Table 1.
Overview of Age, Bodyweight and Tapentadol Dosing in the Different Age Groups of the Tapentadol PK Analysis Population
| Age Group | N (% Female) | Age | Age Unit | Bodyweight (kg) | ROA: Dose |
|---|---|---|---|---|---|
| 12 years to <18 years | 44 (47.7%) | 15 (12–17) | years | 59.7 (41–80) | PO: 1.0 mg/kg |
| 6 years to <12 years | 33 (63.6%) | 9 (6–11) | years | 29.5 (20.2–58) | PO: 1.0 mg/kg |
| 2 years to <6 years | 15 (46.7%) | 3 (2–5) | years | 16.4 (12.7–19.5) | PO: 1.0 mg/kg |
| 6 months to <2 years | 17 (23.5%) | 14 (6–21) | months | 10 (7.5–14.2) | PO: 0.75 mg/kg |
| IV: 0.4 mg/kg | |||||
| 1 month to <6 months | 17 (35.3%) | 3 (1–5) | months | 5.9 (4.3–9) | PO: 0.6 mg/kg |
| IV: 0.4 mg/kg | |||||
| Birth to <1 month (full term) | 14 (35.7%) | 12 (8–28) | days | 3.6 (2.7–4.6) | PO: 0.5 mg/kg |
| IV: 0.4 mg/kg | |||||
| Preterma | 8 (50%) | 12 (8–106) | days | 2.45 (1.6–3.4) | IV: 0.3 or 0.4 mg/kgb |
| All | 148 |
Notes: Data are number of patients (%) or median (range). All patients from NCT01729728, NCT01134536, NCT02221674 and EudraCT 2014–002259-24 were included in this table. aWith gestational age between 30 weeks to <37 weeks. bThe given dose depends on both the gestational and the postnatal age.
Abbreviations: IV, intravenous; PO, oral; ROA, route of administration.