Rocuronium

Patients with Renal Impairment Due to the limited role of the kidney in the excretion of Rocuronium Bromide, usual dosing guidelines should be followed. In patients with renal dysfunction, the duration of neuromuscular blockade was not prolonged; however, there was substantial individual variability (range: 22-90 minutes) [see Clinical Pharmacology].

Patients with Hepatic Impairment Since Rocuronium Bromide is primarily excreted by the liver, it should be used with caution in patients with clinically significant hepatic impairment. Rocuronium Bromide 0.6 mg/kg has been studied in a limited number of patients (n=9) with clinically significant hepatic impairment under steady-state isoflurane anesthesia.

After Rocuronium Bromide 0.6 mg/kg, the median (range) clinical duration of 60 (35–166) minutes was moderately prolonged compared to 42 minutes in patients with normal hepatic function. The median recovery time of 53 minutes was also prolonged in patients with cirrhosis compared to 20 minutes in patients with normal hepatic function.

Four of 8 patients with cirrhosis, who received Rocuronium Bromide 0.6 mg/kg under opioid/nitrous oxide/oxygen anesthesia, did not achieve complete block. These findings are consistent with the increase in volume of distribution at steady state observed in patients with significant hepatic impairment [see Clinical Pharmacology].

If used for rapid sequence induction in patients with ascites, an increased initial dosage may be necessary to assure complete block. Duration will be prolonged in these cases. The use of doses higher than 0.6 mg/kg has not been studied [see Dosage and Administration].

Important Dosing and Administration Information Rocuronium Bromide is for intravenous use only. This drug should only be administered by experienced clinicians or trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents.

Doses of Rocuronium Bromide Injection should be individualized and a peripheral nerve stimulator should be used to monitor drug effect, need for additional doses, adequacy of spontaneous recovery or antagonism, and to decrease the complications of overdosage if additional doses are administered. The dosage information which follows is derived from studies based upon units of drug per unit of body weight.

It is intended to serve as an initial guide to clinicians familiar with other neuromuscular blocking agents to acquire experience with Rocuronium Bromide. In patients in whom potentiation of, or resistance to, neuromuscular block is anticipated, a dose adjustment should be considered [see Dosage and Administration, Warnings and Precautions (5.10, 5.13), Drug Interactions (7.2, 7.3, 7.4, 7.5, 7.6, 7.8, 7.10), and Use in Specific Populations].

Risk of Medication Errors: Accidental administration of neuromuscular blocking agents may be fatal. Store Rocuronium Bromide Injection with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions].

Use by Continuous Infusion Infusion at an initial rate of 10 to 12 mcg/kg/min of Rocuronium Bromide should be initiated only after early evidence of spontaneous recovery from an intubating dose. Due to rapid redistribution [see Clinical Pharmacology] and the associated rapid spontaneous recovery, initiation of the infusion after substantial return of neuromuscular function (more than 10% of control T1) may necessitate additional bolus doses to maintain adequate block for surgery.

Upon reaching the desired level of neuromuscular block, the infusion of Rocuronium Bromide must be individualized for each patient. The rate of administration should be adjusted according to the patient's twitch response as monitored with the use of a peripheral nerve stimulator. In clinical trials, infusion rates have ranged from 4 to 16 mcg/kg/min.

Inhalation anesthetics, particularly enflurane and isoflurane, may enhance the neuromuscular blocking action of nondepolarizing muscle relaxants. In the presence of steady-state concentrations of enflurane or isoflurane, it may be necessary to reduce the rate of infusion by 30% to 50%, at 45 to 60 minutes after the intubating dose.

Spontaneous recovery and reversal of neuromuscular blockade following discontinuation of Rocuronium Bromide infusion may be expected to proceed at rates comparable to that following comparable total doses administered by repetitive bolus injections [see Clinical Pharmacology]. Infusion solutions of Rocuronium Bromide can be prepared by mixing Rocuronium Bromide with an appropriate infusion solution such as 5% glucose in water or lactated Ringers [see Dosage and Administration].

These infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded. Infusion rates of Rocuronium Bromide can be individualized for each patient using the following tables for 3 different concentrations of Rocuronium Bromide solution as guidelines:

Preparation for Administration of Rocuronium Bromide Diluent Compatibility: Rocuronium Bromide is compatible in solution with: [See table below.] Rocuronium Bromide is compatible in the above solutions at concentrations up to 5 mg/mL for 24 hours at room temperature in plastic bags, glass bottles, and plastic syringe pumps.

Drug Admixture Incompatibility: Rocuronium Bromide is physically incompatible when mixed with the following drugs: [See table below.] Table Table Table