Rocuronium Bromide 50 mg/5mL Injection
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Nondepolarizing Neuromuscular Blocker class.
Where does this data come from?
🏭 Manufacturer & labeler
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🩺 Clinical
- Rocuronium is a muscle relaxant your anesthesia team uses to temporarily relax all your muscles — including the ones that control your airway — so they can safely place a breathing...
- Why am I being given rocuronium? What does it actually do?
- No — rocuronium has no effect on consciousness or your ability to feel pain. It only relaxes your muscles. Your anesthesia team will always give you anesthesia or sedation alongsid...
- Will I be awake or feel anything while it's working?
Patient education
Supplement & herbal interactions
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Ask a licensed pharmacist directly — free, answered by our team.
🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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Gluconolactone is a mild organic acid derived from glucose. It functions as a buffer and pH regulator in medicines, helping maintain stable acidity levels and improve product stability.
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UNII 4550K0SC9B
Sodium acetate is a salt derived from acetic acid. It acts as a buffer to help maintain the medicine's pH stability and may serve as a preservative or solubilizer in liquid formulations.
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Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.
4 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Rocuronium Bromide 50 mg/5mL 70756-0669-10 | Lifestar | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium Bromide 50 mg/5mL 43066-0007-10 | Baxter | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium Bromide 50 mg/5mL 43547-0530-10 | Solco | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium Bromide 50 mg/5mL 55150-0225-05 | Eugia | 10 vials | $0.394 | AP | Availability likely | — |
| Rocuronium Bromide 50 mg/5mLthis 00264-5711-10 | B. | 10 syringes | — | — | FDA listed | — |
| Rocuronium Bromide 50 mg/5mL 71872-7262-01 | Medical | 1 vial | — | AP | FDA listed | — |
| Rocuronium Bromide 50 mg/5mL 82449-0001-02 | STERISCIENCE | 10 vials | — | AP | FDA listed | — |
| Rocuronium Bromide 50 mg/5mL 42677-0309-10 | Shandong | 10 vials | — | AP | FDA listed | — |
| Rocuronium Bromide 50 mg/5mL 51662-1546-01 | HF | 5 ml | — | AP | FDA listed | — |
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⏳ Availability & generic status
FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.
Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.
🛈 What do these terms mean?
- Patent
- Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
- Substance patent
- Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
- Formulation (product) patent
- Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
- Method-of-use patent
- A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
- Skinny label
- A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
- Exclusivity
- FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
- Paragraph IV
- A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
- RLD / RS
- Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
- TE / AB rating
- FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
- LOE (loss of exclusivity)
- The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.
Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.
| Patent | Type | Use code | Expires |
|---|---|---|---|
| US 11998605 ↗ | Drug product | — | Jul 22, 2039 |
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🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
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Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00264-5711-10 You're viewing this | 30 BOX in 1 CASE (0264-5711-10) / 10 SYRINGE in 1 BOX / 5 mL in 1 SYRINGE (0264-5711-01) | 2026-05-21 | Active |
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
2 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 )
2.1Important 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) ] .
2.2Dose 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 Cli…
💊 Dosage Forms and Strengths ▾
3 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 ▾
4 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 Cautions ▾
5 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 )
5.1Appropriate 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.
5.2Anaphylaxis 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.
5.3Risk 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.
5.4Need 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.
5.5Residual 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.
5.6Long-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 o…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS 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.
6.1Clinical 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%).
6.2Post-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 ▾
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 )
7.1Antibiotics 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.
7.2Anticonvulsants 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) ] .
7.3Inhalation 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) ] .
7.4Lithium 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) ] .
7.5Local 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) ] .
7.6Magnesium 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 Nondep…
👥 Use in Specific Populations ▾
8 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 )
8.1Pregnancy 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.
8.2Lactation 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.
8.4Pediatric 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 infant…
🤰 Pregnancy ▾
8.1Pregnancy 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 ▾
8.4Pediatric 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 ▾
8.5Geriatric 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 ▾
10 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism 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.
12.2Pharmacodynamics The ED 95 (dose required to produce 95% suppression of the first [T 1 ] mechanomyographic [MMG] response of the adductor pollicis muscle [thumb] to indirect supramaximal train-of-four stimulation of the ulnar nerve) during opioid/nitrous oxide/oxygen anesthesia is approximately 0.3 mg/kg. Patient variability around the ED 95 dose suggests that 50% of patients will exhibit T 1 depression of 91% to 97%. Table 5 presents intubating conditions in patients with intubation initiated at 60 to 70 seconds.
