TABLE 3.
Overview of the final gabapentin dosing regimen administered as three daily dosing events, stratified by weight band.
| Weight group | Study day | Dose (mg/kg) | Cmax (mg/L) | Css (mg/L) | AUC0–8 (mg/L*h) |
|---|---|---|---|---|---|
| >15 kg | 2 | 5 | 2.8 (1.9–4.0) | 0.8 (0.4–1.3) | 6.3 (3.4–10.4) |
| 5–15 kg | 2 | 7 | 2.8 (2.0–4.0) | 0.8 (0.4–1.3) | 6.4 (3.5–10.4) |
| >15 kg | 4 | 10 | 3.5 (2.4–5.0) | 1.2 (0.7–2.2) | 9.7 (5.2–17.6) |
| 5–15 kg | 4 | 14 | 3.5 (2.4–5.2) | 1.2 (0.7–2.2) | 9.9 (5.5–17.5) |
| >15 kg | 13 | 15 | 4.1 (2.8–6.3) | 1.7 (0.9–3.2) | 13.4 (7.1–25.5) |
| 5–15 kg | 13 | 21 | 4.1 (2.9–6.4) | 1.7 (0.9–3.2) | 13.7 (7.6–25.5) |
| >15 kg | 20 | 30 | 6.2 (4.0–10.1) | 3.0 (1.6–5.9) | 24.5 (12.9–47.0) |
| 5–15 kg | 20 | 42 | 6.6 (4.4–10.7) | 3.2 (1.8–6.1) | 25.6 (14.0–49.0) |
| >15 kg | 23 | 45 | 8.3 (5.2–13.8) | 4.4 (2.3–8.3) | 35.0 (18.5–66.1) |
| 5–15 kg | 23 | 63 | 9.1 (5.8–15.3) | 4.7 (2.6–8.9) | 37.2 (20.4–71.2) |
Note: Predicted exposure to gabapentin is summarized by secondary pharmacokinetic parameters at each dose level. Values shown are the medians and 95% confidence intervals.