Esmolol

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
Esmolol Versus Sufentanil on the Quality of Post-cholecystectomy Recovery Laparoscopic Anaesthesia With Orotracheal Intubation on an Outpatient Basis	2025/06/13	NCT07019818	Phase 4	Not yet recruiting	University Hospital, Limoges
Effect of Opioid-free Anaesthesia on Postoperative Delirium in Elderly Patients Undergoing Gastrointestinal Surgery	2025/05/06	NCT06958393	Phase 4	Not yet recruiting	Qianfoshan Hospital
Pre-operative Phentolamine Vs Intraoperative Esmolol Efficacy for Hypotensive Anesthesia in Functional Endoscopic Sinus Surgery	2024/10/01	NCT06620991	Not Applicable	Not yet recruiting	Ain Shams University
REMAP ECMO - Beta Receptor Modulation Trial	2024/07/26	NCT06522594	Phase 2	Recruiting	Erasmus Medical Center
Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Surgery	2024/06/13	NCT06457100	Phase 1	Active, not recruiting	The Second People's Hospital of Huai'an
Esmolol in Sepsis Management:Evaluating Immunomodulatory Effects and Impact on Patient Outcomes	2024/04/30	NCT06390748	Phase 2	Completed	Lin Chen
Study of Microvascular Dysfunction, CFR and Cardioprotective Effect of Early Administration of Esmolol in MI	2024/04/19	NCT06376630	Not Applicable	Recruiting	National Medical Research Center for Cardiology, Ministry of Health of Russian Federation
Impact of Administration of Esmolol on Nociception Level-guided Control of Nociception.	2024/03/04	NCT06291363	Phase 4	Recruiting	Ciusss de L'Est de l'Île de Montréal
Comparison of Effects of Scalp Block and Intravenous Esmolol on Hemodynamic Response Following the Skull Pins Application for Elective Supratentorial Craniotomy	2024/02/20	NCT06268275	Not Applicable	Completed	Khon Kaen University
Effect of Dexmedetomidine vs Esmolol or Placebo on Cerebral Hemodynamics in Septic Shock	2023/12/13	NCT06169475	Not Applicable	Completed	Xinchen Wang

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
esmolol hydrochloride in sodium chloride	Mylan Institutional LLC	67457-657	INTRAVENOUS	10 mg in 1 mL	12/31/2017
Esmolol Hydrochloride	Medical Purchasing Solutions, LLC	71872-7136	INTRAVENOUS	10 mg in 1 mL	5/22/2023
Brevibloc	Baxter Healthcare Corporation	10019-115	INTRAVENOUS	10 mg in 1 mL	4/1/2014
Brevibloc	Baxter Healthcare Corporation	10019-055	INTRAVENOUS	10 mg in 1 mL	4/1/2014
Esmolol Hydrochloride	Henry Schein, Inc.	0404-9785	INTRAVENOUS	10 mg in 1 mL	6/18/2025
BREVIBLOC	Baxter Healthcare Corporation	10019-670	INTRAVENOUS	10 mg in 1 mL	11/1/2017
Esmolol Hydrochloride	Amneal Pharmaceuticals LLC	70121-1717	INTRAVENOUS	20 mg in 1 mL	7/18/2023
Esmolol Hydrochloride	Mylan Institutional LLC	67457-182	INTRAVENOUS	10 mg in 1 mL	4/4/2017
ESMOLOL HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	51662-1371	INTRAVENOUS	10 mg in 1 mL	12/10/2022
Esmolol Hydrochloride	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
No NMPA approvals found for this drug.

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	Interpharma Pty Ltd	Medicine	A	11/2/2022
BREVIBLOC esmolol hydrochloride 2.5 g powder for injection for infusion vial	310943	Phebra Pty Ltd	Medicine	A	1/21/2020
BREVIBLOC Esmolol hydrochloride 100mg/10mL injection	43494	Phebra Pty Ltd	Medicine	A	3/4/1993
BREVIBLOC esmolol hydrochloride 2.5g/10mL injection	43493	Phebra Pty Ltd	Medicine	A	3/4/1993
ESMOLOL HYDROCHLORIDE MEDICIANZ esmolol hydrochloride 100 mg/10 mL solution for injection vial	393118	Medsurge Pharma Pty Ltd	Medicine	A	5/4/2023
ESMOLOL JUNO esmolol hydrochloride100 mg/10 mL solution for injection vial	373831	Juno Pharmaceuticals Pty Ltd	Medicine	A	12/1/2022
ESMOLOL HYDROCHLORIDE MEDSURGE esmolol hydrochloride 100 mg/10 mL solution for injection vial	393119	Medsurge Pharma Pty Ltd	Medicine	A	5/4/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
BREVIBLOC PREMIXED INJECTION	baxter corporation	02309238	Solution - Intravenous	10 MG / ML	9/12/2008
BREVIBLOC LIQ IV 250MG/ML	ohmeda pharmaceutical products, division of boc canada limited	02053101	Liquid - Intravenous	250 MG / ML	12/31/1994
BREVIBLOC INJECTION 250MG/ML	baxter corporation	02188864	Liquid - Intravenous	250 MG / ML	1/17/1997
BREVIBLOC INJECTION 10MG/ML	baxter corporation	02188880	Solution - Intravenous	10 MG / ML	8/16/1996
BREVIBLOC LIQ IV 10MG/ML	ohmeda pharmaceutical products, division of boc canada limited	02053179	Liquid - Intravenous	10 MG / ML	12/31/1994

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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