Orlistat

Xenical

• XENICAL is indicated for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet.
• XENICAL is also indicated to reduce the risk for weight regain after prior weight loss.
• XENICAL is indicated for obese patients with an initial body mass index (BMI) ≥30 kg/m 2 or ≥27 kg/m 2 in the presence of other risk factors (e.g., hypertension, diabetes, dyslipidemia).
• Table 1 illustrates body mass index (BMI) according to a variety of weights and heights.

Alli

• Weight loss aid
• for weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie and low-fat diet

Xenical

• XENICAL 120 mg turquoise capsules imprinted with XENICAL 120 in black ink.
• Capsules: 120 mg.

Alli

Orlistat 60 mg

Xenical

• One 120-mg capsule three times a day with each main meal containing fat (during or up to 1 hour after the meal).
• Advise patients to take a nutritionally balanced, reduced-calorie diet that contains approximately 30% of calories from fat.
• Distribute the daily intake of fat, carbohydrate, and protein over three main meals.
• Advise patients to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition.
• Take the vitamin supplement at least 2 hours before or after the administration of XENICAL, such as at bedtime.
• For patients receiving both XENICAL and cyclosporine therapy, administer cyclosporine 3 hours after XENICAL.

Alli

• read the enclosed brochure for other important information
• diet and exercise are the starting points for any weight loss program. Try these first before adding orlistat. Check with your doctor before starting any exercise program.
• to see if orlistat capsules are right for you, find your height on the chart to the right. You may consider starting a weight loss program with orlistat if your weight is the same or more than the weight shown for your height.
• for overweight adults 18 years and older: take 1 capsule with each meal containing fat
• do not take more than 3 capsules daily
• use with a reduced-calorie, low-fat diet and exercise program until you reach your weight loss goal. Most weight loss occurs in the first 6 months.
• if you stop taking orlistat, continue with your diet and exercise program
• if you start to regain weight after you stop taking orlistat, you may need to start taking orlistat again along with your diet and exercise program
• take a multivitamin once a day, at bedtime, when using orlistat

Xenical

most common adverse events resulting in discontinuation of treatment were gastrointestinal.

Alli

• you develop itching, yellow eyes or skin, dark urine or loss of appetite. There have been rare reports of liver injury in people taking orlistat.
• you develop severe pain in the back or groin, painful urination, blood in your urine, swelling of the legs or feet, or are urinating less often than normal. There have been rare reports of kidney injury in people taking orlistat.
• severe or continuous abdominal pain occurs. This may be a sign of a serious medical condition.
• you are taking medicine for seizures and your seizures happen more often or get worse

Xenical

• XENICAL has drug interactions and can decrease vitamin absorption.
• Take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition.
• Rare cases of severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported.
• Patients may develop oxalate nephrolithiasis and oxalate nephropathy following treatment with XENICAL. Monitor renal function in patients at risk for renal insufficiency. Discontinue XENICAL if oxalate nephropathy develops.
• Substantial weight loss can increase the risk of cholelithiasis.
• Exclude organic causes of obesity (eg, hypothyroidism) before prescribing XENICAL.
• Gastrointestinal events may increase when XENICAL is taken with a diet high in fat (>30% total daily calories from fat).

Alli

• gallbladder problems
• kidney disease or kidney stones
• pancreatitis
• take a multivitamin once a day, at bedtime . Orlistat can reduce the absorption of some vitamins.
• follow a well-balanced, reduced-calorie, low-fat diet. Try starting this diet before taking orlistat.
• orlistat works by preventing the absorption of some of the fat you eat. The fat passes out of your body, so you may have bowel changes. You may get: gas with oily spotting
• loose stools
• more frequent stools that may be hard to control
• eating a low-fat diet lowers the chance of having these bowel changes
• for every 5 pounds you lose from diet alone, orlistat can help you lose 2-3 pounds more. In studies, most people lost 5-10 pounds over 6 months.

Xenical

XENICAL is contraindicated in: Pregnancy Patients with chronic malabsorption syndrome Patients with cholestasis Patients with known hypersensitivity to XENICAL or to any component of this product Pregnancy Chronic malabsorption syndrome Cholestasis Known hypersensitivity to XENICAL or to any component of this product

Alli

• if you are taking cyclosporine
• if you have been diagnosed with problems absorbing food
• if you are not overweight

Xenical

• Cyclosporine: Reduction in cyclosporine plasma levels was observed when XENICAL was coadministered with cyclosporine.
• Fat-soluble Vitamin Supplements and Analogues: All patients should take a daily multivitamin that contains vitamins A, D, E, K, and beta-carotene.
• Levothyroxine: Patients treated concomitantly with XENICAL and levothyroxine should be monitored for changes in thyroid function.
• Warfarin: Patients on chronic stable doses of warfarin who are prescribed XENICAL should be monitored closely for changes in coagulation parameters.
• Amiodarone: A reduction in exposure to amiodarone was observed when XENICAL was co-administered.
• Antiepileptic Drugs: Convulsions have been reported in patients taking XENICAL with antiepileptic drugs. Patients should be monitored for possible changes in frequency or severity of convulsions.

Xenical

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. A minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese, due to the obligatory weight gain that occurs in maternal tissues during pregnancy.