Rocuronium Bromide
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Uses
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.
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Other Information
Rocuronium bromide injection is a non-depolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. Rocuronium bromide is chemically designated as 1-[17ß-(acetyloxy)-3α-hydroxy-2ß-(4-morpholinyl)-5α-androstan-16ß-y1]-1-(2- propenyl) pyrrolidinium bromide.
The structural formula is:
The chemical formula is C32H53BrN2O4 with a molecular weight of 609.70. The partition coefficient of rocuronium bromide in n-octanol/water is 0.5 at 20°C.
Rocuronium bromide injection is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellow/orange, for intravenous injection only. Each mL contains 10 mg rocuronium bromide and 2 mg sodium acetate. The aqueous solution is adjusted to isotonicity with sodium chloride (3.10 mg/mL) and to a pH of 4 with acetic acid and/or sodium hydroxide.
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Rocuronium Bromide Manufacturers
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Remedyrepack Inc.
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Rocuronium Bromide | Remedyrepack Inc.
Rocuronium 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.
In patients in whom potentiation of, or resistance to, neuromuscular block is anticipated, a dose adjustment should be considered [see Dosage and Administration (2.5), Warnings and Precautions (5.9, 5.12), Drug Interactions (7.2, 7.3, 7.4, 7.5, 7.6, 7.8, 7.10), and Use in Specific Populations (8.6)].
The recommended initial dose of rocuronium bromide, 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 [see Drug Interactions (7.3)].
A lower dose of rocuronium bromide (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 [see Clinical Pharmacology (12.2)].
In appropriately premedicated and adequately anesthetized patients, rocuronium bromide 0.6 to 1.2 mg/kg will provide excellent or good intubating conditions in most patients in less than 2 minutes [see Clinical Studies (14.1)].
Maintenance doses of 0.1, 0.15, and 0.2 mg/kg rocuronium bromide, 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 [see Clinical Pharmacology (12.2)]. 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 [see Clinical Pharmacology (12.2)].
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 (12.3)] 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 non-depolarizing 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 (12.2)].
Infusion solutions of rocuronium bromide can be prepared by mixing rocuronium bromide injection with an appropriate infusion solution such as 5% glucose in water or lactated Ringers [see Dosage and Administration (2.6)]. 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 three different concentrations of rocuronium bromide solution as guidelines:
Table 1: Infusion Rates Using Rocuronium Bromide Injection (0.5 mg/mL)*Patient Weight
Drug Delivery Rate (mcg/kg/min)
(kg)
(lbs)
4
5
6
7
8
9
10
12
14
16
Infusion 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
1
Table 2: Infusion Rates Using Rocuronium Bromide Injection (1 mg/mL)*Patient Weight
Drug Delivery Rate (mcg/kg/min)
(kg)
(lbs)
4
5
6
7
8
9
10
12
14
16
Infusion 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
2
Table 3: Infusion Rates Using Rocuronium Bromide Injection (5 mg/mL)*Patient Weight
Drug Delivery Rate (mcg/kg/min)
(kg)
(lbs)
4
5
6
7
8
9
10
12
14
16
Infusion 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
3
The recommended initial intubation dose of rocuronium bromide is 0.6 mg/kg; however, a lower dose of 0.45 mg/kg may be used depending on anesthetic technique and the age of the patient.
For sevoflurane (induction) rocuronium bromide doses of 0.45 mg/kg and 0.6 mg/kg in general produce excellent to good intubating conditions within 75 seconds. When halothane is used, a 0.6 mg/kg dose of rocuronium bromide resulted in excellent to good intubating conditions within 60 seconds.
The time to maximum block for an intubating dose was shortest in infants (28 days up to 3 months) and longest in neonates (birth to less than 28 days). The duration of clinical relaxation following an intubating dose is shortest in children (greater than 2 years up to 11 years) and longest in infants.
When sevoflurane is used for induction and isoflurane/nitrous oxide for maintenance of general anesthesia, maintenance dosing of rocuronium bromide can be administered as bolus doses of 0.15 mg/kg at reappearance of T3 in all pediatric age groups. Maintenance dosing can also be administered at the reappearance of T2 at a rate of 7 to 10 mcg/kg/min, with the lowest dose requirement for neonates (birth to less than 28 days) and the highest dose requirement for children (greater than 2 years up to 11 years).
When halothane is used for general anesthesia, patients ranging from 3 months old through adolescence can be administered rocuronium bromide maintenance doses of 0.075 to 0.125 mg/kg upon return of T1 to 0.25% to provide clinical relaxation for 7 to 10 minutes. Alternatively, a continuous infusion of rocuronium bromide initiated at a rate of 12 mcg/kg/min upon return of T1 to 10% (one twitch present in train-of-four), may also be used to maintain neuromuscular blockade in pediatric patients.
Additional information for administration to pediatric patients of all age groups is presented elsewhere in the label [see Clinical Pharmacology (12.2)].
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. Spontaneous recovery and reversal of neuromuscular blockade following discontinuation of rocuronium bromide infusion may be expected to proceed at rates comparable to that following similar total exposure to single bolus doses [see Clinical Pharmacology (12.2)].
Rocuronium bromide is not recommended for rapid sequence intubation in pediatric patients.
Geriatric patients (65 years or older) exhibited a slightly prolonged median (range) clinical duration of 46 (22 to 73), 62 (49 to 75), and 94 (64 to 138) minutes under opioid/nitrous oxide/oxygen anesthesia following doses of 0.6, 0.9, and 1.2 mg/kg, respectively. No differences in duration of neuromuscular blockade following maintenance doses of rocuronium bromide were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.2, 12.3)].
No differences from patients with normal hepatic and kidney function were observed for onset time at a dose of 0.6 mg/kg rocuronium bromide. When compared to patients with normal renal and hepatic function, the mean clinical duration is similar in patients with end-stage renal disease undergoing renal transplant, and is about 1.5 times longer in patients with hepatic disease. Patients with renal failure may have a greater variation in duration of effect [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)].
