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ANNE ARUNDEL MEDICAL CENTER CRITICAL CARE MEDICATION MANUAL DEPARTMENT OF NURSING AND PHARMACY Guidelines for Use of Intravenous Nicardipine (Cardene IV) MAJOR INDICATION Management of hypertension; only use parenteral (IV) for short-term use when oral treatment is not feasible nor desirable MECHANISM OF ACTION Nicardipine is a calcium channel blocker. It works by inhibiting calcium ion from entering the slow channels of select voltage-sensitive areas of the vascular smooth muscle and myocardium during depolarization. This causes relaxation of coronary vascular smooth muscle and coronary vasodilation. It also increases myocardial oxygen delivery in patients with vasospastic angina. PHARMACOKINETICS Nicardipine IV has a rapid onset of action. It acts within 1-2 minutes. 50% of the maximum effect is observed within 45 minutes with IV continuous infusion. In treatment of acute hypertension in chronic hypertensives, discontinuation of infusion produced a 50% decrease in effect in approximately 30 minutes with gradually decreasing effect over the following 50 hours. Nicardipine IV and oral nicardipine immediate release have duration of action of < 8 hours. The volume of distribution is 8.3 L/kg. More than 95% of nicardipine is bound to plasma protein. 100% of oral nicardipine is absorbed, but there is a large first-pass effect. The peak effect of immediate capsules is 1-2 hours. METABOLISM AND EXCRETION Nicardipine is metabolized by the liver. There is extensive first-pass effect and the major pathway is via CYP3A4. The half-life follows a dose-dependent (non-linear) pharmacokinetics. Calculated half-life is dependent upon serum concentrations. After IV infusion, serum concentrations decrease tri-exponentially: o Alpha half-life: 2.7 minutes o Beta half-life: 44.8 minutes o Terminal half-life: 14.4 hours Half-life over the first 8 hours after oral dosing is 2-4 hours. Terminal half-life (oral) is 8.6 hours. 60% of oral nicardipine is excreted in urine as metabolites. 49% of nicardipine IV is excreted in urine as metabolites. <1% is excreted unchanged. 35% of oral nicardipine is excreted in feces and 43% of nicardipine IV is excreted in feces. ADMINISTRATION AND MONITORING For IV administration, nicardipine should be administered as a slow continuous infusion via central line or via a large peripheral vein. To minimize peripheral venous irritation, change the site of infusion every 12 hours. Monitor blood pressure, heart rate, and EKG (for IV). For premixed bags, do not combine or run in the same line as other medications. Nicardipine IV is not compatible with Sodium Bicarbonate containing solutions or Lactated Ringers. Page 1 of 4 Last updated: July 2016 ANNE ARUNDEL MEDICAL CENTER CRITICAL CARE MEDICATION MANUAL DEPARTMENT OF NURSING AND PHARMACY Guidelines for Use of Intravenous Nicardipine (Cardene IV) Injectable detail for administration: o pH: vial: 3.5 o pH: Premixed bag: 3.7-4.7 For oral administration, administer without regards to meals. Avoid opening or cutting the capsules. DOSING The recommended dosing of IV nicardipine is 5 mg/hour initially with titration in 2.5 mg/hour increments every 5-15 minutes until desired effect is achieved, up to a maximum of 15 mg/hour. Dose Infusion Rate 2.5 mg/hr 25 mL/hr 5 mg/hr 50 mL/hr 7.5 mg/hr 75 mL/hr 10 mg/hr 100 mL/hr 12.5 mg/hr 125 mL/hr 15 mg/hr (maximum) 150 mL/hr Prolonged therapy with IV Nicardipine may require dosage reductions due to drug accumulation. The medication may exhibit a prolonged duration of effect in those patients with renal and/or hepatic insufficiency. IV Nicardipine should be titrated carefully in patients with renal dysfunction and severe hepatic dysfunction. PO for Angina/Hypertension o Immediate release (oral): 20 mg 3 times daily o Usual dosage: 20-40 mg 3 times daily o *Allow > 3 days between dose increases o *Cardene SR has been discontinued in the United States for more than 1 year. CONTRAINDICATIONS Hypersensitivity to nicardipine or any component of the formulation Advanced aortic stenosis Severe CHF Severe hypotension or Cardiogenic Shock PRECAUTIONS Increased angina and/or MI have occurred with initiation or dosage titration of dihydropyridine calcium channel