Table 2.
Statistical summary of pharmacokinetic parameters of azithromycin in children with AOM following a single oral dose of the 60 mg/kg ER or 30 mg/kg IR azithromycin formulationa
| Pharmacokinetic parameter | Geometric mean value (CV%) for group |
ER/IR geometric mean ratio (%) (90% CI) | |
|---|---|---|---|
| 60 mg/kg ER azithromycin (n = 18) | 30 mg/kg IR azithromycin (n = 18) | ||
| AUC0–8 (ng·h/ml) | 2,576 (53) | 2,145 (60) | 120.09 (74.92, 192.51) |
| AUC0–24 (ng·h/ml) | 5,765 (49) | 3,955 (58) | 145.76 (93.74, 226.64) |
| AUC0–72 (ng·h/ml) | 9,848 (52) | 6,234 (60) | 157.98 (98.87, 252.44) |
| Cmax (ng/ml) | 611 (62) | 667 (67) | 91.63 (56.21, 149.38) |
| Tmax (h)b | 3.0 (2.0–8.0) | 2.0 (1.0–4.1) | |
a
CV%, percent coefficient of variation; ER, extended release; IR, immediate release; AUC, area under the curve; Cmax, maximum concentration; Tmax, time to reach maximum concentration.
b
Median (range) for Tmax.