TABLE 3

Simulated Cmax and daily AUC at adjusted dose regimens by renal function group using the covariate model with MDRD-eGFR

PK parameterMedian (90% prediction interval) for the following renal function group and adjusted dose regimena:
Normal, 2 g q8hMild, 2 g q8hModerate, 1.5 g q8hSevere, 1 g q8hESRD, 0.75 g q12h
Cmax, μg/ml90.0 (71.8–111.6)105.4 (83.4–133.5)104.1 (78.8–134.3)95.4 (73.7–122.3)77.5 (61.6–97.5)
Daily AUC, μg · h/ml1,070 (814–1,410)1,344 (972–1,855)1,522 (1,046–2,154)1,599 (1,136–2,231)1,187 (857–1,671)
  • a Normal, subjects with MDRD-eGFR of ≥90 ml/min/1.73 m2; mild, subjects with MDRD-eGFR of 60 to <90 ml/min/1.73 m2; moderate, subjects with MDRD-eGFR of 30 to <60 ml/min/1.73 m2; severe, subjects with MDRD-eGFR of 15 to <30 ml/min/1.73 m2; ESRD, subjects with MDRD-eGFR of <15 ml/min/1.73 m2. The infusion time was 3 h.