Vytorin (patient information)

Overview
Vytorin contains two cholesterol-lowering medications, ezetimibe and simvastatin, available as a tablet in four strengths: − Vytorin 10/10 (ezetimibe 10 mg/simvastatin 10 mg) − Vytorin 10/20 (ezetimibe 10 mg/simvastatin 20 mg) − Vytorin 10/40 (ezetimibe 10 mg/simvastatin 40 mg) − Vytorin 10/80 (ezetimibe 10 mg/simvastatin 80 mg)

Vytorin is a medicine used to lower levels of total cholesterol, LDL (bad) cholesterol, and fatty substances called triglycerides in the blood. In addition, Vytorin raises levels of HDL (good) cholesterol. It is used for patients who cannot control their cholesterol levels by diet alone. You should stay on a cholesterol-lowering diet while taking this medicine.

Vytorin works to reduce your cholesterol in two ways. It reduces the cholesterol absorbed in your digestive tract, as well as the cholesterol your body makes by itself. Vytorin does not help you lose weight.

For more information about cholesterol, see the section called “ What should I know about high cholesterol?”

Who should not take Vytorin?
Do not take Vytorin:


 * If you are allergic to ezetimibe or simvastatin, the active ingredients in Vytorin, or to the inactive ingredients. For a list of inactive ingredients, see the “ Inactive ingredients” section at the end of this information sheet.
 * If you have active liver disease or repeated blood tests indicating possible liver problems.
 * If you are pregnant, or think you may be pregnant, or planning to become pregnant or breast-feeding.

Vytorin is not recommended for use in children under 10 years of age.

What should I tell my doctor before and while taking Vytorin?
Tell your doctor right away if you experience unexplained muscle pain, tenderness, or weakness. This is because on rare occasions, muscle problems can be serious, including muscle breakdown resulting in kidney damage.

The risk of muscle breakdown is greater at higher doses of Vytorin.

The risk of muscle breakdown is greater in patients with kidney problems.

Taking Vytorin with certain substances can increase the risk of muscle problems. It is particularly important to tell your doctor if you are taking any of the following:


 * cyclosporine
 * danazol
 * antifungal agents (such as itraconazole or ketoconazole)
 * fibric acid derivatives (such as gemfibrozil, bezafibrate, or fenofibrate)
 * the antibiotics erythromycin, clarithromycin, and telithromycin
 * HIV protease inhibitors (such as indinavir, nelfinavir, ritonavir, and saquinavir)
 * the antidepressant nefazodone
 * amiodarone (a drug used to treat an irregular heartbeat)
 * verapamil (a drug used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions)
 * large doses (≥1 g/day) of niacin or nicotinic acid
 * large quantities of grapefruit juice (>1 quart daily)

It is also important to tell your doctor if you are taking coumarin anticoagulants (drugs that prevent blood clots, such as warfarin).

Tell your doctor about any prescription and nonprescription medicines you are taking or plan to take, including natural or herbal remedies.

Tell your doctor about all your medical conditions including allergies.

Tell your doctor if you:


 * drink substantial quantities of alcohol or ever had liver problems. Vytorin may not be right for you.
 * are pregnant or plan to become pregnant. Do not use Vytorin if you are pregnant, trying to become pregnant or suspect that you are pregnant. If you become pregnant while taking Vytorin, stop taking it and contact your doctor immediately.
 * are breast-feeding. Do not use Vytorin if you are breast-feeding.

Tell other doctors prescribing a new medication that you are taking Vytorin.

How should I take Vytorin?
Your doctor has prescribed your dose of Vytorin. The available doses of Vytorin are 10/10, 10/20, 10/40, and 10/80. The usual daily starting dose is Vytorin 10/20.


 * Take Vytorin once a day, in the evening, with or without food.
 * Try to take Vytorin as prescribed. If you miss a dose, do not take an extra dose. Just resume your usual schedule.
 * Continue to follow a cholesterol-lowering diet while taking Vytorin. Ask your doctor if you need diet information.
 * Keep taking Vytorin unless your doctor tells you to stop. If you stop taking Vytorin, your cholesterol may rise again.

What should I do in case of an overdose?
Contact your doctor immediately.

What are the possible side effects of Vytorin?
See your doctor regularly to check your cholesterol level and to check for side effects. Your doctor may do blood tests to check your liver before you start taking Vytorin and during treatment.

In clinical studies patients reported the following common side effects while taking Vytorin: headache and muscle pain (see What should I tell my doctor before and while taking Vytorin?).

The following side effects have been reported in general use with either ezetimibe or simvastatin tablets (tablets that contain the active ingredients of Vytorin):


 * allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (which may require treatment right away), rash, hives; joint pain; muscle pain; alterations in some laboratory blood tests; liver problems (sometimes serious); inflammation of the pancreas; nausea; dizziness; tingling sensation; depression; gallstones; inflammation of the gallbladder.

Tell your doctor if you are having these or any other medical problems while on Vytorin. This is not a complete list of side effects. For a complete list, ask your doctor or pharmacist.

What should I know about high cholesterol?
Cholesterol is a type of fat found in your blood. Cholesterol comes from two sources. It is produced by your body and it comes from the food you eat. Your total cholesterol is made up of both LDL and HDL cholesterol.

LDL cholesterol is called “bad” cholesterol because it can build up in the wall of your arteries and form plaque. Over time, plaque build-up can cause a narrowing of the arteries. This narrowing can slow or block blood flow to your heart, brain, and other organs. High LDL cholesterol is a major cause of heart disease and stroke.

HDL cholesterol is called “good” cholesterol because it keeps the bad cholesterol from building up in the arteries.

Triglycerides also are fats found in your body.

General Information about Vytorin
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use Vytorin for a condition for which it was not prescribed. Do not give Vytorin to other people, even if they have the same condition you have. It may harm them.

This summarizes the most important information about Vytorin. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about Vytorin that is written for health professionals. For additional information, visit the following web site: Vytorin.com.

Inactive ingredients:
Butylated hydroxyanisole NF, citric acid monohydrate USP, croscarmellose sodium NF, hydroxypropyl methylcellulose USP, lactose monohydrate NF, magnesium stearate NF, microcrystalline cellulose NF, and propyl gallate NF.