Before Using This Medicine

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.

Other medical problems—The presence of other medical problems may affect the use of eplerenone. Make sure you tell your healthcare professional if you have any other medical problems, especially:

• 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