• Ezetimibe

    (ez et' i mibe)

    WHY is this medicine prescribed?

    Ezetimibe is used together with lifestyle changes (diet, weight-loss, exercise) to reduce the amount of cholesterol (a fat-like substance) and other fatty substances in the blood. It may be used alone or in combination with an HMG-CoA reductase inhibitor (statin). Ezetimibe is in a class of medications called cholesterol-lowering medications. It works by preventing the absorption of cholesterol in the intestine.
    Buildup of cholesterol and fats along the walls of the blood vessels (a process known as atherosclerosis) decreases blood flow, which decreases the oxygen supply to the heart, brain, and other parts of the body. Lowering blood levels of cholesterol and fats may help reduce this buildup and may decrease your chances of developing heart conditions such as angina (chest pain), strokes, and heart attacks. Results of a clinical study that compared people who took ezetimibe and simvastatin with people who took simvastatin alone found that although the group of people taking ezetimibe and simvastatin had lower amounts of cholesterol in the blood, there was no difference between the two groups in the amount of cholesterol and fat buildup on the insides of the blood vessels in the neck. It is not currently understood why the additional lowering of cholesterol levels in the blood did not lead to a greater decrease in cholesterol and fat buildup along the walls of the blood vessels in people taking ezetimibe and simvastatin. Further studies are underway to compare treatment with ezetimibe and simvastatin to treatment with simvastatin alone to see if there is a difference in the risk of developing heart disease. Talk to your doctor if you have questions about the risks and benefits of treating increased amounts of cholesterol in your blood with ezetimibe and other medications.
    In addition to taking a cholesterol-lowering medication, making certain changes in your daily habits can also lower your blood cholesterol levels. You should eat a diet that is low in saturated fat and cholesterol (see SPECIAL DIETARY); exercise 30 minutes on most, if not all, days; and lose weight if you are overweight.

    HOW should this medicine be used?

    Ezetimibe comes as a tablet to take by mouth. It is usually taken once a day with or without food. To help you remember to take ezetimibe, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ezetimibe exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
    Continue to take ezetimibe even if you feel well. Do not stop taking ezetimibe without talking to your doctor.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking ezetimibe,
    • tell your doctor and pharmacist if you are allergic to ezetimibe or any other medications.
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Be sure to mention any of the following: anticoagulants (''blood thinners'') such as warfarin (Coumadin); cyclosporine (Neoral, Sandimmune); fenofibrate (TriCor); and gemfibrozil (Lopid). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • if you are taking cholestyramine (Questran), colesevelam (WellChol), or colestipol (Colestid), take it 4 hours before or 2 hours after ezetimibe.
    • tell your doctor if you have or have ever had liver disease.
    • tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ezetimibe, call your doctor.

    What SPECIAL DIETARY instructions should I follow?

    Eat a low-cholesterol, low-fat diet, which includes cottage cheese, fat-free milk, fish, vegetables, poultry, and egg whites. Use monounsaturated oils such as olive, peanut, and canola oils or polyunsaturated oils such as corn, safflower, soy, sunflower, cottonseed, and soybean oils. Avoid foods with excess fat in them such as meat (especially liver and fatty meat), egg yolks, whole milk, cream, butter, shortening, pastries, cakes, cookies, gravy, peanut butter, chocolate, olives, potato chips, coconut, cheese (other than cottage cheese), coconut oil, palm oil, and fried foods.

    What should I do IF I FORGET to take a dose?

    Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Ezetimibe may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • headache
    • dizziness
    • diarrhea
    • sore throat
    • runny nose
    • sneezing
    • joint pain
    Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:
    • hives
    • rash
    • itching
    • difficulty breathing or swallowing
    • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
    • hoarseness
    • upset stomach
    • extreme tiredness
    • unusual bleeding or bruising
    • lack of energy
    • loss of appetite
    • pain in the upper right part of the stomach
    • yellowing of the skin or eyes
    • flu-like symptoms
    • muscle pain or weakness
    • fever
    • chills
    • pale or fatty stools
    • chest pain
    Ezetimibe may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during treatment to check your body's response to ezetimibe.
    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Zetia®
    • Vytorin® (as a combination product containing Ezetimibe, Simvastatin)

    Simvastatin

    (sim' va stat in)

    WHY is this medicine prescribed?

    Simvastatin is used together with diet, weight-loss, and exercise to reduce the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol ('bad cholesterol') and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol ('good cholesterol') in the blood. Simvastatin may also be used to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 10 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Simvastatin is also used to decrease the risk of heart attacks, strokes, and death, and to decrease the need for surgery to improve blood flow in people who have medical conditions that put them at high risk of developing heart and blood vessel problems. Simvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

    HOW should this medicine be used?

    Simvastatin comes as a tablet to take by mouth. It usually is taken once a day in the evening. Take simvastatin at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take simvastatin exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
    Your doctor may start you on a low dose of simvastatin and gradually increase your dose, not more than once every 4 weeks.
    Continue to take simvastatin even if you feel well. Do not stop taking simvastatin without talking to your doctor.

    Are there OTHER USES for this medicine?

    This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

    What SPECIAL PRECAUTIONS should I follow?

