orlistat (Rx, OTC)

Brand and Other Names:Alli, Xenical
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 60mg (Alli)
  • 120mg (Xenical)

Obesity Management

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)

Rx (Xenical): 120 mg PO q8hr with each fat-containing meal (during or up to 1 hr after the meal), doses >120 mg TID show 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

Also see Administration and Cautions (drug interaction overview)

Dosage Forms & Strengths

capsule

  • 60mg
  • 120mg

Obesity Management

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)

<12 years: Safety and efficacy not established

≥12 years

  • Rx (Xenical): 120 mg PO q8hr with each fat-containing meal (during or up to 1 hr after the meal), doses >120 mg TID show 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
  • Also see Administration and Cautions (drug interaction overview)
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Interactions

Interaction Checker

and orlistat

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    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

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            Contraindicated (0)

              Serious - Use Alternative (1)

              • triheptanoin

                orlistat decreases effects of triheptanoin by Other (see comment). Avoid or Use Alternate Drug. Comment: Coadministration of triheptanoin with orlistat may reduce exposure to the triheptanoin metabolite, heptanoate, and decrease the effects of triheptanoin.

              Monitor Closely (63)

              • abacavir

                orlistat will decrease the level or effect of abacavir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • acetazolamide

                orlistat decreases levels of acetazolamide by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • amiodarone

                orlistat will decrease the level or effect of amiodarone by Other (see comment). Use Caution/Monitor. Reduces absorption of amiodarone

              • atazanavir

                orlistat will decrease the level or effect of atazanavir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • beta carotene

                orlistat decreases levels of beta carotene by drug binding in GI tract. Use Caution/Monitor.

              • carbamazepine

                orlistat decreases levels of carbamazepine by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • clobazam

                orlistat decreases levels of clobazam by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • clonazepam

                orlistat decreases levels of clonazepam by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • clorazepate

                orlistat decreases levels of clorazepate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • cyclosporine

                orlistat decreases levels of cyclosporine by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Administer cyclosporine 3 hours after orlistat .

              • darunavir

                orlistat will decrease the level or effect of darunavir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • diazepam

                orlistat decreases levels of diazepam by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • didanosine

                orlistat will decrease the level or effect of didanosine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • dolutegravir

                orlistat will decrease the level or effect of dolutegravir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • doxercalciferol

                orlistat decreases levels of doxercalciferol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • efavirenz

                orlistat will decrease the level or effect of efavirenz by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • elvitegravir

                orlistat will decrease the level or effect of elvitegravir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • emtricitabine

                orlistat will decrease the level or effect of emtricitabine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • enfuvirtide

                orlistat will decrease the level or effect of enfuvirtide by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • eslicarbazepine acetate

                orlistat decreases levels of eslicarbazepine acetate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • ethosuximide

                orlistat decreases levels of ethosuximide by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • ethotoin

                orlistat decreases levels of ethotoin by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • etravirine

                orlistat will decrease the level or effect of etravirine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • ezogabine

                orlistat decreases levels of ezogabine by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • felbamate

                orlistat decreases levels of felbamate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • fosamprenavir

                orlistat will decrease the level or effect of fosamprenavir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • fosphenytoin

                orlistat decreases levels of fosphenytoin by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • gabapentin

                orlistat decreases levels of gabapentin by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • indinavir

                orlistat will decrease the level or effect of indinavir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • lacosamide

                orlistat decreases levels of lacosamide by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • lamivudine

                orlistat will decrease the level or effect of lamivudine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • lamotrigine

                orlistat decreases levels of lamotrigine by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • levetiracetam

                orlistat decreases levels of levetiracetam by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • levothyroxine

                orlistat decreases levels of levothyroxine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Risk of hypothyroidism. Separate by 4 hours.

              • lorazepam

                orlistat decreases levels of lorazepam by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • maraviroc

                orlistat will decrease the level or effect of maraviroc by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • methsuximide

                orlistat decreases levels of methsuximide by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • nelfinavir

                orlistat will decrease the level or effect of nelfinavir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • nevirapine

                orlistat will decrease the level or effect of nevirapine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • oxcarbazepine

                orlistat decreases levels of oxcarbazepine by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • paricalcitol

                orlistat decreases levels of paricalcitol by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Separate by 2 hours.

