Spironolactone

Spironolactone is a prescription medication used to treat high blood pressure and fluid retention caused by various conditions. It is also used to treat low potassium levels and to diagnose and treat primary hyperaldosteronism, a condition in which the body produces too much of the hormone aldosterone. It is also used to treat certain forms of heart failure. 

This medication belongs to a group of drugs called diuretics ("water pills"). Specifically, it is a "potassium-sparing" diuretic known as an "aldosterone antagonist". By blocking aldosterone, spironolactone helps the body get rid of excess fluid by increasing the amount of salt and water the kidneys remove from the blood, while still keeping potassium in the body. 

This medication comes in tablet and liquid suspension form and is usually taken by mouth once or in divided doses. Spironolactone can be taken with or without food.

Common side effects of spironolactone include headache, nausea, and tiredness. Spironolactone may cause drowsiness. Do not drive or operate heavy machinery until you know how it affects you.

Spironolactone is a prescription medication used to treat high blood pressure and fluid retention caused by various conditions. It is also used to treat low potassium levels and to diagnose and treat primary hyperaldosteronism, a condition in which the body produces too much of the hormone aldosterone. It is also used to treat certain forms of heart failure and to manage edema (swelling) in adults with cirrhosis (when edema did not respond to fluid and salt restrictions).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Spironolactone may be found in some form under the following brand names:

• Aldactazide

• Aldactone

• CaroSpir

• Spironol

• Spironolactone Plus

Serious side effects may occur. See "Drug Precautions" section.

Common side effects include:

• diarrhea
• cramping
• nausea
• vomiting
• impotence
• irregular menstruation
• bleeding after menopause
• fever
• rash
• confusion
• headache
• drowsiness
• tiredness
• enlargement of breasts in men called gynecomastia

This is not a complete list of spironolactone side effects. Ask your doctor or pharmacist for more information.

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

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• ACE inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), quinapril (Accupril), ramipril (Altace) and others
• other medications for high blood pressure
• "loop diuretics" such as furosemide (Lasix) or torsemide (Demadex) and others
• nonsteroidal anti-inflammatory medications such as ibuprofen (Motrin, Nuprin) or naproxen (Aleve) and salicylates
• corticosteroids such as prednisone, hydrocortisone (Cortef), and dexamethasone (Decadron, Dexone, Hexadrol)
• cholestyramine
• lithium (Eskalith, Lithobid)
• potassium products including potassium chloride (K-Dur, Klor-Con, Micro-K), potassium citrate (Urocit-K, Polycitra-K), potassium gluconate, potassium phosphate (Neutra-Phos-K, K-Phos)
• salt substitutes that contain potassium
• alcohol
• narcotics
• barbiturates such as amobarbital (Amytal), butalbital (Fioricet, Fiorinal), phenobarbital (Luminal) and others
• digoxin
• acetylsalicylic Acid (ASA)

This is not a complete list of spironolactone drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects can occur including:

• high potassium levels. The risk for high potassium levels increases if the kidneys do not work as well as they should, if taken with potassium supplements, potassium-containing salt substitutes, or medications that increase potassium. Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. In addition, avoid taking potassium supplements and foods containing high levels of potassium, including salt substitutes. 
• electrolyte imbalance. This medication may affect electrolytes including sodium and potassium. Your doctor will check these levels using a blood test. Warning signs of electrolyte imbalance include:
  • dry mouth
  • thirst
  • weakness
  • lack of energy
  • drowsiness
  • restlessness
  • muscle pains or cramps
  • muscle fatigue
  • low blood pressure
  • decreased urination
  • fast heart rate
  • nausea and vomiting
• low blood pressure and worsening kidney function. Your healthcare provider will monitor your vitals and kidney function. 
• breast enlargement in men. This is called gynecomastia. Tell your healthcare provider if you notice enlargement of the breasts. Gynecomastia is usually reversible.
• low blood pressure and worsening kidney function. Your healthcare provider will monitor your vitals and kidney function. 

This medication may cause drowsiness or dizziness. Do not drive or operate heavy machinery until you know how it affects you.

Do not take spironolactone if you:

• are allergic to spironolactone or any other ingredients in spironolactone
• are not able to produce urine
• have severe kidney disease
• have high potassium levels
• have Addison's disease
• also take the medication eplerenone

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of spironolactone, salt substitutes containing potassium should be avoided.

Before taking spironolactone, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to spironolactone or to any of its ingredients
• have liver disease
• have kidney disease
• have Addison's disease
• take the medication eplerenone
• have electrolyte imbalances
• use salt substitutes, especially potassium-containing salt substitutes
• are allergic to any medications
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Spironolactone falls into category C. In animals studies, pregnant animals were given this medication and had some babies born with problems. There are no well-controlled studies that have been done in humans with spironolactone, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

The active metabolite of spironolactone has been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from spironolactone, a choice should be made whether to stop nursing or to stop use of spironolactone. The importance of the drug to the mother should be considered.

Take spironolactone exactly as prescribed.

• This medication comes in tablet and liquid suspension form and is usually taken by mouth once or twice daily.
• The tablet and liquid suspension forms are not the same and should not be substituted for each other. 
• Spironolactone can be taken with or without food.
• Because spironolactone increases urination, it is best taken in the morning to avoid having to get up in the night to urinate. If you take it more than once a day, take your last dose by late afternoon.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose.

Take spironolactone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The spironolactone dose your doctor recommends will be based on:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

Hyperaldosteronism:

• For the diagnosis of hyperaldosteronism, the daily dosage is 400 mg for either 4 days (short test) or 4 weeks (long test).
• For the treatment of hyperaldosteronism, the dose ranges from 100 mg to 400 mg daily.

Fluid retention: The recommended dose range is 25 to 200 mg daily. 

Fluid retention with Hepatic Cirrhosis: The recommended starting dose is 75 mg and can be given in either single or in divided doses. Your doctor may increase your dose. 

High blood pressure: The recommended dose range is 50 mg to 100 mg daily. 

Low potassium: The recommended dose range is 25 to 100 mg.

Heart failure:

• The recommended starting dose of the liquid suspension form for the treatment of heart failure is 20 mg by mouth once daily.
• The recommended dose range of the tablet form for the treatment of heart failure is 12.5 mg to 50 mg by mouth once daily. 

If you take too much spironolactone call your doctor or Poison Contol Center, or seek emergency medical attention right away.

• Store both the tablet and liquid suspension forms at 20°to 25°C (68° to 77°F).
• Keep this and all medications out of the reach of children.

WARNING

Spironolactone has been shown to be a tumorigen in chronic toxicity studies in rats. Unnecessary use of this drug should be avoided.