Comparison of vancomycin- and teicoplanin-induced histamine release and "red man syndrome".
Twelve healthy adult males participated in a double-blind, randomized, two-way crossover study to determine histamine release and the frequency and severity of "red man syndrome" (RMS) following intravenous administration of vancomycin (15 mg/kg of body weight over 60 min) and teicoplanin (15 mg/kg over 30 min). Concentrations of vancomycin and teicoplanin in serum and concentrations of histamine in plasma were measured at baseline and during and after each infusion. Erythema and pruritus were classified a priori as mild, moderate, or severe. The extent of erythema was determined by the use of a burn chart, and pruritus was assessed by the subject with a rank scale. Global severity of RMS was determined by summation of the individual scores for pruritus and erythema. Baseline areas under the concentration-time curve for histamine were not significantly different for the vancomycin and teicoplanin treatments. Vancomycin caused RMS in 11 of 12 subjects (9 severe and 2 moderate cases) and was associated with a significant increase in plasma histamine (46.7 +/- 31.3 ng.min/ml, P less than 0.05). In contrast, teicoplanin did not cause RMS or elicit significant histamine release (8.7 +/- 13.2 ng.min/ml). Peak concentrations of vancomycin and teicoplanin in serum were 58.8 +/- 8.4 and 148.0 +/- 31.8 micrograms/ml, respectively (P less than 0.05). Assuming equal efficacy, these data suggest that teicoplanin may be a safe alternative agent in subjects experiencing severe RMS due to vancomycin; however, further studies in the clinical setting are needed.
Sahai
J
J
Department of Pharmacy and Pharmaceutics, School of Pharmacy, Medical College of Virginia, Richmond 23298-0581.
Healy
D P
DP
Shelton
M J
MJ
Miller
J S
JS
Ruberg
S J
SJ
Polk
R
R
D000328:Adult; D004311:Double-Blind Method; D004890:Erythema / Q000139:chemically induced*; D006020:Glycopeptides / Q000009:adverse effects / Q000097:blood; D006636:Histamine Release / Q000187:drug effects*; D006801:Humans; D008297:Male; D011537:Pruritus / Q000139:chemically induced / Q000503:physiopathology; D016032:Randomized Controlled Trials as Topic; D017334:Teicoplanin; D014640:Vancomycin / Q000009:adverse effects* / Q000097:blood
D006020:Glycopeptides; D017334:Teicoplanin; D014640:Vancomycin