AMILORIDE HYDROCHLORIDE · SIGMAPHARM LABS LLC
Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to: help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic. prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias.
Details
- Status
- Prescription
- First Approved
- 1981-10-05
- Routes
- ORAL
- Dosage Forms
- TABLET
AMILORIDE HYDROCHLORIDE Approval History
What AMILORIDE HYDROCHLORIDE Treats
4 indicationsAMILORIDE HYDROCHLORIDE is approved for 4 conditions since its original approval in 1986. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Congestive Heart Failure
- Hypertension
- Hypokalemia
- Cardiac Arrhythmias
AMILORIDE HYDROCHLORIDE Competitive Set
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Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in AMILORIDE HYDROCHLORIDE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications AMILORIDE HYDROCHLORIDE treats. First-in-class if their pivotal trials read out positive.
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Active Pipeline
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Key Completed Trials
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Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
AMILORIDE HYDROCHLORIDE FDA Label Details
Indications & Usage
Amiloride HCl is indicated as adjunctive treatment with thiazide diuretics or other kaliureticdiuretic agents in congestive heart failure or hypertension to: help restore normal serum potassium levels in patients who develop hypokalemia on the kaliuretic diuretic. prevent development of hypokalemia in patients who would be exposed to particular risk if hypokalemia were to develop, e.g., digitalized patients or patients with significant cardiac arrhythmias. The use of potassium-conserving agents is often unnecessary in patients receiving diuretics for uncomplicated essential hypertension when s...
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Full clinical data, patents, trials, and competitive landscape for amiloride hydrochloride.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.