Etacrynic acid

Overview

A compound that inhibits symport of sodium, potassium, and chloride primarily in the ascending limb of Henle, but also in the proximal and distal tubules. This pharmacological action results in excretion of these ions, increased urinary output, and reduction in extracellular fluid. This compound has been classified as a loop or high ceiling diuretic.

Indication

For the treatment of high blood pressure and edema caused by diseases like congestive heart failure, liver failure, and kidney failure.

Associated Conditions

Ascites
Congenital Heart Disease (CHD)
Edema
Nephrotic Syndrome

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Ethacrynic Acid Elimination in Non-Muscle Invasive Bladder Cancer Patients Undergoing Transurethral Resection	2016/08/02	NCT02852564	Phase 1	Completed	Eugene Lee, MD
Novel Drug Delivery Technique Via Retroject Device	2014/01/31	NCT02051946	Phase 1	Completed	Molly Walsh
Furosemide Versus Ethacrynic Acid in Children With Congenital Heart Disease	2012/06/27	NCT01628731	Phase 3	Completed	Bambino Gesù Hospital and Research Institute

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Ethacrynic Sodium	Mylan Institutional LLC	67457-297	INTRAVENOUS	50 mg in 50 mL	1/15/2014
Ethacrynic Acid	Amneal Pharmaceuticals NY LLC	69238-1126	ORAL	25 mg in 1 1	12/30/2023
Ethacrynic Acid	ST. MARY'S MEDICAL PARK PHARMACY	60760-773	ORAL	25 mg in 1 1	2/17/2023
EDECRIN	Avera McKennan Hospital	69189-0371	ORAL	25 mg in 1 1	12/10/2015
Ethacrynate Sodium	Zydus Lifesciences Limited	70771-1106	INTRAVENOUS	50 mg in 50 mL	10/17/2022
ethacrynic sodium	Oceanside Pharmaceuticals	68682-012	INTRAVENOUS	50 mg in 50 mL	1/1/2021
SODIUM EDECRIN	Bausch Health US, LLC	25010-210	INTRAVENOUS	50 mg in 50 mL	8/31/2020
ethacrynic sodium	Oceanside Pharmaceuticals	68682-012	INTRAVENOUS	50 mg in 50 mL	8/31/2023
Ethacrynic Acid	Edenbridge Pharmaceuticals LLC.	42799-405	ORAL	25 mg in 1 1	7/21/2021
EDECRIN	Bausch Health US, LLC	25010-215	ORAL	25 mg in 1 1	8/31/2020

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
EDECRIN TAB 50MG	merck frosst canada & cie, merck frosst canada & co.	00016497	Tablet - Oral	50 MG	12/31/1968
EDECRIN	bausch health, canada inc.	02258528	Tablet - Oral	25 MG	10/15/2004

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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