Brand Name(s):

• Aldactone®

IMPORTANT WARNING

Spironolactone has caused tumors in laboratory animals. Talk to your doctor about the risks and benefits of using this medication for your condition.

WHY is this medicine prescribed?

Spironolactone is used to treat certain patients with hyperaldosteronism (the body produces too much aldosterone, a naturally occurring hormone); low potassium levels; and in patients with edema (fluid retention) caused by various conditions, including heart, liver, or kidney disease. Spironolactone is also used alone or with other medications to treat high blood pressure. Spironolactone is in a class of medications called aldosterone receptor antagonists. It causes the kidneys to eliminate unneeded water and sodium from the body into the urine, but reduces the loss of potassium from the body.

HOW should this medicine be used?

Spironolactone comes as a tablet to take by mouth. It usually is taken once a day in the morning or sometimes twice a day . Take spironolactone at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take spironolactone exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Your doctor may start you on a low dose of spironolactone and gradually increase your dose.

Spironolactone controls high blood pressure and hyperaldosteronism, but does not cure these conditions. It may take about 2 weeks or longer before the full effect of spironolactone occurs. Continue to take spironolactone even if you feel well. Do not stop taking spironolactone without talking to your doctor.

Are there OTHER USES for this medicine?

Spironolactone also is used in combination with other medicines to treat precocious puberty (a condition causing children to enter puberty too soon, resulting in the development of sexual characteristics in girls usually younger than 8 years of age and in boys usually younger than 9 years of age) or myasthenia gravis (MG, a disease in which the nerves do not function properly and patients may experience weakness; numbness; loss of muscle coordination; and problems with vision, speech, and bladder control). Spironolactone also may be used to treat certain female patients with abnormal facial hair. Talk to your doctor about the possible risks of using this medication for your condition.

This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before taking spironolactone,

• tell your doctor and pharmacist if you are allergic to spironolactone; any other medications; or the ingredients in spironolactone tablets. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you are taking amiloride (Midamor), potassium supplements, triamterene (Dyrenium). Your doctor may tell you not to take spironolactone if you are taking one or more of these medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril, (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDS) such as ibuprofen (Advil, Motrin), indomethacin (Indocin), and naproxen (Aleve, Naprosyn); barbiturates such as phenobarbital; digoxin (Digitek, Lanoxicaps, Lanoxin); diuretics ('water pills'); lithium (Eskalith, Lithobid); medications to treat high blood pressure; narcotic medications for pain; and oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone).
• tell your doctor if you have kidney disease. Your doctor may tell you not to take spironolactone.
• tell your doctor if you have or have ever had liver disease.
• tell your doctor if you are pregnant, or plan to become pregnant. If you become pregnant while taking spironolactone, call your doctor. Do not breastfeed if you are taking spironolactone.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking spironolactone.
• you should know that drinking alcohol with this medication may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. Talk to your doctor about drinking alcohol while you are taking spironolactone.

What SPECIAL DIETARY instructions should I follow?

Follow your doctor's directions for your meals, including advice for a reduced-salt(sodium) diet and daily exercise program. Avoid potassium-containing salt substitutes while you are taking this medication. Talk with your doctor about the amount of potassium-rich foods (e.g., bananas, prunes, raisins, and orange juice) that you may have in your diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for your next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medicine in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medicine that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medicine.

What should I do in case of OVERDOSE?

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• drowsiness
• confusion
• rash
• nausea
• vomiting
• dizziness
• diarrhea
• tingling in arms and legs
• loss of muscle tone
• weakness or heaviness in legs
• confusion
• lack of energy
• cold, gray skin
• irregular or slow heartbeat

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to spironolactone.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking spironolactone.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

AHFS® Consumer Medication Information. © Copyright, The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 1, 2009.