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Volumn 49, Issue 4, 2009, Pages 407-415

Bioequivalence of 2 intravenous amiodarone formulations in healthy participants

Author keywords

Bioequivalence; Cyclodextrin; Intravenous amiodarone; Pharmacokinetics

Indexed keywords

ALANINE AMINOTRANSFERASE; AMIODARONE; BENZYL ALCOHOL; BETA CYCLODEXTRIN SULFOBUTYL ETHER; CITRATE TRISODIUM; CITRIC ACID; DEETHYLAMIODARONE; POLYSORBATE 80;

EID: 63849314403     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270008330156     Document Type: Article
Times cited : (10)

References (37)
  • 1
    • 0030840868 scopus 로고    scopus 로고
    • The role of intravenous amiodarone in the management of cardiac arrhythmias
    • Desai AD, Chun S., Sung RJ The role of intravenous amiodarone in the management of cardiac arrhythmias. Ann Intern Med. 1997; 127: 294-303.
    • (1997) Ann Intern Med , vol.127 , pp. 294-303
    • Desai, A.D.1    Chun, S.2    Sung, R.J.3
  • 2
    • 0029789278 scopus 로고    scopus 로고
    • Intravenous amiodarone is safe and seems to be effective in termination of paroxysmal supraventricular tachyarrhythmias
    • Cybulski J., Kulakowski P., Makowska E., Czepiel A., Sikora-Frac M., Ceremuzynski L. Intravenous amiodarone is safe and seems to be effective in termination of paroxysmal supraventricular tachyarrhythmias. Clin Cardiol. 1996; 19: 563-566.
    • (1996) Clin Cardiol. , vol.19 , pp. 563-566
    • Cybulski, J.1    Kulakowski, P.2    Makowska, E.3    Czepiel, A.4    Sikora-Frac, M.5    Ceremuzynski, L.6
  • 3
    • 0023726549 scopus 로고
    • Use of intravenous amiodarone for emergency treatment of life-threatening ventricular arrhythmias
    • Helmy I., Herre JM, Gee G., et al. Use of intravenous amiodarone for emergency treatment of life-threatening ventricular arrhythmias. J Am Coll Cardiol. 1988; 12: 1015-1022.
    • (1988) J Am Coll Cardiol , vol.12 , pp. 1015-1022
    • Helmy, I.1    Herre, J.M.2    Gee, G.3
  • 4
    • 0032703766 scopus 로고    scopus 로고
    • Intravenous antiarrhythmic drug therapy in the resuscitation from refractory ventricular arrhythmias
    • Kudenchuk PJ Intravenous antiarrhythmic drug therapy in the resuscitation from refractory ventricular arrhythmias. Am J Cardiol. 1999; 84: 52R - 55R.
    • (1999) Am J Cardiol. , vol.84
    • Kudenchuk, P.J.1
  • 5
    • 0028879601 scopus 로고
    • Dose-ranging study of intravenous amiodarone in patients with life-threatening ventricular tachyarrhythmias. the Intravenous Amiodarone Multicenter Investigators Group
    • Scheinman MM, Levine JH, Cannom DS, et al. Dose-ranging study of intravenous amiodarone in patients with life-threatening ventricular tachyarrhythmias. The Intravenous Amiodarone Multicenter Investigators Group. Circulation. 1995; 92: 3264-3272.
    • (1995) Circulation. , vol.92 , pp. 3264-3272
    • Scheinman, M.M.1    Levine, J.H.2    Cannom, D.S.3
  • 6
    • 0030025539 scopus 로고    scopus 로고
    • Intravenous amiodarone for recurrent sustained hypotensive ventricular tachyarrhythmias. Intravenous Amiodarone Multicenter Trial Group
    • Levine JH, Massumi A., Scheinman MM, et al. Intravenous amiodarone for recurrent sustained hypotensive ventricular tachyarrhythmias. Intravenous Amiodarone Multicenter Trial Group. J Am Coll Cardiol. 1996; 27: 67-75.
    • (1996) J Am Coll Cardiol. , vol.27 , pp. 67-75
    • Levine, J.H.1    Massumi, A.2    Scheinman, M.M.3
  • 7
    • 0028851860 scopus 로고
    • 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
    • Kowey PR, Levine JH, Herre JM, et al. 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: 3255-3263.
    • (1995) Circulation. , vol.92 , pp. 3255-3263
    • Kowey, P.R.1    Levine, J.H.2    Herre, J.M.3
  • 12
    • 0027228097 scopus 로고
    • Studies in phlebitis: VI. Dilution-induced precipitation of amiodarone HCL
    • Ward GH, Yalkowsky SH Studies in phlebitis: VI. Dilution-induced precipitation of amiodarone HCL. J Parenter Sci Technol. 1993; 47: 161-165.
    • (1993) J Parenter Sci Technol. , vol.47 , pp. 161-165
    • Ward, G.H.1    Yalkowsky, S.H.2
  • 13
    • 63849094941 scopus 로고    scopus 로고
