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Inspra

(eplerenone)

How does this medication work? What will it do for me?

Eplerenone belongs to a group of medications called aldosterone antagonists. It is used in combination with other medications to treat heart failure and help prevent worsening heart failure after a heart attack, thereby improving the chances of survival.

It is also used along with other medications to treat mild-to-moderate high blood pressure, when other medications are not tolerated or have reduced your blood pressure enough.

Eplerenone works by blocking aldosterone, a substance the body makes that helps control blood pressure. High levels of aldosterone increase blood pressure and may contribute to heart failure. Blocking aldosterone helps prevent heart failure from worsening.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

To treat heart failure or prevent heart failure after a heart attack, the recommended starting dose is 25 mg given once daily. It is usually increased by your doctor to 50 mg once daily, within 4 weeks. Eplerenone is usually started within 2 weeks of a heart attack.

For treating high blood pressure, the starting dose of eplerenone is 50 mg taken once daily. If your blood pressure has not come down enough after 4 weeks, your doctor may increase the dose of eplerenone to 50 mg taken two times a day.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

Eplerenone can be taken with or without food. Swallow the tablets with water and without chewing.

It is important that this medication be taken exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose for to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?

25 mg
Each yellow, diamond, biconvex, film-coated tablet, debossed "Pfizer" on one side and "NSR" over "25" on the other, contains eplerenone 25 mg. Nonmedicinal ingredients: croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, talc, titanium dioxide, iron oxide yellow, and iron oxide red.

50 mg
Each yellow, diamond, biconvex, film-coated tablet, debossed "Pfizer" on one side and "NSR" over "50" on the other, contains eplerenone 50 mg. Nonmedicinal ingredients: croscarmellose sodium, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, talc, titanium dioxide, iron oxide yellow, and iron oxide red.

Who should NOT take this medication?

Do not take eplerenone if you:

  • are allergic to eplerenone or any ingredients of the medication
  • are taking other medications that may affect how the body gets rid of eplerenone (e.g., ketoconazole, itraconazole, nefazodone, telithromycin, clarithromycin, ritonavir, nelfinavir)
  • are taking potassium supplements or potassium-sparing diuretics (e.g., spironolactone)
  • have high levels of potassium in your blood
  • have severe kidney dysfunction
  • have severe liver dysfunction

In addition, if you are taking this medication for high blood pressure, do not take eplerenone if you:

  • have type 2 diabetes with protein in the urine
  • have moderate-to-severe kidney dysfunction

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • dehydration (i.e., headaches, dizziness, or fainting)
  • dizziness
  • dizziness when getting up from a sitting or lying position (low blood pressure)
  • heartburn
  • indigestion

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • angina or chest pain
  • difficulty breathing
  • fainting
  • increased levels of potassium in the blood (e.g., irregular heartbeat, slowed heart rate, nausea)
  • shortness of breath or difficulty breathing
  • signs of a blood clot in blood vessels, such as sudden vision change or dizziness, chest pain, pain and swelling in the leg muscle
  • signs of heart rhythm changes (e.g., dizziness, fainting, rapid heartbeat, pounding heartbeat)
  • signs of  liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)
  • signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
  • signs of urinary tract infection (e.g., painful or difficult urination or a decrease in the amount of urine)
  • symptoms of hypothyroidism - underactive thyroid gland (e.g., dry skin, constipation, weight gain, fatigue, aches, pains and stiffness, intolerance to cold, depression, memory problems)
  • trouble swallowing
  • weight gain

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a heart attack (e.g., chest pain, shoulder pain, difficulty breathing, dizziness)
  • signs of heart failure (e.g., fast or irregular heartbeat; swelling of lower legs, feet, and abdomen; wheezing; trouble breathing; or shortness of breath)
  • symptoms of an allergic reaction (e.g., swelling of the hands, feet, ankles, face, lips, mouth, or throat; difficulty breathing or swallowing)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Diabetes: People with diabetes that have heart failure after a heart attack, especially those who have proteinuria (protein in the urine), appear to have a higher rate of hyperkalemia (high blood potassium; see below). If you have diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Kidney problems: The safety of eplerenone when used to treat people with moderate-to-severe kidney dysfunction has not been determined. These people should not take eplerenone.

