Spironolactone

Generic

Generic for Aldactone

ID: 16729022716

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100 mg

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TL;DR — Quick Summary

Key facts from the full medication guide below

1 INDICATIONS AND USAGE 1.1 Heart Failure 1.2 Hypertension 1.3 Edema Associated with Hepatic Cirrhosis or Nephrotic Syndrome 1.4 Primary Hyperaldosteronism

🩺What it's for

Spironolactone is an aldosterone antagonist indicated for: The treatment of NYHA Class III IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure ( 1.1). Use as an add-on therapy for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.2).

💊How to take it

Heart Failure: Initiate treatment at 25 mg once daily ( 2.2). Hypertension: Initiate treatment at 25 to 100 mg daily in either single or divided doses ( 2.3). Edema: Initiate therapy in a hospital setting and titrate slowly. The recommended initial daily dose is 100 mg in single or divided doses ( 2.4). Primary hyperaldosteronism: Initiate treatment at 100 to 400 mg in preparation for surgery.

ℹ️Common side effects

⚠️Serious risks

Hyperkalemia: Monitor serum potassium within one week of initiation and regularly thereafter ( 5.1). Hypotension and Worsening Renal Function: Monitor volume status and renal function periodically ( 5.2). Electrolyte and Metabolic Abnormalities: Monitor serum electrolytes, uric acid and blood glucose periodically ( 5.3). Gynecomastia: Spironolactone can cause gynecomastia ( 5.4).

📋Interactions & cautions

Agents increasing serum potassium: Concomitant administration can lead to hyperkalemia ( 5.1, 7.1). Lithium: Increased risk of lithium toxicity ( 7.2). NSAIDs: May reduce the diuretic, natriuretic and antihypertensive effect of spironolactone ( 7.3). Digoxin: spironolactone can interfere with radioimmunologic assays of digoxin exposure ( 7.4). Cholestyramine: Hyperkalemic metabolic acidosis has been reported with concomitant use ( 7.5).

📦Storage & missed dose

Spironolactone tablets USP 25 mg tablets are Light yellow to yellow colored, round, biconvex, film coated tablets with inscription AD on one side and plain on the other side having faint odour of peppermint, supplied as: NDC Number Size 16729-225-01 bottle of 100 with a child-resistant closure 16729-225-16 bottle of 500 16729-225-17 bottle of 1,000 16729-225-19 bottle of 2,500 Spironolactone tablets USP 50 mg tablets are Light orange to orange colored, oval, biconvex, film coated tablets with…

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Spironolactone tablets are indicated as add-on therapy for the treatment of hypertension, to lower blood pressure in patients who are not adequately controlled on other agents. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program's Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

The following clinically significant adverse reactions are described elsewhere in the labeling: Hyperkalemia [see Warnings and Precautions (5.1)] Hypotension and Worsening Renal Function [see Warnings and Precautions (5.2)] Electrolyte and Metabolic Abnormalities [see Warnings and Precautions (5.3)] Gynecomastia [see Warnings and Precautions (5.4] Impaired neurological function/ coma in patients with hepatic impairment, cirrhosis and ascites [see Use in Specific Populations (8.7)] The following adverse reactions associated with the use of spironolactone were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency, reliably, or to establish a causal relationship to drug exposure. Digestive:Gastric bleeding, ulceration, gastritis, diarrhea and cramping, nausea, vomiting. Reproductive:Decreased libido, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, breast and nipple pain. Hematologic:Leukopenia (including agranulocytosis), thrombocytopenia. Hypersensitivity:Fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis. Metabolism:Hyperkalemia, electrolyte disturbances [see Warnings and Precautions (5.1, 5.3)] , hyponatremia, hypovolemia. Musculoskeletal: Leg cramps. Nervous system/psychiatric:Lethargy, mental confusion, ataxia, dizziness, headache, drowsiness. Liver/biliary:A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration. Renal:Renal dysfunction (including renal failure). Skin:Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), drug rash with eosinophilia and systemic symptoms (DRESS), alopecia, pruritis. The most common adverse reaction with spironolactone treatment is gynecomastia ( 5.4, 6). To report SUSPECTED ADVERSE REACTIONS, contact Accord Healthcare, Inc. at 1866-941-7875 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

The Randomized Spironolactone Evaluation Study was a placebo controlled, double-blind study of the effect of spironolactone on mortality in patients with highly symptomatic heart failure and reduced ejection fraction. To be eligible to participate patients had to have an ejection fraction of 35%, NYHA class III IV symptoms, and a history of NYHA class IV symptoms within the last 6 months before enrollment. Patients with a baseline serum creatinine of >2.5 mg/dL or a recent increase of 25% or with a baseline serum potassium of >5.0 mEq/L were excluded. Follow-up visits and laboratory measurements (including serum potassium and creatinine) were performed every four weeks for the first 12 weeks, then every 3 months for the first year, and then every 6 months thereafter. The initial dose of spironolactone was 25 mg once daily. Patients who were intolerant of the initial dosage regimen had their dose decreased to one 25 mg tablet every other day at one to four weeks. Patients who were tolerant of one tablet daily at 8 weeks may have had their dose increased to 50 mg daily at the discretion of the investigator. The mean daily dose at study end for patients randomized to spironolactone was 26 mg. 1663 patients were randomized 1:1 to spironolactone or placebo. 87% of patients were white, 7% black, 2% Asian. 73% were male and median age was 67. The median ejection fraction was 26%. 70% were NYHA class III and 29% class IV. The etiology of heart failure was ischemic in 55%, and non-ischemic in 45%. There was a history of myocardial infarction in 28%, of hypertension in 24%, and of diabetes in 22%. The median baseline serum creatinine was 1.2 mg/dL and the median baseline creatinine clearance was 57 mL/min. At baseline 100% of patients were taking loop diuretic and 95% were taking an ACE inhibitor. Other medications used at any time during the study included digoxin (78%), anticoagulants (58%), aspirin (43%), and beta-blockers (15%). The primary endpoint for The Randomized Spironolactone Evaluation Study was time to all-cause mortality. The Randomized Spironolactone Evaluation Study was terminated early because of significant mortality benefit demonstrated during a planned interim analysis. Compared to placebo, spironolactone reduced the risk of death by 30% (p<0.001; 95% confidence interval 18% to 40%). Spironolactone also reduced the risk of hospitalization for cardiac causes (defined as worsening heart failure, angina, ventricular arrhythmias, or myocardial infarction) by 30% (p <0.001; 95% confidence interval 18% to 41%). The survival curves by treatment group are shown in Figure 1. Figure 1. Survival by Treatment Group in The Randomized Spironolactone Evaluation Study Mortality hazard ratios for some subgroups are shown in Figure 2. The favorable effect of spironolactone on mortality appeared similar for both genders and all age groups except patients younger than 55. There were too few non-whites in The Randomized Spironolactone Evaluation Study to evaluate if the effects differ by race. Spironolactone's benefit appeared greater in patients with low baseline serum potassium levels and less in patients with ejection fractions <0.2. These subgroup analyses must be interpreted cautiously. Figure 2. Hazard Ratios of All-Cause Mortality by Subgroup in The Randomized Spironolactone Evaluation Study Figure 2: The size of each box is proportional to the sample size as well as the event rate. LVEF denotes left ventricular ejection fraction, Ser Creatinine denotes serum creatinine, Cr Clearance denotes creatinine clearance, and ACEI denotes angiotensin-converting enzyme inhibitor.

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Spironolactone

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