In obese patients, the initial dose of rocuronium bromide 0.6 mg/kg should be based upon the patient’s actual body weight [see Clinical Studies (14.1)].
An analysis across all U.S. controlled clinical studies indicates that the pharmacodynamics of rocuronium bromide are not different between obese and non-obese patients when dosed based upon their actual body weight.
Rocuronium metabolism does not depend on plasma cholinesterase so dosing adjustments are not needed in patients with reduced plasma cholinesterase activity.
Because higher doses of rocuronium bromide produce a longer duration of action, the initial dosage should usually not be increased in these patients to reduce onset time; instead, in these situations, when feasible, more time should be allowed for the drug to achieve onset of effect [see Warnings and Precautions (5.7)].
The neuromuscular blocking action of rocuronium bromide is potentiated by isoflurane and enflurane anesthesia. Potentiation is minimal when administration of the recommended dose of rocuronium bromide occurs prior to the administration of these potent inhalation agents. The median clinical duration of a dose of 0.57 to 0.85 mg/kg was 34, 38, and 42 minutes under opioid/nitrous oxide/oxygen, enflurane and isoflurane maintenance anesthesia, respectively. During 1 to 2 hours of infusion, the infusion rate of rocuronium bromide required to maintain about 95% block was decreased by as much as 40% under enflurane and isoflurane anesthesia [see Drug Interactions (7.3)].
Diluent Compatibility: Rocuronium bromide injection is compatible in solution with:
0.9% NaCl solution
sterile water for injection
5% glucose in water
lactated Ringers
5% glucose in saline
Rocuronium bromide injection 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 injection is physically incompatible when mixed with the following drugs:
amphotericin
hydrocortisone sodium succinate
amoxicillin
insulin
azathioprine
intralipid
cefazolin
ketorolac
cloxacillin
lorazepam
dexamethasone
methohexital
diazepam
methylprednisolone
erythromycin
thiopental
famotidine
trimethoprim
furosemide
vancomycin
If rocuronium bromide injection is administered via the same infusion line that is also used for other drugs, it is important that this infusion line is adequately flushed between administration of rocuronium bromide and drugs for which incompatibility with rocuronium bromide has been demonstrated or for which compatibility with rocuronium bromide has not been established.
Infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded.
Rocuronium bromide injection should not be mixed with alkaline solutions [see Warnings and Precautions (5.10)].
Visual Inspection: Parenteral drug products should be inspected visually for particulate matter and clarity prior to administration whenever solution and container permit. Do not use solution if particulate matter is present.
1 50 mg rocuronium bromide in 100 mL solution 2 100 mg rocuronium bromide in 100 mL solution 3 500 mg rocuronium bromide in 100 mL solution -
Cantrell Drug Company
Rocuronium Bromide | American Sales Company
• do not take more than directed (see overdose warning)adults and children 12 years and over
• take 2 geltabs at bedtime • do not take more than 2 geltabs of this product in 24 hourschildren under 12 years
do not use
-
Hospira, Inc.
Rocuronium Bromide | Hospira, Inc.
Rocuronium 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 [see Dosage and Administration (2.5), Warnings and Precautions (5.9, 5.12), Drug Interactions (7.2, 7.3, 7.4, 7.5, 7.6, 7.8, 7.10), and Use in Specific Populations (8.6)].
2.1 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 [see Drug 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 [see Clinical Pharmacology (12.2)].
2.2 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 [see Clinical Studies (14.1)].
2.3 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 [see Clinical Pharmacology (12.2)]. 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 [see Clinical Pharmacology (12.2)].
2.4 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 [see Clinical Pharmacology (12.3)] 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 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 [see Clinical 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 [see Dosage and Administration (2.6)]. These infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded.
Infusion rates of rocuronium bromide injection can be individualized for each patient using the following tables for three 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 solutionPatient Weight
Drug Delivery Rate (mcg/kg/min)
(kg)
(lbs)
4
5
6
7
8
9
10
12
14
16
Infusion 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 solutionPatient Weight
Drug Delivery Rate (mcg/kg/min)
(kg)
(lbs)
4
5
6
7
8
9
10
12
14
16
Infusion 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 solutionPatient Weight
Drug Delivery Rate (mcg/kg/min)
(kg)
(lbs)
4
5
6
7
8
9
10
12
14
16
Infusion 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
2.5 Dosage in Specific PopulationsPediatric Patients
The recommended initial intubation dose of rocuronium bromide injection is 0.6 mg/kg; however, a lower dose of 0.45 mg/kg may be used depending on anesthetic technique and the age of the patient.
For sevoflurane (induction) Rocuronium bromide doses of 0.45 mg/kg and 0.6 mg/kg in general produce excellent to good intubating conditions within 75 seconds. When halothane is used, a 0.6 mg/kg dose of rocuronium bromide injection resulted in excellent to good intubating conditions within 60 seconds.
The time to maximum block for an intubating dose was shortest in infants (28 days up to 3 months) and longest in neonates (birth to less than 28 days). The duration of clinical relaxation following an intubating dose is shortest in children (greater than 2 years up to 11 years) and longest in infants.
When sevoflurane is used for induction and isoflurane/nitrous oxide for maintenance of general anesthesia, maintenance dosing of rocuronium bromide injection can be administered as bolus doses of 0.15 mg/kg at reappearance of T3 in all pediatric age groups. Maintenance dosing can also be administered at the reappearance of T2 at a rate of 7 to 10 mcg/kg/min, with the lowest dose requirement for neonates (birth to less than 28 days) and the highest dose requirement for children (greater than 2 years up to 11 years).
