ezetimibe and simvastatin

Generic Name: ezetimibe and simvastatin (ez ET i mibe and SIM va stat in)
Brand Name: Vytorin

What is ezetimibe and simvastatin?

Ezetimibe reduces the amount of cholesterol absorbed by the body.

Simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins."

Ezetimibe and simvastatin is a combination medicine that reduces blood levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Ezetimibe and simvastatin is used together with a low-fat diet and other treatments to lower total cholesterol in adults and children who are at least 10 years old. It is not known whether this medicine reduces your risk of heart disease.

Ezetimibe and simvastatin may also be used for purposes not listed in this medication guide.

What is the most important information I should know about ezetimibe and simvastatin?

You should not use this medicine if you have active liver disease or abnormal liver function tests.

The following drugs should not be used while you are taking ezetimibe and simvastatin: boceprevir, cyclosporine, danazol, gemfibrozil, imatinib, isoniazid, nefazodone, nicardipine, quinidine, telaprevir, certain antibiotics (clarithromycin, erythromycin, telithromycin), antifungal medication (itraconazole, ketoconazole, posaconazole, voriconazole), or certain HIV/AIDS medication (atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir).

Video: Drugs & Grapefruit

How grapefruit affects different medicines, the levels of severity, and answers your most frequently asked questions.

Do not use ezetimibe and simvastatin if you are pregnant or if you could become pregnant. Use effective birth control.

Do not breast-feed while using this medicine.

What should I discuss with my healthcare provider before taking ezetimibe and simvastatin?

You should not use this medicine if you are allergic to simvastatin (Zocor) or ezetimibe (Vytorin, Zetia), or if you have:

  • active liver disease;

  • abnormal liver function tests; or

  • if you are pregnant or breast-feeding.

The following drugs can increase your risk of serious muscle problems if you take them together with ezetimibe and simvastatin. These drugs should not be used while you are taking simvastatin:

  • cyclosporine;

  • danazol;

  • gemfibrozil;

  • imatinib;

  • isoniazid;

  • nefazodone;

  • an antibiotic--clarithromycin, erythromycin, telithromycin;

  • antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;

  • heart medication--nicardipine, quinidine;

  • hepatitis C medications--boceprevir, telaprevir; or

  • HIV/AIDS medication--atazanavir, delavirdine, fosamprenavir, indinavir, nelfinavir, ritonavir, saquinavir.

Before you start taking ezetimibe and simvastatin, tell your doctor if you are already using any of these other medicines:

  • amiodarone;

  • amlodipine (sometimes in combination medicines--Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide);

  • diltiazem;

  • dronedarone;

  • ranolazine; or

  • verapamil.

To make sure ezetimibe and simvastatin is safe for you, tell your doctor if you have:

  • a thyroid disorder;

  • a history of liver or kidney disease;

  • a history of liver problems caused by alcohol;

  • low blood pressure;

  • an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

  • untreated or uncontrolled seizures;

  • if you drink large amounts of alcohol;

  • if you are older than 65; or

  • if you are of Chinese descent.

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take ezetimibe and simvastatin if you are pregnant. Use effective birth control. Stop using the medicine and tell your doctor right away if you become pregnant.

It is not known whether ezetimibe and simvastatin passes into breast milk or if it could harm a nursing baby. Do not breast-feed while using this medicine.

How should I take ezetimibe and simvastatin?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

While using this medicine, you may need frequent blood tests.

If you have major surgery or a severe injury or infection, make sure any doctor caring for you knows you are taking ezetimibe and simvastatin.

Ezetimibe and simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ezetimibe and simvastatin?

Grapefruit and grapefruit juice may interact with this medicine and lead to unwanted side effects. Avoid the use of grapefruit products while taking ezetimibe and simvastatin.

If you also take cholestyramine, colesevelam, or colestipol: Space your doses apart in order to take ezetimibe and simvastatin either 2 hours before or 4 hours after you take any of these other medications.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Avoid eating foods that are high in fat or cholesterol. Ezetimibe and simvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Ezetimibe and simvastatin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Stop using this medicine and call your doctor at once if you have:

  • little or no urinating, pain in your side or lower back;

  • swelling, rapid weight gain;

  • nausea, upper stomach pain, loss of appetite, unusual tiredness; or

  • dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects may include:

  • headache;

  • diarrhea; or

  • cold symptoms such as stuffy nose, sneezing, sore throat;

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Ezetimibe and simvastatin Dosing Information

Usual Adult Dose for Hyperlipidemia:

Initial dose: 10 mg ezetimibe-10 mg simvastatin or 10 mg ezetimibe-20 mg simvastatin orally once a day in the evening.

The dosage range is 10 mg-10 mg to 10 mg-40 mg per day. Initiation of therapy with 10 mg-10 mg per day may be considered for patients requiring less aggressive LDL-C reductions. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10 mg-40 mg per day in the absence of moderate to severe renal impairment (estimated glomerular filtration rate less than 60 mL/min/1.73 m2). After initiation or titration, lipid levels may be analyzed after 2 or more weeks and dosage adjusted, if needed.

Due to the increased risk of myopathy, including rhabdomyolysis, particularly during the first year of
treatment, use of the 10/80-mg dose of ezetimibe-simvastatin should be restricted to patients who have been taking the 10/80 mg dose chronically (e.g., for 12 months or more) without evidence of muscle toxicity

Patients should be placed on a standard cholesterol-lowering diet before receiving ezetimibe-simvastatin and should continue on this diet during treatment with ezetimibe-simvastatin. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and patient response.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

10 mg ezetimibe-40 mg simvastatin orally once a day in the evening.

Restricted dosing for 10/80 mg ezetimibe-simvastatin should be used as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) in these patients or if such treatments are unavailable.

What other drugs will affect ezetimibe and simvastatin?

Many drugs can interact with ezetimibe and simvastatin. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with ezetimibe and simvastatin, especially:

  • colchicine;

  • digoxin, digitalis;

  • fenofibrate, fenofibric acid;

  • a blood thinner (warfarin, Coumadin); or

  • medicines that contain niacin, or vitamin B3, such as Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others;.

This list is not complete and many other drugs can cause serious or life-threatening medical problems if used together with ezetimibe and simvastatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about ezetimibe and simvastatin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 7.04. Revision Date: 2013-05-30, 2:23:37 PM.

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