can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use this medicine without a doctor's advice if you are breast- feeding a baby. Prescription orlistat (Xenical) should not be given to a child younger than 1. The over- the- counter brand (alli) is not approved for use by anyone younger than 1. How should I take orlistat? Take orlistat exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Never share orlistat with another person, especially someone who has a history of eating disorder. Keep the medication in a place where others cannot get to it. This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions. Orlistat is usually taken 3 times per day with each main meal that contains some fat (no more than 3. You may take the medicine either with your meal or up to 1 hour after eating. If you skip a meal or you eat a meal that does not contain any fat, skip your orlistat dose for that meal. The fat content of your daily diet should not be greater than 3. For example, if you eat 1. Read the label of all food items you consume, paying special attention to the number of servings per container. Your doctor, nutrition counselor, or dietitian can help you develop a healthy eating plan. Orlistat 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. Follow your diet, medication, and exercise routines very closely. Orlistat can make it harder for your body to absorb fat- soluble vitamins, such as vitamins A, D, E, and K. Your doctor may recommend that you take vitamin and mineral supplements while you are taking this medicine. Follow your doctor's instructions about the type of multi- vitamin or mineral supplement to use. Take your vitamin or supplement at bedtime, or at least 2 hours before or after you take orlistat. Store at room temperature away from moisture and heat. Keep the bottle tightly closed. Throw away any unused medicine after the expiration date on the medicine label has passed. Keep track of the amount of medicine used from each new bottle. Orlistat is a drug 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. See also: Dosage Information (in more detail)What happens if I miss a dose? Take the missed dose as soon as you remember, but no more than 1 hour after eating a meal. 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. Do not take extra medicine to make up the missed dose. What happens if I overdose? Seek emergency medical attention or call the Poison Help line at 1- 8. What should I avoid while taking orlistat? Avoid a diet that is high in fat. High- fat meals taken in combination with orlistat can increase your risk of unpleasant side effects on your stomach or intestines. If you also take cyclosporine, do not take it within 3 hours before or 3 hours after you take orlistat. If you also take levothyroxine (such as Synthroid), do not take it within 4 hours before or 4 hours after you take orlistat. Orlistat side effects. Get emergency medical help if you have any signs of an allergic reaction to orlistat: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Stop using orlistat and call your doctor at once if you have: severe pain in your lower back; blood in your urine, painful or difficult urination; kidney problems- -little or no urinating; swelling in your feet or ankles; feeling tired or short of breath; orliver problems- -nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay- colored stools, jaundice (yellowing of the skin or eyes). Common orlistat side effects are caused by its fat- blocking action. These are signs that the medicine is working properly. These side effects are usually temporary and may lessen as you continue using orlistat: oily or fatty stools; oily spotting in your undergarments; orange or brown colored oil in your stool; gas and oily discharge; loose stools, or an urgent need to go to the bathroom, inability to control bowel movements; an increased number of bowel movements; orstomach pain, nausea, rectal pain. This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1- 8. FDA- 1. 08. 8. See also: Side effects (in more detail)Orlistat dosing information. Usual Adult Dose for Obesity: 1. The dose may be taken during the meal or within 1 hour of completing the meal. Usual Pediatric Dose for Obesity: 1. The dose may be taken during the meal or within 1 hour of completing the meal. What other drugs will affect orlistat? Tell your doctor about all medicines you use, and those you start or stop using during your treatment with orlistat, especially: amiodarone; insulin or oral diabetes medicine; seizure medication (especially if your seizures get worse while taking orlistat; a vitamin or mineral supplement that contains beta carotene or vitamin E; orwarfarin (Coumadin, Jantoven). This list is not complete. Other drugs may interact with orlistat, including prescription and over- the- counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. More about orlistat. Consumer resources. Other brands: Xenical, Alli. Professional resources. Related treatment guides. Where can I get more information? Your pharmacist can provide more information about orlistat. