Ezetimibe (Lexi-Drugs)

Pronunciation

(ez ET i mibe)

Brand Names: US

Zetia

Brand Names: Canada

ACH-Ezetimibe; ACT Ezetimibe [DSC]; AG-Ezetimibe; APO-Ezetimibe; AURO-Ezetimibe; BIO-Ezetimibe; Ezetrol; JAMP-Ezetimibe; M-Ezetimibe; Mar-Ezetimibe; MINT-Ezetimibe; MYLAN-Ezetimibe [DSC]; NRA-Ezetimibe; PMS-Ezetimibe; Priva-Ezetimibe; RAN-Ezetimibe; RIVA-Ezetimibe; SANDOZ Ezetimibe; TEVA-Ezetimibe

Pharmacologic Category

Antilipemic Agent, 2-Azetidinone

Dosing: Adult

Note: Use may be considered in patients who do not meet cholesterol treatment goals with dietary modification and maximally-tolerated statin therapy (AHA/ACC [Grundy 2018]).

Homozygous familial hypercholesterolemia: Oral: 10 mg once daily

Homozygous sitosterolemia: Oral: 10 mg once daily

Primary hyperlipidemia: Oral: 10 mg once daily

Secondary prevention of cardiovascular events after acute coronary syndrome (off-label use): Oral: 10 mg once daily (Cannon 2015)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Renal Impairment: Adult

No dosage adjustment necessary.

Dosing: Hepatic Impairment: Adult

Mild impairment (Child-Pugh class A): No dosage adjustment necessary.

Moderate to severe impairment (Child-Pugh class B or C): Use of ezetimibe not recommended.

Dosing: Pediatric

Hyperlipidemia:

Children 5 to 9 years: Limited data available: Oral: 10 mg once daily; dosing based on two studies of monotherapy; a prospective trial (n=17 including six patients ≤9 years) and a retrospective review (n=36, age range: 8 to 17 years) showed significant decreases in total cholesterol and LDL-C; patients were followed up to a mean of 13.6 months, no untoward effects were noted (Clauss 2009; Yeste 2009)

Children ≥10 years and Adolescents: Oral: 10 mg once daily in combination with simvastatin. Has also been shown in small pediatric trials to decrease TC and LDL-C when used as monotherapy as adjunct to dietary changes (Clauss 2009; Yeste 2009)

Dosing: Renal Impairment: Pediatric

Children ≥10 years and Adolescents: No dosage adjustments are recommended.

Dosing: Hepatic Impairment: Pediatric

Children ≥10 years and Adolescents:

Mild hepatic impairment (Child-Pugh score 5-6): No dosage adjustments are recommended.

Moderate to severe impairment (Child-Pugh score 7-15): Use is not recommended.

Use: Labeled Indications

Homozygous familial hypercholesterolemia: In combination with atorvastatin or simvastatin for the reduction of elevated total cholesterol (total-C) and low-density lipoprotein cholesterol (LDL-C) levels in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (eg, LDL apheresis) or if such treatments are unavailable.

Homozygous sitosterolemia: As adjunctive therapy to diet for the reduction of elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia.

Primary hyperlipidemia:

Combination therapy with HMG-CoA reductase inhibitors: In combination with a 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor (statin) as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia.

Combination therapy with fenofibrate: In combination with fenofibrate as adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, apo B, and non-HDL-C in adult patients with mixed hyperlipidemia.

Monotherapy: As adjunctive therapy to diet for the reduction of elevated total-C, LDL-C, apo B, and non-HDL-C in patients with primary (heterozygous familial and nonfamilial) hyperlipidemia.

Use: Off-Label: Adult

  Secondary prevention of cardiovascular events after acute coronary syndromeLevel of Evidence [A]

Data from a multicenter, randomized, double-blind, placebo-controlled trial of patients with a recent acute coronary syndrome (ACS) support the addition of ezetimibe to statin therapy to reduce subsequent cardiovascular death, major coronary event (nonfatal myocardial infarction, unstable angina requiring hospitalization, or coronary revascularization within 30 days), or nonfatal stroke. Patients were eligible for this trial if ACS events occurred within 10 days and LDL cholesterol was ≥50 mg/dL) Ref.

Based on the AHA/ACC guideline on the management of blood cholesterol, the addition of ezetimibe to maximally tolerated statin therapy is effective and recommended for secondary prevention of atherosclerotic cardiovascular disease.

