Pronunciation:

OR-li-stat

Brand Names:

• Alli
• Xenical

Dosage Forms:

• Capsule

Classifications:

Therapeutic—

Dietary Fat Absorption Inhibitor

Pharmacologic—

Lipase Inhibitor

Uses of This Medicine:

Orlistat is used as an aid to help you lose weight. The medicine prevents the digestion of some of the fat you eat. Fats that are not digested cannot be absorbed and therefore do not contribute calories. To give the greatest weight loss, orlistat must be used with a weight-reduction diet.

Orlistat is available only with your doctor's prescription.

Before Using This Medicine:

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:

Allergies—

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.

Children—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of orlistat in children with use in other age groups.

Older adults—

There is no specific information comparing use of orlistat in the elderly with use in younger adults. However, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy—

	Pregnancy Category	Explanation
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.

Breast-feeding—

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.

Other medicines—

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.

• Cyclosporine

Other interactions—

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.

Other medical problems—

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:

• Kidney stones or

• Gallbladder problems—Orlistat may make the condition worse

Proper Use of This Medicine:

Orlistat prevents the absorption of some of the fat you eat. Therefore, you should take it during the meal or within 1 hour of 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.

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.

Dosing—

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.

• For oral dosage form (capsules):
  • For treatment of obesity:
    • Adults—120 milligrams (mg) three times a day with meals containing fat.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

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 as soon as possible if any of the following side effects occur:

More common

Bodyache

chills

cough

fever

headache

nasal congestion

runny nose

sneezing

sore throat

Less common

Tightness in chest

tooth or gum problems

troubled breathing

wheezing

Rare

Bloody or cloudy urine

change in hearing

contagious diarrhea

difficult or painful urination

earache

frequent urge to urinate

pain in ear

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Gas with leaky bowel movements

inability to hold bowel movement

increases in bowel movements

oily bowel movements

oily spotting of underclothes

Less common

Anxiety

back pain

menstrual changes

rectal pain or discomfort

After you stop using this medicine, your body may need time to adjust. Side effects caused by orlistat usually disappear within 2 to 3 days after stopping it.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.