Amiodarone (Nexterone) injection for the treatment and prophylaxis of frequently recurring ventricular fibrillation

Bibliography

• Connolly SJ. Evidence-based analysis of amiodarone efficacy and safety. Circulation 1999;100(19):2025-34
   PubMedGoogle Scholar
• Kowey PR, Marinchak RA, Rials SJ, Intravenous amiodarone. J Am Coll Cardiol 1997;29(6):1190-8
   PubMedGoogle Scholar
• Van Herendael H, Dorian P. Amiodarone for the treatment and prevention of ventricular fibrillation and ventricular tachycardia. Vasc Health Risk Manag 2010;6:465-72
   PubMedGoogle Scholar
• Scheinman MM, Levine JH, Cannom DS, Dose-ranging study of intravenous amiodarone in patients with life-threatening ventricular tachyarrhythmias. The Intravenous Amiodarone Multicenter Investigators Group. Circulation 1995;92:3264-72
   PubMed Web of Science ®Google Scholar
• Levine JH, Massumi A, Scheinman MM, Intravenous amiodarone for recurrent sustained hypotensive ventricular tachyarrhythmias. Intravenous Amiodarone Multicenter Trial Group. J Am Coll Cardiol 1996;27:67-75
   PubMed Web of Science ®Google Scholar
• Kowey PR, Levine JH, Herre JM, Randomized, double-blind comparison of intravenous amiodarone and bretylium in the treatment of patients with recurrent, hemodynamically destabilizing ventricular tachycardia or fibrillation. The Intravenous Amiodarone Multicenter Investigators Group. Circulation 1995;92:3255-63
   PubMed Web of Science ®Google Scholar
• Abraxis Pharmaceutical Products. Amiodarone hydrochloride injection [prescribing information]. Schaumburg, Illinois: Abraxis Pharmaceutical Products website. Available from: http://editor.apppharma.com/PIs/Amiodarone_Inj_45887H_Apr_08.pdf [Accessed 20 July 2011]
   Google Scholar
• Ward GH, Yalkowsky SH. Studies in phlebitis: VI. Dilution-induced precipitation of amiodarone HCL. J Parenter Sci Technol 1993;47:161-5
   PubMedGoogle Scholar
• Chalmers JR, Bobek MB, Militello MA. Visual compatibility of amiodarone hydrochloride injection with various intravenous drugs. Am J Health Syst Pharm 2001;58:504-6
   PubMedGoogle Scholar
• Pearson SD, Trissel LA. Leaching of diethylhexyl phthalate from polyvinyl chloride containers by selected drugs and formulation components. Am J Hosp Pharm 1993;50:1405-9
   PubMedGoogle Scholar
• Center for Devices and Radiological Health: US FDA. Safety Assessment of Di(2-ethylhexyl)phthalate (DEHP) Released From PVC Medical Devices. Center for Devices and Radiological Health; Rockville, MD: 2008
   Google Scholar
• Cushing DJ, Adams MP, Cooper WD, Bioequivalence of 2 intravenous amiodarone formulations in healthy participants. J Clin Pharmacol 2009;49(4):407-15
   PubMedGoogle Scholar
• Food and Drug Administration. NDA approval letter. December 24, 2008. Available from: http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022325s000ltr.pdf [Accessed 20 July 2011]
   Google Scholar
• Gough WB, Zeiler RH, Barecca P, Hypotensive action of commercial intravenous amiodarone and polysorbate 80 in dogs. J Cardiovasc Pharmacol 1982;4:375-80
   PubMed Web of Science ®Google Scholar
• Freedman MD, Somberg JC. Pharmacology and pharmacokinetics of amiodarone. J Clin Pharmacol 1991;31:1061-9
   PubMedGoogle Scholar
• Anastasiou-Nana M, Lewis G, Moulopoulos S. Plasma levels of amiodarone after intravenous and oral administration. J Clin Chem Clin Biochem 1981;19:599-600
