Ezetimibe (e-ZET-i-mibe), Rosuvastatin (roe-soo-va-STAT-in)

Lowers bad cholesterol (LDL) levels and treats homozygous familial hypercholesterolemia (HoFH). This is a combination of a statin and a cholesterol absorption inhibitor.

Brand Name(s):

Roszet

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the tablet whole. Do not crush, break, chew, or dissolve it.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Do not take 2 doses within 12 hours of each other.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how rosuvastatin and ezetimibe work. Tell your doctor if you are using any of the following:
  • Cimetidine, colchicine, cyclosporine, darolutamide, fenofibrate, fenofibric acid, gemfibrozil, niacin, regorafenib
  • Blood thinner (including warfarin)
  • Medicine to treat HIV/AIDS or hepatitis C (including asabuvir/ombitasvir/paritaprevir/ritonavir, atazanavir/ritonavir, elbasvir/grazoprevir, glecaprevir/pibrentasvir, ledipasvir/sofosbuvir, lopinavir/ritonavir, simeprevir, sofosbuvir/velpatasvir, sofosbuvir/velpatasvir/voxilaprevir)
  • Medicine to treat an infection (including erythromycin, fluconazole, itraconazole, ketoconazole)
• If you need to take an antacid that contains aluminum and magnesium, take it at least 2 hours after using this medicine.
• If you are also using cholestyramine, take it at least 4 hours before or 2 hours after you take this medicine.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control during treatment with this medicine.
• Do not breastfeed during treatment with this medicine.
• Tell your doctor if you have kidney disease, diabetes, thyroid problems, severe infection (including sepsis), electrolyte imbalance, seizures, muscle problems, or a history of liver disease. Tell your doctor if you usually have more than 2 drinks of alcohol per day.
• Tell your doctor if you are of Asian descent. You may need a lower dose of this medicine.
• This medicine may cause the following problems:
  • Severe muscle problems (including myopathy, immune-mediated necrotizing myopathy), especially when used with other medicines
  • Rhabdomyolysis (severe muscle weakness) that could lead to kidney damage
  • Liver problems
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Arm, leg, back, or joint pain
• Change in how much or how often you urinate, bloody or cloudy urine, painful urination
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Muscle pain, tenderness, or weakness, fever
• Unusual tiredness or weakness

If you notice these less serious side effects, talk with your doctor:

• Chills, cough, stuffy or runny nose, sore throat
• Constipation, diarrhea
• Dizziness, headache

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088