In the U.S.—

• Antihyperlipidemic

Ezetimibe (e-ZET-e-mibe) is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. Using this medicine may help prevent medical problems caused by such substances clogging the blood vessels.

This medicine is available only with your doctor's prescription, in the following dosage forms:

Oral
• Tablets (U.S.)

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For ezetimibe, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to ezetimibe. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctor's orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a weight-reducing diet. However, check with your doctor before going on any diet.

Pregnancy—Ezetimibe has not been studied in pregnant women. However, studies in animals have shown that ezetimibe may cause birth defects or other problems. Before taking this medicine, make sure your doctor knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known if ezetimibe passes into human breast milk. However, it should not be used during breast-feeding because it may cause serious unwanted effects in nursing babies.

Children—This medicine has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults. This medicine should only be used in children 10 years of age or older.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of ezetimibe in the elderly with use in other age groups, this medicine has been used in elderly patients and is not expected to cause different side effects or problems in older people than it does in younger adults.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your health care professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

• Liver disease (or history of) or
• Liver enzymes, persistently high levels—Use of this medicine may make liver problems worse

Dosing—

The dose of ezetimibe will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of ezetimibe. If your dose is different, do not change it unless your doctor tells you to do so.

Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly.

Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are taking ezetimibe.

• For tablet dosage form:
  • For high cholesterol:
    • Adults: 10 milligrams (mg) once daily. May take with or without food.
    • Children up to 10 years of age—Use is not recommended.
    • Children 10 years of age and older—10 milligrams (mg) once daily. May take with or without food.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. Do not take more than one dose per day.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Keep the medicine from freezing. Do not refrigerate.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your doctor check you at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol. Your doctor can then decide if you should continue to take it.

Check with your doctor immediately if you think that you may be pregnant. Certain cholesterol medications may cause birth defects or other problems in the baby if taken during pregnancy.

Do not take other medicines unless they have been discussed with your doctor. It is very important that you take all of your medicine. Your doctor will discuss with you any changes in your medicine. Ask your doctor if you have any questions.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

• Frequency not determined
  • Bloating;  chills;  constipation;  darkened urine;  fast heartbeat;  fever;  indigestion;  large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs;  loss of appetite;  nausea;  pains in stomach, side or abdomen, possibly radiating to the back;  skin rash;  vomiting ;  yellow eyes or skin 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your doctor if any of the following side effects continue or are bothersome.

• More common
  • Fever;  headache;  muscle pain;  runny nose;  sore throat 
  
  

• Less common
  • Back pain;  body aches or pain;  chest pain;  chills;  cold or flu-like symptoms;  congestion;  coughing;  diarrhea;  difficulty in moving;  dizziness;  dryness or soreness of throat;  hoarseness;  muscle pain or stiffness;  pain in joints ;  pain or tenderness around eyes and cheekbones;  shortness of breath or troubled breathing;  stomach pain;  stuffy nose;  tender, swollen glands in neck;  tightness of chest or wheezing;  trouble in swallowing;  unusual tiredness or weakness;  voice changes 
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.