Description
Fenofibrate is used together with a proper diet to reduce and treat high cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent the development of pancreatitis (inflammation or swelling 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:
- Tablet
- Capsule
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 fenofibrate 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 fenofibrate in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving fenofibrate.
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
- 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 or tenderness, history of or
- Muscle weakness, history of—Use with caution. May make these conditions worse.
- Diabetes or
- Hypothyroidism (an 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, those 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 fenofibrate.
This medicine is usually taken once a day. Take the medicine at the same time each day to maintain the medication's effect.
Fenoglide®, Lipofen®, Lofibra™, and Tricor® should be taken with a meal. Antara® and Triglide® can be taken with or without a meal.
Swallow Antara® capsules, Fenoglide® tablets, Tricor® tablets, or Triglide® tablets whole. Do not open, crush, break, chew, or dissolve them. Do not take chipped or broken Triglide® tablets.
If you are also using cholestyramine, colesevelam, or colestipol, you must take Triglide® or Fenoglide® 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 oral dosage form (capsules):
- For high cholesterol:
- Adults—
- Antara®: At first, 130 milligrams (mg) once a day with a meal. Your doctor may adjust your dose as needed.
- Lipofen®: At first, 150 mg once a day with a meal. Your doctor may adjust your dose as needed.
- Lofibra™: 200 mg once a day with a meal.
- Children—Use and dose must be determined by your doctor.
- Adults—
- For severe hypertriglyceridemia (high triglycerides or fats):
- Adults—
- Antara®: At first, 43 to 130 milligrams (mg) once a day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 130 mg per day.
- Lipofen®: At first, 50 to 150 mg once a day with a meal. Your doctor may adjust your dose as needed. However, the dose is usually not more than 150 mg per day.
- Lofibra™: At first, 67 mg once a day with a meal. Your doctor may increase your dose as needed.
- Children—Use and dose must be determined by your doctor.
- Adults—
- For high cholesterol:
- For oral dosage form (tablets):
- For high cholesterol:
- Adults—
- Fenoglide®: At first, 120 milligrams (mg) per day. Your doctor may adjust your dose as needed.
- Tricor®: At first, 160 mg once a day. Your doctor may adjust your dose as needed.
- Triglide®: 160 mg once a day.
- Children—Use and dose must be determined by your doctor.
- Adults—
- For high triglycerides or fats:
- Adults—
- Fenoglide®: At first, 40 to 120 milligrams (mg) per day. Your doctor may adjust your dose as needed. However, the dose is usually not more than 120 mg per day.
- Tricor®: At first, 54 to 160 mg once a day. Your doctor may adjust your dose as needed.
- Triglide®: 160 mg once a day.
- Children—Use and dose must be determined by your doctor.
- Adults—
- For high cholesterol:
Missed Dose
If you miss a dose of this medicine, 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
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.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep Triglide® tablets in its original container. Protect from heat, light, and moisture.
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 (fat) 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 serious 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 fever. These could be symptoms of a serious muscle problem called myopathy.
Check with your doctor right away if you have dark urine, diarrhea, 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.
Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have bloating, sudden and severe stomach pain, chills, diarrhea, fast heartbeat, fever, indigestion. loss of appetite, nausea, pains in stomach, side, or abdomen, possibly radiating to the back, vomiting.
This medicine may increase your risk of having gallstones. Check with your doctor right away if you have severe stomach pain, especially after eating, with nausea and 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 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, 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 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:
Less common
- Chills
- fever
- hives, itching, skin rash
- muscle aches and pains
- nausea
- stomach pain
- vomiting
Rare
- Dark urine
- muscle cramps, spasms, stiffness, swelling, or weakness
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
- yellow eyes or skin
Incidence not known
- Agitation
- bloating
- bloody urine
- constipation
- cough
- decreased frequency or amount of urine
- difficulty in moving
- fast heartbeat
- increased blood pressure
- increased thirst
- indigestion
- joint pain or swelling
- light-colored stools
- loss of appetite
- lower back or side pain
- pains in the stomach, side, or abdomen, possibly radiating to the back
- pale skin
- swelling of the face, fingers, or lower legs
- upper right stomach pain
- weight gain
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
- Back pain
- diarrhea
- eye irritation
- gas
- increased sensitivity of the skin to sunlight
Incidence not known
- Lack or loss of strength
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.
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