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

Vytorin 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.

Vytorin 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. Vytorin has not been shown to reduce heart attacks or strokes more than simvastatin alone.

Do NOT use Vytorin if:

  • you are allergic to any ingredient in Vytorin
  • 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.

Slideshow: Flashback: FDA Drug Approvals 2013

Before using Vytorin:

Some medical conditions may interact with Vytorin. 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 Vytorin. 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 Vytorin's side effects, such as serious muscle problems
  • Anticoagulants (eg, warfarin) or digoxin because the risk of their side effects may be increased by Vytorin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Vytorin 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 Vytorin:

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

  • An extra patient leaflet is available with Vytorin. Talk to your pharmacist if you have questions about this information.
  • Take Vytorin by mouth with or without food, preferably in the evening, unless directed otherwise by your doctor.
  • Taking Vytorin 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 Vytorin. Check with your doctor if you have questions.
  • For best results, Vytorin 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 Vytorin 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 Vytorin.
  • Most people with high cholesterol do not feel sick. Continue to take Vytorin even if you feel well. Do not miss any doses.
  • If you miss a dose of Vytorin, 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 Vytorin.

Important safety information:

  • Vytorin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Vytorin 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 Vytorin to work. Do not stop taking Vytorin without checking with your doctor.
  • Vytorin may cause liver problems. Rarely, severe and sometimes fatal liver problems have been reported in patients taking "statin" medicines, including Vytorin. Your risk of developing liver problems may be greater if you drink alcohol daily or in large amounts with Vytorin, or if you have a history of liver problems. Check with your doctor before drinking alcohol while you are taking Vytorin. 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 Vytorin before you receive any medical or dental care, emergency care, or surgery. Vytorin may need to be stopped for a few days before certain types of surgery.
  • Muscle problems (myopathy) may occur with Vytorin. The risk of muscle problems may be greater in people who take higher doses of Vytorin, 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 Vytorin.
  • Diabetes patients - Vytorin 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 Vytorin. 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 Vytorin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Vytorin with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.
  • Vytorin 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 Vytorin 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 Vytorin is found in breast milk. Do not breast-feed while taking Vytorin.

Possible side effects of Vytorin:

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 Vytorin:

Store Vytorin 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 Vytorin out of the reach of children and away from pets.

General information:

  • If you have any questions about Vytorin, please talk with your doctor, pharmacist, or other health care provider.
  • Vytorin 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 Vytorin 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 Vytorin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Vytorin. 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 Vytorin.

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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