Ezetimibe and rosuvastatin

Ezetimibe and rosuvastatin is a combination medicine that helps reduce the levels of "bad" cholesterol (low-density lipoprotein, or LDL) in the blood.

Ezetimibe and rosuvastatin is used along with a low-fat diet and other treatments to lower cholesterol in adults.

Ezetimibe and rosuvastatin may also be used for reasons not mentioned in this medication guide.

Follow all instructions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

Take this medicine at the same time each day, with or without food.

Swallow the tablet whole and do not crush, chew, or break it.

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

Inform any doctor who treats you that you are taking this medicine, especially if you have a serious illness, surgery, or medical emergency.

Continue using this medicine even if you feel well. You will need blood tests to check if this medicine is lowering your cholesterol.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use. Take out a tablet only when you are ready to take it.

Dispose of any tablets not used within 30 days.

Use only as directed. Inform your doctor if you are taking other medicines, have any medical conditions, or have allergies.

You should not use ezetimibe and rosuvastatin if you are allergic to rosuvastatin (Crestor) or ezetimibe (Vytorin, Zetia), or if you have:

• active liver disease; or
• cirrhosis.

It may harm an unborn baby. Do not use if you are pregnant. Stop taking the medicine and tell your doctor right away if you become pregnant. Ask your doctor about the best method of birth control to prevent pregnancy while taking ezetimibe and rosuvastatin.

Do not breastfeed.

Ezetimibe and rosuvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. This occurs more often in adults 65 or older, in people of Asian descent, and in people who use certain other medicines or have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Tell your doctor if you have ever had:

• unexplained weakness or muscle pain;
• a thyroid disorder;
• diabetes;
• liver or kidney disease;
• a habit of drinking more than 2 alcoholic drinks per day; or
• liver problems caused by alcohol.

Not approved for use by anyone younger than 18 years old.

Get emergency medical help if you notice signs of an allergic reaction: hives, rash, itching; wheezing, dizziness, trouble breathing; swelling of your face, lips, tongue, or throat.

ezetimibe and rosuvastatin can cause serious side effects. Stop taking ezetimibe and rosuvastatin and call your doctor immediately if you experience:

• unexplained muscle pain, tenderness, or weakness (especially if you also have fever);
• upper stomach pain, loss of appetite;
• severe weakness or tiredness;
• dark colored urine; or
• jaundice (yellowing of the skin or eyes).

Common side effects of ezetimibe and rosuvastatin may include:

• headache, dizziness;
• stomach pain, nausea, diarrhea, constipation;
• muscle or joint pain;
• pain in your hands, legs, or back;
• feeling weak or tired; or
• cold symptoms such as stuffy nose, sneezing, sinus pain, sore throat.

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.

Usual Adult Dose for Hyperlipidemia:

1 tablet orally once a day Tablet strengths available: -Rosuvastatin 5 mg/ezetimibe 10 mg -Rosuvastatin 10 mg/ezetimibe 10 mg -Rosuvastatin 20 mg/ezetimibe 10 mg -Rosuvastatin 40 mg/ezetimibe 10 mg Comments: -Patient's dose should be individualized based on indication, low-density lipoprotein cholesterol (LDL-C), and individual risk for cardiovascular events. -LDL-C may be assessed early as 2 weeks after initiating therapy.-Dose should be adjusted based on LDL-C levels. Uses: -As an adjunct to diet to reduce LDL-C in patients with primary non-familial hyperlipidemia.-Alone or as an adjunct to other LDL-C lowering therapies to reduce LDL-C in patients with homozygous familial hypercholesterolemia (HoFH).

Usual Adult Dose for Homozygous Familial Hypercholesterolemia:

1 tablet orally once a day Tablet strengths available: -Rosuvastatin 5 mg/ezetimibe 10 mg -Rosuvastatin 10 mg/ezetimibe 10 mg -Rosuvastatin 20 mg/ezetimibe 10 mg -Rosuvastatin 40 mg/ezetimibe 10 mg Comments: -Patient's dose should be individualized based on indication, low-density lipoprotein cholesterol (LDL-C), and individual risk for cardiovascular events. -LDL-C may be assessed early as 2 weeks after initiating therapy.-Dose should be adjusted based on LDL-C levels. Uses: -As an adjunct to diet to reduce LDL-C in patients with primary non-familial hyperlipidemia.-Alone or as an adjunct to other LDL-C lowering therapies to reduce LDL-C in patients with homozygous familial hypercholesterolemia (HoFH).

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses within 12 hours.

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

• Avoid taking an antacid within 2 hours after you take ezetimibe and rosuvastatin.

• Grapefruit may interact with ezetimibe and rosuvastatin and lead to unwanted side effects. Avoid the use of grapefruit products.

• Avoid drinking alcohol.

• Avoid eating foods high in fat or cholesterol, or ezetimibe and rosuvastatin will not be as effective.

If you also take cholestyramine, colesevelam, or colestipol: Take your ezetimibe and rosuvastatin dose 2 hours before or 4 hours after you take the other medicine.

Tell your doctor about all your other medicines. Some drugs can increase the risk of serious muscle problems when used with ezetimibe and rosuvastatin, especially:

• colchicine, cyclosporine;
• antifungal medication--fluconazole, itraconazole, ketoconazole;
• a blood thinner--warfarin, Coumadin, Jantoven;
• cancer medicine--darolutamide, regorafenib;
• other cholesterol medications--fenofibrate, fenofibric acid, gemfibrozil, niacin, nicotinic acid;
• hepatitis C medication that contains--dasabuvir, elbasvir, glecaprevir, grazoprevir, ledipasvir, ombitasvir, paritaprevir, pibrentasvir, sofosbuvir, velpatasvir, or voxilaprevir; or
• HIV/AIDS medication--atazanavir, fosamprenavir, lopinavir, ritonavir, simeprevir, tipranavir.

This list is not complete and many other drugs may affect ezetimibe and rosuvastatin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.