Ezetimibe & Atorvastatin

Ezetimibe/atorvastatin is a prescription medication, used in combination with diet and exercise, to treat high cholesterol. It is also used to lower cholesterol in people with homozygous familial hypercholesterolemia (HoFH, a hereditary disorder that causes high cholesterol levels).

Ezetimibe/atorvastatin is a single tablet containing two cholesterol-lowering medicines. Ezetimibe belongs to a group of drugs called cholesterol absorption inhibitors, which block the absorption of cholesterol from the intestines. Atorvastatin belongs to a group of drugs called HMG-CoA reductase inhibitors, also known as statins, which block an enzyme in the body called HMG-CoA reductase. This is a major enzyme involved in making cholesterol in the body.

Ezetimibe/atorvastatin is available as a once-daily tablet containing 10 mg of ezetimibe combined with 10, 20, 40, or 80 mg of atorvastatin. It can be taken at any time of day, with or without food.

Common side effects during clinical trial included elevated enzymes (ALT and AST), and musculoskeletal pain.

Ezetimibe/atorvastatin is a prescription medication used to lower levels of total cholesterol, LDL (bad) cholesterol and fatty substances called triglycerides in the blood. In addition, this medication raises levels of HDL (good) cholesterol.

Ezetimibe/atorvastatin is also used to lower cholesterol in people with homozygous familial hypercholesterolemia (HoFH, a hereditary disorder that causes high cholesterol levels).

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

Ezetimibe & Atorvastatin may be found in some form under the following brand names:

• Liptruzet

Ezetimibe/atorvastatin may cause serious side effects. See "Drug Precautions" section.

The most common side effects of ezetimibe/atorvastatin include:

• muscle and body pain
• changes in your liver function tests

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ezetimibe/atorvastatin. For more information, ask your doctor or pharmacist.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Taking ezetimibe/atorvastatin with certain other medicines or substances can increase the risk of muscle problems or other side effects.

Especially tell your doctor if you take medicines for:

• your immune system
• cholesterol
• infections
• birth control
• heart failure
• HIV or AIDS
• hepatitis C
• gout

Also tell your doctor if you drink large amounts of grapefruit juice.

This is not a complete list of ezetimibe/atorvastatin drug interactions. Ask your doctor or pharmacist for more information.

Ezetimibe/atorvastatin may cause serious side effects including:

• muscle problems. Ezetimibe/atorvastatin can cause serious muscle problems that can lead to kidney problems, including kidney failure. You have a higher chance for muscle problems if you are taking certain other medicines with ezetimibe/atorvastatin. Tell your doctor right away if:
  • you have unexplained muscle pain, tenderness, or weakness, especially if you have a fever or feel more tired than usual, while you take ezetimibe/atorvastatin.
  • you have muscle problems that do not go away even after your doctor has advised you to stop taking ezetimibe/atorvastatin. Your doctor may do further tests to diagnose the cause of your muscle problems.
• liver problems. Your doctor should do blood tests to check your liver before you start taking ezetimibe/atorvastatin and if you have symptoms of liver problems while you take ezetimibe/atorvastatin. Call your doctor right away if you have the following symptoms of liver problems:
  • feel tired or weak
  • loss of appetite
  • upper belly pain
  • dark urine
  • yellowing of your skin or the whites of your eyes

Also call your doctor right away if you have:

• allergic reactions including swelling of the face, lips, tongue, and/or throat that may cause difficulty in breathing or swallowing which may require treatment right away
• nausea and vomiting
• passing brown or dark-colored urine
• you feel more tired than usual
• stomach pain
• allergic skin reactions

Do not take ezetimibe/atorvastatin if you:

• have active liver problems or repeated blood tests showing possible liver problems
• are allergic to ezetimibe or atorvastatin or any of the ingredients in it
• are pregnant or breastfeeding

Grapefruit and grapefruit juice may interact with this medication and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before you take ezetimibe/atorvastatin, tell your doctor if you:

• have a thyroid problem
• have kidney problems
• have diabetes
• have unexplained muscle aches or weakness
• drink more than 2 glasses of alcohol daily or have or have had liver problems
• have any other medical conditions
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Ezetimibe/atorvastatin falls into category X. This medication should not be used in women who are or may become pregnant. Cholesterol and cholesterol derivatives are needed for normal fetal development, therefore, cholesterol-lowering drugs offer no benefit during pregnancy. Drugs in this category may cause fetal harm when administered to a pregnant woman.

It is not known if ezetimibe/atorvastatin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using this medication.

• Take ezetimibe/atorvastatin exactly as your doctor tells you to take it.
• Your doctor will tell you how much ezetimibe/atorvastatin to take and when to take it.
• Your doctor may change your dose if needed.
• Do not open your ezetimibe/atorvastatin pouch until you are ready to take ezetimibe/atorvastatin.
• Take ezetimibe/atorvastatin 1 time each day, with or without food. It may be easier to remember to take your dose if you do it at the same time every day, such as with breakfast, dinner, or at bedtime.
• Tablets should be swallowed whole. Do not crush, dissolve, or chew tablets.
• Keep taking ezetimibe/atorvastatin unless your doctor tells you to stop. If you stop taking ezetimibe/atorvastatin, your cholesterol may rise again.
• If you miss a dose, do not take an extra dose. Just resume your usual schedule.
• If you take too much ezetimibe/atorvastatin, call your doctor or Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room right away.
• See your doctor regularly to check your cholesterol level and to check for side effects. Your doctor may do blood tests to check your liver before you start taking ezetimibe/atorvastatin and during treatment.

What you should avoid while taking ezetimibe/atorvastatin:

• Do not start any new medicines before talking to your doctor. This includes prescription and non-prescription medicines, vitamins, and herbal supplements. Ezetimibe/atorvastatin and certain other medicines can interact causing serious side effects.
• Do not drink more than 2 glasses of alcohol daily.
• Do not get pregnant. If you get pregnant, stop taking ezetimibe/atorvastatin right away and call your doctor.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose range of ezetimibe/atorvastatin is 10/10 mg/day to 10/40 mg/day.

The recommended dosage for patients with homozygous familial hypercholesterolemia is 10/40 mg/day in the evening.

If you take too much ezetimibe/atorvastatin, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.

• Store ezetimibe/atorvastatin at room temperature between 68°F to 77°F (20°C to 25°C).
• Keep ezetimibe/atorvastatin in the foil pouch until you are ready to take it.
• After you remove a ezetimibe/atorvastatin tablet from the blister card, slide the blister card back into the case (where a case is provided) and store in a dry place.
• Write down the date the foil pouch was opened in the space provided.
• Keep ezetimibe/atorvastatin tablets dry and out of the light.
• Safely throw away unused ezetimibe/atorvastatin tablets 30 days after the foil pouch is opened.

Keep ezetimibe/atorvastatin and all medicines out of the reach of children.