Xenical

What is Xenical?

• Orlistat [USAN:INN:BAN]

How does Xenical work?

• Isolated from Streptomyces toxytricini; inhibits 3C protease, viral.

What type of drug is Xenical?

• Anti-Obesity Agents
• Central Nervous System Agents
• Enzyme Inhibitors

What are the other names?

• Synonyms of Orlistat [USAN:INN:BAN]
• Alli
• HSDB 7556
• Orlipastat
• Orlipastatum
• Orlistat
• Ro 18-0647/002
• Tetrahydrolipstatin
• UNII-95M8R751W8

What is Xenical used for?

• Xenical is a reversible inhibitor of gastrointestinal lipases 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.

What are the doses?

• 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.
• For patients receiving both Xenical and levothyroxine therapy, administer levothyroxine and Xenical at least 4 hours apart.

What are the dosage forms?

• Capsules: 120 mg.

Who should not use this medicine?

• Pregnancy
• Chronic malabsorption syndrome
• Cholestasis
• Known hypersensitivity to Xenical or to any component of this product

What are the warnings and precautions?

• 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 increased levels of urinary oxalate following treatment with Xenical.
• Monitor renal function in patients at risk for renal insufficiency.
• 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).

What are the side effects?

• 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.

What are the drug interactions?

• 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.
• Antiretroviral drugs: Loss of virological control has been reported in HIV-infected patients.
• Patients should be monitored frequently for changes in HIV RNA levels.

Can nursing mothers use this medicine?

• Nursing mothers: Caution should be exercised when administered to a nursing woman.

• Dailymed label info on Xenical
• FDA Xenical

Xenical Resources
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