Management Guidelines

Ready-to-use CARDENE® I.V. (nicardipine hydrochloride) is a calcium channel blocker.1 It is the only available FDA-approved premixed formulation of nicardipine hydrochloride, a recommended agent for blood pressure reduction within the following guidelines, including American Heart Association (AHA)/American Stroke Association (ASA) stroke guidelines.

Recommended for Blood Pressure Reduction in These Guidelines
2003 JNC 7 Report (for BP reduction in hypertensive emergencies) 2
2010 AHA/ASA Guidelines for the Management of Spontaneous Intracerebral Hemorrhage3
2012 AHA/ASA Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage4
2013 AHA/ASA Guidelines for the Early Management of Patients With Acute Ischemic Stroke5

Abbreviations: BP, blood pressure; JNC 7, Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.

2003 JNC 7 (for BP Reduction in Hypertensive Emergencies) 2
Examples of hypertensive emergencies include hypertensive encephalopathy, intracerebral hemorrhage, and dissecting aortic aneurysm, among others.
In patients with BP >180/120 mm Hg complicated by evidence of impending or progressive target-organ damage, the general goals for BP control include the following:
  •  Reduce mean arterial BP by no more than 25% within minutes to 1 hour
  •  If stable, reduce to 160/100 to 110 mm Hg within the next 2-6 hours
  •  Avoid excessive falls in pressure that may precipitate renal, cerebral, or coronary ischemia
  •  If this level of BP is well tolerated, further gradual reductions toward a normal BP can
     be implemented over the next 24-48 hours
  •  There are exceptions to the above recommendations: patients with an ischemic stroke in
     which there is no clear evidence from clinical trials to support the use of immediate
     antihypertensive treatment, patients with aortic dissection who should have their SBP
     lowered to <100 mm Hg if tolerated, and patients in whom BP is lowered to enable the
     use of thrombolytic agents

Abbreviations: BP, blood pressure; JNC 7, Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure; SBP, systolic blood pressure.

2010 AHA/ASA Guidelines for the Management of Spontaneous Intracerebral Hemorrhage 3
1. Until ongoing clinical trials of BP intervention for ICH are completed, physicians must
 manage BP on the basis of the present incomplete efficacy evidence. Current
 suggested recommendations for target BP in various situations are listed below and
 may be considered.
• For patients with SBP >200 mm Hg or MAP >150 mm Hg, consider aggressive reduction
 of BP with continuous intravenous infusion, with frequent BP monitoring every 5 minutes
• For patients with SBP >180 mm Hg or MAP >130 mm Hg and the possibility of
 elevated ICP, consider monitoring ICP and reducing BP using intermittent or continuous
 intravenous medications while maintaining a cerebral perfusion pressure >60 mm Hg
• For patients with SBP >180 mm Hg or MAP >130 mm Hg without evidence of elevated
 ICP, consider a modest reduction of BP (eg, MAP of 110 mm Hg or target BP of
 160/90 mm Hg) using intermittent or continuous intravenous medications to control BP
 and clinically reexamine the patient every 15 minutes
2. In patients presenting with a SBP of 150-220 mm Hg, acute lowering of SBP to 140 mm Hg
 is probably safe.
• The INTensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT)
 pilot study “provides an important proof of concept for early BP lowering in patients with
 ICH, but the data are insufficient to recommend a definitive policy”
• The Antihypertensive Treatment in Acute Cerebral Hemorrhage (ATACH) trial “also
 confirms the feasibility and safety of early rapid BP lowering in ICH. This study used
 a 4-tier dose escalation of intravenous nicardipine-based BP lowering in 80 patients
 with ICH”
• “INTERACT and ATACH now represent the best available evidence to help guide
 decisions about BP lowering in ICH”

Abbreviations: BP, blood pressure; ICH, intracerebral hemorrhage; ICP, intracranial pressure; MAP, mean arterial pressure; SBP, systolic blood pressure.

2012 AHA/ASA Guidelines for the Management of Aneurysmal Subarachnoid Hemorrhage 4
1. Between the time of aSAH symptom onset and aneurysmal obliteration, BP should be
  controlled with a titratable agent to balance the risk of stroke, hypertension-related
  rebleeding, and maintenance of cerebral perfusion pressure.
 “A variety of titratable medications are available. Nicardipine may give smoother BP
 control than labetalol and sodium nitroprusside, although data showing different clinical
 outcomes are lacking. Although lowering cerebral perfusion pressure may lead to
 cerebral ischemia, a cohort study of neurologically critically ill patients did not find an
 association between use of nicardipine and reduced brain oxygen tension”
2. The magnitude of BP control to reduce the risk of rebleeding has not been established,
  but a decrease in SBP to <160 mm Hg is reasonable.

