Eplerenone is an aldosterone antagonist sold in the U.S. under 2 brand and generic names, for hypertension and systolic heart failure. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Eplerenone (application ANDA208283). Other eplerenone products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
Hypertension: 50 mg once daily, For inadequate response, increase to 50 mg twice daily. Higher dosages are not recommended. ( 2.2 ) For all patients: Measure serum potassium before starting Eplerenone Tablets and periodically thereafter. ( 2.3 ) 2.2 Hypertension The recommended starting dose of Eplerenone Tablets is 50 mg administered once daily. The full therapeutic effect of Eplerenone Tablets is apparent within 4 weeks. For patients with an inadequate blood pressure response to 50 mg once daily increase the dosage of eplerenone tablets to 50 mg twice daily. Higher dosages of Eplerenone Tablets are not recommended because they have no greater effect on blood pressure than 100 mg and are associated with an increased risk of hyperkalemia [see Clinical Studies (14.2) ]. 2.3 Recommended Monitoring Measure serum potassium before initiating eplerenone tablets therapy, within the first week, and at one month after the start of treatment or dose adjustment. Assess serum potassium periodically thereafter. Check serum potassium and serum creatinine within 3-7 days of a patient initiating a moderate CYP3A inhibitor, angiotensin-II blockers or non-steroidal-anti-inflammatories. 2.4 Dose Modification for Use with Moderate CYP3A Inhibitors In patients with hypertension receiving a moderate CYP3A inhibitor, initiate at 25 mg once daily. For inadequate blood pressure response, dosing may be…
The following adverse reactions are discussed in greater detail in other sections of the labeling: Hyperkalemia [see Warnings and Precautions (5.1) ] Hypertension: In clinical studies, adverse reactions with eplerenone were uncommon. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Breckenridge Pharmaceutical, Inc. at 1-800-367-3395 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in clinical trials of another drug and may not reflect the rates observed in practice. Hypertension Eplerenone has been evaluated for safety in 3091 patients treated for hypertension. A total of 690 patients were treated for over 6 months and 106 patients were treated for over 1 year. In placebo-controlled studies, the overall rates of adverse events were 47% with Eplerenone Tablets and 45% with placebo. Adverse events occurred at a similar rate regardless of age, gender, or race. Therapy was discontinued due to an adverse event in 3% of patients treated with Eplerenone Tablets and 3% of patients given placebo. The most common reasons for discontinuation of Eplerenone Tablets were headache, dizziness, angina pectoris/MI, and increased GGT. Gynecomastia and abnormal vaginal bleeding were…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 68/100 | Prescription | Tablet | Generic | $11 | View → | |
| 2 | Not yet rated | Prescription | Tablet | Generic | $11 |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| E1 | 25 mg | yellow | diamond | — |
| E;25 | 25 mg | yellow | diamond | — |
| E;50 | 50 mg | yellow | diamond | — |
| E1 | 25 mg | yellow | diamond | — |
| E2 | 50 mg | yellow | diamond | — |
| VLE;NSR;25 | 25 mg | yellow |
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
For all patients: Serum potassium >5.5 mEq/L at initiation ( 4 ) Creatinine clearance ≤30 mL/min ( 4 ) Concomitant use with strong CYP3A inhibitors ( 4 , 7.1 ) For the treatment of hypertension: Type 2 diabetes with microalbuminuria ( 4 ) Serum creatinine >2.0 mg/dL in males, >1.8 mg/dL in females ( 4 ) Creatinine clearance <50 mL/min ( 4 ) Concomitant use of potassium supplements or potassium-sparing diuretics ( 4 ) For All Patients Eplerenone Tablets are 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) [see Drug Interactions (7.1) , Clinical Pharmacology (12.3) ]. For Patients Treated for Hypertension Eplerenone Tablets are contraindicated for the treatment of hypertension in patients with: type 2 diabetes with microalbuminuria, serum creatinine >2.0 mg/dL in males or >1.8 mg/dL in females, creatinine clearance <50 mL/min, or concomitant administration of potassium supplements or potassium-sparing diuretics (e.g., amiloride, spironolactone, or triamterene) [see Warnings and Precautions (5.1) , Adverse Reactions (6.2) , Drug Interactions (7) , and Clinical Pharmacology (12.3) ].
Inhibitors: 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. ( 2.4 , 7.1 , 12.3 ) 7.1 CYP3A Inhibitors Eplerenone metabolism is predominantly mediated via CYP3A. Do not use eplerenone with drugs that are strong inhibitors of CYP3A [see Contraindications (4) and Clinical Pharmacology (12.3) ]. In patients with hypertension taking a moderate CYP3A inhibitor, initiate at 25 mg once daily. For inadequate blood pressure response, dosing may be increased to a maximum of 25 mg twice daily [see Dosage and Administration (2.3 , 2.4) and Clinical Pharmacology (12.3) ]. 7.2 Angiotensin II Receptor Antagonists The risk of hyperkalemia increase when eplerenone is used in combination with an ARB. A close monitoring of serum potassium and renal function is recommended, especially in patients at risk for impaired renal function, e.g., the elderly [see Warnings and Precautions (5.1) ]. 7.3 Lithium A drug interaction study of eplerenone with lithium has not been conducted. Lithium toxicity has been reported in patients receiving lithium concomitantly with diuretics. Serum lithium levels should be monitored frequently if Eplerenone Tablets are administered concomitantly with lithium. 7.4 Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) A drug interaction study of eplerenone with an NSAID…
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| VLE;NSR;50 | 50 mg | yellow | diamond | — |
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| 25 | 25 mg | brown | round | — |
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| 50 | 50 mg | brown | round | — |
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