If you have reduced kidney function or kidney disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects.

If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

The safety of eplerenone when used to treat people with severe liver dysfunction has not been determined. These people should not take eplerenone.

Potassium levels: Too much potassium in the blood (hyperkalemia) is one of the most common risks of eplerenone. Hyperkalemia that is not recognized and treated can cause serious heart rhythm problems, which can sometimes be fatal. Your doctor will monitor your potassium levels before starting eplerenone, during the first week of taking eplerenone, and periodically throughout your therapy.

Do not take potassium supplements (including dietary potassium) or salt substitutes at the same time as eplerenone unless directed to do so by your doctor. If you experience an irregular, slow, or weak heartbeat, contact your doctor as soon as possible.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: It is not known if eplerenone passes into breast milk. If you are a breast-feeding mother and are taking this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using this medication have not been established for children. Eplerenone is not recommended for children.

What other drugs could interact with this medication?

There may be an interaction between eplerenone and any of the following:

  • abiraterone
  • alpha agonists (e.g., clonidine, methyldopa)
  • alpha blockers (e.g., alfuzosin, doxazosin, tamsulosin)
  • amifostine
  • amiodarone
  • amphetamines (e.g., dextroamphetamine, lisdexamphetamine)
  • angiotensin converting enzyme inhibitors (ACEIs; e.g., captopril, lisinopril, ramipril)
  • angiotensin receptor blockers (ARBs; e.g., candasartan, irbesartan, losartan)
  • aprepitant
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • barbiturates (e.g., butalbital, phenobarbital)
  • beta-adrenergic blockers (e.g., atenolol, propranolol, sotalol)
  • bicalutamide
  • boceprevir
  • bosentan
  • brimonidine
  • carbamazepine
  • calcium channel blockers (e.g., diltiazem, verapamil)
  • carbamazepine
  • chloramphenicol
  • clotrimazole
  • conivaptan
  • crizotinib
  • cyclosporine
  • dabrafenib
  • dasatinib
  • deferasirox
  • diazoxide
  • dexamethasone
  • digoxin
  • diuretics (water pills; e.g., furosemide, hydrochlorothiazide, triamterene)
  • dronedarone
  • duloxetine
  • enzalutamide
  • fusidic acid
  • grapefruit juice
  • haloperidol
  • heparin
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., delaviridine, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
  • imitinab
  • isoniazid
  • lidocaine
  • lithium
  • low molecular weight heparins (e.g., dalteparin, enoxaparin, tinzaparin)
  • macrolide antibiotics (e.g., clarithromycin, erythromycin)
  • methylphenidate
  • metronidazole
  • mifepristone
  • mitotane
  • monoamine oxidase inhibitors (MAOIs; e.g., moclobemide, phenelzine, rasagiline, selegiline, tranylcypromine)
  • narcotic pain relievers (e.g., codeine, fentanyl, morphine, oxycodone)
  • nefazodone
  • nicardipine
  • nitrofurantoin
  • nonsteroidal anti-inflammatory drugs (NSAIDs; e.g. diclofenac, ibuprofen, ketorolac, naproxen)
  • norfloxacin
  • oxcarbazepine
  • pentoxifylline
  • phenytoin
  • phosphodiesterase 5 inhibitors (e.g., sildenafil, tadalafil, vardenafil)
  • potassium supplements or salt substitutes containing potassium
  • primidone
  • quinidine
  • rifabutin
  • rifampin
  • rituximab
  • St. John's wort
  • sertraline
  • simeprevir
  • sitaxentan
  • sodium phosphates
  • tacrolimus
  • telaprevir
  • tetracycline
  • tocilizumab
  • tolvaptan
  • trimethoprim
  • tyrosine kinase inhibitors (e.g., dasatinib, imatinib)
  • yohimbine

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

All material copyright MediResource Inc. 1996 – 2017. Terms and conditions of use. The contents herein are for informational purposes only. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Source: www.medbroadcast.com/drug/getdrug/Inspra

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