Details

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Manufacturer
Viatris Pharmaceuticals LLC

Registraction Number
MAL19991461AZ

 

Content

• Active Ingredient: Eplerenone 25 mg per tablet
• Formulation: Film-coated tablets

Indication
Inspra is indicated for:

• Heart Failure Post-Myocardial Infarction: To reduce the risk of cardiovascular mortality and morbidity in stable patients with left ventricular dysfunction (LVEF ≤40%) and clinical evidence of heart failure after a recent myocardial infarction (MI).
• Hypertension: As an antihypertensive agent, either alone or in combination with other antihypertensive medications.

Instructions

• Administration:
  • Take one tablet once daily.
  • May be taken with or without food.
  • Swallow the tablet whole with water; do not chew or crush.
• Dosage Adjustment:
  • For heart failure post-MI, initiate with 25 mg daily and titrate to 50 mg daily within 4 weeks, based on serum potassium levels.
  • For hypertension, the usual starting dose is 50 mg daily; may be increased to 100 mg daily if blood pressure is not adequately controlled.
  • Monitoring:
    • Regular monitoring of serum potassium and renal function is recommended, especially in patients with renal impairment or those taking concomitant medications that affect potassium levels.medicines.org.uk
• Contraindications:
  • Hypersensitivity to eplerenone or any component of the tablet.
  • Hyperkalemia (serum potassium >5.0 mmol/L) at initiation.
  • Severe renal impairment (creatinine clearance <30 mL/min).
  • Concomitant use with potassium-sparing diuretics or potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir).
• Precautions:
  • Use with caution in patients with mild-to-moderate renal or hepatic impairment.
  • Avoid concomitant use with potassium supplements or salt substitutes containing potassium.
  • Monitor for signs of hyperkalemia, especially in patients with diabetes, renal dysfunction, or those on other medications that increase potassium levels