Rocuronium

Rocuronium
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

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Overview

Rocuronium is a skeletal muscle relaxant, neuromuscular blocking drug that is FDA approved for the {{{indicationType}}} of general anesthesia; adjunct - induction of neuromuscular blockade, during surgery or mechanical ventilation, induction of neuromuscular blockade intubation, routine tracheal, rapid sequence intubation.. Common adverse reactions include cardiovascular: hypertension (0.1% to 2% ), hypotension (0.1% to 2% ), tachycardia (less than 1% to 5.3% )dermatologic: injection site pain, respiratory: Increased pulmonary vascular resistance (24% ).

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

• Dosage should be individualized and guided by neuromuscular transmission recovery.
• General anesthesia; Adjunct

• Induction of neuromuscular blockade, During surgery or mechanical ventilation

• Initial, 0.6 mg/kg IV
• Maintenance, 0.1 to 0.2 mg/kg IV push, repeat as needed or 0.01 to 0.012 mg/kg/minute continuous IV infusion.

• Induction of neuromuscular blockade - Intubation, Routine tracheal

• Initial, (regardless of anesthesic technique) 0.6 mg/kg IV; or a lower dose of 0.45 mg/kg IV may be used.
• Initial, (with opioid/nitrous oxide/oxygen anesthesia) 0.9 or 1.2 mg/kg large bolus may be used.
• Maintenance, (only after spontaneous recovery from intubation dose) 0.1 to 0.2 mg/kg IV , repeat as needed or 0.01 to 0.012 mg/kg/minute continuous IV infusion.

• Premedication for anesthetic procedure

• Preinduction defasciculating dose: 0.05 to 0.06 mg/kg IV 1.5-3 min prior to succinylcholine administration.

• Rapid sequence intubation: 0.6 to 1.2 mg/kg IV.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

• Premedication for anesthetic procedure, Preinduction defasciculating dose.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Rocuronium in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

• General anesthesia; Adjunct

• Induction of neuromuscular blockade, during surgery or mechanical ventilation: 3 mo to 14 yr

• Initial, 0.6 mg/kg/dose IV
• Maintenance, 0.075 to 0.15 mg/kg IV push as needed (anesthetic agent dependent) or 0.012 mg/kg/min continuous IV infusion

• Induction of neuromuscular blockade - Intubation, Routine tracheal: 3 mo to 14 yr

• Initial, 0.6 mg/kg/dose IV
• Initial, (anesthetic technique and age dependent) 0.45 mg/kg IV may be used
• Maintenance, 0.075 to 0.125 mg/kg IV push as needed or 0.012 mg/kg/min continuous IV infusion

• Rapid sequence intubation: not recommended in pediatric patients although 0.6 to 1.2 mg/kg IV have been used in clinical trials

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Premedication for anesthetic procedure, Preinduction defasciculating dose

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Rocuronium in pediatric patients.

Contraindications

ZEMURON is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents.

Warnings

Appropriate Administration and Monitoring

ZEMURON should be administered in carefully adjusted dosages by or under the supervision of experienced clinicians who are familiar with the drug's actions and the possible complications of its use. The drug should not be administered unless facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available. It is recommended that clinicians administering neuromuscular blocking agents such as ZEMURON employ a peripheral nerve stimulator 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.

5.2 Anaphylaxis

Severe anaphylactic reactions to neuromuscular blocking agents, including ZEMURON, have been reported. These reactions have, in some cases (including cases with ZEMURON), 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.

5.3 Need for Adequate Anesthesia

ZEMURON has no known effect on consciousness, pain threshold, or cerebration. Therefore, its administration must be accompanied by adequate anesthesia or sedation.

5.4 Residual Paralysis

In order to prevent complications resulting from residual paralysis, it is recommended to extubate only after the patient has recovered sufficiently from neuromuscular block. Other factors which could cause residual paralysis after extubation in the post-operative phase (such as drug interactions or patient condition) should also be considered. If not used as part of standard clinical practice the use of a reversal agent should be considered, especially in those cases where residual paralysis is more likely to occur.

