What is Caduet?

Caduet contains a combination of amlodipine and atorvastatin. Atorvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Atorvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Amlodipine is a calcium channel blocker. Amlodipine relaxes the blood vessels, improving blood flow and making it easier for the heart to pump.

Caduet is used to treat high blood pressure (hypertension) or chest pain (angina), and to lower the risk of stroke, heart attack, and other heart complications in people with type 2 diabetes, coronary heart disease, or other risk factors.

Caduet is used in adults and children who are at least 10 years old.

Important Information

You should not Caduet if you have liver disease.

Amlodipine and atorvastatin can harm an unborn baby or cause birth defects. Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

Do not breast-feed while taking Caduet.

Before taking Caduet, tell your doctor if you have ever had liver or kidney disease, heart disease, diabetes, or a thyroid disorder, or if you drink more than 2 alcoholic beverages daily.

In rare cases, Caduet can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Avoid eating foods that are high in fat or cholesterol. Caduet will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Some medicines can cause unwanted or dangerous effects when used with Caduet. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with Caduet.

Before taking this medicine

You should not use Caduet if you are allergic to amlodipine (Norvasc) or atorvastatin (Lipitor), or if:

• you have liver disease; or

• you are pregnant or breast-feeding.

Do not use Caduet if you are pregnant. It could harm the unborn baby or cause birth defects. Use effective birth control to prevent pregnancy while you are using this medicine. If you become pregnant, stop taking this medicine and tell your doctor right away.

Do not breast-feed a baby while you are taking Caduet.

Tell your doctor if you have ever had:

• kidney disease;

• heart disease;

• muscle pain or weakness;

• diabetes;

• a thyroid disorder; or

• if you drink more than 2 alcoholic beverages daily.

Atorvastatin can cause the breakdown of muscle tissue, which can lead to kidney failure. This happens more often in women, in older adults, or people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Certain other drugs can increase your risk of serious muscle problems when used with Caduet. Your doctor may need to change your treatment plan if you use any of the following drugs:

• colchicine;

• cyclosporine;

• medicines that contain niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);

• an antibiotic - clarithromycin, erythromycin;

• antifungal medicine - itraconazole, ketoconazole, voriconazole;

• certain cholesterol medications - gemfibrozil, fenofibric acid, fenofibrate; or

• antiviral medicine to treat hepatitis C or HIV/AIDS - boceprevir, darunavir, fosamprenavir, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir, tipranavir.

How should I take Caduet?

Take Caduet exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Take this medicine at the same time each day, with or without food.

Do not break an Caduet tablet. Tell your doctor if you have trouble swallowing the tablet.

You may need to stop using for a short time if you have:

• uncontrolled seizures;

• an electrolyte imbalance (such as high or low potassium levels in your blood);

• severely low blood pressure;

• a severe infection or illness; or

• surgery or a medical emergency.

You will need frequent medical tests.

You may need to take Caduet on a long-term basis. Keep using this medication even if you feel fine. High blood pressure or high cholesterol often have no symptoms.

Caduet is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

Store at room temperature away from moisture and heat.

Caduet dosing information

Usual Adult Dose of Caduet for Hyperlipidemia:

Initial dose: Amlodipine 5 mg-Atorvastatin 10 to 20 mg orally once a day

Maximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a day

Comments:
-Small adult, fragile, or elderly patients may be started on amlodipine 2.5 mg orally once a day.
-Most coronary artery disease patients will require amlodipine 10 mg orally once a day for adequate effect.
-Patients who require greater than 45% low-density lipoprotein (LDL) reduction may be started on atorvastatin 40 mg orally once a day.
-May be titrated for amlodipine after 1 to 2 weeks and for atorvastatin after 2 to 4 weeks.
-Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson types I and V).

