120 mg TID show no additional benefit OTC (Alli): Up to 60 mg PO q8hr with each fat containing meal Only effective as an adjunct to caloric restriction, increased physical activity, and behavioral modification Also see Administration and Cautions (drug interaction overview) Flatulence Fatty/oily stool Increased defecation Fecal incontinence Nausea Vomiting Reduced absorption of fat soluble vitamins and beta-carotene Liver failure Oxalate nephropathy Leukocytoclastic vasculitis If a meal is missed or contains no fat, dose should be omitted Daily fat intake (30% of calories), carbohydrate, and protein should be evenly distributed over 3 main meals Note: Multivitamin supplement (including vit A, D, E, K) is recommended Postmarketing reports of severe liver injury with hepatocellular necrosis or acute hepatic failure with some cases resulting in liver transplant or death History of hyperoxaluria or calcium oxalate nephrolithiasis; cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported Substantial weight loss can increase risk of cholelithiasis Exclude organic causes of obesisty (eg, hypothyroidism), before prescribing therapy May increase gastrointestinal events when taking a diet high on fat ( Pregnancy Category: X; 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 Lactation: Not recommended; not known if orlistat is distributed in breast milk Take with each fat-containing meal (during or up to 1 hr after the meal) The patient should be on a nutritionally balanced, reduced-calorie diet that contains ~30% of calories from fat Daily intake of fat, carbohydrate, and protein should be distributed over 3 main meals If a meal is occasionally missed or contains no fat, omit the orlistat dose The above information is provided for general informational and educational purposes only. 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