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New Analysis Showed VYTORIN® Superior to Lipitor® in Achieving Lower Levels of LDL Cholesterol, Apolipoprotein B and C-Reactive Protein
Business Wire, March 13, 2006
9621003
VYTORIN(R) (ezetimibe/simvastatin) Tablets
Patient Information about VYTORIN (VI-tor-in)
Generic name: ezetimibe/simvastatin tablets
Read this information carefully before you start taking VYTORIN. Review this information each time you refill your prescription for VYTORIN as there may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about VYTORIN, ask your doctor. Only your doctor can determine if VYTORIN is right for you.
What is VYTORIN?
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
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