5.5 Long-Term Use in an Intensive Care Unit

ZEMURON has not been studied for long-term use in the intensive care unit (ICU). As with other nondepolarizing neuromuscular blocking drugs, apparent tolerance to ZEMURON may develop during chronic administration in the ICU. While the mechanism for development of this resistance is not known, receptor up-regulation may be a contributing factor. It is strongly recommended that neuromuscular transmission be monitored continuously during administration and recovery with the help of a nerve stimulator. Additional doses of ZEMURON or any other neuromuscular blocking agent should not be given until there is a definite response (one twitch of the train-of-four) to nerve stimulation. Prolonged paralysis and/or skeletal muscle weakness may be noted during initial attempts to wean from the ventilator patients who have chronically received neuromuscular blocking drugs in the ICU.

Myopathy after long-term administration of other nondepolarizing neuromuscular blocking agents in the ICU alone or in combination with corticosteroid therapy has been reported. Therefore, for patients receiving both neuromuscular blocking agents and corticosteroids, the period of use of the neuromuscular blocking agent should be limited as much as possible and only used in the setting where in the opinion of the prescribing physician, the specific advantages of the drug outweigh the risk.

5.6 Malignant Hyperthermia (MH)

ZEMURON has not been studied in MH-susceptible patients. Because ZEMURON is always used with other agents, and the occurrence of malignant hyperthermia during anesthesia is possible even in the absence of known triggering agents, clinicians should be familiar with early signs, confirmatory diagnosis, and treatment of malignant hyperthermia prior to the start of any anesthetic.

In an animal study in MH-susceptible swine, the administration of ZEMURON Injection did not appear to trigger malignant hyperthermia.

5.7 Prolonged Circulation Time

Conditions associated with an increased circulatory delayed time, e.g., cardiovascular disease or advanced age, may be associated with a delay in onset time [see Dosage and Administration (2.5)].

5.8 QT Interval Prolongation

The overall analysis of ECG data in pediatric patients indicates that the concomitant use of ZEMURON with general anesthetic agents can prolong the QTc interval [see Clinical Studies (14.3)].

5.9 Conditions/Drugs Causing Potentiation of, or Resistance to, Neuromuscular Block

Potentiation: Nondepolarizing neuromuscular blocking agents have been found to exhibit profound neuromuscular blocking effects in cachectic or debilitated patients, patients with neuromuscular diseases, and patients with carcinomatosis.

Certain inhalation anesthetics, particularly enflurane and isoflurane, antibiotics, magnesium salts, lithium, local anesthetics, procainamide, and quinidine have been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see Drug Interactions (7.3)].

In these or other patients in whom potentiation of neuromuscular block or difficulty with reversal may be anticipated, a decrease from the recommended initial dose of ZEMURON should be considered [see Dosage and Administration (2.5)].

Resistance: Resistance to nondepolarizing agents, consistent with up-regulation of skeletal muscle acetylcholine receptors, is associated with burns, disuse atrophy, denervation, and direct muscle trauma. Receptor up-regulation may also contribute to the resistance to nondepolarizing muscle relaxants which sometimes develops in patients with cerebral palsy, patients chronically receiving anticonvulsant agents such as carbamazepine or phenytoin, or with chronic exposure to nondepolarizing agents. When ZEMURON is administered to these patients, shorter durations of neuromuscular block may occur, and infusion rates may be higher due to the development of resistance to nondepolarizing muscle relaxants.

Potentiation or Resistance: Severe acid-base and/or electrolyte abnormalities may potentiate or cause resistance to the neuromuscular blocking action of ZEMURON. No data are available in such patients and no dosing recommendations can be made.

ZEMURON-induced neuromuscular blockade was modified by alkalosis and acidosis in experimental pigs. Both respiratory and metabolic acidosis prolonged the recovery time. The potency of ZEMURON was significantly enhanced in metabolic acidosis and alkalosis, but was reduced in respiratory alkalosis. In addition, experience with other drugs has suggested that acute (e.g., diarrhea) or chronic (e.g., adrenocortical insufficiency) electrolyte imbalance may alter neuromuscular blockade. Since electrolyte imbalance and acid-base imbalance are usually mixed, either enhancement or inhibition may occur.

5.10 Incompatibility with Alkaline Solutions

ZEMURON, which has an acid pH, should not be mixed with alkaline solutions (e.g., barbiturate solutions) in the same syringe or administered simultaneously during intravenous infusion through the same needle.

