Cardene SR



	Product Overview¹ Click here for a printer friendly version. \| Click here for important safety information. Nicardipine is a calcium entry blocker (slow channel blocker or calcium ion antagonist) that inhibits the transmembrane influx of calcium ions into cardiac muscle and smooth muscle without changing serum calcium concentrations. The contractile processes of cardiac muscle and vascular smooth muscle are dependent upon the movement of extracellular calcium ions into these cells through specific ion channels. The effects of nicardipine are more selective to vascular smooth muscle than cardiac muscle. CARDENE SR is indicated for the treatment of hypertension and may be used alone or in combination with other antihypertensive drugs. In hypertension, CARDENE SR produced decreases in both systolic and diastolic blood pressure throughout the dosing interval in clinical trials. The antihypertensive efficacy of CARDENE SR administered twice daily has been demonstrated using in-clinic blood pressure measures in placebo controlled trials involving patients with mild to moderate hypertension and in trials using 12 or 24 hour ambulatory blood pressure monitoring. The pharmacokinetics of CARDENE SR in elderly hypertensive subjects (mean age 70 years) were compared to those in younger hypertensive subjects (mean age 44 years). After a single dose and after 1 week of dosing with CARDENE SR there were no significant differences in Cmax, Tmax, AUC or clearance between the young and elderly subjects. In both groups of subjects, steady-state plasma levels were significantly higher than following a single dose. In the elderly subjects, a disproportional increase in plasma levels with dose was observed similar to that observed in normal subjects. Clinical studies of nicardipine did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious. Recent evidence supports a central role for calcium channel blockers (CCBs), and in particular the dihydropyridine (DHP) agents, in the treatment of hypertension.² Indeed, the efficacy and safety of DHP CCBs argue for their inclusion in any combination therapy used to treat hypertensive patients.² References CARDENE SR [prescribing information]. Redwood City, Calif: PDL BioPharma, Inc; 2007. Messerli FH, Noll G, Lindholm LH, Haller H, Ruilope LM and Volpe M. The role of dihydropyridine calcium channel blockers in the treatment of hypertension and cardiovascular disease-an update. Euro CVS Med. 2006; 1-6.

Important Safety Information
CARDENE SR is contraindicated in patients with known hypersensitivity to the drug and in patients with advanced aortic stenosis. Reduction of diastolic pressure by any means in these patients may worsen rather than improve myocardial oxygen balance. Caution is advised when administering Cardene SR to patients with angina, congestive heart failure (particularly those who are also taking a ß-blocker), impaired renal or hepatic function, or severe left ventricular dysfunction. Cardene SR provides no protection against the dangers of abrupt ß-blocker withdrawal. The immediate release form of nicardipine caused an increase in angina in 7% of patients compared to 4% on placebo. The most common adverse events were headache (6.2%), pedal edema (5.9%), vasodilation (4.7%), increased angina (4%), palpitation (2.8%), nausea (1.9%), and dizziness (1.6%). Cyclosporine levels should be monitored closely during therapy.

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