Generic Name and Formulations:
Orlistat 120mg; caps.
Indications for XENICAL:
Adjunct to reduced-calorie diet in obesity management, including weight loss and weight maintenance. To reduce risk of weight regain after weight loss. For use in patients with initial body mass index ≥30kg/m2 or ≥27kg/m2 in the presence of other risk factors.
Use with a reduced calorie diet with about 30% of calories from fat; spread fat intake over 3 main meals. 120mg three times daily during or up to 1 hour after each of 3 main meals. If a meal is missed or has no fat, skip dose.
Pregnancy (Cat.X). Chronic malabsorption syndrome. Cholestasis.
Exclude organic causes of obesity (eg, hypothyroidism). Weight loss may affect doses needed for antidiabetic drugs (monitor). Monitor for symptoms of hepatic dysfunction; discontinue if occurs and obtain liver function tests. Hyperoxaluria. Calcium oxalate nephrolithiasis. Renal impairment; monitor renal function. Nursing mothers.
Antagonizes cyclosporine (give dose 3hrs after Xenical). May decrease absorption of fat-soluble vitamins, beta carotene; supplement diet with a multivitamin (separate dosing by at least 2hrs). May antagonize amiodarone. Hypothyroidism with levothyroxine; monitor thyroid function and separate dosing by at least 4hrs. Monitor for convulsions with concomitant antiepileptics. Monitor coagulation parameters with anticoagulants (including warfarin). Monitor HIV RNA levels with concomitant antiretrovirals (eg, atazanavir, ritonavir, tenofovir disoproxil fumarate, emtricitabine, lopinavir/ritonavir, emtricitabine/efavirenz/tenofovir disoproxil fumarate).
GI effects (oily spotting, flatus with discharge, fecal urgency, fatty/oily stools, oily evacuation, increased defecation, fecal incontinence); cholelithiasis; rare: severe liver injury.