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|Eplerenone

Eplerenone

Eplerenone is used for:

Treating high blood pressure and/or improving survival rates in patients who have left ventricular systolic dysfunction and congestive heart failure following a heart attack. It is sometimes used with other medicines. It may also be used for other conditions as determined by your doctor.

Eplerenone is a mineralocorticoid receptor blocker. It works by blocking aldosterone. This widens blood vessels and reduces fluid and sodium retention, lowering blood pressure to help prevent strokes, heart attacks, and kidney problems.

Do NOT use Eplerenone if:

• you are allergic to any ingredient in Eplerenone
• you are taking Eplerenone to treat high blood pressure and you have protein in your urine because of diabetes
• you have severe kidney problems, high blood potassium levels, or type 2 diabetes with protein in your urine
• you are taking clarithromycin, imidazoles (eg, itraconazole, ketoconazole), nefazodone, nelfinavir, ritonavir, or troleandomycin
• you are taking Eplerenone to treat high blood pressure and you are taking potassium supplements or medicines that can increase potassium (eg, amiloride, spironolactone, triamterene)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Eplerenone :

Some medical conditions may interact with Eplerenone . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are not taking Eplerenone to treat high blood pressure and have protein in your urine because of diabetes
• if you have kidney disease

Some MEDICINES MAY INTERACT with Eplerenone . Tell your health care provider if you are taking any other medicines, especially any of the following:

Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen) because the effects of Eplerenone when used to treat high blood pressure may be decreased

Imidazoles (eg, ketoconazole, itraconazole), ketolide or macrolide antibiotics (eg, clarithromycin, troleandomycin), nefazodone, protease inhibitors (eg, ritonavir, nelfinavir ), or verapamil because the side effects of Eplerenone may be increased

Amiloride, angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin-receptor blockers (eg, valsartan), potassium supplements, spironolactone, or triamterene because the risk of abnormal heartbeat due to high blood potassium levels may be increased

Lithium because it may increase lithium blood levels

This may not be a complete list of all interactions that may occur. Ask your health care provider if Eplerenone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Eplerenone :

Use Eplerenone as directed by your doctor. Check the label on the medicine for exact dosing instructions. Check the label on the medicine for exact dosing instructions.

• Take Eplerenone with or without food.
• Take Eplerenone regularly to receive the most benefit from it. Taking Eplerenone at the same time each day will help you remember to take it.
• If you miss a dose of Eplerenone , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Eplerenone .

Important safety information:

• Eplerenone may cause dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Eplerenone . Using Eplerenone alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
• It may take up to 4 weeks to see the full benefit of this medicine on your blood pressure. Do not stop taking Eplerenone without checking with your doctor.
• Do not exceed the recommended dose of Eplerenone . Doing so will not improve your condition faster and may lead to side effects.
• Do not use a salt substitute or a potassium supplement without checking with your doctor.
• Patients being treated for high blood pressure often feel tired or rundown for a few weeks after beginning therapy. Continue taking your medication even though you may not feel quite "normal." Contact your doctor or pharmacist about any new symptoms.
• Additional monitoring of your dose or condition may be needed if you are taking St. John"s wort.
• LAB TESTS, such as blood potassium levels, blood pressure measurements, and kidney function, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Eplerenone with caution in the ELDERLY because they may be more sensitive to its effects.
• Eplerenone is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Eplerenone during pregnancy. It is unknown if Eplerenone is excreted in breast milk. If you are or will be breast-feeding while taking Eplerenone , check with your doctor or pharmacist to discuss the risks to your baby.

Possible side effects of Eplerenone :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Cough; diarrhea; dizziness; flu-like symptoms (fever, chills, muscle ache, tiredness); headache; stomach pain.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal discharge; chest pain; enlarged or swollen breasts; irregular heartbeat; severe muscle weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include irregular heartbeat; severe dizziness; severe muscle weakness.

Store Eplerenone at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Eplerenone out of the reach of children and away from pets.

General information:

• If you have any questions about Eplerenone , please talk with your doctor, pharmacist, or other health care provider.
• Eplerenone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Eplerenone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.