Usual Adult Dose of Caduet for Hypertension:

Initial dose: Amlodipine 5 mg-Atorvastatin 10 to 20 mg orally once a day

Maximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a day

Comments:
-Small adult, fragile, or elderly patients may be started on amlodipine 2.5 mg orally once a day.
-Most coronary artery disease patients will require amlodipine 10 mg orally once a day for adequate effect.
-Patients who require greater than 45% low-density lipoprotein (LDL) reduction may be started on atorvastatin 40 mg orally once a day.
-May be titrated for amlodipine after 1 to 2 weeks and for atorvastatin after 2 to 4 weeks.
-Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson types I and V).

Usual Adult Dose of Caduet for Angina Pectoris:

Initial dose: Amlodipine 5 mg-Atorvastatin 10 to 20 mg orally once a day

Maximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a day

Comments:
-Small adult, fragile, or elderly patients may be started on amlodipine 2.5 mg orally once a day.
-Most coronary artery disease patients will require amlodipine 10 mg orally once a day for adequate effect.
-Patients who require greater than 45% low-density lipoprotein (LDL) reduction may be started on atorvastatin 40 mg orally once a day.
-May be titrated for amlodipine after 1 to 2 weeks and for atorvastatin after 2 to 4 weeks.
-Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson types I and V).

Usual Adult Dose for Coronary Artery Disease:

Initial dose: Amlodipine 5 mg-Atorvastatin 10 to 20 mg orally once a day

Maximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a day

Comments:
-Small adult, fragile, or elderly patients may be started on amlodipine 2.5 mg orally once a day.
-Most coronary artery disease patients will require amlodipine 10 mg orally once a day for adequate effect.
-Patients who require greater than 45% low-density lipoprotein (LDL) reduction may be started on atorvastatin 40 mg orally once a day.
-May be titrated for amlodipine after 1 to 2 weeks and for atorvastatin after 2 to 4 weeks.
-Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson types I and V).

Usual Adult Dose for Prevention of Cardiovascular Disease:

Initial dose: Amlodipine 5 mg-Atorvastatin 10 to 20 mg orally once a day

Maximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a day

Comments:
-Small adult, fragile, or elderly patients may be started on amlodipine 2.5 mg orally once a day.
-Most coronary artery disease patients will require amlodipine 10 mg orally once a day for adequate effect.
-Patients who require greater than 45% low-density lipoprotein (LDL) reduction may be started on atorvastatin 40 mg orally once a day.
-May be titrated for amlodipine after 1 to 2 weeks and for atorvastatin after 2 to 4 weeks.
-Atorvastatin has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson types I and V).

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if your next dose is due in less than 12 hours. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking Caduet?

Avoid eating foods high in fat or cholesterol, or Caduet will not be as effective.

Avoid drinking alcohol. It can raise triglyceride levels and increase your risk of liver damage. Alcohol can also increase some of the side effects of Caduet.

Grapefruit may interact with this medicine and lead to unwanted side effects. Avoid the use of grapefruit products.

Caduet side effects

Get emergency medical help if you have signs of an allergic reaction to Caduet: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, atorvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark colored urine.

Call your doctor at once if you have:

• muscle stiffness, tremors, abnormal muscle movements;

• severe drowsiness, feeling like you might pass out;

• worsening chest pain, or chest pain spreading to the arm or jaw, nausea, sweating, general ill feeling; or

• liver problems - upper stomach pain, loss of appetite, tiredness, dark urine, jaundice (yellowing of the skin or eyes).

Common Caduet side effects may include:

• muscle or joint pain;

• diarrhea;

• nausea, upset stomach; or

• swelling in your legs or ankles.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Caduet?

Certain other drugs can increase your risk of serious muscle problems, and it is very important that your doctor knows if you are using any of them. Tell your doctor about all your other medicines, especially:

• antibiotic or antifungal medicine;

• birth control pills;

• cholesterol-lowering medication;

• heart medication; or

• medicine to treat HIV or AIDS.

This list is not complete. Other drugs may interact with amlodipine and atorvastatin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Caduet only for the indication prescribed.