Rocuronium Bromide - Rocuronium Bromide injection, Solution
(Rocuronium Bromide)Rocuronium Bromide - Rocuronium Bromide injection, Solution Prescribing Information
Rocuronium bromide injection is indicated for inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
To be administered only by experienced clinicians or adequately trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents. (
Rocuronium bromide injection is for intravenous use only.
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 injection.
In patients in whom potentiation of, or resistance to, neuromuscular block is anticipated, a dose adjustment should be considered [
Accidental administration of neuromuscular blocking agents may be fatal. Store rocuronium bromide with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [
• Individualize the dose for each patient. ()2.1 Important Dosing and Administration InformationRocuronium bromide injection 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 injection.
In patients in whom potentiation of, or resistance to, neuromuscular block is anticipated, a dose adjustment should be considered [
seeDosage and Administration (2.6),Warnings and Precautions (5.10,5.13),Drug Interactions (7.2,7.3,7.4,7.5,7.6,7.8,7.10),andUse in Specific Populations (8.6)].Risk of Medication ErrorsAccidental administration of neuromuscular blocking agents may be fatal. Store rocuronium bromide with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [
see Warnings and Precautions (5.3)].• Peripheral nerve stimulator recommended for determination of drug response and need for additional doses, and to evaluate recovery. ()2.1 Important Dosing and Administration InformationRocuronium bromide injection 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 injection.
In patients in whom potentiation of, or resistance to, neuromuscular block is anticipated, a dose adjustment should be considered [
seeDosage and Administration (2.6),Warnings and Precautions (5.10,5.13),Drug Interactions (7.2,7.3,7.4,7.5,7.6,7.8,7.10),andUse in Specific Populations (8.6)].Risk of Medication ErrorsAccidental administration of neuromuscular blocking agents may be fatal. Store rocuronium bromide with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [
see Warnings and Precautions (5.3)].• Store rocuronium bromide with cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product. ()2.1 Important Dosing and Administration InformationRocuronium bromide injection 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 injection.
In patients in whom potentiation of, or resistance to, neuromuscular block is anticipated, a dose adjustment should be considered [
seeDosage and Administration (2.6),Warnings and Precautions (5.10,5.13),Drug Interactions (7.2,7.3,7.4,7.5,7.6,7.8,7.10),andUse in Specific Populations (8.6)].Risk of Medication ErrorsAccidental administration of neuromuscular blocking agents may be fatal. Store rocuronium bromide with the cap and ferrule intact and in a manner that minimizes the possibility of selecting the wrong product [
see Warnings and Precautions (5.3)].• Tracheal intubation: Recommended initial dose is 0.6 mg/kg. ()2.2 Dose for Tracheal IntubationThe recommended initial dose of rocuronium bromide injection, regardless of anesthetic technique, is 0.6 mg/kg. Neuromuscular block sufficient for intubation (80% block or greater) is attained in a median (range) time of 1 (0.4 to 6) minute(s) and most patients have intubation completed within 2 minutes. Maximum blockade is achieved in most patients in less than 3 minutes. This dose may be expected to provide 31 (15 to 85) minutes of clinical relaxation under opioid/nitrous oxide/oxygen anesthesia. Under halothane, isoflurane, and enflurane anesthesia, some extension of the period of clinical relaxation should be expected [
].seeDrug Interactions (7.3)A lower dose of rocuronium bromide injection (0.45 mg/kg) may be used. Neuromuscular block sufficient for intubation (80% block or greater) is attained in a median (range) time of 1.3 (0.8 to 6.2) minute(s), and most patients have intubation completed within 2 minutes. Maximum blockade is achieved in most patients in less than 4 minutes. This dose may be expected to provide 22 (12 to 31) minutes of clinical relaxation under opioid/nitrous oxide/oxygen anesthesia. Patients receiving this low dose of 0.45 mg/kg who achieve less than 90% block (about 16% of these patients) may have a more rapid time to 25% recovery, 12 to 15 minutes.
