Rocuronium Bromide
Injection, Solution · Intravenous
Current shortage
Rocuronium Bromide, Injection, 50 mg/5 mL (10 mg/mL) (NDC 0409-1403-10) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0781-3220-92) – Available (Sandoz Inc., updated Sep 18, 2026)
Rocuronium Bromide, Injection, 100 mg/10 mL (NDC 43066-013-10) – Available (Baxter Healthcare, updated Sep 17, 2026)
Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0143-9251-10) – Available (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots will be available. Product will be made available as it is released.
Rocuronium Bromide, Injection, 100 mg/10 mL (10 mg/mL) (NDC 0409-7037-10) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 71288-700-06) – Available (Meitheal Pharmaceuticals, Inc., updated Aug 27, 2026)
Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 0143-9250-10) – Available (Hikma Pharmaceuticals USA, Inc., updated Sep 18, 2026)
Additional lots will be available. Product will be made available as it is released.
Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 67457-228-05) – Available (Mylan Institutional, a Viatris Company, updated Sep 17, 2026)
Rocuronium Bromide, Injection, 10 mg/1 mL (NDC 71288-718-11) – Available (Meitheal Pharmaceuticals, Inc., updated Aug 27, 2026)
Rocuronium Bromide, Injection, 100 mg/10 mL (10 mg/mL) (NDC 0409-5160-10) – Available (Hospira, Inc., a Pfizer Company, updated Sep 22, 2026)
Uses
1 INDICATIONS AND USAGE ROCURONIUM BROMIDE INJECTION is indicated 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. ROCURONIUM BROMIDE INJECTION is a nondepolarizing neuromuscular blocking agent indicated 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.
Dosage and administration
To be administered only by experienced clinicians or adequately trained individuals supervised by an experienced clinician familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents ( 2.1 ) ROCURONIUM BROMIDE INJECTION is for intravenous use only Individualize the dose for each patient ( 2.1 ) Peripheral nerve stimulator recommended for determination of drug response and need for additional doses, and to evaluate recovery ( 2.1 ) Store ROCURONIUM BROMIDE INJECTION in a manner that minimizes the possibility of selecting the wrong product ( 2.1 ) Tracheal intubation: Recommended initial dose is 0.6 mg/kg ( 2.2 ) Rapid sequence intubation: 0.6 mg/kg to 1.2 mg/kg ( 2.3 ) Maintenance doses: Guided by response to prior dose, not administered until recovery is evident ( 2.4 ) Continuous infusion: Initial rate of 10 mcg/kg/min to 12 mcg/kg/min. Start only after early evidence of spontaneous recovery from an intubating dose ( 2.5 ) 2.1 Important Dosing and Administration Information 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 (2.6) , Warnings and Precautions ( 5.10 , 5.13 ), Drug Interactions ( 7.2 , 7.3 , 7.4 , 7.5 , 7.6 , 7.8 , 7.10 ), Use in Specific Populations ( 8.6 )] . Risk of Medication Errors Accidental administration of neuromuscular blocking agents may be fatal. Store ROCURONIUM BROMIDE INJECTION in prefilled syringe within its sealed unit box in a manner that minimizes the possibility of selecting the wrong product [see Warnings and Precautions (5.3) ] . 2.2 Dose for Tracheal Intubation 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 mg/kg 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) ] . 2.3 Rapid Sequence Intubation In appropriately premedicated and adequately anesthetized patients, rocuronium bromide 0.6 mg/kg 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) ] . 2.4 Maintenance Dosing Maintenance doses of 0.1 mg/kg, 0.15 mg/kg, and 0.2 mg/kg rocuronium bromide, administered at 25% recovery of control T 1 (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) ] . 2.5 Use by Continuous Infusion Infusion at an initial rate of 10 mcg/kg/min 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 T 1 ), may necessitate additional bolus doses to maintain adequate block for surgery. Upon reaching the desired level of neuromuscular block, the infusion of rocuronium bromide must be individualized for each patient. The rate of administration should be adjusted according to the patient’s twitch response as monitored with the use of a peripheral nerve stimulator. In clinical trials, infusion rates have ranged from 4 to 16 mcg/kg/min. Inhalation anesthetics, particularly enflurane and isoflurane, may enhance the neuromuscular blocking action of nondepolarizing muscle relaxants.
