Overview
Esmolol, commonly marketed under the trade name Brevibloc, is a cardioselective beta-1 receptor blocker. It has a rapid onset but short duration of action without causing significant intrinsic sympathomimetic or membrane stabilizing activities at recommended therapeutic doses. It works by blocking beta-adrenergic receptors in the heart, which leads to decreased force and rate of heart contractions. Esmolol prevents the action of two naturally occurring substances: epinephrine and norepinephrine. The FDA withdrew its approval for the use of all parenteral dosage form drug products containing esmolol hydrochloride that supply 250 milligrams/milliliter of concentrated esmolol per 10-milliliter ampule. Other esmolol formulations are still available for use.
Indication
For the rapid control of ventricular rate in patients with atrial fibrillation or atrial flutter in perioperative, postoperative, or other emergent circumstances where short term control of ventricular rate with a short-acting agent is desirable. Also used in noncompensatory sinus tachycardia where the rapid heart rate requires specific intervention.
Associated Conditions
- Hypertension
- Tachycardia
- Abnormal ventricular rate
- Heart rate abnormal
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/13 | Phase 4 | Not yet recruiting | University Hospital, Limoges | ||
2025/05/06 | Phase 4 | Not yet recruiting | Qianfoshan Hospital | ||
2024/10/01 | Not Applicable | Not yet recruiting | |||
2024/07/26 | Phase 2 | Recruiting | |||
2024/06/13 | Phase 1 | Active, not recruiting | The Second People's Hospital of Huai'an | ||
2024/04/30 | Phase 2 | Completed | Lin Chen | ||
2024/04/19 | Not Applicable | Recruiting | National Medical Research Center for Cardiology, Ministry of Health of Russian Federation | ||
2024/03/04 | Phase 4 | Recruiting | Ciusss de L'Est de l'Île de Montréal | ||
2024/02/20 | Not Applicable | Completed | |||
2023/12/13 | Not Applicable | Completed | Xinchen Wang |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Mylan Institutional LLC | 67457-657 | INTRAVENOUS | 10 mg in 1 mL | 12/31/2017 | |
| Medical Purchasing Solutions, LLC | 71872-7136 | INTRAVENOUS | 10 mg in 1 mL | 5/22/2023 | |
| Baxter Healthcare Corporation | 10019-115 | INTRAVENOUS | 10 mg in 1 mL | 4/1/2014 | |
| Baxter Healthcare Corporation | 10019-055 | INTRAVENOUS | 10 mg in 1 mL | 4/1/2014 | |
| Henry Schein, Inc. | 0404-9785 | INTRAVENOUS | 10 mg in 1 mL | 6/18/2025 | |
| Baxter Healthcare Corporation | 10019-670 | INTRAVENOUS | 10 mg in 1 mL | 11/1/2017 | |
| Amneal Pharmaceuticals LLC | 70121-1717 | INTRAVENOUS | 20 mg in 1 mL | 7/18/2023 | |
| Mylan Institutional LLC | 67457-182 | INTRAVENOUS | 10 mg in 1 mL | 4/4/2017 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1371 | INTRAVENOUS | 10 mg in 1 mL | 12/10/2022 | |
| Eugia US LLC | 55150-194 | INTRAVENOUS | 100 mg in 10 mL | 8/17/2023 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Esmolol Hydrochloride and Sodium Chloride Injection | 国药准字H20227017 | 化学药品 | 注射剂 | 2/10/2022 | |
| Esmolol Hydrochloride and Sodium Chloride Injection | 国药准字H20213476 | 化学药品 | 注射剂 | 6/16/2021 | |
| Esmolol Hydrochloride and Sodium Chloride Injection | 国药准字H20244006 | 化学药品 | 注射剂 | 6/11/2024 | |
| Esmolol Hydrochloride and Sodium Chloride Injection | 国药准字H20234172 | 化学药品 | 注射剂 | 9/19/2023 | |
| Esmolol Hydrochloride and Sodium Chloride Injection | 国药准字H20193417 | 化学药品 | 注射剂 | 12/30/2019 | |
| Esmolol Hydrochloride and Sodium Chloride Injection | 国药准字H20249055 | 化学药品 | 注射剂 | 10/16/2024 | |
| Esmolol Hydrochloride and Sodium Chloride Injection | 国药准字H20244931 | 化学药品 | 注射剂 | 9/19/2024 | |
| Esmolol Hydrochloride Injection | 国药准字H20055298 | 化学药品 | 注射剂 | 9/15/2020 | |
| Esmolol Hydrochloride Injection | 国药准字H20055991 | 化学药品 | 注射剂 | 7/31/2020 | |
| Esmolol Hydrochloride Injection | 国药准字H20064640 | 化学药品 | 注射剂 | 1/16/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ESMOLOL NORIDEM esmolol hydrochloride 100 mg/10 mL solution for injection ampoule | 375799 | Medicine | A | 11/2/2022 | |
| BREVIBLOC esmolol hydrochloride 2.5 g powder for injection for infusion vial | 310943 | Medicine | A | 1/21/2020 | |
| BREVIBLOC Esmolol hydrochloride 100mg/10mL injection | 43494 | Medicine | A | 3/4/1993 | |
| BREVIBLOC esmolol hydrochloride 2.5g/10mL injection | 43493 | Medicine | A | 3/4/1993 | |
| ESMOLOL HYDROCHLORIDE MEDICIANZ esmolol hydrochloride 100 mg/10 mL solution for injection vial | 393118 | Medicine | A | 5/4/2023 | |
| ESMOLOL JUNO esmolol hydrochloride100 mg/10 mL solution for injection vial | 373831 | Medicine | A | 12/1/2022 | |
| ESMOLOL HYDROCHLORIDE MEDSURGE esmolol hydrochloride 100 mg/10 mL solution for injection vial | 393119 | Medicine | A | 5/4/2023 |
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