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Generic Name: eplerenone (Oral route)

e-PLER-en-one

Commonly used brand name(s)

In the U.S.

  • Inspra

Available Dosage Forms:

  • Tablet

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Aldosterone Receptor Antagonist

Uses For Inspra

Eplerenone belongs to the general class of medicines called antihypertensives. It is used alone or together with other medicines to treat high blood pressure (hypertension). This medicine is also used to treat congestive heart failure (CHF) after a heart attack.

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High blood pressure adds to the work load of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Hypertension may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

This medicine is available only with your doctor's prescription.

Before Using Inspra

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of eplerenone in children with hypertension below 4 years of age. Safety and efficacy have not been established.

Appropriate studies have not been performed on the relationship of age to the effects of eplerenone in children with heart failure. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of eplerenone in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution in patients receiving eplerenone.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with 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 doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Amiloride
  • Clarithromycin
  • Cobicistat
  • Itraconazole
  • Ketoconazole
  • Nefazodone
  • Nelfinavir
  • Potassium
  • Ritonavir
  • Spironolactone
  • Triamterene
  • Troleandomycin

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alacepril
  • Arsenic Trioxide
  • Benazepril
  • Captopril
  • Carbamazepine
  • Ceritinib
  • Cilazapril
  • Dabrafenib
  • Delapril
  • Enalaprilat
  • Enalapril Maleate
  • Erythromycin
  • Eslicarbazepine Acetate
  • Fluconazole
  • Fosinopril
  • Imidapril
  • Lisinopril
  • Mitotane
  • Moexipril
  • Pentopril
  • Perindopril
  • Piperaquine
  • Primidone
  • Quinapril
  • Ramipril
  • Saquinavir
  • Siltuximab
  • Spirapril
  • Temocapril
  • Trandolapril
  • Verapamil
  • Zofenopril

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Licorice

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Diabetes with microalbuminuria or
  • Hyperkalemia (high potassium in the blood) or
  • Kidney disease, severe —Should not be used in patients with these conditions.
  • Kidney disease—Use with caution. Effects may be increased because of slower removal of the medicine from the body.

Proper Use of Inspra

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and changes in the types of foods you eat, especially foods high in sodium. Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For congestive heart failure after a heart attack:
      • Adults—At first, 25 milligrams (mg) once a day, then your dose may be increased to 50 mg once a day. Your doctor may adjust your dose as needed and tolerated.
      • Children—Use and dose must be determined by your doctor.
    • For high blood pressure:
      • Adults, teenagers, and children above 4 years of age—At first, 50 milligrams (mg) once a day. Your doctor may increase your dose to 50 mg two times a day.
      • Children up to 4 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Inspra

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and to decide if you should continue to take it. Blood tests may be needed to check for unwanted effects.

Do not take the following medicines if you are using eplerenone:

  • Amiloride (e.g., Midamor®) or
  • Clarithromycin (e.g., Biaxin®) or
  • Itraconazole (e.g., Sporanox®) or
  • Ketoconazole (e.g., Nizoral®) or
  • Nefazodone (e.g., Serzone®) or
  • Nelfinavir (e.g., Viracept®) or
  • Ritonavir (e.g., Norvir®) or
  • Spironolactone (e.g., Aldactone®) or
  • Triamterene (e.g., Dyrenium®) or
  • Troleandomycin (e.g., Tao®).

Do not take other medicines unless they have been discussed with your doctor. This especially includes potassium supplements or salt substitutes containing potassium.

This medicine may increase the amount of potassium in your blood. Check with your doctor right away if you are having abdominal or stomach pain; confusion; difficulty with breathing; irregular heartbeats; nausea or vomiting; nervousness; numbness or tingling in the hands, feet, or lips; shortness of breath; or weakness or heaviness of the legs.

Inspra Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common
  • Excess of cholesterol in the blood
  • excess of triglycerides in the blood
Incidence not known
  • Abdominal or stomach pain
  • arm, back, or jaw pain
  • chest pain or discomfort
  • chest tightness or heaviness
  • confusion
  • difficulty with breathing
  • dizziness
  • fast or irregular heartbeat
  • headache
  • irregular heartbeat
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • nausea
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • pain or discomfort in the arms, jaw, back, or neck
  • rash
  • shortness of breath
  • sweating
  • vomiting
  • weakness or heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Abnormal vaginal bleeding
  • breast pain
  • chills
  • cloudy urine
  • cough
  • diarrhea
  • fever
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • swelling of the breasts or breast soreness in both females and males
  • unusual tiredness or weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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