CARDENE I.V. has a low risk of hypotension vs sodium nitroprusside in patients with severe hypertension1
Results of a multicenter, open-label, randomized, parallel-group
study (N=121) comparing CARDENE I.V. with intravenous sodium nitroprusside in patients with severe hypertension.
Achieve BP goal with easy administration
Easily titrated to desired BP target with no correlation between patient's weight and
dose response 2
Minimal dose adjustments required to achieve and maintain therapeutic effect within a narrow range 1
Intended for intravenous use; therefore, an arterial line is not required to monitor therapy 2
Therapy should be continued as long as IV acute BP control is needed 2
No limitations on duration of infusion 2
Well-documented safety profile
No detrimental antihypertensive effects reported in patients with
Reactive airway disease2
COPD (chronic obstructive pulmonary disease)2
Asthma2
Age ≥65 years2
Other features include
Has no significant effect on intracranial pressure4
Does not decrease heart rate5
No detrimental effects on cardiac conduction system2
Is not associated with coronary steal2
Adverse events were generally not serious, and most were expected consequences of vasodilation 2
Most common side effects are headache (14.6%), hypotension (5.6%),
nausea/vomiting (4.9%), and tachycardia (3.5%)2
Proven tolerability
*A multicenter, prospective, randomized, open-label study to
evaluate the efficacy and safety of CARDENE I.V. compared
with SNP. The initial infusion dose used for CARDENE I.V.
in this study (10 mg/hr) differs from the recommended
initial dose in the package insert (5 mg/hr). Adverse events
occurred in 17 patients: 5/71 (7%) for CARDENE I.V. and
12/68 (18%) on SNP, P=NS. Six patients receiving SNP
discontinued therapy due to adverse events versus no
patient receiving CARDENE I.V.
- = Not observed in study.
†An open-label, randomized, parallel-group study evaluating
the efficacy and safety of CARDENE I.V. compared with SNP in
patients with severe hypertension. Patients may have had more
than one adverse clinical event. Adverse events were reported in
24/62 (39%) patients receiving CARDENE I.V. and 34/60 (56%)
patients receiving SNP.
‡P<.05.
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.
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.
2.
CARDENE I.V.
[prescribing information]. Bedminster, NJ: EKR Therapeutics,
Inc; 2008.
3.
Combes P, Durand M. Comparison of nicardipine and sodium nitroprusside in the
treatment of hypertension after coronary bypass surgery (a pilot study). Acta Anaesthesiologica. 1992;43:113-119.
4.
Nishiyama T, Yokoyama T, Matsukawa T, Hanaoka K. Continuous nicardipine infusion to
control blood pressure after evacuation of acute cerebral hemorrhage. Can J Anesth. 2000;47:1196-1201.
5.
Neely CF. Postoperative hypertension. In: Goldmann DR, Brown FH, Guarnieri DM, eds.
Perioperative Medicine-The Medical Care of the Surgical Patient. 2nd ed. New York, NY: McGraw-Hill; 1994:531-542.
6.
Halpern NA, Goldberg M, Neely C, et al. Postoperative hypertension: a multicenter,
prospective, randomized comparison between intravenous nicardipine and sodium nitroprusside. Crit Care Med. 1992;20:1637-1643.
7.
Wallin JD, Fletcher E, Ram CV, et al. Intravenous nicardipine for the treatment of severe hypertension. A double-blind, placebo-controlled multicenter trial. Arch Intern Med.
1989;149:2662-2669.
8
IV Nicardipine Study Group.Efficacy and safety of intravenous nicardipine in the control of postoperative hypertension. Chest. 1991;99:393-398.