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed. Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Side Effects, Interactions, Warning, Dosage & Uses. CLINICAL PHARMACOLOGYMechanism Of Action. Orlistat is a reversible inhibitor of gastrointestinal. It exerts its therapeutic activity in the lumen of the stomach and. The inactivated enzymes are thus unavailable. As undigested triglycerides are not absorbed. Pharmacodynamics. Dose- response Relationship. The dose- response relationship for orlistat in human. Figure 1. The effect is the percentage of ingested fat. Both individual data (open. Figure 1. Figure 1 : Dose- Response Relationship for Orlistat in. Human Volunteers. At the recommended therapeutic dose of 1. Ethanol does not affect orlistat's effect on preventing. Other Short- term Studies. Adults. In several studies of up to 6- weeks duration, the effects. XENICAL on gastrointestinal and systemic physiological. Postprandialcholecystokinin plasma concentrations were lowered after multiple doses of XENICAL. There were no clinically significant changes observed in. In addition, no effects on plasma triglyceride levels. XENICAL in these. In a 3- week study of 2. XENICAL (1. 20 mg three. Pediatrics. In a 3- week study of 3. XENICAL (1. 20 mg three times a day) did not significantly affect the. The iron balance. Following oral. dosing with 3. C- orlistat, plasma radioactivity peaked at. L). In therapeutic studies involving monitoring of. L or 0. 0. 2 . Orlistat minimally. Metabolism. Based on an oral 1. C- orlistat mass balance. M1 ((the hydrolyzed . M1 and M3 have an open . In view of this low inhibitory activity and the low plasma. L and 1. 08 ng/m. L for M1 and. M3, respectively, 2 to 4 hours after a dose), these metabolites are considered. The primary metabolite M1 had a short. M3. eliminated at a slower rate (half- life approximately 1. Elimination. Following a single oral dose of 3. C- orlistat. in both normal weight and obese subjects, fecal excretion of the unabsorbed. Orlistat and its M1 and M3. Approximately 9. 7% of the. The cumulative renal excretion of total radioactivity was. C- orlistat. The time to reach. The disposition of. Based. on limited data, the half- life of the absorbed orlistat is in the range of 1 to. Specific Populations. No pharmacokinetic study was conducted for specific. Drug Interactions. Alcohol. In a multiple- dose study in 3. XENICAL and 4. 0 grams of alcohol (e. Amiodarone. In a pharmacokinetic study conducted in healthy. Day 1. 4 co- administered with a single. Day 4, a 2. 3 – 2. The effect of commencing orlistat treatment in patients on. Cyclosporine. In a multiple- dose study, coadministration of 5. XENICAL three times daily decreased. AUC and Cmax by 3. In the same study. XENICAL three times daily decreased cyclosporine AUC. Cmax by 1. 7% and 4%, respectively. Digoxin. In 1. 2 normal- weight subjects receiving XENICAL 1. XENICAL did not alter the pharmacokinetics of a. Fat- soluble Vitamin Supplements and Analogues. A pharmacokinetic interaction study showed a 3. XENICAL. XENICAL inhibited absorption of a vitamin E acetate supplement. The effect of XENICAL on the absorption of supplemental. D, vitamin A, and nutritionally- derived vitamin K is not known at this. Glyburide. In 1. 2 normal- weight subjects receiving orlistat 8. Nifedipine (extended- release tablets)In 1. XENICAL 1. 20 mg. XENICAL did not alter the bioavailability of. Oral Contraceptives. In 2. 0 normal- weight female subjects, the treatment of. XENICAL 1. 20 mg three times a day for 2. Phenytoin. In 1. 2 normal- weight subjects receiving XENICAL 1. XENICAL did not alter the pharmacokinetics of a. Pravastatin. In a 2- way crossover study of 2. XENICAL 1. 20 mg three times a day for 6. XENICAL did not affect the pharmacokinetics of pravastatin. Warfarin. In 1. 2 normal- weight subjects, administration of XENICAL. R- and S- enantiomers) or pharmacodynamics. Factor VII). Although undercarboxylated osteocalcin. K nutritional status, was unaltered with XENICAL. K levels tended to decline in subjects taking XENICAL. During the first year of therapy, the. During. the second year of therapy, some studies assessed continued weight loss and. XENICAL on weight regain. The majority of these. In the XENDOS study. Caucasians. 1% other), the time to onset of type 2 diabetes was assessed in addition to. In all these studies, treatment with XENICAL and placebo. XENICAL plus diet and placebo plus diet. During the weight loss and weight maintenance period, a. In addition, all patients were offered. One- year Results : Weight Loss, Weight Maintenance, And Risk. Factors. Pooled data from five clinical trials indicated that the. XENICAL. and 5. 