Ezetimibe/ simvastatin

Generic Name: ezetimibe/simvastatin (e-ZET-i-mibe/SIM-va-STAT-in)
Brand Name: Vytorin

Ezetimibe/ simvastatin is used for:

Treating high cholesterol along with a cholesterol-lowering diet. It may also be used for other conditions as determined by your doctor.

Ezetimibe/simvastatin is a combination of 2 medicines. Ezetimibe is an antihyperlipidemic agent. It works by reducing the amount of cholesterol that your body absorbs from your diet. Simvastatin is an HMG-CoA reductase inhibitor or "statin." It works by blocking an enzyme that is necessary for your body to make cholesterol. Lowering cholesterol levels in the blood reduces the chance of heart disease, heart attacks, and strokes.

Do NOT use ezetimibe/ simvastatin if:

  • you are allergic to any ingredient in ezetimibe/simvastatin
  • you have liver problems or unexplained abnormal liver function test results
  • you are pregnant, may become pregnant, or are breast-feeding
  • you are taking another medicine that contains simvastatin or ezetimibe
  • you take boceprevir, clarithromycin, cobicistat, cyclosporine, danazol, erythromycin, gemfibrozil, an HIV protease inhibitor (eg, ritonavir), itraconazole, ketoconazole, nefazodone, posaconazole, telaprevir, telithromycin, or voriconazole

Contact your doctor or health care provider right away if any of these apply to you.

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Before using ezetimibe/ simvastatin:

Some medical conditions may interact with ezetimibe/simvastatin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have low blood pressure, kidney problems, diabetes, low thyroid function, muscle problems or a family history of muscle problems, or serious metabolism, hormonal, or electrolyte problems
  • if you drink alcohol or have a history of seizures, liver problems, or alcohol abuse
  • if you are scheduled for major surgery or have recently had a major surgery or a serious injury, or if you have a serious infection

Some MEDICINES MAY INTERACT with ezetimibe/simvastatin. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amiodarone, amlodipine, azole antifungals (eg, itraconazole, ketoconazole, posaconazole, voriconazole), boceprevir, cobicistat, colchicine, cyclosporine, danazol, diltiazem, dronedarone, fibrates (eg, clofibrate, fenofibrate, gemfibrozil), HIV protease inhibitors (eg, ritonavir), lomitapide, macrolide antibiotics (eg, clarithromycin, erythromycin), nefazodone, niacin, nicotinic acid, ranolazine, telaprevir, telithromycin, or verapamil because they may increase the risk of ezetimibe/simvastatin's side effects, such as serious muscle problems
  • Anticoagulants (eg, warfarin) or digoxin because the risk of their side effects may be increased by ezetimibe/simvastatin

This may not be a complete list of all interactions that may occur. Ask your health care provider if ezetimibe/simvastatin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ezetimibe/ simvastatin:

Use ezetimibe/simvastatin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with ezetimibe/simvastatin. Talk to your pharmacist if you have questions about this information.
  • Take ezetimibe/simvastatin by mouth with or without food, preferably in the evening, unless directed otherwise by your doctor.
  • Taking ezetimibe/simvastatin at the same time each day will help you remember to take it.
  • If you also take a bile acid sequestrant (eg, cholestyramine, colestipol, colesevelam), do not take it within 4 hours before or 2 hours after taking ezetimibe/simvastatin. Check with your doctor if you have questions.
  • For best results, ezetimibe/simvastatin should be used along with exercise, a low-cholesterol/low-fat diet, and a weight-loss program if you are overweight. Follow the diet and exercise program given to you by your health care provider.
  • Eating grapefruit or drinking grapefruit juice may increase the amount of ezetimibe/simvastatin in your blood, which may increase your risk of serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than 1 quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking ezetimibe/simvastatin.
  • Most people with high cholesterol do not feel sick. Continue to take ezetimibe/simvastatin even if you feel well. Do not miss any doses.
  • If you miss a dose of ezetimibe/simvastatin, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use ezetimibe/simvastatin.

