Adult Dosing

Primary hypercholesterolemia

• 10 mg PO qd taken either alone or in combination w/ statin

Mixed dyslipidemia

• 10 mg PO qd in combination w/ fenofibrate

Homozygous familial hypercholesterolemia

• 10 mg PO qd in combination w/ statin

Homozygous familial sitosterolemia

• 10 mg PO qd

Pediatric Dosing

Heterozygous familial hypercholesterolemia

• Child >10 yrs: 10 mg PO qd in combination w/ statin

Dyslipidemias [Non FDA approved]

• Child >10 yrs: 10 mg PO qd in combination w/ statin

[Outline]

• Adult Dosing
• Pediatric Dosing

• Ezetimibe is indicated for the following:
• Primary (heterozygous familial and nonfamilial) hyperlipidemia (either alone or in combination with an HMG-CoA reductase inhibitor)
• Mixed hyperlipidemia in combination with fenofibrate
• Homozygous familial hypercholesterolemia (HoFH), in combination with atorvastatin or simvastatin
• Homozygous sitosterolemia, in combination with statins

• It is contraindicated in the following in known hypersensitivity to any of the components of the ingredients
• If used in combination with HMG-CoA reductase inhibitor, use is contraindicated in
• Acute liver disease or unexplained elevations of transaminase
• Known/suspected pregnancy
• Woman who may become pregnant
• Lactation

• N/A

Renal Dose Adjustment

• Renal impairment: No dose adjustments

Hepatic Dose Adjustment

• Mild impairment: No dose adjustments
• Moderate/Severe impairment: Use not recommended

See Supplemental Patient Information

• Not indicated in fredrickson type I, III, IV and V dyslipidemias
• If coadministered with bile acid sequestrants, give ezetimibe either 2 hours before or 4 hours after the bile acid sequestrant
• Monitor liver function initially and then as recommended for the statin (if given with a statin)
• It should be used in conjunction with standard cholesterol-lowering diet
• Persistent elevations of hepatic transaminases can occur when added to a statin. Monitor hepatic transaminases periodically. If ALT or AST 3 times ULN persist, consider withdrawal of either statin or ezetimibe
• Rare cases of rhabdomylosis/myopathy with acute renal failure have been reported when a statin is used in combination with ezetimibe; withhold temporarily in patients with acute serious condition suggestive of myopathy or in patients with predisposition to development of renal failure

Cautions: Use cautiously in

• Hepatic impairment
• Co-administration of fibrates other than fenofibrate (safety not established)
• Concomitant cholestyramine

Supplemental Patient Information

• Instruct patient to notify physican of any unexplained muscle pain, tenderness, weakness, or any other unusual feelings

Pregnancy Category:C

Breastfeeding: Safety unknown, alternate drugs might be preferred. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 17 February 2011). Manufacturer suggests ezetimibe should not be used in nursing mothers unless the potential benefit justifies the potential risk to the infant.

• LABTESTS: Liver enzyme abnormalities, Alanine aminotransferase increased
• MUSC: Rhabdomyolysis, myopathy, arthralgia, back pain, pain in extremity
• RESP: Upper respiratory tract infection, sinusitis
• GI: Diarrhea
• HEPA: Cholelithiasis
• EENT: Nasopharyngitis
• CNS: Fatigue
• MISC: Hypersensitivity reaction, anaphylaxis reaction, angioedema, influenza

• Antihyperlipidemic; lowers blood cholesterol by inhibiting the absorption of cholesterol by the small intestine
• Metabolized in small intestine and liver via glucuronide conjugation
• Excreted in feces 78% (69% unchanged); urine: 11%
• Half-life: 22 hrs

US Trade Name(s)

• Zetia

US Availability

Zetia

• TABS: 10 mg

Canadian Trade Name(s)

• Ezetrol

Canadian Availability

Ezetrol

• TABS: 10 mg

UK Trade Name(s)

• Ezetrol

UK Availability

Ezetrol

• TABS: 10 mg

Australian Trade Name(s)

• Ezetrol

Australian Availability

Ezetrol

• TABS: 10 mg

[Outline]

Endocrine/Metabolic

Antihyperlipidemic Agents

Cholesterol Absorption Inhibitors

Cardiovascular

Antihyperlipidemic Agents

Cholesterol Absorption Inhibitors

Pricing data from www.DrugStore.com in U.S.A.

• Zetia 10 MG TABS [Bottle] (MERCK/SCHERING-PLOUGH PHARM)
  30 mg = $145.99
  90 mg = $405.98

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

• Zetia (EZETIMIBE 10 mg) (A-S Medication Solutions LLC)
• Zetia 10 MG Oral Tablet (MSP Distribution Services (C) LLC)
• Zetia 10 MG Oral Tablet (Physicians Total Care, Inc.)