Table 5. Percent of Excellent or Good Intubating Conditions and Median (Range) Time to Completion of Intubation in Patients with Intubation Initiated at 60 to 70 Seconds Rocuronium Bromide Dose (mg/kg) Administered over 5 sec Percent of Patients with Excellent or Good Intubating Conditions Time to Completion of Intubation (min) Adults Excludes patients undergoing Cesarean section. 18 to 64 yrs 0.45 (n=43) 0.6 (n=51) 86% 96% 1.6 (1.0-7.0) 1.6 (1.0-3.2) Infants Pediatric patients were under halothane anesthesia.
3 mo to 1 yr 0.6 (n=18) Pediatric † 1 to 12 yrs 0.6 (n=12) 100% 100% 1.0 (1.0-1.5) 1.0 (0.5-2.3) Excellent intubating conditions = jaw relaxed, vocal cords apart and immobile, no diaphragmatic movement. Good intubating conditions = same as excellent but with some diaphragmatic movement. Table 6 presents the time to onset and clinical duration for the initial dose of ROCURONIUM BROMIDE INJECTION under opioid/nitrous oxide/oxygen anesthesia in adults and geriatric patients, and under halothane anesthesia in pediatric patients.
Table 6. Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose during Opioid/Nitrous Oxide/Oxygen Anesthesia (Adults) and Halothane Anesthesia (Pediatric Patients) Rocuronium Bromide Dose (mg/kg) Administered over 5 sec Time to ≥80% Block (min) Time to Maximum Block (min) Clinical Duration (min) Adults 18 to 64 yrs 0.45 (n=50) 0.6 (n=142) 0.9 (n=20) 1.2 (n=18) 1.3 (0.8-6.2) 1.0 (0.4-6.0) 1.1 (0.3-3.8) 0.7 (0.4-1.7) 3.0 (1.3-8.2) 1.8 (0.6-13.0) 1.4 (0.8-6.2) 1.0 (0.6-4.7) 22 (12-31) 31 (15-85) 58 (27-111) 67 (38-160) Geriatric ≥65 yrs 0.6 (n=31) 0.9 (n=5) 1.2 (n=7) 2.3 (1.0-8.3) 2.0 (1.0-3.0) 1.0 (0.8-3.5) 3.7 (1.3-11.3) 2.5 (1.2-5.0) 1.3 (1.2-4.7) 46 (22-73) 62 (49-75) 94 (64-138) Infants 3 mo to 1 yr 0.6 (n=17) 0.8 (n=9) – – 0.8 (0.3-3.0) 0.7 (0.5-0.8) 41 (24-68) 40 (27-70) Pediatric 1 to 12 yrs 0.6 (n=27) 0.8 (n=18) 0.8 (0.4-2.0) – 1.0 (0.5-3.3) 0.5 (0.3-1.0) 26 (17-39) 30 (17-56) n = the number of patients who had time to maximum block recorded.
Clinical duration = time until return to 25% of control T 1 . Patients receiving doses of 0.45 mg/kg who achieved less than 90% block (16% of these patients) had about 12 to 15 minutes to 25% recovery. Table 7 presents the time to onset and clinical duration for the initial dose of ROCURONIUM BROMIDE INJECTION under sevoflurane (induction) and isoflurane/nitrous oxide (maintenance) anesthesia in pediatric patients.
Table 7. Median (Range) Time to Onset and Clinical Duration Following Initial (Intubating) Dose During Sevoflurane (induction) and Isoflurane/Nitrous Oxide (maintenance) Anesthesia (Pediatric Patients) Rocuronium Bromide Dose (mg/kg) Administered over 5 sec Time to Maximum Block (min) Time to Reappearance T 3 (min) Neonates birth to <28 days 0.45 (n=5) 0.6 (n=10) 1 (n=6) 1.1 (0.6-2.2) 1.0 (0.2-2.1) 0.6 (0.3-1.8) 40.3 (32.5-62.6) 49.7 (16.6-119.0) 114.4 (92.6-136.3) Infants 28 days to ≤3 mo 0.45 (n=9) 0.6 (n=11) 1 (n=5) 0.5 (0.4-1.3) 0.4 (0.2-0.8) 0.3 (0.2-0.7) 49.1 (13.5-79.9) 59.8 (32.3-87.8) 103.3 (90.8-155.4) Toddlers >3 mo to ≤2 yr…
🧬 Mechanism of Action ▾
12.1Mechanism 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 / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING ROCURONIUM BROMIDE INJECTION 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.
📋 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
💬 Information for Patients ▾
17 PATIENT COUNSELING 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.