Table 2.
Noncompartmental Pharmacokinetic Parameters of Moxifloxacin Following Administration of a Single Intravenous Dose in 3 Pediatric Age Groups (Geometric Mean/Geometric CV)a
| Variable | Cohort 1 ≥6 to ≤14 years (N = 12) |
Cohort 2 ≥2 to <6 years (N = 12) |
Cohort 3 >3 months to <2 years (N = 7) |
|||
|---|---|---|---|---|---|---|
| 5 mg/kg (N = 7) |
6 mg/kg (N = 5) |
7 mg/kg (N = 7) |
8 mg/kg (N = 5) |
9 mg/kg (N = 6) |
10 mg/kg (N = 1) |
|
| AUC (mg • h/L) | 19.73/30.53 | 24.04/24.11 | 28.21/42.75 | 27.18/19.29 | 25.52/17.26 | 40.51/– |
| Cmax (mg/L) | 3.16/33.33 | 4.61/17.10 | 6.51/43.54 | 5.64/10.71 | 5.31/14.67 | 5.96/– |
| t1/2 (h) | 7.89/34.32 | 6.16/23.99 | 5.66/18.79 | 6.03/24.78 | 6.82/35.10 | 5.94/– |
| CL (L/h) | 8.11/40.08 | 6.24/32.37 | 4.36/26.19 | 4.51/21.75 | 3.68/27.10 | 2.20/– |
| CL (L/h/kg)b | 0.25/30.53 | 0.25/24.16 | 0.25/42.78 | 0.30/19.71 | 0.35/17.28 | 0.25/– |
| Vss (L) | 73.86/49.67 | 45.00/10.55 | 26.80/20.30 | 28.46/26.61 | 23.45/31.35 | 16.74/– |
| Vss (L/kg)b | 2.31/35.51 | 1.80/12.49 | 1.52/21.52 | 1.86/9.62 | 2.25/16.84 | 1.88/– |
| AEur (%) | 14.75/34.47 | 16.97/26.69 | 22.58/55.26 | 17.89/34.90 | – | – |
AEur, amount of drug excreted via urine in the first 36 hours; AUC, area under the curve; CL, clearance; Cmax, maximum drug concentration in plasma after single-dose administration; CV, geometric coefficient of variation; t1/2, half-life; Vss, volume of distribution at steady state.
a
Data obtained with 5 mg/kg and 6 mg/kg doses in Cohort 1, 7 mg/kg and 8 mg/kg in Cohort 2, and 9 mg/kg and 10 mg/kg in Cohort 3 are shown separately.
b
Values are normalized to body weight.