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Ready-to-Use CARDENE I.V. Product Overview

General Description

Ready-to-Use CARDENE I.V. is a premixed intravenous (IV) formulation of the calcium ion influx inhibitor (slow channel blocker or calcium channel blocker) nicardipine hydrochloride. It is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable.1

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 Hemorrhage2

  • 2007 AHA/ASA Guidelines for:

    • The Management of Spontaneous Intracerebral Hemorrhage in Adults3

    • The Early Management of Adults With Ischemic Stroke4

  • 2005 AHA Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care (Adult Stroke)5

  • 2003 JNC 7 (for treatment of hypertensive emergencies)6,*

 
In addition to meeting treatment guidelines, Ready-to-Use CARDENE I.V. supports compliance with The Joint Commission standards and American Society of Health-System Pharmacists guidelines for dispensing and storing medications.7,8

  • Both recommend that when possible, medications be available in a ready-to-administer form

 

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

How CARDENE I.V. Works
Efficacy of CARDENE I.V.
Well-Documented Safety Profile
Dosing and Administration

 

How CARDENE I.V. Works

Administered directly into the bloodstream, CARDENE I.V. inhibits calcium ions from entering cardiac and vascular smooth muscle cells. The contractile processes of cardiac muscle and vascular smooth muscle depend upon the movement of extracellular calcium ions into these cells through specific ion channels. The drug, which is more selective to vascular smooth muscle, causes arteries to dilate and blood pressure to decrease.1

CARDENE I.V. produces significant decreases in systemic vascular resistance (SVR).1 Abrupt increase in SVR triggers acute hypertension.9,10

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Efficacy of CARDENE I.V.

CARDENE I.V. has been well studied in the short-term treatment of acute hypertension. The drug provides smooth, predictable blood pressure control.1

A clinical trial of the efficacy and safety of CARDENE I.V. in patients with severe hypertension showed the drug to be as effective as sodium nitroprusside with a lower risk of hypotension and fewer dosing adjustments. In this study, 98% of patients achieved a therapeutic response with CARDENE I.V. compared with 93% of patients who received sodium nitroprusside.12

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.13

Because postoperative hypertension occurs in 4%-30% of patients after cardiac and noncardiac surgery, rapid control of the condition is desirable.14 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.15 

 

Click here for Safety and Tolerability Information

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

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Well-Documented Safety Profile

Clinical trials demonstrated the safety and tolerability of CARDENE I.V.

  • No detrimental antihypertensive effects were reported in patients with

    • Reactive airway disease1

    • Chronic obstructive pulmonary disease (COPD)1

    • Asthma1

    • Age ≥65 years1

  • Other safety/tolerability characteristics include:

    • No significant increase of intracranial pressure16,17

    • No decrease in heart rate1

    • No detrimental effects on cardiac conduction system1

    • Not associated with coronary steal1

  • Adverse events were generally not serious, and most were expected consequences of vasodilation1

    • Most common side effects are headache (14.6%), hypotension (5.6%), nausea/vomiting (4.9%),
      and tachycardia (3.5%)1

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Dosing and Administration

Ready-to-Use CARDENE I.V. is administered as a slow continuous infusion at a concentration of either
0.2 mg/mL (40 mg in 200 mL) or 0.1 mg/mL (20 mg in 200 mL). With constant infusion, blood pressure begins to fall within minutes.1

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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. 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: 108.191395. 3. 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. 4. 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. 5. 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Part 9: adult stroke. Circulation. 2005;112:IV-111-IV-120.  6. 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. 7. Rich DS. New JCAHO medication management standards for 2004. Am J Health-Syst Pharm. 2004;61(13):1349-1358. 8. American Society of Health-System Pharmacists. ASHP guidelines: minimum standard for pharmacies in hospitals. Am J Health-Syst Pharm. 1995;52(23):2711-2717. 9. Marik PE, Varon J. Hypertensive crises: challenges and management. Chest. 2007;131(6):1949-1962. 10. Rose JC, Mayer SA. Optimizing blood pressure in neurological emergencies. Neurocrit Care. 2004;1(3):287-299. 11. Kaplan NM. Systemic hypertension: mechanisms and diagnosis. In: Zipes DP, Libby P, Bonow R, Braunwald E, eds. Braunwald’s Heart Disease: A Textbook of Cardiovascular Medicine. 7th ed. Philadelphia, PA: Elsevier Saunders; 2005:959-987. 12. 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. 13. 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. 14. Fischell TA, Maheshwari A. Current applications for nicardipine in invasive and interventional cardiology. J Invasive Cardiol. 2004;16:428-432. 15. IV Nicardipine Study Group. Efficacy and safety of intravenous nicardipine in the control of postoperative hypertension. Chest. 1991;99(2):393-398. 16. Nishiyama T, Yokoyama T, Matsukawa T, Hanaoka K. Continuous nicardipine infusion to control blood pressure after evacuation of acute cerebral hemorrhage. Can J Anaesth. 2000;47(12):1196-1201. 17. Narotam PK, Puri V, Roberts JM, et al. Management of hypertensive emergencies in acute brain disease: evaluation of the treatment effects of intravenous nicardipine on cerebral oxygenation. J Neurosurg. 2008;109(6):1065-1074.

 

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