Important Safety Information for CARDENE® I.V. (nicardipine hydrochloride) Premixed Injection
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 for CARDENE I.V.
Important Safety Information for CLEVIPREX® (clevidipine) injectable emulsion
CLEVIPREX® (clevidipine) is contraindicated in patients with:
- Allergies to soybeans, soy products, eggs, or egg products;
- Defective lipid metabolism seen in conditions such as pathologic hyperlipemia, lipoid nephrosis, or acute pancreatitis if it is accompanied by hyperlipidemia; and
- Severe aortic stenosis.
CLEVIPREX is intended for intravenous use. Use aseptic technique and discard any unused product within 12 hours of stopper puncture.
Hypotension and reflex tachycardia are potential consequences of rapid upward titration of CLEVIPREX. If either occurs, decrease the dose of CLEVIPREX. There is limited experience with short-duration therapy with beta-blockers as a treatment for CLEVIPREX-induced tachycardia. Beta-blocker use for this purpose is not recommended.
CLEVIPREX contains approximately 0.2 g of lipid per mL (2.0 kcal). Lipid intake restrictions may be necessary for patients with significant disorders of lipid metabolism.
Dihydropyridine calcium channel blockers can produce negative inotropic effects and exacerbate heart failure. Monitor heart failure patients carefully.
CLEVIPREX is not a beta-blocker, does not reduce heart rate, and gives no protection against the effects of abrupt beta-blocker withdrawal. Beta-blockers should be withdrawn only after a gradual reduction in dose.
Patients who receive prolonged CLEVIPREX infusions and are not transitioned to other antihypertensive therapies should be monitored for the possibility of rebound hypertension for at least 8 hours after the infusion is stopped.
There is no information to guide use of CLEVIPREX in treating hypertension associated with pheochromocytoma.
Most common adverse reactions for CLEVIPREX (>2%) are headache, nausea, and vomiting.
CLEVIPREX® (clevidipine) injectable emulsion is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure when oral therapy is not feasible or not desirable.
Please see Full Prescribing Information for CLEVIPREX.
References: 1. CARDENE I.V. (nicardipine hydrochloride) Premixed Injection Prescribing Information. Cary, NC: Chiesi USA, Inc.; 2016. 2. Marik PE, Varon J. Hypertensive crises: challenges and management. Chest. 2007;131(6):1949-1962. 3. Rose JC, Mayer SA. Optimizing blood pressure in neurological emergencies. Neurocrit Care. 2004;1(3):287-299. 4. 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. 5. Kaplan NM. Systemic hypertension: mechanisms and diagnosis. In: Zipes DP, Libby P, Bonow R, Braunwald E, eds. Braunwald’s Heart Disease: a Textbook of Cardiovascular Medicine. 7th ed. Philadelphia, PA: Elsevier Saunders; 2005;959-987. 6. Cleviprex [package insert]. Parsippany, NJ: The Medicines Company; 2013. 7. Kieler-Jensen N, Jolin-Mellgård A, Nordlander M, Ricksten SE. Coronary and systemic hemodynamic effects of clevidipine, an ultra-short-acting calcium antagonist, for treatment of hypertension after coronary artery surgery. Acta Anaesthesiol Scand. 2000; 44(2):186-193. 8. Brevibloc [package insert]. Deerfield, IL: Baxter Healthcare Corporation; 2014. 9. Grillo P, Bruder N, Auquier P, et al. Esmolol blunts the cerebral blood flow velocity increase during emergence from anesthesia in neurosurgical patients. Anesth Analg. 2003;96(4):1145-1149. 10. Singh PP, Dimich I, Sampson I, Sonnenklar N. A comparison of esmolol and labetalol for the treatment of perioperative hypertension in geriatric ambulatory surgical patients. Can J Anaesth. 1992;39(6):559-562. 11. Ezri T, Szmuk P, Warters RD, et al. Changes in onset time of rocuronium in patients pretreated with ephedrine and esmolol–the role of cardiac output. Acta Anaesthesiol Scand. 2003;47(9):1067-1072. 12. Nitropress [package insert]. Bridgewater, NJ: Valeant Pharmaceuticals North America, LLC; 2015. 13. van Wezel HB, Koolen JJ, Visser CA, et al. Antihypertensive and anti-ischemic effects of nicardipine and nitroprusside in patients undergoing coronary artery bypass grafting. Amer J Cardiol. 1989;64:22H-27H. 14. van Wezel HB, Koolen JJ, Visser CA, et al. The efficacy of nicardipine and nitroprusside in preventing poststernotomy hypertension. J Cardiothorac Anesth. 1989;3(6):700-706. 15. Nitroglycerin Injection [package insert]. Shirley, NY: American Regent Laboratories, Inc; 2005. 16. Cooke CR, Wall BM, Huch KM, Mangold T. Cardiovascular effects of vasopressin following V1 receptor blockade compared to effects of nitroglycerin. Am J Physiol Regul Integr Comp Physiol. 2001;281(3):R887-R893. 17. Loh E, Elkayam U, Cody R, et al. A randomized multicenter study comparing the efficacy and safety of intravenous milrinone and intravenous nitroglycerin in patients with advanced heart failure. J Card Fail. 2001;7(2):114-121. 18. Hydralazine hydrochloride [package insert]. Lake Forest, IL: Akorn Inc.; 2012. 19. Labetalol [package insert]. Bedford, OH: Bedford Laboratories; 2012. 20. Sladen RN, Klamerus KJ, Swafford MWG, et al. Labetalol for the control of elevated blood pressure following coronary artery bypass grafting. J Cardiothorac Anesth. 1990;4(2):210-221. 21. Le Bret F, Coriat P, Gosgnach M, et al. Transesophageal echocardiographic assessment of left ventricular function in response to labetalol for control of postoperative hypertension. J Cardiothorac Vasc Anesth. 1992;6(4):433-437.