Aldactone

Name: Aldactone

Why is this medication 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.

What is the dosage for spironolactone?

  • Aldactone may be taken with or without food. The dosage range is 25-400 mg daily in single or divided doses.
  • The initial dose for treating edema in adults is 100 mg daily as a single dose or divided doses. The dose may be adjusted after 5 days based on response. The recommended dose range is 25 to 200 mg daily. The initial dose should be continued for at least 5 days before increasing the dose. If there is no adequate response after 5 days, a second diuretic may be added.
  • The dose for treating high blood pressure (hypertension) is 50 to 100 mg daily in single or divided doses.
  • The dose for treating hypokalemia is 25 to 100 mg daily.

Indications

ALDACTONE (spironolactone) is indicated in the management of:

Primary Hyperaldosteronism for

Establishing the diagnosis of primary hyperaldosteronism by therapeutic trial.

Short-term preoperative treatment of patients with primary hyperaldosteronism.

Long-term maintenance therapy for patients with discrete aldosterone-producing adrenal adenomas who are judged to be poor operative risks or who decline surgery.

Long-term maintenance therapy for patients with bilateral micro or macronodular adrenal hyperplasia (idiopathic hyperaldosteronism).

Edematous Conditions for Patients with:

Congestive Heart Failure

For the management of edema and sodium retention when the patient is only partially responsive to, or is intolerant of, other therapeutic measures. ALDACTONE is also indicated for patients with congestive heart failure taking digitalis when other therapies are considered inappropriate.

Cirrhosis Of The Liver Accompanied By Edema And/Or Ascites

Aldosterone levels may be exceptionally high in this condition. ALDACTONE is indicated for maintenance therapy together with bed rest and the restriction of fluid and sodium.

Nephrotic Syndrome

For nephrotic patients when treatment of the underlying disease, restriction of fluid and sodium intake, and the use of other diuretics do not provide an adequate response.

Essential Hypertension

ALDACTONE is indicated 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. 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.

Usually in combination with other drugs, ALDACTONE is indicated for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate.

Hypokalemia

For the treatment of patients with hypokalemia when other measures are considered inappropriate or inadequate. ALDACTONE is also indicated for the prophylaxis of hypokalemia in patients taking digitalis when other measures are considered inadequate or inappropriate.

Severe Heart Failure (NYHA class III - IV)

To increase survival, and to reduce the need for hospitalization for heart failure when used in addition to standard therapy.

Usage In Pregnancy

The routine use of diuretics in an otherwise healthy woman is inappropriate and exposes mother and fetus to unnecessary hazard. Diuretics do not prevent development of toxemia of pregnancy, and there is no satisfactory evidence that they are useful in the treatment of developing toxemia.

Edema during pregnancy may arise from pathologic causes or from the physiologic and mechanical consequences of pregnancy.

ALDACTONE is indicated in pregnancy when edema is due to pathologic causes just as it is in the absence of pregnancy (however, see PRECAUTIONS: Pregnancy). Dependent edema in pregnancy, resulting from restriction of venous return by the expanded uterus, is properly treated through elevation of the lower extremities and use of support hose; use of diuretics to lower intravascular volume in this case is unsupported and unnecessary. There is hypervolemia during normal pregnancy which is not harmful to either the fetus or the mother (in the absence of cardiovascular disease), but which is associated with edema, including generalized edema, in the majority of pregnant women. If this edema produces discomfort, increased recumbency will often provide relief. In rare instances, this edema may cause extreme discomfort that is not relieved by rest. In these cases, a short course of diuretics may provide relief and may be appropriate.

Overdose

The oral LD50 of ALDACTONE is greater than 1000 mg/kg in mice, rats, and rabbits.

Acute overdosage of ALDACTONE may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Hyperkalemia may occur, especially in patients with impaired renal function.

Treatment

Induce vomiting or evacuate the stomach by lavage. There is no specific antidote. Treatment is supportive to maintain hydration, electrolyte balance, and vital functions.

Patients who have renal impairment may develop spironolactone-induced hyperkalemia. In such cases, ALDACTONE should be discontinued immediately. With severe hyperkalemia, the clinical situation dictates the procedures to be employed. These may include the intravenous administration of calcium chloride solution, sodium bicarbonate solution and/or the oral or parenteral administration of glucose with a rapid-acting insulin preparation. These are temporary measures to be repeated as required. Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered. Persistent hyperkalemia may require dialysis.