Dosage forms and strengths
Injection: 50 mg/5 mL (10 mg/mL) rocuronium bromide as a clear, colorless to yellowish solution in single-dose luer-lock prefilled glass syringes. Injection: 50 mg/5 mL (10 mg/mL) rocuronium bromide ( 3 )
Contraindications
Rocuronium bromide is contraindicated in patients known to have hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents [see Warnings and Precautions (5.2) ] . Hypersensitivity (e.g., anaphylaxis) to rocuronium bromide or other neuromuscular blocking agents ( 4 )
Warnings and precautions
Appropriate Administration and Monitoring: Use only if facilities for intubation, mechanical ventilation, oxygen therapy, and an antagonist are immediately available ( 5.1 ) Anaphylaxis: Severe anaphylaxis has been reported. Consider cross-reactivity among neuromuscular blocking agents ( 5.2 ) Risk of Death due to Medication Errors: Accidental administration can cause death ( 5.3 ) Need for Adequate Anesthesia: Must be accompanied by adequate anesthesia or sedation ( 5.4 ) Residual Paralysis: Consider using a reversal agent in cases where residual paralysis is more likely to occur ( 5.5 ) 5.1 Appropriate Administration and Monitoring Rocuronium bromide 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 rocuronium bromide 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 rocuronium bromide, have been reported. These reactions have, in some cases (including cases with rocuronium bromide) been life threatening and fatal. Due to the potential severity of these reactions, the necessary precautions, such as the immediate availability of appropriate emergency treatment, should be taken. Precautions should also be taken in those patients who have had previous anaphylactic reactions to other neuromuscular blocking agents, since cross-reactivity between neuromuscular blocking agents, both depolarizing and nondepolarizing, has been reported. 5.3 Risk of Death due to Medication Errors Administration of ROCURONIUM BROMIDE INJECTION results in paralysis, which may lead to respiratory arrest and death, a progression that may be more likely to occur in a patient for whom it is not intended. Confirm proper selection of intended product and avoid confusion with other injectable solutions that are present in critical care and other clinical settings. If another healthcare provider is administering the product, ensure that the intended dose is clearly labeled and communicated. 5.4 Need for Adequate Anesthesia Rocuronium bromide has no known effect on consciousness, pain threshold, or cerebration. Therefore, its administration must be accompanied by adequate anesthesia or sedation. 5.5 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. Geriatric patients (65 years or older) may be at increased risk for residual 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. 5.6 Long-Term Use in an Intensive Care Unit Rocuronium bromide has not been studied for long-term use in the intensive care unit (ICU). As with other nondepolarizing neuromuscular blocking drugs, apparent tolerance to rocuronium bromide 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 rocuronium bromide 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 non-depolarizing 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. 5.7 Malignant Hyperthermia (MH) Rocuronium bromide has not been studied in MH-susceptible patients. Because rocuronium bromide 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 [see Adverse Reactions (6.2)] . In an animal study in MH-susceptible swine, the administration of ROCURONIUM BROMIDE INJECTION did not appear to trigger malignant hyperthermia. 5.8 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 (2.6) ] . 5.9 QT Interval Prolongation The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium bromide with general anesthetic agents can prolong the QTc interval [see Clinical Studies (14.3) ] .
Side effects
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 (5.5) ] Myopathy [see Warnings and Precautions (5.6) ] Increased pulmonary vascular resistance [see Warnings and Precautions (5.12) ] Most common adverse reactions (2%) are transient hypotension and hypertension To report SUSPECTED ADVERSE REACTIONS, contact B.Braun Medical Inc at 1-833-425-1464 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 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 U.S. (n=1137) and Europe (n=1394) totaled 2531 patients. The patients exposed in the U.S. clinical studies provide the basis for calculation of adverse reaction rates. The following adverse reactions were reported in patients administered rocuronium bromide (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 of another ROCURONIUM BROMIDE INJECTION product, the most commonly reported reactions were transient hypotension (2%) and hypertension (2%); these are in greater frequency than the U.S. studies (0.1% and 0.1%). Changes in heart rate and blood pressure were defined differently from in the U.S. 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, rocuronium bromide 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 rocuronium bromide 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%). 6.2 Post-Marketing Experience The following adverse reactions have been identified during post-approval use of ROCURONIUM BROMIDE INJECTION. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Immune system disorders In clinical practice, there have been reports of severe allergic reactions (anaphylactic and anaphylactoid reactions and shock) with rocuronium bromide, including some that have been life-threatening and fatal [see Warnings and Precautions (5.2) ] . General disorders and administration site conditions There have been reports of malignant hyperthermia with the use of ROCURONIUM BROMIDE INJECTION [see Warnings and Precautions (5.7) ] .
