Description:
Cardene® (nicardipine hydrochloride) is a calcium ion influx inhibitor (slow channel blocker or calcium channel blocker). Cardene I.V. premixed injection for intravenous administration is available in both single (1x) and double (2x) concentrations. The 1x preparation contains 20 mg of nicardipine hydrochloride per 200 mL (0.1 mg/mL) in either dextrose or sodium chloride. The 2x preparation contains 40 mg of nicardipine hydrochloride per 200 mL (0.2 mg/mL) in either dextrose or sodium chloride.

Indication:
Cardene® IV is indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable.  For prolonged control of blood pressure, patients should be transferred to oral medication as soon as their clinical condition permits.

Additional information about CARDENE® IV is available at www.cardeneiv.com

Full Prescribing Information

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.

Cardene® is a registered trademark of EKR Therapeutics, Inc., Bedminster, NJ, USA