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Safety Information

INSPRA®(eplerenone)

Indications and Clinical Use:

INSPRA is indicated as an adjunct to standard therapy to reduce the risk of cardiovascular mortality and hospitalization for heart failure in patients with NYHA class II systolic chronic heart failure and left ventricular systolic dysfunction. A reduction in cardiovascular mortality was not observed in patients ≥75 years with NYHA class II systolic chronic heart failure (HF) and left ventricular systolic dysfunction.

INSPRA is indicated as an adjunct to standard therapy to reduce the risk of mortality and hospitalization for heart failure following myocardial infarction in clinically stable adult patients who have evidence of heart failure and left ventricular systolic dysfunction (ejection fraction ≤40%). A reduction in mortality was not observed in clinically stable patients ≥75 years with evidence of HF and left ventricular systolic dysfunction.

Contraindications:

  • Clinically significant hyperkalemia
  • Severe hepatic impairment (Child-Pugh Class C)
  • Serum potassium >5.0 mmol/L at initiation
  • Severe renal impairment (eGFR <30 mL/min/1.73 m2)
  • Concomitant use with potassium-sparing diuretics, potassium supplements or strong CYP3A4 inhibitors

Most serious warnings and precautions:

  • Hyperkalemia: serum potassium level must be measured before initiating therapy, within 1 week and at 1 month after the first dose or after a dose adjustment, and periodically thereafter
  • Serum creatinine: should not be administered to patients with initial value >221 µmol/L
  • Pediatric patients: not recommended for use

Other relevant warnings and precautions:

  • Not recommended in nursing women

For more information:

Please consult the product monograph by clicking here for important information relating to adverse reactions, drug interactions, and dosing information.

INSPRA ® Pfizer Caribe Limited, owner/Pfizer Canada Inc., Licensee