              • perampanel

                orlistat decreases levels of perampanel by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • phenobarbital

                orlistat decreases levels of phenobarbital by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • phenytoin

                orlistat decreases levels of phenytoin by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • pregabalin

                orlistat decreases levels of pregabalin by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • primidone

                orlistat decreases levels of primidone by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • raltegravir

                orlistat will decrease the level or effect of raltegravir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • rilpivirine

                orlistat will decrease the level or effect of rilpivirine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • ritonavir

                orlistat will decrease the level or effect of ritonavir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • rufinamide

                orlistat decreases levels of rufinamide by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • saquinavir

                orlistat will decrease the level or effect of saquinavir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • stavudine

                orlistat will decrease the level or effect of stavudine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • tenofovir AF

                orlistat will decrease the level or effect of tenofovir AF by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • tenofovir DF

                orlistat will decrease the level or effect of tenofovir DF by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • tiagabine

                orlistat decreases levels of tiagabine by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • tipranavir

                orlistat will decrease the level or effect of tipranavir by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • topiramate

                orlistat decreases levels of topiramate by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • valproic acid

                orlistat decreases levels of valproic acid by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • vigabatrin

                orlistat decreases levels of vigabatrin by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              • vitamin D

                orlistat will decrease the level or effect of vitamin D by Other (see comment). Use Caution/Monitor. When combination must be used, may consider administering vitamin D at least 2 hours before or after administration of orlistat.

              • warfarin

                orlistat decreases effects of warfarin by Other (see comment). Use Caution/Monitor. Comment: Orlistat may decrease vitamin K absorption; patients on chronic stable doses of warfarin who are prescribed orlistat should be monitored closely for changes in coagulation parameters.

              • zidovudine

                orlistat will decrease the level or effect of zidovudine by inhibition of GI absorption. Applies only to oral form of both agents. Use Caution/Monitor. Loss of virological control reported in HIV-infected patients taking orlistat concomitantly. Exact mechanism is unclear, but may include a drug-drug interaction that inhibits systemic absorption of the antiretroviral drug. Monitor HIV RNA levels frequently and if increased HIV viral load confirmed, discontinue orlistat.

              • zonisamide

                orlistat decreases levels of zonisamide by inhibition of GI absorption. Applies only to oral form of both agents. Modify Therapy/Monitor Closely. Risk of convulsions.

              Minor (19)

              • atorvastatin

                orlistat increases effects of atorvastatin by pharmacodynamic synergism. Minor/Significance Unknown.

              • chlorpropamide

                orlistat increases effects of chlorpropamide by pharmacodynamic synergism. Minor/Significance Unknown.

              • ciprofibrate

                orlistat increases effects of ciprofibrate by pharmacodynamic synergism. Minor/Significance Unknown.

              • fenofibrate micronized

                orlistat increases effects of fenofibrate micronized by pharmacodynamic synergism. Minor/Significance Unknown.

              • fenofibric acid

                orlistat increases effects of fenofibric acid by pharmacodynamic synergism. Minor/Significance Unknown.

              • fluvastatin

                orlistat increases effects of fluvastatin by pharmacodynamic synergism. Minor/Significance Unknown.

              • glimepiride

                orlistat increases effects of glimepiride by pharmacodynamic synergism. Minor/Significance Unknown.

              • glipizide

                orlistat increases effects of glipizide by pharmacodynamic synergism. Minor/Significance Unknown.

              • glyburide

                orlistat increases effects of glyburide by pharmacodynamic synergism. Minor/Significance Unknown.

              • lovastatin

                orlistat increases effects of lovastatin by pharmacodynamic synergism. Minor/Significance Unknown.

              • pitavastatin

                orlistat increases effects of pitavastatin by pharmacodynamic synergism. Minor/Significance Unknown.

              • pravastatin

                orlistat increases effects of pravastatin by pharmacodynamic synergism. Minor/Significance Unknown.

              • rosuvastatin

                orlistat increases effects of rosuvastatin by pharmacodynamic synergism. Minor/Significance Unknown.

              • simvastatin

                orlistat increases effects of simvastatin by pharmacodynamic synergism. Minor/Significance Unknown.

              • tolazamide

                orlistat increases effects of tolazamide by pharmacodynamic synergism. Minor/Significance Unknown.

              • tolbutamide

                orlistat increases effects of tolbutamide by pharmacodynamic synergism. Minor/Significance Unknown.

