Concise Prescribing Info
HTN (alone or in combination w/ other antihypertensives). Addition to standard therapy to reduce the risk of CV mortality & morbidity in stable patients w/ left ventricular dysfunction [left ventricular ejection fraction (LVEF) ≤40%] & clinical evidence of heart failure after recent MI; adult w/ NYHA class II (chronic) heart failure & left ventricular systolic dysfunction (LVEF ≤35%).
Dosage/Direction for Use
HTN Initially 50 mg once daily. Max: 100 mg daily. Heart failure-post MI Initially 25 mg once daily & titrate to the target dose of 50 mg once daily w/in 4 wk taking into account the serum K level. Maintenance: 50 mg once daily. NYHA class II (chronic) heart failure Initially 25 mg once daily & titrate to the target dose of 50 mg once daily w/in 4 wk taking into account the serum K level. Moderate renal impairment (CrCl 30-60 mL/min) 25 mg every other day & dose should be adjusted based on the K level.
May be taken with or without food.
Hypersensitivity. Clinically significant hyperkalemia or w/ conditions associated w/ hyperkalemia, serum K level >5.0 mmol/L (mEq/L) at initiation, moderate to severe renal impairment (CrCl <50 mL/min) in post MI heart failure or CrCl <30 mL/min in NYHA class II (chronic heart failure), severe hepatic impairment (Child-Pugh class C). Hypertensive patients w/ type 2 diabetes w/ microalbuminuria, serum creatinine >2 mg/dL in males or >1.8 mg/dL in females. K supplements; K-sparing diuretics or potent inhibitors of CYP450 3A4 (eg, ketoconazole, itraconazole & ritonavir).
Special Precautions
Hyperkalemia. Regularly monitor K levels in patients w/ impaired renal function including diabetic microalbuminuria. In combination w/ ACE inhibitors &/or ARBs or CYP3A4 inducers. Concomitant use w/ K supplements or K containing salt substitutes. May affect ability to drive or operate machinery. Mild to moderate hepatic impairment. Pregnancy & lactation. Childn. Elderly.
Adverse Reactions
Hyperkalemia; dizziness; cough; diarrhea. HTN: Flu-like illness; hypertriglyceridemia, hypercholesterolemia; abdominal pain; increased γ-glutamyl transferase & alanine aminotransferase; albuminuria; fatigue. Heart failure post MI & NYHA class II (chronic heart failure): Infection; dehydration; syncope; MI; hypotension; nausea, constipation; pruritus; muscle spasms, musculoskeletal pain; renal impairment; increased blood urea.
Drug Interactions
Increased risk of hyperkalemia w/ K-sparing diuretics, ACE inhibitor &/or ARB. Significant pharmacokinetic interactions w/ CYP3A4 inhibitors potent (eg, ketoconazole, itraconazole, ritonavir, erythromycin) & mild to moderate (eg, saquinavir, verapamil or fluconazole). Decreased AUC w/ CYP3A4 inducers (eg, St. John's wort).
MIMS Class
ATC Classification
C03DA04 - eplerenone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Inspra FC tab 25 mg
Inspra FC tab 50 mg
Register or sign in to continue
Asia's one-stop resource for medical news, clinical reference and education
Sign up for free
Already a member? Sign in