TABLE 3

Arithmetic mean (SD) doripenem plasma pharmacokinetic parameters per stratification and age groupa

ParameterNeonate (<4 wk in CA), 5 mg/kgInfant (4 to <12 wk in CA): <8 wk in CA, 5 mg/kg, and ≥8 wk in CA, 8 mg/kg
<32 wk in GA≥32 to ≤44 wk in GA<32 wk in GA; group 5≥32 to ≤44 wk in GA; group 6
<14 days in CA; group 1≥14 days in CA; group 2<14 days in CA; group 3≥14 days in CA; group 4
n888869
Cinf (μg/ml)11.9 (4.11)12.7 (2.65)13.7 (2.03)9.91 (0.723)9.90 (5.13)b12.3 (3.71)
Cmax (μg/ml)12.2 (3.67)13.2 (2.12)13.7 (2.03)9.91 (0.723)10.8 (4.83)b12.3 (3.71)
tmax (h), median (range)1.00 (1.00–1.50)1.00 (1.00–1.50)1.00 (1.00–1.00)1.00 (0.98–1.00)1.00 (1.00–1.58)b1.00 (0.98–1.07)
AUClast (μg · h/ml)37.2 (5.93)42.0 (7.72)39.4 (6.39)24.6 (3.77)35.0 (14.8)30.0 (6.91)c
AUC (μg · h/ml)55.3 (10.1)d54.6 (11.7)d49.2 (10.9)26.2 (4.62)32.9 (15.1)e32.2 (6.80)c
t1/2 (h)4.22 (0.429)d3.40 (0.894)d2.85 (0.641)1.66 (0.385)2.03 (0.369)e1.67 (0.644)c
CL/BW (ml/min/kg)1.56 (0.340)d1.59 (0.370)d1.78 (0.434)3.27 (0.589)3.07 (0.474)e3.01 (0.476)c
Vz/BW (liters/kg)0.564 (0.0975)d0.455 (0.0859)d0.424 (0.0597)0.461 (0.0907)0.548 (0.151)e0.422 (0.125)c
CLCRf (ml/min/kg)
    Baseline18.8 (4.98)28.5 (7.27)d15.1 (5.49)24.2 (6.44)29.7 (7.74)18.4 (4.71)d
    End of study17.8 (4.89)30.3 (6.80)d16.1 (6.07)24.7 (5.66)31.2 (10.1)22.2 (6.15)d
  • a Subjects <8 weeks in CA received doripenem as a 5-mg/kg 1-hour i.v. infusion; subjects ≥8 weeks in CA received doripenem as an 8-mg/kg 1-hour i.v. infusion.

  • b n = 5.

  • c n = 8.

  • d n = 7.

  • e n = 4.

  • f CLCR was calculated using the Schwartz equation.