Usual Adult Dose for Obesity

Prescription strength (Xenical[R]):
120 mg orally 3 times a day with each main meal containing fat

Non-prescription (over-the-counter; Alli[R]):
60 mg orally 3 times a day with each main meal containing fat

Comments:

• This drug should be taken during, or up to 1 hour after meals; if a meal is skipped or contains no fat, the dose may be skipped.
• Doses above 120 mg 3 times a day have not been shown to provide additional benefit.
• During therapy, patients should receive a nutritionally balanced, reduced-calorie diet containing approximately 30% of calories from fat.

Uses: For the management of weight loss and weight maintenance when used in conjunction with a reduced calorie diet.

Usual Pediatric Dose for Obesity

12 years or older:
Prescription strength (Xenical[R]):
120 mg orally 3 times a day with each main meal containing fat

Comments:

• This drug should be taken during, or up to 1 hour after meals; if a meal is skipped or contains no fat, the dose may be skipped.
• Doses above 120 mg 3 times a day have not been shown to provide additional benefit; the over the counter orlistat product (Alli[R]) is not labeled for pediatric use.
• During therapy, patients should receive a nutritionally balanced, reduced-calorie diet containing approximately 30% of calories from fat.

Uses: For the management of weight loss and weight maintenance when used in conjunction with a reduced calorie diet.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

No adjustment recommended

Dose Adjustments

Patients with diabetes mellitus:

• Dose adjustment of diabetes medications may be necessary; monitor glycemic control closely

Precautions

CONTRAINDICATIONS:

• Pregnancy
• Chronic malabsorption syndrome
• Cholestasis
• Hypersensitivity to the active substance or any product excipients

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Take orally with each main meal containing fat; may take up to 1 hour after a meal
• Dose may be skipped if a meal is missed or meal does not contain fat
• A vitamin supplement that contains fat-soluble vitamins should be taken while taking this drug

Multivitamin: Take at least 2 hours before or after this drug (e.g. bedtime)
Cyclosporine: Take 3 hours before or after this drug; measure cyclosporine levels
Levothyroxine: Take at least 4 hours before or after this drug; monitor thyroid function

General:

• This drug is intended for obese patients with an initial body mass index (BMI) of 30 kg/m2 or greater OR 27 kg/m2 in the presence of other risk factors such as hypertension diabetes, or dyslipidemia. The manufacturer's package insert can be consulted for BMI charts.
• Substantial weigh loss can increase the risk of cholelithiasis.

Monitoring:

• Monitor for signs and symptoms of hepatotoxicity; obtain liver function tests if these develop
• Monitor renal function in patients at risk for renal impairment

Patient advice:

• Patients should be instructed to adhere to a nutritionally balanced low-calorie diet that derives approximately 30% or less of its calories from fat; consuming higher amounts of fat may make the common side effects worse.
• Patients should understand that they should not take this drug at the same time as their multivitamin; other drugs may need to be taken separately as well and they should speak with their healthcare professional regarding all concomitant medication use.
• Patients should be instructed to immediately report signs and symptoms of hepatic dysfunction (e.g., itching, yellow eyes or skin, dark urine, or loss of appetite) or severe, continuous abdominal pain.
• Patients should be instructed to report changes in glycemic control or seizure activity.
• Patients should not take this drug if they are pregnant, breastfeeding, or have chronic malabsorption syndrome.