Caduet

Caduet is a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, an HMG-CoA reductase inhibitor (statin). It is used for patients for whom treatment with both amlodipine and atorvastatin is appropriate. Caduet is not indicated for children. The combination has not been studied in this age group, although the individual components are approved for certain pediatric uses. Doctors generally prefer to titrate amlodipine and atorvastatin separately in children rather than use a fixed-dose combination.

Amlodipine Uses

• Treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions.
• Treatment of coronary artery disease.

Atorvastatin Uses

• To reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adults with multiple risk factors for coronary heart disease (CHD) but without clinically evident CHD.
• To reduce the risk of MI and stroke in adults with type 2 diabetes mellitus with multiple risk factors for CHD but without clinically evident CHD.
• To reduce the risk of non-fatal MI, fatal and non-fatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adults with clinically evident CHD.
• As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia.
• As an adjunct to diet to reduce LDL-C in adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).
• As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia.
• As an adjunct to diet for the treatment of adults with primary dysbetalipoproteinemia.
• As an adjunct to diet for the treatment of adults with hypertriglyceridemia.

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 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.

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 a Caduet tablet. Tell your doctor if you have trouble swallowing the tablet.

You may need to stop using it 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.

You should not Caduet if you have liver disease.

Amlodipine and atorvastatin can harm an unborn baby. If you become pregnant, stop taking this medicine and tell your doctor right away.

Do not breastfeed 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 called rhabdomyolysis that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults, people with kidney disease or poorly controlled hypothyroidism (an underactive thyroid), who take certain types of medication or consume large quantities of grapefruit juice. Tell your healthcare provider right away if you experience unexplained muscle pain, tenderness, or weakness particularly if accompanied by malaise or fever.

Caduet may cause liver enzyme elevations and possibly liver failure. Tell your healthcare provider right away if you experience fatigue, unexplained weight loss (anorexia), right upper abdominal discomfort, dark urine, or yellowing of the skin or eyes.

Caduet may also cause increases in HbA1c (a marker of blood glucose control over the last 2 to 3 months) and fasting serum glucose levels. Make sure you practice healthy living, including partaking in regular exercise, maintaining a healthy body weight, and making healthy food choices.

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.

Do not use Caduet if you:

• are allergic to Caduet, amlodipine (Norvasc), atorvastatin (Lipitor), or any of the inactive ingredients in the tablets
• have liver disease.

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, older adults, or people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Pregnancy

This medicine can harm an unborn baby. If you become pregnant, stop taking this medicine and tell your doctor right away.

Breastfeeding

Do not breastfeed a baby while you are taking Caduet.

Common Caduet side effects may include:

• muscle or joint pain;
• diarrhea;
• nausea, upset stomach; or
• swelling in your legs or ankles.

Serious 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;
• muscle weakness in your hips, shoulders, neck, and back;
• trouble lifting your arms, trouble climbing or standing;
• 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).

Other side effects reported with Caduet include:

• tendon rupture
• nerve pain
• depression
• lung problems
• skin conditions and rashes
• rarely, cognitive impairment (including memory loss, forgetfulness, amnesia, memory impairment, and confusion) has been associated with statin use, including Caduet. This was generally nonserious, and reversible once the statin was stopped, with variable times to symptom onset (1 day to years) and symptom resolution (average of 3 weeks).
• new or worsening myasthenia gravis (a condition causing muscle weakness)

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 the FDA at 1-800-FDA-1088.

Usual Adult Dose of Caduet for Hyperlipidemia:

Initial dose: Amlodipine 5 mg-Atorvastatin 10 to 20 mg orally once a dayMaximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a dayComments:-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 dayMaximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a dayComments:-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 dayMaximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a dayComments:-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 dayMaximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a dayComments:-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 dayMaximum dose: Amlodipine 10 mg-Atorvastatin 80 mg orally once a dayComments:-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).

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.

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

If you also take nitroglycerin for chest pain, do not stop taking it 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.

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:

• birth control pills;
• heart medication; or
• medicine to prevent organ transplant rejection, such as cyclosporine;
• colchicine;
• medications 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, letermovir, lopinavir, nelfinavir, ritonavir, saquinavir, telaprevir, tipranavir.

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.

Store at room temperature in the original container.

Pfizer Inc.

Active ingredients: amlodipine besylate, atorvastatin calciumInactive ingredients: calcium carbonate, croscarmellose sodium, microcrystalline cellulose, pregelatinized starch, polysorbate 80, hydroxypropyl cellulose, purified water, colloidal silicon dioxide (anhydrous), magnesium stearate.Film coating: Opadry® II White 85F28751 (polyvinyl alcohol, titanium dioxide, PEG 3000, and talc) or Opadry® II Blue 85F10919 (polyvinyl alcohol, titanium dioxide, PEG 3000, talc, and FD&C blue #2).