Toleration of intravenous azithromycin.
OBJECTIVE
To study the toleration of various infusate concentrations of single intravenous doses of azithromycin.


METHODS
Randomized, double-blind, two-treatment, two-period, crossover.


METHODS
Clinical pharmacology unit.


METHODS
Twenty-four healthy men aged 19-41 years.


METHODS
All subjects were initially randomized to receive single 1-hour intravenous infusions of azithromycin 1 g at infusate concentrations of 1, 2, or 5 mg/mL (n = 6 each) compared with placebo (n = 6). Subjects who were randomized to receive 1 mg/mL concentrations were subsequently administered 5 mg/mL concentrations at least 2 weeks later, those given 2 mg/mL were crossed over to 4 mg/mL, and those in the 5-mg/mL group were crossed over to 1 mg/mL concentrations.


METHODS
Subjects recorded intravenous infusion toleration using visual analog scales ranging from 0 (no signs or symptoms) to 10 (poor toleration) for erythema, pain, swelling, and tenderness. Vascular Doppler recordings were obtained during and after infusion cephalad to the infusion site.


RESULTS
Infusion site reactions increased in incidence and severity with infusion concentrations of 4 and 5 mg/mL; the most frequent reactions were tenderness and erythema. There were no apparent trends in Doppler readings.


CONCLUSIONS
Single doses of azithromycin 1 g at infusate concentrations up to 2 mg/mL were well tolerated when administered over 1 hour to healthy men.
Luke
D R
DR
Department of Clinical Research, Pfizer Central Research, Groton, CT 06340, USA.
Foulds
G
G
D000328:Adult; D000900:Anti-Bacterial Agents / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood; D017963:Azithromycin / Q000008:administration & dosage* / Q000009:adverse effects* / Q000097:blood; D018592:Cross-Over Studies; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004890:Erythema / Q000139:chemically induced; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D010147:Pain Measurement
D000900:Anti-Bacterial Agents; D017963:Azithromycin