Table 1.
Azithromycin Pharmacokinetic Parameters in Humans, Rhesus Monkeys, and Rhesus Monkey Amniotic Fluid
| Variable | First Dose |
Multiple Dose |
||||||
|---|---|---|---|---|---|---|---|---|
| Cmax, µg/mL | Tmax, h | AUC12, µg×h/mL | t1/2, h | Cmax, µg/mL | Tmax, h | AUC12, µg×h/mL | t1/2, h | |
| Humana | 3.63 ± 1.73 | 1.0 | 9.6 ± 4.8 | 68 | … | … | … | … |
| Rhesus MPb | 3.9 ± 1.3 | 0.7 ± 0.2 | 4.8 ± 1.3 | 34.9 ± 47.8 | 5.5 ± 1.8 | 0.5 | 7.4 ± 1.8 | 66.0 ± 45.1 |
| Rhesus AFc | 0.05 ± 0.05 | 8.2 ± 7.2 | 0.22 ± 0.03 | 156 ± 37 | 0.7 ± 0.5 | 4.9 ± 4.6 | 6.3 ± 4.5 | 129 ± 59 |
Data are mean ± standard deviation where available. Sample size is 10 for rhesus maternal plasma first dose and 4 for multiple dose.
Abbreviations: AF, amniotic fluid; AUC12, area under the concentration-time curve after 12 hours; Cmax, maximum concentration; MP, maternal plasma; Tmax, time to maximum concentration; t1/2, elimination half-life.
a Data are for a single 500-mg dose [38].
b Generated from noncompartmental analysis.
c The first dose and multiple dose t1/2 in amniotic fluid is based on data from 2 and 3 animals, respectively, who underwent extended sampling following that dose. First dose Cmax and Tmax are from 10 animals. For the remaining parameters in the amniotic fluid, the sample size is 4 animals each.