CADUET SUMMARY
CADUET® (amlodipine besylate/atorvastatin calcium) Tablets
CADUET® (amlodipine besylate and atorvastatin calcium) tablets combine the long-acting calcium channel blocker amlodipine besylate with the synthetic lipid-lowering agent atorvastatin calcium.
CADUET (amlodipine and atorvastatin) is indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.
- Hypertension: Amlodipine is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents;
- Chronic Stable Angina: Amlodipine is indicated for the treatment of chronic stable angina, for the treatment of confirmed or suspected vasospastic angina and for the treatment of hypertension. 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.
AND
- Heterozygous Familial and Nonfamilial: 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:
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LDL-C remains >/= 190 mg/dL or
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LDL-C remains >/= 160 mg/dL and:
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there is a positive family history of premature cardiovascular disease or
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two or more other CVD risk factors are present in the pediatric patients.
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