Drug interactions
Succinylcholine: Use before succinylcholine has not been studied ( 7.11 ) Nondepolarizing muscle relaxants: Interactions have been observed ( 7.7 ) Enhanced rocuronium bromide activity possible: Inhalation anesthetics ( 7.3 ), certain antibiotics ( 7.1 ), quinidine ( 7.10 ), magnesium ( 7.6 ), lithium ( 7.4 ), local anesthetics ( 7.5 ), procainamide ( 7.8 ) Reduced rocuronium bromide activity possible: Anticonvulsants ( 7.2 ) 7.1 Antibiotics Drugs which may enhance the neuromuscular blocking action of nondepolarizing agents such as rocuronium bromide include certain antibiotics (e.g., aminoglycosides; vancomycin; tetracyclines; bacitracin; polymyxins; colistin; and sodium colistimethate). If these antibiotics are used in conjunction with rocuronium bromide, prolongation of neuromuscular block may occur. 7.2 Anticonvulsants In 2 of 4 patients receiving chronic anticonvulsant therapy, apparent resistance to the effects of rocuronium bromide was observed in the form of diminished magnitude of neuromuscular block or shortened clinical duration. As with other nondepolarizing neuromuscular blocking drugs, if rocuronium bromide 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 (5.10) ] . 7.3 Inhalation Anesthetics Use of inhalation anesthetics (enflurane > isoflurane > halothane) has been shown to enhance the activity of other neuromuscular blocking agents. Isoflurane and enflurane may also prolong the duration of action of initial and maintenance doses of rocuronium bromide and decrease the average infusion requirement of rocuronium bromide by 40% compared to opioid/nitrous oxide/oxygen anesthesia. No definite interaction between rocuronium bromide 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 rocuronium bromide 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 rocuronium bromide 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 T 1 ) is not affected by halothane but is prolonged by enflurane (15% longer) and isoflurane (62% longer). Reversal-induced recovery of rocuronium bromide neuromuscular block is minimally affected by anesthetic technique [see Dosage and Administration (2.6) and Warnings and Precautions (5.10) ] . 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 (5.10) ] . 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 (5.10) ] . 7.6 Magnesium Magnesium salts administered for the management of pre-eclampsia or eclampsia of pregnancy may enhance neuromuscular blockade [see Warnings and Precautions (5.10) ] . 7.7 Nondepolarizing Muscle Relaxants There are no controlled studies documenting the use of rocuronium bromide 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 (5.10) ] . 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 rocuronium bromide. 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 rocuronium bromide [see Warnings and Precautions (5.10) ] . 7.11 Succinylcholine The use of rocuronium bromide before succinylcholine, for the purpose of attenuating some of the side effects of succinylcholine, has not been studied. If rocuronium bromide is administered following administration of succinylcholine, it should not be given until recovery from succinylcholine has been observed. The median duration of action of rocuronium bromide 0.6 mg/kg administered after a 1 mg/kg dose of succinylcholine when T 1 returned to 75% of control was 36 minutes (range 14 to 57, n=12) vs . 28 minutes (range: 17 to 51, n=12) without succinylcholine.