5.11 Increase in Pulmonary Vascular Resistance

ZEMURON may be associated with increased pulmonary vascular resistance, so caution is appropriate in patients with pulmonary hypertension or valvular heart disease [see Clinical Studies (14.1)].

5.12 Use In Patients with Myasthenia

In patients with myasthenia gravis or myasthenic (Eaton-Lambert) syndrome, small doses of nondepolarizing neuromuscular blocking agents may have profound effects. In such patients, a peripheral nerve stimulator and use of a small test dose may be of value in monitoring the response to administration of muscle relaxants.

5.13 Extravasation

If extravasation occurs, it may be associated with signs or symptoms of local irritation. The injection or infusion should be terminated immediately and restarted in another vein.

Adverse Reactions

Clinical Trials Experience

In clinical trials, the most common adverse reactions (2%) are transient hypotension and hypertension.

The following adverse reactions are described, or described in greater detail, in other sections:

   Anaphylaxis [see Warnings and Precautions (5.2)]
   Residual paralysis [see Warnings and Precautions (5.4)]
   Myopathy [see Warnings and Precautions (5.5)]
   Increased pulmonary vascular resistance [see Warnings and Precautions (5.11)]

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical studies in the US (n=1137) and Europe (n=1394) totaled 2531 patients. The patients exposed in the US clinical studies provide the basis for calculation of adverse reaction rates. The following adverse reactions were reported in patients administered ZEMURON (all events judged by investigators during the clinical trials to have a possible causal relationship):

Adverse reactions in greater than 1% of patients: None

Adverse reactions in less than 1% of patients (probably related or relationship unknown):

   Cardiovascular: arrhythmia, abnormal electrocardiogram, tachycardia

   Digestive: nausea, vomiting

   Respiratory: asthma (bronchospasm, wheezing, or rhonchi), hiccup

   Skin and Appendages: rash, injection site edema, pruritus

In the European studies, the most commonly reported reactions were transient hypotension (2%) and hypertension (2%); these are in greater frequency than the US studies (0.1% and 0.1%). Changes in heart rate and blood pressure were defined differently from in the US studies in which changes in cardiovascular parameters were not considered as adverse events unless judged by the investigator as unexpected, clinically significant, or thought to be histamine related.

In a clinical study in patients with clinically significant cardiovascular disease undergoing coronary artery bypass graft, hypertension and tachycardia were reported in some patients, but these occurrences were less frequent in patients receiving beta or calcium channel-blocking drugs. In some patients, ZEMURON was associated with transient increases (30% or greater) in pulmonary vascular resistance. In another clinical study of patients undergoing abdominal aortic surgery, transient increases (30% or greater) in pulmonary vascular resistance were observed in about 24% of patients receiving ZEMURON 0.6 or 0.9 mg/kg.

In pediatric patient studies worldwide (n=704), tachycardia occurred at an incidence of 5.3% (n=37), and it was judged by the investigator as related in 10 cases (1.4%).

Postmarketing Experience

In clinical practice, there have been reports of severe allergic reactions (anaphylactic and anaphylactoid reactions and shock) with ZEMURON, including some that have been life-threatening and fatal [see Warnings and Precautions (5.2)].

Because these reactions were reported voluntarily from a population of uncertain size, it is not possible to reliably estimate their frequency.

Drug Interactions

Antibiotics

Drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as ZEMURON include certain antibiotics (e.g., aminoglycosides; vancomycin; tetracyclines; bacitracin; polymyxins; colistin; and sodium colistimethate). If these antibiotics are used in conjunction with ZEMURON, prolongation of neuromuscular block may occur.

7.2 Anticonvulsants

In 2 of 4 patients receiving chronic anticonvulsant therapy, apparent resistance to the effects of ZEMURON was observed in the form of diminished magnitude of neuromuscular block, or shortened clinical duration. As with other nondepolarizing neuromuscular blocking drugs, if ZEMURON is administered to patients chronically receiving anticonvulsant agents such as carbamazepine or phenytoin, shorter durations of neuromuscular block may occur and infusion rates may be higher due to the development of resistance to nondepolarizing muscle relaxants. While the mechanism for development of this resistance is not known, receptor up-regulation may be a contributing factor [see Warnings and Precautions (5.9)].

