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Ready-to-Use CARDENE I.V.: Supporting Guidelines

In the treatment of acute hypertension, Ready-to-Use CARDENE I.V. provides smooth, predictable blood pressure (BP) control and offers rapid onset of therapeutic activity, with BP reductions in 10 to 12 minutes.1 Ready-to-Use CARDENE I.V., which is immediately available for rapid intervention and enables practical point-of-use storage, supports a variety of treatment and medications guidelines.

Treatment Guidelines
Standards for Dispensing and Storing Medications

Treatment Guidelines

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

    • When blood pressure is elevated, short-acting, continuous-infusion IV agents with reliable dose-response relationship and favorable safety profile are desirable.2 Ready-to-Use CARDENE I.V. is an agent that meets these criteria

  • 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,*

    • See Important Safety Information

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

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Standards for Dispensing and Storing Medications

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.8,9

  • Providing medication in ready-to-administer form when possible8,9

  • Standardizing drug concentrations8

  • Providing medication to meet patient needs when the pharmacy is closed8

  • Limiting preparation of admixtures by nursing staff9

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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:10.1161/STROKEAHA.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, del Zoppo G, Alberts MJ, et al. Guidelines for the early management of patients 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(6):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. Rynn KO, Hughes FL, Faley B. An emergency department approach to drug treatment of hypertensive urgency and emergency. J Pharm Prac. 2005;18(5):363-376. 8. Rich DS. New JCAHO medication management standards for 2004. Am J Health-Syst Pharm. 2004;61(13):1349-1358. 9. American Society of Health-System Pharmacists. ASHP guidelines: minimum standard for pharmacies in hospitals. Am J Health-Syst Pharm. 1995;52(23):2711-2717.

 

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