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|Cerivastatin

CERIVASTATIN (Systemic)*†

Some commonly used brand names are:

In the U.S.—

• Not commercially available

In Canada—

• Not commercially available

*† Not commercially available in the U.S. and Canada.

Category

• Antihyperlipidemic

Description

Cerivastatin (se-RIV-a-stat-in) 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.

Cerivastatin belongs to the group of medicines called 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors. It works by blocking an enzyme that is needed by the body to make cholesterol, thereby reducing the amount of cholesterol in the blood.

Cerivastatin is available only with your doctor"s prescription, in the following dosage form:

• Oral
• Tablets

Before Using This Medicine

In addition to its helpful effects in treating your medical problem, this type of medicine may have some harmful effects.

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 cerivastatin, the following should be considered:

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

Pregnancy—Cerivastatin should not be used during pregnancy or by women who plan to become pregnant in the near future. This medicine blocks formation of cholesterol, which is necessary for the fetus to develop properly. Cerivastatin may cause birth defects or other problems in the baby if taken during pregnancy. An effective form of birth control should be used during treatment with these medicines. Check with your doctor immediately if you think you have become pregnant while taking this medicine . Be sure you have discussed this with your doctor.

Breast-feeding—Cerivastatin passes into breast milk and should not be used during breast-feeding because it may cause serious unwanted effects in nursing babies.

Children—Studies on cerivastatin have been done only in adult patients and there is no specific information comparing use of cerivastatin in children with use in other age groups.

Older adults—This medicine has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different 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 cerivastatin it is especially important that your health care professional know if you are taking any of the following:

• Antifungals, azole (e.g., Diflucan) or
• Erythromycin (e.g., Erythrocin) or
• Immunosuppressants, especially cyclosporine (e.g., Sandimmune) or
• Niacin (nicotinic acid)—Use of these medicines with cerivastatin may increase the risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure

• Gemfibrozil (e.g., Lopid)—Use of this medicine with cerivastatin is not recommended due to the risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure

Other medical problems—The presence of other medical problems may affect the use of cerivastatin. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcohol abuse (or history of) or
• Liver disease or
• Liver enzymes, persistently high levels—Use of this medicine may make liver problems worse

• Convulsions (seizures), not well-controlled, or
• Electrolyte or metabolic enzyme deficiencies or disorders or
• Infection, severe or
• Low blood pressure or
• Major surgery or trauma, recent—Patients with these conditions may be at risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure

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 doctor"s 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 weight-reducing diet. However, check with your doctor before going on any diet.

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.

Remember that this medicine will not cure your condition but it does help control it. Therefore, you must continue to take it as directed if you expect to keep your cholesterol levels down.

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.

Dosing—The dose of cerivastatin 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 cerivastatin. If your dose is different, do not change it unless your doctor tells you to do so:

• Oral dosage forms (tablets):
  • Not commercially available

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.

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.

Check with your doctor immediately if you think that you may be pregnant . HMG-CoA reductase inhibitors may cause birth defects or other problems in the baby if taken during pregnancy.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Do not take over-the-counter (OTC) niacin preparations without consulting your doctor. Niacin may increase cerivastatin adverse effects on muscle, which can lead to serious kidney problems.

Do not use excessive amounts of alcohol while taking cerivastatin because it can worsen the adverse effects of this medicine on the liver.

Check with your doctor immediately if you experience unexplained muscle pain, tenderness, or weakness, especially if it is accompanied by unusual tiredness or fever, because the medicine"s adverse effects on muscle can lead to serious kidney problems.

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:

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

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:

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.

Developed: 08/10/1998
Revised: 6/18/2002

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