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Eplerenone

Class
Diuretics
Subclass
Mineralocorticoid receptor antagonists
Substance name
Eplerenone
Brand names
Inspra®
Common formulations
Film-coated tablet
Dosage and administration
Adults patients
HFrEF • After myocardial infarction
•
Start at: 25 mg PO daily
•
Maintenance: 50 mg PO daily
•
Maximum: 50 mg per day
Titrate over 4 weeks and adjust based on serum potassium levels.
Hypertension
•
Start at: 50 mg PO daily
•
Maintenance: 50 mg PO q12-24h
•
Maximum: 100 mg per day
HFrEF • Off-label
•
Start at: 25 mg PO daily
•
Maintenance: 50 mg PO daily
Primary aldosteronism • Off-label
•
Start at: 25 mg PO BID
•
Maintenance: 50 mg PO BID
Other off-label uses
•
Treatment of diabetic nephropathy in patients with diabetes mellitus type 2
•
Treatment of HFpEF
Indications for use
Labeled indications
Adults
•
Treatment of HFrEF (after myocardial infarction)
•
Treatment of hypertension
Off-label indications
Adults
•
Treatment of diabetic nephropathy in patients with diabetes mellitus type 2
•
Treatment of HFpEF
•
Treatment of HFrEF
•
Treatment of primary aldosteronism
Safety risks
Contraindications
Hypersensitivity to eplerenone or its components
Hypertension in patients with diabetes mellitus type 2 with microalbuminuria or elevated serum creatinine
•
Do not use eplerenone for hypertension in patients with diabetes mellitus type 2 with microalbuminuria or serum creatinine > 2.0 mg/dL in males or > 1.8 mg/dL in females
Warnings and precautions
Increased serum potassium
•
Use extreme caution in patients with impaired renal function, diabetes, proteinuria, or taking ACEis, ARBs, NSAIDs, or moderate CYP3A inhibitors. Monitor serum potassium levels periodically.
Specific populations
Renal impairment
eGFR ≥ 50 mL/min/1.73 m²
•
Use with caution. Do not use for hypertension with CrCl < 50 mL/min.
eGFR 30-49 mL/min/1.73 m²
•
Start at dose of 25 mg every other day. Maximal dose of 25 mg. Do not exceed frequency of once daily.
eGFR ≤ 30 mL/min/1.73 m²
•
Do not use.
Renal replacement therapy
Continuous renal replacement
•
Use with caution.
Intermittent hemodialysis
•
Use with caution.
Peritoneal dialysis
•
Use with caution.
Hepatic impairment
Child-Pugh A (mild)
•
Use acceptable. No dose adjustment required.
Child-Pugh B (moderate)
•
Use acceptable. No dose adjustment required.
Child-Pugh C (severe)
•
Use with caution.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: B3
•
Use only if benefits outweigh potential risks. Evidence of fetal harm in animals.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown drug levels in breastfed infants.
No overt adverse effects reported in breastfed infants.
Adverse reactions
Common 1-10%
•
↓ serum sodium, ↑ serum creatinine, ↑ serum potassium, ↑ serum triglycerides, abdominal pain, cough, diarrhea, dizziness, fatigue, vaginal bleeding
Uncommon < 1%
•
Gynecomastia, ↑ liver enzymes, ↑ serum cholesterol, ↑ serum uric acid, breast pain
Unknown frequency
•
Angioedema, ↑ serum gamma-glutamyltransferase, myocardial infarction, renal failure, angina pectoris, headache, infertility, amenorrhea, hirsutism, skin rash, hypotension, bradycardia, paresthesia, weakness, menstrual irregularity
Interactions
Drug(s)
Check Interactions
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