    • Amiodarone Hydrochloride AHFS 24:04.04
    • Trissel LA, ed. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists;
    • Trissel LA Amiodarone hydrochloride AHFS 24:04.04. In: Trissel LA, ed. Handbook on Injectable Drugs. 14 th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007: 112-118.
    • (2007) Handbook on Injectable Drugs , pp. 112-118
    • Trissel, L.A.1
  • 14
    • 0035869079 scopus 로고    scopus 로고
    • Visual compatibility of amiodarone hydrochloride injection with various intravenous drugs
    • Chalmers JR, Bobek MB, Militello MA Visual compatibility of amiodarone hydrochloride injection with various intravenous drugs. Am J Health Syst Pharm. 2001; 58: 504-506.
    • (2001) Am J Health Syst Pharm , vol.58 , pp. 504-506
    • Chalmers, J.R.1    Bobek, M.B.2    Militello, M.A.3
  • 15
    • 0027292887 scopus 로고
    • Leaching of diethylhexyl phthalate from polyvinyl chloride containers by selected drugs and formulation components
    • Pearson SD, Trissel LA Leaching of diethylhexyl phthalate from polyvinyl chloride containers by selected drugs and formulation components. Am J Hosp Pharm. 1993; 50: 1405-1409.
    • (1993) Am J Hosp Pharm , vol.50 , pp. 1405-1409
    • Pearson, S.D.1    Trissel, L.A.2
  • 17
    • 62149151400 scopus 로고    scopus 로고
    • A novel amiodarone microemulsion injectable formulation [abstract]
    • Kessler D., Palepu N., Tustian A., et al. A novel amiodarone microemulsion injectable formulation [abstract]. AAPS PharmSci. 2002; 4: W4122.
    • (2002) AAPS PharmSci. , vol.4 , pp. 4122
    • Kessler, D.1    Palepu, N.2    Tustian, A.3
  • 18
    • 33847290854 scopus 로고    scopus 로고
    • Solubilization of an amphiphilic drug by poly(ethylene oxide)-block-poly(ester) micelles
    • 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: 406-413.
    • (2007) Eur J Pharm Biopharm , vol.65 , pp. 406-413
    • Elhasi, S.1    Astaneh, R.2    Lavasanifar, A.3
  • 19
    • 10744221284 scopus 로고    scopus 로고
    • Lack of a hypotensive effect with rapid administration of a new aqueous formulation of intravenous amiodarone
    • Somberg JC, Timar S., Bailin SJ, et al. Lack of a hypotensive effect with rapid administration of a new aqueous formulation of intravenous amiodarone. Am J Cardiol. 2004; 93: 576-581.
    • (2004) Am J Cardiol , vol.93 , pp. 576-581
    • Somberg, J.C.1    Timar, S.2    Bailin, S.J.3
  • 22
    • 0033555874 scopus 로고    scopus 로고
    • Sample size determination for proving equivalence based on the ratio of two means for normally distributed data
    • Hauschke D., Kieser M., Diletti E., Burke M. Sample size determination for proving equivalence based on the ratio of two means for normally distributed data. Stat Med. 1999; 18: 93-105.
    • (1999) Stat Med , vol.18 , pp. 93-105
    • Hauschke, D.1    Kieser, M.2    Diletti, E.3    Burke, M.4
  • 24
    • 0041663518 scopus 로고    scopus 로고
    • Effect of length of sampling schedule and washout interval on magnitude of drug carryover from period 1 to period 2 in two-period, two-treatment bioequivalence studies and its attendant effects on determination of bioequivalence
    • Dhariwal K., Jackson A. Effect of length of sampling schedule and washout interval on magnitude of drug carryover from period 1 to period 2 in two-period, two-treatment bioequivalence studies and its attendant effects on determination of bioequivalence. Biopharm Drug Dispos. 2003; 24: 219-228.
    • (2003) Biopharm Drug Dispos , vol.24 , pp. 219-228
    • Dhariwal, K.1    Jackson, A.2
  • 26
    • 0029990432 scopus 로고    scopus 로고
    • Disposition of intravenous amiodarone in subjects with normal and impaired renal function
    • Ujhelyi MR, Klamerus KJ, Vadiei K., et al. Disposition of intravenous amiodarone in subjects with normal and impaired renal function. J Clin Pharmacol. 1996; 36: 122-130.
    • (1996) J Clin Pharmacol , vol.36 , pp. 122-130
    • Ujhelyi, M.R.1    Klamerus, K.J.2    Vadiei, K.3
  • 27
    • 0029844852 scopus 로고    scopus 로고
    • Pharmacokinetics of intravenous amiodarone in patients with impaired left ventricular function
