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|Caduet

AMLODIPINE AND ATORVASTATIN (Systemic)†

Some commonly used brand names are:

In the U.S.—

• Caduet

† Not commercially available in Canada.

Category

• Antianginal
• Antihypertensive
• Antihyperlipidemic

Description

Amlodipine (am-LOE-di-peen)and Atorvastatin (a-TOR-va-stat-in) is a combination of a calcium channel blocker and HMG-CoA reductase inhibitor. Amlodipine is used to treat angina (chest pain) or high blood pressure. Atorvastatin is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood.

High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

The exact way in which this medicine works is not known. Amlodipine is a type of medicine known as a calcium channel blocker. Calcium channel blocking agents affect the movement of calcium into the cells of the heart and blood vessels. Atorvastatin is used to lower cholesterol and triglyceride (fat-like substances) levels in the blood. The action of both medicines together is to relax blood vessels, lower blood pressure, and decrease the amount of cholesterol in the blood.

Amlodipine and atorvastatin is available only with your doctor"s prescription, in the following dosage forms:

• Oral
• Tablets (U.S.)

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 amlodipine and atorvastatin, the following should be considered:

Allergies—Tell your doctor if you have ever had any unusual or allergic reaction to amlodipine or atorvastatin. Also tell your doctor and pharmacist if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—Studies with this combination medicine have not been done in pregnant women. However, use of any of the HMG-CoA reductase inhibitors during pregnancy, can cause serious birth defects or other problems. Therefore, it is important that you check with your doctor immediately if you think that you may be pregnant. Be sure that you have discussed this with your doctor before taking this combination medicine.

Breast-feeding—It is not known whether amlodipine passes into breast milk. Atorvastatin passes into the breast milk of animals. Amlodipine and atorvastatin combination should not be used during breast-feeding because it may cause serious unwanted effects in nursing babies.

Children—Studies on this combination medicine have been done only in adult patients, and there is no specific information comparing use of amlodipine and atorvastatin in children with use in other age groups.

Atorvastatin alone is safe to use in boys and some girls 10 to 17 years of age for treating certain types of high cholesterol.

Adolescent girls taking atorvastatin should be counseled on appropriate contraceptive methods.

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 or if they cause different side effects or problems in older people. However, elderly people may be especially sensitive to the effects of amlodipine which may increase the chance of side effects during treatment.

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 amlodipine and atorvastatin, it is especially important that your doctor and pharmacist know if you are taking any of the following:

• Alcohol—May cause liver problems and should not be used while taking atorvastatin

• Azole antifungals (fluconazole [e.g., Diflucan], miconazole injection [e.g., Monistat IV], ketoconazole [e.g., Nizoral], itraconazole [e.g., Sporanox], voriconazole [e.g., Vfend]) or
• Cyclosporine (e.g., Sandimmune) or
• Erythromycin (e.g., Erythrocin) or
• Fibric Acid Derivatives, such as
  • Clofibrate (e.g., Atromid-S) or
  • Fenofibrate (e.g., Tricor) or
  • Gemfibrozil (e.g., Lopid) or
• Niacin (nicotinic acid) in lipid-lowering doses—Use of these medicines with atorvastatin may increase the risk of developing muscle problems (causing the release of muscle pigment into the urine) that may lead to kidney failure

• Digoxin (e.g., Lanoxin)—Using this medicine with atorvastatin may cause there to be more digoxin in your body

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

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

• Aortic stenosis, severe (abnormally narrow aorta)—Use of this medicine may increase the chance of low blood pressure

• Congestive heart failure—There is a small chance that amlodipine may make this condition 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 or
• Myopathy (a disorder of muscle tissue or muscles)—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

• Coronary artery disease, severe, obstructive—Use of this medicine may result in other heart problems

Proper Use of This Medicine

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. Also, this medicine works best if there is a constant amount in the blood. To help keep this amount constant, do not miss any doses and take the medicine at the same time each day.

Before prescribing the atorvastatin and amlodipine combination for your condition, your doctor will probably try to control your condition by prescribing a personal diet for you. Follow carefully the special diet your doctor gave 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.

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

• For oral dosage form (tablets):
  • Adults—1 tablet a day, tablet strength is determined by your doctor.
  • Children—Use and 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. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

It is important that your doctor check your progress at regular visits. This will allow your doctor to make sure the medicine is working properly and to change the dosage if needed.

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 atorvastatin"s adverse effects on muscle, which can lead to serious kidney problems.

Do not use excessive amounts of alcohol while taking atorvastatin 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.

Checking with physician before discontinuing medication because a gradual reduction in dose may be necessary

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.

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

Developed: 11/08/2004

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