Drug NameVytorin (Ezetimibe/Simvastatin) Drug UsesVytorin (Ezetimibe/Simvastatin) is used for reducing total cholesterol, LDL cholesterol, and triglycerides and for increasing HDL cholesterol.
Vytorin is available in a 20 mg dosage ( 10 mg of ezetimibe and 10 mg of simvastatin) and in a 30 mg dosage (10 mg of ezetimibe, and 20 mg of simvastatin). How to useThe recommended dose range of Vytorin is 10/10 mg to 10/80 mg, and it is administered once daily in the evening with or with out food. Therapy usually is initiated with 10/20 mg daily, but individuals who need more than a 55% reduction in LDL cholesterol can be started on 10/40 mg daily. Drug Class and MechanismVytorin is a combination of ezetimibe (Zetia) and simvastatin (Zocor) that is used for treating high levels of cholesterol in the blood. Vytorin reduces total cholesterol and low density lipoprotein cholesterol while it increases high density lipoprotein cholesterol. The ezetimibe component of Vytorin lowers blood cholesterol by blocking the absorption of cholesterol, including dietary cholesterol, from the intestine. It does not affect the absorption of triglycerides. The simvastatin component of Vytorin belongs to a class of drugs called HMG-CoA reductase inhibitors, commonly called "statins". Statins reduce cholesterol by blocking an enzyme in the liver (HMG-CoA reductase) that produces cholesterol. Statins lower total and LDL cholesterol in the blood as well as triglycerides. They also increase HDL cholesterol. LDL cholesterol is believed to be an important cause of coronary artery disease. Lowering LDL cholesterol levels slows and may even reverse coronary artery disease. Raising HDL cholesterol levels also may slow coronary artery disease. Vytorin was approved by the FDA in July, 2004. Missed DoseIf you miss a dose of Zyvox, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once. Storage Vytorin should be stored at room temperature, 20-25 degrees C (68-77 degrees F). Possible Side EffectsHeadache may occur. If this effect persists or worsens, notify your doctor or pharmacist promptly. This drug can sometimes cause muscle damage. Although uncommon, this may lead to very serious muscle damage called rhabdomyolysis, which in rare cases can be fatal. Seek immediate medical attention if you develop: muscle pain/tenderness/weakness (especially with fever or unusual tiredness). Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: yellowing eyes and skin, dark urine, severe fatigue, stomach/abdominal pain, persistent nausea, change in the amount of urine. A serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist. More InformationDo not share this medication with others. Laboratory and/or medical tests (e.g., blood cholesterol levels, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. For best results, this product should be used along with exercise, a low-cholesterol or low-fat diet, and a weight-loss program if you are overweight. Also to help reduce your risk of heart attacks and strokes, check your blood pressure regularly, seek medical treatment if your blood pressure is high, and stop smoking. Consult your doctor for more details. Warnings/PrecautionsBefore taking ezetimibe/simvastatin, tell your doctor or pharmacist if you think you are allergic to it; or to other drugs called "statins"; or if you have any other allergies. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: active liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: heart disease, history of liver disease, kidney disease, underactive thyroid (hypothyroidism), poorly controlled diabetes, alcohol use. Developing severe muscle damage, which is rare, can sometimes lead to serious kidney problems (see the Side Effects section in this handout). This medication is usually temporarily stopped if you have any condition which can increase your risk of developing kidney problems. Before you stop taking your medication, notify your doctor immediately if you have any of the following conditions: major surgery, trauma, serious illness (e.g., sepsis or severe metabolic, endocrine, or electrolyte disorders), very low blood pressure, uncontrolled seizures. Limit alcoholic beverages. Daily use of alcohol may increase your chance for serious side effects. Caution is advised when using this drug in the elderly because they may be more sensitive to its side effects, especially muscle damage. This medication must not be used during pregnancy. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is recommended that young girls and women of child-bearing age use effective birth control to prevent pregnancy while taking this drug. One of these drugs (simvastatin) may cause harm to your unborn child. It is not known if either drug passes into breast milk. A drug similar to simvastatin passes into breast milk, and because of this drug's potential risk of undesirable effects on a nursing infant, breast-feeding is not recommended while using ezetimibe/simvastatin. Consult your doctor before breast-feeding.
What is ezetimibe and simvastatin?
Ezetimibe and simvastatin are cholesterol-lowering medicines. They reduce the amount of cholesterol (a type of fat) absorbed by the body and block the production of cholesterol in the body.