Level of Evidence Definitions
  Level of Evidence Scale
Clinical Practice Guidelines

Diabetes Mellitus:

AACE/ACE, “Consensus Statement on the Comprehensive Type 2 Diabetes Management Algorithm- 2019 Executive Summary,” January 2019

American Diabetes Association, “Standards of Medical Care in Diabetes – 2019,” January 2019

Dyslipidemia:

AACE/ACE, “Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease,” April 2017

ACC, “2017 Focused Update of the 2016 ACC Expert Consensus Decision Pathway on the Role of Non-Statin Therapies for LDL-Cholesterol Lowering in the Management of Atherosclerotic Cardiovascular Disease Risk,” October 2017

ACC/AHA, “2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults,” November 2013

AHA/ACC, “Guideline on the management of blood cholesterol,” November 2018

Canadian Cardiovascular Society, “2012 Update of the Canadian Cardiovascular Society Guidelines for the Diagnosis and Treatment of Dyslipidemia for the Prevention of Cardiovascular Disease in the Adult, 2012

NLA, “National Lipid Association Recommendations for Patient-Centered Management of Dyslipidemia” Part 1: April 2015; Part 2: December 2015

The Kidney Disease: Improving Global Outcomes (KDIGO), “Lipid Management in Chronic Kidney Disease: Synopsis of the Kidney Disease: Improving Global Outcomes 2013 Clinical Practice Guideline,” December 2013

Administration: Oral

May be administered without regard to meals. May be taken at the same time as a statin or fenofibrate. Administer ≥2 hours before or ≥4 hours after bile acid sequestrants.

Administration: Pediatric

Oral: May be taken without regard to meals or time of day; may be administered with an HMG-CoA reductase inhibitor (eg, atorvastatin, simvastatin) or fenofibrate. Administer ≥2 hours before or ≥4 hours after bile acid sequestrants.

Dietary Considerations

Before initiation of therapy, patients should be placed on a standard cholesterol-lowering diet for 6 weeks and the diet should be continued during drug therapy.

Storage/Stability

Store at 25°C (77°F); excursions are permitted between 15°C and 30°C (59°F and 86°F). Protect from moisture.

Medication Patient Education with HCAHPS Considerations

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience joint pain, diarrhea, or loss of strength and energy. Have patient report immediately to prescriber muscle pain or muscle weakness (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Medication Safety Issues
  Sound-alike/look-alike issues:
Contraindications

Hypersensitivity to ezetimibe or any component of the formulation; concomitant use with an HMG-CoA reductase inhibitor (statin) in patients with active hepatic disease or unexplained persistent elevations in serum transaminases; pregnancy and breastfeeding (when used concomitantly with a statin)

Warnings/Precautions

Concerns related to adverse effects:

• Elevated hepatic transaminases: A higher incidence of elevated transaminases (≥3 x ULN) has been observed with concomitant use of ezetimibe and statins compared to statin monotherapy; transaminase changes were generally not associated with symptoms or cholestasis and returned to baseline with or without discontinuation of therapy. Consider discontinuation of ezetimibe and/or the statin for persistently elevated transaminases (ALT or AST ≥3 x ULN).

• Myopathy: Myopathy, including rhabdomyolysis, has been reported (rarely) with ezetimibe monotherapy; risk may be increased with concomitant use of a statin or fibrate. Discontinue ezetimibe and statin or fibrate immediately if myopathy is suspected or confirmed (symptomatic patient with CPK >10 x ULN).

Disease-related concerns:

• Hepatic impairment: Systemic exposure is increased in hepatic impairment. Use with caution in patients with mild hepatic impairment (Child-Pugh class A); use is not recommended in patients with moderate or severe hepatic impairment (Child-Pugh classes B and C).

• Renal impairment: Use with caution in patients with severe renal impairment (CrCl ≤30 mL/minute/1.73 m2); systemic exposure is increased ~1.5-fold. If using concurrent simvastatin in patients with moderate to severe renal impairment (CrCl <60 mL/minute/1.73m2), the manufacturer of ezetimibe recommends that simvastatin doses exceeding 20 mg be used with caution and close monitoring for adverse events (eg, myopathy).

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant drug interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Other warnings/precautions:

• Hyperlipidemia: Secondary causes of hyperlipidemia should be ruled out prior to therapy.

