Overview
A pyrazine compound inhibiting sodium reabsorption through sodium channels in renal epithelial cells. This inhibition creates a negative potential in the luminal membranes of principal cells, located in the distal convoluted tubule and collecting duct. Negative potential reduces secretion of potassium and hydrogen ions. Amiloride is used in conjunction with diuretics to spare potassium loss. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p705)
Indication
For use as adjunctive treatment with thiazide diuretics or other kaliuretic-diuretic agents in congestive heart failure or hypertension.
Associated Conditions
- Ascites
- Calcium Nephrolithiasis
- Congestive Heart Failure (CHF)
- Hypertension
- Hypokalemia
- Metabolic Alkalosis
- Polyuria
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/11 | Phase 2 | Recruiting | |||
2024/05/16 | Phase 3 | Completed | Ospedale San Raffaele | ||
2024/01/25 | Phase 2 | Not yet recruiting | Laura Huppert, MD, BA | ||
2023/03/03 | Phase 1 | Recruiting | |||
2022/02/08 | Phase 4 | Recruiting | |||
2021/11/18 | N/A | Active, not recruiting | |||
2021/10/15 | Phase 3 | Terminated | |||
2021/09/16 | Phase 4 | Active, not recruiting | |||
2020/04/02 | Phase 4 | Completed | |||
2019/11/29 | Early Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 0555-0483 | ORAL | 5 mg in 1 1 | 12/27/2022 | |
| Physicians Total Care, Inc. | 54868-0667 | ORAL | 5 mg in 1 1 | 11/17/2010 | |
| Carilion Materials Management | 68151-0162 | ORAL | 5 mg in 1 1 | 8/19/2016 | |
| WINDLAS BIOTECH LIMITED | 57721-671 | ORAL | 5 mg in 1 1 | 7/13/2021 | |
| Padagis US LLC | 0574-0292 | ORAL | 5 mg in 1 1 | 4/30/2022 | |
| Par Pharmaceutical, Inc. | 49884-117 | ORAL | 5 mg in 1 1 | 12/21/2021 | |
| Sigmapharm Laboratories, LLC | 42794-005 | ORAL | 5 mg in 1 1 | 1/10/2023 | |
| Physicians Total Care, Inc. | 54868-5214 | ORAL | 5 mg in 1 1 | 4/22/2011 | |
| A-S Medication Solutions | 50090-0513 | ORAL | 5 mg in 1 1 | 4/30/2020 | |
| Bryant Ranch Prepack | 63629-2114 | ORAL | 5 mg in 1 1 | 12/21/2021 |
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 |
|---|---|---|---|---|---|
| AA-AMILZIDE TABLET | SIN06538P | TABLET | 5 mg | 8/22/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Amiloride Hydrochloride Tablets | 国药准字H10900017 | 化学药品 | 片剂 | 3/3/2020 | |
| Amiloride Hydrochloride Tablets | 国药准字H10900030 | 化学药品 | 片剂 | 7/24/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| APO-AMILZIDE TAB 50/5MG | N/A | N/A | N/A | 6/24/1997 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| FRUMIL furosemide (frusemide) 40 mg and amiloride hydrochloride dihydrate 5 mg tablets | 143489 | Medicine | A | 8/20/2007 | |
| Moduretic Tablets | 10499 | Medicine | A | 7/22/1991 |
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