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Full Prescribing Information

To view the full prescribing information for Ready-to-Use CARDENE I.V., click a link below.

40 mg in 200 mL (0.2 mg/mL) Sodium Chloride or Dextrose
20 mg in 200 mL (0.1 mg/mL) Sodium Chloride or Dextrose

To view the full prescribing information for CARDENE I.V. Ampul 25 mg in 10 mL (2.5 mg/mL),
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Important Safety Information
Close monitoring of the blood pressure is required during therapy. CARDENE I.V. is contraindicated in patients with known hypersensitivity to the drug and in patients with advanced aortic stenosis. Reduction of diastolic pressure and reduced afterload may worsen rather than improve myocardial oxygen balance. Caution is advised when administering CARDENE I.V. to patients with impaired renal or hepatic function, in combination with a beta-blocker in patients with congestive heart failure, or portal hypertension. Observe caution in patients with significant left ventricular dysfunction due to possible negative inotropic effect. CARDENE I.V. gives no protection against the dangers of abrupt beta-blocker withdrawal; beta-blocker dosage should be gradually reduced. Levels of cyclosporine should be closely monitored during therapy. The most common side effects of CARDENE I.V. are headache (14.6%), hypotension (5.6%), nausea/vomiting (4.9%), and tachycardia (3.5%). Less frequent adverse effects, in each case occurring at 1.4%, include ECG abnormalities, postural hypotension, ventricular extrasystoles, injection-site reaction, dizziness, sweating and polyuria.

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© EKR Therapeutics, Inc. All rights reserved. July 2009.