TABLE 3

Geometric mean (% coefficient of variation) PK parameters for sulbactam

PK parametercNormal renal function (n = 8)RIESRD period
Mild (n = 6)Moderate (n = 6)Severe (n = 7)1 (n = 5)2 (n = 6)
Dose (mg)1,0001,0001,000500500500
Cmax (μg/ml)17.0 (17.1)22.1 (25.3)27.1 (28.9)20.2 (26.0)23.7 (32.8)20.1 (23.2)
Tmax (h)a3.0 (2.0–3.0)3.0 (2.0–3.0)3.0 (2.0–3.2)3.0 (3.0–4.0)3.0 (2.0–3.5)3.0 (3.0–4.0)
Half-life (h)1.8 (37.9)2.0 (15.1)3.0 (43.6)4.6 (34.0)9.2 (52.8)10.0 (51.6)
AUC0–last (h · μg/ml)62.8 (14.7)85.3 (28.7)126 (42.3)136 (40.2)280 (71.5)127 (37.1)
AUC0–inf (h · μg/ml)63.0 (14.7)85.8 (28.1)126 (42.0)136 (40.2)288 (73.9)131 (43.1)b
CL (ml/h)15,900 (14.7)11,700 (28.1)7,930 (42.0)3,660 (40.4)1,740 (73.9)3,820 (43.1)b
Vz (ml)40,100 (38.3)32,800 (20.4)33,700 (18.3)25,000 (15.8)23,100 (19.6)55,000 (20.0)b
CLR or CLD (ml/h)10,300 (22.6)10,900 (26.6)6,950 (43.6)1,550 (69.6)10,500 (24.7)
Feu/FeHD0.65 (19.3)0.93 (3.8)0.88 (16.8)0.42 (26.3)0.41 (40.5)
  • a Median (range).

  • b n = 5.

  • c AUC0–last or AUC0–inf, area under the concentration-time curve, time 0 to last or time 0 to infinity; CL, clearance; CLD, estimated hemodialysis recovery clearance; CLR, renal clearance; Cmax, peak plasma concentration; FeHD, fraction of dose removed by hemodialysis; Feu, fraction of the dose renally eliminated; Tmax, time to peak plasma concentration; Vz, terminal volume of distribution.