When halothane is used for general anesthesia, patients ranging from 3 months old through adolescence can be administered rocuronium bromide injection maintenance doses of 0.075 to 0.125 mg/kg upon return of T1 to 0.25% to provide clinical relaxation for 7 to 10 minutes. Alternatively, a continuous infusion of rocuronium bromide injection initiated at a rate of 12 mcg/kg/min upon return of T1 to 10% (one twitch present in train-of-four) may also be used to maintain neuromuscular blockade in pediatric patients.
Additional information for administration to pediatric patients of all age groups is presented elsewhere in the label [see Clinical Pharmacology (12.2)].
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. Spontaneous recovery and reversal of neuromuscular blockade following discontinuation of rocuronium bromide infusion may be expected to proceed at rates comparable to that following similar total exposure to single bolus doses [see Clinical Pharmacology (12.2)].
Rocuronium bromide injection is not recommended for rapid sequence intubation in pediatric patients.
Geriatric Patients
Geriatric patients (65 years or older) exhibited a slightly prolonged median (range) clinical duration of 46 (22 to 73), 62 (49 to 75), and 94 (64 to 138) minutes under opioid/nitrous oxide/oxygen anesthesia following doses of 0.6, 0.9, and 1.2 mg/kg, respectively. No differences in duration of neuromuscular blockade following maintenance doses of rocuronium bromide injection were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.2, 12.3)].
Patients with Renal or Hepatic Impairment
No differences from patients with normal hepatic and kidney function were observed for onset time at a dose of 0.6 mg/kg rocuronium bromide injection. When compared to patients with normal renal and hepatic function, the mean clinical duration is similar in patients with end-stage renal disease undergoing renal transplant, and is about 1.5 times longer in patients with hepatic disease. Patients with renal failure may have a greater variation in duration of effect [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)].
Obese Patients
In obese patients, the initial dose of rocuronium bromide injection 0.6 mg/kg should be based upon the patient’s actual body weight [see Clinical Studies (14.1)].
An analysis across all US controlled clinical studies indicates that the pharmacodynamics of rocuronium bromide injection are not different between obese and non-obese patients when dosed based upon their actual body weight.
Patients with Reduced Plasma Cholinesterase Activity
Rocuronium metabolism does not depend on plasma cholinesterase so dosing adjustments are not needed in patients with reduced plasma cholinesterase activity.
Patients with Prolonged Circulation Time
Because higher doses of rocuronium bromide injection produce a longer duration of action, the initial dosage should usually not be increased in these patients to reduce onset time; instead, in these situations, when feasible, more time should be allowed for the drug to achieve onset of effect [see Warnings and Precautions (5.7)].
Patients with Drugs or Conditions Causing Potentiation of Neuromuscular Block
The neuromuscular blocking action of rocuronium bromide injection is potentiated by isoflurane and enflurane anesthesia. Potentiation is minimal when administration of the recommended dose of rocuronium bromide injection occurs prior to the administration of these potent inhalation agents. The median clinical duration of a dose of 0.57 to 0.85 mg/kg was 34, 38, and 42 minutes under opioid/nitrous oxide/oxygen, enflurane and isoflurane maintenance anesthesia, respectively. During 1 to 2 hours of infusion, the infusion rate of rocuronium bromide injection required to maintain about 95% block was decreased by as much as 40% under enflurane and isoflurane anesthesia [see Drug Interactions (7.3)].
2.6 Preparation for Administration of Rocuronium Bromide InjectionDiluent Compatibility
Rocuronium bromide injection is compatible in solution with:
0.9% NaCl solution sterile water for injection
5% glucose in water lactated Ringers
5% glucose in salineRocuronium bromide injection 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 injection is physically incompatible when mixed with the following drugs:
amphotericin hydrocortisone sodium succinate
amoxicillin insulin
azathioprine intralipid
cefazolin ketorolac
cloxacillin lorazepam
dexamethasone methohexital
diazepam methylprednisolone
erythromycin thiopental
famotidine trimethoprim
furosemide vancomycinIf rocuronium bromide injection is administered via the same infusion line that is also used for other drugs, it is important that this infusion line is adequately flushed between administration of rocuronium bromide injection and drugs for which incompatibility with rocuronium bromide injection has been demonstrated or for which compatibility with rocuronium bromide injection has not been established.
Infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded.
Rocuronium bromide injection should not be mixed with alkaline solutions [see Warnings and Precautions (5.10)].
Visual Inspection
Parenteral drug products should be inspected visually for particulate matter and clarity prior to administration whenever solution and container permit. Do not use solution if particulate matter is present.
-
Teva Parenteral Medicines, Inc
Rocuronium Bromide | Smiths Medical Asd, Inc.
Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug, specific references should be checked for any possible incompatibility with sodium chloride. The volume of the preparation to be used for diluting or dissolving any drug for injection is dependent on the vehicle concentration, dose and route of administration as recommended by the manufacture.
Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered. Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
INSTRUCTIONS FOR USE
To open ampuls, using gauze, place thumb and forefinger on color line, break at constriction.
Table I (Recommended Dosages) summarizes the recommended volumes and concentrations of Lidocaine Hydrochloride Injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required only solutions containing epinephrine should be used, except in those cases where vasopressor drugs may be contraindicated.There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Lidocaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).
These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for elderly and debilitated patients and patients with cardiac and/or liver disease.
The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of Lidocaine Hydrochloride Injection, USP will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Lidocaine Hydrochloride Injection, USP may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.
Epidural Anesthesia
For an epidural test dose, only the following available specific product of Lidocaine Hydrochloride and Epinephrine Injection, USP by Hospira is recommended:
1.5% with epinephrine 1:200,000.................... 5 mL single-dose ampuls
For epidural anesthesia, only the following available specific products of Lidocaine Hydrochloride and Epinephrine Injection, USP by Hospira are recommended:
1% with epinephrine 1:200,000............................ 30 mL single-dose ampuls
30 mL single-dose vials
1.5% with epinephrine 1:200,000.......................... 30 mL single-dose ampuls
30 mL single-dose vials
2% with epinephrine 1:200,000................................ 20 mL single-dose vials
Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block provided they are employed as single-dose units. These solutions contain no bacteriostatic agent.