Use in specific populations
Pregnancy: Not recommended for rapid sequence induction in patients undergoing Cesarean section. ( 8.1 , 14.1 ) Pediatric Use: Onset time and duration will vary with dose, age, and anesthetic technique. Not recommended for rapid sequence intubation in pediatric patients ( 8.4 ) 8.1 Pregnancy Risk Summary Available data from controlled trials, case series, and over decades of use of rocuronium bromide in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are potential risks when rocuronium bromide is used during labor or delivery (see Clinical Considerations ) . Based on data from umbilical cord blood sampling, rocuronium bromide is transferred across the placenta [see Clinical Studies (14.1) ] . In animal reproduction studies, there was no evidence of teratogenicity when rocuronium bromide was administered intravenously to pregnant, conscious, nonventilated rats and rabbits at 15%-30% and 25%, respectively, the human intubation dose of 0.6-1.2 mg/kg during the period of organogenesis (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Labor or Delivery Magnesium sulfate used in the management of pre-eclampsia or eclampsia in pregnancy may enhance neuromuscular blockade [see Warnings and Precautions (5.10) ] . The use of another ROCURONIUM BROMIDE INJECTION product in Cesarean section has been studied in a limited number of patients. Adverse events in this study included low APGAR scores in neonates at 5 minutes and poor intubation conditions in some pregnant women who received rocuronium bromide [see Clinical Studies (14.1) ] . Therefore, ROCURONIUM BROMIDE INJECTION is not recommended for rapid sequence induction in Cesarean section patients. Data Animal Data 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 three times a day to rats (0.3 mg/kg, 15% to 30% of human intubation dose of 0.6 to 1.2 mg/kg based on the body surface unit of mg/m 2 ) 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. 8.2 Lactation Risk Summary There are no available data on the presence of rocuronium bromide in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ROCURONIUM BROMIDE INJECTION and any potential adverse effects on the breastfed infant from ROCURONIUM BROMIDE INJECTION or from the underlying maternal condition. 8.4 Pediatric Use The use of another ROCURONIUM BROMIDE INJECTION product 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 (2.6) and Clinical Studies (14.3) ] . Another ROCURONIUM BROMIDE INJECTION product was also studied in pediatric patients up to 17 years of age, including neonates, under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia. Onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique. The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium bromide with general anesthetic agents can prolong the QTc interval. The data also suggest that rocuronium bromide may increase heart rate. However, it was not possible to conclusively identify an effect of rocuronium bromide independent of that of anesthesia and other factors. Additionally, when examining plasma levels of rocuronium bromide in correlation to QTc interval prolongation, no relationship was observed [see Dosage and Administration (2.6) , Warnings and Precautions (5.9) , Clinical Studies (14.3) ] . ROCURONIUM BROMIDE INJECTION 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 (2.6) , Clinical Pharmacology (12.2) ] . 8.5 Geriatric Use Another ROCURONIUM BROMIDE INJECTION product was administered to 140 geriatric patients (65 years or greater) in U.S. 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.
Pregnancy
8.1 Pregnancy Risk Summary Available data from controlled trials, case series, and over decades of use of rocuronium bromide in pregnant women have not identified a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are potential risks when rocuronium bromide is used during labor or delivery (see Clinical Considerations ) . Based on data from umbilical cord blood sampling, rocuronium bromide is transferred across the placenta [see Clinical Studies (14.1) ] . In animal reproduction studies, there was no evidence of teratogenicity when rocuronium bromide was administered intravenously to pregnant, conscious, nonventilated rats and rabbits at 15%-30% and 25%, respectively, the human intubation dose of 0.6-1.2 mg/kg during the period of organogenesis (see Data ) . The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Labor or Delivery Magnesium sulfate used in the management of pre-eclampsia or eclampsia in pregnancy may enhance neuromuscular blockade [see Warnings and Precautions (5.10) ] . The use of another ROCURONIUM BROMIDE INJECTION product in Cesarean section has been studied in a limited number of patients. Adverse events in this study included low APGAR scores in neonates at 5 minutes and poor intubation conditions in some pregnant women who received rocuronium bromide [see Clinical Studies (14.1) ] . Therefore, ROCURONIUM BROMIDE INJECTION is not recommended for rapid sequence induction in Cesarean section patients. Data Animal Data 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 three times a day to rats (0.3 mg/kg, 15% to 30% of human intubation dose of 0.6 to 1.2 mg/kg based on the body surface unit of mg/m 2 ) 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.