Clinical pharmacology

Mechanism Of Action

ALDACTONE (spironolactone) is a specific pharmacologic antagonist of aldosterone, acting primarily through competitive binding of receptors at the aldosterone-dependent sodium-potassium exchange site in the distal convoluted renal tubule. ALDACTONE causes increased amounts of sodium and water to be excreted, while potassium is retained. ALDACTONE acts both as a diuretic and as an antihypertensive drug by this mechanism. It may be given alone or with other diuretic agents that act more proximally in the renal tubule.

Aldosterone Antagonist Activity

Increased levels of the mineralocorticoid, aldosterone, are present in primary and secondary hyperaldosteronism. Edematous states in which secondary aldosteronism is usually involved include congestive heart failure, hepatic cirrhosis, and nephrotic syndrome. By competing with aldosterone for receptor sites, ALDACTONE provides effective therapy for the edema and ascites in those conditions. ALDACTONE counteracts secondary aldosteronism induced by the volume depletion and associated sodium loss caused by active diuretic therapy.

ALDACTONE is effective in lowering the systolic and diastolic blood pressure in patients with primary hyperaldosteronism. It is also effective in most cases of essential hypertension, despite the fact that aldosterone secretion may be within normal limits in benign essential hypertension.

Through its action in antagonizing the effect of aldosterone, ALDACTONE inhibits the exchange of sodium for potassium in the distal renal tubule and helps to prevent potassium loss.

ALDACTONE has not been demonstrated to elevate serum uric acid, to precipitate gout, or to alter carbohydrate metabolism.

Pharmacokinetics

ALDACTONE is rapidly and extensively metabolized. Sulfur-containing products are the predominant metabolites and are thought to be primarily responsible, together with ALDACTONE, for the therapeutic effects of the drug. The following pharmacokinetic data were obtained from 12 healthy volunteers following the administration of 100 mg of spironolactone (ALDACTONE film-coated tablets) daily for 15 days. On the 15th day, spironolactone was given immediately after a low-fat breakfast and blood was drawn thereafter.

  Accumulation Factor: AUC (0-24 hr, day 15)/AUC (0-24 hr, day 1) Mean Peak Serum Concentration Mean (SD) Post Steady-State Half-Life
7-α-(thiomethyl) spirolactone (TMS) 1.25 391 ng/mL at 3.2hr 13.8 (6.4) (terminal)
6-β-hydroxy-7-a-(thiomethyl) spirolactone (HTMS) 1.50 125 ng/mL at 5.1hr 15.0 hr (4.0)(terminal)
Canrenone (C) 1.41 181 ng/mL at 4.3 hr 16.5 hr (6.3) (terminal) Approximately
Spironolactone 1.30 80 ng/mL at 2.6 hr Approximately 1.4 hr (0.5) (β half-life)

The pharmacological activity of spironolactone metabolites in man is not known. However, in the adrenalectomized rat the antimineralocorticoid activities of the metabolites C, TMS, and HTMS, relative to spironolactone were 1.10, 1.28, and 0.32, respectively. Relative to spironolactone, their binding affinities to the aldosterone receptors in rat kidney slices were 0.19, 0.86, and 0.06, respectively.

In humans, the potencies of TMS and 7-α-thiospirolactone in reversing the effects of the synthetic mineralocorticoid, fludrocortisone, on urinary electrolyte composition were 0.33 and 0.26, respectively, relative to spironolactone. However, since the serum concentrations of these steroids were not determined, their incomplete absorption and/or first-pass metabolism could not be ruled out as a reason for their reduced in vivo activities.

Spironolactone and its metabolites are more than 90% bound to plasma proteins. The metabolites are excreted primarily in the urine and secondarily in bile.

The effect of food on spironolactone absorption (two 100 mg ALDACTONE tablets) was assessed in a single-dose study of 9 healthy, drug-free volunteers. Food increased the bioavailability of unmetabolized spironolactone by almost 100%. The clinical importance of this finding is not known.

