Jane S. Ricciuti, RPh, MS


April 05, 2004

In This Article

Cardiovascular Agents

(amlodipine/atorvastatin) Tablets

Manufacturer: Pfizer Inc.

Drug Approval Classification: Original New Drug Application (Approval Date: 01/30/04)

Indication: This new drug application provides for the use of Caduet (amlodipine besylate/atorvastatin calcium) in patients for whom treatment with both amlodipine and atorvastatin is appropriate as indicated.

  • Amlodipine is indicated for the treatment of:

    • Hypertension,

    • Chronic stable angina, and

    • Vasospastic angina (Prinzmetal's or variant angina).

  • Atorvastatin is indicated for the treatment of:

    • Heterozygous familial and nonfamilial hypercholesterolemia,

    • Elevated serum triglyceride (TG) levels,

    • Primary dysbetalipoproteinemia,

    • Homozygous familial hypercholesterolemia, and

    • Boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia.

Dosing: Caduet tablets contain amlodipine besylate and atorvastatin calcium equivalent to amlodipine and atorvastatin in the dose strengths described below:

Tablet Strength (amlodipine besylate/ atorvastatin calcium) mg:

  • 5/40

  • 5/80

  • 10/40

  • 10/80

  • 5/10

  • 5/20

  • 10/10

  • 10/20

Caduet (amlodipine/atorvastatin) Tablets Labeling