Pediatric use
8.4 Pediatric Use The use of another ROCURONIUM BROMIDE INJECTION product 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 (2.6) and Clinical Studies (14.3) ] . Another ROCURONIUM BROMIDE INJECTION product was also studied in pediatric patients up to 17 years of age, including neonates, under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia. Onset time and clinical duration varied with dose, the age of the patient, and anesthetic technique. The overall analysis of ECG data in pediatric patients indicates that the concomitant use of rocuronium bromide with general anesthetic agents can prolong the QTc interval. The data also suggest that rocuronium bromide may increase heart rate. However, it was not possible to conclusively identify an effect of rocuronium bromide independent of that of anesthesia and other factors. Additionally, when examining plasma levels of rocuronium bromide in correlation to QTc interval prolongation, no relationship was observed [see Dosage and Administration (2.6) , Warnings and Precautions (5.9) , Clinical Studies (14.3) ] . ROCURONIUM BROMIDE INJECTION 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 (2.6) , Clinical Pharmacology (12.2) ] .
Geriatric use
8.5 Geriatric Use Another ROCURONIUM BROMIDE INJECTION product was administered to 140 geriatric patients (65 years or greater) in U.S. 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 (2.6) , Warnings and Precautions (5.5) , Clinical Pharmacology (12.2) , and Clinical Studies (14.2) ] .
Overdosage
Overdosage with neuromuscular blocking agents may result in neuromuscular block beyond the time needed for surgery and anesthesia. The primary treatment is maintenance of a patent airway, controlled ventilation, and adequate sedation until recovery of normal neuromuscular function is assured. Once evidence of recovery from neuromuscular block is observed, further recovery may be facilitated by administration of an anticholinesterase agent in conjunction with an appropriate anticholinergic agent. Reversal of Neuromuscular Blockade Anticholinesterase agents should not be administered prior to the demonstration of some spontaneous recovery from neuromuscular blockade. The use of a nerve stimulator to document recovery is recommended. Patients should be evaluated for adequate clinical evidence of neuromuscular recovery, e.g., 5-second head lift, adequate phonation, ventilation, and upper airway patency. Ventilation must be supported while patients exhibit any signs of muscle weakness. Recovery may be delayed in the presence of debilitation, carcinomatosis, and concomitant use of certain drugs which enhance neuromuscular blockade or separately cause respiratory depression. Under such circumstances the management is the same as that of prolonged neuromuscular blockade.
Description
11 DESCRIPTION ROCURONIUM BROMIDE INJECTION is a nondepolarizing neuromuscular blocking agent. Rocuronium bromide is chemically designated as 1-[17β-(acetyloxy)-3α-hydroxy-2β-(4-morpholinyl)-5α-androstan-16β-yl]-1-(2-propenyl) pyrrolidinium bromide. The molecular formula is C 32 H 53 BrN 2 O 4 and its molecular weight is 609.70 g/mol. The structural formula is: Rocuronium bromide is an almost white to pale yellow, hygroscopic powder. It is soluble in water and dichloromethane, slightly soluble in ethanol and methanol. It has a partition coefficient of 0.5 at 20°C. ROCURONIUM BROMIDE INJECTION is supplied as a sterile, nonpyrogenic, isotonic solution that is clear, colorless to yellowish in single-dose luer-lock prefilled glass syringes, for intravenous use only. Each mL contains 10 mg rocuronium bromide (equivalent to 8.7 mg of rocuronium) and the following inactive ingredients: 25 mg of gluconolactone, 5 mg sodium acetate trihydrate, 5 mg sodium citrate dihydrate in water for injection. The formulation has a pH of 3.8 – 4.2. Structural formula
Mechanism of action
12.1 Mechanism of Action Rocuronium bromide is a nondepolarizing neuromuscular blocking agent with a rapid to intermediate onset depending on dose and intermediate duration. It acts by competing for cholinergic receptors at the motor end-plate. This action is antagonized by acetylcholinesterase inhibitors, such as neostigmine and edrophonium.