Clinical Studies

Severe Heart Failure

The Randomized Aldactone Evaluation Study (RALES) was a multinational, double-blind study in patients with an ejection fraction of ≤ 35%, a history of New York Heart Association (NYHA) class IV heart failure within 6 months, and class III - IV heart failure at the time of randomization. All patients were required to be taking a loop diuretic and, if tolerated, an ACE inhibitor. 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.

Patients were randomized 1:1 to spironolactone 25 mg orally once daily or matching placebo. Followup 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. Dosing could be withheld for serious hyperkalemia or if the serum creatinine increased to > 4.0 mg/dL. Patients who were intolerant of the initial dosage regimen had their dose decreased to one 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 two tablets daily at the discretion of the investigator.

RALES enrolled 1663 patients (3% U.S.) at 195 centers in 15 countries between March 24, 1995 and December 31, 1996. The study population was primarily white (87%, with 7% black, 2% Asian, and 4% other), male (73%), and elderly (median age 67). The median ejection fraction was 0.26. Seventy percent were NYHA class III and 29% class IV. The presumed 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. The mean daily dose at study end for the patients randomized to spironolactone was 26 mg.

Concomitant medications included a loop diuretic in 100% of patients and an ACE inhibitor in 97%. Other medications used at any time during the study included digoxin (78%), anticoagulants (58%), aspirin (43%), and beta-blockers (15%).

The primary endpoint for RALES was time to all-cause mortality. RALES was terminated early, after a mean follow-up of 24 months, because of significant mortality benefit detected on a planned interim analysis. The survival curves by treatment group are shown in Figure 1.

Figure 1: Survival by Treatment Group in RALES

Spironolactone reduced the risk of death by 30% compared to placebo (p < 0.001; 95% confidence interval 18% to 40%). Spironolactone reduced the risk of cardiac death, primarily sudden death, and death from progressive heart failure by 31% compared to placebo (p < 0.001; 95% confidence interval 18% to 42%).

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%). Changes in NYHA class were more favorable with spironolactone: In the spironolactone group, NYHA class at the end of the study improved in 41% of patients and worsened in 38% compared to improved in 33% and worsened in 48% in the placebo group (p < 0.001).

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 RALES to draw any conclusions about differential effects 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 RALES

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.

Aldactone Overview

Aldactone 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.

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, Aldactone 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 form and is usually taken once or twice daily. Aldactone can be taken with or without food.

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

Uses of Aldactone

Aldactone 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.

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

What other drugs will affect spironolactone?

Taking this medicine with other drugs that make you dizzy or lower your blood pressure can worsen these effects. Ask your doctor before taking spironolactone with a narcotic pain medicine, muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with spironolactone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Actions

  • Synthetic steroid mineralocorticoid receptor antagonist (aldosterone antagonist).215 256 265 266

  • Exhibits magnesium- and potassium-sparing,224 230 233 natriuretic,232 247 diuretic,224 232 and hypotensive215 224 225 227 effects by competitively inhibiting the physiologic effects of the adrenocortical hormone aldosterone on the distal renal tubules, myocardium,225 226 228 232 and vasculature.232 233 265

  • Generally does not cause potassium depletion or affect glucose metabolism or uric acid excretion.265

  • Androgen and progesterone receptor antagonist.206 208 209 210 211 215 256 265 266 267 268

Uses For Aldactone

Spironolactone is used in combination with other medicines to treat high blood pressure (hypertension) and heart failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.

Spironolactone is also used to diagnose and treat hyperaldosteronism, a condition in which the adrenal gland produces too much hormone called aldosterone. This medicine may also be used to treat fluid retention (edema) in patients with congestive heart failure, liver cirrhosis, or a kidney disorder called nephrotic syndrome.

Spironolactone is a potassium-sparing diuretic (water pill). It prevents your body from absorbing too much salt and keeps your potassium levels from getting too low. This medicine is also used to treat or prevent hypokalemia (low potassium levels in the blood).

This medicine is available only with your doctor’s prescription.

