Metolazone

Generic Name: Metolazone

Brand Names: Mykrox, Zaroxolyn

Drug Type: Small Molecule

Chemical Formula: C_₁₆H_₁₆ClN_₃O_₃S

CAS Number: 17560-51-9

Unique Ingredient Identifier: TZ7V40X7VX

Overview

A quinazoline-sulfonamide that is considered a thiazide-like diuretic which is long-acting so useful in chronic renal failure. It also tends to lower blood pressure and increase potassium loss.

Indication

用于治疗水肿及高血压。

Associated Conditions

Edema
Hypertension
Mild Hypertension
Moderate Hypertension

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Efficacy and Safety of Combination Diuretic Therapy in Patients With Acute Decompensated Heart Failure and Volume Overload	2024/05/16	NCT06414759	Phase 4	Recruiting	Cairo University
Role of Active Deresuscitation After Resuscitation:	2024/03/22	NCT06326112	Phase 2	Not yet recruiting	Unity Health Toronto
Acetazolamide or Metolazone in Acute Heart Failure	2024/02/22	NCT06273397	Not Applicable	Not yet recruiting	Clinica Alemana de Santiago
OPTIMAL DIURETIC THERAPIES FOR ACUTE HEART FAILURE WITH VOLUME OVERLOAD	2024/04/15	2024-510633-17-00	Phase 3	Recruiting	Region Hovedstaden, Region Hovedstaden
Diuretic Strategies in Acute Heart Failure Patients At High Risk for Diuretic Resistance	2023/08/14	NCT05986773	Phase 4	Terminated	Stadtspital Zürich
Metolazone As Early Add On Therapy For Acute Decompensated Heart Failure	2022/12/01	NCT05633758	Phase 2	Withdrawn	Scripps Health
DAPAgliflozin Versus Thiazide Diuretic in Patients With Heart Failure and Diuretic RESISTance	2021/04/26	NCT04860011	Phase 3	Active, not recruiting	NHS Greater Glasgow and Clyde
Efficacy of Diuretics in Kidney Disease	2020/09/09	NCT04542304	Phase 2	Terminated	Stanford University
Ertugliflozin in Chronic Heart Failure	2020/06/18	NCT04438213	Phase 2	Recruiting	Yale University
Sequential Nephron Blockade in Acute Heart Failure	2019/11/15	NCT04163588	Phase 3	UNKNOWN	Policlinico Casilino ASL RMB

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
METOLAZONE	Aarkish Pharmaceuticals NJ Inc.	81005-126	ORAL	10 mg in 1 1	12/14/2023
Metolazone	Aphena Pharma Solutions - Tennessee, LLC	43353-890	ORAL	2.5 mg in 1 1	2/26/2014
Metolazone	Bryant Ranch Prepack	63629-8733	ORAL	5 mg in 1 1	12/11/2023
metolazone	Aphena Pharma Solutions - Tennessee, LLC	71610-142	ORAL	2.5 mg in 1 1	9/10/2018
Metolazone	A-S Medication Solutions	50090-6802	ORAL	2.5 mg in 1 1	5/4/2021
Metolazone	Carilion Materials Management	68151-2939	ORAL	10 mg in 1 1	10/1/2004
Metolazone	Golden State Medical Supply, Inc.	51407-432	ORAL	5 mg in 1 1	3/15/2023
METOLAZONE	Alembic Pharmaceuticals Inc.	62332-534	ORAL	10 mg in 1 1	4/26/2022
Metolazone	Mylan Pharmaceuticals Inc.	0378-6174	ORAL	10 mg in 1 1	10/1/2004
metolazone	Major Pharmaceuticals	0904-6916	ORAL	2.5 mg in 1 1	8/23/2022

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
DIULO Tablets - Bottle	33298	Proqualix Pty Ltd - in Administration	Medicine	A	10/29/1991
DIULO Tablets - Blisters	32324	Proqualix Pty Ltd - in Administration	Medicine	A	10/24/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
ZAROXOLYN TAB 10MG	rhone-poulenc rorer canada inc.	00888427	Tablet - Oral	10 MG	12/31/1974
ZAROXOLYN	sanofi-aventis canada inc	00888400	Tablet - Oral	2.5 MG	12/31/1974
ZAROXOLYN	aventis pharma inc	00888419	Tablet - Oral	5 MG	8/22/1997

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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