Ezetimibe

Ezetimibe is used along with diet, alone or in combination with another cholesterol-lowering medications (HMG-CoA reductase inhibitors [statins]) to reduce the amount of low-density lipoprotein (LDL) cholesterol ('bad cholesterol') in the blood in adults and children 10 years of age or older who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). It is also used along with diet, alone or in combination with other cholesterol-lowering medications (HMG-CoA reductase inhibitors [statins] or fenofibrate) in adults who have too many fats in the blood. Ezetimibe is also used with other medications to reduce the amount of LDL cholesterol in the blood in adults and children 10 years of age or older who have homozygous familial hypercholesterolemia (HoFH; an inherited condition in which cholesterol cannot be removed from the body normally). It is also used to reduce the amount of other fatty substances in the blood in adults and children 9 years of age or older who have homozygous familial sitosterolemia (an inherited condition in which fatty substances from vegetable oils, nuts, and other plant-based foods cannot be removed from the body normally). Ezetimibe is in a class of medications called cholesterol-lowering medications. It works by preventing the absorption of cholesterol in the intestine.

Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats may help prevent heart disease, angina (chest pain), strokes, and heart attacks.

Ezetimibe comes as a tablet to take by mouth. It is usually taken once a day with or without food. To help you remember to take ezetimibe, take it around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ezetimibe exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Continue to take ezetimibe even if you feel well. Do not stop taking ezetimibe without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking ezetimibe,

• tell your doctor and pharmacist if you are allergic to ezetimibe, any other medications, or any of the ingredients in ezetimibe tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• if you are taking cholestyramine (Locholest^®, Prevalite^®), colesevelam (WellChol^®), or colestipol (Colestid^®), take it 4 hours before or 2 hours after ezetimibe.
• tell your doctor if you have or have ever had liver disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking ezetimibe, call your doctor.

Eat a low-fat, low-cholesterol diet. Be sure to follow all exercise and dietary recommendations made by your doctor or dietitian. You can also visit the National Cholesterol Education Program (NCEP) website for additional dietary information at https://www.nhlbi.nih.gov/health/public/heart/chol/chol_tlc.pdf.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Ezetimibe may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• sore throat
• runny nose
• sneezing
• joint, back, arm, or leg pain

Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately or get emergency medical help:

• hives; rash; itching; difficulty breathing or swallowing; hoarseness; or swelling of the face, throat, tongue, lips, or eyes
• fast heartbeat
• dizziness or fainting
• upset stomach
• extreme tiredness
• unusual bleeding or bruising
• lack of energy
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• flu-like symptoms
• muscle pain or weakness
• fever
• chills
• light-colored bowel movements

Ezetimibe may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before and during treatment to check your body's response to ezetimibe.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Zetia^®
• Roszet^® (as a combination product containing Ezetimibe, Rosuvastatin)^¶

• Liptruzet^® (containing Atorvastatin, Ezetimibe)^¶
• Lypqozet^® (containing Atorvastatin, Ezetimibe)
• Nexlizet^® (containing Bempedoic Acid, Ezetimibe)
• Vytorin^® (containing Ezetimibe, Simvastatin)