Monograph Details
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Cardiovascular System
> CHF and arrhythmias
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INSPRA |
| Manufacturer |
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Pfizer Labs |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Aldosterone receptor blocker (mineralocorticoid-selective). |
| Generic Name |
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Eplerenone 25mg, 50mg; tabs. |
| Indications |
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To improve survival of stable patients with left ventricular systolic dysfunction (ejection fraction ≤40%) and clinical evidence of CHF after acute MI. |
| Children |
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Not recommended. |
| Adults |
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Initially 25mg once daily; titrate within 4 weeks to 50mg once daily. Adjust based on serum K+ (see literature). |
| Contraindications |
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Hyperkalemia (serum K+ >5.5mEq/L) at initiation, severe renal impairment (CrCl ≤30mL/min), or concomitant potent CYP3A4 inhibitors (eg, ketoconazole, itraconazole, nefazodone, troleandomycin, clarithromycin, ritonavir, nelfinavir). |
| Precautions |
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Severe hepatic impairment. Renal dysfunction. Serum creatinine >2mg/dL (males) or >1.8mg/dL (females), CrCl ≤ 50mL/min, or diabetes with proteinuria. Monitor serum K+ at baseline, within 1st week, at 1 month after starting and after dose adjustment, then periodically. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended. |
| Interactions |
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CYP3A4 inhibitors (see Contraindications and Dose). NSAIDs may antagonize antihypertensive effects. Angiotensin II receptor blockers, ACEIs increase hyperkalemia risk. Monitor lithium. |
| Adverse Reactions |
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Hyperkalemia, dizziness, GI upset, abdominal pain, cough, flu-like symptoms, albuminuria; increased serum creatinine, triglycerides, cholesterol; decreased serum sodium; rare: sex hormone related effects, increased BUN, uric acid, liver enzymes. |
| How Supplied |
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Tabs—30, 90 |
| Additional Resources |
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• Related Prescribing Note |
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