8 lbs in the placebo- treated patients. After 1 year of treatment, the. XENICAL- treated patients and. One thousand seventy two (6. XENICAL and 7. 01 (6. Of the patients who completed 1 year of treatment, 5. XENICAL (1. 20 mg three times a day) and 3. The percentages of patients achieving . Study 1. 4 1. 61 was. The relative changes in risk factors associated with. XENICAL and placebo are presented for. Population as a Whole. The changes in metabolic, cardiovascular and. Table 7. One year of therapy with XENICAL. Table 7 : Mean Change in Risk Factors From Randomization. Following 1- Year Treatment Population as a Whole. Risk Factor. XENICAL 1. HDL increased in the placebo group by 2. XENICAL group by. In the population with abnormal blood pressure at baseline (systolic. BP. . For patients with a diastolic. Fasting insulin decreased more. XENICAL than placebo (- 3. L) from randomization to 1 year in. A greater. reduction in waist circumference for XENICAL vs placebo (- 7. The diet utilized during the. For studies 1. 41. C and 1. 41. 85, patients'. XENICAL in conjunction. Study 1. 43. 02 was conducted to evaluate the. XENICAL on weight regain in patients who. In study 1. 41. 19. C, patients treated with placebo regained. XENICAL regained 2. In. study 1. 41. 85, patients treated with placebo regained 6. XENICAL regained 3. In study 1. 43. 02, patients treated with placebo regained 5. XENICAL. regained 3. Two- year Results : Long- term Weight Control And Risk. Factors. The treatment effects of XENICAL were examined for 2. Table 6). At the end of year 1, the patients' diets were. The diet prescribed in the second year. XENICAL was shown to be more. Pooled data from four clinical studies indicate that 7. XENICAL and 7. 6% of. Pooled. data from four clinical studies indicate that the mean weight loss difference. XENICAL 1. 20 mg three times a day and placebo treatment groups at year 2. ITT LOCF) was 3%. In the. same studies cited in the One- year Results (see Table 6), the percentages. Study 1. 4 1. 61 was. The relative changes in risk factors associated with. Population as a Whole. The relative differences in risk factors between. XENICAL and placebo were similar to the results following 1 year. LDL- cholesterol, LDL/HDL ratio, triglycerides. The relative differences between. HDL cholesterol and systolic blood pressure were less than. Population With Abnormal Risk Factors at Randomization. The relative differences in risk factors between. XENICAL and placebo were similar to the results following 1 year. LDL- and HDL- cholesterol, triglycerides, fasting insulin, diastolic. The relative differences between. LDL/HDL ratio and isolated systolic blood pressure were. Four- year Results : Long- term Weight Control And Risk. Factors. In the 4- year double- blind, placebo- controlled XENDOS. XENICAL in delaying the onset of type 2 diabetes and on. Thirty- four percent of the. XENICAL group completed the 4- year study. At the end of the study, the mean percent weight loss in. XENICAL group. (p < 0. Figure 2). Forty- five percent of the placebo patients and 7. XENICAL patients lost . Following 4. years of treatment, 2. XENICAL patients. This finding was. Table 1. 0 and Figure 3). XENICAL did not reduce the risk for the. The effect of XENICAL to delay the onset of type 2. IGT is presumably due to weight loss, and not. The effect. of XENICAL on weight loss is adjunctive to diet and exercise. Table 1. 0 : Incidence Rate of Diabetes at Year 4 by. OGTT Status at Baseline*OGTT at Baseline. Normal. Impaired. All. Treatment. Placebo. XENICALPlacebo. XENICALPlacebo. XENICALNumber of patients*1. Life table rate. Thirty percent of. XENICAL achieved at least a 5% or greater reduction in. For HDL cholesterol, there was a +6. XENICAL and +8. 6% increase on placebo, p > 0. Systolic blood pressure. Hg on XENICAL and increased by +4. Hg on placebo. p > 0. Diastolic blood pressure decreased by - 0. Hg for XENICAL and by. Hg for placebo, p > 0. Glucose Tolerance In Obese Patients. Two- year studies that included oral glucose tolerance. OGTT) status at. randomization was either normal, impaired, or diabetic. The progression from a normal OGTT at randomization to a. OGTT following 2 years of treatment with XENICAL (n=2. Following treatment with XENICAL, 0. In patients found to have an impaired OGTT at. XENICAL compared to. After 1 year of treatment, 4. XENICAL patients had a normal oral glucose tolerance test while. XENICAL patients became diabetic. All study. participants had a baseline BMI that was 2 units greater than the US weighted. Body mass index was the primary. During the study, all patients were instructed to take a. XENICAL. Patients were also maintained on a well- balanced, reduced- calorie. In addition, all. Approximately 6. 5% of patients in each treatment group. Following one year of treatment, BMI decreased by an.
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