Xenical (Orlistat) Indications and Dosage
Xenical (Orlistat) Indications and Dosage
For the treatment of obesity (including weight loss and weight maintenance) in conjunction with a reduced-calorie diet and appropriate exercise:
NOTE: Orlistat is indicated for obese patients with a BMI >= 30 kg/m2 or a BMI >= 27 kg/m2 in the presence of other risk factors (e.g., hypertension, diabetes mellitus, or dyslipidemia). The BMI is calculated by dividing weight in kilograms by height in meters squared. Conversion factors for calculation; Weight in pounds (lbs.) divided by 2.2 = kilogram weight (kg); Height in inches x 0.0254 = height in meters (m).
Oral dosage:
Adults and adolescents >= 12 years: One capsule (120 mg) PO three times per day with each main meal containing fat, taken during the meal or up to one hour after the meal. Doses greater than recommended did not increase weight loss. NOTE: Because orlistat may reduce the absorption of fat-soluble vitamins A, D, E, K, and beta-carotene, it is recommended patients take a daily multivitamin containing these vitamins at least 2 hours before or after orlistat. The results of a 2-year, randomized, double-blind, placebo-controlled study from 18 US research centers indicate orlistat plus reduced-calorie diet significantly increased weight loss and lessened weight gain in obese adults with BMI’s of 30 - 43 kg/m2. Fasting insulin and low-density lipoprotein cholesterol (LDL-C) serum levels were also significantly decreased in the orlistat group. Similar results were observed in European trials. Pooled data from clinical trials also indicate improvement in cardiovascular risk parameters in treated patients. Another multicenter clinical trial showed significant improvement in glycemic control for obese patients with type 2 diabetes treated with orlistat; statistically significant decreases in HbA1c, fasting blood glucose, and sulfonylurea dosage were reported. Results from a 4-year study that involved 3304 obese patients with normal or impaired glucose tolerance indicated a 37% relative risk reduction in the development of type 2 diabetes in patients with impaired glucose tolerance and treated with orlistat vs. placebo. The results are hypothesized to be due to the additional weight loss vs. any metabolic alteration due to orlistat. Compared with lifestyle changes alone, orlistat plus lifestyle changes resulted in a greater reduction in the incidence of type 2 diabetes over 4 years. In a 21-day study in adolescents, orlistat reduced fat absorption by roughly 27%, but no significant changes were noted in the balance of calcium, phosphorus, magnesium, copper or zinc in the active vs. placebo groups. Iron balance was decreased similarly in both the orlistat and placebo groups.
Maximum Dosage Limits:
- Adults: 360 mg/day PO.
- Elderly: 360 mg/day PO.
- Adolescents >= 12 years: 360 mg/day PO.
- Children: Safe and effective use has not been established.
Patients with hepatic impairment:
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with renal impairment:
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
Intermittent hemodialysis:
Specific guidelines for dosage adjustments in intermittent hemodialysis are not available; it appears that no dosage adjustments are needed.
[ Last revised: 11/5/2004 2:51:00 PM ]
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