HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use eplerenone tablets safely and effectively. See full prescribing information for eplerenone tablets.
Eplerenone tablets, for oral use
Initial U.S. Approval: 2002
INDICATIONS AND USAGE
Eplerenone is an aldosterone antagonist indicated for:
DOSAGE AND ADMINISTRATION
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. (2.1)
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. (2.2)
For all patients: Measure serum potassium before starting eplerenone and periodically thereafter. (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 25 mg, 50 mg (3)
WARNINGS AND PRECAUTIONS
HFrEF Post-MI: Most common adverse reactions (>2% and more frequent than with placebo): hyperkalemia and increased creatinine. (6.1)
Hypertension: In clinical studies, adverse reactions with eplerenone were uncommon. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Greenstone LLC at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION.
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