Eplerenone is an aldosterone antagonist indicated for improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction, among other approved uses. MedsAcross supplies Eplerenone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
INSPRA is an aldosterone antagonist indicated for: • Improving survival of stable adult patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. • The treatment of hypertension in adults, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Source: US FDA prescribing information
Eplerenone binds to the mineralocorticoid receptor and blocks the binding of aldosterone, a component of the renin-angiotensin-aldosterone-system (RAAS). Aldosterone synthesis, which occurs primarily in the adrenal gland, is modulated by multiple factors, including angiotensin II and non-RAAS mediators such as adrenocorticotropic hormone (ACTH) and potassium. Aldosterone binds to mineralocorticoid receptors in both epithelial (e.g., kidney) and nonepithelial (e.g., heart, blood vessels, and brain) tissues and increases blood pressure through induction of sodium reabsorption and possibly other mechanisms. Eplerenone has been shown to produce sustained increases in plasma renin and serum aldosterone, consistent with inhibition of the negative regulatory feedback of aldosterone on renin secretion.
Source: US FDA prescribing information
HFrEF Post-MI: Initiate treatment with 25 mg once daily. Titrate to maximum of 50 mg once daily within 4 weeks, as tolerated. Dose adjustments may be required based on potassium levels. Hypertension: 50 mg once daily, alone or combined with other antihypertensive agents. For inadequate response, increase to 50 mg twice daily. Higher dosages are not recommended. For all patients: Measure serum potassium before starting INSPRA and periodically thereafter.
Source: US FDA prescribing information
For All Patients INSPRA is contraindicated in all patients with: • serum potassium >5.5 mEq/L at initiation, • creatinine clearance ≤30 mL/min, or • concomitant administration of strong CYP3A inhibitors (e.g., ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, and nelfinavir).
Source: US FDA prescribing information
• Hyperkalemia: Patients with decreased renal function, diabetes, proteinuria or patients who are taking ACEs and ARBs, NSAIDs or moderate CYP3A inhibitors are at increased risk. Monitor serum potassium levels and adjust dose as needed.
Source: US FDA prescribing information
The following adverse reactions are discussed in greater detail in other sections of the labeling: • Hyperkalemia HFrEF Post-MI: Most common adverse reactions (>2% and more frequent than with placebo): hyperkalemia and increased creatinine. Hypertension: In clinical studies, adverse reactions with INSPRA were uncommon.
Source: US FDA prescribing information
• CYP3A Inhibitors: In post-MI HFrEF patients, do not exceed 25 mg once daily when used with moderate CYP3A inhibitors (e.g., verapamil, erythromycin, saquinavir, fluconazole). In patients with hypertension, initiate at 25 mg once daily. For inadequate blood pressure response, dosing may be increased to a maximum of 25 mg twice daily.
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted to 15-30°C (59-86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Eplerenone, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Eplerenone 25 mg tabletOralGeneric name | — | US FDA | Available on request |
| Eplerenone 50 mg tabletOralGeneric name | — | US FDA | Available on request |
| Inspra 25 mg tabletOral | Viatris Specialty | US FDA | Available on request |
| Inspra 50 mg tabletOral | Viatris Specialty | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 27 September 2002 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Eplerenone in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 4 presentations of Eplerenone and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Eplerenone, including Inspra.
Yes. The US FDA first approved Eplerenone on 27 September 2002, according to Drugs@FDA.
No listed presentation of Eplerenone is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Eplerenone is classified under ATC code C03DA04 (Eplerenone).
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