Xenical 120mg
Xenical blocks some of the fat that you eat, keeping it from being absorbed by your body. it 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 and is to used only by adults Xenical 120mg
Xenical 120mg Prescribing Information
Package insert / product label
Generic name: orlistat
Dosage form: capsule
Drug class: Peripherally acting antiobesity agents
These highlights do not include all the information needed to use XENICAL safely and effectively.
See full prescribing information for XENICAL.
See full prescribing information for XENICAL.
(orlistat)XENICAL Capsules for oral use
Initial U.S. Approval: 1999
Recent Major Changes
- Warnings and Precautions, Oxalate Nephrolithiasis and Oxalate Nephropathy with Renal Failure
Indications and Usage for Xenical
- This mediction 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.
- It is also indicated to reduce the risk for weight regain after prior weight loss.
Xenical Dosage and Administration
- 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. ( 2)
- Advise patients to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition. ( 2)
- 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.
Dosage Forms and Strengths
- Capsules: 120 mg.
Contraindications
- Pregnancy
- Chronic malabsorption syndrome
- Cholestasis
- Known hypersensitivity to XENICAL or to any component of this product
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 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).
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