Flumazenil

Overview

Fumazenil is an imidazobenzodiazepine derivative and a potent benzodiazepine receptor antagonist that competitively inhibits the activity at the benzodiazepine recognition site on the GABA/benzodiazepine receptor complex, thereby reversing the effects of benzodiazepine on the central nervous system.

Indication

For the complete or partial reversal of the sedative effects of benzodiazepines in cases where general anesthesia has been induced and/or maintained with benzodiazepines, and where sedation has been produced with benzodiazepines for diagnostic and therapeutic procedures. Also for the management of benzodiazepine overdose as an adjunct for appropriate supportive and symptomatic measures.

Associated Conditions

Sedation caused by benzodiazepine

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Finding ED90 of Flumazenil for Selective Improvement of Respiratory Distress by Remimazolam	2024/08/20	NCT06563063	Not Applicable	Completed	Yonsei University
Flumazenil Antagonism of Remimazolam in Kidney Transplant Patients	2024/08/01	NCT06531369	Phase 1	Not yet recruiting	Qianfoshan Hospital
Comparison of Remimazolam and Propofol on Emergence in Elderly Orthopedic Patients Under General Anesthesia	2024/07/22	NCT06513923	Phase 4	Completed	Central South University
Effect of Remazolam on Anesthesia Recovery in Patients Undergoing Fundus Surgery	2024/01/16	NCT06205719	Early Phase 1	Not yet recruiting	Sichuan Provincial People's Hospital
Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam	2023/07/11	NCT05939674	Not Applicable	Recruiting	Pusan National University Yangsan Hospital
Impact of Flumazenil on the Emergence Delirium	2023/01/12	NCT05681377	Phase 4	Completed	Korea University Guro Hospital
Clinical Application Value of Remazolam Combined With Sugammadex Sodium in Anesthesia for Endotracheal Surgery Under Bronchoscopy	2022/07/21	NCT05468671	Phase 4	Completed	Zhejiang Cancer Hospital
Comparison of Recovery From General Anesthesia in Remimazolam With Flumazenil vs. Propofol	2022/06/28	NCT05435911	Not Applicable	Completed	Seoul National University Hospital
Comparison of Remimazolam With Flumazenil vs. Propofol During RFCA for Atrial Fibrillation	2022/05/31	NCT05397886	Not Applicable	Completed	Seoul National University Hospital
Reversal of Remimazolam by a Single Dose of Flumazenil	2022/05/19	NCT05382806	Not Applicable	Completed	Konkuk University Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Flumazenil	Hikma Pharmaceuticals USA Inc.	0143-9683	INTRAVENOUS	0.1 mg in 1 mL	11/20/2023
Flumazenil	Sina Health Inc	70385-2021	INTRAVENOUS	0.1 mg in 1 mL	4/9/2017
Flumazenil	Medical Purchasing Solutions, LLC	71872-7008	INTRAVENOUS	0.1 mg in 1 mL	10/13/2022
Flumazenil	West-ward Pharmaceutical Corp.	0641-6032	INTRAVENOUS	0.1 mg in 1 mL	9/28/2011
Flumazenil	Medical Purchasing Solutions, LLC	71872-7038	INTRAVENOUS	0.1 mg in 1 mL	5/31/2023
FLUMAZENIL	HF Acquisition Co. LLC, DBA HealthFirst	51662-1254	INTRAVENOUS	0.1 mg in 1 mL	1/28/2024
FLUMAZENIL	HF Acquisition Co. LLC, DBA Health First	51662-1253	INTRAVENOUS	0.1 mg in 1 mL	1/29/2024
Flumazenil	REMEDYREPACK INC.	70518-3456	INTRAVENOUS	0.1 mg in 1 mL	1/11/2024
Flumazenil	Fresenius Kabi USA, LLC	63323-424	INTRAVENOUS	0.1 mg in 1 mL	10/20/2017
FLUMAZENIL	HF Acquisition Co LLC, DBA HealthFirst	51662-1579	INTRAVENOUS	0.1 mg in 1 mL	6/28/2021

