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Uses and Administration Adverse Effects and Precautions Natriuretic tive study2 comparing nesiritide with inotrope therapy or maintenance dose is 30mg three times daily, but daily doses Uses and Administration glyceryl trinitrate in patients with acute decompensated of between 60 and 120 mg in divided doses may be given. Nesiritide is a recombinant brain natriuretic peptide (see heart failure found a similar risk of in-hospital mortality Modified-release preparations of nicardipine hydrochloride p. 1444. 1) used in the management of acutely decom­ with nesiritide and glyceryl trinitrate, which was signifi­ for dosage twice daily are also available. pensated heart failure (below). It is given intravenously as cantly lower than the risk with inotrope therapy. How­ Nicardipine hydrochloride may be given by slow the citrate, but dosage is expressed in terms of the base. The ever, a meta-analysis3 of controlled studies comparing intravenous infusion as a lOO micrograms/mL solution in initial dose of nesiritide is 2 micrograms/kg by intravenous nesiritide with non-inotrope control therapy found that the short-term treatment of hypertension. An initial injection over l minute, followed by a maintenance there was a trend to higher mortality at 30 days in patients infusion rate of 5 mg/hour is recommended, increased, as infusion of IOnanograms/kg per minute. given nesiritide; the results were not statistically signifi­ necessary, up to a maximum of 15 mg/hour and cant, but became so after correction of the number of subsequently reduced to 3 mg/hour. For more information Heart failure. The use of nesiritide in acute decompen­ deaths in one of the studies.4 A later meta-analysis5 also regarding suitable diluents and incompatibilities, see sated heart failure (p. 1262.3) has been reviewed l·4 It found a trend towards increased mortality with nesiritide Incompatibility, above. For intravenous use in children, may be used for short-term treatment as an alternative to at 30 days, but the results again were not statistically sig­ see below. standard intravenous therapy with vasodilators, inotropes, nificant, and there was no difference in mortality between Reduced oral doses of nicardipine hydrochloride and or diuretics, and appears to have no proarrhythmic effects; nesiritide and control patients at 180 days. longer dosing intervals may be necessary in patients with however, its effects on mortality are controversial (see I. Yancy CW. Benefit-risk assessment of nesiritide in the treatment of hepatic or renal impairment (see helow). under Adverse Effects and Precautions, below) and its role acute decompensated heart failure. Drug Safety 2007; 30: 765-81. 2. WT et al. in therapy remains unclear. There is some evidence that it Abraham , In-hospital mortality in patients with acute decompensated heart failure requiring intravenous vasoactive medica­ Reviews. to standard therapy'·' and may be safely used in addition tions: an analysis from the Acute Decompensated Heart Failure National I 1. Curran MP, et al. Intravenous nicardipine: its use in the short-term may have a role as a more prolonged treatment in patients Registry (ADHERE). JAm Coil Cardiol 2005; 46: 57-64. treatment of hypertension and various other indications. Drugs 2006; 66: I755-82. awaiting cardiac transplantation.8 Nesiritide has also been 3. Sackner-Bernstein JD, et al. Short-term risk of death after treatment given intermittently for outpatient management of chronic with nesiritide for decompensated heart failure: a pooled analysis of randomized controlled trials. JAMA 2005; 293: I900-5. advised against such use.ll heart failure,9,10 but some have 4. Aaronson KD, Sackner-Bernstein J. Risk of death associated with Administration in children. Intravenous infusion of nicar­ l. Vichiendilokku! A, et al. Nesiritide: a novel approach for acute heart nesiritide in patients with acutely decompensated heart failure. lAMA dipine has been used in both infants and children for the failure. Ann Pharmacother 2003; 37: 247-58. 2006; 296: 1465-6. 2. Keating GM, Goa KL. Nesiritide: a review of its use in acute 5. Arora RR, et al. Short and long-term mortality with nesiritide. Am Heart J management of hypertension. In studies1·4 in patients decompensated hean failure. Drugs2003; 63: 47-70. 2006; 152: 1084-90. aged between 2 days and 17 years, initial doses ranged 3. Yancy CW. Benefit-risk assessment of nesiritide in the treatment of from 0.2 to 5 micrograms/kg per minute, with mainte­ Drug Safety 2007; 30: 765-81. acute decompensated heart failure. nance infusions of 0.15 to 6micrograms/kg per minute. 