Orlistat

XENICAL is indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: adults and pediatric patients aged 12 years and older with obesity. adults with overweight in the presence of at least one weight-related comorbid condition. XENICAL is an intestinal lipase inhibitor indicated in combination with a reduced calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in: adults and pediatric patients aged 12 years and older with obesity. adults with overweight in the presence of at least one weight-related comorbid condition.

Orlistat is a reversible inhibitor of gastrointestinal lipases. It exerts its therapeutic activity in the lumen of the stomach and small intestine by forming a covalent bond with the active serine residue site of gastric and pancreatic lipases. The inactivated enzymes are thus unavailable to hydrolyze dietary fat in the form of triglycerides into absorbable free fatty acids and monoglycerides. Undigested triglycerides are not absorbed, resulting in a caloric deficit.

The recommended dosage of XENICAL is one 120 mg capsule taken orally three times a day with each main meal containing fat (during or up to 1 hour after the meal). Take XENICAL with 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. Skip the dose of XENICAL if a meal is missed or contains no fat. Resume XENICAL at the next scheduled main meal containing fat. Administer a multivitamin containing fat-soluble vitamins once daily at least 2 hours before or 2 hours after administration of XENICAL, or at bedtime. Recommended Dosage and Administration The recommended dosage of XENICAL is one 120 mg capsule taken orally three times a day with each main meal containing fat (during or up to 1 hour after the meal).

XENICAL is contraindicated in patients with: chronic malabsorption syndrome cholestasis known hypersensitivity to orlistat or any of the inactive ingredients in XENICAL. Serious hypersensitivity reactions, including anaphylactic reactions and angioedema, have been reported with XENICAL. Chronic malabsorption syndrome. Cholestasis. Known hypersensitivity to orlistat or any of the inactive ingredients in XENICAL

Loss of Effect of Certain Medications and Dietary Supplements with Coadministration of XENICAL: Serious outcomes due to the loss of effect of cyclosporine, levothyroxine, warfarin, amiodarone, antiepileptic drugs, antiretroviral drugs, certain fat-soluble vitamins, and beta carotene have been reported with coadministration of XENICAL. Liver Injury: Severe liver injury with hepatocellular necrosis or acute hepatic failure have been reported in patients treated with XENICAL, some cases resulted in liver transplant or death. Instruct patients to report any symptoms of hepatic dysfunction, immediately discontinue if symptoms occur and obtain liver function tests. Oxalate Nephrolithiasis and Oxalate Nephropathy with Renal Failure: Monitor renal function in patients at increased risk for oxalate nephropathy. Discontinue XENICAL in patients who develop oxalate nephropathy.

Most common treatment emergent adverse reactions (≥5% and at least twice that of placebo) include oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation and fecal incontinence.

Cyclosporine: Avoid simultaneous coadministration with XENICAL. Administer cyclosporine 3 hours after XENICAL. Monitor for effectiveness. Fat-soluble Vitamin Supplements and Analogues: Administer a multivitamin supplement at least 2 hours before or 2 hours after the administration of XENICAL, or at bedtime. Levothyroxine: Avoid simultaneous coadministration with XENICAL. Administer levothyroxine and XENICAL at least 4 hours apart. Monitor for changes in thyroid function. Anticoagulants including Warfarin: Monitor for changes in coagulation parameters. Amiodarone: Monitor patients as clinically indicated. Antiepileptic Drugs: Monitor patients for changes in seizure frequency. Antiretroviral Drugs: Monitor HIV RNA levels frequently and discontinue XENICAL if there is an increase in HIV viral load.

Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).