ZETIA is a medicine used to lower levels of total cholesterol and LDL (Bad) Cholesterol in the blood. ZETIA is for patients who cannot control their cholesterol levels by diet and exercise alone. It can be used by itself or with other medicines to treat high cholesterol. You should stay on a cholesterol-lowering diet while taking this medicine.
In a clinical study of people with high cholesterol, ZETIA, when added to a healthy diet, was proven to lower LDL (Bad) Cholesterol by an average of 18%. Individual results may vary.
In a clinical study, people who added ZETIA to their statin medication reduced their LDL (Bad) Cholesterol on average by an additional 25% compared with 4% in people who added a placebo (a pill with no medication). Individual results may vary.
Unlike some statins, ZETIA has not been shown to prevent heart disease or heart attacks.
ZETIA works in the digestive tract like other cholesterol-lowering medicines. But ZETIA is unique in the way it helps block the absorption of cholesterol that comes from food. ZETIA complements your efforts to help lower your LDL (Bad) Cholesterol. See how.
In clinical studies patients reported few side effects while taking ZETIA. These included diarrhea, joint pains, and feeling tired.
Patients have experienced severe muscle problems while taking ZETIA, usually when ZETIA was added to a statin drug. If you experience unexplained muscle pain, tenderness, or weakness while taking ZETIA, contact your doctor immediately. You need to do this promptly, because on rare occasions, these muscle problems can be serious, with muscle breakdown resulting in kidney damage.
Additionally, the following side effects have been reported in general use:
Allergic reactions (which may require treatment right away) including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing, rash, and hives
Raised red rash, sometimes with target-shaped lesions
Joint pain
Muscle aches
Alterations in some laboratory blood tests
Liver problems
Stomach pain
Inflammation of the pancreas
Nausea
Dizziness
Tingling sensation
Depression
Headache
Gallstones
Inflammation of the gallbladder
Tell your doctor if you are having these or any other medical problems while on ZETIA. For a complete list of side effects, ask your doctor or pharmacist.
If you are allergic to ezetimibe, the active ingredient in ZETIA, or to the inactive ingredients.
If you have active liver disease, do not take ZETIA while taking cholesterol-lowering medicines called statins.
If you are pregnant or breast-feeding, do not take ZETIA while taking a statin.
If you are a woman of child-bearing age, you should use an effective method of birth control to prevent pregnancy while using ZETIA added to statin therapy.
ZETIA has not been studied in children under age 10.
Take ZETIA once a day, with or without food. It may be easier to remember to take your dose if you do it at the same time every day, such as with breakfast, dinner, or at bedtime. If you also take another medicine to reduce your cholesterol, ask your doctor if you can take them at the same time.
If you forget to take ZETIA, take it as soon as you remember. However, do not take more than 1 dose of ZETIA a day.
Continue to follow a cholesterol-lowering diet while taking ZETIA. Ask your doctor if you need diet information.
Keep taking ZETIA unless your doctor tells you to stop. It is important that you keep taking ZETIA even if you do not feel sick.
See your doctor regularly to check your cholesterol level and to check for side effects. Your doctor may do blood tests to check your liver before you start taking ZETIA with a statin and during treatment.
Unlike some statins, ZETIA has not been shown to prevent heart disease or heart attacks. Important Risk Information About ZETIA
ZETIA is a prescription medicine and should not be taken by people who are allergic to any of its ingredients. ZETIA can be taken alone or with a statin. Statins should not be taken by women who are nursing or pregnant or who may become pregnant, or by anyone with liver problems. If you have ever had liver problems or are pregnant or nursing, your doctor will decide if ZETIA alone is right for you. Your doctor may do blood tests to check your liver before you start taking ZETIA with a statin and during treatment.
Unexplained muscle pain or weakness could be a sign of a rare but serious side effect and should be reported to your doctor right away. In clinical studies, patients reported few side effects while taking ZETIA. These included diarrhea, joint pains, and tiredness.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit
www.fda.gov/medwatch, or call 1-800-FDA-1088.