Orlistat

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Because orlistat works by blocking the absorption of dietary fat, it is likely that you will experience some changes in bowel habits. These generally occur during the first weeks of treatment; however, they may continue throughout your use of orlistat.
These changes may include

• oily spotting
• gas with discharge
• urgent need to go to the bathroom
• oily or fatty stools 
• an oily discharge
• increased number of bowel movements
• an inability to control bowel movements 
• Due to the presence of undigested fat, the oil seen in a bowel movement may be clear or have a coloration such as orange or brown.

These bowel changes are a natural effect of blocking the fat from being absorbed and indicate that orlistat is working. They generally occur early in treatment, particularly after meals containing higher amounts of fat than are recommended. These symptoms are often temporary and may lessen or disappear as you continue treatment and keep to your recommended diet of meals containing no more than about 30% fat. However, these side effects may occur in some individuals over a period of 6 months or longer.

• In obese adolescent patients treated with orlistat, the side effects reported were similar to those observed in adults.
• If you are concerned about these or any other side effects you experience while taking orlistat, talk to your doctor or pharmacist.

• Orlistat comes as a capsule to be taken with liquid at each main meal that contains fat.
• You can take orlistat in conjunction with a mildly reduced-calorie diet up to 3 times a day.
• Each time you take orlistat, your meal should contain no more than about 30% of calories from fat. 
• Take orlistat during meals or up to one hour after a meal. If you occasionally miss a meal or have a meal without fat, you can omit your dose of orlistat. 
• You should use orlistat together with a nutritionally balanced, mildly reduced-calorie diet that contains no more than about 30% of calories from fat. 
• You should evenly divide your daily intake of fat, carbohydrates, and protein over 3 main meals.
• You should try to follow a healthy eating plan such as the one developed by the American Heart Association. 
• Following this eating plan will help you lose weight while decreasing some of the possible gastrointestinal effects you may experience while taking orlistat.

Obesity

Prescription orlistat (e.g., Xenical) is used as an adjunct to caloric restriction, increased physical activity, and behavioral modification in the treatment of exogenous obesity; also used to reduce the risk of weight regain after initial loss.1 6 7 8 15 17 27 36

Use prescription orlistat in patients with initial body mass index (BMI) of ≥30 kg/m2; also use in those with BMI of ≥27 kg/m2 in the presence of risk factor or disease (e.g., hypertension, diabetes mellitus, hyperlipidemia).1 15 27 To calculate BMI, divide weight in kilograms (kg) by height in meters (m) squared.1

Used as self-medication (e.g., Alli) to promote weight loss in overweight adults ≥18 years of age; use in conjunction with a reduced-calorie, low-fat diet.46

In the U.S.

• Alli
• Xenical

Available Dosage Forms:

• Capsule

Therapeutic Class: Dietary Fat Absorption Inhibitor

Pharmacologic Class: Lipase Inhibitor

• Tell all of your health care providers that you take orlistat. This includes your doctors, nurses, pharmacists, and dentists.
• Drugs used to treat seizures may not work as well while you take this medicine. Call your doctor right away if your seizures happen more often or get worse while you take orlistat.
• Liver problems have happened with this medicine. Sometimes, this has been very bad and has led to the need for a liver transplant or death. Liver problems may happen in people with or without liver disease. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• If you are pregnant or you get pregnant while taking orlistat, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about orlistat, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about orlistat. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using orlistat.

Review Date: October 4, 2017

(OR li stat)

• Alli [OTC]
• Xenical

Obesity management:

OTC: Weight loss in overweight adults when used along with a reduced-calorie and low-fat diet.

Rx: Obesity management, including weight loss and weight maintenance, when used in conjunction with a reduced-calorie diet; to reduce the risk for weight regain after prior weight loss.

Limitations of use: Orlistat is indicated for obese patients with an initial body mass index of ≥30 kg/m2 or ≥27 kg/m2 in the presence of other risk factors (eg, hypertension, diabetes, dyslipidemia).

Obesity management: Oral:

Xenical: 120 mg 3 times daily with each main meal containing fat (during or up to 1 hour after the meal); omit dose if meal is occasionally missed or contains no fat.

Alli: OTC labeling: 60 mg 3 times daily with each main meal containing fat (maximum dose: 180 mg/day).

Dosing adjustment with concomitant therapy:

Cyclosporine: Administer cyclosporine 3 hours after orlistat.

Levothyroxine: Administer levothyroxine and orlistat at least 4 hours apart and monitor for changes in thyroid function.

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied). However, dosage adjustment unlikely due to low systemic absorption.

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

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

Never share orlistat with another person, especially someone with a history of eating disorders.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Orlistat is usually taken 3 times per day with each main meal that contains some fat (no more than 30% of the calories for that meal). You may take the medicine either with your meal or up to 1 hour after eating.

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

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.

Orlistat can make it harder for your body to absorb certain vitamins, and you may need to take a vitamin and mineral supplement while you are taking this medicine. Follow your doctor's instructions about the type of supplement to use. Take the supplement at bedtime, or at least 2 hours before or after you take orlistat.

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

Keep track of your medicine. This medicine may be misused as a weight-loss aid, and you should be aware if anyone is using your medicine improperly or without a prescription.

Data not available