Renal Failure: Due to the limited role of the kidney in the excretion of ZEMURON™ (rocuronium bromide) Injection, usual dosing guidelines should be adequate. ZEMURON™ 0.6 mg/kg has been evaluated in three single center trials (n=30, ages 19-61 years) in patients undergoing renal transplant surgery, or shunt procedures in preparation for dialysis. After ZEMURON™ 0.6 mg/kg, the time to maximum block was about 1-2 minutes and was not different from patients without renal dysfunction. The mean ± SD clinical duration of 54 ± 22 minutes was not considered prolonged compared to 46 ± 12 minutes in normal patients; however, there was substantial variation (range, 22-90 minutes). The spontaneous recovery rate from 25 to 75% of control in renal dysfunction patients of 27 ± 11 minutes was similar to 28 ± 20 minutes in normal patients (see Pharmacokinetics subsection of CLINICAL PHARMACOLOGY).
In general, patients undergoing cadaver kidney transplant have a small reduction in clearance which is offset pharmacokinetically by a corresponding increase in volume, such that the net effect is an unchanged plasma half-life. Patients with demonstrated liver cirrhosis have a marked increase in their volume of distribution resulting in a plasma half-life approximately twice that of patients with normal hepatic function. Table 4 shows the pharmacokinetic parameters in subjects with either impaired renal or hepatic function.
Table 4. Pharmacokinetic Parameters in Adults with Normal Renal and Hepatic Function (n=10, ages 23-65),
Renal Transplant Patients (n=10, ages 21-45) and Hepatic Dysfunction Patients (n=9, ages 31-67)During Isoflurane Anesthesia (Mean ± SD)