Overview
Triamterene (2,4,7-triamino-6-phenylpteridine) is a potassium-sparing diuretic that is used in the management of hypertension. It works by promoting the excretion of sodium ions and water while decreasing the potassium excretion in the distal part of the nephron in the kidneys by working on the lumenal side. Since it acts on the distal nephron where only a small fraction of sodium ion reabsorption occurs, triamterene is reported to have limited diuretic efficacy. Due to its effects on increased serum potassium levels, triamterene is associated with a risk of producing hyperkalemia. Triamterene is a weak antagonist of folic acid, and a photosensitizing drug. Triamterene was approved by the Food and Drug Administration in the U.S. in 1964. Currently, triamterene is used in the treatment of edema associated with various conditions as monotherapy and is approved for use with other diuretics to enhance diuretic and potassium-sparing effects. It is also found in a combination product with hydrochlorothiazide that is used for the management of hypertension or treatment of edema in patients who develop hypokalemia on hydrochlorothiazide alone.
Indication
Triamterene is indicated for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and the nephrotic syndrome; also in steroid-induced edema, idiopathic edema, and edema due to secondary hyperaldosteronism. Triamterene in combination with hydrochlorothiazide is indicated for the managment of hypertension or treatment of edema in patients who develop hypokalemia following hydrochlorothiazide monotherapy, and in patients who require thiazide diuretic and in whom the development of hypokalemia cannot be risked. Triamterene allows the maintenance of potassium balance when given in combination with loop diuretics and thiazides.
Associated Conditions
- Edema
- Edema caused by Secondary hyperaldosteronism
- Edema caused by corticosteroid therapy
- Hypertension
- Hypokalemia caused by diuretics
- Idiopathic Edema
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2021/11/18 | N/A | Active, not recruiting | |||
2015/08/13 | Phase 4 | UNKNOWN | |||
1999/10/28 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Denton Pharma, Inc. DBA Northwind Pharmaceuticals | 70934-143 | ORAL | 37.5 mg in 1 1 | 10/22/2019 | |
| Northwind Pharmaceuticals | 51655-722 | ORAL | 37.5 mg in 1 1 | 1/1/2023 | |
| Carilion Materials Management | 68151-1494 | ORAL | 50 mg in 1 1 | 4/29/2015 | |
| Northwind Pharmaceuticals, LLC | 82868-022 | ORAL | 37.5 mg in 1 1 | 10/24/2023 | |
| A-S Medication Solutions | 50090-6736 | ORAL | 75 mg in 1 1 | 8/26/2023 | |
| Viona Pharmaceuticals Inc | 72578-090 | ORAL | 37.5 mg in 1 1 | 10/31/2023 | |
| Concordia Pharmaceuticals Inc. | 59212-002 | ORAL | 50 mg in 1 1 | 7/3/2023 | |
| Apotex Corp. | 60505-2657 | ORAL | 75 mg in 1 1 | 12/15/2023 | |
| Bryant Ranch Prepack | 71335-0326 | ORAL | 75 mg in 1 1 | 2/24/2022 | |
| Northwind Pharmaceuticals | 51655-510 | ORAL | 37.5 mg in 1 1 | 1/1/2023 |
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 |
|---|---|---|---|---|---|
| APO-TRIAZIDE TABLET | SIN06552P | TABLET | 50 mg | 9/11/1991 |
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 |
|---|---|---|---|---|---|
| RIVA-ZIDE 50/25MG TABLETS | laboratoire riva inc. | 02240846 | Tablet - Oral | 50 MG | 11/5/1999 |
| PENTA-TRIAMTERENE HCTZ TABLETS | pentapharm ltd. | 02238638 | Tablet - Oral | 50 MG | 7/12/1999 |
| DYRENIUM 50 | 01919563 | Tablet - Oral | 50 MG | 12/31/1992 | |
| DYRENIUM 100 | 01919571 | Tablet - Oral | 100 MG | 12/31/1992 | |
| APO TRIAZIDE | 00441775 | Tablet - Oral | 50 MG | 12/31/1984 | |
| NU-TRIAZIDE TAB 50 MG/25 MG | nu-pharm inc | 00865532 | Tablet - Oral | 50 MG | 12/31/1990 |
| TEVA-TRIAMTERENE/HCTZ | teva canada limited | 00532657 | Tablet - Oral | 50 MG | 12/31/1981 |
| PRO-TRIAZIDE | PRO DOC LIMITEE | 00519367 | Tablet - Oral | 50 MG | 12/31/1985 |
| DYAZIDE TAB | smithkline beecham pharma division of smithkline beecham inc | 01919547 | Tablet - Oral | 50 MG | 12/31/1992 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| SALIDUR 77,6 MG / 25 MG COMPRIMIDOS | Laboratorios Almirall S.L. | 53542 | COMPRIMIDO | Medicamento Sujeto A Prescripción Médica | 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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