In the U.S.—

In Canada—

• Antidiuretic, central diabetes insipidus
• Antihyperlipidemic

Clofibrate ( kloe-FYE-brate) 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, in the following dosage form:

Oral
• Capsules (U.S. and Canada)

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.

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 clofibrate, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to clofibrate. Also tell your health care professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Diet—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.

Pregnancy—Use of clofibrate is not recommended during pregnancy. Although studies have not been done in pregnant women, studies in rabbits have shown that the fetus may not be able to break down and get rid of this medicine as well as the mother. Because of this, it is possible that clofibrate may be harmful to the fetus if you take it while you are pregnant or for up to several months before you become pregnant. Be sure that you have discussed this with your doctor before taking this medicine, especially if you plan to become pregnant in the near future.

Breast-feeding—Clofibrate passes into breast milk. This medicine is not recommended during breast-feeding because it may cause unwanted effects in nursing babies.

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.

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 clofibrate, it is especially important that your health care professional knows if you are taking the following:

• Anticoagulants (blood thinners)—Use with clofibrate may increase the effects of the anticoagulant

• 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

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 clofibrate 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 clofibrate. If your dose is different, do not change it unless your doctor tells you to do so.

The number of capsules that you take depends on the strength of 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—

To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be sure that any discarded medicine is out of the reach of children.

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.

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 you think you have taken an overdose or 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 
  
  

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

• 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 above may also occur in some patients. If you notice any other effects, check with your doctor.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, clofibrate is used in certain patients with the following medical condition:

• Certain types of diabetes insipidus (water diabetes)

Other than the above information, there is no additional information relating to proper use, precautions, or side effects for this use.