CARDENE^® I.V.

(nicardipine hydrochloride)
Premixed Injection

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^® I.V. is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not 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^® I.V. is available at www.cardeneiv.com

Full Prescribing Information

Important Safety Information
CARDENE I.V. Premixed Injection is contraindicated in patients with advanced aortic stenosis because part of the effect of CARDENE I.V. is secondary to reduced afterload.

In administering nicardipine, close monitoring of blood pressure and heart rate is required. Nicardipine may occasionally produce symptomatic hypotension or tachycardia. Avoid systemic hypotension when administering the drug to patients who have sustained an acute cerebral infarction or hemorrhage.

Increases in frequency, duration, or severity of angina have been seen in chronic therapy with oral nicardipine. Induction or exacerbation of angina has been seen in less than 1% of coronary artery disease patients treated with CARDENE I.V. The mechanism of this effect has not been established.

Titrate slowly when using CARDENE I.V., particularly in combination with a beta-blocker, in patients with heart failure or significant left ventricular dysfunction because of possible negative inotropic effects.

Since nicardipine is metabolized in the liver, consider lower dosages and closely monitor responses in patients with impaired liver function or reduced hepatic blood flow.

When nicardipine was given to mild to moderate hypertensive patients with moderate renal impairment, a significantly lower systemic clearance and higher area under the curve (AUC) was observed. These results are consistent with those seen after oral administration of nicardipine. Titrate gradually in patients with renal impairment.

To reduce the possibility of venous thrombosis, phlebitis, local irritation, swelling, extravasation, and the occurrence of vascular impairment, administer drug through large peripheral veins or central veins rather than arteries or small peripheral veins, such as those on the dorsum of the hand or wrist. To minimize the risk of peripheral venous irritation, change the site of the drug infusion every 12 hours.

Most common adverse reactions are headache (15%), hypotension (6%), nausea/vomiting (5%), and tachycardia (4%).

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