TABLE 2.
Comparison of predicted AUC0-24,ss, Cmax,ss, and Cmin,ss from children following dosing regimen of 7.5 mg/kg b.i.d.a
| Age | PK parameter |
||
|---|---|---|---|
| AUC0-24,ss (μg.h.ml) | Cmax,ss (μg/ml) | Cmin,ss (μg/ml) | |
| 6 mo to < 2 yr | 51.7 (26.8-75) | 5.6 (3.2-7.3) | 0.6 (0.26-1.2) |
| 2 to <5 yr | 50 (41.7-65.2) | 5.4 (4.2-6.6) | 0.6 (0.25-1.1) |
| 5 to <10 yr | 55.6 (46.9-83.3) | 5.4 (3.7-7.1) | 0.9 (0.38-1.6) |
| 10 to 18 yr | 55.7 (42.0-83.5) | 6.3 (4.6-8.1) | 0.6 (0.2-1.4) |
| Adultb | 47.7 (41.8-55.1) | 5.5 (5.0-6.8) | 0.4 (0.3-0.55) |
a
Data are presented as the median (10th percentile to 90th percentile). The dosage regimen was 7.5 mg/kg b.i.d (not exceeding 250 mg/dose), 500 mg q.d. for children more than 50 kg.
b
The adult dose of 500 mg q.d was based on observed data from study IV.