Pronunciation:

ez-ET-i-mibe

Brand Names:

• Zetia

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antihyperlipidemic

Pharmacologic—

Cholesterol Absorption Inhibitor

Uses of This Medicine:

Ezetimibe 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.

Before Using This Medicine:

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 this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

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.

Pregnancy—

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Clofibrate
• Gemfibrozil

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

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

Proper Use of This Medicine:

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.

Dosing—

The dose of this medicine 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 this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. 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 using the medicine.

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.

• 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. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

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.

Tell your doctor if you experience any unexplained muscle pain, tenderness, or weakness.

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.

Side Effects of This Medicine:

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

Abdominal fullness

black tarry stools

bleeding gums

bloating

blood in urine or stools

chills

constipation

darkened urine

fast heartbeat

fever

gaseous abdominal pain

general tiredness or weakness

indigestion

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, sex organs

loss of appetite

light-colored stools

muscle cramps or spasms

muscular tenderness, wasting or weakness

nausea

pains in stomach, side or abdomen, possibly radiating to the back

pinpoint red spots on skin

recurrent fever

severe nausea

skin rash

unusual bleeding or bruising

upper right abdominal pain

vomiting

yellow eyes or skin

Some 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. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

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 may also occur in some patients. If you notice any other effects, check with your healthcare professional.