TRIAMTERENE · TP ANDA HOLDINGS
INDICATIONS & USAGE Triamterene Capsules USP is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism. Triamterene Capsules USP may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential.
Details
- Status
- Prescription
- First Approved
- 1964-08-10
- Routes
- ORAL
- Dosage Forms
- CAPSULE
TRIAMTERENE Approval History
What TRIAMTERENE Treats
3 indicationsTRIAMTERENE is approved for 3 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
TRIAMTERENE Boxed Warning
Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including triamterene. 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 triamterene, when dosages are changed or...
Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including triamterene. 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 triamterene, when dosages are changed or with any illness that may influence renal function.
TRIAMTERENE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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 TRIAMTERENE's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications TRIAMTERENE treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to TRIAMTERENE
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
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.
TRIAMTERENE FDA Label Details
Indications & Usage
INDICATIONS & USAGE Triamterene Capsules USP is indicated in the treatment of edema associated with congestive heart failure, cirrhosis of the liver and the nephrotic syndrome; steroid-induced edema, idiopathic edema and edema due to secondary hyperaldosteronism. Triamterene Capsules USP may be used alone or with other diuretics, either for its added diuretic effect or its potassium-sparing potential. It also promotes increased diuresis when patients prove resistant or only partially responsive to thiazides or other diuretics because of secondary hyperaldosteronism. Usage in Pregnancy. The rou...
Abnormal elevation of serum potassium levels (greater than or equal to 5.5 mEq/liter) can occur with all potassium-sparing agents, including triamterene. Hyperkalemia is more likely to occur in patients with renal impairment and diabetes (even without evidence of renal impairment), and in the elderl...
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DYRENIUM
Full clinical data, patents, trials, and competitive landscape for triamterene.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.