Drug Notebook

FDA Alerts

  • Tumorigenic in chronic toxicity studies in rats. Use for FDA-approved indications; avoid unnecessary use.
  • Spironolactone/hydrochlorothiazide fixed combination not indicated for initial therapy of edema or hypertension. Individualize dosage. If the fixed combination represents the dosage so determined, its use may be more convenient in patient management. The treatment of hypertension and edema is not static but must be reevaluated as conditions in each patient warrant. (See Dosage and Administration.)

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spironolactone
(spir ON oh LAK tone)

What is spironolactone?
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).

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.

Aldactazide 25-25MG Tablets PFIZER U.S.30/$35.99 or 90/$87.98
Aldactazide 50-50MG Tablets PFIZER U.S.30/$54.99 or 90/$149.97
Aldactone 100MG Tablets PFIZER U.S.30/$79.99 or 90/$215.97
Aldactone 25MG Tablets PFIZER U.S.30/$33.99 or 90/$81.97
Aldactone 50MG Tablets PFIZER U.S.30/$51.99 or 90/$135.96
Spironolactone 100MG Tablets ACTAVIS ELIZABETH30/$34.99 or 90/$79.99
Spironolactone 25MG Tablets GREENSTONE30/$15.99 or 60/$22.98
Spironolactone 50MG Tablets ACTAVIS ELIZABETH30/$21.99 or 90/$46.97
Spironolactone-HCTZ 25-25MG Tablets URL30/$16.99 or 60/$22.98

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What are the possible side effects of spironolactone?

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. Tell your doctor about any unusual or bothersome side effect.

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How should I take spironolactone?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Take each dose with a full glass of water. To be sure this medication is not causing harmful effects, your blood will need to be tested on a regular basis. It is important that you not miss any scheduled visits to your doctor. This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using spironolactone.

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What is the most important information I should know about spironolactone?
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.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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What other drugs will affect spironolactone?
Before taking this medication, tell your doctor if you are using any of the following drugs: lithium (Eskalith, Lithobid); digoxin (digitalis, Lanoxin); steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others; an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik); or

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Can I take this if I am pregnant or trying to get pregnant or if I am breastfeeding?

Spironolactone has not been formally assigned to a pregnancy category by the FDA. Some experts believe it should be assigned to pregnancy category D based on animal studies that have shown antiandrogenic effects on male fetuses when the mother was administered spironolactone. Some experts believe that diuretics, in general, are contraindicated in pregnancy, except when necessary in patients with cardiovascular disease, since they do not prevent or alter the course of toxemia and they may cause a decrease in placental perfusion. There are no controlled data in human pregnancy. Spironolactone is only recommended for use in pregnancy when there are no alternatives and benefit outweighs risk.

Data from the Michigan Medicaid surveillance study failed to reveal an association between the use of spironolactone and congenital abnormalities (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). This was a retrospective study of 229,101 completed pregnancies between 1985 and 1992, of which 31 were exposed to spironolactone at some time during the first trimester and 51 were exposed to the drug at any time during pregnancy. Of these pregnancies, 2 cardiovascular defects and a single case of cleft palate were observed. These observations did not achieve statistical significance. These data do not support an association between spironolactone and birth defects, although the number of pregnancies with known exposure to the drug is small.

The main active metabolite of spironolactone, canrenone, is excreted into human milk. Spironolactone is considered compatible with breast-feeding by the American Academy of Pediatrics. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

The active metabolite of spironolactone is excreted into human milk, with a milk to maternal serum drug concentration ratio of 0.72 at 2 hours after dosing, and 0.51 at 14 hours after dosing. The authors of this report estimate that, if an infant consumes 1,000 mL of milk per day and the milk to maternal plasma concentration ratio is 0.8, the maximum amount of canrenone the nursing infant receives per day is about 0.2% of the mother's daily dose. The authors found no electrolyte or other side effects in the infant, but recommend periodically checking the infant's serum electrolytes during breast-feeding when the mother is taking spironolactone.

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Who should NOT use this medication?

  • Anuria.
  • Acute renal insufficiency
  • Substantial impairment of renal excretory function.
  • Hyperkalemia.
  • Known hypersensitivity to spironolactone or any ingredient in the formulation.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Overdose symptoms may include drowsiness, confusion, red skin rash, nausea, vomiting, or diarrhea.

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What should I discuss with my doctor before taking spironolactone?
Do not use this medication if you have: kidney disease or are unable to urinate; high potassium levels (hyperkalemia); or if you are taking potassium supplements or other potassium-sparing diuretics such as Aldactazide, amiloride (Midamor, Moduretic), or triamterene (Dyrenium, Dyazide, Maxzide). Before using spironolactone, tell your doctor if you have: heart disease; liver disease; or if you are using a steroid, or another diuretic. If you have any of these conditions, you may need a dose adjustment or special tests to safely take spironolactone.

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Can I stop taking the medication if I feel better?
Even though you may feel better you should not stop taking your high blood pressure medication without first checking with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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