Fenofibric acid

Fenofibric acid helps lower cholesterol and triglycerides (fatty acids) in the blood. High levels of these fats in the blood are linked to a higher risk of atherosclerosis (clogged arteries).

Fenofibric acid is sometimes prescribed along with other medications that lower cholesterol.

Fenofibric acid may also be used for reasons not mentioned in this medication guide.

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.

You may take fenofibric acid with or without food.

Swallow the tablet or capsule whole and do not crush, chew, dissolve, or open it.

You may need frequent medical tests. Even if you have no symptoms, tests can help your doctor determine if fenofibric acid is effective.

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.

Store at room temperature away from moisture and heat.

You should not take fenofibric acid if you have liver disease, gallbladder disease, severe kidney disease, or if you are breastfeeding a baby.

Fenofibric acid 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.

You should not take this medicine if you are allergic to fenofibric acid or fenofibrate, or if you have:

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

Do not breastfeed while using this medicine, and for at least 5 days after your last dose.

Tell your doctor if you have ever had:

• kidney disease;
• liver disease; or
• gallbladder problems.

Fenofibric acid can cause the breakdown of muscle tissue, which can lead to kidney failure. This occurs more often in older adults, or people who have kidney disease, diabetes, or poorly controlled hypothyroidism (underactive thyroid).

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Fenofibric acid is not approved for use by anyone younger than 18 years old.

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

In rare cases, fenofibric acid can cause a condition that leads to the breakdown of skeletal muscle tissue, which may result in 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-colored urine.

Also call your doctor immediately if you have:

• sharp stomach pain spreading to your back or shoulder blade;
• loss of appetite, stomach pain right after eating a meal;
• jaundice (yellowing of the skin or eyes);
• fever, chills, weakness, sore throat, mouth sores, unusual bruising or bleeding;
• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or
• swelling, warmth, or redness in an arm or leg.

Common side effects of fenofibric acid may include:

• runny nose, sneezing; or
• abnormal laboratory tests.

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.

Usual Adult Dose for Hypertriglyceridemia:

Capsules:-Initial dose: 45 to 135 mg orally once a day-Maximum dose: 135 mg once a dayTablets:-Initial dose: 35 to 105 mg orally per day-Maximum dose: 105 mg once a dayComments:-Dosages should be individualized according to patient response and if necessary, adjusted following repeat lipid determinations at 4 to 8 week intervals.-Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention.-Elevated triglycerides (TG) levels of 2000 mg/dL or higher may increase the risk of developing pancreatitis; the effect of therapy reducing this risk has not been adequately studied. Uses: -As an adjunct to diet to reduce TG in patients with severe hypertriglyceridemia (500 mg/dL or greater)

Usual Adult Dose for Hyperlipidemia:

Capsules:135 mg orally once a dayTablets:105 mg orally once a dayUse: As an adjunct to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), TG, and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.

Usual Adult Dose for Dyslipidemia:

Capsules:135 mg orally once a dayTablets:105 mg orally once a dayUse: As an adjunct to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), TG, and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in patients with primary hypercholesterolemia or mixed dyslipidemia.

Take the medicine as soon as possible, but skip the missed dose if it is close to the time for your next dose. Do not take two doses at the same time.

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

• Avoid eating foods high in fat or cholesterol, or fenofibric acid will not be as effective.

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

Some medicines can make fenofibric acid much less effective when taken at the same time. If you take any of the following medicines, take your fenofibric acid dose 1 hour before or 4 to 6 hours after you take the other medicine.

• cholestyramine;
• colesevelam; or
• colestipol.

Tell your doctor about all your other medicines, especially:

• other cholesterol lowering medicines;
• colchicine;
• a blood thinner such as warfarin, Coumadin, Jantoven; or
• drugs that weaken the immune system such as cancer medicine, steroids, and medicines to prevent organ transplant rejection.

This list is not complete. Other drugs may affect fenofibric acid, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.