CLOFIBRATE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Abitrate
• Atromid-S

In Canada?

• Atromid-S
• Claripex
• Novofibrate

Generic name product may be available in the U.S.

Category

• Antidiuretic, central diabetes insipidus
• Antihyperlipidemic

Description

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

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

Clofibrate is available only with your doctor's prescription, in the followingdosage form:

Oral
• Capsules (U.S. and Canada)

Before Using This Medicine

In addition to its helpfuleffects in treating your medical problem, this medicine may have some harmfuleffects.

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 clofibratewith effects in those who used a placebo (sugar pill). The results of thisstudy suggested that clofibrate might increase the patient's risk of cancer,liver disease, and pancreatitis (inflammation of the pancreas), although itmight also decrease the risk of heart attack. It may also increase the riskof gallstones and problems from gallbladder surgery. Other studies have notfound all of these effects. Be sure you have discussed this with your doctorbefore taking this medicine.

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

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

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

Breast-feeding?Clofibrate passes into breast milk. This medicineis not recommended during breast-feeding because it may cause unwanted effectsin nursing babies.

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

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults. Although there is no specific informationcomparing use of clofibrate in the elderly with use in other age groups, thismedicine is not expected to cause different side effects or problems in olderpeople than it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. When you are takingclofibrate, it is especially important that your health care professionalknows if you are taking the following:

• Anticoagulants (blood thinners)?Use with clofibrate may increasethe effects of the anticoagulant

Other medical problems?The presence of other medicalproblems may affect the use of clofibrate. Make sure you tell your doctorif 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 therisk of side effects

• Underactive thyroid?Clofibrate may cause or make muscle diseaseworse

Proper Use of This Medicine

Before prescribingmedicine for your condition, your doctor will probably try to control yourcondition by prescribing a personal diet for you. Such a diet may be low infats, sugars, and/or cholesterol. Many people are able to control their conditionby 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 properlyfollowed.

Also, this medicine is less effective if you are greatly overweight. Itmay be very important for you to go on a reducing diet. However, check withyour 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 theiractive 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 longertime than your doctor ordered.

Follow carefully the special diet your doctor gaveyou. This is the most important part of controlling your conditionand is necessary if the medicine is to work properly.

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

Dosing?The dose of clofibrate will be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage 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 fourdoses.
    • Children?Dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, take it assoon as possible. However, if it is almost time for your next dose, skip themissed 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 otherdamp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is very important that your doctor check your progress atregular visits. This will allow your doctor to see if the medicineis working properly to lower your cholesterol and triglyceride levels andto decide if you should continue to take it.

Do not stop taking this medicine without first checkingwith your doctor. When you stop taking this medicine, your blood fatlevels may increase again. Your doctor may want you to follow a special dietto 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 mayneed medical attention.

Check with your doctor immediately if you thinkyou 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 possibleif 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; swellingof feet or lower legs

Other side effects may occur that usually do not need medicalattention. These side effects may go away during treatment as your body adjuststo the medicine. However, check with your doctor if any of the following sideeffects 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 abovemay also occur in some patients. If you notice any other effects, check withyour doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor 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 relatingto proper use, precautions, or side effects for this use.