Important safety information:

  • Ezetimibe/simvastatin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use ezetimibe/simvastatin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • It may take several weeks for ezetimibe/simvastatin to work. Do not stop taking ezetimibe/simvastatin without checking with your doctor.
  • Ezetimibe/simvastatin may cause liver problems. Rarely, severe and sometimes fatal liver problems have been reported in patients taking "statin" medicines, including ezetimibe/simvastatin. Your risk of developing liver problems may be greater if you drink alcohol daily or in large amounts with ezetimibe/simvastatin, or if you have a history of liver problems. Check with your doctor before drinking alcohol while you are taking ezetimibe/simvastatin. Tell your doctor right away if you experience symptoms of liver problems (eg, yellowing of the skin or eyes; dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness).
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Tell your doctor or dentist that you take ezetimibe/simvastatin before you receive any medical or dental care, emergency care, or surgery. Ezetimibe/simvastatin may need to be stopped for a few days before certain types of surgery.
  • Muscle problems (myopathy) may occur with ezetimibe/simvastatin. The risk of muscle problems may be greater in people who take higher doses of ezetimibe/simvastatin, in people older than 64 years old, in females, or in people who have kidney problems or low thyroid function. It may also be greater in those who take it with certain other medicines (eg, niacin), especially in Chinese patients. Tell your doctor right away if you notice any unexplained muscle pain, tenderness, or weakness, especially if you also have a fever or general body discomfort. Tell your doctor if you have muscle problems that persist even after your doctor has told you to stop taking ezetimibe/simvastatin.
  • Diabetes patients - Ezetimibe/simvastatin may increase your blood sugar levels. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Rarely, changes to the skin, hair, and nails (eg, discoloration, dryness, hair loss) may occur. Check with your doctor if these effects become bothersome or cause you concern.
  • If you are able to become pregnant, use effective birth control to prevent pregnancy while taking ezetimibe/simvastatin. Talk with your doctor or pharmacist if you have questions about effective birth control.
  • Lab tests, including blood cholesterol levels, liver function, and creatine phosphokinase (CPK) blood levels, may be performed while you take ezetimibe/simvastatin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use ezetimibe/simvastatin with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.
  • Ezetimibe/simvastatin should be used with extreme caution in CHILDREN younger than 10 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use ezetimibe/simvastatin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if ezetimibe/simvastatin is found in breast milk. Do not breast-feed while taking ezetimibe/simvastatin.

Possible side effects of ezetimibe/ simvastatin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; headache; symptoms of upper respiratory tract infection (eg, mild cough or sore throat, runny or stuffy nose, sneezing).

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); breathing problems (eg, persistent cough, shortness of breath); burning, numbness, or tingling; change in the amount of urine produced; confusion; decreased sexual ability; depression; difficult or painful urination; dizziness; fever, chills, or persistent sore throat; irregular heartbeat; joint pain; memory problems; muscle tenderness, pain, or weakness (with or without fever and fatigue); red, swollen, blistered, or peeling skin; severe stomach or back pain (with or without nausea or vomiting); swelling of the hands, ankles, or feet; symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe stomach pain, yellowing of the skin or eyes); trouble sleeping; unusual bruising or bleeding; unusual tiredness or weakness; vomiting.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of ezetimibe/simvastatin:

Store ezetimibe/simvastatin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep ezetimibe/simvastatin out of the reach of children and away from pets.

General information:

  • If you have any questions about ezetimibe/simvastatin, please talk with your doctor, pharmacist, or other health care provider.
  • Ezetimibe/simvastatin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ezetimibe/simvastatin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ezetimibe/simvastatin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ezetimibe/simvastatin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using ezetimibe/simvastatin.

Issue Date: September 3, 2014
Database Edition 14.3.1.003
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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