EKR Therapeutics Commences Shipments of Premixed Double Concentration Cardene[R] I.V. (nicardipine hydrochloride) Ready-to-Use Bags.
Approved by the Food and Drug Administration (FDA) in early November 2008, premixed double concentration Cardene I.V. preparations consist of 200 ml Ready-to-Use (RTU) intravenous bags containing 40 mg of the calcium channel blocker nicardipine hydrochloride (0.2 mg/ml) in either dextrose or sodium chloride.
EKR's product offerings of Cardene I.V. RTU bags also include single (1X) concentration preparations of 200 ml bags containing 20 mg of nicardipine hydrochloride (0.1 mg/ml) introduced into the marketplace in September. Both the 2X and 1X Cardene I.V. RTU Bags support TJC1 and ASHP2 standards for dispensing medication in the most ready to administer form. "Additionally, these premixed I.V. bags represent important next-generation advancements in the Cardene product franchise," noted Howard Weisman, EKR's Chairman & CEO.
"Previously available only in glass ampules for dilution prior to infusion, Cardene I.V. has an established 15 year legacy of managing acute hypertension," said Weisman. "In general, with premixed ready-to-use I.V. bags, hospitals and healthcare providers can eliminate point-of-care medication admixture errors while facilitating rapid intervention in emergency settings in comparison to product handling procedures requiring drug reconstitution before administration."
"Moreover, with the introduction of double concentration RTU bags, EKR has taken a significant step in expanding our Cardene I.V. product mix to pursue growth opportunities in a variety of acute-care settings, from the ambulance and emergency department to the operating room and into the intensive care unit," noted Weisman. He concluded, saying "Our ability to ramp up production and make the 2X preparations available to the marketplace within a month of FDA approval is a testament to the talents and efficiency of the EKR team and our commitment to excellence as an acute-care specialty pharmaceutical company."
About Cardene I.V.
Cardene[R] I.V. is a patented formulation of the anti-hypertensive agent nicardipine hydrochloride. Originally approved by FDA in 1992, Cardene I.V. is a calcium ion influx inhibitor indicated for the short-term treatment of hypertension when oral therapy is not feasible or desirable. In July and November 2008, FDA approved, respectively, single and double concentration Cardene I.V. Premixed Injections in dextrose and sodium chloride Ready-to-Use intravenous bags.
Administered intravenously, Cardene I.V. reduces the influx of calcium ions into cardiac and vascular smooth muscle cells through specific ion channels in the cell membrane. The drug, which is more selective for vascular smooth muscle cells, causes arterioles to dilate thereby lowering blood pressure. In clinical trials, adverse events of Cardene I.V. were generally not serious, and most were expected consequences of vasodilation. Cardene I.V. is arteriolar specific and is not associated with atrial fibrillation. Cardene I.V. is also not associated with rebound hypertension and has no adverse effect on lipid levels. Most common side effects of Cardene I.V. therapy are headache (14.6%), hypotension (5.6%), nausea/vomiting (4.9%), and tachycardia (3.5%). Cardene I.V. is contraindicated in patients with known hypersensitivity to the drug and in patients with advanced aortic stenosis. Close monitoring of the blood pressure is required during therapy. Full prescribing, safety, and additional information on Cardene I.V. is available at www.cardeneiv.com.
About EKR Therapeutics
EKR Therapeutics is a privately held specialty pharmaceutical company focused on identifying, fostering and targeting the growth of novel acute-care hospital products to improve outcomes and patient quality of life. Backed by the strength of its management team, the dedication of its field force of product specialists and its commitment to excellence in customer service and medical education, EKR has been organized to be a class leader in commercializing products to address unmet and under-satisfied medical needs or to otherwise enhance the therapeutic value of acute-care products. The Company's growing product portfolio includes Cardene([R]) I.V. (nicardipine hydrochloride), Cardene([R]) I.V. Premixed Injections, Cardene([R]) SR, Retavase([R]) (reteplase recombinant), DepoDur([R]) (morphine sulfate extended-release liposomal injection) and Gelclair([R]) (bioadherent oral gel). For additional information about EKR visit the Company's website at www.ekrtx.com.
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|Date:||Dec 10, 2008|
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