Aldactone Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known
  • Abdominal or stomach cramping, burning, or tenderness
  • bleeding gums
  • bloody or black, tarry stools
  • bloody urine
  • breast pain
  • chest pain
  • chills
  • clay-colored stools
  • clear or bloody discharge from the nipple
  • cloudy urine
  • coma
  • confusion
  • constipation
  • convulsions
  • cough or hoarseness
  • dark urine
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • difficulty with swallowing
  • dimpling of the breast skin
  • dizziness
  • drowsiness
  • fast or irregular heartbeat
  • fever with or without chills
  • general feeling of tiredness or weakness
  • headache
  • heartburn
  • hives, itching, or skin rash
  • increased thirst
  • indigestion
  • inverted nipple
  • loss of appetite
  • lower back or side pain
  • lump in the breast or under the arm
  • muscle pain or cramps
  • muscle spasms or twitching
  • nausea and vomiting
  • painful or difficult urination
  • persistent crusting or scaling of the nipple
  • pinpoint red spots on the skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • redness or swelling of the breast
  • severe stomach pain
  • shakiness and unsteady walk
  • sore on the skin of the breast that does not heal
  • sore throat
  • sores, ulcers, or white spots on the lips or in the mouth
  • swelling of the face, fingers, feet, ankles, or lower legs
  • swollen, painful, or tender lymph glands in the neck, armpit, or groin
  • tightness in the chest
  • trembling
  • troubled breathing
  • unpleasant breath odor
  • unsteadiness, trembling, or other problems with muscle control or coordination
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting of blood or material that looks like coffee grounds
  • weight gain
  • yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose
  • Irregular heartbeat
  • nervousness
  • numbness or tingling in the hands, feet, or lips
  • rash with flat lesions or small raised lesions on the skin
  • reddened skin
  • weakness or heaviness of the legs

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known
  • Burning feeling in the chest or stomach
  • hair loss or thinning of the hair
  • leg cramps
  • sores, welting, or blisters
  • stomach upset
  • swelling of the breasts or breast soreness in both females and males
  • unusual dullness or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

What do I need to tell my doctor BEFORE I take Aldactone?

  • If you have an allergy to spironolactone or any other part of Aldactone.
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have any of these health problems: Addison's disease, high potassium levels, or kidney disease.
  • If you are not able to pass urine.
  • If you are taking any of these drugs: Amiloride, eplerenone, or triamterene.
  • If you are breast-feeding or plan to breast-feed.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Aldactone with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

How is this medicine (Aldactone) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

Tablets:

  • Take with or without food. Take with food if it causes an upset stomach.

Liquid (suspension):

  • Take with or without food. Always take with food or always take on an empty stomach.
  • Shake well before use.
  • Measure liquid doses carefully. Use the measuring device that comes with Aldactone. If there is none, ask the pharmacist for a device to measure this medicine.

All products:

  • To gain the most benefit, do not miss doses.
  • Keep taking Aldactone (spironolactone) as you have been told by your doctor or other health care provider, even if you feel well.
  • This medicine may cause you to pass urine more often. To keep from having sleep problems, try to take before 6 pm.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Aldactone, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Aldactone. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Aldactone.

Review Date: October 4, 2017

Warnings

Potassium supplementation

Potassium supplementation, either in the form of medication or as a diet rich in potassium, should not ordinarily be given in association with Aldactone therapy. Excessive potassium intake may cause hyperkalemia in patients receiving Aldactone (see Precautions: General).

Concomitant administration of Aldactone with the following drugs or potassium sources may lead to severe hyperkalemia:

  • other potassium-sparing diuretics
  • ACE inhibitors
  • angiotensin II antagonists
  • aldosterone blockers
  • non-steroidal anti-inflammatory drugs (NSAIDs), e.g., indomethacin
  • heparin and low molecular weight heparin
  • other drugs or conditions known to cause hyperkalemia
  • potassium supplements
  • diet rich in potassium
  • salt substitutes containing potassium

Aldactone should not be administered concurrently with other potassium-sparing diuretics. Aldactone, when used with ACE inhibitors or indomethacin, even in the presence of a diuretic, has been associated with severe hyperkalemia. Extreme caution should be exercised when Aldactone is given concomitantly with these drugs.

