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What is the most important information I should know about eplerenone?

You may not be able to take this medication if you have severe kidney disease, high potassium levels in your blood, or type 2 diabetes with protein in your urine.

You also may not be able to take eplerenone if you are also taking ketoconazole (Nizoral), itraconazole (Sporanox), nefazodone, clarithromycin (Biaxin), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), or troleandomycin (Tao).

Before taking eplerenone, tell your doctor if you have kidney or liver disease, high cholesterol, or high triglycerides.

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

To be sure this medication is helping your condition and is not causing harmful effects, your blood pressure will need to be checked on a regular basis. Your potassium levels will also need to be checked with frequent blood tests. Do not miss any scheduled appointments.

Keep using this medicine as directed, even if you feel well. Hypertension often has no symptoms, so you may not know when your blood pressure is high.

What is eplerenone?

Eplerenone blocks the actions of the hormone aldosterone in the body. Aldosterone is important for the regulation of blood pressure.

Eplerenone is used to treat congestive heart failure after a heart attack. Eplerenone is also used to treat high blood pressure (hypertension).

Eplerenone may also be used for other purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking eplerenone?

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

• high potassium levels in your blood (hyperkalemia);

• severe kidney disease;

• type 2 diabetes (not insulin-dependent) with protein in your urine; or

• if you are also taking ketoconazole (Nizoral), itraconazole (Sporanox), nefazodone, clarithromycin (Biaxin), nelfinavir (Viracept), ritonavir (Norvir, Kaletra), or troleandomycin (Tao).

Before taking eplerenone, tell your doctor if you are allergic to any drugs, or if you have:

• kidney disease;

• liver disease; or

• high cholesterol or triglycerides;

If you have any of these conditions, you may need a dose adjustment or special tests to safely use eplerenone.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether eplerenone passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.