How supplied
50 mg/5 mL (10 mg/mL), a clear, colorless to yellowish solution in single-dose luer-lock prefilled glass syringes is available in the following presentation: Unit of Sale Concentration (per total volume) REF NDC 0264-5711-10 Box of 10 5 mL Single-Dose Luer Lock Prefilled Syringe 50 mg/5 mL (10 mg/mL) PFS5711 Store at 20°C to 25°C (68°F to 77°F); with excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature]. DO NOT FREEZE. Discard unused portion.
Patient information
Obtain information about your patient’s medical history, current medications, any history of hypersensitivity to rocuronium bromide or other neuromuscular blocking agents. If applicable, inform your patients that certain medical conditions and medications might influence how ROCURONIUM BROMIDE INJECTION works. In addition, inform your patient that severe anaphylactic reactions to neuromuscular blocking agents, including ROCURONIUM BROMIDE INJECTION, have been reported. Since allergic cross-reactivity has been reported in this class, request information from your patients about previous anaphylactic reactions to other neuromuscular blocking agents.
Label text from the FDA structured product label by B. Braun Medical Inc. (revised Jul 17, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Rocuronium Bromide in 51 products
Rocuronium Bromide NDC products (51)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 43066-013 | Rocuronium Bromide 100 mg/10mL Injection | Baxter Healthcare Corporation | ANDA |
| 43066-007 | Rocuronium Bromide 50 mg/5mL Injection | Baxter Healthcare Corporation | ANDA |
| 71839-142 | Rocuronium Bromide 10 mg/mL Injection, Solution | BE Pharmaceuticals Inc. | ANDA |
| 71839-141 | Rocuronium Bromide 10 mg/mL Injection, Solution | BE Pharmaceuticals Inc. | ANDA |
| 65145-131 | Rocuronium Bromide 10 mg/mL Injection, Solution | Caplin Steriles Limited | ANDA |
| 65145-130 | Rocuronium Bromide 10 mg/mL Injection, Solution | Caplin Steriles Limited | ANDA |
| 72572-651 | Rocuronium Bromide 10 mg/mL Injection | Civica, Inc. | ANDA |
| 72572-650 | Rocuronium Bromide 10 mg/mL Injection | Civica, Inc. | ANDA |
| 55150-225 | Rocuronium Bromide 50 mg/5mL Injection, Solution | Eugia US LLC | ANDA |
| 55150-226 | Rocuronium Bromide 100 mg/10mL Injection, Solution | Eugia US LLC | ANDA |
| 68083-364 | Rocuronium Bromide 10 mg/mL Injection | Gland Pharma Limited | ANDA |
| 68083-365 | Rocuronium Bromide 10 mg/mL Injection | Gland Pharma Limited | ANDA |
| 51662-1641 | Rocuronium Bromide 10 mg/mL Injection, Solution | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1640 | Rocuronium Bromide 10 mg/mL Injection, Solution | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1354 | Rocuronium Bromide 10 mg/mL Injection, Solution | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1355 | Rocuronium Bromide 10 mg/mL Injection, Solution | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1545 | Rocuronium Bromide 100 mg/10mL Injection, Solution | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1546 | Rocuronium Bromide 50 mg/5mL Injection, Solution | HF Acquisition Co LLC, DBA HealthFirst | ANDA |
| 51662-1711 | Rocuronium Bromide 10 mg/mL Injection | HF Acquisition Co. LLC, DBA HealthFirst | ANDA |
| 51662-1710 | Rocuronium Bromide 10 mg/mL Injection | HF Acquisition Co. LLC, DBA HealthFirst | ANDA |
| 0143-9251 | Rocuronium Bromide 10 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0143-9250 | Rocuronium Bromide 10 mg/mL Injection | Hikma Pharmaceuticals USA Inc. | ANDA |
| 0409-1403 | Rocuronium Bromide 10 mg/mL Injection, Solution | Hospira, Inc. | ANDA |
| 0409-3189 | Rocuronium Bromide 10 mg/mL Injection, Solution | Hospira, Inc. | ANDA |