Geriatric Considerations

The definition of and, therefore, when to treat hyperlipidemia in the elderly is a controversial issue. According to the 2013 ACC/AHA Guidelines on the Treatment of Blood Cholesterol to Reduce Atherosclerotic Cardiovascular Risk in Adults, there are no supporting data for the routine use of nonstatin drugs in combination with a statin to further reduce atherosclerotic cardiovascular disease (ASCVD) events. Evidence for nonstatins in statin-intolerant patients is also lacking (Stone 2013). It is the authors’ belief that pharmacologic treatment be reserved for those who are unable to obtain a desirable plasma cholesterol concentration by diet alone and for whom the benefits of treatment are believed to outweigh the potential adverse effects, drug interactions, and cost of treatment.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies. Use is contraindicated in pregnant women who require combination therapy with an HMG-CoA reductase inhibitor. If treatment for familial hypercholesterolemia is needed during pregnancy, other agents are preferred (Wiegman 2015).

Breast-Feeding Considerations

It is not known if ezetimibe is present in breast milk. According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of exposure to the infant and the benefits of treatment to the mother. Use is contraindicated in breastfeeding women who require combination therapy with an HMG-CoA reductase inhibitor.

Briggs’ Drugs in Pregnancy & Lactation
Adverse Reactions

1% to 10%:

Central nervous system: Fatigue (2%)

Gastrointestinal: Diarrhea (4%)

Hepatic: Increased serum transaminases (with HMG-CoA reductase inhibitors; ≥3 x ULN: 1%)

Infection: Influenza (2%)

Neuromuscular & skeletal: Arthralgia (3%), limb pain (3%)

Respiratory: Upper respiratory tract infection (4%), sinusitis (3%)

<1%, postmarketing, and/or case reports: Abdominal pain, anaphylaxis, angioedema, autoimmune hepatitis (Stolk 2006), cholecystitis, cholelithiasis, cholestatic hepatitis (Stolk 2006), depression, dizziness, erythema multiforme, headache, hepatitis, hypersensitivity reaction, increased creatine phosphokinase, myalgia, myopathy, nausea, pancreatitis, paresthesia, rhabdomyolysis, skin rash, thrombocytopenia, urticaria

Metabolism/Transport Effects

Substrate of OATP1B1/1B3 (SLCO1B1/1B3)

Drug Interactions 

Bezafibrate: May enhance the adverse/toxic effect of Ezetimibe. Specifically, the risk of myopathy and cholelithiasis may be increased. Risk X: Avoid combination

Bile Acid Sequestrants: May decrease the absorption of Ezetimibe. Management: Administer ezetimibe at least 2 hours before or 4 hours after any bile acid sequestrant. Risk D: Consider therapy modification

CycloSPORINE (Systemic): Ezetimibe may increase the serum concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase the serum concentration of Ezetimibe. Risk C: Monitor therapy

Eltrombopag: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates. Risk C: Monitor therapy

Fenofibrate and Derivatives: May enhance the adverse/toxic effect of Ezetimibe. Specifically, the risk of myopathy and cholelithiasis may be increased. Risk C: Monitor therapy

Gemfibrozil: May enhance the adverse/toxic effect of Ezetimibe. Specifically, the risk of myopathy and cholelithiasis may be increased. Gemfibrozil may increase the serum concentration of Ezetimibe. Risk X: Avoid combination

Teriflunomide: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates. Risk C: Monitor therapy

Tolvaptan: May increase the serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates. Risk D: Consider therapy modification

Monitoring Parameters

ACC/AHA blood cholesterol guideline recommendations (ACC/AHA [Grundy 2018]; ACC/AHA [Stone 2013]):

Lipid panel (total cholesterol, HDL, LDL, triglycerides): Lipid profile (fasting or nonfasting) before initiating treatment. Fasting lipid profile should be rechecked 4 to 12 weeks after starting therapy and every 3 to 12 months thereafter (AHA/ACC [Grundy 2018]).

Hepatic transaminase levels: Baseline LFTs (reasonable); when used in combination with statin therapy, monitor LFTs when clinically indicated; discontinue use of ezetimibe if ALT elevations >3 times upper limit of normal persist. When used in combination with fenofibrate, monitor LFTs and signs and symptoms of cholelithiasis.