In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2-3 mL of the indicated concentration per dermatome).
Caudal and Lumbar Epidural Block: As a precaution against the adverse experiences sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2-3 mL of 1.5% lidocaine injection should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10-15 µg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient “epinephrine response” within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Lidocaine Hydrochloride and Epinephrine Injection, USP through the catheter should be avoided, and, when feasible, fractional doses should be administered.
In the event of the known injection of a large volume of local anesthetic solution into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.
Maximum Recommended Dosages
Adults: For normal healthy adults, the individual maximum dose of Lidocaine Hydrochloride and Epinephrine Injection, USP should not exceed 7 mg/kg (3.5 mg/lb) of body weight and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine, the maximum individual dose should not exceed 4.5 mg/kg (2 mg per lb) of body weight, and in general it is recommended that the maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may be administered if required to produce adequate anesthesia.
The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients and non-obstetrical patients is 200 mg total. One half of the total dose is usually administered to each side. Inject slowly five minutes between sides. (See also discussion of paracervical block in PRECAUTIONS).
Pediatric Population: It is difficult to recommend a maximum dose of any drug for pediatric patients, since this varies as a function of age and weight. For pediatric patients over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child’s age and weight. For example, in a child of 5 years weighing 50 lbs., the dose of lidocaine HCl should not exceed 75-100 mg (1.5-2 mg/lb).
In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% sodium chloride injection in order to obtain the required final concentration.
FOR EPIDURAL USE ONLY.
Note: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Do not use the injection if its color is pinkish or darker than slightly yellow or if it contains a precipitate.
Table I Recommended Dosages of Lidocaine Hydrochloride Injection, USP for Various Anesthetic Procedures in Normal Healthy AdultsLidocaine Hydrochloride Injection, USP (without Epinephrine)
Procedure
Conc. (%)
Vol. (mL)
Total Dose (mg)
Infiltration
Percutaneous
Intravenous Regional0.5 or 1.0
0.5
1-60
10-60
5-300
50-300
Peripheral Nerve Blocks, e.g.
Brachial
Dental
Intercostal
Paravertebral
Pudendal (each side)
Paracervical Obstetrical Analgesia (each side)
1.5
2.0
1.0
1.0
1.0
1.015-20
1-5
3
3-5
10
10225-300
20-100
30
30-50
100
100Sympathetic Nerve Blocks, e.g.
Cervical (stellate ganglion)
Lumbar
1.0
1.0
5
5-10
50
50-100
Central Neural Blocks
Epidural*
Thoracic
Lumbar
Analgesia
Anesthesia
Caudal
Obstetrical Analgesia
Surgical Anesthesia
1.0
1.0
1.5
2.0
1.0
1.520-30
25-30
15-20
10-15
20-30
15-20200-300
250-300
225-300
200-300
200-300
225-300*Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/ dermatome).
THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A GUIDE. OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED.
Sterilization, Storage and Technical Procedures: Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection as they have been related to incidence of swelling and edema. When chemical disinfection of multi-dose vials is desired, either isopropyl alcohol (91%) or 70% ethyl alcohol is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of USP grade, contain denaturants which are injurious to rubber and, therefore, are not to be used. It is recommended that chemical disinfection be accomplished by wiping the vial stopper or ampul thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use.
Do not autoclave.
Table 1 (Recommended Dosages) summarizes the recommended volumes and concentrations of Lidocaine Hydrochloride Injection, USP for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults and refer to the use of epinephrine-free solutions. When larger volumes are required only solutions containing epinephrine should be used, except in those cases where vasopressor drugs may be contraindicated.
There have been adverse event reports of chondrolysis in patients receiving intra-articular infusions of local anesthetics following arthroscopic and other surgical procedures. Lidocaine is not approved for this use (see WARNINGS and DOSAGE AND ADMINISTRATION).
These recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes and concentrations to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia and degree of muscular relaxation required, duration of anesthesia required, and the physical condition of the patient. In all cases the lowest concentration and smallest dose that will produce the desired result should be given. Dosages should be reduced for children and for elderly and debilitated patients and patients with cardiac and/or liver disease.
The onset of anesthesia, the duration of anesthesia and the degree of muscular relaxation are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Thus, an increase in volume and concentration of Lidocaine Hydrochloride Injection will decrease the onset of anesthesia, prolong the duration of anesthesia, provide a greater degree of muscular relaxation and increase the segmental spread of anesthesia. However, increasing the volume and concentration of Lidocaine Hydrochloride Injection may result in a more profound fall in blood pressure when used in epidural anesthesia. Although the incidence of side effects with lidocaine is quite low, caution should be exercised when employing large volumes and concentrations, since the incidence of side effects is directly proportional to the total dose of local anesthetic agent injected.
For intravenous regional anesthesia, only the 50 mL single-dose vial containing 0.5% Lidocaine Hydrochloride Injection, USP should be used.
Epidural Anesthesia
For epidural anesthesia, only the following available specific products of Lidocaine Hydrochloride Injection by Hospira are recommended:
1%. . . . . . . . . . . . . . . . . . . . 30 mL single-dose teartop vials
1.5%. . . . . . . . . . . . . . . . . . . . . . . 20 mL single-dose ampuls
2%. . . . . . . . . . . . . . . . . . . . . . . . . 10 mL single-dose ampuls
Although these solutions are intended specifically for epidural anesthesia, they may also be used for infiltration and peripheral nerve block provided they are employed as single dose units. These solutions contain no bacteriostatic agent. In epidural anesthesia, the dosage varies with the number of dermatomes to be anesthetized (generally 2−3 mL of the indicated concentration per dermatome).
