CADUET is a combination of two medications, Norvasc^® (amlodipine besylate) and Lipitor^® (atorvastatin calcium), and is indicated in patients for whom treatment with both Norvasc and Lipitor is appropriate.

Norvasc is indicated for the treatment of hypertension; treatment of chronic stable or vasospastic angina; and to reduce the risk of a coronary revascularization procedure and hospitalization due to angina in patients with recently angiographically documented CAD and without heart failure.

Lipitor is indicated as an adjunct to diet to reduce the risk of myocardial infarction (MI), stroke, revascularization procedures, and angina in adult patients with multiple risk factors but without clinically evident coronary heart disease (CHD); to reduce the risk of MI and stroke in patients with type 2 diabetes and without clinically evident CHD, but with multiple risk factors; to reduce the risk of nonfatal MI, fatal and nonfatal stroke, revascularization procedures, hospitalization for congestive heart failure, and angina in adult patients with clinically evident CHD; 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.

Important Safety Information

CADUET is contraindicated in patients with active liver disease or unexplained persistent elevations of hepatic transaminases; in women who are or may become pregnant or who are nursing; in patients with hypersensitivity to any component of this medication.

Rare cases of rhabdomyolysis have been reported with the atorvastatin component of CADUET and with other statins. Tell patients to promptly report muscle pain, tenderness, or weakness. Predisposing factors include advanced age (≥65), uncontrolled hypothyroidism, and renal impairment. Patients with a history of renal impairment merit closer monitoring. In cases of myopathy or rhabdomyolysis, therapy should be temporarily withheld or discontinued.

The concomitant use of higher doses of atorvastatin with certain drugs such as cyclosporine and strong CYP3A4 inhibitors (e.g., clarithromycin, itraconazole, and HIV protease inhibitors) increased the risk of myopathy/rhabdomyolysis. Lower doses of the atorvastatin component of CADUET should be considered. Physicians should carefully monitor patients for signs or symptoms of myopathy early during therapy and when titrating the dose of either drug.

It is recommended that liver function tests be performed prior to and at 12 weeks following both the initiation of CADUET therapy and any elevation in dose of the atorvastatin component, and periodically thereafter. If ALT or AST values >3 x ULN persist, dose reduction or withdrawal of CADUET is recommended.

Generally CCBs should be used with caution in patients with heart failure. In studies with amlodipine, there has been no evidence of worsened heart failure.

In a controlled clinical trial, the most common adverse events were edema, headache, and dizziness. These were similar to those reported previously with amlodipine and/or atorvastatin.

In a post hoc analysis of the SPARCL study in patients without CHD who had a stroke or TIA within the preceding 6 months, a higher incidence of hemorrhagic stroke was seen in the atorvastatin 80-mg group compared with placebo (2.3% vs. 1.4%). Some baseline characteristics, including hemorrhagic and lacunar stroke on study entry, were associated with a higher incidence of hemorrhagic stroke in the atorvastatin group.

Please see full prescribing information.

CADUET^® (amlodipine besylate/atorvastatin calcium)

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