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 Vancomycin is widely used for the treatment of infections caused by gram-positive organisms. The most common adverse effect of intravenously administered vancomycin is "red man syndrome" which is characterized by erythema, pruritus, and in severe cases angioedema and cardiovascular complications (1,3,8,10,11,15). We have previously shown that vancomycin-induced red man syndrome is associated with histamine release (13).Teicoplanin is an investigational glycopeptide antibiotic similar in structure and spectrum of activity to vancomycin and is currently under study for the treatment and prophylaxis of infections due to gram-positive organisms (17, 18). There have been two anecdotal reports of teicoplanininduced red man syndrome (B. Fant, personal communication); however, the frequency and severity of this reaction have not been systematically studied. The purpose of this investigation was to compare histamine release and the incidence and severity of red man syndrome following intravenous administration of vancomycin and teicoplanin to healthy adult volunteers.
MATERIALS AND METHODSThis study was approved by the Committee on the Conduct of Human Research, Medical College of Virginia Hospitals, and written informed consent was obtained from the participants. Subjects were admitted to the Biopharmaceutics Research Center, School of Pharmacy, Medical College of Virginia, on the morning of each study day.Volunteers. Twelve healthy adult, Caucasian, male volunteers participated in a double-blind, randomized, two-way crossover study. There was a 2-week washout period between treatments. The mean ± standard deviation age and * Corresponding author. weight were 24.1 + 1.2 years and 76.9 + 5.5 kg, respectively. Exclusion criteria for subjects were previous exposure to vancomycin and/or teicoplanin, smoking, total body weight more than 10% above or below ideal weight, known hypersensitivity to any drug, chronic illnesses, atopy, laboratory abnormalities on entry into the study, requirements for any medication, and use of antihistamine-containing products within 7 days prior to entering the study. Subjects were instructed to avoid all medications throughout the study period. No subject ingested alcohol or caffeine 48 h prior to each study day, and subjects fasted overnight and for 3 h after administration of each antibiotic.Drug administration and sample collection. All antibiotic doses were prepared by the same investigator (D.P.H.