Abbreviations: aSAH, aneurysmal subarachnoid hemorrhage; BP, blood pressure; SBP, systolic blood pressure.

2013 AHA/ASA Guidelines for the Early Management of Patients With Acute Ischemic Stroke 5
In acute ischemic stroke patients who are potential candidates for acute reperfusion therapy:
• Nicardipine IV and labetalol IV are potential approaches to reducing BP in patients
 otherwise eligible for acute reperfusion therapy except that BP >185/110 mm Hg.
 Other agents (hydralazine, enalaprilat, etc) may be considered when appropriate
• Nicardipine IV or labetalol IV can be used for management of BP during and after
 recombinant tissue plasminogen activator or other acute reperfusion therapy to maintain
 BP at or below 180/105 mm Hg when SBP is 180-230 mm Hg or DBP is 105-120 mm Hg.
 If BP is not controlled or DBP >140 mm Hg, sodium nitroprusside should be considered
In acute ischemic stroke patients who are not potential candidates for acute reperfusion therapy:
• Consideration should be given to lowering BP if SBP >220 mm Hg or DBP >120 mm Hg,
 or as indicated for other concomitant medical conditions that would benefit from BP
 reduction (myocardial ischemia, aortic dissection, heart failure)

Abbreviations: BP, blood pressure; DBP, diastolic blood pressure; IV, intravenous; SBP, systolic blood pressure.

Standards and Guidelines for Dispensing and Storing Medications

Ready-to-use CARDENE I.V. supports The Joint Commission standards and American Society of Health-System Pharmacists guidelines for dispensing and storing medications.6,7

  • "Medications are dispensed in the most ready-to-administer forms commercially available…"6
  • "Whenever possible, medications shall be available for inpatient use in single-unit packages and in a ready-to-administer form."7
  • Drug concentrations must be standardized and limited6
  • A system must be in place to safely provide medications to meet patient needs when the pharmacy is closed6,7
  • Preparation of admixtures outside the pharmacy (eg, on nursing units) should be minimized7

Indication

CARDENE® I.V. (nicardipine hydrochloride) Premixed Injection is indicated for the short-term treatment of hypertension when oral therapy is not feasible or not desirable. For prolonged control of blood pressure, transfer patients to oral medication as soon as their clinical condition permits.1

Important Safety Information

CARDENE I.V. is contraindicated in patients with advanced aortic stenosis.

Hypotension and reflex tachycardia may potentially occur during treatment with CARDENE I.V.; therefore, close monitoring of blood pressure and heart rate is required. If unacceptable hypotension or tachycardia occurs, the infusion should be discontinued.

Slow titration of CARDENE I.V. is recommended in patients with heart failure or significant left ventricular dysfunction, particularly in combination with a beta-blocker.

Close monitoring of response to CARDENE I.V. is advised in patients with angina, heart failure, impaired hepatic function, or renal impairment.

To reduce the possibility of venous thrombosis, phlebitis, local irritation, and extravasation, administer CARDENE I.V. through large peripheral veins or central veins rather than arteries or small peripheral veins. If CARDENE I.V. is administered in a peripheral vein, to minimize the risk of venous irritation, change the site of infusion every 12 hours.

The most common adverse reactions (>3%) are headache, nausea/vomiting, hypotension, and tachycardia.

Please see full Prescribing Information.

References: 1. CARDENE I.V. (nicardipine hydrochloride) Premixed Injection Prescribing Information. Cary, NC: Cornerstone Therapeutics Inc.; 2013. 2. 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. 3. Morgenstern LB, Hemphill JC III, Anderson C, et al; on behalf of American Heart Association Stroke Council and Council on Cardiovascular Nursing. Guidelines for the management of spontaneous intracerebral hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2010;41(9):2108-2129. doi:10.1161/STR.0b013e3181ec611b. 4. Connolly ES, Rabinstein AA, Carhuapoma JR, et al. Guidelines for the management of aneurysmal subarachnoid hemorrhage: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2012;43(6):1711-1737. doi:10.1161/STR.0b013e3182587839. 5. Jauch EC, Saver JL, Adams HP, et al. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44(3):870-947. doi:10.1161/STR.0b013e318284056a. 6. The Joint Commission. Medication management. In: 2013 Hospital Accreditation Standards. Oakbrook Terrace, IL: The Joint Commission; 2013:MM1-MM24. 7. ASHP Council on Pharmacy Practice. ASHP guidelines: minimum standard for pharmacies in hospitals. In: Hawkins B, ed. Best Practices for Hospital & Health-System Pharmacy. 2012-2013 ed. Bethesda, MD: American Society of Health-System Pharmacists; 2012:453-463.

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Dosing & Administration

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