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Esmolol

Generic Name
Esmolol
Brand Names
Brevibloc
Drug Type
Small Molecule
Chemical Formula
C16H25NO4
CAS Number
81147-92-4
Unique Ingredient Identifier
MDY902UXSR

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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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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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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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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Company
Licence No.
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Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

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