DYRENIUM (triamterene)
DYRENIUM is indicated for the treatment of Edema; Congestive Heart Failure; Cirrhosis; Nephrotic Syndrome; Secondary Hyperaldosteronism.
Details
- Status
- Prescription
- First Approved
- 1964-08-10
- Routes
- ORAL
- Dosage Forms
- CAPSULE
DYRENIUM Approval History
What DYRENIUM Treats
5 indicationsDYRENIUM is approved for 5 conditions since its original approval in 1964. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Edema
- Congestive Heart Failure
- Cirrhosis
- Nephrotic Syndrome
- Secondary Hyperaldosteronism
DYRENIUM Boxed Warning
Warnings Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including Dyrenium. Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the elderly or severely ill. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients receiving Dyrenium, when dosages are changed...
Warnings Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including Dyrenium. Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the elderly or severely ill. Since uncorrected hyperkalemia may be fatal, serum potassium levels must be monitored at frequent intervals especially in patients receiving Dyrenium, when dosages are changed or with any illness that may influence renal function.
DYRENIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Active Pipeline
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Key Completed Trials
Completed studies with published results, ranked by significance
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.
DYRENIUM FDA Label Details
Indications & Usage
DYRENIUM is indicated for the treatment of Edema; Congestive Heart Failure; Cirrhosis; Nephrotic Syndrome; Secondary Hyperaldosteronism.
Warnings Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including Dyrenium. Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the ...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.