7.3 Inhalation Anesthetics

Use of inhalation anesthetics has been shown to enhance the activity of other neuromuscular blocking agents (enflurane > isoflurane > halothane).

Isoflurane and enflurane may also prolong the duration of action of initial and maintenance doses of ZEMURON and decrease the average infusion requirement of ZEMURON by 40% compared to opioid/nitrous oxide/oxygen anesthesia. No definite interaction between ZEMURON and halothane has been demonstrated. In one study, use of enflurane in 10 patients resulted in a 20% increase in mean clinical duration of the initial intubating dose, and a 37% increase in the duration of subsequent maintenance doses, when compared in the same study to 10 patients under opioid/nitrous oxide/oxygen anesthesia. The clinical duration of initial doses of ZEMURON of 0.57 to 0.85 mg/kg under enflurane or isoflurane anesthesia, as used clinically, was increased by 11% and 23%, respectively. The duration of maintenance doses was affected to a greater extent, increasing by 30% to 50% under either enflurane or isoflurane anesthesia.

Potentiation by these agents is also observed with respect to the infusion rates of ZEMURON required to maintain approximately 95% neuromuscular block. Under isoflurane and enflurane anesthesia, the infusion rates are decreased by approximately 40% compared to opioid/nitrous oxide/oxygen anesthesia. The median spontaneous recovery time (from 25% to 75% of control T1) is not affected by halothane, but is prolonged by enflurane (15% longer) and isoflurane (62% longer). Reversal-induced recovery of ZEMURON neuromuscular block is minimally affected by anesthetic technique [see Dosage and Administration (2.5) and Warnings and Precautions (5.9)].

7.4 Lithium Carbonate

Lithium has been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see Warnings and Precautions (5.9)].

7.5 Local Anesthetics

Local anesthetics have been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see Warnings and Precautions (5.9)].

7.6 Magnesium

Magnesium salts administered for the management of toxemia of pregnancy may enhance neuromuscular blockade [see Warnings and Precautions (5.9)].

7.7 Nondepolarizing Muscle Relaxants

There are no controlled studies documenting the use of ZEMURON before or after other nondepolarizing muscle relaxants. Interactions have been observed when other nondepolarizing muscle relaxants have been administered in succession.

7.8 Procainamide

Procainamide has been shown to increase the duration of neuromuscular block and decrease infusion requirements of neuromuscular blocking agents [see Warnings and Precautions (5.9)].

7.9 Propofol

The use of propofol for induction and maintenance of anesthesia does not alter the clinical duration or recovery characteristics following recommended doses of ZEMURON.

7.10 Quinidine

Injection of quinidine during recovery from use of muscle relaxants is associated with recurrent paralysis. This possibility must also be considered for ZEMURON [see Warnings and Precautions (5.9)].

7.11 Succinylcholine

The use of ZEMURON before succinylcholine, for the purpose of attenuating some of the side effects of succinylcholine, has not been studied.

If ZEMURON is administered following administration of succinylcholine, it should not be given until recovery from succinylcholine has been observed. The median duration of action of ZEMURON 0.6 mg/kg administered after a 1 mg/kg dose of succinylcholine when T1 returned to 75% of control was 36 minutes (range: 14-57, n=12) vs. 28 minutes (range: 17-51, n=12) without succinylcholine.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C Developmental toxicology studies have been performed with rocuronium bromide in pregnant, conscious, nonventilated rabbits and rats. Inhibition of neuromuscular function was the endpoint for high-dose selection. The maximum tolerated dose served as the high dose and was administered intravenously 3 times a day to rats (0.3 mg/kg, 15%-30% of human intubation dose of 0.6-1.2 mg/kg based on the body surface unit of mg/m2) from Day 6 to 17 and to rabbits (0.02 mg/kg, 25% human dose) from Day 6 to 18 of pregnancy. High-dose treatment caused acute symptoms of respiratory dysfunction due to the pharmacological activity of the drug. Teratogenicity was not observed in these animal species. The incidence of late embryonic death was increased at the high dose in rats, most likely due to oxygen deficiency. Therefore, this finding probably has no relevance for humans because immediate mechanical ventilation of the intubated patient will effectively prevent embryo-fetal hypoxia. However, there are no adequate and well-controlled studies in pregnant women. ZEMURON should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Rocuronium in women who are pregnant.

