Cardene I.V. Efficacy and Dosing

Efficacy comparable to sodium nitroprusside, with significantly fewer dose adjustments and adverse effects^2,6

May be used in patients with obstructive airway disease¹

No special precautions necessary in patients with asthma and chronic obstructive airway disease

No detrimental effects on the cardiac conduction system have been seen¹

The efficacy of sodium nitroprusside...

Rapid onset of therapeutic activity with blood pressure (BP) reductions in 10 to 12 minutes¹

Percentage of cumulative responders in a multicenter, open-label, randomized, parallel group study (N=121). Therapeutic response was defined as diastolic blood pressure (DBP) ≤95 mm Hg or a decrease in DBP ≥25 mm Hg or systolic blood pressure (SBP) ≤160 mm Hg or a decrease in SBP ≥50 mm Hg.

Adapted from Neutel JM et al.

...without as many dose adjustments^5,6

Results of a multicenter, open-label, randomized, parallel group study (N=121) comparing the efficacy and safety of CARDENE I.V. with intravenous sodium nitroprusside in patients with severe hypertension.

Results of a multicenter, prospective, randomized, open-label trial (N=139) comparing CARDENE I.V. with intravenous sodium nitroprusside for the treatment of postoperative hypertension. Therapeutic response was defined as =15% BP reduction. The initial infusion dose used for CARDENE I.V. in this study (10 mg/hr) differs from the recommended initial dose in the package insert (5 mg/hr).

Cardene I.V. Dosing

Predictable titration for precise control

Achieve BP goal with easy administration

Easily titrated to desired BP target with no correlation between patient's weight and dose response¹

Minimal dose adjustments required to achieve and maintain therapeutic effect within a narrow range⁵

CARDENE I.V. is intended for intravenous use, therefore, an arterial line is not required to monitor therapy¹

CARDENE I.V. therapy should be continued as long as BP control is needed¹

For RAPID or GRADUAL BP control¹

1.	Initiate therapy at 5 mg/hr (50 mL/hr)

2.	If desired results are not achieved: Increase infusion rate by 2.5 mg/hr (25 mL/hr) (Dosage should not exceed 15 mg/hr [150 mL/hr])

For RAPID control,
every 5 minutes

For GRADUAL control,
every 15 minutes

3.	When desired result is achieved:

For RAPID control,
decrease rate to
3 mg/hr (30 mL/hr)

For GRADUAL control,
maintain infusion rate

Maintenance: The rate of infusion should be adjusted as needed to maintain desired response.

WARNING: Ampuls must be diluted before infusion. CARDENE I.V. is NOT compatible with Sodium Bicarbonate (5%) Injection, USP, or Lactated Ringer's Injection, USP.

CARDENE I.V. is administered by slow continuous infusion at a CONCENTRATION OF 0.1 MG/ML. Each ampul (25 mg/10 mL) should be diluted with 240 mL of compatible intravenous fluid (see Prescribing Information), resulting in 250 mL of solution at a concentration of 0.1 mg/mL.

Preparation

WARNING: AMPULS MUST BE DILUTED BEFORE INFUSION

Dilution

CARDENE I.V. is administered by slow continuous infusion at a CONCENTRATION OF 0.1 MG/ML

Each ampul (25 mg/10 mL) should be diluted with 240 mL of compatible intravenous fluid (see Prescribing Information), resulting in 250 mL of solution at a concentration of 0.1 mg/mL

Compatibility

CARDENE I.V. has been found to be compatible and stable in glass or polyvinyl chloride containers for 24 hours at controlled room temperature with:

Dextrose (5%) Injection, USP

Dextrose (5%) and Sodium Chloride (0.45%) Injection, USP

Dextrose (5%) and Sodium Chloride (0.9%) Injection, USP

Dextrose (5%) with 40 mEq Potassium, USP

Sodium Chloride (0.45%) Injection, USP

Sodium Chloride (0.9%) Injection, USP

CARDENE I.V. is NOT compatible with Sodium Bicarbonate (5%) Injection,USP, or Lactated Ringer's Injection,USP.

Stability

The diluted solution is stable for 24 hours at room temperature

Inspection

CARDENE I.V. is normally light yellow in color. As with all parenteral drugs, CARDENE I.V. should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit

How Supplied

CARDENE I.V. is available in packages of 10 ampuls as follows: 25 mg (2.5 mg/mL), NDC 67286-0812-3

Store at controlled room temperature 20° to 25°C (68° to 77°F)

Freezing does not adversely affect the product, but exposure to elevated temperatures should be avoided

Protect from light. Store ampuls in carton until used

Please see full Prescribing Information.

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.

Please see full prescribing information.

	References
	1.	CARDENE I.V. [prescribing information]. Bedminster, NJ: EKR Therapeutics, Inc; 2008.
	2.	2005 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Part 9: adult stroke. Circulation. 2005;112:IV-111-IV-120.
	3.	Adams HP, del Zoppo G, Alberts MJ, et al. Guidelines for the early management of patients with ischemic stroke. A Guideline From the American Heart Association/American Stroke Association Stroke Council, Clinical Cardiology Council, Cardiovascular Radiology and Intervention Council, and the Atherosclerotic Peripheral Vascular Disease and Quality of Care Outcomes in Research Interdisciplinary Working Groups. Stroke. 2007;38:1655-1711.
	4.	Adams H, Adams R, Del Zoppo G, et al. Guidelines for the early management of patients with ischemic stroke: 2005 guidelines update: a scientific statement from the Stroke Council of the American Heart Association/American Stroke Association. Stroke. 2005;36:916–923.
	5.	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.
	6.	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.