A large bolus dose of 0.9 or 1.2 mg/kg can be administered under opioid/nitrous oxide/oxygen anesthesia without adverse effects to the cardiovascular system [
].seeClinical Pharmacology (12.2)• Rapid sequence intubation: 0.6 to 1.2 mg/kg. ()2.3 Rapid Sequence IntubationIn appropriately premedicated and adequately anesthetized patients, rocuronium bromide injection 0.6 to 1.2 mg/kg will provide excellent or good intubating conditions in most patients in less than 2 minutes [
].seeClinical Studies (14.1)• Maintenance doses: Guided by response to prior dose, not administered until recovery is evident. ()2.4 Maintenance DosingMaintenance doses of 0.1, 0.15, and 0.2 mg/kg rocuronium bromide injection, administered at 25% recovery of control T1(defined as 3 twitches of train-of-four), provide a median (range) of 12 (2 to 31), 17 (6 to 50) and 24 (7 to 69) minutes of clinical duration under opioid/nitrous oxide/oxygen anesthesia [
]. In all cases, dosing should be guided based on the clinical duration following initial dose or prior maintenance dose and not administered until recovery of neuromuscular function is evident. A clinically insignificant cumulation of effect with repetitive maintenance dosing has been observed [seeClinical Pharmacology (12.2)].seeClinical Pharmacology (12.2)• Continuous infusion: Initial rate of 10 to 12 mcg/kg/min. Start only after early evidence of spontaneous recovery from an intubating dose. ()2.5 Use by Continuous InfusionInfusion at an initial rate of 10 to 12 mcg/kg/min of rocuronium bromide injection should be initiated only after early evidence of spontaneous recovery from an intubating dose. Due to rapid redistribution [
] 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.seeClinical Pharmacology (12.3)Upon reaching the desired level of neuromuscular block, the infusion of rocuronium bromide injection 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 [
].seeClinical Pharmacology (12.2)Infusion solutions of rocuronium bromide injection can be prepared by mixing rocuronium bromide injection with an appropriate infusion solution such as 5% glucose in water or lactated Ringers [
]. These infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded.seeDosage and Administration (2.7)Infusion rates of rocuronium bromide injection can be individualized for each patient using the following tables for 3 different concentrations of rocuronium bromide injection solution as guidelines:
Table 1: Infusion Rates Using Rocuronium Bromide Injection (0.5 mg/mL)50 mg rocuronium bromide injection in 100 mL solution Patient WeightDrug Delivery Rate (mcg/kg/min)(kg)(lbs)45678910121416Infusion Delivery Rate (mL/hr)10
22
4.8
6
7.2
8.4
9.6
10.8
12
14.4
16.8
19.2
15
33
7.2
9
10.8
12.6
14.4
16.2
18
21.6
25.2
28.8
20
44
9.6
12
14.4
16.8
19.2
21.6
24
28.8
33.6
38.4
25
55
12
15
18
21
24
27
30
36
42
48
35
77
16.8
21
25.2
29.4
33.6
37.8
42
50.4
58.8
67.2
50
110
24
30
36
42
48
54
60
72
84
96
60
132
28.8
36
43.2
50.4
57.6
64.8
72
86.4
100.8
115.2
70
154
33.6
42
50.4
58.8
67.2
75.6
84
100.8
117.6
134.4
80
176
38.4
48
57.6
67.2
76.8
86.4
96
115.2
134.4
153.6
90
198
43.2
54
64.8
75.6
86.4
97.2
108
129.6
151.2
172.8
100
220
48
60
72
84
96
108
120
144
168
192
Table 2: Infusion Rates Using Rocuronium Bromide Injection (1 mg/mL)100 mg rocuronium bromide injection in 100 mL solution Patient WeightDrug Delivery Rate (mcg/kg/min)(kg)(lbs)45678910121416Infusion Delivery Rate (mL/hr)10
22
2.4
3
3.6
4.2
4.8
5.4
6
7.2
8.4
9.6
15
33
3.6
4.5
5.4
6.3
7.2
8.1
9
10.8
12.6
14.4
20
44
4.8
6
7.2
8.4
9.6
10.8
12
14.4
16.8
19.2
25
55
6
7.5
9
10.5
12
13.5
15
18
21
24
35
77
8.4
10.5
12.6
14.7
16.8
18.9
21
25.2
29.4
33.6
50
110
12
15
18
21
24
27
30
36
42
48
60
132
14.4
18
21.6
25.2
28.8
32.4
36
43.2
50.4
57.6
70
154
16.8
21
25.2
