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 |
|---|---|---|---|---|---|
2023/08/28 | Phase 3 | Recruiting | Zhiming Jiang | ||
2023/05/09 | Phase 2 | Completed | |||
2023/03/15 | Phase 3 | Recruiting | Consorcio Centro de Investigación Biomédica en Red (CIBER) | ||
2023/01/27 | Not Applicable | Recruiting | |||
2023/01/23 | Phase 4 | Not yet recruiting | Xiumei Song | ||
2022/12/02 | Phase 4 | Recruiting | Yongtao Sun | ||
2022/10/05 | Not Applicable | Recruiting | |||
2022/05/25 | Not Applicable | UNKNOWN | |||
2021/10/11 | Phase 4 | UNKNOWN | Meshalkin Research Institute of Pathology of Circulation | ||
2021/07/02 | N/A | Completed | Zonguldak Bulent Ecevit University |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| General Injectables & Vaccines, Inc | 52584-017 | INTRAVENOUS | 10 mg in 1 mL | 1/18/2017 | |
| Mylan Institutional LLC | 67457-658 | INTRAVENOUS | 20 mg in 1 mL | 12/31/2017 | |
| Baxter Healthcare Corporation | 10019-672 | INTRAVENOUS | 10 mg in 1 mL | 1/31/2018 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1322 | INTRAVENOUS | 10 mg in 1 mL | 2/19/2024 | |
| Sagent Pharmaceuticals | 25021-309 | INTRAVENOUS | 20 mg in 1 mL | 7/24/2018 | |
| Baxter Healthcare Corporation | 10019-668 | INTRAVENOUS | 20 mg in 1 mL | 1/31/2018 | |
| Sagent Pharmaceuticals | 25021-308 | INTRAVENOUS | 10 mg in 1 mL | 7/24/2018 | |
| Gland Pharma Limited | 68083-211 | INTRAVENOUS | 10 mg in 1 mL | 7/4/2023 | |
| Amneal Pharmaceuticals LLC | 70121-1716 | INTRAVENOUS | 10 mg in 1 mL | 7/18/2023 | |
| West Ward Pharmaceutical Corporation | 0641-2965 | INTRAVENOUS | 10 mg in 1 mL | 11/6/2007 |
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H20093381 | 化学药品 | 注射剂（小容量注射剂） | 3/22/2024 | |
| Esmolol Hydrochloride Injection | 国药准字H20253719 | 化学药品 | 注射剂 | 3/25/2025 | |
| Esmolol Hydrochloride Injection | 国药准字H20234228 | 化学药品 | 注射剂 | 9/28/2023 | |
| Esmolol Hydrochloride Injection | 国药准字H20243275 | 化学药品 | 注射剂 | 2/23/2024 | |
| Esmolol Hydrochloride Injection | 国药准字H20234407 | 化学药品 | 注射剂 | 10/27/2023 | |
| Esmolol Hydrochloride Injection | 国药准字H20243401 | 化学药品 | 注射剂 | 3/29/2024 | |
| Esmolol Hydrochloride Injection | 国药准字H20058029 | 化学药品 | 注射剂 | 4/29/2020 | |
| Esmolol Hydrochloride Injection | 国药准字H20055990 | 化学药品 | 注射剂 | 7/31/2020 | |
| Esmolol Hydrochloride Injection | 国药准字H20067090 | 化学药品 | 注射剂 | 6/22/2020 | |
| Esmolol Hydrochloride Injection | 国药准字H20056800 | 化学药品 | 注射剂 | 6/25/2021 |
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. | |||||