Flolipid is used together with diet to lower blood levels of "bad" cholesterol (low-density lipoprotein, or LDL), to increase levels of "good" cholesterol (high-density lipoprotein, or HDL), and to lower triglycerides (a type of fat in the blood).

Flolipid is also used to lower the risk of stroke, heart attack, and other heart complications in people with diabetes, coronary heart disease, or other risk factors.

Flolipid is used in adults and children who are at least 10 years old.

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

Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.

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

Flolipid is usually taken in the evening or at bedtime.

Take Flolipid oral suspension (liquid) on an empty stomach.

Shake the liquid for at least 20 seconds before you measure a dose. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

You may need to take Flolipid on a long-term basis. You may need to stop using this medicine for a short time if you have surgery or a medical emergency. Do not stop taking this medicine unless your doctor tells you to.

Flolipid is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

You will need frequent medical tests.

Store at room temperature away from moisture, heat, and light.

Do not refrigerate or freeze the liquid medicine. Throw away any liquid that has not been used within 1 month after you first opened the bottle.

You should not take Flolipid if you are allergic to it, or if:

• you have active liver disease; or

• you are pregnant or breastfeeding (if you are taking the oral suspension).

Some medicines can cause unwanted or dangerous effects when used with Flolipid. Your doctor may change your treatment plan if you also use medicine such as:

• cyclosporine;

• danazol;

• gemfibrozil;

• imatinib;

• lomitapide;

• nefazodone;

• an antibiotic or antifungal medicine;

• tuberculosis medicine;

• heart or blood pressure medication; or

• antiviral medicine to treat hepatitis C or HIV/AIDS.

Tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• diabetes;

• a thyroid disorder;

• if you are of Asian descent; or

• if you drink more than 2 alcoholic beverages daily.

Flolipid can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Do not use Flolipid if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using Flolipid. Stop taking this medicine and tell your doctor right away if you become pregnant.

Do not breastfeed.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

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

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

Avoid eating foods high in fat or cholesterol, or Flolipid will not be as effective.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Flolipid can cause the breakdown of muscle tissue, which can lead 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, or dark urine.

Also call your doctor at once if you have:

• muscle weakness in your hips, shoulders, neck, and back;

• trouble lifting your arms, trouble climbing or standing; or

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Common side effects of Flolipid may include:

• headache;

• nausea, stomach pain, constipation; or

• cold symptoms such as stuffy nose, sneezing, 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.

Tell your doctor about all your other medicines, especially:

• any other cholesterol medication--niacin, fenofibrate, fenofibric acid, and others; or

• a blood thinner--warfarin, Coumadin, Jantoven.

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