HIGHLIGHTS OF PRESCRIBING INFORMATIONThese 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 USAGEINSPRA is an aldosterone antagonist indicated for:
DOSAGE AND ADMINISTRATIONHFrEF 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 STRENGTHSTablets: 25 mg, 50 mg (3) CONTRAINDICATIONSWARNINGS AND PRECAUTIONS
ADVERSE REACTIONSHFrEF 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. DRUG INTERACTIONS
See 17 for PATIENT COUNSELING INFORMATION. Revised: 8/2020 |

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INSPRA®Highlights (eplerenone)
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