Obesity:

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.

Adult Dosage:

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.

Children Dosage:

<12yrs: not established.

XENICAL Contraindications:

Pregnancy. Chronic malabsorption syndrome. Cholestasis.

XENICAL Warnings/Precautions:

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. Monitor renal function in patients at increased risk for oxalate nephropathy (including those with renal impairment, history of hyperoxaluria or calcium oxalate nephrolithiasis); discontinue if oxalate nephropathy develops. Nursing mothers.

XENICAL Classification:

Lipase inhibitor.

XENICAL Interactions:

Antagonizes cyclosporine (give dose 3hrs after Xenical). May decrease absorption of fat-soluble vitamins, beta carotene; supplement diet with a fat-soluble containing 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).

Adverse Reactions:

GI effects (oily spotting, flatus with discharge, fecal urgency, fatty/oily stools, oily evacuation, increased defecation, fecal incontinence); cholelithiasis; rare: severe liver injury.

Drug Elimination:

Fecal excretion of the unabsorbed drug was found to be the major route of elimination. Approximately 97% of the administered radioactivity was excreted in feces; 83% of that was found to be unchanged orlistat.

Generic Drug Availability:

NO

How Supplied:

Caps—90