Reference Range

Treatment goals: May vary depending on clinical condition, different clinical practice guidelines, and expert opinion. Refer to clinical practice guidelines for specific treatment goals.

Advanced Practitioners Physical Assessment/Monitoring

Use caution in presence of hepatic impairment. If used as monotherapy, dose adjustment is unnecessary in renal impairment. Assess lipid profile at beginning of and at regular intervals during therapy. Teach patient to report signs of hepatic or muscle reactions.

Nursing Physical Assessment/Monitoring

Assess lipid profile at beginning of and at regular intervals during therapy. Teach patient to report signs of hepatic or muscle reactions. Consider dietary assessment and plan for teaching.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Zetia: 10 mg

Generic: 10 mg

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Ezetrol: 10 mg

Generic: 10 mg

Anatomic Therapeutic Chemical (ATC) Classification
  • C10AX09
Generic Available (US)

Yes

Pricing: US

Tablets (Ezetimibe Oral)

10 mg (per each): $2.62 – $13.21

Tablets (Zetia Oral)

10 mg (per each): $13.80

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer’s AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Mechanism of Action

Inhibits absorption of cholesterol at the brush border of the small intestine via the sterol transporter, Niemann-Pick C1-Like1 (NPC1L1). This leads to a decreased delivery of cholesterol to the liver, reduction of hepatic cholesterol stores and an increased clearance of cholesterol from the blood; decreases total C, LDL-cholesterol (LDL-C), ApoB, and triglycerides (TG) while increasing HDL-cholesterol (HDL-C).

Pharmacodynamics/Kinetics

Note: Pharmacokinetic data in children and adolescents ≥10 years of age are reported to be similar to that in adult patients.

Onset of action: Within 1 week; Maximum effect: 2-4 weeks

Protein binding: >90% to plasma proteins

Metabolism: Undergoes glucuronide conjugation in the small intestine and liver; forms metabolite (active); may undergo enterohepatic recycling

Bioavailability: Variable

Hepatic impairment: Moderate hepatic impairment (Child-Pugh score 7-9): AUC increased 3-4 times; Severe hepatic impairment (Child-Pugh 10-15): AUC increased 5-6 times

Renal impairment: Severe renal dysfunction (CrCl <30 mL/minute/1.73 m2): AUC increased 1.5 times

Half-life elimination: 22 hours (ezetimibe and metabolite)

Time to peak, plasma: 4-12 hours (ezetimibe); 1-2 hours (active metabolite); Effects: ~2 weeks

Excretion: Feces (78%, 69% as ezetimibe); urine (11%, 9% as metabolite)

Pharmacodynamics/Kinetics: Additional Considerations

Geriatric: Plasma concentrations are approximately 2-fold higher.

Gender: Plasma concentrations for total ezetimibe were slightly higher (less than 20%) in women than in men.

Local Anesthetic/Vasoconstrictor Precautions

No information available to require special precautions

Effects on Dental Treatment

No significant effects or complications reported

Effects on Bleeding

No information available to require special precautions

FDA Approval Date
October 25, 2002
References

American Diabetes Association (ADA). 9. Cardiovascular disease and risk management: standards of medical care in diabetes-2018. Diabetes Care. 2018a;41(suppl 1): S86-S104. doi: 10.2337/dc18-S009.[PubMed 29222380]10.2337/dc18-S009

Cannon CP, Blazing MA, Giugliano RP, et al. Ezetimibe added to statin therapy after acute coronary syndromes. N Engl J Med. 2015;372(25):2387-2397.[PubMed 26039521]

Ezetrol (ezetimibe) [product monograph]. Kirkland, Quebec, Canada: Merck Canada Inc; October 2017.

Grundy SM, Stone NJ, Bailey AL, et al. 2018 AHA/ACC/AACVPR/AAPA/ABC/ACPM/ADA/AGS/APhA/ASPC/NLA/PCNA guideline on the management of blood cholesterol [published online November 10, 2018]. Circulation. 2018.[PubMed 30586774]

Gustavson LE, Schweitzer SM, Burt DA, et al, “Evaluation of the Potential for Pharmacokinetic Interaction Between Fenofibrate and Ezetimibe: A Phase I, Open-Label, Multiple-Dose, Three-Period Crossover Study in Healthy Subjects,” Clin Ther, 2006, 28 (3):373-87.[PubMed 16750452]