blockers. Peripheral edema more common in oral therapy is a common side effect that occurs within 2-3 weeks of initiating therapy. Tachycardia may occur; therefore, heart rate should be closely monitored. Use with caution in patients with mild to moderate aortic stenosis. Nicardipine may reduce coronary perfusion resulting in ischemia. In concomitant use with a beta-blocker in patients with severe left ventricular dysfunction, nicardipine may worsen symptoms of heart failure due to its negative inotropic effects. Use with caution in patients with hepatic impairment or reduced hepatic blood flow. Page 2 of 4 Last updated: July 2016 ANNE ARUNDEL MEDICAL CENTER CRITICAL CARE MEDICATION MANUAL DEPARTMENT OF NURSING AND PHARMACY Guidelines for Use of Intravenous Nicardipine (Cardene IV) Use with caution in patients with hypertrophic cardiomyopathy and outflow tract obstruction because a reduction in afterload may worsen symptoms. Initiate at the lower end of the dosing range for elderly. Peripheral infusion sites should be changed every 12 hours to minimize infusion site reactions. Avoid use of small peripheral veins. Rebound angina may occur in patients with CAD with abrupt withdrawal. Hypotension or syncope DRUG INTERACTIONS Antifungal agents (azole derivatives, systemic) may enhance adverse effects of nicardipine. P-glycoprotein/ABCB1 inhibitors (nicardipine) may increase the serum concentration of topotecan and vincristine (liposomal); therefore, avoid combination. Carbamazepine may increase the metabolism of nicardipine. Therefore, for patients receiving concomitant carbamazepine consider calcium channel blocker dose adjustments or alternative therapy. Nicardipine may enhance the hypotensive effect of carvedilol. Nicardipine may increase the serum concentration of carvedilol and precipitate signs of heart failure in patients on carvedilol. P-glycoprotein/ABCB1 inhibitors (nicardipine) may increase serum concentrations of the active metabolites of dabigatran etexilate; therefore dose reductions of dabigatran may be needed. Grapefruit juice may increase the serum concentration of nicardipine; therefore monitor therapy. Nicardipine may increase the serum concentrations of lacosamide; therefore, consider therapy modification. Many more drug interactions (CYP 3A4), please consult pharmacy as needed. ADVERSE EFFECTS Cardiovascular: flushing (6-10%), pedal edema (dose-related; 7-8%), exacerbation of angina pectoris (dose-related; 6%), hypotension (IV 6%), palpitations (3-4%), tachycardia (1-4%), orthostatic hypotension, ventricular extrasystoles. Rarely: AV block, ST segment depression, inverted T waves. Central nervous system: headache (6-15%), dizziness (4-7%) Gastrointestinal: nausea and vomiting (IV 5%) Neuromuscular & skeletal: weakness (4-6%) Miscellaneous: sweating, thrombocytopenia, injection site reactions COMMENTS Avoid grape fruit juice. Cardene SR has been discontinued in the United States for more than 1 year. For treatment over dosage, the infusion should be stopped and standard measures including monitoring of cardiac and respiratory functions should be implemented. The patient should be positioned so as to avoid cerebral anoxia (Trendelenburg). Page 3 of 4 Last updated: July 2016 ANNE ARUNDEL MEDICAL CENTER CRITICAL CARE MEDICATION MANUAL DEPARTMENT OF NURSING AND PHARMACY Guidelines for Use of Intravenous Nicardipine (Cardene IV) REFERENCES Nicardipine. In: Lexi-Drugs Online [Internet Database]. Hudson, OH: Lexi-Comp, Inc. Updated 2016 Jul 1. IV Additive Service Drug Name (Generic) Nicardipine Premixed Bags 20 mg / 200 mL Nicardipine 25 mg ampules (2.5 mg/mL, 10 mL) – must be diluted before use Storage Requirements Store at room temp. Protect from light until ready to use. Ampules should be protected from light until used and stored at room temperature. Preparation None required Resulting Concentration 0.1 mg/mL Stability Per manufacturer’s expiration date on product Inject 10 mL of 0.1 mg/mL Resulting solution Nicardipine is stable at room (Cardene) 2.5 temperature for 24 mg/mL into a hours. 250 mL bag of NSS or D5W. ** ** Final concentration slightly less than 0.1mg/mL due to overfill in bag but close enough as will titrate to response. Page 4 of 4 Last updated: July 2016