Fibricor

Generic Name: fenofibric acid (FEN oh FYE brik AS id)Brand Names: Fibricor, Trilipix

What is Fibricor (fenofibric acid)?

Fenofibric acid helps reduce cholesterol and triglycerides (fatty acids) in the blood. High levels of these types of fat in the blood are associated with an increased risk of atherosclerosis (clogged arteries).

Fenofibric acid is used to treat high cholesterol and high triglyceride levels. It is sometimes given together with other cholesterol-lowering medications.

Fenofibric acid may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Fibricor (fenofibric acid)?

You should not use fenofibric acid if you have liver disease, gallbladder disease, severe kidney disease (or if you are on dialysis), or if you are breast-feeding a baby.

Before you take fenofibric acid, tell your doctor if you have kidney disease, diabetes, or underactive thyroid.

Fenofibric acid is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

Avoid drinking alcohol while taking fenofibric acid. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking fenofibric acid.

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

In rare cases, fenofibric acid 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 muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine.What should I discuss with my healthcare provider before taking Fibricor (fenofibric acid)?

You should not use fenofibric acid if you have:

• severe kidney disease (or if you are on dialysis);
• liver disease;

• gallbladder disease; or

• if you are breast-feeding a baby.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take fenofibric acid:

• kidney disease;

• diabetes; or

• underactive thyroid.

FDA pregnancy category C. It is not known whether this medication is harmful to an unborn baby. Before you take fenofibric acid, tell your doctor if you are pregnant or plan to become pregnant during treatment. Fenofibric acid should not be used by nursing mothers. Do not take fenofibric acid without telling your doctor if you are breast-feeding a baby.

How should I take Fibricor (fenofibric acid)?

Take fenofibric acid exactly as it was prescribed for you. Do not take the medication in larger amounts or for longer than recommended by your doctor. Follow the directions on your prescription label.

Take the medicine with a full glass of water.

You may take fenofibric acid with or without food.

If you also take cholestyramine (Questran), colesevelam (Welchol), or colestipol (Colestid), take these medicines at least 1 hour after taking fenofibric acid, or 4 to 6 hours before taking fenofibric acid. Do not take any of these medicines at the same time you take fenofibric acid.

"Statin" cholesterol-lowering medications may be taken at the same time as fenofibric acid.

Fenofibric acid is only part of a complete program of treatment that may also include diet, exercise, weight control, and other medications. Follow your diet, medication, and exercise routines very closely.

To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications. Do not change your doses or medication schedule without advice from your doctor.

To be sure this medication is helping your condition and not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney, liver, and gallbladder function may also need to be tested. Do not miss any scheduled visits to your doctor.

Store fenofibric acid at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a fenofibric acid overdose are not known.

What should I avoid while taking Fibricor (fenofibric acid)?

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

Avoid drinking alcohol while taking fenofibric acid. Alcohol can raise triglyceride levels, and may also damage your liver while you are taking fenofibric acid.

Fibricor (fenofibric acid) side effects

In rare cases, fenofibric acid can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Stop taking fenofibric acid and call your doctor right away if you have muscle pain, tenderness, or weakness especially if you also have fever, nausea or vomiting, and dark colored urine. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking fenofibric acid and call your doctor at once if you have any of these other serious side effects:

• sharp stomach pain spreading to your back or shoulder blade;

• stomach pain just after eating a meal;

• nausea, vomiting, fever, clay-colored stools, jaundice (yellowing of the skin or eyes);

• pain or swelling in one or both legs; or

• chest pain, sudden cough, wheezing, rapid breathing, fast heart rate.

Less serious side effects may include:

• headache, dizziness;

• tired feeling;

• joint pain, mild back pain;

• runny or stuffy nose, sore throat; or

• diarrhea, constipation, bloating, indigestion.

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.

What other drugs will affect Fibricor (fenofibric acid)?

Tell your doctor about all other medications you use, especially:

• cyclosporine (Neoral, Sandimmune, Gengraf); or

• a blood thinner such as warfarin (Coumadin);

• a diuretic (water pill);

• birth control pills or hormone replacement therapy; or

• a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal, InnoPran), and others.

This list is not complete and there may be other drugs that can interact with fenofibric acid. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about fenofibric acid.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2006 Cerner Multum, Inc. Version: 1.03. Revision Date: 09/13/2009 12:26:18 PM.