Ezetimibe/ atorvastatin

Generic Name: ezetimibe/atorvastatin (e-ZET-i-mibe/a-TOR-va-STAT-in)
Brand Name: Liptruzet

Ezetimibe/ atorvastatin is used for:

Lowering high cholesterol and triglycerides in certain patients. It also increases high-density lipoprotein (HDL) ("good") cholesterol levels. It is used along with an appropriate diet. It may also be used for other conditions as determined by your doctor.

Ezetimibe/atorvastatin is a combination of 2 medicines. Ezetimibe is an antihyperlipidemic agent. It works by reducing the amount of cholesterol that your body absorbs from your diet. Atorvastatin is an HMG-CoA reductase inhibitor or "statin." It works by reducing the production of certain fatty substances in the body, including cholesterol.

Do NOT use ezetimibe/ atorvastatin if:

  • you are allergic to any ingredient in ezetimibe/atorvastatin
  • you have liver problems or unexplained abnormal liver function test results
  • you are pregnant, may become pregnant, or are breast-feeding
  • you are taking another medicine that contains atorvastatin or ezetimibe
  • you take cyclosporine, gemfibrozil, mibefradil, posaconazole, telaprevir, or tipranavir plus ritonavir
  • you take or have taken conivaptan within the past 7 days

Contact your doctor or health care provider right away if any of these apply to you.

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Before using ezetimibe/ atorvastatin:

Some medical conditions may interact with ezetimibe/atorvastatin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are able to become pregnant
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you have low blood pressure, kidney problems, diabetes, thyroid problems, muscle problems (eg, pain, weakness), or a serious infection
  • if you have metabolism, hormonal, or electrolyte problems
  • if you drink alcohol or have a history of seizures, liver problems, or alcohol abuse
  • if you are scheduled for major surgery or have recently had a major surgery, a serious injury, or a stroke

Some MEDICINES MAY INTERACT with ezetimibe/atorvastatin. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Amiodarone, azole antifungals (eg, fluconazole, itraconazole, posaconazole, voriconazole), cobicistat, colchicine, conivaptan, cyclosporine, daptomycin, delavirdine, diltiazem, fibrates (eg, clofibrate, fenofibrate, gemfibrozil), fusidic acid, HCV protease inhibitors (eg, boceprevir, telaprevir), HIV protease inhibitors (eg, ritonavir), imatinib, macrolide antibiotics (eg, clarithromycin, erythromycin), mibefradil, mifepristone, nefazodone, niacin, nicotinic acid, quinine, streptogramins (eg, dalfopristin, quinupristin), telithromycin, or verapamil because they may increase the risk of ezetimibe/atorvastatin's side effects, such as serious muscle problems
  • Bosentan, carbamazepine, efavirenz, rifamycins (eg, rifampin), or St. John's wort because they may decrease ezetimibe/atorvastatin's effectiveness
  • Anticoagulants (eg, warfarin), cimetidine, digoxin, certain hormonal contraceptives (eg, certain birth control pills), lomitapide, sirolimus, spironolactone, or tacrolimus because the risk of their side effects may be increased by ezetimibe/atorvastatin

This may not be a complete list of all interactions that may occur. Ask your health care provider if ezetimibe/atorvastatin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use ezetimibe/ atorvastatin:

Use ezetimibe/atorvastatin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with ezetimibe/atorvastatin. Talk to your pharmacist if you have questions about this information.
  • Take ezetimibe/atorvastatin by mouth with or without food.
  • Do not open the foil pouch until you are ready to take ezetimibe/atorvastatin.
  • Swallow ezetimibe/atorvastatin whole. Do not break, crush, dissolve, or chew before swallowing.
  • Taking ezetimibe/atorvastatin at the same time each day will help you remember to take it.
  • If you also take a bile acid sequestrant (eg, cholestyramine, colestipol, colesevelam), do not take it within 4 hours before or 2 hours after taking ezetimibe/atorvastatin. Check with your doctor if you have questions.
  • Eating grapefruit or drinking grapefruit juice may increase the amount of ezetimibe/atorvastatin in your blood, which may increase your risk of serious side effects. The risk may be greater with large amounts of grapefruit or grapefruit juice. Avoid large amounts of grapefruit or grapefruit juice (eg, more than 1 quart daily). Talk with your doctor or pharmacist if you have questions about including grapefruit or grapefruit juice in your diet while you are taking ezetimibe/atorvastatin.
  • Continue to take ezetimibe/atorvastatin even if you feel well. Do not miss any doses.
  • If you miss a dose of ezetimibe/atorvastatin, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use ezetimibe/atorvastatin.

