Eplerenone

Eplerenone is used alone or in combination with other medications to treat high blood pressure. Eplerenone is in a class of medications called mineralocorticoid receptor antagonists. It works by blocking the action of aldosterone, a natural substance in the body that raises blood pressure.

High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

Eplerenone comes as a tablet to take by mouth. It is usually taken once or twice a day, with or without food. To help you remember to take eplerenone, take it around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take eplerenone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of eplerenone and increase your dose after 4 weeks.

Eplerenone controls high blood pressure but does not cure it. It may take 4 weeks or longer before you feel the full benefit of eplerenone. Continue to take eplerenone even if you feel well. Do not stop taking eplerenone without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking eplerenone,

• tell your doctor and pharmacist if you are allergic to eplerenone, any other medications, or any ingredients in eplerenone tablets. Ask your pharmacist for a list of the ingredients.

• do not take eplerenone if you are taking amiloride (Midamor), amiloride and hydrochlorothiazide, itraconazole (Onmel, Sporanox), ketoconazole (Nizoral), potassium supplements, spironolactone (Aldactone), spironolactone and hydrochlorothiazide (Aldactazide), triamterene (Dyrenium), or triamterene and hydrochlorothiazide (Dyazide, Maxzide).

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, and nutritional supplements you are taking. Be sure to mention any of the following: angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten), enalapril (Vasotec, in Vaseretic), fosinopril, lisinopril (in Prinzide, in Zestoretic), and quinapril (Accupril, in Accuretic, in Quinaretic); angiotensin II receptor antagonists such as azilsartan (Edarbi, in Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, in Benicar HCT), telmisartan (Micardis, in Micardis HCT, in Twynsta), and valsartan (Diovan, in Diovan HCT, Exforge); aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); cimetidine (Tagamet); clarithromycin (Biaxin); danazol; delavirdine (Rescriptor); diltiazem (Cardizem, Dilacor, Tiazac, others); erythromycin (E.E.S., E-Mycin, Erythrocin); fluconazole (Diflucan); fluoxetine (Prozac, Sarafem, Selfemra); fluvoxamine (Luvox); HIV protease inhibitors such as indinavir (Crixivan), ritonavir (Norvir, in Kaletra), and saquinavir (Invirase); isoniazid (Laniazid, in Rifamate, Rifater); lithium (Lithobid); metronidazole (Flagyl); nefazodone; verapamil (Calan, Covera, Verelan, in Tarka); and zafirlukast (Accolate). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have or have ever had high blood levels of potassium, diabetes, gout, or liver or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking eplerenone, call your doctor.

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.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Eplerenone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • headache

  • dizziness

  • diarrhea

  • stomach pain

  • cough

  • excessive tiredness

  • flu-like symptoms

  • breast enlargement or tenderness

  • abnormal vaginal bleeding

• Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them, call your doctor immediately:

  • chest pain

  • tingling in arms and legs

  • loss of muscle tone

  • weakness or heaviness in legs

  • confusion

  • lack of energy

  • cold, gray skin

  • irregular heartbeat

• Eplerenone may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• fainting

• dizziness

• blurred vision

• upset stomach

• tingling in arms and legs

• loss of muscle tone

• weakness or heaviness in legs

• confusion

• lack of energy

• cold, gray skin

• irregular or slow heartbeat

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.