Inspra

Inspra

eplerenone

Manufacturer:

Pfizer USA

Distributor:

Viatris
Concise Prescribing Info
Contents
Eplerenone
Indications/Uses
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; in adults w/ NYHA class II (chronic) heart failure & left ventricular systolic dysfunction (LVEF ≤35%).
Dosage/Direction for Use
HTN Initially 50 mg once daily, may increase to 100 mg daily if BP control is inadequate. Max: 100 mg daily. Heart failure-post MI Initially 25 mg once daily & titrated in 1 step to the target dose of 50 mg once daily w/in 4 w, taking into account the serum K level. Maintenance: 50 mg once daily. Max: 50 mg daily. Dose adjustment: Serum K ≥6 mmol/L (or mEq/L) Withhold treatment. May re-start at a dose of 25 mg every other day when K levels have fallen <5 mmol (or mEq/L); 5.5-5.9 mmol/L (or mEq/L) Decrease 50 mg once daily to 25 mg once daily; decrease 25 mg once daily to 25 mg every other day; decrease 25 mg every other day to withhold; 5-5.4 mmol/L (or mEq/L) No dose adjustment; <5 mmol/L (or mEq/L) Increase 25 mg every other day to 25 mg once daily; increase 25 mg once daily to 50 mg once daily. NYHA class II (chronic) heart failure Initially 25 mg once daily & titrated to the target dose of 50 mg once daily w/in 4 wktaking into account the serum K level. Concomitant use w/ mild to moderate CYP3A4 inhibitors (eg, erythromycin, saquinavir, verapamil, & fluconazole) 25 mg once daily. Moderate renal impairment (CrCl 30-60 mL/min) Initially 25 mg every other day, & dose should be adjusted based on the K level.
Administration
May be taken with or without food.
Contraindications
Hypersensitivity. Clinically significant hyperkalemia or w/ conditions associated w/ hyperkalemia. Serum K level >5 mmol/L (mEq/L) at initiation. Hypertensive patients w/ type 2 diabetes w/ microalbuminuria, serum creatinine >2 mg/dL (or >177 μmol/L) in males or >1.8 mg/dL (or >159 μmol/L) in females, & using K supplements. Concomitant use w/ K-sparing diuretics or potent inhibitors of CYP450 3A4 (eg, ketoconazole, itraconazole, & ritonavir). 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).
Special Precautions
Increased risk of hyperkalemia. Regularly monitor K levels in patients w/ impaired renal function, including diabetic microalbuminuria. Combination w/ ACE inhibitors &/or ARBs. Co-administration w/ CYP3A4 inducers is not recommended. Do not use w/ K supplements or salt substitute containing K. May affect ability to drive or operate machinery. Mild to moderate hepatic impairment. Pregnancy & lactation. Childn (hypertensive patients <4 yr & w/ heart failure). Elderly.
Adverse Reactions
Hyperkalemia; dizziness; cough; diarrhea. HTN: Flu-like illness; hypertriglyceridemia, hypercholesterolemia; abdominal pain; increased γ-glutamyl transferase & ALT; 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 inhibitors &/or ARBs. Increased AUC w/ potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, & ritonavir) & mild to moderate CYP3A4 inhibitors (eg, erythromycin, saquinavir, verapamil, & fluconazole). Decreased AUC w/ potent CYP3A4 inducers (eg, St. John's wort).
MIMS Class
Diuretics
ATC Classification
C03DA04 - eplerenone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Presentation/Packing
Form
Inspra FC tab 25 mg
Packing/Price
30's
Form
Inspra FC tab 50 mg
Packing/Price
30's
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