   Google Scholar
• Venkatesh N, Somani P, Bersohn M, Electropharmacology of amiodarone: absence of relationship to serum, myocardial, and cardiac sarcolemmal membrane drug concentrations. Am Heart J 1986;112:916-22
   PubMedGoogle Scholar
• Ujhelyi MR, Klamerus KJ, Vadiei K, Disposition of intravenous amiodarone in subjects with normal and impaired renal function. J Clin Pharmacol 1996;36:122-30
   PubMedGoogle Scholar
• Morady F, DiCarlo LA, Krol RB, Acute and chronic effects of amiodarone on ventricular refractoriness, intraventricular conduction and ventricular tachycardia induction. J Am Coll Cardiol 1986;7:148-57
   PubMedGoogle Scholar
• Gomes JAC, Kang PS, Hariman RJ, Electrophysiologic effects and mechanisms of termination of supraventricular tachycardia by intravenous amiodarone. J Am Coll Cardiol 1984;107:214-21
   Google Scholar
• Kodama I, Kamiya K, Toyama J. Cellular electropharmacology of amiodarone. Cardiovasc Res 1997;35(1):13-29
   PubMedGoogle Scholar
• Charlier R. Cardiac actions in the dog of a new antagonist of adrenergic excitation which does not produce competitive blockade of adrenoceptors. Br J Pharmacol 1970;39:668-7
   PubMedGoogle Scholar
• Helmy I, Herre JM, Gee G, Use of intravenous amiodarone for emergency treatment of life-threatening ventricular arrhythmias. J Am Coll Cardiol 1988;12:1015-22
   PubMed Web of Science ®Google Scholar
• Schmidt A, Konig W, Binner L, Efficacy and safety of intravenous amiodarone in acute refractory arrhythmias. Clin Cardiol 1988;11:481-5
   PubMedGoogle Scholar
• Mooss AN, Mohiuddin SM, Hee TT, Efficacy and tolerance of high-dose intravenous amiodarone for recurrent, refractory ventricular tachycardia. Am J Cardiol 1990;65:609-14
   PubMedGoogle Scholar
• Kudenchuk PJ, Cobb LA, Copass MK, Amiodarone for resuscitation after out-of-hospital cardiac arrest due to ventricular fibrillation. N Engl J Med 1999;341(12):871-8
   PubMed Web of Science ®Google Scholar
• Dorian P, Cass D, Shwartz B, Amiodarone as compared with lidocaine for shock resistant ventricular fibrillation. N Engl J Med 2002;346(12):884-90
   PubMed Web of Science ®Google Scholar
• Marill KA, deSouza IS, Nishijima DK, Amiodarone is poorly effective for the acute termination of ventricular tachycardia. Ann Emerg Med 2006;47(3):217-24
   PubMedGoogle Scholar
• Tomlinson DR, Cherian P, Betts TR, Bashir Y. Intravenous amiodarone for the pharmacological termination of haemodynamically-tolerated sustained ventricular tachycardia: is bolus dose amiodarone an appropriate first-line treatment? Emerg Med J 2008;25(1):15-18
   PubMedGoogle Scholar
• Schutzenberger W, Leisch F, Kerschner K, Clinical efficacy of intravenous amiodarone in the short-term treatment of recurrent sustained ventricular tachycardia and ventricular fibrillation. Br Heart J 1989;62(5):367-71
   PubMedGoogle Scholar
• Gorgels AP, van den Dool A, Hofs A, Comparison of procainamide and lidocaine in terminating sustained monomorphic ventricular tachycardia. Am J Cardiol 1996;78(1):43-6
   PubMedGoogle Scholar
• Somberg JC, Bailin SJ, Haffajee CI, Intravenous lidocaine versus intravenous amiodarone (in a new aqueous formulation) for incessant ventricular tachycardia. Am J Cardiol 2002;90(8):853-9
