HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use INSPRA safely and effectively. See full prescribing information for INSPRA.
INSPRA® (eplerenone) tablets, for oral use
Initial U.S. Approval: 2002
INDICATIONS AND USAGE
INSPRA 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 INSPRA 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 INSPRA were uncommon. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. 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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