Jacobson TA, Maki KC, Orringer CE, et al; NLA Expert Panel. National Lipid Association recommendations for patient-centered management of dyslipidemia: part 2 [published correction appears in J Clin Lipidol. 2016;10(1):211]. J Clin Lipidol. 2015;9(6)(suppl):S1-S122.e1.[PubMed 26699442]

Jacobson TA, Marman A, McKenney JM, et al, “Safety Considerations With Gastrointestinally Active Lipid-Lowering Drugs,” Am J Cardiol, 2007, 99(6A):47C-55C.[PubMed 17368279]

Jellinger PS, Handelsman Y, Rosenblit PD, et al. American Association of Clinical Endocrinologists and American College of Endocrinology guidelines for management of dyslipidemia and prevention of cardiovascular disease. Endocr Pract. 2017;23(suppl 2):1-87. doi: 10.4158/EP171764.APPGL.[PubMed 28437620]10.4158/EP171764.APPGL

Mauro VF and Tuckerman CE, “Ezetimibe for Management of Hypercholesterolemia,” Ann Pharmacother, 2003, 37(6):839-48.[PubMed 12773075]

Peto R, Emberson J, Landray M, et al, “Analysis of Cancer Data From Three Ezetimibe Trials,” N Engl J Med, 2008, 359(13):1357-66. Available at http://content.nejm.org/cgi/content/full/NEJMsa0806603[PubMed 18765432]

Rossebo AB, Pederson TR, Boman K, et al, “Intensive Lipid Lowering With Simvastatin and Ezetimibe in Aortic Stenosis,” N Engl J Med, 2008, 359(13):1343-56. Available at http://content.nejm.org/cgi/content/full/NEJMoa0804602[PubMed 18765433 ]

Stolk MF, Becx MC, Kuypers KC, et al, “Severe Hepatic Side Effects of Ezetimibe,” Clin Gastroenterol Hepatol, 2006, 4(7):908-11.[PubMed 16797241]

Stone NJ, Robinson J, Lichtenstein AH, et al, 2013 ACC/AHA Guideline on the Treatment of Blood Cholesterol to Reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines [published online ahead of print November 12, 2013].Circulation. 2013.

“Three New Drugs for Hyperlipidemia,” Med Lett Drugs Ther, 2003, 45(1151):17-9.[PubMed 12612501]

von Bergmann K, Salen G, Lutjohann D, et al, “Ezetimibe Effectively Reduces Serum Plant Sterols in Patients With Sitosterolemia (abstract).” 73rd European Atherosclerosis Society Congress, 2002. Available at http://www.kenes.com/73eas/program/abstracts/405.doc

Tonelli M, Wanner C; Kidney Disease: Improving Global Outcomes Lipid Guideline Development Work Group Members. Lipid management in chronic kidney disease: synopsis of the Kidney Disease: Improving Global Outcomes 2013 clinical practice guideline. Ann Intern Med. 2014;160(3):182. doi: 10.7326/M13-2453.[PubMed 24323134]

Wiegman A, Gidding SS, Watts GF, et al. Familial hypercholesterolaemia in children and adolescents: gaining decades of life by optimizing detection and treatment. Eur Heart J. 2015;36(36):2425-2437. doi: 10.1093/eurheartj/ehv157.[PubMed 26009596]

Zetia (ezetimibe) [prescribing information]. Whitehouse Station, NJ: Merck/Schering-Plough; August 2013.

Brand Names: International

Absorcol (ES); Centex (PY); Cholinor (BD); Ezemibe (LK); Ezentia (TH); Ezeta (BD); Ezetib (IN); Ezetrol (AE, AR, AT, AU, BD, BE, BG, BH, CH, CL, CN, CO, CR, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GR, GT, HK, HN, HR, ID, IE, IL, IS, JO, KR, KW, LB, LT, LU, LV, MT, MX, MY, NI, NL, NO, NZ, PA, PE, PH, PL, PT, QA, RO, RU, SA, SE, SG, SI, SK, SV, TH, TW, VE, VN); Ezgal (BE); Ezitab (BD); Ezitoget (VN); Ibet (PY); Ledipsa (PH); Maxetibe (PY); Mibe (LK); Zemil (LB); Zemitra (PK); Zetavim (UY); Zetex (SA); Zetia (BR, JP, PE); Zient (CR, DO, GT, HN, MX, NI, PA, SG, SV); Zytovyrin (VN)

