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orlistat (Rx, OTC)Brand and Other Names:Alli, Xenical

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 60mg
  • 120mg
more...

Obesity Management

Rx (Xenical): 120 mg PO q8hr with each fat-containing meal (during or up to 1 hr after the meal), dose >360 mg/day shows no additional benefit

OTC (Alli): Up to 60 mg PO q8hr with each fat containing meal

Only effective as an adjunct to caloric restriction, increased physical activity, and behavioral modification

Indicated in patients with pretreatment BMI >30 kg/m², or BMI >27 kg/m² in presence of other risk factors or diseases (eg, HTN, DM, hyperlipidemia)

Take vitamin supplement at least 2 hr before or after taking orlistat, such as bedtime

If patient receiving cyclosporine, administer cyclosporine 3 hr after orlistat

For patients receiving levothyroxine, administer orlistat 4 hr apart

Dosage Forms & Strengths

capsule

  • 60mg
  • 120mg
more...

Obesity Management

<12 years

  • Safety and efficacy not established

>12 years

  • Administer as in adults
  • Rx (Xenical): 120 mg PO q8hr with each fat-containing meal (during or up to 1 hr after the meal), dose >360 mg/day shows no additional benefit
  • OTC (Alli): Up to 60 mg PO q8hr with each fat containing meal
  • Only effective as an adjunct to caloric restriction, increased physical activity, and behavioral modification
  • Indicated in patients with pretreatment BMI >30 kg/m², or BMI >27 kg/m² in presence of other risk factors or diseases (eg, HTN, DM, hyperlipidemia)
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Interactions

Interaction Checker

orlistat and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            1-10%

            Oily spotting (5%)

            Frequency Not Defined

            Flatulence

            Fatty/oily stool

            Increased defecation

            Fecal incontinence

            Nausea

            Vomiting

            Reduced absorption of fat soluble vitamins and beta-carotene

            Liver failure

            Oxalate nephropathy

            Leukocytoclastic vasculitis

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            Warnings

            Contraindications

            Pregnancy

            Chronic malabsorption syndrome

            Cholestasis

            Hypersensitivity

            Cautions

            If a meal is missed or contains no fat, dose should be omitted

            Daily fat intake (30% of calories), carbohydrate, and protein should be evenly distributed over 3 main meals

            Note: Multivitamin supplement (including vit A, D, E, K) is recommended

            Postmarketing reports of severe liver injury with hepatocellular necrosis or acute hepatic failure with some cases resulting in liver transplant or death

            History of hyperoxaluria or calcium oxalate nephrolithiasis; cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure have been reported

            Substantial weight loss can increase risk of cholelithiasis

            Exclude organic causes of obesisty (eg, hypothyroidism), before prescribing therapy

            May increase gastrointestinal events when taking a diet high on fat (>30% total daily calories from fat)

            Diabetes mellitus

            Avoid with anorexia nervosa or bulimia

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            Pregnancy & Lactation

            Pregnancy Category: X; weight loss offers no potential benefit to a pregnant woman and may result in fetal harm; a minimum weight gain, and no weight loss, is currently recommended for all pregnant women, including those who are already overweight or obese

            Lactation: Not recommended; not known if orlistat is distributed in breast milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Inhibits gastric and pancreatic lipases, prevents triglyceride hydrolysis resulting in decreased absorption of dietary fats

            Absorption

            Bioavailability: 5%; absorption is very low and systemic absorption of orlistat is not required for clinical efficacy

            Onset: 24-48 hr

            Duration: 48-72 hr

            Peak Plasma Time: 6-8 hr

            Distribution

            Protein Bound: 99%

            Metabolism

            Metabolized in intestinal wall

            Metabolites: M1 & M3 (both probably inactive)

            Elimination

            Half-Life: 1-2 hr

            Renal Clearance: 0.1% of dose/hr

            Excretion: Feces 95-97% (including biliary); urine < 3%

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            Formulary

            FormularyPatient Discounts

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            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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