Uses
Obesity
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.
Use 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).
Dosage and Administration
Administration
Oral Administration
Administer orally 3 times daily, during (or up to 1 hour after) each main meal containing fat. However, efficacy apparently not affected by administering the drug up to 2 hours after midmeal.
Omit orlistat dose if a meal occasionally is missed or contains no fat.
Distribute daily fat (30% of calories), carbohydrate, and protein intake evenly over 3 main meals; administration of orlisatat with any one very high-fat meal increases potential for adverse GI effects.
Manufacturer recommends use of vitamin supplement containing fat-soluble vitamins. Administer multivitamin ≥2 hours before or after orlistat; administer vitamin supplement at bedtime for convenience. (See Vitamin Supplementation under Cautions.)
Dosage
Adults
Obesity
Oral
120 mg 3 times daily with each main meal containing fat. No additional benefit with dosages >120 mg 3 times daily.
Reassess weight management and therapy periodically. Safety and efficacy beyond 2 years not established in clinical studies. However, if effective for weight loss or maintenance and no serious adverse effects occur, may continue orlistat as long as clinically indicated.
Cautions
Contraindications
Warnings/Precautions
Warnings
Obesity Evaluation
Rule out organic causes of obesity (e.g., hypothyroidism) before initiating orlistat therapy.
Cyclosporine Interaction
Do not administer concomitantly with cyclosporine; administer cyclosporine 2 hours before or after orlistat. (See Specific Drugs under Interactions.)
General Precautions
Hyperoxaluria
Possible increased concentrations of urinary oxalate. Caution in patients with a history of hyperoxaluria or calcium oxalate nephrolithiasis.
Misuse Potential
Avoid use in inappropriate patient populations (e.g., those with anorexia nervosa or bulimia).
Diabetes Mellitus
Weight loss may improve glycemic control; dose reductions or discontinuance of concomitant antidiabetic therapy (e.g., insulin, sulfonylureas, metformin) may be necessary.
Dietary Guidelines
Adherence to dietary recommendations minimizes adverse GI effects related to fat intake, as well as contributing to weight loss.
Vitamin Supplementation
Fat-soluble vitamin deficiency is unlikely but possible (Specific Drugs under Interactions). Manufacturer considers routine (once daily) supplementation with fat-soluble vitamins (A,D, E, K) a prudent precaution (see Oral Administration under Dosage and Administration).
Specific Populations
Pregnancy
Category B; use not recommended.
Lactation
Not known whether orlistat is distributed into milk; use not recommended.
Pediatric Use
Safety and efficacy not established in children <18 years of age.
Geriatric Use
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.
Common Adverse Effects
Oily spotting, flatus with discharge, fecal urgency, fatty/oily stool, oily evacuation, increased defecation, fecal incontinence.
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