HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CADUET safely and effectively. See full prescribing information for CADUET.
CADUET® (amlodipine besylate and atorvastatin calcium) tablets, for oral use
Initial U.S. Approval: 2004
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
CADUET is a combination of amlodipine besylate, a calcium channel blocker, and atorvastatin calcium, a HMG CoA-reductase inhibitor, indicated in patients for whom treatment with both amlodipine and atorvastatin is appropriate.
Amlodipine is indicated for the treatment of hypertension, to lower blood pressure (1.1). Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Amlodipine is indicated for the treatment of Coronary Artery Disease (1.2).
DOSAGE AND ADMINISTRATION
DOSAGE FORMS AND STRENGTHS
Tablets contain amlodipine besylate equivalent to amlodipine 2.5, 5, or 10 mg and atorvastatin calcium equivalent to atorvastatin 10, 20, 40, or 80 mg (3).
WARNINGS AND PRECAUTIONS
Most common adverse reaction (3% greater than placebo) to amlodipine is edema (6.1).
Most common adverse reactions leading to atorvastatin discontinuation were myalgia and diarrhea (6.1).
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
USE IN SPECIFIC POPULATIONS
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
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