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Important Safety Information

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CARDENE SR is contraindicated in patients with known hypersensitivity to the drug and in patients with advanced aortic stenosis. Reduction of diastolic pressure by any means in these patients may worsen rather than improve myocardial oxygen balance. Caution is advised when administering Cardene SR to patients with angina, congestive heart failure (particularly those who are also taking a ß-blocker), impaired renal or hepatic function, or severe left ventricular dysfunction. Cardene SR provides no protection against the dangers of abrupt ß-blocker withdrawal. The immediate release form of nicardipine caused an increase in angina in 7% of patients compared to 4% on placebo. The most common adverse events were headache (6.2%), pedal edema (5.9%), vasodilation (4.7%), increased angina (4%), palpitation (2.8%), nausea (1.9%), and dizziness (1.6%). Cyclosporine levels should be monitored closely during therapy.

Important Safety Information
CARDENE SR is contraindicated in patients with known hypersensitivity to the drug and in patients with advanced aortic stenosis. Reduction of diastolic pressure by any means in these patients may worsen rather than improve myocardial oxygen balance. Caution is advised when administering Cardene SR to patients with angina, congestive heart failure (particularly those who are also taking a ß-blocker), impaired renal or hepatic function, or severe left ventricular dysfunction. Cardene SR provides no protection against the dangers of abrupt ß-blocker withdrawal. The immediate release form of nicardipine caused an increase in angina in 7% of patients compared to 4% on placebo. The most common adverse events were headache (6.2%), pedal edema (5.9%), vasodilation (4.7%), increased angina (4%), palpitation (2.8%), nausea (1.9%), and dizziness (1.6%). Cyclosporine levels should be monitored closely during therapy.
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© 2008 PDL BioPharma, Inc. All rights reserved. Please see full prescribing information. May 2007. CAR0151