CARDENE® I.V. (nicardipine hydrochloride) User Guide

>>NARRATOR: When timely, precise blood pressure
control is critical, CARDENE I.V. nicardipine hydrochloride premixed injection is a proven
steady, premixed ready agent for use in a variety of hypertensive emergencies. CARDENE I.V. 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. This program reviews the dosing and administration
of CARDENE I.V. and provides clinical evidence to support its use in appropriate patients. CARDENE I.V. nicardipine hydrochloride is
available in formulations of 40mg in 200 mL and 20 mg in 200 mL in either sodium chloride
or dextrose solutions straight from your automated dispensing cabinet. The premixed ready formulation is immediately
available for rapid intervention at the point of care and minimizes the risk of medication
admixture errors. CARDENE I.V. can be stored at room temperature
in its original packaging for 24 months. Before administering CARDENE I.V., inspect
the product for particulate matter and discoloration. Check for leaks by squeezing the bag firmly
and ensure that the seal is intact. If leaks are found, discard the bag as sterility
may be impaired. Note that there is only one port on the bag. Do not combine CARDENE I.V. with any product
in the same intravenous line or premixed container. When connecting the administration set, fully
insert the spike into the port and twist until the line is firmly attached. CARDENE I.V. should be administered through
large peripheral veins or central veins. CARDENE I.V. does not contain soy or egg allergens. The most common adverse reactions occurring
in more than 3% of patients are headache, nausea, vomiting, hypotension and tachycardia. The starting dose for CARDENE I.V. is 5mg
per hour in patients not receiving oral nicardipine. The infusion rate for this formulation containing
40mg of CARDENE I.V. in 200mL of normal saline is 25mL per hour. You can administer CARDENE I.V. using rapid
or gradual titration in increments of 2.5mg per hour up to a maximum dose of 15mg per
hour. For rapid titration increase the dose every
5 minutes. Once the desired blood pressure is achieved,
decrease the infusion rate to 3mg per hour. For gradual titration, increase the dose every
15 minutes until desired blood pressure is achieved. For either approach, adjust the infusion rate
as needed to maintain the desired blood pressure. This chart shows dose to infusion rate conversion. You can find this information at
or within the full prescribing information. Monitor blood pressure and heart rate continually
during infusion and avoid a too-rapid or excessive blood pressure drop during treatment. Now, let’s review some of the evidence that
demonstrates how CARDENE I.V. performs in clinical settings. CARDENE I.V. begins to work within minutes. In a multicenter randomized study 110 patients
with hypertensive emergencies were treated with CARDENE I.V. in the emergency department. Median initial systolic blood pressure was
212.5 and most of these patients had history of hypertension. By 15 minutes the mean percent change in systolic
blood pressure from baseline was within target range. 92% of patients reached their target systolic
blood pressure range within 30 minutes using the rapid titration schedule. In addition to a rapid onset of effect, CARDENE
I.V. also demonstrated smooth, predictable blood pressure control over 24 hours. In a study of hypertensive patients admitted
through the emergency department for primary intracerebral hemorrhage, subarachnoid hemorrhage
or acute ischemic stroke CARDENE I.V. was initiated at a dose of 5mg per hour and increased
using gradual titration every 15 minutes by 2.5mg per hour until target systolic blood
pressure range was reached or a maximum of 15mg per hour was achieved. 89% of patients achieved their respective
target ranges based on consensus guidelines within 60 minutes. The majority of patients did not require a
dose adjustment to reach goal and no rescue therapy was needed in any patient. CARDENE I.V. maintained blood pressure control
for 24 hours. Discontinuation of CARDENE I.V. infusion is
followed by a 50% offset of action in about 30 minutes. If treatment includes transfer to an oral
antihypertensive agent other than oral nicardipine, initiate therapy upon discontinuation of CARDENE
I.V. premixed injection. If oral nicardipine is to be used, administer
the first dose one hour prior to discontinuation of the infusion. For proven steady control of blood pressure
in hypertensive emergencies, CARDENE I.V. delivers rapid precise control within minutes. CARDENE I.V. increases cardiac output and
has not been associated with coronary steal, bradycardia or rebound hypertension. The premixed ready formulation is immediately
available at the point of care, which helps minimize medication admixture errors. The sealed product is stable for 24 months
in original packaging under appropriate storage conditions. 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. 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 (greater
than 3%) are headache, nausea/vomiting, hypotension, and tachycardia. Please see full prescribing information. For more information about this important
solution for hypertensive emergencies visit or call 888-466-6505.

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