Ezetimibe & Simvastatin

Ezetimibe/simvastatin is a prescription medication used in combination with diet and exercise to treat high cholesterol. It is also used to lower cholesterol in people with homozygous familial hypercholesterolemia (HoFH, a hereditary disorder that causes high cholesterol levels).

This medication is a single tablet containing two prescription medicines, ezetimibe and simvastatin. Ezetimibe belongs to a group of drugs called cholesterol absorption inhibitors, which block the absorption of cholesterol from the intestines. Simvastatin belongs to a group of drugs called HMG-CoA reductase inhibitors, also known as statins, which block an enzyme in the body called HMG-CoA reductase. This is a major enzyme involved in making cholesterol in the body.

This medication comes in tablet form and is usually taken once daily, in the evening. Ezetimibe/simvastatin can be taken with or without food.

Common side effects include headache, muscle pain, and diarrhea.

Ezetimibe/simvastatin is a prescription medicine used to lower levels of total cholesterol, LDL (bad) cholesterol, and fatty substances called triglycerides in the blood. In addition, ezetimibe/simvastatin raises levels of HDL (good) cholesterol. 

Ezetimibe/simvastatin is also used to lower cholesterol in people with homozygous familial hypercholesterolemia (HoFH, a hereditary disorder that causes high cholesterol levels).

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

Ezetimibe & Simvastatin may be found in some form under the following brand names:

• Juvisync

• Liptruzet

• Simcor

• Vytorin

• Zetia

• Zocor

See your doctor regularly to check your cholesterol level and to check for side effects. Your doctor should do blood tests to check your liver before you start taking ezetimibe/simvastatin and if you have any symptoms of liver problems while you take ezetimibe/simvastatin. Call your doctor right away if you have the following symptoms of liver problems:

• feel tired or weak
• loss of appetite
• upper belly pain
• dark urine
• yellowing of your skin or the whites of your eyes

In clinical studies patients reported the following common side effects while taking ezetimibe/simvastatin: headache, muscle pain, and diarrhea.

The following side effects have been reported in general use with ezetimibe/simvastatin:

• allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing (which may require treatment right away), rash, hives; raised red rash, sometimes with target-shaped lesions; joint pain; muscle pain; alterations in some laboratory blood tests; liver problems (sometimes serious); inflammation of the pancreas; nausea; dizziness; tingling sensation; depression; gallstones; inflammation of the gallbladder; trouble sleeping; poor memory; memory loss; confusion; erectile dysfunction; breathing problems including persistent cough and/or shortness of breath or fever.

Tell your doctor if you are having these or any other medical problems while on ezetimibe/simvastatin. This is not a complete list of side effects. For a complete list, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Certain anti-fungal medicines including:
  • itraconazole
  • ketoconazole
  • posaconazole
• HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir, tipranavir, or atazanavir),
• Certain antibiotics, including:
  • erythromycin
  • clarithromycin
  • telithromycin
• nefazodone
• A fibric acid medicine for lowering cholesterol called gemfibrozil
• cyclosporine
• danazol

Taking ezetimibe/simvastatin with certain substances can increase the risk of muscle problems. It is especially important to tell your doctor if you take:

• fibric acid derivatives (such as fenofibrate)
• amiodarone (a drug used to treat an irregular heartbeat)
• verapamil, diltiazem, amlodipine, or ranolazine (drugs used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions)
• large quantities of grapefruit juice (more than 1 quart daily)
• colchicine (a medicine used to treat gout)
• voriconazole (an anti-fungal medicine)
• large doses of niacin or nicotinic acid

Tell your doctor if you are taking niacin or a niacin-containing product, as this may increase your risk of muscle problems, especially if you are Chinese.

It is also important to tell your doctor if you are taking coumarin anticoagulants (drugs that prevent blood clots, such as warfarin).

Ezetimibe/simvastatin includes a statin medication called simvastatin. Statin medications carry a rare but serious risk of:

• liver damage
• memory loss or confusion
• increase in blood sugar levels (hyperglycemia)
• type 2 diabetes
• immune-mediated muscle breakdown

Certain statins can increase risk of muscle weakness as well.  It is important to consult your physician to discuss the benefits and risks associated with using this medication.

Do not take ezetimibe/simvastatin:

• If you are allergic to ezetimibe or simvastatin, or to the inactive ingredients.
• If you have active liver disease or repeated blood tests indicating possible liver problems.
• If you are pregnant, or think you may be pregnant, or planning to become pregnant or breastfeeding.
• If you are a woman of childbearing age, you should use an effective method of birth control to prevent pregnancy while using ezetimibe/simvastatin.

Ezetimibe/simvastatin has not been studied in children under 10 years of age.

Grapefruit and grapefruit juice may interact with ezetimibe/simvastatin and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before receiving this medication, tell your doctor:

• about all the medicines you take, including any prescription and nonprescription medicines, vitamins, and herbal supplements
• about all of your medical conditions including allergies
• if you drink substantial quantities of alcohol or if you have ever had liver problems
• if you are pregnant or breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ezetimibe/simvastatin falls into category X. Do not use this medication if you are pregnant, trying to become pregnant or suspect that you are pregnant. If you become pregnant while taking ezetimibe/simvastatin, stop taking it and contact your doctor immediately.

Tell your doctor if you are breastfeeding. 

It is not known if ezetimibe/simvastatin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using ezetimibe/simvastatin.

• Take ezetimibe/simvastatin exactly as your doctor tells you to take it.
• Take ezetimibe/simvastatin once a day, in the evening, with or without food.
• If you miss a dose, do not take an extra dose. Just resume your usual schedule.
• Continue to follow a cholesterol-lowering diet while taking ezetimibe/simvastatin. Ask your doctor if you need diet information.
• Keep taking ezetimibe/simvastatin unless your doctor tells you to stop. If you stop taking ezetimibe/simvastatin, your cholesterol may rise again.

Take ezetimibe/simvastatin exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

• Patients taking Verapamil or Diltiazem: the dose of ezetimibe/simvastatin should not exceed 10/10 mg/day.
• Patients taking Amiodarone, Amlodipine or Ranolazine: the dose of ezetimibe/simvastatin should not exceed 10/20 mg/day.
• Patients taking Bile Acid Sequestrants (cholestyramine (Locholest light, Locholest, Prevalite), colestipol (Colestid, Flavored Colestid ), and colesevelam (Welchol) : dosing of ezetimibe/simvastatin should occur either ≥2 hours before or ≥4 hours after administration of a bile acid sequestrant.

If you take too much ezetimibe/simvastatin contact your doctor right away or call your local Poison Control Center.

• Store this medicine at room temperature away from excess heat and moisture.
• Keep this and all medicines out of the reach of children.