TY - JOUR
T1 - Comparative safety, tolerance, and pharmacokinetics of amphotericin B lipid complex and amphotericin B desoxycholate in healthy male volunteers
AU - Kan, V. L.
AU - Bennett, J. E.
AU - Amantea, M. A.
AU - Smolskis, M. C.
AU - McManus, E.
AU - Grasela, D. M.
AU - Sherman, J. W.
N1 - Copyright:
Copyright 2017 Elsevier B.V., All rights reserved.
PY - 1991/8
Y1 - 1991/8
N2 - Amphotericin B lipid complex (ABLC), a lipid complex formulation of amphotericin B, and amphotencin B desoxycholate (AB) were compared for safety, tolerance, and pharmacokinetics in two groups of eight healthy male volunteers. After a 1-mg test dose, study drug was infused at 0.1, 0.25, and 0.5 mg/kg; the 0.5-mg/kg dose was not given to subjects receiving AB ABLC caused few acute adverse effects except for mild somnolence (drowsiness) in six volunteers. In addition, three of eight ABLC recipients had asymptomatic, transient serum transaminase elevations that resolved spontaneously. The AB recipients experienced more acute side effects but only one had a mild shaking chill; three of eight also experienced sleepiness. No significant changes in vital signs, electrocardiograms, oximetry, pulmonary function, or clinical status were observed in either group. Due to its increased estimated volume of distribution and estimated clearance, ABLC yielded decreased amphotericin B levels and area under the serum concentration versus time curve relative to AB.
AB - Amphotericin B lipid complex (ABLC), a lipid complex formulation of amphotericin B, and amphotencin B desoxycholate (AB) were compared for safety, tolerance, and pharmacokinetics in two groups of eight healthy male volunteers. After a 1-mg test dose, study drug was infused at 0.1, 0.25, and 0.5 mg/kg; the 0.5-mg/kg dose was not given to subjects receiving AB ABLC caused few acute adverse effects except for mild somnolence (drowsiness) in six volunteers. In addition, three of eight ABLC recipients had asymptomatic, transient serum transaminase elevations that resolved spontaneously. The AB recipients experienced more acute side effects but only one had a mild shaking chill; three of eight also experienced sleepiness. No significant changes in vital signs, electrocardiograms, oximetry, pulmonary function, or clinical status were observed in either group. Due to its increased estimated volume of distribution and estimated clearance, ABLC yielded decreased amphotericin B levels and area under the serum concentration versus time curve relative to AB.
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U2 - 10.1093/infdis/164.2.418
DO - 10.1093/infdis/164.2.418
M3 - Review article
C2 - 1856491
AN - SCOPUS:0025816499
SN - 0022-1899
VL - 164
SP - 418
EP - 421
JO - Journal of Infectious Diseases
JF - Journal of Infectious Diseases
IS - 2
ER -