Ezetimibe and simvastatin

Ezetimibe lowers the amount of cholesterol your body absorbs. Simvastatin belongs to a group of drugs called HMG CoA reductase inhibitors, or "statins."

Ezetimibe and simvastatin is a combination medicine that helps lower the levels of "bad" cholesterol (low-density lipoprotein, or LDL), raise the levels of "good" cholesterol (high-density lipoprotein, or HDL), and reduce triglycerides (a type of fat in the blood).

Ezetimibe and simvastatin is used along 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 if ezetimibe and simvastatin decreases your risk of heart disease.

Ezetimibe and simvastatin may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take ezetimibe and simvastatin in the evening, with or without food.

You will need frequent medical tests.

Make sure any doctor caring for you knows that you use ezetimibe and simvastatin, especially if you have an infection, injury, or surgery.

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

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

You should not use ezetimibe and simvastatin if you have active liver disease or abnormal liver function tests.

Do not use ezetimibe and simvastatin if you are pregnant or breastfeeding.

Tell your doctor about all your current medicines and any that you start or stop using. Many drugs can interact, and some drugs should not be used together.

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

• active liver disease; or
• abnormal liver function tests.

Do not use if you are pregnant. This medicine can harm an unborn baby. Use effective birth control to prevent pregnancy. Stop taking this medicine and tell your doctor immediately if you become pregnant.

Do not breastfeed while taking ezetimibe and simvastatin.

Ezetimibe and simvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. This is more common in women, older adults, people of Chinese descent, and those with kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Other medicines may increase your risk of serious muscle problems if you take them with ezetimibe and simvastatin. Do not take these medicines at the same time:

• cyclosporine;
• danazol;
• gemfibrozil;
• nefazodone;
• an antibiotic--clarithromycin, erythromycin, telithromycin;
• antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;
• hepatitis C medications--boceprevir, telaprevir; or
• HIV/AIDS medication--atazanavir, cobicistat, indinavir, nelfinavir, ritonavir, saquinavir, tipranavir.

Your doses of certain other medicines may need to be adjusted while you are taking ezetimibe and simvastatin. This includes:

• amiodarone or dronedarone;
• amlodipine (sometimes in combination medicines--Azor, Caduet, Consensi, Exforge, Lotrel, Prestalia, Twynsta, Tribenzor);
• colchicine;
• diltiazem, verapamil;
• fenofibrate, fenofibric acid;
• lomitapide;
• ranolazine; or
• medicines that contain niacin, nicotinic acid, or vitamin B3, such as Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others.

Tell your doctor if you have ever had:

• unexplained weakness or muscle pain;
• a thyroid disorder;
• liver or kidney disease;
• liver problems caused by alcohol;
• a habit of drinking more than 2 alcoholic drinks per day; or
• if you are older than 65.

Ezetimibe and simvastatin is not approved for use by anyone younger than 10 years old.

This medicine should not be given to a girl who has not yet had menstrual periods.

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

This medicine may cause serious side effects. Stop using this medicine and call your doctor right away if you have:

• unexplained muscle pain, tenderness, or weakness;
• muscle weakness in your hips, shoulders, neck, and back;
• trouble lifting your arms, trouble climbing or standing;
• fever, unusual tiredness;
• upper stomach pain, loss of appetite;
• dark colored urine; or
• jaundice (yellowing of the skin or eyes).

Common side effects of ezetimibe and simvastatin may include:

• headache;
• muscle pain;
• abnormal liver function tests;
• 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.

Take the medicine as soon as possible, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

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

Grapefruit may interact with ezetimibe and simvastatin and cause unwanted side effects. Avoid using grapefruit products.

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

Avoid eating foods high in fat or cholesterol, or ezetimibe and simvastatin will not work as well.

If you also take cholestyramine, colesevelam, or colestipol: Take your ezetimibe and simvastatin dose 2 hours before or 4 hours after you take the other medicine.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect ezetimibe and simvastatin, especially:

• a blood thinner like warfarin, Coumadin, or Jantoven; or
• heart or blood pressure medication.

This list is not complete, and many other drugs may affect ezetimibe and simvastatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.