Table 2.
Summary of plasma voriconazole pharmacokinetic parameters in children (study A) compared to adults (study B)
| Study group and parametera | Value for group at indicated dosage on: |
||
|---|---|---|---|
| Day 1, first IV dose | Day 7 of IV treatment (SS) | Day 7 of PO treatment (SS) | |
| Children (n) | 7 mg/kg (33) | 7 mg/kg q12h (36) | 200 mg q12h (33) |
| AUC0-12 (μg·h/ml) | |||
| Geometric mean (CV, %) | 7.85 (71) | 21.4 (110) | 18.6 (134) |
| Median (range) | 7.00 (2.43–36.6) | 21.8 (5.02–162) | 20.1 (1.70–203) |
| Cmax (μg/ml) | |||
| Geometric mean (CV, %) | 2.15 (47) | 4.26 (71) | 3.62 (87) |
| Median (range) | 1.99 (0.90–6.68) | 4.19 (1.48–15.4) | 4.11 (0.51–18.0) |
| Cmin (μg/ml) | |||
| Geometric mean (CV, %) | 0.61 (160) | 0.52 (181)b | |
| Median (range) | 0.61 (0.06–10.9) | 0.49 (0.04–12.8)b | |
| Tmax (h) | |||
| Median (range) | 2.30 (1.72–4.08) | 2.30 (1.00–4.07) | 1.07 (0.73–8.03) |
| Adults (reference) (n) | 6 mg/kg (35) | 4 mg/kg q12h (33) | 200 mg q12h (34) |
| AUC0-12 (μg·h/ml) | |||
| Geometric mean (CV, %) | 13.9 (32) | 34.9 (53) | 13.7 (78) |
| Median (range) | 13.3 (7.43–29.7) | 37.6 (13.7–104) | 12.8 (4.89–61.6) |
| Cmax (μg/ml) | |||
| Geometric mean (CV, %) | 3.13 (20) | 4.65 (36) | 2.51 (48) |
| Median (range) | 3.05 (2.08–4.88) | 4.60 (2.48–9.92) | 2.45 (1.23–6.84) |
| Cmin (μg/ml) | |||
| Geometric mean (CV, %) | 1.78 (72) | 0.51 (119) | |
| Median (range) | 2.08 (0.38–7.35) | 0.46 (0.14–4.27) | |
| Tmax (h) | |||
| Median (range) | 1.97 (1.97–1.97) | 1.3 (1.3–1.3) | 1.0 (1.0–2.0) |
a
AUC0-12, area under the curve over 12-h dosing interval; Cmax, maximum plasma concentration; Cmin, minimum plasma concentration; Tmax, time to reach Cmax; SS, steady state.
b
n = 32.