Important Safety Information
CARDENE® I.V. (nicardipine hydrochloride) 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.
CARDENE I.V. may elevate serum concentrations of cyclosporine or tacrolimus. Serum concentrations of cyclosporine or tacrolimus should be monitored during coadministration with CARDENE I.V.
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.
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.
Please see Full Prescribing Information.
References: 1. CARDENE I.V. (nicardipine hydrochloride) Premixed Injection Prescribing Information. Cary, NC: Chiesi USA, Inc.; 2016. 2. Nicardipine Hydrochloride Injection [package insert]. Detroit, MI: Caraco Pharmaceutical Laboratories, Ltd.; 2009. 3. Flynn EA, Pearson RE, Barker KN. Observational study of accuracy in compounding i.v. admixtures at five hospitals. Am J Health Syst Pharm. 1997;54(8):904-912. 4. The Joint Commission. Medication management. In: 2015 Hospital Accreditation Standards. Oakbrook Terrace, IL: The Joint Commission; 2015:MM1-MM26. 5. American Society of Health-System Pharmacists. ASHP guidelines: minimum standard for pharmacies in hospitals. Am J Health Syst Pharm. 2013;70(18):1619-1630. 6. Institute for Safe Medication Practices. Proceedings from the ISMP Sterile Preparation Compounding Safety Summit: Guidelines for SAFE Preparation of Sterile Compounds. http://www.ismp.org/tools/guidelines/IVSummit/IVCGuidelines.pdf. Accessed February 26, 2016. 7. van der Linden P, Douchamps J, Schmitt C, Forget D. Ready-to-use injection preparations versus conventional reconstituted admixtures: economic evaluation in a real-life setting. Pharmacoeconomics. 2002;20(8):529-536. 8. Fanikos J, Erickson A, Munz KE, et al. 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. Bernard J-M, Pinaud M, François T, et al. Deliberate hypotension with nicardipine or nitroprusside during total hip arthroplasty. Anesth Analg. 1991;73(3):341-345. 10. 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.