Important safety information:

  • Ezetimibe/atorvastatin may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use ezetimibe/atorvastatin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Ezetimibe/atorvastatin may cause liver problems. Rarely, severe and sometimes fatal liver problems have been reported in patients taking "statin" medicine, including ezetimibe/atorvastatin. Drinking alcohol daily or in large amounts may increase the risk of liver problems with ezetimibe/atorvastatin. Check with your doctor before drinking alcohol while you are taking ezetimibe/atorvastatin. Tell your doctor right away if you experience symptoms of liver problems (eg, dark urine; pale stools; severe or persistent nausea, loss of appetite, or stomach pain; unusual tiredness; yellowing of the skin or eyes).
  • Do NOT take more than the recommended dose without checking with your doctor.
  • Follow the diet and exercise program given to you by your health care provider.
  • Tell your doctor or dentist that you take ezetimibe/atorvastatin before you receive any medical or dental care, emergency care, or surgery.
  • Muscle problems (myopathy) may occur with ezetimibe/atorvastatin. Report any unexplained muscle pain, tenderness, or weakness to your doctor right away, especially if you also have a fever or general body discomfort. Tell your doctor if you have muscle problems that persist even after your doctor has told you to stop taking ezetimibe/atorvastatin.
  • Diabetes patients - Ezetimibe/atorvastatin may increase your blood sugar levels. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • If you are able to become pregnant, use effective birth control to prevent pregnancy while taking ezetimibe/atorvastatin. Talk with your doctor or pharmacist if you have questions about effective birth control.
  • Lab tests, including blood cholesterol levels, liver function, and creatine phosphokinase (CPK) blood levels, may be performed while you take ezetimibe/atorvastatin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use ezetimibe/atorvastatin with caution in the ELDERLY; they may be more sensitive to its effects, especially muscle problems.
  • Ezetimibe/atorvastatin should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use ezetimibe/atorvastatin if you are pregnant. Avoid becoming pregnant while you are taking it. If you think you may be pregnant, contact your doctor right away. It is not known if ezetimibe/atorvastatin is found in breast milk. Do not breast-feed while taking ezetimibe/atorvastatin.

Possible side effects of ezetimibe/ atorvastatin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; dizziness; mild cough or sore throat; runny or stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing or swallowing; tightness in the chest; swelling of the mouth, face, lips, throat, or tongue; unusual hoarseness); burning, numbness, or tingling; change in the amount of urine produced; confusion; depression; difficult, frequent, or painful urination; fever, chills, or persistent sore throat; joint pain; memory problems; muscle tenderness, pain, or weakness (with or without fever and fatigue); persistent pain, soreness, redness, or swelling of a tendon or joint; red, swollen, blistered, or peeling skin; severe stomach or back pain (with or without nausea or vomiting); symptoms of liver problems (eg, dark urine, loss of appetite, pale stools, severe stomach pain, yellowing of the skin or eyes).

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of ezetimibe/atorvastatin:

Store ezetimibe/atorvastatin at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Store in the foil pouch until use. Throw away any unused tablets 30 days after the foil pouch is opened. Do not store in the bathroom. Keep ezetimibe/atorvastatin out of the reach of children and away from pets.

General information:

  • If you have any questions about ezetimibe/atorvastatin, please talk with your doctor, pharmacist, or other health care provider.
  • Ezetimibe/atorvastatin is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take ezetimibe/atorvastatin or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about ezetimibe/atorvastatin. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to ezetimibe/atorvastatin. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using ezetimibe/atorvastatin.

Issue Date: April 2, 2014
Database Edition 14.2.1.001
Copyright © 2014 Wolters Kluwer Health, Inc.

Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using this medicine.

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