| 0409-9558 | Rocuronium Bromide 10 mg/mL Injection, Solution | Hospira, Inc. | ANDA |
| 0409-7037 | Rocuronium Bromide 10 mg/mL Injection, Solution | Hospira, Inc. | ANDA |
| 0409-5160 | Rocuronium Bromide 10 mg/mL Injection, Solution | Hospira, Inc. | ANDA |
| 70756-670 | Rocuronium Bromide 100 mg/10mL Injection | Lifestar Pharma LLC | ANDA |
| 70756-669 | Rocuronium Bromide 50 mg/5mL Injection | Lifestar Pharma LLC | ANDA |
| 71872-7309 | Rocuronium Bromide 10 mg/mL Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7262 | Rocuronium Bromide 50 mg/5mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7207 | Rocuronium Bromide 10 mg/mL Injection, Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7036 | Rocuronium Bromide 10 mg/mL Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7317 | Rocuronium Bromide 10 mg/mL Injection | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7344 | Rocuronium Bromide 10 mg/mL Injection, Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71872-7372 | Rocuronium Bromide 10 mg/mL Injection, Solution | Medical Purchasing Solutions, LLC | ANDA |
| 71288-700 | Rocuronium Bromide 10 mg/mL Injection | Meitheal Pharmaceuticals Inc. | ANDA |
| 71288-718 | Rocuronium Bromide 10 mg/mL Injection | Meitheal Pharmaceuticals Inc. | ANDA |
| 67457-228 | Rocuronium Bromide 10 mg/mL Injection | Mylan Institutional LLC | ANDA |
| 84549-131 | Rocuronium Bromide 10 mg/mL Injection, Solution | ProPharma Distribution | ANDA |
| 84549-141 | Rocuronium Bromide 10 mg/mL Injection, Solution | ProPharma Distribution | ANDA |
| 84549-687 | Rocuronium Bromide 10 mg/mL Injection | ProPharma Distribution | ANDA |
| 25021-687 | Rocuronium Bromide 10 mg/mL Injection | Sagent Pharmaceuticals | ANDA |
| 0781-3220 | Rocuronium Bromide 10 mg/mL Injection, Solution | Sandoz Inc | ANDA |
| 42677-309 | Rocuronium Bromide 50 mg/5mL Injection, Solution | Shandong New Time Pharmaceutical Co., Ltd. | ANDA |
| 42677-310 | Rocuronium Bromide 100 mg/10mL Injection, Solution | Shandong New Time Pharmaceutical Co., Ltd. | ANDA |
| 43547-530 | Rocuronium Bromide 50 mg/5mL Injection | Solco Healthcare US, LLC | ANDA |
| 43547-531 | Rocuronium Bromide 100 mg/10mL Injection | Solco Healthcare US, LLC | ANDA |
| 82449-001 | Rocuronium Bromide 50 mg/5mL Injection, Solution | STERISCIENCE SPECIALTIES PRIVATE LIMITED | ANDA |
| 39822-4200 | Rocuronium Bromide 10 mg/mL Solution | XGen Pharmaceuticals DJB, Inc. | ANDA |
| 0264-5711 | Rocuronium Bromide 50 mg/5mL Injection | B. Braun Medical Inc. | NDA |
Rocuronium Bromide recalls
- D-0371-2024 Mar 20, 2024 · Class II · Terminated
cGMP Deviations: Products were stored outside the drug label specifications.
Frequently asked questions
What is Rocuronium Bromide used for?
1 INDICATIONS AND USAGE ROCURONIUM BROMIDE INJECTION is indicated 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. ROCURONIUM BROMIDE INJECTION is a nondepolarizing neuromuscular blocking agent indicated as an adjunct to general anesthesia to facilitate both…
What are the side effects of Rocuronium Bromide?
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 (5.5) ] Myopathy [see Warnings and Precautions (5.6) ] Increased pulmonary vascular resistance [see… See the full label for the complete list.
Who makes Rocuronium Bromide?
Rocuronium Bromide is listed by 22 labelers in the FDA NDC directory, including Baxter Healthcare Corporation, BE Pharmaceuticals Inc., Caplin Steriles Limited, Civica, Inc..
Has Rocuronium Bromide been recalled?
The FDA enforcement database lists 1 recall for Rocuronium Bromide, most recently D-0371-2024 (class ii): cGMP Deviations: Products were stored outside the drug label specifications.