Inspra

What is Inspra (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 is the most important information I should know about Inspra (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.

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 should I discuss with my healthcare provider before taking Inspra (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.

How should I take Inspra (eplerenone)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Eplerenone may be taken with or without food.

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 happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include slow heart rate, weak pulse, muscle weakness, dizziness, or feeling like you might pass out.

What should I avoid while taking Inspra (eplerenone)?

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

This drug side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling); or

• low potassium (confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling).

Less serious side effects may include:

• diarrhea, stomach pain;

• cough;

• dizziness;

• tired feeling;

• fever, chills, body aches, flu symptoms;

• vaginal bleeding; or

• breast swelling or tenderness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Inspra (eplerenone)?

Many drugs can interact with eplerenone. Below is just a partial list. Tell your doctor if you are using:

• lithium (Lithobid, Eskalith, others);

• other blood pressure medications such as candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), or valsartan (Diovan);

• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), or troleandomycin (Tao);

• an antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral);

• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);

• an NSAID (non-steroidal anti-inflammatory drugs) such as ibuprofen (Motrin, Advil), diclofenac (Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), naproxen (Aleve, Naprosyn), and others; or

• HIV/AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir);

• an "SSRI" antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil); or

• a tricyclic antidepressant such as amitriptyline (Elavil, Etrafon), clomipramine (Anafranil), doxepin (Sinequan), imipramine (Janimine, Tofranil), and others.

This list is not complete and there may be other drugs that can interact with eplerenone. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about eplerenone.

• Remember, keep this and all other medicines out of the reach of children, never share your medicines with others and use this medication only for the condition prescribed.
• Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.