   PubMed Web of Science ®Google Scholar
• Credner SC, Klingenheben T, Mauss O, Electrical storm in patients with transvenous implantable cardioverter-defibrillators. Incidence, management and prognostic implications. J Am Coll Cardiol 1998;32(7):1909-15
   PubMedGoogle Scholar
• Kavesh NG, Olsovsky MR, Freudenberger RS, Intravenous amiodarone suppression of electrical storm refractory to chronic oral amiodarone. Pacing Clin Electrophysiol 1999;22(4 Pt 1):665-7
   PubMedGoogle Scholar
• Neumar RW, Otto CW, Link MS, Part 8: adult Advanced Cardiovascular Life Support: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation 2010;122:S729-67
   PubMed Web of Science ®Google Scholar
• Nguyen PT, Scheinman MM, Seger J. Polymorphous ventricular tachycardia: clinical characterization, therapy, and the QT interval. Circulation 1986;74:340-9
   PubMedGoogle Scholar
• Kowey PR. Overall safety survey for the intravenous amiodarone trials [abstract]. Circulation 1994;90(Suppl I):I-545
   Google Scholar
• Cushing DJ, Cooper WD, Gralinski MR, Lipicky RJ. The hypotensive effect of intravenous amiodarone is sustained throughout the maintenance infusion period. Clin Exp Pharmacol Physiol 2010;37(3):358-61
   PubMedGoogle Scholar
• Krantz JC, Carr CJ, Bird JG, Cook S. Sugar alcohols: XXVI. Pharmacodynamic studies of polyoxyalkylene derivatives of hexitol anhdride partial fatty acid esters. J Pharmacol Exp Ther 1948;93(2):188-95
   PubMedGoogle Scholar
• Platou ES, Refsum H. Acute electrophysiologic and blood pressure effects of amiodarone and its solvent in the dog. Acta Pharmacol Toxicol 1986;58(3):163-8
   PubMedGoogle Scholar
• Torres-Arraut E, Singh S, Pickoff AS. Electrophysiologic effects of Tween-80 in the myocardium and specialized conduction system of the canine heart. J Electrocardiol 1984;17(2):145-51
   PubMedGoogle Scholar
• Yasaka WJ, Eichbaum FW, Oga S. Antiarrhythmic effects of solvents: III. Effects of propylene glycol and benzyl alcohol on contractile force of isolated rabbit heart. Cardiovasc Res 1979;13(12):717-22
   PubMedGoogle Scholar
• Hohnloser SH, Kleingenheben T, Singh BN. Amiodarone-associated proarrhythmic effects: a review with special reference to torsade de pointes tachycardia. Ann Intern Med 1994;121(7):529-35
   PubMed Web of Science ®Google Scholar
• Brown MA, Smith WM, Lubbe WF, Norris RM. Amiodarone-induced torsades de pointes. Eur Heart J 1986;7(3):234-9
   PubMedGoogle Scholar
• Vrobel TR, Miller PE, Mostow ND, Rakita L. A general overview of amiodarone toxicity: its prevention, detection, and management. Prog Cardiovasc Dis 1989;31(6):393-426
   PubMedGoogle Scholar
• Tagliamonte E, Cice G, Ducceschi V, Acute hepatitis following amiodarone administration. Minerva Cardioangiol 1997;45(9):451-6
   PubMedGoogle Scholar
• Kosinski EJ, Albin JB, Young E, Hemodynamic effects of intravenous amiodarone. J Am Coll Cardiol 1984;4(3):565-70
   PubMedGoogle Scholar
• Trissel LA. Amiodarone hydrochloride AHFS 24:04.04. In: Trissel LA, editor. Handbook on Injectable Drugs. 14th edition. American Society of Health-System Pharmacists; Bethesda, MD: 2007. p. 112-18
   Google Scholar
• Kessler D, Palepu N, Tustian A, A novel amiodarone microemulsion injectable formulation [abstract]. AAPS Pharm Sci 2002;4:W4122
   Google Scholar
