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CADUET (AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM) TABLETS: INDICATIONS AND USAGE

Caduet (Amlodipine and Atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.

Amlodipine

Hypertension: Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents;

Coronary Artery Disease (CAD)

Chronic Stable Angina

Amlodipine is indicated for the treatment of chronic stable angina. Amlodipine may be used alone or in combination with other antianginal or antihypertensive agents.

Vasospastic Angina (Prinzmetal's or Variant Angina)

Amlodipine is indicated for the treatment of confirmed or suspected vasospastic angina. Amlodipine may be used as monotherapy or in combination with other antianginal drugs.

Angiographically Documented CAD

In patients with recently documented CAD by angiography and without heart failure or an ejection fraction < 40%, amlodipine is indicated to reduce the risk of hospitalization due to angina and to reduce the risk of a coronary revascularization procedure.

Atorvastatin

Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is recommended as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with CHD or multiple risk factors for CHD, the atorvastatin component of Caduet can be started simultaneously with diet restriction.

Prevention of Cardiovascular Disease

In adult patients without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as age, smoking, hypertension, low HDLC, or a family history of early coronary heart disease, atorvastatin is indicated to:

  • Reduce the risk of myocardial infarction
  • Reduce the risk of stroke
  • Reduce the risk for revascularization procedures and angina

    In patients with type 2 diabetes, and without clinically evident coronary heart disease, but with multiple risk factors for coronary heart disease such as retinopathy, albuminuria, smoking, or hypertension, Lipitor is indicated to:

  • Reduce the risk of myocardial infarction
  • Reduce the risk of stroke

    In patients with clinically evident coronary heart disease, Lipitor is indicated to:

  • Reduce the risk of non-fatal myocardial infarction
  • Reduce the risk of fatal and non-fatal stroke
  • Reduce the risk for revascularization procedures
  • Reduce the risk of hospitalization for CHF
  • Reduce the risk of angina

    Heterozygous Familial and Nonfamilial Hyperlipidemia

    Atorvastatin is indicated as an adjunct to diet to reduce elevated total-C, LDL-C, apo B, and TG levels and to increase HDL-C in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Fredrickson Types IIa and IIb).

    Elevated Serum TG Levels

    Atorvastatin is indicated as an adjunct to diet for the treatment of patients with elevated serum TG levels (Fredrickson Type IV)

    Primary Dysbetalipoproteinemia

    Atorvastatin is indicated for the treatment of patients with primary dysbetalipoproteinemia (Fredrickson Type III) who do not respond adequately to diet.

    Homozygous Familial Hypercholesterolemia

    Atorvastatin is indicated to reduce total-C and LDL-C in patients with homozygous familial hypercholesterolemia as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unavailable.

    Pediatric Patients

    Atorvastatin is indicated as an adjunct to diet to reduce total-C, LDL-C, and apo B levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia if after an adequate trial of diet therapy the following findings are present:

    a. LDL-C remains >= 190 mg/dL or
    b. LDL-C remains >= 160 mg/dL and:

  • there is a positive family history of premature cardiovascular disease or
  • two or more other CVD risk factors are present in the pediatric patients.

    The antidyslipidemic component of Caduet has not been studied in conditions where the major lipoprotein abnormality is elevation of chylomicrons (Fredrickson Types I and V).

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