Aldactone

DRUG DESCRIPTION

Aldactone (spironolactone) oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7?-mercapto-3-oxo-17?-pregn-4-ene-21-carboxylic acid ?-lactone acetate, which has the following structural formula:

Aldactone®
  (spironolactone) Structural Formula Illustration

Spironolactone is practically insoluble in water, soluble in alcohol, and freely soluble in benzene and in chloroform.

Inactive ingredients include calcium sulfate, corn starch, flavor, hypromellose, iron oxide, magnesium stearate, polyethylene glycol, povidone, and titanium dioxide.

What are the possible side effects of spironolactone (Aldactone)?

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • numbness or tingly feeling;
  • muscle pain or weakness;
  • slow, fast, or uneven heartbeat;
  • feeling drowsy, restless, or light-headed;
  • urinating less than usual or not at all;
  • shallow breathing;
  • ...

Read All Potential Side Effects and See Pictures of Aldactone »

What are the precautions when taking spironolactone (Aldactone)?

Before taking spironolactone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: no urine output (anuria), severe kidney disease, high blood potassium (hyperkalemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver or kidney problems, untreated mineral imbalance (e.g., low sodium).

Before having surgery, tell your doctor or dentist that you are taking this medication.

This...

Read All Potential Precautions of Aldactone »


Aldactone Consumer (continued)

SIDE EFFECTS: Drowsiness, lightheadedness, stomach upset, diarrhea, nausea, vomiting, or headache may occur. To minimize lightheadedness, get up slowly when rising from a seated or lying position. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: dizziness, increased thirst, change in the amount of urine, mental/mood changes, unusual fatigue/weakness, muscle spasms, menstrual period changes, breast enlargement (gynecomastia) in men, sexual function problems.

This medication may lead to high levels of potassium, especially in patients with kidney problems. If not treated, very high potassium levels can be fatal. Tell your doctor immediately if you notice any of the following unlikely but serious side effects: slow/irregular heartbeat, muscle weakness.

Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), severe stomach/abdominal pain, persistent nausea/vomiting, vomit that looks like coffee grounds, dark urine, yellowing of the eyes/skin.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking spironolactone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: no urine output (anuria), severe kidney disease, high blood potassium (hyperkalemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver or kidney problems, untreated mineral imbalance (e.g., low sodium).

Before having surgery, tell your doctor or dentist that you are taking this medication.

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.

This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.


Aldactone Patient Information Including Side Effects

Brand Names: Aldactone

Generic Name: spironolactone (Pronunciation: spir ON oh LAK tone)

  • What is spironolactone (Aldactone)?
  • What are the possible side effects of spironolactone (Aldactone)?
  • What is the most important information I should know about spironolactone (Aldactone)?
  • What should I discuss with my doctor before taking spironolactone (Aldactone)?
  • How should I take spironolactone (Aldactone)?
  • What happens if I miss a dose (Aldactone)?
  • What happens if I overdose (Aldactone)?
  • What should I avoid while taking spironolactone (Aldactone)?
  • What other drugs will affect spironolactone (Aldactone)?
  • Where can I get more information?

What is spironolactone (Aldactone)?

Spironolactone 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.

Spironolactone is 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.

Spironolactone also treats fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver, or a kidney disorder called nephrotic syndrome. This medication is also used to treat or prevent hypokalemia (low potassium levels in the blood).

Spironolactone may also be used for other purposes not listed in this medication guide.

What are the possible side effects of spironolactone (Aldactone)?

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

Stop using this medication and call your doctor at once if you have any of these serious side effects:

  • numbness or tingly feeling;
  • muscle pain or weakness;
  • slow, fast, or uneven heartbeat;
  • feeling drowsy, restless, or light-headed;
  • urinating less than usual or not at all;
  • shallow breathing;
  • tremors, confusion; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • mild nausea or vomiting;
  • dizziness, headache;
  • gas, stomach pain; or
  • skin rash.

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. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about spironolactone (Aldactone)?

Do not use this medication if you have kidney disease, urination problems, or high levels of potassium in your blood. Do not use potassium supplements or other diuretics while you are taking spironolactone.

Before using this medication, tell your doctor if you have liver disease, or if you use a steroid or another diuretic.

Avoid drinking alcohol, which can increase some of the side effects of spironolactone.

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

Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking spironolactone.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

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