Liptruzet contains a combination of atorvastatin and ezetimibe Ezetimibe reduces the amount of cholesterol absorbed by the body.

Atorvastatin belongs to a group of drugs called HMG CoA reductase inhibitors, or "statins."

Liptruzet reduces blood levels of "bad" cholesterol, such as low-density lipoprotein (LDL), apolipoprotein-B (apo-B), triglycerides, or non-high-density lipoprotein (non-HDL).

Liptruzet is used together with a low-fat diet and other treatments to lower total cholesterol in adults with familial hypercholesterolemia (an inherited type of high cholesterol).

It is not known whether Liptruzet reduces your risk of heart disease.

Liptruzet may also be used for purposes not listed in this medication guide.

You should not use Liptruzet if you have active liver disease or abnormal liver function tests.

Do not use Liptruzet if you are pregnant or if you could become pregnant. Use effective birth control.

Do not breast-feed while using Liptruzet.

Before taking Liptruzet

You should not use Liptruzet if you are allergic to atorvastatin (Lipitor) or ezetimibe (Vytorin, Zetia), or if you have:

• active liver disease;

• abnormal liver function tests; or

• if you are pregnant or breast-feeding.

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

• a thyroid disorder;

• a history of liver or kidney disease;

• a history of liver problems caused by alcohol;

• gallbladder disease or a history of gallstones;

• low blood pressure;

• a history of blood clot or stroke, including "mini-stroke" (TIA);

• diabetes;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• untreated or uncontrolled seizures;

• if you drink large amounts of alcohol; or

• if you are older than 65.

FDA pregnancy category X. Liptruzet can harm an unborn baby or cause birth defects. Do not use Liptruzet if you are pregnant. Use effective birth control. Stop using the medicine and tell your doctor right away if you become pregnant.

It is not known whether atorvastatin and ezetimibe passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Liptruzet.

Take Liptruzet exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, or dissolve a Liptruzet tablet. Swallow it whole.

While using this medicine, you may need frequent blood tests.

If you have major surgery or a severe injury or infection, make sure any doctor caring for you knows you are taking Liptruzet.

Store at room temperature away from moisture and heat. Keep Liptruzet tablets in the foil pouch or plastic case when not in use.

After opening a foil pouch, store it in a dry place protected from light. Discard any tablets not used within 30 days after opening the pouch.

Each time you take a tablet out of a blister card, place the card back into the plastic case.

You should not use Liptruzet if you are allergic to atorvastatin (Lipitor) or ezetimibe (Vytorin, Zetia), or if you have:

• active liver disease;

• abnormal liver function tests; or

• if you are pregnant or breast-feeding.

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

• a thyroid disorder;

• a history of liver or kidney disease;

• a history of liver problems caused by alcohol;

• gallbladder disease or a history of gallstones;

• low blood pressure;

• a history of blood clot or stroke, including "mini-stroke" (TIA);

• diabetes;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• untreated or uncontrolled seizures;

• if you drink large amounts of alcohol; or

• if you are older than 65.

FDA pregnancy category X. Liptruzet can harm an unborn baby or cause birth defects. Do not use Liptruzet if you are pregnant. Use effective birth control. Stop using the medicine and tell your doctor right away if you become pregnant.

It is not known whether atorvastatin and ezetimibe passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using Liptruzet.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

Grapefruit and grapefruit juice may interact with this medicine and lead to unwanted side effects. Avoid the use of grapefruit products while taking Liptruzet.

Avoid eating foods that are high in fat or cholesterol. Liptruzet will not be as effective in lowering your cholesterol if you do not follow a cholesterol lowering diet plan.

If you also take cholestyramine, colesevelam, or colestipol: Space your doses apart in order to take Liptruzet either 2 hours before or 4 hours after you take any of these other medications.

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

In rare cases, atorvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading 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, and dark colored urine.

Stop using Liptruzet and call your doctor at once if you have:

• nausea, upper stomach pain, loss of appetite;

• itching, unusual tiredness; or

• dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common Liptruzet side effects may include:

• mild muscle pain;

• stomach pain, diarrhea; or

• joint pain.

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.

Many drugs can interact with this medicine. Not all possible interactions are listed here. Tell your doctor about all your medications and any you start or stop using during treatment with Liptruzet, especially:

• colchicine;

• cyclosporine;

• digoxin, digitalis;

• imatinib;

• isoniazid;

• nefazodone;

• niacin, vitamin B3;

• St. John's wort;

• an antibiotic--clarithromycin, erythromycin, rifampin, telithromycin;

• antifungal medication--itraconazole, ketoconazole, posaconazole, voriconazole;

• birth control pills;

• a blood thinner (warfarin, Coumadin);

• heart medication--nicardipine, quinidine;

• hepatitis C medications--boceprevir, telaprevir;

• HIV/AIDS medication--atazanavir, darunavir, delavirdine, efavirenz, fosamprenavir, indinavir, lopinavir, nelfinavir, nevirapine, ritonavir, saquinavir, tipranavir;

• other cholesterol medications, especially fenofibrate, fenofibric acid, gemfibrozil, or any other "statin" medicine.

• seizure medication--carbamazepine, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone; or

• tuberculosis medication--rifabutin, rifampin, rifapentine.

This list is not complete and many other drugs can interact with Liptruzet. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Give a list of all your medicines to any healthcare provider who treats you.