Eplerenone is used to lower 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 purposes not listed in this medication guide.

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 you start or stop using. Many drugs can interact, and some drugs should not be used together.

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.

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 day

Use: 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 day
Maintenance dose: 50 mg orally once or twice a day
Maximum dose: 100 mg/day

Comments:
-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.

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.

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 attention or call the Poison Help line at 1-800-222-1222.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Talk to your doctor about drinking grapefruit juice while taking this medicine.

Do not use salt substitutes containing potassium while you are taking eplerenone. If your doctor prescribes a low-salt or low-sodium diet, follow these directions carefully.

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

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 at once 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.

Tell your doctor about all your current medicines. 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.

Keep all appointments with your doctor and the laboratory. Your doctor will check your blood pressure regularly and order certain lab tests to check your body's response to eplerenone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.