Caudal and Lumbar Epidural Block: As a precaution against the adverse experiences sometimes observed following unintentional penetration of the subarachnoid space, a test dose such as 2−3 mL of 1.5% lidocaine hydrochloride should be administered at least 5 minutes prior to injecting the total volume required for a lumbar or caudal epidural block. The test dose should be repeated if the patient is moved in a manner that may have displaced the catheter. Epinephrine, if contained in the test dose (10−15 mcg have been suggested), may serve as a warning of unintentional intravascular injection. If injected into a blood vessel, this amount of epinephrine is likely to produce a transient "epinephrine response" within 45 seconds, consisting of an increase in heart rate and systolic blood pressure, circumoral pallor, palpitations and nervousness in the unsedated patient. The sedated patient may exhibit only a pulse rate increase of 20 or more beats per minute for 15 or more seconds. Patients on beta-blockers may not manifest changes in heart rate, but blood pressure monitoring can detect an evanescent rise in systolic blood pressure. Adequate time should be allowed for onset of anesthesia after administration of each test dose. The rapid injection of a large volume of Lidocaine Hydrochloride Injection through the catheter should be avoided, and, when feasible, fractional doses should be administered.
In the event of the known injection of a large volume of local anesthetic solutions into the subarachnoid space, after suitable resuscitation and if the catheter is in place, consider attempting the recovery of drug by draining a moderate amount of cerebrospinal fluid (such as 10 mL) through the epidural catheter.
Maximum Recommended Dosages
NOTE: The products accompanying this insert do not contain epinephrine.
Adults: For normal healthy adults, the individual maximum recommended dose of lidocaine HCl with epinephrine should not exceed 7 mg/kg (3.5 mg/lb) of body weight and in general it is recommended that the maximum total dose not exceed 500 mg. When used without epinephrine, the maximum individual dose should not exceed 4.5 mg/kg (2 mg/lb) of body weight and in general it is recommended that the maximum total dose does not exceed 300 mg. For continuous epidural or caudal anesthesia, the maximum recommended dosage should not be administered at intervals of less than 90 minutes. When continuous lumbar or caudal epidural anesthesia is used for non-obstetrical procedures, more drug may be administered if required to produce adequate anesthesia.
The maximum recommended dose per 90 minute period of lidocaine hydrochloride for paracervical block in obstetrical patients and non-obstetrical patients is 200 mg total. One-half of the total dose is usually administered to each side. Inject slowly five minutes between sides. (See also discussion of paracervical block in PRECAUTIONS).
For intravenous regional anesthesia, the dose administered should not exceed 4 mg/kg in adults.
Children: It is difficult to recommend a maximum dose of any drug for children, since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child’s age and weight. For example, in a child of 5 years weighing 50 lbs., the dose of lidocaine HCl should not exceed 75 — 100 mg (1.5 — 2 mg/lb). The use of even more dilute solutions (i.e., 0.25 — 0.5%) and total dosages not to exceed 3 mg/kg (1.4 mg/lb) are recommended for induction of intravenous regional anesthesia in children.
In order to guard against systemic toxicity, the lowest effective concentration and lowest effective dose should be used at all times. In some cases it will be necessary to dilute available concentrations with 0.9% sodium chloride injection in order to obtain the required final concentration.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever the solution and container permit. Solutions that are discolored and/or contain particulate matter should not be used.
Table 1
Recommended Dosages of Lidocaine Hydrochloride Injection, USP for Various Anesthetic
Procedures in Normal Healthy Adults
Lidocaine Hydrochloride Injection, USP (without Epinephrine)
Procedure
Conc. (%)
Vol. (mL)
Total Dose (mg)
Infiltration
Percutaneous
0.5 or 1.0
1−60
5−300
Intravenous Regional
0.5
10−60
50−300
Peripheral Nerve Blocks, e.g.
Brachial
1.5
15−20
225−300
Dental
2.0
1−5
20−100
Intercostal
1.0
3
30
Paravertebral
1.0
3−5
30−50
Pudendal (each side)
1.0
10
100
Paracervical
Obstetrical Analgesia
(each side)
1.0
10
100
Sympathetic Nerve Blocks, e.g.
Cervical (stellate ganglion)
1.0
5
50
Lumbar
1.0
5−10
50−100
Central Neural Blocks
Epidural*
Thoracic
1.0
20−30
200−300
Lumbar
Analgesia
1.0
25−30
250−300
Anesthesia
1.5
15−20
225−300
2.0
10−15
200−300
Caudal
Obstetrical Analgesia
1.0
20−30
200−300
Surgical Anesthesia
1.5
15−20
225−300
*Dose determined by number of dermatomes to be anesthetized (2 to 3 mL/dermatome).
THE ABOVE SUGGESTED CONCENTRATIONS AND VOLUMES SERVE ONLY AS A GUIDE. OTHER VOLUMES AND CONCENTRATIONS MAY BE USED PROVIDED THE TOTAL MAXIMUM RECOMMENDED DOSE IS NOT EXCEEDED.
Sterilization, Storage and Technical Procedures: Disinfecting agents containing heavy metals, which cause release of respective ions (mercury, zinc, copper, etc.) should not be used for skin or mucous membrane disinfection as they have been related to incidence of swelling and edema. When chemical disinfection of multi-dose vials is desired, either isopropyl alcohol (91%) or 70% ethyl alcohol is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of USP grade, contain denaturants which are injurious to rubber and, therefore, are not to be used. It is recommended that chemical disinfection be accomplished by wiping the vial stopper thoroughly with cotton or gauze that has been moistened with the recommended alcohol just prior to use.
-
Sandoz Inc
Rocuronium Bromide | Putney Inc
Infections of the respiratory tract and soft tissues.
Patients weighing 40 kg (88 lbs) or more: 250 to 500 mg every 6 hours.
Patients weighing less than 40 kg (88 lbs): 25 to 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.
Infections of the gastrointestinal and genitourinary tracts (including those caused by Neisseria gonorrhoeae in females).