The combination of ezetimibe and simvastatin lowers "bad" cholesterol in the blood, (also called LDL, or low-density lipoprotein) and raises "good" cholesterol (also called HDL, or high-density lipoprotein). Lowering your LDL and raising your HDL cholesterol levels may reduce your risk of hardened arteries, which can lead to heart attacks, stroke, and circulation problems.
Ezetimibe and simvastatin may also be used for other purposes not listed in this medication guide.
What is the most important information I should know about ezetimibe and simvastatin?
Ezetimibe and simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.
It may take up to 2 weeks of using this medicine before your cholesterol levels improve. For best results, keep using the medication as directed. Your cholesterol will need to be measured with blood tests at regular intervals. Do not miss any scheduled visits to your doctor. This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. In rare cases, ezetimibe and simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine.
What should I discuss with my healthcare provider before taking ezetimibe and simvastatin?
You should not use this medication if you are allergic to ezetimibe (Zetia) or simvastatin (Zocor), or if you have:
Before taking ezetimibe and simvastatin, tell your doctor if you are allergic to any drugs, or if you have:
If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.
In rare cases, ezetimibe and simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue. This condition can lead to kidney failure. Call your doctor at once if you have unexplained muscle pain or tenderness, muscle weakness, fever or flu symptoms, and dark colored urine. FDA pregnancy category X. This medication can cause birth defects. Do not use ezetimibe and simvastatin if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. It is not known whether ezetimibe and simvastatin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medication to a child younger than 10 years old.
How should I take ezetimibe and simvastatin?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Ezetimibe and simvastatin is usually taken once daily in the evening with or without food. Follow your doctor's instructions.
It may take up to 2 weeks of using this medicine before your cholesterol levels improve. For best results, keep using the medication as directed. Your cholesterol will need to be measured with blood tests at regular intervals. Do not miss any scheduled visits to your doctor.
Ezetimibe and simvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.
Store ezetimibe and simvastatin at room temperature away from moisture and heat.
What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
An overdose of ezetimibe and simvastatin is not expected to produce life-threatening symptoms.
What should I avoid while taking ezetimibe and simvastatin?
Avoid eating foods that are high in fat or cholesterol. Ezetimibe and simvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.
If you take another cholesterol-lowering medication such as cholestyramine (Locholest, Prevalite, Questran), colestipol (Colestid), or colesevelam (Welchol), take your ezetimibe and simvastatin dose at least 2 hours before or 4 hours after the other medication(s).
Grapefruit and grapefruit juice may interact with ezetimibe and simvastatin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Avoid drinking alcohol while taking ezetimibe and simvastatin. Alcohol may increase your risk of liver damage. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Ezetimibe and simvastatin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.
Ezetimibe and simvastatin side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using ezetimibe and simvastatin and call your doctor at once if you have any of these serious side effects:
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muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
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nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, and jaundice (yellowing of the skin or eyes);
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pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
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easy bruising or bleeding; or
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vision problems.
Less serious side effects may include:
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numbness or tingly feeling;
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headache;
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dizziness;
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depressed mood;
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constipation, diarrhea;
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cough, sore throat, runny or stuffy nose;
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joint pain, back pain; or
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sleep problems (insomnia).
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.
What other drugs will affect ezetimibe and simvastatin?
Many drugs can interact with ezetimibe and simvastatin. Below is just a partial list. Tell your doctor if you are using:
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amiodarone (Cordarone, Pacerone);
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cholestyramine (Questran), colestipol (Colestid), or colesevelam (Welchol);
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cyclosporine (Sandimmune, Neoral);
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danazol (Danocrine);
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digoxin (Lanoxin, Lanoxicaps);
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gemfibrozil (Lopid), fenofibrate (Tricor) or clofibrate (Atromid-S);
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nefazodone (Serzone);
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niacin (Nicolar, Nicobid, Slo-Niacin, others);
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verapamil (Calan, Covera-HS, Isoptin, Verelan);
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a blood thinner such as warfarin (Coumadin);
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an antibiotic such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Ery-Tab, others), itraconazole (Sporanox), ketoconazole (Nizoral), or telithromycin (Ketek); or
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HIV medicines such as amprenavir (Agenerase), atazanavir (Reyataz), efavirenz (Sustiva), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), ritonavir (Norvir), saquinavir (Invirase), or tipranavir (Aptivus).
This list is not complete and there may be other drugs not listed that can affect ezetimibe and simvastatin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
Where can I get more information?
- Your pharmacist can provide more information about ezetimibe and simvastatin.
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