    Before taking simvastatin,
    • tell your doctor and pharmacist if you are allergic to simvastatin , any other medications, or any of the ingredients in simvastatin tablets. Ask your doctor or pharmacist for a list of the ingredients.
    • tell your doctor if you are taking antifungal medications such as itraconazole (Sporanox), ketoconazole (Nizoral), and posaconazole (Noxafil); bocepravir (Victrelis); clarithromycin (Biaxin, in PrevPac); cyclosporine (Gengraf, Neoral, Sandimmune); danazol; erythromycin (E.E.S., E-Mycin, Erythrocin); gemfibrozil (Lopid); HIV protease inhibitors such as atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), indinavir (Crixivan), lopinavir (in Kaletra), nelfinavir (Viracept), ritonavir (Norvir, in Kaletra), saquinavir (Invirase), and tipranavir (Aptivus); nefazodone; telaprevir (Incivek); and telithromycin (Ketek). Your doctor will probably tell you not to take simvastatin if you are taking these medications.
    • tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Cordarone, Pacerone); amlodipine (Norvasc, in Caduet, in Lotrel); anticoagulants ('blood thinners') such as warfarin (Coumadin, Jantoven); colchicine (Colcrys); digoxin (Digitek, Lanoxicaps, Lanoxin); diltiazem (Cardizem, Dilacor, Tiazac); other cholesterol-lowering medications such as fenofibrate (Tricor) and niacin (nicotinic acid, Niacor, Niaspan); ranolazine (Ranexa); verapamil (Calan, Covera, Isoptin, Verelan); and voriconazole (Vfend). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
    • tell your doctor if you have liver disease. Your doctor will order blood tests to see how well your liver is working even if you do not think you have liver disease. Your doctor will probably tell you not to take simvastatin if you have liver disease or if the tests show that you may be developing liver disease.
    • tell your doctor if you drink more than two alcoholic beverages per day and if you are Asian, especially if you are Chinese. Also tell your doctor if you have or have ever had an underactive thyroid gland, diabetes, seizures, low blood pressure, or kidney disease.
    • tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant during your treatment with simvastatin. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking simvastatin, stop taking simvastatin and call your doctor immediately. Simvastatin can harm the fetus.
    • tell your doctor if you are breast-feeding. You should not breast-feed while you are taking simvastatin.
    • you should know that the risk that you will develop serious muscle and kidney problems during your treatment with simvastatin is higher if you are 65 years of age or older. Talk to your doctor about the risks of taking simvastatin.
    • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking simvastatin. If you are hospitalized due to serious injury or infection, tell the doctor who treats you that you are taking simvastatin.
    • ask your doctor about the safe use of alcoholic beverages while you are taking simvastatin. Alcohol can increase the risk of serious side effects.

    What SPECIAL DIETARY instructions should I follow?

    Eat a low-cholesterol, low-fat diet, which includes cottage cheese, fat-free milk, fish, vegetables, poultry, and egg whites and increase the amount of soluble fiber in your diet with foods such as oatmeal, kidney beans, and apples. Use monounsaturated oils such as olive, peanut, and canola oils or polyunsaturated oils such as corn, safflower, soy, sunflower, cottonseed, and soybean oils. Avoid foods with excess fat in them such as meat (especially liver and fatty meat), egg yolks, whole milk, cream, butter, shortening, pastries, cakes, cookies, gravy, peanut butter, chocolate, potato chips, coconut, cheese (other than cottage cheese), coconut oil, palm oil, and fried foods. Talk with your doctor or dietitian if you have any questions or would like more information about low-fat, low-cholesterol diets.
    Avoid drinking large quantities (more than 1 quart [approximately1 liter] a day) of grapefruit juice while taking simvastatin.

    What should I do IF I FORGET to take a dose?

    Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue the regular dosing schedule. Do not take a double dose to make up for a missed one.

    What SIDE EFFECTS can this medicine cause?

    Simvastatin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
    • constipation
    • stomach pain
    • nausea
    • headache
    • memory loss or forgetfulness
    • confusion
    Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately or get emergency medical help.
    • muscle pain, tenderness, or weakness
    • dark red urine
    • decreased urination
    • lack of energy, tiredness, or weakness
    • loss of appetite
    • pain in the upper right part of the stomach
    • yellowing of the skin or eyes
    • dark colored urine
    • fever or chills
    • flushing
    • blisters
    • rash
    • hives
    • itching
    • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
    • difficulty breathing or swallowing
    • hoarseness
    • joint pain
    • sensitivity to light
    This medication may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.
    If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch ] or by phone [1-800-332-1088].

    What should I know about STORAGE and DISPOSAL of this medication?

    Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

    What should I do in case of OVERDOSE?

    In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

    What OTHER INFORMATION should I know?

    Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests during your treatment, especially if you develop symptoms of liver damage.
    Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
    It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

    Brand Names

    • Zocor®
    • Juvisync® (as a combination product containing Simvastatin, Sitagliptin)
    • Simcor® (as a combination product containing Niacin, Simvastatin)
    • Vytorin® (as a combination product containing Ezetimibe, Simvastatin)
    • Also available generically
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