Patients weighing 40 kg (88 lbs) or more: 500 mg every 6 hours.
Patients weighing less than 40 kg (88 lbs): 50 mg/kg/day in equally divided doses at 6- to 8- hour intervals.
In the treatment of chronic urinary tract and intestinal infections, frequent bacteriological and clinical appraisal is necessary. Smaller doses than those recommended above should not be used. Higher doses should be used for stubborn or severe infections. In stubborn infections, therapy may be required for several weeks. It may be necessary to continue clinical and/or bacteriological follow-up for several months after cessation of therapy.
Urethritis in males due to N. gonorrhoeae.
Adults – Two doses of 500 mg each at an interval of 8 to 12 hours. Treatment may be repeated if necessary or extended if required.
In the treatment of complications of gonorrheal urethritis, such as prostatitis and epididymitis, prolonged and intensive therapy is recommended. Cases of gonorrhea with a suspected primary lesion of syphilis should have darkfield examinations before receiving treatment. In all other cases where concomitant syphilis is suspected, monthly serological tests should be made for a minimum of four months. The doses for the preceding infections may be given by either the intramuscular or intravenous route. A change to oral ampicillin may be made when appropriate.
Bacterial MeningitisAdults and children – 150 to 200 mg/kg/day in equally divided doses every 3 to 4 hours. (Treatment may be initiated with intravenous drip therapy and continued with intramuscular injections.) The doses for other infections may be given by either the intravenous or intramuscular route.
SepticemiaAdults and children – 150 to 200 mg/kg/day. Start with intravenous administration for at least three days and continue with the intramuscular route every 3 to 4 hours.
Treatment of all infections should be continued for a minimum of 48 to 72 hours beyond the time that the patient becomes asymptomatic or evidence of bacterial eradication has been obtained. A minimum of 10-days treatment is recommended for any infection caused by Group A beta-hemolytic streptococci to help prevent the occurrence of acute rheumatic fever or acute glomerulonephritis.
-
Hospira, Inc.
Rocuronium Bromide | Hospira, Inc.
Rocuronium 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 [see Dosage and Administration (2.5), Warnings and Precautions (5.9, 5.12), Drug Interactions (7.2, 7.3, 7.4, 7.5, 7.6, 7.8, 7.10), and Use in Specific Populations (8.6)].
2.1 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 [see Drug 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 [see Clinical Pharmacology (12.2)].
2.2 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 [see Clinical Studies (14.1)].
2.3 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 [see Clinical Pharmacology (12.2)]. 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 [see Clinical Pharmacology (12.2)].
2.4 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 [see Clinical Pharmacology (12.3)] 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 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 [see Clinical 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 [see Dosage and Administration (2.6)]. These infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded.
Infusion rates of rocuronium bromide injection can be individualized for each patient using the following tables for three 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 solutionPatient Weight
Drug Delivery Rate (mcg/kg/min)
(kg)
(lbs)
4
5
6
7
8
9
10
12
14
16
Infusion 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 solutionPatient Weight
Drug Delivery Rate (mcg/kg/min)
(kg)
(lbs)
4
5
6
7
8
9
10
12
14
16
Infusion 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 solutionPatient Weight
Drug Delivery Rate (mcg/kg/min)
(kg)
(lbs)
4
5
6
7
8
9
10
12
14
16
Infusion 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
2.5 Dosage in Specific PopulationsPediatric Patients
The recommended initial intubation dose of rocuronium bromide injection is 0.6 mg/kg; however, a lower dose of 0.45 mg/kg may be used depending on anesthetic technique and the age of the patient.
For sevoflurane (induction) Rocuronium bromide doses of 0.45 mg/kg and 0.6 mg/kg in general produce excellent to good intubating conditions within 75 seconds. When halothane is used, a 0.6 mg/kg dose of rocuronium bromide injection resulted in excellent to good intubating conditions within 60 seconds.
The time to maximum block for an intubating dose was shortest in infants (28 days up to 3 months) and longest in neonates (birth to less than 28 days). The duration of clinical relaxation following an intubating dose is shortest in children (greater than 2 years up to 11 years) and longest in infants.
When sevoflurane is used for induction and isoflurane/nitrous oxide for maintenance of general anesthesia, maintenance dosing of rocuronium bromide injection can be administered as bolus doses of 0.15 mg/kg at reappearance of T3 in all pediatric age groups. Maintenance dosing can also be administered at the reappearance of T2 at a rate of 7 to 10 mcg/kg/min, with the lowest dose requirement for neonates (birth to less than 28 days) and the highest dose requirement for children (greater than 2 years up to 11 years).
When halothane is used for general anesthesia, patients ranging from 3 months old through adolescence can be administered rocuronium bromide injection maintenance doses of 0.075 to 0.125 mg/kg upon return of T1 to 0.25% to provide clinical relaxation for 7 to 10 minutes. Alternatively, a continuous infusion of rocuronium bromide injection initiated at a rate of 12 mcg/kg/min upon return of T1 to 10% (one twitch present in train-of-four) may also be used to maintain neuromuscular blockade in pediatric patients.
Additional information for administration to pediatric patients of all age groups is presented elsewhere in the label [see Clinical Pharmacology (12.2)].
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. Spontaneous recovery and reversal of neuromuscular blockade following discontinuation of rocuronium bromide infusion may be expected to proceed at rates comparable to that following similar total exposure to single bolus doses [see Clinical Pharmacology (12.2)].
Rocuronium bromide injection is not recommended for rapid sequence intubation in pediatric patients.
Geriatric Patients
Geriatric patients (65 years or older) exhibited a slightly prolonged median (range) clinical duration of 46 (22 to 73), 62 (49 to 75), and 94 (64 to 138) minutes under opioid/nitrous oxide/oxygen anesthesia following doses of 0.6, 0.9, and 1.2 mg/kg, respectively. No differences in duration of neuromuscular blockade following maintenance doses of rocuronium bromide injection were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in response between elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.2, 12.3)].
