Vytorin

Generic name: Ezetimbe and simvastatin

What is Vytorin?

Vytorin is a cholesterol-lowering drug. It is used along with a special diet to lower the amount of fatty material in the blood—triglycerides and LDL (or "bad") cholesterol—that can build up on artery walls and block blood flow. At the same time, Vytorin raises HDL (or "good") cholesterol, which helps prevent fats from building up and clogging the arteries.

What is the most important information I should know about Vytorin?

LDL cholesterol is called "bad" cholesterol because it can build up in the wall of your arteries and form plaque. Over time, plaque buildup 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 one of the causes for 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.

Vytorin may cause a serious muscle condition called rhabdomyolysis, especially if you are taking a high dose or if you are taking certain other medicines with Vytorin. You should tell your doctor right away if you feel any muscle weakness, pain, or tenderness, especially with a fever.

It is important to remember that Vytorin is a supplement—not a substitute—for other measures to control your cholesterol. For the 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 healthcare provider.

Keep taking Vytorin unless your doctor tells you to stop. If you stop taking it, your cholesterol may rise again. It may take several weeks for Vytorin to work.

If you also take a bile acid sequestrant (such as cholestyramine, colestipol, or colesevelam), do not take it within 2 hours before or 4 hours after taking Vytorin. Check with your doctor if you have questions.

Vytorin may harm your liver. Your risk may be greater if you drink alcohol while you are using Vytorin. Talk to your doctor before you take Vytorin if you drink substantial amounts of alcohol per day (more than two alcoholic beverages per day).

Do not drive or perform other possibly unsafe tasks until you know how you react to Vytorin; this medication may cause drowsiness or change in vision. These effects may be worse if you take it with alcohol or certain medicines.

Proper dental care is important while you are taking Vytorin. Brush and floss your teeth and visit the dentist regularly.

Eating grapefruit or drinking grapefruit juice may increase the amount of Vytorin in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice (more than one 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.

Who should not take Vytorin?

You should not take Vytorin if you are allergic or sensitive to ezetimbe, simvastatin, or any other ingredient in Vytorin. You should also not take Vytorin if you are pregnant or think you may be pregnant, planning to become pregnant, breastfeeding, or if you have active liver disease or liver problems.

What should I tell my doctor before I take the first dose of Vytorin?

Mention all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Vytorin. Also, talk to your doctor about your complete medical history, especially if you have kidney, thyroid, or liver problems; drink substantial amounts of alcoholic beverages per day (more than two alcoholic beverages); or have a history of muscle aches or weakness, low blood pressure, uncontrolled seizures, metabolic problems, electrolyte problems, or diabetes. In addition, tell your doctor if you have recently had major trauma, a severe infection, and if you recently had an organ transplant or are currently taking medication to suppress a rejection reaction.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Adults: The usual dosage is 10/10 milligrams (mg) (10 mg of ezetimbe and 10 mg of simvastatin) to 10/80 mg (10 mg of ezetimbe and 80 mg of simvastatin) taken once a day. The recommended staring dose is 10/20 mg (10 mg of ezetimbe and 20 mg of simvastatin) taken once a day. Two or more weeks after the initiation of Vytorin therapy lipid levels should be analyzed and, if necessary, the dose adjusted.

Patients with Homozygous Familial Hypercholesterolemia

Adults: The usual dosage is 10/40 mg to 10/80 mg taken once daily in the evening.

Vytorin has not been studied in children under 10 years of age.

How should I take Vytorin?

Vytorin should be taken once daily in the evening, with or without food.

Dosing of Vytorin should occur at least 2 hours before or 4 hours after administration of a bile acid sequestrant.

Keep taking Vytorin unless your doctor tells you to stop. If you stop taking it, your cholesterol may rise again. It may take some time to see the effects of Vytorin.

Continue to follow a cholesterol-lowering diet while taking Vytorin. Ask your doctor if you need diet information.

Eating grapefruit or drinking grapefruit juice may increase the amount of Vytorin in your blood, which may increase your risk for serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice (more than one 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.

Proper dental care is important while you are taking Vytorin. Brush and floss your teeth and visit the dentist regularly.

What should I avoid while taking Vytorin?

You should not become pregnant or breastfeed while taking Vytorin. You should also not drink more than 1 quart of grapefruit juice per day.

Do not drive or perform other possibly unsafe tasks until you know how you react to Vytorin; this medication may cause drowsiness or change in vision. These effects may be worse if you take it with alcohol or certain medicines.

What are possible food and drug interactions associated with Vytorin?

If Vytorin is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Vytorin with the following: amiodarone; antifungal agents, such as itraconazole or ketoconazole; clarithromycin; cyclosporine; danazol; erythromycin; fibric acid derivatives, such as gemfibrozil, bezafibrate, or fenofibrate; grapefruit juice (more than 1 quart daily); HIV protease inhibitors, such as indinavir, nelfinavir, ritonavir, and saquinavir; nefazodone; niacin or nicotinic acid; telithromycin; and verapamil.

What are the possible side effects of Vytorin?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include: headache, nausea, rash, flu-like symptoms, pain in the arms or legs, tiredness, upper respiratory tract infection

Serious side effects may include: hives, joint pain, muscle pain, swelling of the face/lips/tongue/throat

Vytorin may cause a serious muscle condition called rhabdomyolysis, especially if you are taking a high dose or if you are taking certain other medicines with Vytorin. You should tell your doctor right away if you feel any muscle weakness, pain, or tenderness, especially with a fever.

Can I receive Vytorin if I am pregnant or breastfeeding?

Do not take Vytorin if you are pregnant or breastfeeding. Vytorin can cause serious harm to your unborn baby. It is not known if Vytorin is found in breast milk. Tell your doctor immediately if you are pregnant, plan to become pregnant, or if you are breastfeeding.

What should I do if I miss a dose of Vytorin?

If you miss a dose of Vytorin, do not double your next dose. Skip the dose you missed and then return to your normal dosing schedule.

How should I store Vytorin?

Store at room temperature, away from heat, moisture, and light. Do not store in the bathroom.