29.4
33.6
37.8
42
50.4
58.8
67.2
80
176
19.2
24
28.8
33.6
38.4
43.2
48
57.6
67.2
76.8
90
198
21.6
27
32.4
37.8
43.2
48.6
54
64.8
75.6
86.4
100
220
24
30
36
42
48
54
60
72
84
96
Table 3: Infusion Rates Using Rocuronium Bromide Injection (5 mg/mL)500 mg rocuronium bromide injection in 100 mL solution Patient WeightDrug Delivery Rate (mcg/kg/min)(kg)(lbs)45678910121416Infusion Delivery Rate (mL/hr)10
22
0.5
0.6
0.7
0.8
1
1.1
1.2
1.4
1.7
1.9
15
33
0.7
0.9
1.1
1.3
1.4
1.6
1.8
2.2
2.5
2.9
20
44
1
1.2
1.4
1.7
1.9
2.2
2.4
2.9
3.4
3.8
25
55
1.2
1.5
1.8
2.1
2.4
2.7
3
3.6
4.2
4.8
35
77
1.7
2.1
2.5
2.9
3.4
3.8
4.2
5
5.9
6.7
50
110
2.4
3
3.6
4.2
4.8
5.4
6
7.2
8.4
9.6
60
132
2.9
3.6
4.3
5
5.8
6.5
7.2
8.6
10.1
11.5
70
154
3.4
4.2
5
5.9
6.7
7.6
8.4
10.1
11.8
13.4
80
176
3.8
4.8
5.8
6.7
7.7
8.6
9.6
11.5
13.4
15.4
90
198
4.3
5.4
6.5
7.6
8.6
9.7
10.8
13
15.1
17.3
100
220
4.8
6
7.2
8.4
9.6
10.8
12
14.4
16.8
19.2
Rocuronium bromide is available as
• 5 mL multiple dose vials containing 50 mg rocuronium bromide injection (10 mg/mL)• 10 mL multiple dose vials containing 100 mg rocuronium bromide injection (10 mg/mL)
• Labor and Delivery: Not recommended for rapid sequence induction in patients undergoing Cesarean section. ()8.2 Labor and DeliveryThe use of rocuronium bromide in Cesarean section has been studied in a limited number of patients [
]. Rocuronium bromide is not recommended for rapid sequence induction in Cesarean section patients.seeClinical Studies (14.1)• Pediatric Use: Onset time and duration will vary with dose, age, and anesthetic technique. Not recommended for rapid sequence intubation in pediatric patients. ()8.4 Pediatric UseThe use of rocuronium bromide has been studied in pediatric patients 3 months to 14 years of age under halothane anesthesia. Of the pediatric patients anesthetized with halothane who did not receive atropine for induction, about 80% experienced a transient increase (30% or greater) in heart rate after intubation. One of the 19 infants anesthetized with halothane and fentanyl who received atropine for induction experienced this magnitude of change [
seeDosage and Administration (2.6)].andClinical Studies (14.3)Rocuronium bromide was also studied in pediatric patients up to 17 years of age, including neonates, under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia. Onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique. The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium bromide with general anesthetic agents can prolong the QTc interval. The data also suggest that rocuronium bromide may increase heart rate. However, it was not possible to conclusively identify an effect of rocuronium bromide independent of that of anesthesia and other factors. Additionally, when examining plasma levels of rocuronium bromide in correlation to QTc interval prolongation, no relationship was observed [
seeDosage and Administration (2.6),Warnings and Precautions (5.9),].andClinical Studies (14.3)Rocuronium bromide is not recommended for rapid sequence intubation in pediatric patients. Recommendations for use in pediatric patients are discussed in other sections [
seeDosage and Administration (2.6)].andClinical Pharmacology (12.2)
Rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [
Severe anaphylactic reactions to neuromuscular blocking agents, including rocuronium bromide, have been reported. These reactions have, in some cases (including cases with rocuronium bromide), been life threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Precautions should also be taken in those patients who have had previous anaphylactic reactions to other neuromuscular blocking agents, since cross-reactivity between neuromuscular blocking agents, both depolarizing and nondepolarizing, has been reported.