Overview
Rocuronium (rapid onset-curonium) is a desacetoxy analogue of vecuronium with a more rapid onset of action. It is an aminosteroid non-depolarizing neuromuscular blocker or muscle relaxant used in modern anaesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation. Introduced in 1994, rocuronium has rapid onset, and intermediate duration of action. It is commonly marketed under the trade names Zemuron and Esmeron. The drug is associated with the risk of developing allergic reactions in some high-risk patients, such as those with asthma. However, there was a similar incidence of allergic reactions associated with other non-depolarizing neuromuscular blocking agents. Sugammadex is a γ-cyclodextrin derivative that has been introduced as a novel agent to reverse the action of rocuronium.
Indication
For inpatients and outpatients as an adjunct to general anesthesia to facilitate both rapid sequence and routine tracheal intubation, and to provide skeletal muscle relaxation during surgery or mechanical ventilation.
Associated Conditions
- Muscle fasciculation caused by succinylcholine
Research Report
Rocuronium Bromide: A Comprehensive Pharmacological and Clinical Monograph
1.0 Executive Summary
Rocuronium is an aminosteroid, nondepolarizing neuromuscular blocking agent (NMBA) distinguished in modern anesthetic practice by its characteristically rapid onset of action and intermediate duration.[1] As a cornerstone of anesthesia, it is employed as an adjunct to general anesthesia to facilitate both routine and rapid sequence tracheal intubation (RSI), as well as to provide profound skeletal muscle relaxation during surgical procedures and for patients requiring mechanical ventilation.[3] Its primary clinical advantage lies in its ability to achieve intubating conditions at a speed comparable to the depolarizing agent succinylcholine, particularly when administered at higher doses, but with a more favorable and safer side-effect profile, establishing it as a critical alternative for RSI.[5]
A transformative development in the clinical use of rocuronium has been the introduction of sugammadex, a selective relaxant binding agent (SRBA). While the neuromuscular blockade induced by rocuronium can be partially reversed by traditional acetylcholinesterase inhibitors like neostigmine, sugammadex offers a unique mechanism that allows for rapid, complete, and reliable reversal of even deep levels of blockade.[1] This innovation has profoundly enhanced the safety profile and clinical utility of rocuronium, allowing for more aggressive dosing with a reliable safety net.[7]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/14 | Not Applicable | Completed | Hebei Medical University Fourth Hospital | ||
2025/06/29 | Not Applicable | Active, not recruiting | Tamas Vegh, MD | ||
2025/06/29 | Not Applicable | Not yet recruiting | Tamas Vegh, MD | ||
2025/06/25 | Not Applicable | Recruiting | Harbin Medical University | ||
2024/11/27 | Not Applicable | Recruiting | 4th Military Clinical Hospital with Polyclinic, Poland | ||
2024/11/07 | Not Applicable | Recruiting | |||
2024/08/21 | Phase 4 | Not yet recruiting | Nordsjaellands Hospital | ||
2024/05/03 | Phase 4 | Recruiting | University Hospital of Split | ||
2024/01/26 | Phase 4 | Completed | |||
2023/10/26 | N/A | Completed | Institut Jantung Negara |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Solco Healthcare US, LLC | 43547-531 | INTRAVENOUS | 100 mg in 10 mL | 3/31/2025 | |
HF Acquisition Co LLC, DBA HealthFirst | 51662-1355 | INTRAVENOUS | 10 mg in 1 mL | 3/1/2021 | |
Medical Purchasing Solutions, LLC | 71872-7036 | INTRAVENOUS | 10 mg in 1 mL | 5/31/2023 | |
Hospira, Inc. | 0409-7037 | INTRAVENOUS | 10 mg in 1 mL | 6/6/2023 | |
Hikma Pharmaceuticals USA Inc. | 0143-9251 | INTRAVENOUS | 10 mg in 1 mL | 3/5/2024 | |
Athenex Pharmaceutical Division, LLC. | 70860-651 | INTRAVENOUS | 10 mg in 1 mL | 4/20/2020 | |
HF Acquisition Co LLC, DBA HealthFirst | 51662-1545 | INTRAVENOUS | 100 mg in 10 mL | 4/9/2022 | |
Baxter Healthcare Corporation | 43066-007 | INTRAVENOUS | 50 mg in 5 mL | 3/31/2019 | |
Medical Purchasing Solutions, LLC | 71872-7207 | INTRAVENOUS | 10 mg in 1 mL | 5/3/2023 | |
Piramal Critical Care Inc | 66794-229 | INTRAVENOUS | 100 mg in 10 mL | 12/21/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
ESMERON INJECTION 50 mg/5ml | SIN09479P | INJECTION | 10 mg/ml | 8/19/1997 | |
NOVERON SOLUTION FOR INJECTION 10MG/ML | SIN17025P | INJECTION, SOLUTION | 10mg/ml | 6/12/2024 | |
ROCURONIUM KABI SOLUTION FOR INJECTION/INFUSION 10MG/ML | SIN15106P | INJECTION, SOLUTION | 10mg/ml | 10/25/2016 | |
ROCURONIUM-HAMELN INJECTION 10MG/ML | SIN15237P | INJECTION, SOLUTION | 10 mg/1ml | 5/16/2017 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
No PPB approvals found for this drug. |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ROCURONIUM BROMIDE INJECTION | Juno Pharmaceuticals Corp. | 02469774 | Solution - Intravenous | 10 MG / ML | 1/17/2019 |
ROCURONIUM BROMIDE INJECTION | eugia pharma inc. | 02528657 | Solution - Intravenous | 10 MG / ML | 10/8/2024 |
ROCURONIUM BROMIDE INJECTION | omega laboratories limited | 02382415 | Solution - Intravenous | 10 MG / ML | 8/2/2012 |
ROCURONIUM BROMIDE INJECTION | 02318121 | Solution - Intravenous | 10 MG / ML | 2/10/2009 | |
ROCURONIUM BROMIDE INJECTION SDZ | 02390566 | Solution - Intravenous | 10 MG / ML | N/A | |
ROCURONIUM BROMIDE INJECTION | 02529831 | Solution - Intravenous | 10 MG / ML | 2/26/2024 | |
INJECTABLE ROCURONIUM BROMIDE | omega laboratories limited | 02539489 | Solution - Intravenous | 10 MG / ML | N/A |
ROCURONIUM BROMIDE INJECTION | auro pharma inc | 02498820 | Solution - Intravenous | 10 MG / ML | 11/24/2020 |
ROCURONIUM BROMIDE INJECTION | hikma canada limited | 02517744 | Solution - Intravenous | 10 MG / ML | 9/29/2023 |
ZEMURON | Merck Canada Inc | 02108208 | Solution - Intravenous | 10 MG / ML | 12/31/1995 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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