Orlistat

What is Orlistat?

• Orlistat (Xenical; Alli) is a reversible inhibitor of gastrointestinal lipases used with a low calorie diet to increase weight loss in people with obesity.
• Orlistat may help obese people lose weight and keep the weight off.

Orlistat

Orlistat Structural Formulae

Orlistat ball-and-stick model

Orlistat3Dan

What are the uses of this medicine?

• Orlistat (Xenical; Alli) is used for obesity management including weight loss and weight maintenance when used in conjunction with a reduced-calorie diet.
• Orlistat (Xenical; Alli) is also indicated to reduce the risk for weight regain after prior weight loss.
• Prescription orlistat is used in overweight people who may also have high blood pressure, diabetes, high cholesterol, or heart disease.

How does this medicine work?

• Orlistat (or' li stat) is a tetrahydrolipstatin, a saturated derivative of lipstatin which is a potent natural inhibitor of gastric and pancreatic lipase.
• Orlistat when taken with meals inhibits the digestion of dietary fats and prevents their absorption, thus reducing caloric intake.
• When used in conjunction with caloric restriction and exercise, orlistat improves weight loss.

Who Should Not Use this medicine ?

This medicine cannot be used in:

• Pregnancy
• Patients with chronic malabsorption syndrome
• Patients with cholestasis
• Patients with known hypersensitivity to Orlistat or to any component of this product

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention the medications listed below:

• cyclosporine (Gengraf, Neoral, Sandimmune, Restasis, Sangcya)
• beta-carotene or vitamin E supplements
• levothyroxine (Levo-T, Levolet, Levothyroid, Levothyroxine Sodium, Levoxyl, Novothyrox, Synthroid, Tirosint, Unithroid).
• warfarin (Athrombin, Athrombin-K, Coumadin, Jantoven, Panwarfin, Warfarin Sodium)
• amiodarone (Cordarone, Pacerone)
• medicines used to treat seizures. They may not work as well while you take XENICAL. Talk to your doctor right away if your seizures happen more often or get worse while you take XENICAL.
• antiretroviral medicines used to treat HIV. They may not work as well while you take XENICAL.

Is this medicine FDA approved?

• Orlistat as Xenical was approved for use in the United States in 1999, and an over-the-counter formulation of the drug (Alli) was approved in 2007.

How should this medicine be used?

Recommended dosage:

• 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 ,Orlistat such as at bedtime.
• For patients receiving both Orlistat and cyclosporine therapy, administer cyclosporine 3 hours after Orlistat.
• For patients receiving both Orlistat and levothyroxine therapy, administer levothyroxine and Orlistat at least 4 hours apart.
• Doses above 120 mg three times a day have not been shown to provide additional benefit.

Administration:

• Orlistat comes as a capsule and a nonprescription capsule to take by mouth.
• It is usually taken three times a day with each main meal that contains fat.
• Take orlistat during a meal or up to 1 hour after a meal.
• If a meal is missed or does not have fat, you may skip your dose.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 120 mg.
• Orlistat 60 mg

This medicine is available in fallowing brand namesː

• Xenical; Alli

What side effects can this medication cause?

The most common side effects of this medicine include:

• oily rectal discharge
• passing gas with oily discharge
• urgent need to have a bowel movement
• oily or fatty stools
• increased number of bowel movements
• being unable to control your bowel movements

Orlistat may cause serious side effects, including:

• Lowered absorption of certain vitamins in your body
• Severe liver problems
• Kidney problems
• Gallstones

What special precautions should I follow?

• Orlistathas drug interactions and can decrease vitamin absorption.
• Take a multivitamin supplement that contains fat-soluble vitamins to ensure adequate nutrition.
• There have been rare postmarketing reports of severe liver injury with hepatocellular necrosis or acute hepatic failure in patients treated with Orlistat, with some of these cases resulting in liver transplant or death.
• Patients may develop increased levels of urinary oxalate following treatment with Orlistat. 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 Orlistat.
• Gastrointestinal events may increase when Orlistat is taken with a diet high in fat (>30% total daily calories from fat).
• Orlistat may interact with concomitant drugs including cyclosporine, levothyroxine, warfarin, amiodarone, antiepileptic drugs, and antiretroviral drugs.
• It is not known ifOrlistat is present in human milk. Caution should be exercised when Orlistat is administered to a nursing woman.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Pregnancy Category X.
• Orlistat is contraindicated during pregnancy, because weight loss offers no potential benefit to a pregnant woman and may result in fetal harm.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients below the age of 12 have not been established.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: orlistat
• Inactive Ingredients: microcrystalline cellulose, sodium starch glycolate, sodium lauryl sulfate, povidone, talc, gelatin and titanium dioxide.
• Turquoise capsule shell: FD&C Blue No. 2, with black printing ink containing pharmaceutical grade shellac, propylene glycol, strong ammonium solution, potassium hydroxide and black iron oxide.

Who manufactures and distributes this medicine?

XENICAL:

• XENICAL® is a registered trademark of CHEPLAPHARM Arzneimittel GmbH.

Licensed by:

• CHEPLAPHARM Arzneimittel GmbH
• Ziegelhof 24, 17489 Greifswald, Germany

Distributed by:

• H2-Pharma, LLC, 2010 Berry Chase Place
• Montgomery, AL , USA

Alli: Distributed by:

• GSK Consumer Healthcare
• Warren, NJ
• Made in India

What should I know about storage and disposal of this medication?

XENICAL:

• Store XENICAL at 59°F to 86°F (15°C to 30°C).
• Keep XENICAL in a tightly closed container.
• Do not use XENICAL after the expiration date on the bottle.
• Safely throw away medicine that is out of date or no longer needed.

Alli:

• store at 20 - 25oC (68 - 77oF).
• protect drug from excessive light, humidity and temperatures over 30oC (86oF).

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• Dailymed label info on Orlistat
• FDA Orlistat