CARDENE I.V. 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. Indication
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 CARDENE I.V. Full Prescribing Information.
CLEVIPREX Important Safety Information
CLEVIPREX® (clevidipine) Injectable Emulsion 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) is a dihydropyridine calcium channel blocker indicated for the reduction of blood pressure (BP) when oral therapy is not feasible or not desirable.
Please see CLEVIPREX Full Prescribing Information.
References: 1. CARDENE I.V. (nicardipine hydrochloride) Premixed Injection Prescribing Information. Cary, NC: Chiesi USA, Inc.; 2018. 2. 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. 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(12):1637-1643. 4. IV Nicardipine Study Group. Efficacy and safety of intravenous nicardipine in the control of postoperative hypertension. Chest. 1991;99(2):393-398. 5. Roitberg BZ, Hardman J, Urbaniak K, et al. Prospective randomized comparison of safety and efficacy of nicardipine and nitroprusside drip for control of hypertension in the neurosurgical intensive care unit. Neurosurgery. 2008;63(1):115-121.