Demonstrated Safety and Tolerability

Ready-to-Use CARDENE I.V., 40 mg in 200 mL (0.2 mg/mL) or 20 mg in 200 mL (0.1 mg/mL), offers the safety benefits of a premixed, ready-to-administer formulation:

• Eliminates medication admixture errors
  
  

• Supports The Joint Commission standards and American Society of Health-System Pharmacists guidelines for dispensing and storing medications^1,2

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

Safety and Tolerability in Clinical Trials

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

• No detrimental antihypertensive effects were reported in patients with

• Reactive airway disease³

• Chronic obstructive pulmonary disease (COPD)³

• Asthma³

• Age ≥65 years³
  
  

• Other safety/tolerability characteristics include:

• No significant increase of intracranial pressure^4,5

• No decrease in heart rate³

• No detrimental effects on cardiac conduction system³

• Not associated with coronary steal³

Tolerability vs sodium nitroprusside

CARDENE I.V. has a lower risk of hypotension than sodium nitroprusside in patients with
severe hypertension.

• Causes significantly less dizziness, nausea, and vomiting than sodium nitroprusside⁶

Tolerability vs placebo

Two hundred forty-four patients participated in 2 multicenter, double-blind, placebo-controlled trials.

• Adverse events were generally not serious, and most were expected consequences of vasodilation³
  
  

• Most common side effects are headache (14.6%), hypotension (5.6%), nausea/vomiting (4.9%), and tachycardia (3.5%)³

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. Rich DS. New JCAHO medication management standards for 2004. Am J Health-Syst Pharm. 2004;61(13):
1349-1358. 2. American Society of Health-System Pharmacists. ASHP guidelines: minimum standard for pharmacies in hospitals. Am J Health-Syst Pharm. 1995;52(23):2711-2717. 3. CARDENE I.V. prescribing information, 2008. EKR Therapeutics, Bedminster, NJ. 4. 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. 5. 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. 6. 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.

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