Spironolactone

Spironolactone

What is Spironolactone?

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

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

Spironolactone is also used to diagnose or treat a condition in which your body has too much aldosterone. Aldosterone is a hormone produced by your adrenal glands that helps regulate salt and water levels in your body.

Warnings

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

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

Before you take this medicine

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

• Addison's disease (an adrenal disease);

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

• if you are unable to urinate; or

• if you also take eplerenone.

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

• an electrolyte imbalance (e.g. 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 planning to become pregnant. Heart failure, liver cirrhosis, or uncontrolled high blood pressure during pregnancy can cause medical problems for the mother or baby.Your doctor should decide whether you take spironolactone if you are pregnant.

Breastfeeding while using spironolactone may not be safe. Ask your doctor about any risks.

How should I take spironolactone?

Take spironolactone exactly as your doctor has told you. Follow all instructions on your prescription label and read any medication guides or instructions for use. Your doctor may occasionally change your dose.

Do not share this medicine with anyone else, even if they have the same symptoms as you.

You can take spironolactone with or without food, but take it the same way each time.

You need frequent medical examinations.

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

If you need surgery, tell your surgeon that you are currently using this medicine. You may need to take a short break.

If you are being treated for high blood pressure, continue taking this medication even if you feel well. High blood pressure often causes no symptoms. You may need to take blood pressure medication for the rest of your life.

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

Dosage information

Usual adult dose for edema:

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

Duration of therapy: When administered as a sole diuretic, the initial dose should be continued for at least 5 days, after which the initial dose can be adjusted to an optimal maintenance dose.

Comments:

– A second diuretic, acting more proximally to 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.

Used:

-Treatment of edematous disease in patients with heart failure who have a partial response to or are intolerant to other therapeutic measures or who are taking digitalis when other therapies are deemed inappropriate.

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

-Treatment of edematous diseases 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 produce sufficient effect.

Usual adult dose for high blood pressure:

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

Duration of therapy: To achieve maximum response, treatment should be continued for at least 2 weeks. The dose can then be adjusted according to the patient's response.

Usual Adult Dose for Heart Failure:

Initial dose: 25 mg orally once daily provided 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 who tolerate the initial dose: May be increased to 50 mg orally once daily as clinically indicated

-Patients unable to tolerate initial dose: May be reduced to 25 mg orally every other day

Use: To increase survival and reduce the need for hospitalization in patients with severe heart failure (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-term 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:

– In long-term testing, correction of hypokalemia and hypertension provides presumptive evidence of primary hyperaldosteronism.

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

Used:

-First diagnostic measure to provide presumptive evidence of primary hyperaldosteronism in patients on a normal diet.

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

-Long-term maintenance therapy for patients unsuitable for surgery or suffering from idiopathic hyperaldosteronism.

Usual Adult Dose for Hypokalemia:

25 to 100 mg orally per day

Used:

-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.

What happens if I miss a dose?

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

What happens if I overdose?

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

What to avoid

Drinking alcohol can increase certain side effects.

Do not use potassium supplements or salt substitutes unless directed by your doctor.

Avoid a high-salt diet. Too much salt causes your body to retain water and may make this medication less effective.

Avoid driving and dangerous activities until you know how spironolactone affects you. Your reactions may be affected. Avoid getting up too quickly from sitting or lying down as this could cause you to feel dizzy.

Spironolactone side effects

If necessary, get emergency medical helpSigns of an allergic reaction to spironolactone:hives; difficulty breathing; Swelling of your face, lips, tongue, or throat.

Call your doctor immediately if you have:

• a light-headed feeling, as if you were going to faint;

• little or no urination;

• high potassium level –nausea, weakness, tingling, chest pain, irregular heartbeat, loss of movement; O

• Signs of other electrolyte disorders –Increased thirst or urination, confusion, vomiting, muscle pain, slurred speech, severe weakness, numbness, loss of coordination, feeling unsteady.

Common side effects of spironolactone 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 can report side effects to FDA at 1-800-FDA-1088.

What other drugs affect spironolactone?

Using spironolactone with other drugs that cause dizziness may worsen this effect. Consult your doctor before taking opioid medications, sleeping pills, muscle relaxants, or medications for anxiety, depression, or seizures.

Tell your doctor about all other medicines you are taking, especially:

• colchicine;

• digoxin;

• Lithium;

• loperamide;

• trimethoprim;

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

• medicines to prevent blood clots; or

• NSAIDs (non-steroidal anti-inflammatory drugs) –Aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib, diclofenac, indomethacin, meloxicam and others.

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

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More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use spironolactone only for the prescribed indication.