In the U.S.—

• Antihypertensive

Eplerenone ( ep-LAYR-eh-nown) belongs to the general class of medicines called antihypertensives. It is used to treat high blood pressure (hypertension).

High blood pressure adds to the work load of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Hypertension may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

This medicine is available only with your healthcare professional's prescription, in the following dosage forms:

Oral
• Tablets (U.S.)

In deciding to use a medicine, the risks of using the medicine must be weighed against the good it will do. This is a decision you and your healthcare professional will make. For eplerenone the following should be considered:

Allergies—Tell your healthcare professional if you have ever had any unusual or allergic reaction to eplerenone. Also tell your healthcare professional if you are allergic to any other substances, such as foods, preservatives, or dyes.

Pregnancy—eplerenone has not been studied in pregnant women. Before taking this medicine, make sure that your healthcare professional knows if you are pregnant or if you may become pregnant.

Breast-feeding—It is not known whether eplerenone passes into breast milk. Although most medicines pass into breast milk in small amounts, many of them may be used safely while breast-feeding. Mothers who are taking this medicine and who wish to breast-feed should discuss this with their healthcare professional.

Children—Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of eplerenone in children with use in other age groups.

Older adults—Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. Although eplerenone has been given to a limited number of elderly people and has not been shown to cause different side effects in the elderly than in other age groups. Some elderly people may have a greater sensitivity to certain medicines.

Other medicines—Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your healthcare professional may want to change the dose, or other precautions may be necessary. When you are taking eplerenone, it is especially important that your healthcare professional know if you are taking any of the following:

• Angiotensin-converting enzyme (ACE) inhibitors (Benazepril [e.g., Lotensin], captopril [e.g., Capoten, Capozide], enalapril [e.g., Lexxel, Teczem, Vaseretic, Vasotec], fosinopril [e.g., Monopril], lisinopril [e.g., Prinivil, Prinizide, Zestril, Zestoretic], moexipril [e.g., Uniretic, Univasc], perindopril [e.g., Aceon], quinapril [e.g., Accupril, Accuretic], ramipril [e.g., Altace], trandolapril [e.g., Mavik]) or
• Angiotensin II receptor antagonists (Candesartan [e.g., Atacand], eprosartan [e.g., Teveten], irbesartan [e.g., Avapro, Avalide], losartan [e.g., Cozaar, Hyzaar], olmesartan [e.g., Benicar], telmisartan [e.g., Micardis], valsartan [e.g., Diovan])—Use with eplerenone may cause high blood levels of potassium, which may increase the chance of side effects

• Erythromycin [e.g., E-Mycin] or
• Fluconazole [e.g., Diflucan] or
• Saquinavir [e.g., Fortovase] or
• Verapamil [e.g., Calan, Isoptin, Verelan]—A decrease in the dose of eplerenone may be needed if taken with these medications.

• Itraconazole [e.g., Sporanox] or
• Ketoconazole [e.g., Nizoral]—Do not take any of these medicines with eplerenone.

• Potassium sparing diuretics (Amiloride [e.g., Midamor], Spironolactone [e.g., Aldactone], Triamterene [e.g., Dyrenium]—These medicines should not be used together with eplerenone.

• Potassium supplements (vitamins) or
• Salt substitutes containing potassium—These medicines should not be used together with eplerenone.

• Diabetes mellitus (sugar diabetes), Type II with microalbuminuria—Use of eplerenone may cause serious side effects in patients with type 2 diabetes and microalbuminuria.

• Kidney disease or
• Liver disease—These conditions may affect how much eplerenone is in your body. Your healthcare professional will decide if eplerenone can be used if you have kidney or liver disease.

• Potassium, serum high (a blood test)—this medicine may cause serious side effects if used in patients with high levels of potassium in thier blood

Dosing—

The dose of eplerenone will be different for different patients. Follow your healthcare professional's orders or the directions on the label. The following information includes only the average doses of eplerenone. If your dose is different, do not change it unless your healthcare professional tells you to do so.

• For oral (tablets):
  • For high blood pressure:
    • Adults—50 milligrams (mg) once a day, may be increased by your healthcare professional as needed to 50 milligrams (mg) two times a day.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

To store this medicine:

• Keep out of the reach of children.
• Do not store in the bathroom, near the kitchen sink, or in other damp places. Heat or moisture may cause the medicine to break down.
• Do not keep outdated medicine or medicine no longer needed. Ask your health care professional how you should dispose of any medicine you do not use. Be sure that any discarded medicine is out of the reach of children.

It is very important that your healthcare professional check your progress at regular visits. This will allow your healthcare professional to see if the medicine is working properly and to decide if you should continue to take it.

Do not take other medicines unless they have been discussed with your healthcare professional. This especially includes potassium supplements or salt substitutes containing potassium. Check with your healthcare professional before taking amiloride, spironolactone, triamterene, ketoconazole, or itraconazole.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your healthcare professional immediately if any of the following side effects occur:

• Less common
  • Excess of cholesterol in the blood;  excess of triglycerides in the blood  
  
  

• Incidence unknown
  • Abdominal pain;  arm, back or jaw pain ;  chest pain or discomfort;  chest tightness or heaviness;  confusion;  difficult breathing;  dizziness;  fast or irregular heartbeat;  headache ;  irregular heartbeat;  nausea;  nervousness;  numbness or tingling in hands, feet, or lips;  pain or discomfort in arms, jaw, back or neck;  shortness of breath;  sweating;  vomiting ;  weakness or heaviness of legs 
  
  

Other side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. However, check with your healthcare professional if any of the following side effects continue or are bothersome.

• Less Common
  • Abnormal vaginal bleeding;  breast pain ;  chills;  cloudy urine;  cough;  diarrhea;  fever;  general feeling of discomfort or illness;  joint pain;  loss of appetite;  muscle aches and pains;  stomach pain ;  swelling of the breasts or breast soreness in both females and males;  unusual tiredness or weakness  
  
  

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your healthcare professional.