Tuesday, October 11, 2016

Ezetimibe and simvastatin


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

Brand Names: Vytorin


What is ezetimibe and simvastatin?

Ezetimibe reduces the amount of cholesterol absorbed by the body.


Ezetimibe and simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Ezetimibe and simvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).


The combination of ezetimibe and simvastatin is used to treat high cholesterol in adults and children who are at least 10 years old.


Ezetimibe and simvastatin may also be used for purposes not listed in this medication guide.


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


You should not take ezetimibe and simvastatin if you are allergic to it, if you have liver disease, or if you are pregnant or breast-feeding. In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine. Never take ezetimibe and simvastatin in larger amounts, or for longer than recommended by your doctor. Follow your doctor's dosing instructions very carefully. Taking too much of this medication may cause serious or life-threatening side effects.

There are many other drugs that should not be used together with ezetimibe and simvastatin. Tell your doctor about all medications you use. Keep a list of all your medicines and show it to any healthcare provider who treats you.


Before taking ezetimibe and simvastatin, tell your doctor if you have ever had liver or kidney disease, diabetes, or a thyroid disorder, if you are of Chinese descent, or if you drink more than 2 alcoholic beverages daily.


This medicine can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects. Do not drink more than 1 quart of grapefruit juice daily.


What should I discuss with my healthcare provider before taking ezetimibe and simvastatin?


You should not take ezetimibe and simvastatin if you are allergic to it, if you have liver disease, or if you are pregnant or breast-feeding. In rare cases, simvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid). You may also be more likely to develop this condition if you are of Chinese descent and you take high-dose ezetimibe and simvastatin while also taking medication that contains niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others).

The following drugs can increase your risk of serious muscle problems if you take them together with simvastatin. These drugs should not be used while you are taking simvastatin:



  • cyclosporine (Gengraf, Neoral, Sandimmune);




  • danazol (Danocrine);




  • gemfibrozil (Lopid);




  • nefazodone (an antidepressant);




  • the antibiotics clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), and telithromycin (Ketek);




  • the antifungal medications itraconazole (Sporanox), ketoconazole (Nizoral), and posaconazole (Noxafil); or




  • the HIV/AIDS medications atazanavir (Reyataz), darunavir (Prezista), fosamprenavir (Lexiva), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), saquinavir (Invirase), and tipranavir (Aptivus).



Before you start taking ezetimibe and simvastatin, tell your doctor if you are already using any of these other medicines:



  • amiodarone (Cordarone, Pacerone);




  • amlodipine (Norvasc, Caduet, Exforge, Lotrel, Tekamlo, Tribenzor, Twynsta, Amturnide);




  • diltiazem (Cartia, Cardizem);




  • ranolazine (Ranexa); or




  • verapamil (Calan, Covera, Isoptin, Verelan).



To make sure you can safely take ezetimibe and simvastatin, tell your doctor if you have any of these other conditions:


  • history of liver disease;

  • history of kidney disease;


  • diabetes;




  • a thyroid disorder; or




  • if you drink more than 2 alcoholic beverages daily.




FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take ezetimibe and simvastatin if you are pregnant. Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking ezetimibe and simvastatin. Ezetimibe and simvastatin may pass into breast milk and could harm a nursing baby. Do not breast-feed while you are taking ezetimibe and simvastatin.

How should I take ezetimibe and simvastatin?


Take exactly as prescribed. Never take this medicine in larger amounts, or for longer than recommended by your doctor. Follow your doctor's dosing instructions very carefully. Taking too much of this medication may cause serious or life-threatening side effects.


Ezetimibe and simvastatin is usually taken once daily in the evening, with or without food. Your doctor may occasionally change your dose to make sure you get the best results.


To be sure this medication is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your liver function should be tested every 3 to 6 months. Visit your doctor regularly. You may need to take ezetimibe and simvastatin on a long-term basis for the treatment of high cholesterol. You may need to stop using simvastatin for a short time if you have surgery or a medical emergency. Do not stop taking this medication unless your doctor tells you to.

