DrugindexOnline^{2nd edition}

Generic Name: Orlistat (OR-li-stat)
Brand Name: Xenical

Xenical is used for:

Managing obesity in adults and adolescents 12 years and older. It is also used to reduce the risk of weight regain after previous weight loss.

Xenical is a gastrointestinal lipase inhibitor. It works by inhibiting the digestion of fats from the diet and should be used with a reduced-calorie diet.

Do NOT use Xenical if:

• you are allergic to any ingredient in Xenical
• you constantly have problems absorbing food (chronic malabsorption)
• you have gallbladder problems
• you have cholestasis (a problem of bile flow from the liver to the intestines)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Xenical :

Some medical conditions may interact with Xenical . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have an underactive thyroid

Some MEDICINES MAY INTERACT with Xenical . Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin) because side effects, including risk of bleeding, may be increased by Xenical
• Cyclosporine because its effectiveness may be severely decreased by Xenical . Cyclosporine should be taken at least 2 hours before or after orlistat to ensure maximum absorption of cyclosporine into the bloodstream

This may not be a complete list of all interactions that may occur. Ask your health care provider if Xenical may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Xenical :

Use Xenical as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Xenical . Talk to your pharmacist if you have questions about this information.
• Take Xenical by mouth with or up to 1 hour after each main meal that contains fat (up to 3 per day).
• If a meal is missed or contains no fat, do not take a dose of Xenical .
• You should take a multivitamin supplement containing vitamins A, D, E, and K to ensure good nutrition. The supplement should be taken at least 2 hours before or after you take Xenical , such as at bedtime.
• If you miss a dose of Xenical , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Xenical .

Important safety information:

• Do NOT take more than the recommended dose without checking with your doctor. Exceeding the recommended dose will not make you lose more weight and may increase side effects.
• Tell your doctor or dentist that you take Xenical before you receive any medical or dental care, emergency care, or surgery.
• Follow the diet program given to you by your health care provider. Your daily intake of fat should be divided evenly over 3 meals.
• Eating a meal high in fat while taking Xenical increases the risk of side effects involving the stomach and intestines.
• Diabetes patients - Xenical may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Additional monitoring of your dose or condition may be needed if you are taking amiodarone.
• Xenical should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Xenical while you are pregnant. It is not known if Xenical is found in breast milk. Do not breast-feed while taking Xenical .

Possible side effects of Xenical :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Bowel movement urgency; gas with discharge; inability to control bowel movements; increased number of bowel movements; oily discharge; oily or fatty stools; oily spotting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe or persistent stomach pain.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Xenical :

Store Xenical below 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Xenical out of the reach of children and away from pets.

General information:

• If you have any questions about Xenical , please talk with your doctor, pharmacist, or other health care provider.
• Xenical is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is summary only. It does not contain all information about Xenical . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.