Overview
Hydrochlorothiazide is the most commonly prescribed thiazide diuretic. It is indicated to treat edema and hypertension. Hydrochlorothiazide use is common but declining in favour of angiotensin converting enzyme inhibitors. Many combination products are available containing hydrochlorothiazide and angiotensin converting enzyme inhibitors or angiotensin II receptor blockers. Hydrochlorothiazide was granted FDA approval on 12 February 1959.
Background
Hydrochlorothiazide is the most commonly prescribed thiazide diuretic. It is indicated to treat edema and hypertension. Hydrochlorothiazide use is common but declining in favour of angiotensin converting enzyme inhibitors. Many combination products are available containing hydrochlorothiazide and angiotensin converting enzyme inhibitors or angiotensin II receptor blockers. Hydrochlorothiazide was granted FDA approval on 12 February 1959.
Indication
Hydrochlorothiazide is indicated alone or in combination for the management of edema associated with congestive heart failure, hepatic cirrhosis, nephrotic syndrome, acute glomerulonephritis, chronic renal failure, and corticosteroid and estrogen therapy. Hydrochlorothiazide is also indicated alone or in combination for the management of hypertension.
Associated Conditions
- Calcium Nephrolithiasis
- Cirrhosis of the Liver
- Congestive Heart Failure (CHF)
- Diabetes Insipidus
- Edema
- Hypertension
- Hypertension, Essential Hypertension
- Hypokalemia caused by diuretics
- Nephrotic Syndrome
- Pre-Eclampsia
- Premenstrual tension with edema
- Renal tubular acidosis
- Sodium retention
- Stroke
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/06/13 | Not Applicable | Recruiting | |||
2024/11/08 | Not Applicable | Completed | ALI KAMAL M. SAMI | ||
2023/11/01 | Phase 2 | Recruiting | |||
2023/06/23 | Phase 4 | Recruiting | |||
2022/07/05 | Phase 4 | Not yet recruiting | |||
2022/05/13 | Phase 3 | Not yet recruiting | |||
2021/11/18 | N/A | Active, not recruiting | |||
2021/06/22 | Phase 1 | Recruiting | |||
2020/12/21 | Early Phase 1 | Active, not recruiting | |||
2020/12/04 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lifestar Pharma LLC | 70756-813 | ORAL | 12.5 mg in 1 1 | 12/19/2023 | |
| Bryant Ranch Prepack | 63629-2430 | ORAL | 25 mg in 1 1 | 7/31/2019 | |
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-143 | ORAL | 25 mg in 1 1 | 10/22/2019 | |
| Glenmark Pharmaceuticals Inc., USA | 68462-841 | ORAL | 12.5 mg in 1 1 | 8/3/2023 | |
| Physicians Total Care, Inc. | 54868-4785 | ORAL | 25 mg in 1 1 | 11/4/2009 | |
| RPK Pharmaceuticals, Inc. | 53002-2785 | ORAL | 25 mg in 1 1 | 11/2/2022 | |
| MedVantx, Inc. | 66116-300 | ORAL | 12.5 mg in 1 1 | 12/7/2012 | |
| PD-Rx Pharmaceuticals, Inc. | 43063-482 | ORAL | 12.5 mg in 1 1 | 5/10/2023 | |
| Par Pharmaceutical, Inc. | 49884-786 | ORAL | 12.5 mg in 1 1 | 10/10/2023 | |
| Aidarex Pharmaceuticals LLC | 33261-904 | ORAL | 25 mg in 1 1 | 1/11/2014 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 3/13/2013 | ||
Authorised | 3/13/2013 | ||
Authorised | 3/13/2013 | ||
Authorised | 4/19/2002 | ||
Authorised | 10/15/2009 | ||
Authorised | 10/16/1998 | ||
Authorised | 4/19/2002 | ||
Authorised | 1/18/2007 | ||
Authorised | 11/3/2009 | ||
Authorised | 4/22/2002 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| MICARDIS PLUS TABLET 40/12.5 mg | SIN12394P | TABLET | 12.5 mg | 8/20/2003 | |
| SARTOCAD H 100/25 FILM COATED TABLET 100MG/25MG | SIN15422P | TABLET, FILM COATED | 25mg | 2/9/2018 | |
| HYZAAR TABLET | SIN09429P | TABLET, FILM COATED | 12.5 mg | 7/31/1997 | |
| CO-DIOVAN 80/12.5 TABLET | SIN10538P | TABLET, FILM COATED | 12.5mg | 12/12/1998 | |
| CO-ERBETAN FILM-COATED TABLET 300MG/12.5MG | SIN15178P | TABLET, FILM COATED | 12.50mg | 2/20/2017 | |
| LOSARB PLUS FILM-COATED TABLET 100 MG/25 MG | SIN14466P | TABLET, FILM COATED | 25 mg | 12/19/2013 | |
| CO-DIOVAN 160/25 TABLET | SIN12011P | TABLET, FILM COATED | 25 mg | 7/3/2002 | |
| COAPROVEL FILM-COATED TABLET 300/12.5 mg | SIN11647P | TABLET, FILM COATED | 12.50 mg | 8/28/2001 | |
| CONVERIDE FILM COATED TABLET 300MG/12.5MG | SIN15459P | TABLET, FILM COATED | 12.5mg | 3/23/2018 | |
| VALSARTAN HCT SANDOZ FILM-COATED TABLET 160MG/25MG | SIN16127P | TABLET, FILM COATED | 25 mg | 3/22/2021 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Hydrochlorothiazide Tablets | 国药准字H15020698 | 化学药品 | 片剂 | 4/13/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H61020420 | 化学药品 | 片剂 | 1/15/2021 | |
| Hydrochlorothiazide Tablets | 国药准字H63020059 | 化学药品 | 片剂 | 5/21/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H23020304 | 化学药品 | 片剂(素片) | 6/22/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H22021134 | 化学药品 | 片剂 | 4/26/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H14020967 | 化学药品 | 片剂 | 4/20/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H14020796 | 化学药品 | 片剂 | 9/2/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H22020122 | 化学药品 | 片剂 | 2/24/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H14021386 | 化学药品 | 片剂 | 7/28/2020 | |
| Hydrochlorothiazide Tablets | 国药准字H22021388 | 化学药品 | 片剂 | 4/8/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ZYLTAN H TAB | N/A | N/A | N/A | 10/20/2010 | |
| LODOZ MERCK TAB 5/6.25 | N/A | N/A | N/A | 1/11/2002 | |
| COTIASAR 50MG+12.5MG TAB | N/A | N/A | N/A | 4/18/2008 | |
| APO-AMILZIDE TAB 50/5MG | N/A | N/A | N/A | 6/24/1997 | |
| CO-DIOVAN 160/12.5 TAB | N/A | N/A | N/A | 2/8/2002 | |
| LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE TABLETS 50MG/12.5MG | N/A | N/A | N/A | 10/11/2023 | |
| EXFORGE HCT TABLETS 10MG/160MG/12.5MG (SPAIN) | N/A | N/A | N/A | 11/14/2013 | |
| CO-DIOVAN TAB 160/25MG | N/A | N/A | N/A | 2/26/2010 | |
| LOTANOS COMP TABLETS 50MG/12.5MG | N/A | N/A | N/A | 8/26/2019 | |
| JUBVALSAR H TABLETS 160MG/12.5MG | N/A | N/A | N/A | 10/14/2015 |