Ezetimibe And Simvastatin

Ezetimibe And Simvastatin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

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Overview

Ezetimibe And Simvastatin is an Antihyperlipidemic that is FDA approved for the treatment of primary hyperlipidemia, homozygous familial hypercholesterolemia (HoFH). Common adverse reactions include headache, increased ALT, myalgia, upper respiratory tract infection, and diarrhea.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate.

Primary Hyperlipidemia

VYTORIN® is indicated for the reduction of elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), triglycerides (TG), and non-high-density lipoprotein cholesterol (non-HDL-C), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia or mixed hyperlipidemia.

Homozygous Familial Hypercholesterolemia (HoFH)

VYTORIN is indicated for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

Limitations of Use

No incremental benefit of VYTORIN on cardiovascular morbidity and mortality over and above that demonstrated for simvastatin has been established.

VYTORIN has not been studied in Fredrickson type I, III, IV, and V dyslipidemias.

Dosing Information

The usual dosage range is 10/10 mg/day to 10/40 mg/day. The recommended usual starting dose is 10/10 mg/day or 10/20 mg/day. VYTORIN should be taken as a single daily dose in the evening, with or without food. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10/40 mg/day in the absence of moderate to severe renal impairment (estimated glomerular filtration rate <60 mL/min/1.73 m2). After initiation or titration of VYTORIN, lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ezetimibe And Simvastatin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ezetimibe And Simvastatin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Coadministration of ezetimibe with simvastatin at doses greater than 40 mg/day has not been studied in adolescents. Also, VYTORIN has not been studied in patients younger than 10 years of age or in pre-menarchal girls.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ezetimibe And Simvastatin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ezetimibe And Simvastatin in pediatric patients.

Contraindications

VYTORIN is contraindicated in the following conditions:

• Concomitant administration of strong CYP3A4 inhibitors (e.g., itraconazole, ketoconazole, posaconazole, voriconazole, HIV protease inhibitors, boceprevir, telaprevir, erythromycin, clarithromycin, telithromycin, nefazodone, and cobicistat-containing products).
• Concomitant administration of gemfibrozil, cyclosporine, or danazol.
• Hypersensitivity to any component of this medication.
• Active liver disease or unexplained persistent elevations in hepatic transaminase levels.
• Women who are pregnant or may become pregnant. Serum cholesterol and triglycerides increase during normal pregnancy, and cholesterol or cholesterol derivatives are essential for fetal development. Because HMG-CoA reductase inhibitors (statins), such as simvastatin, decrease cholesterol synthesis and possibly the synthesis of other biologically active substances derived from cholesterol, VYTORIN may cause fetal harm when administered to a pregnant woman. Atherosclerosis is a chronic process and the discontinuation of lipid-lowering drugs during pregnancy should have little impact on the outcome of long-term therapy of primary hypercholesterolemia. There are no adequate and well-controlled studies of VYTORIN use during pregnancy; however, in rare reports congenital anomalies were observed following intrauterine exposure to statins. In rat and rabbit animal reproduction studies, simvastatin revealed no evidence of teratogenicity. VYTORIN should be administered to women of childbearing age only when such patients are highly unlikely to conceive. If the patient becomes pregnant while taking this drug, VYTORIN should be discontinued immediately and the patient should be apprised of the potential hazard to the fetus.

• Nursing mothers. It is not known whether simvastatin is excreted into human milk; however, a small amount of another drug in this class does pass into breast milk. Because statins have the potential for serious adverse reactions in nursing infants, women who require VYTORIN treatment should not breastfeed their infants [see Use in Specific Populations].

Warnings

There is limited information regarding Ezetimibe And Simvastatin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Ezetimibe And Simvastatin Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Ezetimibe And Simvastatin Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Ezetimibe And Simvastatin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Ezetimibe And Simvastatin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ezetimibe And Simvastatin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ezetimibe And Simvastatin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ezetimibe And Simvastatin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Ezetimibe And Simvastatin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Ezetimibe And Simvastatin in geriatric settings.

Gender

There is no FDA guidance on the use of Ezetimibe And Simvastatin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ezetimibe And Simvastatin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ezetimibe And Simvastatin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ezetimibe And Simvastatin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ezetimibe And Simvastatin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ezetimibe And Simvastatin in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Ezetimibe And Simvastatin Administration in the drug label.

Monitoring

There is limited information regarding Ezetimibe And Simvastatin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Ezetimibe And Simvastatin and IV administrations.

Overdosage

There is limited information regarding Ezetimibe And Simvastatin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Ezetimibe And Simvastatin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Ezetimibe And Simvastatin Mechanism of Action in the drug label.

Structure

There is limited information regarding Ezetimibe And Simvastatin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Ezetimibe And Simvastatin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Ezetimibe And Simvastatin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Ezetimibe And Simvastatin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Ezetimibe And Simvastatin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Ezetimibe And Simvastatin How Supplied in the drug label.

Storage

There is limited information regarding Ezetimibe And Simvastatin Storage in the drug label.

Images

Drug Images

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Patient Counseling Information

There is limited information regarding Ezetimibe And Simvastatin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Ezetimibe And Simvastatin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Ezetimibe And Simvastatin Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Ezetimibe And Simvastatin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.