Labor and Delivery

The use of ZEMURON in Cesarean section has been studied in a limited number of patients [see Clinical Studies (14.1)]. ZEMURON is not recommended for rapid sequence induction in Cesarean section patients.

Nursing Mothers

There is no FDA guidance on the use of Rocuronium in women who are nursing.

Pediatric Use

The use of ZEMURON 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 [see Dosage and Administration (2.5) and Clinical Studies (14.3)].

ZEMURON 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 ZEMURON with general anesthetic agents can prolong the QTc interval. The data also suggest that ZEMURON may increase heart rate. However, it was not possible to conclusively identify an effect of ZEMURON independent of that of anesthesia and other factors. Additionally, when examining plasma levels of ZEMURON in correlation to QTc interval prolongation, no relationship was observed [see Dosage and Administration (2.5), Warnings and Precautions (5.8), and Clinical Studies (14.3)].

ZEMURON is not recommended for rapid sequence intubation in pediatric patients. Recommendations for use in pediatric patients are discussed in other sections [see Dosage and Administration (2.5) and Clinical Pharmacology (12.2)].

Geriatic Use

ZEMURON was administered to 140 geriatric patients (65 years or greater) in US clinical trials and 128 geriatric patients in European clinical trials. The observed pharmacokinetic profile for geriatric patients (n=20) was similar to that for other adult surgical patients [see Clinical Pharmacology (12.3)]. Onset time and duration of action were slightly longer for geriatric patients (n=43) in clinical trials. Clinical experiences and recommendations for use in geriatric patients are discussed in other sections [see Dosage and Administration (2.5), Clinical Pharmacology (12.2), and Clinical Studies (14.2)].

Gender

There is no FDA guidance on the use of Rocuronium with respect to specific gender populations.

Race

There is no FDA guidance on the use of Rocuronium with respect to specific racial populations.

Renal Impairment

Due to the limited role of the kidney in the excretion of ZEMURON, usual dosing guidelines should be followed. In patients with renal dysfunction, the duration of neuromuscular blockade was not prolonged; however, there was substantial individual variability (range: 22-90 minutes) [see Clinical Pharmacology (12.3)].

Hepatic Impairment

Since ZEMURON is primarily excreted by the liver, it should be used with caution in patients with clinically significant hepatic impairment. ZEMURON 0.6 mg/kg has been studied in a limited number of patients (n=9) with clinically significant hepatic impairment under steady-state isoflurane anesthesia. After ZEMURON 0.6 mg/kg, the median (range) clinical duration of 60 (35-166) minutes was moderately prolonged compared to 42 minutes in patients with normal hepatic function. The median recovery time of 53 minutes was also prolonged in patients with cirrhosis compared to 20 minutes in patients with normal hepatic function. Four of 8 patients with cirrhosis, who received ZEMURON 0.6 mg/kg under opioid/nitrous oxide/oxygen anesthesia, did not achieve complete block. These findings are consistent with the increase in volume of distribution at steady state observed in patients with significant hepatic impairment [see Clinical Pharmacology (12.3)]. If used for rapid sequence induction in patients with ascites, an increased initial dosage may be necessary to assure complete block. Duration will be prolonged in these cases. The use of doses higher than 0.6 mg/kg has not been studied [see Dosage and Administration (2.5)].

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Rocuronium in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Rocuronium in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Rocuronium Administration in the drug label.

Monitoring

There is limited information regarding Rocuronium Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Rocuronium and IV administrations.

Overdosage

There is limited information regarding Rocuronium overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Rocuronium Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Rocuronium Mechanism of Action in the drug label.

Structure

There is limited information regarding Rocuronium Structure in the drug label.

Pharmacodynamics

There is limited information regarding Rocuronium Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Rocuronium Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Rocuronium Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Rocuronium Clinical Studies in the drug label.

How Supplied

There is limited information regarding Rocuronium How Supplied in the drug label.

Storage

There is limited information regarding Rocuronium Storage in the drug label.

Images

Drug Images

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Patient Counseling Information

There is limited information regarding Rocuronium Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Rocuronium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Rocuronium Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Rocuronium Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.