              • vitamin A

                orlistat decreases levels of vitamin A by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Separate by 2 hours.

              • vitamin E

                orlistat decreases levels of vitamin E by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. May cause fat-soluble vitamin malabsorption. Separate by 2 hours.

              • vitamin K1 (phytonadione)

                orlistat decreases levels of vitamin K1 (phytonadione) by inhibition of GI absorption. Applies only to oral form of both agents. Minor/Significance Unknown. Separate by 2 hours.

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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

              Multivitamin supplement (including vitamin A, D, E, K) is recommended; supplement should be taken once a day at least 2 hours before or after the administration of orlistat, such as at bedtime

              Postmarketing reports of severe liver injury with hepatocellular necrosis or acute hepatic failure with some cases resulting in liver transplant or death; patients should be instructed to report any symptoms of hepatic dysfunction (anorexia, pruritus, jaundice, dark urine, light-colored stools, or right upper quadrant pain) while receiving therapy; when these symptoms occur, this and other suspect medications should be discontinued immediately and liver function tests and ALT and AST levels obtained

              Some patients may develop increased levels of urinary oxalate following treatment; cases of oxalate nephrolithiasis and oxalate nephropathy with renal failure reported; monitor renal function when prescribing therapy to patients at risk for renal impairment and use with caution in those with a history of hyperoxaluria or calcium oxalate nephrolithiasis

              Substantial weight loss can increase risk of cholelithiasis

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

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

              Weight-loss may affect glycemic control in patients with diabetes mellitus; a reduction in dose of oral hypoglycemic medication (eg, sulfonylureas) or insulin may be required in some patients

              Avoid with anorexia nervosa or bulimia

              Drug interaction overview

              • Cyclosporine: Should not be simultaneously coadministered with cyclosporine; can decrease cyclosporine exposure; to reduce chance of a drug-drug interaction, cyclosporine should be taken at least 3 hours before or after orlistat
              • Levothyroxine: Administer 4 hr apart; monitored for changes in thyroid function
              • Amiodarone PO: A pharmacokinetic study showed reduced amiodarone and desethylamiodarone systemic exposure when coadministered with orlistat
              • Antiepileptic drugs (AEDs): Convulsions reported with coadministration of AEDs and orlistat; monitor serum AED levels
              • Antiretroviral drugs: Loss of virological control has been reported in HIV-infected patients taking orlistat concomitantly with antiretroviral drugs; HIV RNA levels should be frequently monitored in patients taking orlistat and antiretrovirals drugs; if HIV viral load increases, discontinue orlistat
              • Warfarin
                • Vitamin K absorption may be decreased with orlistat
                • Reports of decreased prothrombin, increased INR, and unbalanced anticoagulant treatment resulting in change of hemostatic parameters have been with coadministration of orlistat and anticoagulants
                • Patients on chronic stable doses of warfarin or other anticoagulants who are prescribed orlistat should be monitored closely for coagulation parameters changes
              • Vitamin supplements
                • Orlistat may reduce absorption of some fat-soluble vitamins and beta-carotene
                • Instruct patient to take a multivitamin containing fat-soluble vitamins to ensure adequate nutrition
                • Take vitamin supplement at least 2 hr before or after taking orlistat, such as at bedtime
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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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              Administration

              Oral Administration

              Take with each fat-containing meal (during or up to 1 hr after the meal)

              The patient should be on a nutritionally balanced, reduced-calorie diet that contains ~30% of calories from fat

              Daily intake of fat, carbohydrate, and protein should be distributed over 3 main meals

              If a meal is occasionally missed or contains no fat, omit the orlistat dose

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              Images

              BRAND FORM. UNIT PRICE PILL IMAGE
              Xenical oral
              -
              120 mg capsule
              Xenical oral
              -
              120 mg capsule
              Xenical oral
              -
              120 mg capsule
              Alli oral
              -
              60 mg capsule

              Copyright © 2010 First DataBank, Inc.