• Somberg JC, Timar S, Bailin SJ, Lack of a hypotensive effect with rapid administration of a new aqueous formulation of intravenous amiodarone. Am J Cardiol 2004;93(5):576-81
   PubMedGoogle Scholar
• Somberg JC, Cvetanovic I, Ranade V, Comparative effects of rapid bolus administration of aqueous amiodarone versus 10-min Cordarone IV infusion on mean arterial blood pressure in conscious dogs. Cardiovasc Drugs Ther 2004;18(5):345-51
   PubMedGoogle Scholar
• Somberg JC, Cao W, Cvetanovic I, Pharmacology and toxicology of a new aqueous formulation of intravenous amiodarone (Amio-Aqueous) compared with Cordarone IV. Am J Ther 2005;12:9-16
   PubMedGoogle Scholar
• Kipp JE, Doty MJ, Rebbeck CL, Eilert JY. inventors. Baxter international, assignee. Amiodarone-containing parenteral administration. US6479541; 2002
   Google Scholar
• Elhasi S, Astaneh R, Lavasanifar A. Solubilization of an amphiphilic drug by poly(ethylene oxide)-block-poly(ester) micelles. Eur J Pharm Biopharm 2007;65:406-13
   PubMed Web of Science ®Google Scholar
• Loftsson T, Jarho P, Masson M, Jarvinen T. Cyclodextrins in drug delivery. Expert Opin Drug Deliv 2005;2(2):335-51
   PubMedGoogle Scholar
• Stella VJ, He Q. Cyclodextrins. Toxicol Pathol 2008;36(1):30-42
   PubMed Web of Science ®Google Scholar
• Cushing DJ, Kowey PR, Cooper WD, PM101: a cyclodextrin-based intravenous formulation of amiodarone devoid of adverse hemodynamic effects. Eur J Pharmacol 2009;607(1-3):167-72
   PubMed Web of Science ®Google Scholar
• Cushing DJ, Cooper WD, Gralinski MR, Comparison of the cardiac electrophysiology and general toxicology of two formulations of intravenous amiodarone in dogs. Cardiovasc Toxicol 2009;9(3):126-33
   PubMedGoogle Scholar
• Cushing DJ, Adams MP, Cooper WD, Evaluation of the effects of PM101, a cyclodextrin-based formulation of intravenous amiodarone, on blood pressure in healthy humans. Am J Cardiol 2009;104(8):1152-7
   PubMedGoogle Scholar
• Souney PF, Cooper WD, Cushing DJ. PM101: intravenous amiodarone formulation changes can improve medication safety. Expert Opin Drug Saf 2010;9:319-33
   PubMed Web of Science ®Google Scholar
• Souney PF, Cowee J, Mosher G, Cushing DJ. Stability of intravenous amiodarone formulations in glass, polyolefin, and polyvinylchloride containers over 72 h. Presented at: Midyear Clinical Meeting of the American Society of Health System Pharmacists; December 2008; Orlando, FL
   Google Scholar
• Cushing DJ, Adams MP, Cooper WD, Comparative bioavailability of a premixed, ready-to-use formulation of intravenous amiodarone with traditional admixture in healthy subjects. J Clin Pharmacol 2011. [Epub ahead of print]
   Google Scholar
• Parshuram CS, To T, Seto W, Systematic evaluation of errors occurring during the preparation of intravenous medication. CMAJ 2008;178:42-8
   PubMed Web of Science ®Google Scholar
• Skibinski KA, White BA, Lin LI, Effects of technological interventions on the safety of a medication-use system. Am J Health Syst Pharm 2007;64:90-6
   PubMed Web of Science ®Google Scholar
• Fanikos J, Erickson A, Munz KE, Observations on the use of ready-to-use and point-of-care activated parenteral products in automated dispensing cabinets in US hospitals. Am J Health Syst Pharm 2007;64:2037-43
   PubMed Web of Science ®Google Scholar