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 at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

See also: Ezetimibe and simvastatin dosage (in more detail)

What happens if I miss a dose?


Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.


What happens if I overdose?


Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking ezetimibe and simvastatin?


Grapefruit and grapefruit juice may interact with simvastatin and lead to potentially dangerous effects. Do not drink more than 1 quart of grapefruit juice daily.

If you also take cholestyramine (Prevalite, Questran) or colestipol (Colestid), avoid taking them within 2 hours after or 4 hours before you take 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.


Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

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 taking ezetimibe and simvastatin and call your doctor at once if you have any of these serious side effects:

  • unexplained muscle pain, tenderness, or weakness;




  • fever, unusual tiredness, and dark colored urine;




  • swelling, weight gain, urinating less than usual or not at all;




  • chest pain, dry cough, wheezing, feeling short of breath;




  • severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate; or




  • nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).



Less serious side effects may include:



  • headache, memory problems, dizziness, depressed mood;




  • back pain, joint pain, mild muscle pain;




  • numbness or tingly feeling;




  • trouble having an erection;




  • diarrhea;




  • sleep problems (insomnia); or




  • cold symptoms such as stuffy nose, sneezing, sore throat.



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.


Ezetimibe and simvastatin Dosing Information


Usual Adult Dose for Hyperlipidemia:

Initial dose: 10 mg ezetimibe-10 mg simvastatin or 10 mg ezetimibe-20 mg simvastatin orally once a day in the evening.

The dosage range is 10 mg-10 mg to 10 mg-40 mg per day. Initiation of therapy with 10 mg-10 mg per day may be considered for patients requiring less aggressive LDL-C reductions. Patients who require a larger reduction in LDL-C (greater than 55%) may be started at 10 mg-40 mg per day.

Patients should be placed on a standard cholesterol-lowering diet before receiving ezetimibe-simvastatin and should continue on this diet during treatment with ezetimibe-simvastatin. The dosage should be individualized according to the baseline LDL-C level, the recommended goal of therapy, and the patient's response.

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

10 mg ezetimibe-40 mg simvastatin orally once a day in the evening.


What other drugs will affect ezetimibe and simvastatin?


Tell your doctor about all other medications you use, especially:



  • colchicine (Colcrys);




  • digoxin (Lanoxin);




  • a blood thinner such as warfarin (Coumadin, Jantoven);




  • fenofibric acid (Fibricor, Trilipix), or fenofibrate (Antara, Fenoglide, Lipofen, Lofibra, Tricor, Triglide);




  • antifungal medications such as fluconazole (Diflucan) or voriconazole (Vfend);




  • medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);




  • drugs that weaken your immune system, such as steroids, cancer medicine, or medicines used to prevent organ transplant rejection, such as sirolimus (Rapamune), or tacrolimus (Prograf); or




  • any other "statin" medication such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Altoprev, Mevacor), pravastatin (Pravachol), rosuvastatin (Crestor), or other medication that contains simvastatin (Simcor, Zocor).



This list is not complete and there are many other drugs that can cause serious or life threatening medical problems if you take them together with ezetimibe and simvastatin. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.



More ezetimibe and simvastatin resources


  • Ezetimibe and simvastatin Side Effects (in more detail)
  • Ezetimibe and simvastatin Dosage
  • Ezetimibe and simvastatin Use in Pregnancy & Breastfeeding
  • Ezetimibe and simvastatin Drug Interactions
  • Ezetimibe and simvastatin Support Group
  • 14 Reviews for Ezetimibe and simvastatin - Add your own review/rating


Compare ezetimibe and simvastatin with other medications


  • High Cholesterol
  • High Cholesterol, Familial Heterozygous
  • High Cholesterol, Familial Homozygous


Where can I get more information?


  • Your pharmacist can provide more information about ezetimibe and simvastatin.

See also: ezetimibe and simvastatin side effects (in more detail)



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