    • Vadiei K., O'Rangers EA, Klamerus KJ, et al. Pharmacokinetics of intravenous amiodarone in patients with impaired left ventricular function. J Clin Pharmacol. 1996; 36: 720-727.
    • (1996) J Clin Pharmacol , vol.36 , pp. 720-727
    • Vadiei, K.1    O'Rangers, E.A.2    Klamerus, K.J.3
  • 28
    • 0030808985 scopus 로고    scopus 로고
    • Population pharmacokinetics of intravenous amiodarone and comparison with two-stage pharmacokinetic analysis
    • Vadiei K., Troy S., Korth-Bradley J., Chiang ST, Zimmerman JJ Population pharmacokinetics of intravenous amiodarone and comparison with two-stage pharmacokinetic analysis. J Clin Pharmacol. 1997; 37: 610-617.
    • (1997) J Clin Pharmacol , vol.37 , pp. 610-617
    • Vadiei, K.1    Troy, S.2    Korth-Bradley, J.3    Chiang, S.T.4    Zimmerman, J.J.5
  • 29
    • 62149152108 scopus 로고
    • Sugar alcohols: XXVI. Pharmacodynamic studies of polyoxyalkylene derivatives of hexitol anhdride partial fatty acid esters
    • 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: 188-195.
    • (1948) J Pharmacol Exp Ther. , vol.93 , pp. 188-195
    • Krantz, J.C.1    Carr, C.J.2    Bird, J.G.3    Cook, S.4
  • 30
    • 0022404616 scopus 로고
    • Histamine-releasing properties of Polysorbate 80 in vitro and in vivo: Correlation with its hypotensive action in the dog
    • Masini E., Planchenault J., Pezziardi F., Gautier P., Gagnol JP Histamine-releasing properties of Polysorbate 80 in vitro and in vivo: correlation with its hypotensive action in the dog. Agents Actions. 1985; 16: 470-477.
    • (1985) Agents Actions , vol.16 , pp. 470-477
    • Masini, E.1    Planchenault, J.2    Pezziardi, F.3    Gautier, P.4    Gagnol, J.P.5
  • 31
    • 0021337014 scopus 로고
    • Electrophysiologic effects of Tween 80 in the myocardium and specialized conduction system of the canine heart
    • 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: 145-151.
    • (1984) J Electrocardiol. , vol.17 , pp. 145-151
    • Torres-Arraut, E.1    Singh, S.2    Pickoff, A.S.3
  • 32
    • 0018698740 scopus 로고
    • Antiarrhythmic effects of solvents: III. Effects of propylene glycol and benzyl alcohol on contractile force of isolated rabbit heart
    • 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: 717-722.
    • (1979) Cardiovasc Res. , vol.13 , pp. 717-722
    • Yasaka, W.J.1    Eichbaum, F.W.2    Oga, S.3
  • 33
    • 17144364342 scopus 로고    scopus 로고
    • Pharmacology and toxicology of a new aqueous formulation of intravenous amiodarone (Amio-Aqueous) compared with Cordarone IV
    • Somberg JC, Cao W., Cvetanovic I., Ranade V., Molnar J. Pharmacology and toxicology of a new aqueous formulation of intravenous amiodarone (Amio-Aqueous) compared with Cordarone IV. Am J Ther. 2005; 12: 9-16.
    • (2005) Am J Ther , vol.12 , pp. 9-16
    • Somberg, J.C.1    Cao, W.2    Cvetanovic, I.3    Ranade, V.4    Molnar, J.5
  • 34
    • 0037108010 scopus 로고    scopus 로고
    • Intravenous lidocaine versus intravenous amiodarone (in a new aqueous formulation) for incessant ventricular tachycardia
    • Somberg JC, Bailin SJ, Haffajee CI, et al. Intravenous lidocaine versus intravenous amiodarone (in a new aqueous formulation) for incessant ventricular tachycardia. Am J Cardiol. 2002; 90: 853-859.
    • (2002) Am J Cardiol , vol.90 , pp. 853-859
    • Somberg, J.C.1    Bailin, S.J.2    Haffajee, C.I.3
  • 37
    • 0037974454 scopus 로고    scopus 로고
    • The pharmacokinetics and pharmacodynamics of propofol in a modified cyclodextrin formulation (Captisol) versus propofol in a lipid formulation (Diprivan): An electroencephalographic and hemodynamic study in a porcine model
    • Egan TD, Kern SE, Johnson KB, Pace NL The pharmacokinetics and pharmacodynamics of propofol in a modified cyclodextrin formulation (Captisol) versus propofol in a lipid formulation (Diprivan): an electroencephalographic and hemodynamic study in a porcine model. Anesth Analg. 2003; 97: 72-79.
    • (2003) Anesth Analg , vol.97 , pp. 72-79
    • Egan, T.D.1    Kern, S.E.2    Johnson, K.B.3    Pace, N.L.4


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