Description
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.
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Capsule, Delayed Release
- Tablet
Before Using
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 this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.
Breastfeeding
Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.
Drug Interactions
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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Ciprofibrate
Using this medicine 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
- Anisindione
- Atorvastatin
- Cerivastatin
- Cholestyramine
- Colchicine
- Colesevelam
- Colestipol
- Cyclosporine
- Dicumarol
- Ezetimibe
- Fluvastatin
- Lovastatin
- Phenprocoumon
- Pitavastatin
- Pravastatin
- Rosuvastatin
- Simvastatin
- Tacrolimus
- Warfarin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Rosiglitazone
Other Interactions
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 this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Blood clotting problems (eg, deep vein thrombosis, pulmonary embolism), history of or
- Heart disease or
- Muscle pain, tenderness, or 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, history of or
- Kidney disease, severe (eg, end-stage kidney disease, patients receiving dialysis) or
- Liver disease (including cirrhosis), active—Should not be used in patients with these conditions.
Proper Use
Take this medicine 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 this medicine, 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. If you have excess body weight, your doctor may tell you to exercise to lose this weight before using this medicine. Also avoid drinking alcohol before and during treatment with fenofibric acid.
Swallow the delayed-release capsule or tabletwhole. Do not open, crush, break, dissolve, or chew it.
You may take this medicine with or without food.
This medicine 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.
If you are also using cholestyramine, colesevelam, or colestipol, you must take fenofibric acid at least 1 hour before or 4 to 6 hours after you take these medicines.
Dosing
The dose of this medicine 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 this medicine. 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 high triglycerides:
- For oral dosage form (tablets):
- Adults—35 to 105 milligrams (mg) once a day. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (delayed-release capsules):
- Adults—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 oral dosage form (tablets):
- For mixed dyslipidemia or primary hypercholesterolemia:
- For oral dosage form (tablets):
- Adults—105 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (delayed-release capsules):
- Adults—135 milligrams (mg) once a day.
- Children—Use and dose must be determined by your doctor.
- For oral dosage form (tablets):
Missed Dose
If you miss a dose of this medicine, 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
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.
Call your doctor right away if you have a headache, stomach pain, vomiting, dark urine, loss of appetite, weight loss, general feeling of tiredness or weakness, light-colored stools, upper right stomach pain, or yellow eyes or skin. These could be symptoms of liver problems.
Check with your doctor right away if you have 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.
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.
This medicine may increase your risk of gallstones. Call your doctor right away if you have severe stomach pain with nausea and vomiting.
Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Tell your doctor right away if you have bloating, sudden and severe stomach pain, chills, constipation, darkened urine, fast heartbeat, fever, indigestion. loss of appetite, nausea, pains in stomach, side, or abdomen, possibly radiating to the back, pale stools, vomiting.
This medicine may cause serious allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.
Serious skin reactions, including Steven-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, itching, joint or muscle pain, painful or difficult urination, rash, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, unusual bleeding or bruising, or unusual tiredness or weakness.
This medicine may lower 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 this medicine without first checking with your doctor. When you stop taking this medicine, your blood fat levels may increase again. Your doctor may want you to follow a special diet to help prevent that.
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.
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
- sore throat
- unusual tiredness or weakness
Less common
- Bladder pain
- bloody or cloudy urine
- blurred vision
- chest tightness
- 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 aches, cramps, spasms, or stiffness
- muscle or bone pain
- nausea
- nervousness
- pain in the arms or legs
- pounding in the ears
- shivering
- slow or fast heartbeat
- sweating
- swollen joints
- trouble sleeping
- vomiting
Incidence not known
- Agitation
- bloating
- coma
- confusion
- constipation
- darkened urine
- decreased urine output
- indigestion
- irritability
- lethargy
- pains in the stomach, side, or abdomen, possibly radiating to the back
- seizures
- stupor
- swelling of the face, ankles, or hands
- yellow eyes or skin
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:
More common
- Runny or stuffy nose
- sneezing
Less common
- Acid or sour stomach
- belching
- difficulty having a bowel movement (stool)
- heartburn
- pain or tenderness around the eyes and cheekbones
- stomach discomfort, upset, or pain
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.
DRG-20072494
