Aldactone is a potassium-sparing diuretic (water pill) that prevents your body from absorbing too much salt and keeps your potassium levels from getting too low.

Aldactone is used to treat heart failure, high blood pressure (hypertension), or hypokalemia (low potassium levels in the blood).

Aldactone also treats fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or a kidney disorder called nephrotic syndrome.

Aldactone is also used to diagnose or treat a condition in which you have too much aldosterone in your body. Aldosterone is a hormone produced by your adrenal glands to help regulate the salt and water balance in your body.

You should use Aldactone with caution if you have kidney problems, high levels of potassium in your blood, Addison's disease, if you are unable to urinate, or if you are also taking eplerenone.

Aldactone has caused tumors in animals but it is not known whether this could occur in people. Do not use this medicine for any condition that has not been checked by your doctor.

Take Aldactone exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Do not share this medicine with another person, even if they have the same symptoms you have.

You may take Aldactone with or without food, but take it the same way each time.

You will need frequent medical tests.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Aldactone.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from heat, light, and moisture.

Usual Adult Dose of Aldactone for Edema:

25 to 200 mg orally per day in single or divided doses

Duration of therapy: When given as the sole diuretic, continue the initial dose for at least 5 days, after which the initial dose may be adjusted to an optimal maintenance dose.

Comments:

-A second diuretic that acts more proximally at the renal tubule may be added if adequate diuresis has not been achieved after 5 days. The dose of this drug should remain unchanged if a second diuretic is added.

Uses:

-Treatment of edematous conditions in patients with congestive heart failure who are only partially responsive to or intolerant of other therapeutic measures or who are taking digitalis when other therapies are considered inappropriate.

-Treatment of edematous conditions in patients with liver cirrhosis accompanied by edema and/or ascites.

-Treatment of edematous conditions in patients with nephrotic syndrome when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.

Usual Adult Dose of Aldactone for Hypertension:

Initial dose: 50 to 100 mg orally per day in single or divided doses

Duration of therapy: Treatment should be continued for at least 2 weeks to achieve a maximum response. Subsequently, the dose may be adjusted according to patient response.

Usual Adult Dose for Congestive Heart Failure:

Initial dose: 25 mg orally once a day assuming serum potassium is less than or equal to 5 mEq/L and serum creatinine is less than or equal to 2.5 mg/dL

Maintenance dose:

-Patients tolerant of initial dose: May increase to 50 mg orally once a day as clinically indicated

-Patients intolerant of initial dose: May decrease to 25 mg orally every other day

Use: To increase survival and reduce the need for hospitalization of severe heart failure patients (New York Heart Association [NYHA] class III to IV) when used in addition to standard therapy.

Usual Adult Dose for Primary Hyperaldosteronism:

Diagnostic dose:

-Long test: 400 mg orally per day for 3 to 4 weeks

-Short test: 400 mg orally per day for 4 days

Maintenance dose: 100 to 400 mg orally per day until surgery; may be used long-term at the lowest effective dose in patients deemed unsuitable for surgery.

Comments:

-For the long test, correction of hypokalemia and hypertension provides presumptive evidence of primary hyperaldosteronism.

-For the short test, increased serum potassium with this drug and a decrease upon discontinuation provide presumptive evidence of primary hyperaldosteronism.

Uses:

-Initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.

-Short-term preoperative treatment of patients with primary hyperaldosteronism.

-Long-term maintenance therapy for patients deemed unsuitable for surgery or those with idiopathic hyperaldosteronism.

Usual Adult Dose for Hypokalemia:

25 to 100 mg orally per day

Uses:

-Treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate.

-Prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.

You should not use Aldactone if you are allergic to spironolactone, or if you have:

• Addison's disease (an adrenal gland disorder);

• high levels of potassium in your blood (hyperkalemia);

• if you are unable to urinate; or

• if you are also taking eplerenone.

To make sure Aldactone is safe for you, tell your doctor if you have:

• an electrolyte imbalance (such as low levels of calcium, magnesium, or sodium in your blood);

• kidney disease;

• liver disease; or

• heart disease.

Tell your doctor if you are pregnant or plan to become pregnant. Having congestive heart failure, cirrhosis, or uncontrolled high blood pressure during pregnancy may lead to medical problems in the mother or the baby. Your doctor should decide whether you take Aldactone if you are pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Drinking alcohol can increase certain side effects.

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

Avoid a diet high in salt. Too much salt will cause your body to retain water and can make this medication less effective.

Avoid driving or hazardous activity until you know how this medicine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Get emergency medical help if you have signs of an allergic reaction to Aldactone: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• little or no urination;

• high potassium level - nausea, weakness, tingly feeling, chest pain, irregular heartbeats, loss of movement; o

• signs of other electrolyte imbalances - increased thirst or urination, confusion, vomiting, muscle pain, slurred speech, severe weakness, numbness, loss of coordination, feeling unsteady.

Common Aldactone side effects may include:

• 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.

Using Aldactone with other drugs that make you dizzy can worsen this effect. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety, depression, or seizures.

Tell your doctor about all your other medicines, especially:

• colchicine;

• digoxin;

• lithium;

• loperamide;

• trimethoprim;

• heart or blood pressure medicine (especially another diuretic);

• medicine to prevent a blood clot; or

• NSAIDs (nonsteroidal anti-inflammatory drugs) - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam, and others.

This list is not complete. Other drugs may interact with spironolactone, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

You might feel a little dizzy or lightheaded while taking spironolactone.

Let your doctor know if you experience any severe or unusual side effects while using this medicine.

Your dosage will depend on your medical condition, your age, and other factors.

Follow your doctor’s instructions carefully when taking this medicine.

Spironolactone is used “off-label” to treat other conditions, such as:

• Precocious puberty (when children enter puberty too soon)
• Abnormal facial hair or hair loss in women
• Acne
• Myasthenia gravis (a disease where nerves don’t function properly)

The medicine is also sometimes given to block testosterone in transgender women.