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Brand Names: Vytorin

Generic Name: ezetimibe and simvastatin (Pronunciation: ez ET i mibe and SIM va stat in)

• What is ezetimibe and simvastatin (Vytorin)?
• What are the possible side effects of ezetimibe and simvastatin (Vytorin)?
• What is the most important information I should know about ezetimibe and simvastatin (Vytorin)?
• What should I discuss with my healthcare provider before taking ezetimibe and simvastatin (Vytorin)?
• How should I take ezetimibe and simvastatin (Vytorin)?
• What happens if I miss a dose (Vytorin)?
• What happens if I overdose (Vytorin)?
• What should I avoid while taking ezetimibe and simvastatin (Vytorin)?
• What other drugs will affect ezetimibe and simvastatin (Vytorin)?
• Where can I get more information?

What is ezetimibe and simvastatin (Vytorin)?

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.

Vytorin 10-10 mg

oblong, white, imprinted with 311

Vytorin 10-20 mg

oblong, white, imprinted with 312

Vytorin 10-40 mg

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Vytorin 10-80 mg

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What are the possible side effects of ezetimibe and simvastatin (Vytorin)?

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:

• muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;
• nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, and jaundice (yellowing of the skin or eyes);
• pancreatitis (severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate);
• easy bruising or bleeding; or
• vision problems.

Less serious side effects may include:

• numbness or tingly feeling;
• headache, dizziness, memory problems;
• depressed mood;
• constipation, diarrhea;
• cough, sore throat, runny or stuffy nose;
• joint pain, back pain; or
• sleep problems (insomnia).

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ezetimibe and simvastatin (Vytorin)?

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 (Vytorin)?

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

• liver disease; or
• if you are pregnant or breast-feeding.

Before taking ezetimibe and simvastatin, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;
• diabetes;
• an underactive thyroid;
• a muscle disorder; or
• if you use steroid medicine or hormones (including birth control pills).

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 (Vytorin)?

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 (Vytorin)?

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 (Vytorin)?

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 (Vytorin)?

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.

What other drugs will affect ezetimibe and simvastatin (Vytorin)?

Many drugs can interact with ezetimibe and simvastatin. Below is just a partial list. Tell your doctor if you are using:

• amiodarone (Cordarone, Pacerone);
• cholestyramine (Questran), colestipol (Colestid), or colesevelam (Welchol);
• cyclosporine (Sandimmune, Neoral);
• danazol (Danocrine);
• digoxin (Lanoxin, Lanoxicaps);
• gemfibrozil (Lopid), fenofibrate (Tricor) or clofibrate (Atromid-S);
• nefazodone (Serzone);
• niacin (Nicolar, Nicobid, Slo-Niacin, others);
• verapamil (Calan, Covera-HS, Isoptin, Verelan);
• a blood thinner such as warfarin (Coumadin);
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Ery-Tab, others), itraconazole (Sporanox), ketoconazole (Nizoral), or telithromycin (Ketek); or
• 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.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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