Generic Name: orlistat (Oral route)
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Dietary Fat Absorption Inhibitor
Pharmacologic Class: Lipase Inhibitor
Orlistat is used together with a reduced-calorie diet to help you lose weight and to help keep the lost weight from returning. It is also used in overweight people who may also have diabetes, high blood pressure, high cholesterol, or heart disease.
Orlistat works by keeping your intestines from absorbing some of the fats from the food that you eat. The undigested fat goes out of your body in your bowel movements.
This medicine is available both over-the-counter (OTC) and with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of orlistat in teenagers. Safety and efficacy have not been established in children below 12 years of age.
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of orlistat in the elderly.
|All Trimesters||B||Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain orlistat. It may not be specific to Xenical. Please read with care.
Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.
This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Talk to your doctor if you have any questions.
Orlistat prevents the absorption of some of the fat you eat. Therefore, you should take it with liquids during the meal or up to one hour after eating. If you occasionally miss a meal or eat a meal that contains no fat, you should skip the dose of orlistat.
Because orlistat may decrease the amount of some vitamins that your body can absorb from food, you will need to take a multivitamin supplement once a day. Take the vitamin supplement at least 2 hours before or after taking orlistat. You may also take your multivitamin supplement at bedtime.
When using orlistat, your diet should contain no more than 30% of calories as fat. More fat in your diet will increase the side effects of this medicine. Your diet should be nutritionally balanced, and your daily intake of fat, carbohydrates, and protein should be distributed over three main meals.
Follow your doctor's instructions carefully on a reduced-calorie diet plan and regular exercise. Talk with your doctor before starting any exercise program.
If you are using cyclosporine (e.g., Neoral®, Sandimmune®) and levothyroxine (e.g., Levothroid®, Synthroid®), do not take them at the same time that you take this medicine. It is best to take cyclosporine at least 2 hours before or 2 hours after taking orlistat. Levothyroxine must be used at least 4 hours before or 4 hours after you take orlistat.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
Ask your healthcare professional how you should dispose of any medicine you do not use.
It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.
For patients with diabetes: Weight loss may result in an improvement in your condition, and your doctor may need to change your dose of oral diabetes medicine or insulin.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:More common
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More common
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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