Generic Name: orlistat (OR li stat)
Brand Name: alli, Xenical

What is orlistat?

Orlistat blocks some of the fat that you eat, keeping it from being absorbed by your body.

Orlistat is used together with a reduced-calorie diet and weight maintenance to treat obesity in people with certain risk factors (such as diabetes, high blood pressure, and high cholesterol or triglycerides).

Orlistat may also be used for purposes not listed in this medication guide.

It is dangerous to purchase orlistat on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of "alli" purchased on the Internet have been found to contain sibutramine (Meridia), a prescription weight loss medication that can have dangerous side effects in certain people. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

What is the most important information I should know about orlistat?

Do not take orlistat if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight or obese.

You should not take this medication if you are allergic to orlistat, if you are pregnant, or if you have gallbladder problems or chronic malabsorption syndrome (an inability to absorb food and nutrients properly).

Before taking orlistat, tell your doctor if you have an underactive thyroid, a history of gallstones or pancreatitis, type 1 or type 2 diabetes, an eating disorder, liver or kidney disease, or if you take other weight-loss medications (prescription or over-the-counter).

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Do not give over-the-counter orlistat (alli) to a child younger than 18 years old. Prescription orlistat (Xenical) should not be used by anyone age 12 to 18 without the advice of a doctor.

Orlistat should be used only by the person for whom it was prescribed. Never share orlistat with another person, especially someone who has a history of eating disorder. Keep the medication in a place where others cannot get to it.

Orlistat is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

Avoid a diet that is high in fat. High-fat meals taken in combination with orlistat can increase your risk of unpleasant side effects on your stomach or intestines.

What should I discuss with my healthcare provider before taking orlistat?

You should not take orlistat if you are allergic to it, or if you have:

  • gallbladder problems;

  • chronic malabsorption syndrome (an inability to absorb food and nutrients properly); or

  • if you are pregnant.

To make sure you can safely take orlistat, tell your doctor if you have any of these other conditions:

  • an underactive thyroid;

  • a history of gallstones or kidney stones;

  • a history of pancreatitis;

  • liver disease;

  • kidney disease;

  • type 1 or type 2 diabetes;

  • an eating disorder (anorexia or bulimia); or

  • if you take any other weight-loss medications (prescription or over-the-counter).

FDA pregnancy category X. Do not use orlistat if you are pregnant. Weight loss is not recommended during pregnancy, even if you are overweight or obese. Stop taking orlistat and tell your doctor right away if you become pregnant.

Taking orlistat can make it harder for your body to absorb certain vitamins. These vitamins are important if you are nursing a baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give over-the-counter orlistat (alli) to a child younger than 18 years old. Prescription orlistat (Xenical) should not be used by anyone age 12 to 18 without the advice of a doctor.

Orlistat should be used only by the person for whom it was prescribed. Never share orlistat with another person, especially someone who has a history of eating disorder. Keep the medication in a place where others cannot get to it.

How should I take orlistat?

Take exactly as directed on the label, or as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Orlistat is only part of a complete program of treatment that also includes diet, exercise, and weight control. Your daily intake of fat, protein, and carbohydrates should be evenly divided over all of your daily meals. Follow your diet, medication, and exercise routines very closely.

Take orlistat during or within 1 hour after a meal that contains some fat (no more than 30% of the calories for that meal). Orlistat is usually taken 3 times daily.

If you skip a meal or you eat a meal that does not contain any fat, skip your orlistat dose for that meal.

The fat content of your daily diet should not be greater than 30% of your total daily caloric intake. For example, if you eat 1200 calories per day, no more than 360 of those calories should be in the form of fat.

Read the label of all food items you consume, paying special attention to the number of servings per container. Your doctor, nutrition counselor, or dietitian can help you develop a healthy eating plan.

Your doctor may recommend you take vitamin and mineral supplements while you are taking orlistat. This medication can make it harder for your body to absorb fat-soluble vitamins, such as vitamins A, D, E, and K. Follow your doctor's instructions about the type of multi-vitamin or mineral supplement to use.

Take your vitamin or supplement at bedtime, or at least 2 hours before or after you take orlistat.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed. Throw away any unused orlistat after the expiration date on the medicine label has passed.

Keep track of the amount of medicine used from each new bottle. Orlistat is a drug that may be misused as a weight-loss aid, and you should be aware if anyone is using your medicine improperly or without a prescription.

What happens if I miss a dose?

Take the missed dose as soon as you remember, but no more than 1 hour after eating a meal. If it has been more than an hour since your last meal, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

If you miss a meal, or if you have a meal without fat, you can skip your dose of orlistat for that meal also.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking orlistat?

Avoid a diet that is high in fat. High-fat meals taken in combination with orlistat can increase your risk of unpleasant side effects on your stomach or intestines.

Orlistat side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using orlistat and call your doctor at once if you have a serious side effect such as:

  • severe pain in your lower back, blood in your urine;

  • urinating less than usual or not at all;

  • drowsiness, confusion, mood changes, increased thirst;

  • swelling, weight gain, feeling short of breath;

  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or

  • nausea, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

The following side effects occur commonly with the use of orlistat. They are the natural effects of orlistat's fat-blocking action and are actually signs that the medication is working properly. These side effects are usually temporary and may lessen as you continue treatment with orlistat:

  • oily spotting in your undergarments;

  • oily or fatty stools;

  • orange or brown colored oil in your stool;

  • gas with discharge, an oily discharge;

  • loose stools, or an urgent need to go to the bathroom, inability to control bowel movements;

  • an increased number of bowel movements;

  • stomach pain, nausea, vomiting, diarrhea, rectal pain; or

  • weakness, dark urine, clay-colored stools, itching, loss of appetite, or jaundice (yellowing of the skin or eyes).

Other side effects that may occur while taking orlistat include:

  • problems with your teeth or gums;

  • cold symptoms such as stuffy nose, sneezing, cough;

  • fever, chills, sore throat, flu symptoms;

  • headache, back pain; or

  • mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect orlistat?

Tell your doctor about all other medications you use, especially:

  • cyclosporine (Gengraf, Neoral, Sandimmune);

  • a vitamin or mineral supplement that contains beta carotene or vitamin E;

  • levothyroxine (Synthroid, Levoxyl, Levothroid);

  • insulin or diabetes medications you take by mouth;

  • digoxin (digitalis, Lanoxin, Lanoxicaps); or

  • a blood thinner such as warfarin (Coumadin, Jantoven).

This list is not complete and other drugs may interact with orlistat. Tell your doctor about all medications you use. This includes prescription, over the counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about orlistat.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 10.01. Revision Date: 2012-03-09, 10:11:09 AM.

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