Pronunciation:

kloe-FYE-brate

Classifications:

Chemical—

Fibric Acid

Uses of This Medicine:

Clofibrate is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. This may help prevent medical problems caused by such substances clogging the blood vessels.

Clofibrate may also be used for other conditions as determined by your doctor.

Clofibrate is available only with your doctor's prescription.

Before Using This Medicine:

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:

In addition to its helpful effects in treating your medical problem, this medicine may have some harmful effects.You may have read or heard about a study called the World Health Organization (WHO) Study. This study compared the effects in patients who used clofibrate with effects in those who used a placebo (sugar pill). The results of this study suggested that clofibrate might increase the patient's risk of cancer, liver disease, and pancreatitis (inflammation of the pancreas), although it might also decrease the risk of heart attack. It may also increase the risk of gallstones and problems from gallbladder surgery. Other studies have not found all of these effects. Be sure you have discussed this with your doctor before taking this medicine.

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.

Children—

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of clofibrate in children with use in other age groups. However, use is not recommended in children under 2 years of age since cholesterol is needed for normal development.

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of clofibrate in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Breast-feeding—

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.

Other 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 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.

• Atorvastatin
• Colchicine
• Cyclosporine
• Ezetimibe
• Fluvastatin
• Lovastatin
• Pitavastatin
• Pravastatin
• Rosuvastatin
• Simvastatin

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.

• Chlorpropamide
• Furosemide
• Rifampin
• Rifapentine
• Tolazamide

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:

• Gallstones or
• Stomach or intestinal ulcer—May make these conditions worse

• Heart disease or
• Kidney disease or
• Liver disease—Higher blood levels may result and increase the risk of side effects

• Underactive thyroid—Clofibrate may cause or make muscle disease worse

Proper Use of This Medicine:

Before prescribing medicine for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Such a diet may be low in fats, sugars, and/or cholesterol. Many people are able to control their condition by carefully following their doctors' orders for proper diet and exercise. Medicine is prescribed only when additional help is needed and is effective only when a schedule of diet and exercise is properly followed.

Also, this medicine is less effective if you are greatly overweight. It may be very important for you to go on a reducing diet. However, check with your doctor before going on any diet.

Make certain your health care professional knows if you are on a low-sodium, low-sugar, or any other special diet. Most medicines contain more than their active ingredient.

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

Follow carefully the special diet your doctor gave you. This is the most important part of controlling your condition and is necessary if the medicine is to work properly.

Stomach upset may occur but usually lessens after a few doses. Take this medicine with food or immediately after meals to lessen possible stomach upset.

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—1.5 to 2 grams a day. This is divided into two to four doses.
    • Children—Dose must be determined by your doctor.

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—

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.

Precautions While Using This Medicine:

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 levels and to decide if you should continue to take it.

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.

Side Effects of This Medicine:

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:

Rare

Chest pain

irregular heartbeat

shortness of breath

stomach pain (severe) with nausea and vomiting

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Blood in urine

cough or hoarseness

decrease in urination

fever or chills

lower back or side pain

painful or difficult urination

swelling of feet or lower legs

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

Diarrhea

nausea

Less common or rare

Decreased sexual ability

headache

increased appetite or weight gain (slight)

muscle aches or cramps

sores in mouth and on lips

stomach pain, gas, or heartburn

unusual tiredness or weakness

vomiting

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.