fenofibric acid (Oral route)

fen-oh-FYE-brik AS-id

Commonly used brand name(s)

In the U.S.

  • Fibricor
  • Trilipix

Available Dosage Forms:

  • Tablet
  • Capsule, Delayed Release

Therapeutic Class: Antihyperlipidemic

Chemical Class: Fibric Acid

Uses For fenofibric acid

Fenofibric acid is used together with a proper diet to treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation of the pancreas) caused by high levels of triglycerides in the blood.

Slideshow: Grapefruit and Medicines - A Possible Deadly Mix?

Grapefruit and grapefruit juice can react adversely with over 85 prescription medications.

Fenofibric acid may also be used together with cholesterol-lowering medicines called "statins" to prevent certain types of heart problems in patients with risk factors for heart problems.

fenofibric acid is available only with your doctor's prescription.

Before Using fenofibric acid

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For fenofibric acid, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to fenofibric acid or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of fenofibric acid in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fenofibric acid in the elderly. However, elderly patients are more likely to have kidney problems, which may require caution and an adjustment in the dose for patients receiving fenofibric acid.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking fenofibric acid, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using fenofibric acid with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Acenocoumarol
  • Atorvastatin
  • Cerivastatin
  • Colchicine
  • Dicumarol
  • Fluvastatin
  • Lovastatin
  • Pitavastatin
  • Pravastatin
  • Rosuvastatin
  • Simvastatin
  • Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of fenofibric acid. Make sure you tell your doctor if you have any other medical problems, especially:

  • Blood clotting problems (e.g., deep vein thrombosis, pulmonary embolism), history of or
  • Muscle pain or tenderness, history of or
  • Muscle weakness, history of—Use with caution. May make these conditions worse.
  • Diabetes or
  • Hypothyroidism (underactive thyroid) or
  • Kidney problems—Use with caution. May cause side effects to become worse.
  • Gallbladder disease, or history of or
  • Kidney disease, severe or
  • Liver disease (including cirrhosis) or
  • Liver enzymes, persistently elevated—Should not be used in patients with these conditions.
  • Heart disease (e.g., coronary heart disease) or
  • Stroke—fenofibric acid has not been shown to lower risk of having these medical problems.

Proper Use of fenofibric acid

Use fenofibric acid only as directed by your doctor. Do not use more of it, do not use it more often, or do not use it for a longer time than your doctor ordered.

In addition to fenofibric acid, your doctor may change your diet to one that is low in fat, sugar, and cholesterol. Carefully follow your doctor's order about any special diet.

fenofibric acid will not cure your high cholesterol problem, but it does help control it. You must continue to take it as directed if you expect to keep your cholesterol levels down.

Swallow the delayed-release capsule whole. Do not crush, break, or chew it.

You may take fenofibric acid with or without food.

If you also take another medicine called a statin, you may take fenofibric acid and the statin at the same time each day.

fenofibric acid should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Dosing

The dose of fenofibric acid will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of fenofibric acid. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (delayed-release capsules):
    • For high triglycerides:
      • Adults—At first, 45 to 135 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
      • Children—Use and dose must be determined by your doctor.
    • For mixed dyslipidemia:
      • Adults—135 milligrams (mg) once a day, taken with or without another medicine called a statin.
      • Children—Use and dose must be determined by your doctor.
    • For primary hyperlipidemia:
      • Adults—135 milligrams (mg) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of fenofibric acid, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using fenofibric acid

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly to lower your cholesterol and triglyceride (fats) levels and to decide if you should continue to take it. Blood and urine tests may be needed to check for unwanted effects.

Check with your doctor right away if you experience unexplained muscle pain, tenderness, or weakness, especially if you also have unusual tiredness or a fever. These could be symptoms of a serious muscle problem called myopathy.

Stop using fenofibric acid and check with your doctor right away if you have dark-colored urine, diarrhea, a fever, muscle cramps or spasms, muscle pain or stiffness, or feel very tired or weak. These could be symptoms of a serious muscle problem called rhabdomyolysis, which can cause kidney problems.

Call your doctor right away if you have severe stomach pain with nausea and vomiting. fenofibric acid may increase your risk of gallstones.

Pancreatitis may occur while you are using fenofibric acid. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.

Serious skin reactions can occur with fenofibric acid. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using fenofibric acid.

fenofibric acid lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

Do not stop taking fenofibric acid without first checking with your doctor. When you stop taking fenofibric acid, your blood fat levels may increase again. Your doctor may want you to follow a special diet to help prevent that.

Avoid large amounts of grapefruit juice (more than 1 quart each day) while you are taking fenofibric acid. Grapefruit juice can increase the amount of fenofibric acid in the body, which may increase your chance of having muscle problems.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

fenofibric acid Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • ear congestion
  • fever
  • headache
  • loss of voice
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Less common
  • Bladder pain
  • bloody or cloudy urine
  • blurred vision
  • cough producing mucus
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty with moving
  • dizziness
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • lower back or side pain
  • muscle aching or cramping
  • muscle or bone pain
  • muscle pain or stiffness
  • muscle spasms
  • nausea
  • nervousness
  • pain in the arms or legs
  • pounding in the ears
  • shivering
  • shortness of breath
  • slow or fast heartbeat
  • sweating
  • swollen joints
  • tightness in the chest
  • trouble sleeping
  • vomiting
  • wheezing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Acid or sour stomach
  • belching
  • difficulty having a bowel movement (stool)
  • heartburn
  • indigestion
  • pain or tenderness around the eyes and cheekbones
  • sleeplessness
  • stomach discomfort, upset, or pain
  • unable to sleep

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

See also: Side effects (in more detail)

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