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              Patient Handout

              Patient Education
              orlistat oral

              ORLISTAT - ORAL

              (OR-li-stat)

              COMMON BRAND NAME(S): Alli, Xenical

              USES: This medication is used with a doctor-approved exercise, behavior change, and reduced-calorie diet program to help you lose weight. It is used by certain overweight people, such as those who are obese or have weight-related medical problems. Taking orlistat can also help keep you from gaining back weight you have lost. Losing weight and keeping it off can lessen the many health risks that come with obesity, including heart disease, diabetes, high blood pressure, and a shorter life.Dietary fats need to be broken down into smaller pieces before the body can absorb them. Orlistat works by blocking the enzyme that breaks down fats in your diet. This undigested fat then passes out of your body in your bowel movement. Orlistat does not block the absorption of calories from sugar and other non-fat foods, so you still need to restrict your total intake of calories.

              HOW TO USE: If you are taking the over-the-counter product to self-treat, read all directions on the product package before taking this medication.If your doctor has prescribed this medication, read the Patient Information Leaflet if available from your pharmacist before you start taking orlistat and each time you get a refill. Take this medication as directed by your doctor, by mouth with liquid sometime during each meal that contains fat or within 1 hour after the meal, usually 3 times daily. If you miss a meal or your meal contains no fat, skip that dose of the medication. To decrease the chance of unpleasant side effects, it is very important that no more than 30% of the calories in your diet come from fat. Your daily intake of fat, protein, and carbohydrates should be evenly spread over 3 main meals.Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.Because this drug can interfere with the absorption of certain vitamins (fat-soluble vitamins including A, D, E, K), a daily multivitamin supplement containing these nutrients is recommended. Take the multivitamin at least 2 hours before or 2 hours after taking orlistat (such as at bedtime).If you take cyclosporine, take it at least 3 hours before or after orlistat to make sure the full dose of cyclosporine is absorbed into your bloodstream. If you take levothyroxine, take it at least 4 hours before or after orlistat.You should see some weight loss within 2 weeks after you start orlistat. Tell your doctor if your condition does not improve or if it worsens.

              SIDE EFFECTS: Changes in your bowel function often occur because of the unabsorbed fat. Fatty/oily stool, oily spotting, intestinal gas with discharge, a feeling of needing to have a bowel movement right away, increased number of bowel movements, or poor bowel control may occur. These side effects may get worse if you eat more fat than you should. If these effects persist or worsen, notify your doctor promptly.If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Stop taking this medication and tell your doctor right away if any of these rare but serious side effects occur: symptoms of liver disease (such as persistent nausea/vomiting, severe stomach/abdominal pain, dark urine, yellowing eyes/skin), symptoms of kidney stones (such as back pain, pain when urinating, pink/bloody urine).A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

              PRECAUTIONS: Before taking orlistat, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: a certain digestive problem (chronic malabsorption syndrome), a certain gall bladder problem (cholestasis), underactive thyroid (hypothyroidism), kidney stones/problems (such as calcium oxalate kidney stones, hyperoxaluria), certain eating disorders (anorexia nervosa/bulimia), HIV infection, seizures.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).If you are diabetic, weight loss may improve your blood sugar control. Be sure to check your blood sugar regularly and tell your doctor the results. Your doctor may need to adjust your diabetes medication, exercise program, or diet.This medication must not be used during pregnancy. Weight loss offers no potential benefit to a pregnant woman and may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor right away.It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

              DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Some products that may interact with this drug include: "blood thinners" (such as warfarin), HIV medications (such as atazanavir, efavirenz, emtricitabine, lopinavir, ritonavir, tenofovir).If you are taking medications to treat seizures, orlistat may cause these drugs to not work as well. Stop taking orlistat and tell your doctor right away if your seizures are happening more often or are getting worse.

              OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

              NOTES: If this medication has been prescribed for you, do not share this medication with others.For best results, this medication should be used along with a doctor-approved exercise program and diet plan. Consult your doctor or dietician for help designing an appropriate exercise and food plan for you.

              MISSED DOSE: If you miss a dose, take it as soon as you remember unless it has been more than 1-2 hours since your meal. In that case, skip the missed dose since most of the fat from your meal will already have been absorbed and the medication will not work. Do not double the dose to catch up.

              STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details.

              Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

              IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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              Formulary

              FormularyPatient Discounts

              Adding plans allows you to compare formulary status to other drugs in the same class.

              To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

              Adding plans allows you to:

              • View the formulary and any restrictions for each plan.
              • Manage and view all your plans together – even plans in different states.
              • Compare formulary status to other drugs in the same class.
              • Access your plan list on any device – mobile or desktop.

              The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

              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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              Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.