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.
Blood pressure measurement displayed on this page not indicative of outcomes. |
References:
1. Data on file, EKR Therapeutics; Bedminster, NJ.; 2. IV Nicardipine Study Group. Efficacy and safety of intravenous nicardipine in the control of postoperative hypertension. Chest. 1991; 99(2):393-398. 3. 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. 4. 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(7):623-628. 5. Wallin JD, Fletcher E, Ram VS, 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. 6. CARDENE I.V. prescribing information, 2008. EKR Therapeutics, Bedminster, NJ. 7. Ruble J. Impact safety, efficiency, and the bottom line with premixed IV products. Pharm Purchasing Prod. February 2008. http://www.pppmag.com. Accessed August 28, 2008. 8. Fanikos J, Erickson A, Munz KE, Sanborn MD, Ludwig BC, Van Hassel T. Observations on the use of ready-to-use and point-of-care activated parenteral products in automated dispensing cabinets in U.S. hospitals. Am J Health Syst Pharm. 2007; 64(19):2037-2043. 9. Joint Commission International Accreditation Standards for Hospitals, 3rd ed. Joint Commission International. January 2008. |
