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All about: Ezetimibe/Simvastatin

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Generic Name: Ezetimibe/Simvastatin (ez-ET-i-mibe/SIM-va-STAT-in)
Brand Name: Vytorin

Ezetimibe/Simvastatin is used for:

Treating high cholesterol along with a cholesterol-lowering diet. It may also be used for other conditions as determined by your doctor.

Ezetimibe/Simvastatin is a combination of 2 medicines. Ezetimibe works by reducing the amount of cholesterol that your body absorbs from your diet. Simvastatin is an HMG-CoA reductase inhibitor or "statin." It works by blocking an enzyme that is necessary for your body to make cholesterol. Lowering cholesterol levels in the blood reduces the chance of heart disease, heart attacks, and strokes.

Do NOT use Ezetimibe/Simvastatin if:

  • you are allergic to any ingredient in Ezetimibe/Simvastatin
  • you have liver problems or ongoing abnormal liver function test results
  • you are taking other medicines that contain simvastatin or ezetimibe
  • you are taking an HIV protease inhibitor (eg, ritonavir, lopinavir, nelfinavir), itraconazole, ketoconazole, a macrolide or ketolide antibiotic (eg, erythromycin, clarithromycin, troleandomycin), mibefradil, or nefazodone
  • you are pregnant or breast-feeding

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ezetimibe/Simvastatin :

Some medical conditions may interact with Ezetimibe/Simvastatin . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are a woman of childbearing age
  • if you have kidney problems, muscle problems or a family history of muscle problems, low blood pressure, uncontrolled seizures, or serious metabolic, endocrine, or electrolyte problems
  • if you are scheduled for major surgery, have recently had a major trauma, or have a severe infection or history of alcohol abuse
  • if you have had an organ transplant and are taking medicine to suppress a rejection reaction

Some MEDICINES MAY INTERACT with Ezetimibe/Simvastatin . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Bosentan, carbamazepine, cholestyramine, hydantoins (eg, phenytoin), rifampin, or St. John's wort because they may decrease Ezetimibe/Simvastatin 's effectiveness
  • Amiodarone, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), cyclosporine, danazol, delavirdine, diltiazem, fibrates (eg, clofibrate, fenofibrate), fluconazole, gemfibrozil, HIV protease inhibitors (eg, ritonavir), imatinib, itraconazole, ketoconazole, macrolide antibiotics (eg, erythromycin), macrolide immunosuppressives (eg, tacrolimus), mibefradil, nefazodone, streptogramins, telithromycin, verapamil, or voriconazole because side effects, such as muscle pain, may occur
  • Anticoagulants (eg, warfarin) because the risk of their side effects may be increased by Ezetimibe/Simvastatin

This may not be a complete list of all interactions that may occur. Ask your health care provider if Ezetimibe/Simvastatin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ezetimibe/Simvastatin :

Use Ezetimibe/Simvastatin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Ezetimibe/Simvastatin . Talk to your pharmacist if you have questions about this information.
  • Take Ezetimibe/Simvastatin by mouth with or without food, preferably in the evening, unless directed otherwise by your doctor.
  • If you also take a bile acid sequestrant (eg, cholestyramine, colestipol, colesevelam), do not take it within 2 hours before or 4 hours taking Ezetimibe/Simvastatin . Check with your doctor if you have questions.
  • For best results, Ezetimibe/Simvastatin 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 health care provider.
  • Do not drink large amounts of grapefruit juice (more than 1 quart daily) or eat large amounts of grapefruit while taking Ezetimibe/Simvastatin . Grapefruit and grapefruit juice may increase the risk of side effects from Ezetimibe/Simvastatin .
  • Most people with high cholesterol do not feel sick. Do not miss any doses. Taking Ezetimibe/Simvastatin at the same time each day will help you to remember to take it.
  • If you miss a dose of Ezetimibe/Simvastatin , 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.

Ask your health care provider any questions you may have about how to use Ezetimibe/Simvastatin .

Important safety information:

  • Ezetimibe/Simvastatin may cause drowsiness or changes in vision. These effects may be worse if you take it with alcohol or certain medicines. Use Ezetimibe/Simvastatin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • It may take several weeks for Ezetimibe/Simvastatin to work.
  • Proper dental care is important while you are taking Ezetimibe/Simvastatin . Brush and floss your teeth and visit the dentist regularly.
  • Ezetimibe/Simvastatin may harm your liver. Your risk may be greater if you drink alcohol while you are using Ezetimibe/Simvastatin . Talk to your doctor before you take Ezetimibe/Simvastatin or other fever reducers if you drink more than 3 drinks with alcohol per day.
  • Ezetimibe/Simvastatin may cause injury to your muscles, especially when taken at higher doses or when taken with certain other medicines. Contact your doctor immediately if you experience muscle pain, tenderness, or weakness, especially with a fever.
  • Lab tests, including blood cholesterol levels, liver function tests, or muscle tests, may be performed while you use Ezetimibe/Simvastatin . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Ezetimibe/Simvastatin should be used with extreme caution in CHILDREN younger than 11 years old; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Ezetimibe/Simvastatin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if Ezetimibe/Simvastatin is found in breast milk. Do not breast-feed while taking Ezetimibe/Simvastatin .

Possible side effects of Ezetimibe/Simvastatin :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Flu-like symptoms; headache; pain in the arms or legs; tiredness; upper respiratory tract infection.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision or vision changes; change in the amount of urine; chest pain; dark urine; fast heartbeat; fever; loss of appetite; muscle tenderness, pain, or weakness; nausea; stomach tenderness; unexplained pain in the stomach or mid-upper back; unusual bruising or bleeding; unusual tiredness; vomiting; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Ezetimibe/Simvastatin :

Store Ezetimibe/Simvastatin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Ezetimibe/Simvastatin out of the reach of children and away from pets.

General information:

  • If you have any questions about Ezetimibe/Simvastatin , please talk with your doctor, pharmacist, or other health care provider.
  • Ezetimibe/Simvastatin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Ezetimibe/Simvastatin . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 5, 2007
Database Edition 07.3.1.003
Copyright © 2007 Wolters Kluwer Health, Inc.

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