Xenical Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Xenical Indications
Indications
Xenical Dosage and Administration
Adult
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
<12yrs: not established.
Renal Impairment
Patients may develop increased levels of urinary oxalate following treatment with Xenical. Monitor renal function in patients at risk for renal insufficiency.
Xenical Contraindications
Contraindications
Pregnancy. Chronic malabsorption syndrome. Cholestasis.
Xenical Boxed Warnings
Not Applicable
Xenical Warnings/Precautions
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 Pharmacokinetics
Absorption
Systemic exposure of orlistat is minimal.
Distribution
Orlistat was >99% bound to plasma proteins.
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.
Xenical Interactions
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).
Xenical Adverse Reactions
Adverse Reactions
Xenical Clinical Trials
Xenical Note
Not Applicable