Zetia reduces the level of total cholesterol and LDL (bad) cholesterol in the blood. Zetia is used to treat high cholesterol in people who cannot control their cholesterol levels by diet and exercise alone.

Zetia works to reduce the amount of cholesterol your body absorbs. You should stay on a cholesterol-lowering diet while taking this medicine.

Zetia is sometimes given together with other cholesterol-lowering medications.

Zetia is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Some cholesterol medications should not be taken at the same time. If you take Zetia with another cholesterol medicine, follow your doctor's dosing instructions very carefully.

You should not use Zetia if you have moderate to severe liver disease. You should not use Zetia with a "statin" cholesterol medicine if you have active liver disease, or if you are pregnant or breast-feeding a baby.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Take Zetia exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Zetia is usually taken once daily at the same time each day.

You may take Zetia with or without food.

Zetia may be taken at the same time with fenofibrate, or with a statin medication such as atorvastatin, lovastatin, simvastatin, pravastatin, or fluvastatin.

Your treatment may also include diet, exercise, weight control, and blood tests.

You may need frequent medical tests, even if you have no symptoms.

Your cholesterol levels may not improve for up to 2 weeks.

Store at room temperature away from moisture and heat.

Usual Adult Dose of Zetia for Hyperlipidemia:

10 mg orally once a day

Uses:
-For use as monotherapy or in combination with an HMG-CoA reductase inhibitor (statin) as an adjunct to diet to reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia
-For use as combination therapy with fenofibrate as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia
-As an adjunct to diet to reduce elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia
-For use as combination therapy with atorvastatin or simvastatin to reduce elevated total-C and LDL-C levels in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable

Usual Adult Dose of Zetia for Homozygous Familial Hypercholesterolemia:

10 mg orally once a day

Uses:
-For use as monotherapy or in combination with an HMG-CoA reductase inhibitor (statin) as an adjunct to diet to reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia
-For use as combination therapy with fenofibrate as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia
-As an adjunct to diet to reduce elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia
-For use as combination therapy with atorvastatin or simvastatin to reduce elevated total-C and LDL-C levels in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable

Usual Adult Dose of Zetia for Sitosterolemia:

10 mg orally once a day

Uses:
-For use as monotherapy or in combination with an HMG-CoA reductase inhibitor (statin) as an adjunct to diet to reduce elevated total cholesterol (total-C), low-density lipoprotein cholesterol (LDL-C), apolipoprotein B (Apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in patients with primary (heterozygous familial and non-familial) hyperlipidemia
-For use as combination therapy with fenofibrate as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia
-As an adjunct to diet to reduce elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia
-For use as combination therapy with atorvastatin or simvastatin to reduce elevated total-C and LDL-C levels in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable

Usual Pediatric Dose for Hyperlipidemia:

10 years or older: 10 mg orally once a day

Uses:
-For use as monotherapy or in combination with a statin as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia
-For use as combination therapy with a fenofibrate as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia
-As an adjunct to diet to reduce elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia
-For use as combination therapy with atorvastatin or simvastatin for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable

Usual Pediatric Dose for Homozygous Familial Hypercholesterolemia:

10 years or older: 10 mg orally once a day

Uses:
-For use as monotherapy or in combination with a statin as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia
-For use as combination therapy with a fenofibrate as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia
-As an adjunct to diet to reduce elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia
-For use as combination therapy with atorvastatin or simvastatin for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable

Usual Pediatric Dose for Sitosterolemia:

10 years or older: 10 mg orally once a day

Uses:
-For use as monotherapy or in combination with a statin as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with primary (heterozygous familial and non-familial) hyperlipidemia
-For use as combination therapy with a fenofibrate as an adjunct to diet to reduce elevated total-C, LDL-C, Apo B, and non-HDL-C in patients with mixed hyperlipidemia
-As an adjunct to diet to reduce elevated sitosterol and campesterol levels in patients with homozygous familial sitosterolemia
-For use as combination therapy with atorvastatin or simvastatin for the reduction of elevated total-C and LDL-C in patients with homozygous familial hypercholesterolemia, as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable

You should not use Zetia if you are allergic to ezetimibe, or if you have:

• moderate to severe liver disease.

Zetia is not approved for use by anyone younger than 10 years old.

You should not use Zetia with a "statin" cholesterol medicine (Zocor, Lipitor, Crestor, and others) if:

• you have active liver disease;

• you are pregnant; or

• you are breastfeeding a baby.

Statin cholesterol medications can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in women, in older adults, or people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

To make sure Zetia is safe for you, tell your doctor if you have:

• liver disease;

• kidney disease; or

• unexplained muscle pain or weakness.

Tell your doctor if you are pregnant or breastfeeding.

Use effective birth control to prevent pregnancy while you are using Zetia with a statin medicine. Tell your doctor if you plan to become pregnant.

Do not breastfeed if you take Zetia with a statin medicine.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid eating foods high in fat or cholesterol, or Zetia will not be as effective.

Get emergency medical help if you have signs of an allergic reaction to Zetia: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Zetia can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark urine.

Side effects may be more likely in older adults.

Common side effects of Zetia may include:

• diarrhea;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• pain in an arm or leg;

• joint pain; or

• muscle pain while taking Zetia with a statin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you also take other cholesterol medication: Take Zetia 2 hours before or 4 hours after taking cholestyramine, colestipol, or colesevelam.

Tell your doctor about all your other medicines, especially:

• cyclosporine;

• fenofibric acid;

• gemfibrozil; or

• a blood thinner - warfarin, Coumadin, Jantoven.

This list is not complete. Other drugs may interact with ezetimibe, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.