Patients with Renal or Hepatic Impairment
No differences from patients with normal hepatic and kidney function were observed for onset time at a dose of 0.6 mg/kg rocuronium bromide injection. When compared to patients with normal renal and hepatic function, the mean clinical duration is similar in patients with end-stage renal disease undergoing renal transplant, and is about 1.5 times longer in patients with hepatic disease. Patients with renal failure may have a greater variation in duration of effect [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)].
Obese Patients
In obese patients, the initial dose of rocuronium bromide injection 0.6 mg/kg should be based upon the patient’s actual body weight [see Clinical Studies (14.1)].
An analysis across all US controlled clinical studies indicates that the pharmacodynamics of rocuronium bromide injection are not different between obese and non-obese patients when dosed based upon their actual body weight.
Patients with Reduced Plasma Cholinesterase Activity
Rocuronium metabolism does not depend on plasma cholinesterase so dosing adjustments are not needed in patients with reduced plasma cholinesterase activity.
Patients with Prolonged Circulation Time
Because higher doses of rocuronium bromide injection produce a longer duration of action, the initial dosage should usually not be increased in these patients to reduce onset time; instead, in these situations, when feasible, more time should be allowed for the drug to achieve onset of effect [see Warnings and Precautions (5.7)].
Patients with Drugs or Conditions Causing Potentiation of Neuromuscular Block
The neuromuscular blocking action of rocuronium bromide injection is potentiated by isoflurane and enflurane anesthesia. Potentiation is minimal when administration of the recommended dose of rocuronium bromide injection occurs prior to the administration of these potent inhalation agents. The median clinical duration of a dose of 0.57 to 0.85 mg/kg was 34, 38, and 42 minutes under opioid/nitrous oxide/oxygen, enflurane and isoflurane maintenance anesthesia, respectively. During 1 to 2 hours of infusion, the infusion rate of rocuronium bromide injection required to maintain about 95% block was decreased by as much as 40% under enflurane and isoflurane anesthesia [see Drug Interactions (7.3)].
2.6 Preparation for Administration of Rocuronium Bromide InjectionDiluent Compatibility
Rocuronium bromide injection is compatible in solution with:
0.9% NaCl solution sterile water for injection
5% glucose in water lactated Ringers
5% glucose in salineRocuronium bromide injection 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 injection is physically incompatible when mixed with the following drugs:
amphotericin hydrocortisone sodium succinate
amoxicillin insulin
azathioprine intralipid
cefazolin ketorolac
cloxacillin lorazepam
dexamethasone methohexital
diazepam methylprednisolone
erythromycin thiopental
famotidine trimethoprim
furosemide vancomycinIf rocuronium bromide injection is administered via the same infusion line that is also used for other drugs, it is important that this infusion line is adequately flushed between administration of rocuronium bromide injection and drugs for which incompatibility with rocuronium bromide injection has been demonstrated or for which compatibility with rocuronium bromide injection has not been established.
Infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded.
Rocuronium bromide injection should not be mixed with alkaline solutions [see Warnings and Precautions (5.10)].
Visual Inspection
Parenteral drug products should be inspected visually for particulate matter and clarity prior to administration whenever solution and container permit. Do not use solution if particulate matter is present.
-
Mylan Institutional Llc
Rocuronium Bromide | Mylan Institutional Llc
Rocuronium 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.
In patients in whom potentiation of, or resistance to, neuromuscular block is anticipated, a dose adjustment should be considered [see Dosage and Administration (2.5), Warnings and Precautions (5.9, 5.12), Drug Interactions (7.2, 7.3, 7.4, 7.5, 7.6, 7.8, 7.10), and Use in Specific Populations (8.6)].
2.1 Dose for Tracheal IntubationThe recommended initial dose of rocuronium bromide, 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 [see Drug Interactions (7.3)].
A lower dose of rocuronium bromide (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 [see Clinical Pharmacology (12.2)].
2.2 Rapid Sequence IntubationIn appropriately premedicated and adequately anesthetized patients, rocuronium bromide 0.6 to 1.2 mg/kg will provide excellent or good intubating conditions in most patients in less than 2 minutes [see Clinical Studies (14.1)].
2.3 Maintenance DosingMaintenance doses of 0.1, 0.15, and 0.2 mg/kg rocuronium bromide, 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 [see Clinical Pharmacology (12.2)]. 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 [see Clinical Pharmacology (12.2)].
2.4 Use by Continuous InfusionInfusion 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 (12.3)] 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 non-depolarizing 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 (12.2)].
Infusion solutions of rocuronium bromide can be prepared by mixing rocuronium bromide injection with an appropriate infusion solution such as 5% glucose in water or lactated Ringers [see Dosage and Administration (2.6)]. 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 three different concentrations of rocuronium bromide solution as guidelines:
Table 1: Infusion Rates Using Rocuronium Bromide Injection (0.5 mg/mL)* * 50 mg rocuronium bromide in 100 mL solution.Patient Weight
Drug Delivery Rate (mcg/kg/min)
(kg)
(lbs)
4
5
6
7
8
9
10
12
14
16
Infusion 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 in 100 mL solution.Patient Weight
Drug Delivery Rate (mcg/kg/min)
(kg)
(lbs)
4
5
6
7
8
9
10
12
14
16
Infusion 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 in 100 mL solution.Patient Weight
Drug Delivery Rate (mcg/kg/min)
(kg)
(lbs)
4
5
6
7
8
9
10
12
14
16
Infusion 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
2.5 Dosage in Specific Populations Pediatric PatientsThe recommended initial intubation dose of rocuronium bromide is 0.6 mg/kg; however, a lower dose of 0.45 mg/kg may be used depending on anesthetic technique and the age of the patient.
