DESCRIPTION
Alli is a nonprescription version of the prescription weight loss drug Xenical (orlistat). It is the only nonprescription medication approved by the Food and Drug Administration for weight loss. Alli is used for weight loss in adults (18 years and older) who are overweight.

To lose weight, you need to consume fewer calories than your body needs to maintain your current weight. Alli prevents some of the fat in the foods you eat from being absorbed into your body. This makes a big difference in the total calories that enter your system, because 1 gram of fat contains more than twice as many calories as 1 gram of protein or carbohydrate.

Alli is not a miracle pill or a quick fix. It is meant to be used as part of a total weight loss program that includes a reduced-calorie, low-fat diet and increased physical activity. Alli will help you lose about 50% more weight than you would with diet and exercise alone. So instead of losing 10 pounds, you could lose 15 pounds or more by taking Alli.

ORIGINAL USES (ON-LABEL)
Weight loss in overweight adults, 18 years and older, when used along with a reduced-calorie, low-fat diet and exercise program.

POTENTIAL SIDE EFFECTS
The side effects that may occur when you take Alli are effects of the treatment—they happen because of the way Alli works. The fat that this drug prevents from being absorbed passes out of your body naturally. This may cause some bowel changes, such as: Gas with oily spotting, loose stools, more frequent stools that may be difficult to control.

Eating a low-fat diet lowers the chance of having these bowel changes. Be sure to limit your fat to about 15 grams per meal.

Alli works only in the digestive tract. It will not cause jitters, sleeplessness, or a racing heart.

CAUTIONS
  • Alli should not be used by people who have had an organ transplant, especially if they take the medicine cyclosporine.
  • If you take warfarin (a blood thinning medicine) or medicines for diabetes or thyroid disease, talk with your doctor or pharmacist before you use Alli. Your doses of those medicines may need to be adjusted.
  • Do not use Alli with any other weight loss products.
  • Because Alli prevents some fat from being absorbed, it also can reduce the absorption of certain vitamins (called fat-soluble vitamins). Be sure to take a multivitamin that includes vitamins A, D, E, and K and beta-carotene while you are taking orlistat 60 mg. Take the multivitamin once a day, 2 hours before or after your dose of Alli. Many people find bedtime to be a convenient time for taking the multivitamin.
  • Patients are directed to consult with a primary care provider first if they have ever had gallbladder problems, kidney stones, or pancreatitis. Patients who experience severe or continuous abdominal pain while taking Alli should discontinue use of the product and consult a primary care provider.
  • In case of overdose, the patient should be observed for 24 hours. Any systemic effects attributable to the lipase-inhibiting properties of orlistat 60 mg should be rapidly reversible.
CONTRAINDICATIONS
Organ transplant recipient; problems absorbing food (i.e., chronic malabsorption syndrome); hypersensitivity to any ingredients in orlistat pills.

DRUG INTERACTIONS
Do not use with cyclosporine; use with caution in patients taking warfarin, antidiabetic agents, or thyroid medications (doses of these drugs may need to be adjusted during orlistat therapy).

FOOD INTERACTIONS
Having an occasional alcoholic beverage should not interfere with Alli. However, a small glass of alcohol often contains 100 calories or more, so it is best to limit the amount of alcohol you drink if you are trying to lose weight or maintain a weight loss.

PREGNANCY AND BREAST-FEEDING CAUTIONS
Pregnancy category B (no adequate and well-controlled studies in pregnant women); not recommended for use during pregnancy.

Most women who are pregnant or breast-feeding should not attempt to lose weight. So, Alli is not recommended for use by women who are pregnant or breast-feeding. If you are pregnant or breast-feeding and think you need to lose weight, be sure to talk with your obstetrician or primary care provider.

SPECIAL INFORMATION
The term "overweight" means that a person weighs more than what is considered to be healthy for a given height. Being overweight increases the likelihood of diseases such as high blood pressure, type 2 diabetes, heart disease, and some types of cancer. The more overweight you are, the more likely you are to have health problems. A number known as the body mass index (BMI), which is calculated from weight and height, is used to determine whether a person is underweight, normal weight, or overweight. You can find out your BMI from charts and calculators available on the Internet or in many weight loss books.





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What is Alli?
Alli (nonprescription orlistat 60 mg) is the only nonprescription medication available for weight loss, which makes it the only FDA-approved weight loss aid available without a prescription.
BRAND NAME
Alli

GENERIC NAME
Orlistat

CHEMICAL CLASS
Lipase inhibitor

THERAPEUTIC CLASS
Weight control agent
AVAIL FORMS
Capsules — Oral 60 mg.
DOSAGE
Adult
Take one Alli capsule up to three times each day, with each meal that contains fat. You may take the capsule during the meal (this is best) or up to 1 hour after the meal.

If you eat more than three meals each day, take the Alli pills with the three largest meals that contain fat. Do not take more than three capsules in a single day.