Eplerenone

Eplerenone is a prescription medication used to treat congestive heart failure after a heart attack and is also used to treat hypertension (high blood pressure).

• Eplerenone is available under the following different brand names: Inspra

Common side effects of Eplerenone include:

• headache
• dizziness
• diarrhea
• stomach pain
• nausea
• cough or flu-like symptoms (such as fever, chills, body aches, unusual tiredness),
• vaginal bleeding
• breast swelling or tenderness

Serious side effects of Eplerenone include:

• a light-headed feeling,
• diarrhea
• vomiting
• little or no urination
• fast or irregular heartbeats
• trouble breathing
• swelling in the feet or lower legs
• high potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement

Rare side effects of Eplerenone include:

• abnormal vaginal bleeding
• enlarged or sore breasts in men’s
• symptoms of a high potassium blood level (such as muscle weakness, slow/irregular heartbeat)

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 25 mg
• 50 mg

Hypertension (HTN)

Adult and geriatric dosage

• Initial 50 mg orally once a day; may increase to 50 mg orally every 12 hours; may take up to four weeks for a full therapeutic response; hyperkalemia may occur with doses above 100 mg/day

Heart Failure Post Myocardial Infarction

Adult and geriatric dosage

• Initial 25 mg orally once a day; may titrate to a maximum of 50 mg once daily within 4 weeks as tolerated
• Dose adjustments may be required based on potassium levels

Dosage Considerations – Should be Given as Follows:

• See "Dosages"

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, healthcare provider, or pharmacist first.

• Eplerenone has severe interactions with the following drugs:
  • chloramphenicol
  • cobicistat
  • itraconazole
  • lopinavir
  • mifepristone
  • nefazodone
  • nirmatrelvir/ritonavir
  • saquinavir
  • tipranavir
• Eplerenone has serious interactions with the following drugs:
  • amiloride
  • apalutamide
  • ceritinib
  • diltiazem
  • drospirenone
  • enzalutamide
  • fexinidazole
  • idelalisib
  • isoniazid
  • ketoconazole
  • levoketoconazole
  • lofexidine
  • potassium acid phosphate
  • potassium chloride
  • potassium phosphates, IV
  • spironolactone
  • triamterene
  • tucatinib
  • voxelotor
• Eplerenone has moderate interactions with at least 70 other drugs
• Eplerenone has minor interactions with at least 102 other drugs

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Hypersensitivity
• For all patients: Serum potassium is more than 5.5 mEq/L at initiation, Creatinine clearance at 30 mL/min and less Concomitant use with strong CYP3A inhibitors For the treatment of HTN: Type 2 diabetes with microalbuminuria Serum creatinine more than 2.0 mg/dL in males, more than 1.8 mg/dL in women Creatinine clearance is less than 50 mL/min Concomitant use of potassium supplements or potassium-sparing diuretics
• For all patients
  • Serum potassium is more than 5.5 mEq/L at initiation
  • Creatinine clearance at 30 mL/min and less
  • Concomitant use with strong CYP3A inhibitors
• For the treatment of HTN
  • Type 2 diabetes with microalbuminuria
  • Serum creatinine is more than 2.0 mg/dL in men and more than 1.8 mg/dL in women
  • Creatinine clearance is less than 50 mL/min
  • Concomitant use of potassium supplements or potassium-sparing diuretics

Effects of drug abuse

• None

Short-Term Effects

• See "What Are Side Effects Associated with Using Eplerenone?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Eplerenone?"

Cautions

• Hyperkalemia, liver dysfunction, metabolic or respiratory acidosis, renal impairment, hypersensitivity to spironolactone
• The risk for hyperkalemia is higher in patients with impaired renal function, proteinuria, and diabetes and those concomitantly treated with angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, nonsteroidal anti-inflammatory drugs, and moderate CYP3A inhibitors
• Patients taking moderate CYP3A inhibitors that cannot be avoided should have their dose of eplerenone reduced

Pregnancy and Lactation

• Available data from published case reports on eplerenone use during pregnancy are insufficient to establish a drug-associated risk for major birth defects, miscarriage, and adverse maternal or fetal outcomes; in animal studies, no adverse developmental effects were observed when eplerenone was administered to pregnant rats and rabbits during organogenesis at exposures 32 and 31 times, respectively, the human exposure at the 100 mg/d therapeutic dose
• HTN in pregnancy increases the maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean section and postpartum hemorrhage); HTN increases the fetal risk for intrauterine growth restriction and intrauterine death; pregnant women with HTN should be carefully monitored and managed accordingly
• Infertility
  • Based on animal data, therapy may compromise male fertility; in mature rates, male fertility was decreased with eplerenone exposure at 17 times the 100 mg/d human therapeutic dose; reversibility of effect not evaluated
• Lactation
  • There are no human data available on whether eplerenone is present in human milk or has effects on breastfed infants or milk production; eplerenone was present in the milk of lactating rats; when a drug is present in animal milk, the drug will likely be present in human milk