Vytorin

Vytorin is a prescription medicine that contains the cholesterol-lowering medicines simvastatin and ezetimibe. Simvastatin belongs to a group of drugs called HMG-CoA reductase inhibitors, or "statins." Ezetimibe is a cholesterol absorption inhibitor.

Vytorin is used along with diet to lower elevated low-density lipoprotein cholesterol (LDL-C), or bad cholesterol in:

• adults with primary hyperlipidemia (high level of fats in your blood).
• adults and children 10 years of age and older with heterozygous familial hypercholesterolemia (HeFH). HeFH is an inherited condition that causes high levels of bad cholesterol.

Vytorin is also used with other cholesterol-lowering treatments to lower elevated LDL-C levels in adults with homozygous familial hypercholesterolemia (HoFH). HoFH is an inherited condition that causes high levels of bad cholesterol.

Simvastatin, when used as a component of Vytorin, is used to lower:

• the risk of death by lowering the risk of heart disease death.
• the risk of heart attacks and strokes.
• the need for certain types of heart and blood vessel procedures to improve blood flow called arterial revascularization in people with known heart, cerebrovascular disease (conditions that affect blood flow and the blood vessels in the brain), peripheral vascular disease (a blood circulation disorder that causes the blood vessels outside of your heart and brain to narrow, block, or spasm), and diabetes, who are at high risk for heart disease problems.

The safety and effectiveness of Vytorin has not been established in children younger than 10 years of age with inherited heterozygous familial hypercholesterolemia (HeFH) or other types of hyperlipidemia.

Take Vytorin exactly as prescribed. 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 this medicine in the evening, with or without food.

While using ezetimibe and simvastatin, you may need frequent blood tests.

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

Vytorin is only part of a complete program of treatment 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 Vytorin if you have acute liver failure or decompensated cirrhosis.

Tell your doctor if you are pregnant or if you could become pregnant. Your doctor will decide if you should continue taking Vytorin.

Do not breastfeed while using ezetimibe and simvastatin.

The following drugs should not be used while you are taking Vytorin: boceprevir, cyclosporine, danazol, gemfibrozil, nefazodone, telaprevir, certain antibiotics (clarithromycin, erythromycin, telithromycin), antifungal medication (itraconazole, ketoconazole, posaconazole, voriconazole), or certain HIV/AIDS medication (atazanavir, cobicistat (Stribild, Tybost), indinavir, nelfinavir, ritonavir, saquinavir, tipranavir).

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

• acute liver failure or decompensated cirrhosis.

Tell your doctor if you are pregnant. This medicine can harm an unborn baby. Stop taking this medicine and tell your doctor at once if you become pregnant, so they can decide if you should continue treatment.

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

Other medicines may increase your risk of serious muscle problems if you take them together with Vytorin. 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 Vytorin. 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 (especially if you are of Chinese descent).

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.

Vytorin 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 to Vytorin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using this medicine and call your doctor at once 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
• new or worsening symptoms of myasthenia gravis (a condition that causes muscle weakness); or
• jaundice (yellowing of the skin or eyes).

Common Vytorin side effects may include:

• headache;
• muscle pain;
• abnormal liver function tests;
• diarrhea; or
• cold symptoms such as stuffy nose, sneezing, sore throat.
• increased blood sugar levels.

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 you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

Grapefruit may interact with ezetimibe and simvastatin and lead to unwanted side effects. Avoid the use of 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 be as effective.

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 your current medicines. Many drugs can interact with ezetimibe and simvastatin, especially:

• a blood thinner such as warfarin, Coumadin, or Jantoven; or
• daptomycin (you may need to temporarily stop taking Vytorin); or
• heart or blood pressure medication.

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