Eplerenone

Eplerenone is used to reduce the risk of death from heart failure after a heart attack.

Eplerenone is also used to treat high blood pressure (hypertension).

Eplerenone may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Eplerenone may be taken with or without food.

You may need blood tests, and your blood pressure will need to be checked often.

If you have high blood pressure, keep using eplerenone even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Store at room temperature away from moisture and heat.

You may not be able to take eplerenone if you have severe kidney disease, high potassium levels in your blood, or type 2 diabetes with increased levels of albumin (a protein) in your urine.

Tell your doctor about all your current medicines and any that you start or stop using. Many drugs can interact, and some drugs should not be used together.

You may not be able to take this medicine if you are allergic to eplerenone, or if you have:

• high potassium levels in your blood (hyperkalemia);
• severe kidney disease; or
• type 2 diabetes with increased levels of albumin (a protein) in your urine.

Some medicines can cause unwanted or dangerous effects when used with eplerenone. Your doctor may change your treatment plan if you also use:

• nefazodone;
• a potassium supplement;
• an antibiotic--clarithromycin, telithromycin;
• antifungal medicine--itraconazole, ketoconazole;
• a diuretic or "water pill"--amiloride, spironolactone, triamterene; or
• antiviral medicine to treat HIV/AIDS--indinavir, nelfinavir, ritonavir, saquinavir.

Tell your doctor if you have ever had:

• kidney disease;
• diabetes;
• liver disease;
• high cholesterol or triglycerides; or
• if you take other heart or blood pressure medications.

Tell your doctor if you are pregnant or breastfeeding.

It is not known whether eplerenone will harm an unborn baby. However, having high blood pressure during pregnancy may cause complications such as diabetes or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). Heart failure can get worse during pregnancy and may cause complications such as premature birth. The benefit of treating hypertension or heart failure may outweigh any risks to the baby.

This medicine may affect fertility (ability to have children) in men.

Get emergency medical help if you have signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat.

Eplerenone may cause serious side effects. Call your doctor right away if you have:

• a light-headed feeling, like you might pass out;
• diarrhea, vomiting;
• little or no urination;
• fast or irregular heartbeats;
• trouble breathing;
• swelling in your feet or lower legs; or
• high potassium--nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement.

Common side effects of eplerenone may include:

• high potassium;
• headache; or
• dizziness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 25 mg orally once a day; titrate to the target dose preferably within 4 weeks as tolerated.Target dose: 50 mg orally once a dayUse: To improve survival of stable patients with symptomatic heart failure with reduced ejection fraction (40% or less) after an acute myocardial infarction.

Usual Adult Dose for Hypertension:

Initial dose: 50 mg orally once a dayMaintenance dose: 50 mg orally once or twice a dayMaximum dose: 100 mg/dayComments:-Full therapeutic effect is apparent within 4 weeks.-Patients with inadequate blood pressure response to the initial dose may be increased to 50 mg twice a day.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Do not use potassium supplements or salt substitutes unless your doctor has instructed you to.

Tell your doctor about all the medicines you are currently taking. Many drugs can affect eplerenone, especially:

• lithium;
• heart or blood pressure medicine--amiodarone, benazepril, diltiazem, dronedarone, enalapril, lidocaine, lisinopril, olmesartan, valsartan, verapamil, and others; or;
• NSAIDs (nonsteroidal anti-inflammatory drugs)--aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete and many other drugs may affect eplerenone. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.