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INSPRA® (eplerenone) Highlights

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:

  • Improving survival of stable patients with symptomatic heart failure with reduced ejection fraction (HFrEF) after an acute myocardial infarction. (1.1)
  • The treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. (1.2)

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)

CONTRAINDICATIONS

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)

WARNINGS AND PRECAUTIONS

  • 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. (5.1)

ADVERSE REACTIONS

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.

DRUG INTERACTIONS

  • 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. (2.4, 7.1, 12.3)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2020

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