4. Tong AT, Rozner MA. The role of ne�iritide in heart failure. Expert Opin Interactions Drug Metab Toxicol 2009; 5: 823-34. Adverse effects were rare; one study4 reported adverse K.M pulmonary hypertension in The risk of hypotension may be increased in patients 5. O'Dell , et al. Nesiritide for secondary effects in 5 of 31 treatment courses, including tachycardia, patients with end-stage heart failure. Am J Health-Syst Pharm 2005; 62: receiving nesiritide with other drugs that lower blood flushing, palpitations. and hypotension. There has also 606-9. pressure. 6. Smull DL, Jorde UP. Concomitant use of nesiritide and milrinone in been a report5 of the successful use of intravenous infu­ decompensated congestive heart failure. Am J Health-Syst Pharm 2005; sion of nicardipine in 8 preterm infants (gestational age 28 62: 291-5. Pharmacokinetics to 36 weeks). Infusions were given at a dose of 0.5 to 7. Sakr A, et a!. Nesiritide in the initial management of acute 2 micrograms/kg per minute and continued for periods of decompensated congestive heart failure. Conn Med2008; 72: 517-2 3. Nesiritide is cleared from the circulation by 3 mechanisms: 3 to 36 days. Hypotension, oedema, or tachycardia were 8. Witteles R, et al. natriuretic peptide is effective therapy before uptake into cells; proteolytic cleavage by endopeptidases; care. Ann 141: 895. and excretion by the kidneys. It has a biphasic elimination. not seen. 9. Sheikh-Taha M. Intermittent nesiritide therapy in outpatients with The BNFC suggests that neonates and children up to age Pharm 2005; 62: 196-8. with a terminal elimination half-life of 18 minutes. chronic heart failure. Am J Health-Syst 18 years may be given nicardipine hydrochloride by I 0. Schwarz ER, et al. Intermittent outpatient nesiritide infusion reduces hospital admissions in patients with advanced heart failure. J Cardiovasc Preparations continuous intravenous infusion for the management of Pharmacal Ther 2007; 12: 232-6. .................. ....... hypertensive crises. The initial dose is 500 nanograms/kg MA treatment of heart II. Bauer JB, Randazzo . Nesiritide for outpatient Proprietary Preparations (details are given in Volume B) per minute. adjusted according to response; the usual failure. Am J Health"Syst Pharm 2005; 62: 2639-42. Single-ingredient Preparations. Arg.: Natrecor; Canad.: Natrecor; maintenance dose is 1 to 4micrograms/kg per minute, with Indon.: Natrecort; Israel: Noratak; Singapore: Natrecort; a maximum dose of 250micrograms/minute. Adverse Effects and Precautions Switz.: Noratakt; USA: Natrecor; Venez. : Natrecor. 1. Treluyer JM, et al. Intravenous nicardipine in hypertensive children. Bur J Pediatr 1993; 152: 7l2-4. The most common adverse effects of nesiritide relate to 2. Sartori SC, et at. Intravenous nicardipine for treatment ol systemic vasodilatation and include hypotension, headache, and hyperten.:;ion in children. Pediatrics I999; 104 676-7. dizziness. Nausea and vomiting, abdominal pain, back pain, Nicardipine Hydrochloride 3. Tobias JD. Nicardipine to control mean angina pectoris, insomnia, and anxiety, have also been (BANM, USAN, r/NNM) cardiothoracic surgery in infants and children. Am reported. Cardiac arrhythmias have occurred but may be 4. Flynn JT, et al. Intravenous nicardipine for treatment of severe hypertension in children. .JPediatr 200I; 139: 38-43. HidfOdoruro de .· ni<:ardipln6; Nicardipina Cioridrato; Nicar" associated with the underlying condition. Adverse effects on 5. Gouyon JB, et al. Intravenous nicardipine in hypertensive preterm renal function have been reported. If hypotension occurs dipine; Chlorhydrate de; Nfcardipini Hydrochloridum; infants. Arch Dis Child 1997; 76: F126-F127. the infusion of nesiritide should be stopped or the dose Niqrdiptno, hidrodorum de: Nii<ardrpiinihydroklcridi; Nikar­ reduced and general supportive measures should be used; dlpirV H1ctroklorur; : Nikardiplohydrok!orid; RS-69216; RS- Administration in hepatic or renal impairment. Reduced the hypotension may persist for several hours. 69216-XX-O:Z,O; YC HvtKilPJllA!lt-1HafM ApoxnopVlA. �93; doses of nicardipine hydrochloride and longer dosing Nesiritide should not be used as primary therapy in 2-[Benzyl(trletbyl)amino]etbyl methyl A-dihydro-2,6- 1 intervals may be necessary in patients with hepatic or patients with cardiogenic shock or with hypotension. It is dimethyl-4-(3:ni1;topheoyl)pyrldine-3,5-dicarboxylare hydro­ not recommended in patients with low cardiac filling renal impairment. US licensed product information has J::hloride. · · pressures or in those for whom vasodilators are recommended an initial oral dose of 20 mg twice daily in inappropriate, such as those with significant valvular C;J:l79N;00,HCI":516.0 . patients with hepatic impairment. CAS - 55985-JJ-S lnic:.ardJvin.e): 54521··84-3 (nicarqipine stenosis, restrictive or obstructive cardiomyopathy, con­ . strictive pericarditis, or pericardia! tamponade. hyd(ochlotide). ATC- C08CA.04. Cerebrovascular disorders. Nimodipine (p. 1455.3)
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