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.
Background
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/02/12 | Phase 4 | Completed | |||
2020/09/03 | Not Applicable | UNKNOWN | Shanghai Zhongshan Hospital | ||
2020/04/22 | Phase 2 | Terminated | |||
2020/03/13 | Not Applicable | UNKNOWN | Kasr El Aini Hospital | ||
2020/02/11 | Phase 4 | UNKNOWN | |||
2020/02/07 | Phase 2 | Completed | |||
2019/11/29 | Early Phase 1 | Completed | David N. Proctor, PhD | ||
2019/09/12 | Phase 4 | UNKNOWN | |||
2019/06/26 | Phase 3 | Completed | |||
2019/05/29 | N/A | UNKNOWN |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1444 | INTRAVENOUS | 100 mg in 10 mL | 1/29/2024 | |
| Fresenius Kabi USA, LLC | 63323-652 | INTRAVENOUS | 10 mg in 1 mL | 2/22/2016 | |
| Medical Purchasing Solutions, LLC | 71872-7049 | INTRAVENOUS | 100 mg in 10 mL | 5/30/2023 | |
| WG Critical Care, LLC | 44567-450 | INTRAVENOUS | 10 mg in 1 mL | 8/23/2023 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1427 | INTRAVENOUS | 10 mg in 1 mL | 2/22/2020 | |
| Baxter Healthcare Corporation | 10019-120 | INTRAVENOUS | 10 mg in 1 mL | 4/1/2014 | |
| Baxter Healthcare Corporation | 10019-666 | INTRAVENOUS | 20 mg in 1 mL | 11/1/2017 | |
| Henry Schein, Inc | 0404-9825 | INTRAVENOUS | 10 mg in 1 mL | 2/18/2022 | |
| A-S Medication Solutions | 50090-4512 | INTRAVENOUS | 100 mg in 10 mL | 3/17/2017 | |
| Eugia US LLC | 55150-421 | INTRAVENOUS | 20 mg in 1 mL | 8/4/2023 |
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 |
|---|---|---|---|---|---|
| Esmolol Hydrochloride Injection | 国药准字H20093380 | 化学药品 | 注射剂（小容量注射剂） | 3/22/2024 | |
| Esmolol Hydrochloride Injection | 国药准字H20067089 | 化学药品 | 注射剂 | 6/22/2020 | |
| Esmolol Hydrochloride Injection | 国药准字H20244395 | 化学药品 | 注射剂 | 7/9/2024 | |
| Esmolol Hydrochloride Injection | 国药准字H20249552 | 化学药品 | 注射剂 | 12/1/2024 | |
| Esmolol Hydrochloride Injection | 国药准字H19991059 | 化学药品 | 注射剂 | 2/16/2020 | |
| Esmolol Hydrochloride Injection | 国药准字H20243122 | 化学药品 | 注射剂 | 1/30/2024 | |
| Esmolol Hydrochloride Injection | 国药准字H20237092 | 化学药品 | 注射剂 | 8/11/2023 | |
| Esmolol Hydrochloride Injection | 国药准字H20066757 | 化学药品 | 注射剂 | 9/22/2020 | |
| Esmolol Hydrochloride Injection | 国药准字H20243402 | 化学药品 | 注射剂 | 3/29/2024 | |
| Esmolol Hydrochloride Injection | 国药准字H20234338 | 化学药品 | 注射剂 | 10/18/2023 |
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. | |||||