Spironolactone

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; heart failure; and in patients with edema (fluid retention) caused by various conditions, including liver, or kidney disease. It 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.

High blood pressure is a common condition and when not treated, can cause damage to the brain, heart, blood vessels, kidneys and other parts of the body. Damage to these organs may cause heart disease, a heart attack, heart failure, stroke, kidney failure, loss of vision, and other problems. In addition to taking medication, making lifestyle changes will also help to control your blood pressure. These changes include eating a diet that is low in fat and salt, maintaining a healthy weight, exercising at least 30 minutes most days, not smoking, and using alcohol in moderation.

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.

HOW should this medicine be used?

Spironolactone comes as a tablet and suspension (liquid; Carospir) to take by mouth. It usually is taken once or twice a day. Take spironolactone suspension consistently either with food or without food each time. 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.

Shake the oral suspension well before each use to mix the medication evenly.

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

Spironolactone tablets and suspension release the medication differently in your body and cannot be substituted for one another. Only take the spironolactone product prescribed by your doctor and do not switch to a different spironolactone product unless your doctor says that you should.

Spironolactone controls high blood pressure, edema, heart failure, 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.

What SPECIAL PRECAUTIONS should I follow?

Before taking spironolactone,

• tell your doctor and pharmacist if you are allergic to spironolactone; any other medications; or any of the ingredients in spironolactone tablets. Ask your pharmacist for a list of the ingredients.

• tell your doctor if you are taking eplerenone (Inspra). Your doctor may tell you not to take spironolactone if you are taking this medication.

• 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 any of the following: aminoglycoside antibiotics such as amikacin, gentamicin, kanamycin, neomycin (Neo-Rx, Neo-Fradin), streptomycin, and tobramycin (Tobi); angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten), enalapril (Vasotec), fosinopril, lisinopril (in Prinzide, in Zestoretic), moexipril (Univasc, in Uniretic), perindopril, (Aceon), quinapril (Accupril, in Accuretic, in Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); angiotensin II antagonists (angiotensin receptor blockers; ARBs) such as azilsartan (Edarbi, Edarbyclor), candesartan (Atacand, in Atacand HCT), eprosartan (Teveten, in Teveten HCT), irbesartan (Avapro, in Avalide), losartan (Cozaar, in Hyzaar), olmesartan (Benicar, in Azor, Benicar HCT, Tribenzor), telmisartan (Micardis, in Micardis HCT), and valsartan (Diovan, in Diovan HCT, Exforge); aspirin and other nonsteroidal anti-inflammatory medications (NSAIDS) such as ibuprofen (Advil, Motrin), indomethacin (Indocin, Tivorbex), and naproxen (Aleve, Naprosyn); barbiturates such as phenobarbital; cholestyramine (Prevalite); cisplatin; digoxin (Lanoxin); diuretics ('water pills') including potassium-sparing diuretics such as amiloride (Midamor) and triamterene (Dyrenium, in Dyazide, in Maxzide); heparin or low-molecular-weight heparin enoxaparin (Lovenox); lithium (Lithobid); medications to treat high blood pressure; narcotic medications for pain; oral steroids such as dexamethasone, methylprednisolone (Medrol), and prednisone (Rayos); potassium supplements; and trimethoprim (Primsol, in Bactrim).

• tell your doctor if you have Addison's disease or other conditions that may cause high blood levels of potassium, or kidney disease. Your doctor may tell you not to take spironolactone.

• tell your doctor if you have liver disease.

• tell your doctor if you are pregnant, or plan to become pregnant, or are breastfeeding. If you become pregnant while taking spironolactone, call your doctor.

• 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?

Spironolactone may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• vomiting
• diarrhea
• stomach pain or cramps
• enlarged or painful breasts in men or women
• irregular menstrual periods
• vaginal bleeding in post-menopausal ('after the change of life', the end of monthly menstrual periods) women
• difficulty maintaining or achieving an erection
• deepening of voice
• increased hair growth on parts of the body
• drowsiness
• tiredness
• restlessness

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

• muscle weakness, pain, or cramps
• pain, burning, numbness, or tingling in the hands or feet
• inability to move arms or legs
• changes in heartbeat
• confusion
• nausea
• extreme tiredness
• dry mouth, thirst, dizziness, unsteadiness, headache, or other signs of dehydration
• unusual bleeding or bruising
• lack of energy
• loss of appetite
• pain in the upper right part of the stomach
• yellowing of the skin or eyes
• flu-like symptoms
• rash
• hives
• itching
• difficulty breathing or swallowing
• vomiting blood
• blood in stools
• decreased urination
• fainting

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• drowsiness
• confusion
• rash
• nausea
• vomiting
• dizziness
• diarrhea
• tingling in arms and legs
• loss of muscle tone
• weakness or heaviness in legs
• 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.