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
FLUMAZENIL-BAXTER SOLUTION FOR INJECTION 0.5 MG/5 ML	Baxter Pharmaceuticals India Private Limited	SIN15209P	INJECTION, SOLUTION	0.1 mg/mL	4/11/2017
ANEXATE INJECTION 0.5 mg/5 ml	CENEXI SAS	SIN01509P	INJECTION	0.5 mg/5 ml	5/25/1988
FLUMAZENIL KABI SOLUTION FOR INJECTION OR INFUSION 0.1MG/ML	Fresenius Kabi Austria GmbH	SIN15610P	INJECTION, SOLUTION	0.1mg/ml	1/9/2019
FLUMAZENIL-HAMELN INJECTION 0.1MG/ML	Siegfried Hameln GmbH	SIN15750P	SOLUTION, STERILE	0.1 mg per ml	7/23/2019
FLUMAZENIL-BAXTER SOLUTION FOR INJECTION 1 MG/10 ML	Baxter Pharmaceuticals India Private Limited	SIN15210P	INJECTION, SOLUTION	0.1 mg/mL	4/11/2017
GP-FLUMAZENIL SOLUTION FOR I.V. INJECTION 0.5 MG/5 ML	AROMA İLAÇ SAN. LTD. ŞTİ	SIN17223P	INJECTION, SOLUTION	0.5 mg/5ml	4/23/2025

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
FLUMAZENIL KABI flumazenil 1mg/10mL solution for injection ampoules	260017	Fresenius Kabi Australia Pty Ltd	Medicine	A	10/25/2016
GenRx Flumazenil flumazenil 0.5 mg / 5 mL solution for injection ampoule	236673	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	2/15/2016
ANEXATE 0.5mg/5mL injection	13706	Pharmaco Australia Ltd	Medicine	A	8/23/1991
Flumazenil-Baxter flumazenil 0.5 mg/5 mL solution for injection ampoule	231405	Baxter Healthcare Pty Ltd	Medicine	A	12/2/2015
APO-Flumazenil flumazenil 0.5 mg/ 5 mL solution for injection ampoule	236674	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	2/15/2016
Flumazenil-Baxter flumazenil 1 mg/10 mL solution for injection ampoule	231406	Baxter Healthcare Pty Ltd	Medicine	A	12/2/2015
FLUMAZENIL KABI flumazenil 0.5mg/5mL solution for injection ampoules	260016	Fresenius Kabi Australia Pty Ltd	Medicine	A	10/25/2016

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ANEXATE INJ 0.1MG/ML	Hoffmann-La Roche Limited	00874019	Solution - Intravenous	0.1 MG / ML	12/31/1991
FLUMAZENIL INJECTION, USP	fresenius kabi canada ltd	02266342	Solution - Intravenous	0.1 MG / ML	11/5/2007
FLUMAZENIL INJECTION SDZ	Sandoz Canada, Inc.	02388995	Solution - Intravenous	0.1 MG / ML	N/A
JAMP-FLUMAZENIL	Jamp Pharma Corporation	02431750	Solution - Intravenous	0.1 MG / ML	N/A
FLUMAZENIL INJECTION, USP	Mylan Pharmaceuticals ULC	02430169	Solution - Intravenous	0.1 MG / ML	N/A
FLUMAZENIL INJECTION	Sandoz Canada, Inc.	02249561	Solution - Intravenous	0.1 MG / ML	4/21/2004

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
FLUMAZENILO HIKMA 0,1 MG/ML SOLUCION INYECTABLE Y PARA PERFUSION EFG	Hikma Farmaceutica (Portugal) S.A.	82049	SOLUCIÓN INYECTABLE Y PARA PERFUSIÓN	Uso Hospitalario	Commercialized
ANEXATE 1 mg/10 ml SOLUCION INYECTABLE	Cheplapharm Arzneimittel Gmbh	57807	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
FLUMAZENIL ALTAN 0,1 MG/ML SOLUCION INYECTABLE EFG	Altan Pharmaceuticals Sa	68190	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
FLUMAZENIL B. BRAUN 0,1 mg/ml SOLUCION INYECTABLE EFG	B. Braun Melsungen Ag	69020	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
FLUMAZENILO FRESENIUS KABI 0,1 mg/ml INYECTABLE EFG	Fresenius Kabi España, S.A.U.	67260	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized
ANEXATE 0,5 mg/5 ml SOLUCION INYECTABLE	Cheplapharm Arzneimittel Gmbh	57806	SOLUCIÓN INYECTABLE	Uso Hospitalario	Commercialized

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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