Ezetimibe (Patient Education – Adult Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(ez ET i mibe)

Brand Names: US

Zetia

Brand Names: Canada

Ezetrol

What is this drug used for?
  • It is used to lower cholesterol.
What do I need to tell my doctor BEFORE I take this drug?
  • If you have an allergy to ezetimibe or any other part of this drug.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have liver disease or raised liver enzymes.
  • If you are pregnant.
  • If you are breast-feeding or plan to breast-feed.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this drug with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take this drug?
  • Tell all of your health care providers that you take this drug. This includes your doctors, nurses, pharmacists, and dentists.
  • Have blood work checked as you have been told by the doctor. Talk with the doctor.
  • Follow the diet and workout plan that your doctor told you about.
  • Do not take colestipol or cholestyramine within 4 hours before or 2 hours after this drug.
  • This drug may affect how much of some other drugs are in your body. If you are taking other drugs, talk with your doctor. You may need to have your blood work checked more closely while taking this drug with your other drugs.
  • Use birth control that you can trust to prevent pregnancy while taking this drug.
  • If you are pregnant or you get pregnant while taking this drug, call your doctor right away.
What are some side effects that I need to call my doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Muscle pain or weakness.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
  • Joint pain.
  • Diarrhea.
  • Feeling tired or weak.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best taken?
  • Use this drug as ordered by your doctor. Read all information given to you. Follow all instructions closely.
  • Take with or without food.
  • Take this drug at the same time of day.
  • To gain the most benefit, do not miss doses.
  • Keep taking this drug as you have been told by your doctor or other health care provider, even if you feel well.
What do I do if I miss a dose?
  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else’s drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
Ezetimibe (Patient Education – Pediatric Medication)
You must carefully read the “Consumer Information Use and Disclaimer” below in order to understand and correctly use this information
Pronunciation

(ez ET i mibe)

Brand Names: US

Zetia

Brand Names: Canada

Ezetrol

What is this drug used for?
  • It is used to lower cholesterol.
What do I need to tell the doctor BEFORE my child takes this drug?
  • If your child has an allergy to this drug or any part of this drug.
  • If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If your child has liver disease or raised liver enzymes.
  • If your child is pregnant or may be pregnant.
  • Talk with the doctor if your child is breast-feeding a baby or plans to breast-feed a baby.
  • This is not a list of all drugs or health problems that interact with this drug.
  • Tell the doctor and pharmacist about all of your child’s drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for your child to take this drug with all of his/her drugs and health problems. Do not start, stop, or change the dose of any drug your child takes without checking with the doctor.
What are some things I need to know or do while my child takes this drug?
  • Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists.
  • Have your child’s blood work checked often. Talk with your child’s doctor.
  • Have your child follow the diet and workout plan your child’s doctor told you about.
  • Do not give cholestyramine or colestipol within 4 hours before or 2 hours after this drug.
  • This drug may affect how much of some other drugs are in the body. If your child is taking other drugs, talk with the doctor. Your child may need to have blood work checked more closely while taking this drug with other drugs.
  • If your child is or may be sexually active:
  • Have your child use birth control to prevent pregnancy while taking this drug.
  • If your child is pregnant:
  • If your child is pregnant or gets pregnant while taking this drug, call the doctor right away.
What are some side effects that I need to call my child’s doctor about right away?
  • WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child’s doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:
  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Muscle pain or weakness.
What are some other side effects of this drug?
  • All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child’s doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:
  • Joint pain.
  • Feeling tired or weak.
  • Diarrhea.
  • These are not all of the side effects that may occur. If you have questions about side effects, call your child’s doctor. Call your child’s doctor for medical advice about side effects.
  • You may report side effects to your national health agency.
How is this drug best given?
  • Give this drug as ordered by your child’s doctor. Read all information given to you. Follow all instructions closely.
  • Give this drug at the same time of day.
  • Give this drug with or without food.
  • To gain the most benefit, do not miss giving your child doses.
  • Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
What do I do if my child misses a dose?
  • Give a missed dose as soon as you think about it.
  • If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
  • Do not give 2 doses at the same time or extra doses.
How do I store and/or throw out this drug?
  • Store at room temperature.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
General drug facts
  • If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
  • Do not share your child’s drug with others and do not give anyone else’s drug to your child.
  • Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
  • Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.