Ezetimibe (ez-ET-i-mide), Simvastatin (sim-va-STAT-in)

Treats high cholesterol and triglycerides (fats) in the blood. This is a combination of 2 medicines. It contains a cholesterol absorption inhibitor (ezetimibe) and an HMG-CoA reductase inhibitor (simvastatin), also called a "statin."

Brand Name(s):

Vytorin

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• You may take this medicine with or without food.
• Take the medicine in the evening, unless your doctor tells you otherwise.
• If you are also using cholestyramine (Questran®), take it at least 2 hours after or 4 hours before you take this medicine.
• Carefully follow your doctor's instructions about diet and exercise. This medicine is part of a complete plan for lowering cholesterol and triglycerides in your blood.
• This medicine comes with patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any leftover medicine after you have finished your treatment. You will also need to throw away old medicine after the expiration date has passed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using amiodarone (Cordarone®), cholestyramine (Questran®), cimetidine (Tagamet®), colchicine (Colcrys®), digoxin (Lanoxin®), fenofibrate (Tricor®), niacin, ranolazine (Ranexa®), certain blood pressure medicines (such as amlodipine, diltiazem, verapamil, Calan®, Cardizem®, Norvasc®, or Verelan®), voriconazole (Diflucan®, Vfend®), or a blood thinner (such as warfarin, Coumadin®).
• Do not drink alcohol while you are using this medicine.
• Do not drink more than 1 quart of grapefruit juice each day.

Warnings While Using This Medicine:

• Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.
• Make sure your doctor knows if you have severe kidney disease, diabetes, thyroid problems, a history of muscle pain or weakness, or a history of liver disease. Tell your doctor if you drink alcohol on a regular basis.
• Chinese patients who are taking large amounts of niacin (greater than 1 gram or 1000 milligrams per day) together with this medicine may have an increased risk for muscle injury. Talk to your doctor if you are Chinese or have Chinese ancestry and take large amounts of niacin (Niacor®, Niaspan®). You may need a different dose of this medicine.
• Stop using this medicine and call your doctor right away if you have unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of a serious muscle problem called myopathy. Myopathy is more common when high doses of simvastatin (eg, 80 milligrams (mg)) with ezetimibe 10 mg are used, but some people get myopathy with lower doses.
• Stop using this medicine and check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. You may need to stop using this medicine several days before having surgery or medical tests.
• Your doctor will need to check your blood at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools.
• Fever, chills, cough, runny nose, sore throat, and body aches.
• Muscle pain, tenderness, or weakness.
• Nausea, vomiting, loss of appetite, or pain in your upper stomach.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, gas, or mild stomach pain.
• Headache.
• Joint pain.
• Mild skin rash.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088