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Consistent and Reliable Blood Pressure Control

Ready-to-Use CARDENE I.V. is indicated for short-term treatment of hypertension when oral therapy is not feasible or desirable.1 Ready-to-Use CARDENE I.V. is immediately available for rapid intervention and enables practical point-of-use storage.2,3

Premixed and ready-to-use, the medication

  • Provides smooth, predictable blood pressure (BP) control1

  • Offers rapid onset of therapeutic activity, with BP reductions in 10 to 12 minutes1

Ready-to-Use CARDENE I.V. is the only available premixed formulation of nicardipine hydrochloride. This calcium channel blocker is recommended in all the following guidelines:

  • 2009 American Heart Association (AHA)/American Stroke Association (ASA) Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage4

  • 2007 AHA/ASA Guidelines for:

    • The Management of Spontaneous Intracerebral Hemorrhage in Adults5

    • The Early Management of Adults With Ischemic Stroke6

  • 2005 AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (Adult Stroke)7

  • 2003 JNC 7 (for treatment of hypertensive emergencies)8,*

 

*The Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment
  of High Blood Pressure.

 

Efficacy in Clinical Trials
Ready-to-Use CARDENE I.V. Dosing
How Supplied

 

Efficacy in Clinical Trials

Clinical trials have shown the efficacy of CARDENE I.V. in a variety of patients with hypertension.

A clinical trial of patients presenting to the emergency room with severe hypertension—3 consecutive diastolic BPs  >120 mm Hg or 3 consecutive systolic BPs  >200 mm Hg—showed the efficacy of CARDENE I.V. versus sodium nitroprusside.9

 

CARDENE I.V. is as effective as sodium nitroprusside...


“[CARDENE I.V.] is as effective as nitroprusside for the immediate treatment of severe hypertension,
but has the advantage of producing fewer adverse clinical effects.”
—Neutel JM et al. Am J Hypertens. 1994 9  

 

 

 

…With a lower risk of hypotension

 

...And fewer dosing adjustments

There were approximately twice as many dosing adjustments (mean) in the nitroprusside group vs the CARDENE I.V. group (3.3 vs 1.7, respectively; P<.01).9

In another study of patients with severe hypertension, with or without end-organ damage, CARDENE I.V. effectively and safely controlled the acute increase in blood pressure in 92% of patients.10

Because postoperative hypertension occurs in 4%-30% of patients after cardiac and noncardiac surgery, rapid control of the condition is desirable.11 In a randomized study involving patients who had undergone cardiac or noncardiac surgery, intravenous CARDENE I.V. was effective in controlling blood pressure in 94% of patients. A therapeutic response was achieved in a mean time of 11.5 (± 0.8) minutes.12 

In double-blind, placebo-controlled trials, adverse experiences were generally not serious, and most were expected consequences of vasodilation. The most common side effects are headache (14.6%),
hypotension (5.6%), nausea/vomiting (4.9%), and tachycardia (3.5%).1

Click here for Safety and Tolerability Information


Please see Important Safety Information at the bottom of the page.

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Ready-to-Use CARDENE I.V. Dosing

 

Easy administration…

Ready-to-Use CARDENE I.V. offers easy administration and dosing.

  • Easily titrated to desired BP target with no correlation between patient's weight and dose response1

  • Minimal dose adjustments required to achieve and maintain therapeutic effect within a narrow range9

  • Intended for intravenous use; no intra-arterial line required to monitor BP1

  • Can be continued as long as IV BP control is needed1

 

…for RAPID or GRADUAL BP control

Ready-to-Use CARDENE I.V. is administered by slow continuous infusion at a concentration of 0.2 mg/mL
(40 mg in 200 mL) or 0.1 mg/mL (20 mg in 200 mL).

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How Supplied

 



Galaxy® is a registered trademark of Baxter International.

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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.

Please see full prescribing information.

References: 1. CARDENE I.V. prescribing information, 2008. EKR Therapeutics, Bedminster, NJ. 2. Ruble J. Impact safety, efficiency, and the bottom line with premixed IV products. Pharm Purchasing Prod. February 2008:34-38, vi. 3. Fanikos J, Erickson A, Munz KE, et al. Observations on the use of ready-to-use and point-of-care activated parenteral products in automated dispensing cabinets in U.S. hospitals. Am J Health-Syst Pharm. 2007;64(19):2037-2043. 4. Bederson JB, Connolly ES Jr, Batjer HH, et al. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a statement for healthcare professionals from a special writing group of the Stroke Council, American Heart Association. Stroke. 2009;40(3):994-1025. doi:10.1161/STROKEAHA.108.191395. 5. Broderick J, Connolly S, Feldmann E, et al. Guidelines for the management of spontaneous intracerebral hemorrhage in adults: 2007 update: a guideline from the American Heart Association/American Stroke Association Stroke Council, High Blood Pressure Research Council, and the Quality of Care and Outcomes in Research Interdisciplinary Working Group. Stroke. 2007;38(6):2001-2023. 6. Adams HP Jr, del Zoppo G, Alberts MJ, et al. Guidelines for the early management of adults with ischemic stroke: a guideline from the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups. Stroke. 2007;38(5):1655-1711. 7. 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Part 9: adult stroke. Circulation. 2005;112:IV-111-IV-120. 8. Chobanian AV, Bakris GL, Black HR, et al; National High Blood Pressure Education Program Coordinating Committee. Seventh Report of the Joint National Committee on Prevention, Detection Evaluation, and Treatment of High Blood Pressure. Hypertension. 2003;42(6):1206-1252. 9. Neutel JM, Smith DHG, Wallin D, et al. A comparison of intravenous nicardipine and sodium nitroprusside in the immediate treatment of severe hypertension. Am J Hypertens. 1994;7:623-628. 10. Wallin JD, Fletcher E, Ram CVS, et al. Intravenous nicardipine for the treatment of severe hypertension: a double-blind, placebo-controlled multicenter trial. Arch Intern Med. 1989;149(12):2662-2669. 11. Fischell TA, Maheshwari A. Current applications for nicardipine in invasive and interventional cardiology. J Invasive Cardiol. 2004;16:428-432. 12. IV Nicardipine Study Group. Efficacy and safety of intravenous nicardipine in the control of postoperative hypertension. Chest. 1991;99(2):393-398.

 

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