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.
Background
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
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/07/21 | Phase 4 | Completed | |||
2022/07/12 | Not Applicable | Completed | |||
2022/06/21 | Not Applicable | Completed | |||
2022/04/25 | N/A | Completed | |||
2022/03/24 | Early Phase 1 | UNKNOWN | |||
2022/03/15 | Not Applicable | Completed | |||
2021/10/28 | Early Phase 1 | Completed | |||
2021/05/05 | Phase 4 | UNKNOWN | Bozyaka Training and Research Hospital | ||
2021/05/03 | Phase 4 | Completed | Matias Vested | ||
2021/03/30 | Not Applicable | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Hikma Pharmaceuticals USA Inc. | 0143-9250 | INTRAVENOUS | 10 mg in 1 mL | 3/5/2024 | |
| Caplin Steriles Limited | 65145-130 | INTRAVENOUS | 10 mg in 1 mL | 3/15/2023 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1546 | INTRAVENOUS | 50 mg in 5 mL | 2/19/2024 | |
| Bryant Ranch Prepack | 72162-2263 | INTRAVENOUS | 50 mg in 5 mL | 2/23/2024 | |
| Meitheal Pharmaceuticals Inc. | 71288-700 | INTRAVENOUS | 10 mg in 1 mL | 5/9/2023 | |
| Eugia US LLC | 55150-225 | INTRAVENOUS | 50 mg in 5 mL | 8/5/2023 | |
| Phlow Corporation | 81565-204 | INTRAVENOUS | 10 mg in 1 mL | 2/22/2024 | |
| Hospira, Inc. | 0409-1403 | INTRAVENOUS | 10 mg in 1 mL | 8/29/2023 | |
| Piramal Critical Care Inc | 66794-228 | INTRAVENOUS | 50 mg in 5 mL | 12/21/2023 | |
| Hospira, Inc. | 0409-9558 | INTRAVENOUS | 10 mg in 1 mL | 5/30/2019 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Rocuronium Bromide Injection | 国药准字H20249722 | 化学药品 | 注射剂 | 12/10/2024 | |
| Rocuronium Bromide Injection | 国药准字H20249723 | 化学药品 | 注射剂 | 12/10/2024 | |
| Rocuronium Bromide Injection | 国药准字H20183109 | 化学药品 | 注射剂 | 12/5/2022 | |
| Rocuronium Bromide Injection | 国药准字H20183254 | 化学药品 | 注射剂 | 7/5/2023 | |
| Rocuronium Bromide Injection | 国药准字H20244041 | 化学药品 | 注射剂 | 6/18/2024 | |
| Rocuronium Bromide Injection | 国药准字HJ20140847 | 化学药品 | 注射剂 | 8/24/2023 | |
| Rocuronium Bromide Injection | 国药准字H20213909 | 化学药品 | 注射剂 | 11/30/2021 | |
| Rocuronium Bromide Injection | 国药准字H20213910 | 化学药品 | 注射剂 | 11/30/2021 | |
| Rocuronium Bromide Injection | 国药准字H20244042 | 化学药品 | 注射剂 | 6/18/2024 | |
| Rocuronium Bromide Injection | 国药准字H20183264 | 化学药品 | 注射剂 | 2/14/2023 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||