For sevoflurane (induction) rocuronium bromide doses of 0.45 mg/kg and 0.6 mg/kg in general produce excellent to good intubating conditions within 75 seconds. When halothane is used, a 0.6 mg/kg dose of rocuronium bromide resulted in excellent to good intubating conditions within 60 seconds.
The time to maximum block for an intubating dose was shortest in infants (28 days up to 3 months) and longest in neonates (birth to less than 28 days). The duration of clinical relaxation following an intubating dose is shortest in children (greater than 2 years up to 11 years) and longest in infants.
When sevoflurane is used for induction and isoflurane/nitrous oxide for maintenance of general anesthesia, maintenance dosing of rocuronium bromide can be administered as bolus doses of 0.15 mg/kg at reappearance of T3 in all pediatric age groups. Maintenance dosing can also be administered at the reappearance of T2 at a rate of 7 to 10 mcg/kg/min, with the lowest dose requirement for neonates (birth to less than 28 days) and the highest dose requirement for children (greater than 2 years up to 11 years).
When halothane is used for general anesthesia, patients ranging from 3 months old through adolescence can be administered rocuronium bromide maintenance doses of 0.075 to 0.125 mg/kg upon return of T1 to 0.25% to provide clinical relaxation for 7 to 10 minutes. Alternatively, a continuous infusion of rocuronium bromide initiated at a rate of 12 mcg/kg/min upon return of T1 to 10% (one twitch present in train-of-four), may also be used to maintain neuromuscular blockade in pediatric patients.
Additional information for administration to pediatric patients of all age groups is presented elsewhere in the label [see Clinical Pharmacology (12.2)].
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. Spontaneous recovery and reversal of neuromuscular blockade following discontinuation of rocuronium bromide infusion may be expected to proceed at rates comparable to that following similar total exposure to single bolus doses [see Clinical Pharmacology (12.2)].
Rocuronium bromide is not recommended for rapid sequence intubation in pediatric patients.
Geriatric PatientsGeriatric patients (65 years or older) exhibited a slightly prolonged median (range) clinical duration of 46 (22 to 73), 62 (49 to 75), and 94 (64 to 138) minutes under opioid/nitrous oxide/oxygen anesthesia following doses of 0.6, 0.9, and 1.2 mg/kg, respectively. No differences in duration of neuromuscular blockade following maintenance doses of rocuronium bromide were observed between these subjects and younger subjects, but greater sensitivity of some older individuals cannot be ruled out [see Clinical Pharmacology (12.2) and Clinical Studies (14.2)]. [See also Warnings and Precautions (5.4).]
Patients with Renal or Hepatic ImpairmentNo differences from patients with normal hepatic and kidney function were observed for onset time at a dose of 0.6 mg/kg rocuronium bromide. When compared to patients with normal renal and hepatic function, the mean clinical duration is similar in patients with end-stage renal disease undergoing renal transplant, and is about 1.5 times longer in patients with hepatic disease. Patients with renal failure may have a greater variation in duration of effect [see Use in Specific Populations (8.6, 8.7) and Clinical Pharmacology (12.3)].
Obese PatientsIn obese patients, the initial dose of rocuronium bromide 0.6 mg/kg should be based upon the patient’s actual body weight [see Clinical Studies (14.1)].
An analysis across all U.S. controlled clinical studies indicates that the pharmacodynamics of rocuronium bromide are not different between obese and non-obese patients when dosed based upon their actual body weight.
Patients with Reduced Plasma Cholinesterase ActivityRocuronium metabolism does not depend on plasma cholinesterase so dosing adjustments are not needed in patients with reduced plasma cholinesterase activity.
Patients with Prolonged Circulation TimeBecause higher doses of rocuronium bromide produce a longer duration of action, the initial dosage should usually not be increased in these patients to reduce onset time; instead, in these situations, when feasible, more time should be allowed for the drug to achieve onset of effect [see Warnings and Precautions (5.7)].
Patients with Drugs or Conditions Causing Potentiation of Neuromuscular BlockThe neuromuscular blocking action of rocuronium bromide is potentiated by isoflurane and enflurane anesthesia. Potentiation is minimal when administration of the recommended dose of rocuronium bromide occurs prior to the administration of these potent inhalation agents. The median clinical duration of a dose of 0.57 to 0.85 mg/kg was 34, 38, and 42 minutes under opioid/nitrous oxide/oxygen, enflurane and isoflurane maintenance anesthesia, respectively. During 1 to 2 hours of infusion, the infusion rate of rocuronium bromide required to maintain about 95% block was decreased by as much as 40% under enflurane and isoflurane anesthesia [see Drug Interactions (7.3)].
2.6 Preparation for Administration of Rocuronium Bromide InjectionDiluent Compatibility: Rocuronium bromide injection is compatible in solution with:
0.9% NaCl solution
sterile water for injection
5% glucose in water
lactated Ringers
5% glucose in saline
Rocuronium bromide injection 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 injection is physically incompatible when mixed with the following drugs:
amphotericin
hydrocortisone sodium succinate
amoxicillin
insulin
azathioprine
Intralipid
cefazolin
ketorolac
cloxacillin
lorazepam
dexamethasone
methohexital
diazepam
methylprednisolone
erythromycin
thiopental
famotidine
trimethoprim
furosemide
vancomycin
If rocuronium bromide injection is administered via the same infusion line that is also used for other drugs, it is important that this infusion line is adequately flushed between administration of rocuronium bromide and drugs for which incompatibility with rocuronium bromide has been demonstrated or for which compatibility with rocuronium bromide has not been established.
Infusion solutions should be used within 24 hours of mixing. Unused portions of infusion solutions should be discarded.
Rocuronium bromide injection should not be mixed with alkaline solutions [see Warnings and Precautions (5.10)].
Visual Inspection: Parenteral drug products should be inspected visually for particulate matter and clarity prior to administration whenever solution and container permit. Do not use solution if particulate matter is present.
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