Hyperkalemia in patients with severe heart failure

Hyperkalemia may be fatal. It is critical to monitor and manage serum potassium in patients with severe heart failure receiving Aldactone. Avoid using other potassium-sparing diuretics. Avoid using oral potassium supplements in patients with serum potassium > 3.5 mEq/L. RALES excluded patients with a serum creatinine > 2.5 mg/dL or a recent increase in serum creatinine > 25%. The recommended monitoring for potassium and creatinine is one week after initiation or increase in dose of Aldactone, monthly for the first 3 months, then quarterly for a year, and then every 6 months. Discontinue or interrupt treatment for serum potassium > 5 mEq/L or for serum creatinine > 4 mg/dL. (See Clinical Studies: Severe heart failure, and Dosage and Administration: Severe heart failure.)

Aldactone should be used with caution in patients with impaired hepatic function because minor alterations of fluid and electrolyte balance may precipitate hepatic coma.

Lithium generally should not be given with diuretics (see Precautions: Drug interactions).

Overdosage

The oral LD50 of Aldactone is greater than 1000 mg/kg in mice, rats, and rabbits.

Acute overdosage of Aldactone may be manifested by drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness, or diarrhea. Rarely, instances of hyponatremia, hyperkalemia, or hepatic coma may occur in patients with severe liver disease, but these are unlikely due to acute overdosage. Hyperkalemia may occur, especially in patients with impaired renal function.

Treatment

Induce vomiting or evacuate the stomach by lavage. There is no specific antidote. Treatment is supportive to maintain hydration, electrolyte balance, and vital functions.

Patients who have renal impairment may develop spironolactone-induced hyperkalemia. In such cases, Aldactone should be discontinued immediately. With severe hyperkalemia, the clinical situation dictates the procedures to be employed. These may include the intravenous administration of calcium chloride solution, sodium bicarbonate solution and/or the oral or parenteral administration of glucose with a rapid-acting insulin preparation. These are temporary measures to be repeated as required. Cationic exchange resins such as sodium polystyrene sulfonate may be orally or rectally administered. Persistent hyperkalemia may require dialysis.

PRINCIPAL DISPLAY PANEL - 50 mg Label

NDC 0025-1041-31

100 Tablets
Rx only

Aldactone®
spironolactone
tablets, USP

50 mg

Pfizer
Distributed by
G.D. Searle LLC
Division of Pfizer Inc, NY, NY 10017

What happens if i miss a dose (aldactone)?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What is Aldactone?

Aldactone (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.

Aldactone 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.

Aldactone 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).

Aldactone may also be used for purposes not listed in this medication guide.

What should I avoid?

Drinking alcohol can increase certain side effects of Aldactone.

Do not use salt substitutes or low-sodium milk products that contain potassium. These products could cause your potassium levels to get too high while you are taking Aldactone.

Avoid a high-salt diet. Too much salt will cause your body to retain water, which may reduce the effectiveness of this medicine.

Aldactone may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Spironolactone Pregnancy Warnings

Use is considered contraindicated; use during pregnancy requires the benefit be weighed against the risk to the fetus. AU TGA pregnancy category: B3 US FDA pregnancy category: C Comments: Adequate methods of contraception should be encouraged.

Animal studies have revealed an increased resorption rate, decreased live fetuses, and progestational and antiandrogenic effects. There are no controlled data in human pregnancy. AU TGA pregnancy category B3: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have shown evidence of an increased occurrence of fetal damage, the significance of which is considered uncertain in humans. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Adverse Effects

Frequency Not Defined

Gastric bleeding

Ulceration

Gastritis

Decreased libido

Inability to achieve or maintain erection

Postmenopausal bleeding

Breast and nipple pain

Thrombocytopenia

Fever

Urticaria

Maculopapular or erythematous cutaneous eruptions

Anaphylactic reactions

Vasculitis

Hyperkalemia

Electrolyte disturbances

Hyponatremia

Hypovolemia

Lethargy

Mental confusion

Ataxia

Dizziness

Headache

Drowsiness

Renal dysfunction (including renal failure)

Chloasma

Drowsiness

Lethargy

Headache

Mental confusion

Rash

Urticaria

Stevens-Johnson syndrome

Toxic epidermal necrolysis

Drug rash with eosinophilia and systemic symptoms (DRESS)

Gynecomastia

Impotence

Menstrual disorders

Abdominal cramping

Diarrhea

Gastritis

Nausea

Vomiting

Breast pain

Leukopenia

Electrolyte disturbances

Leg cramps

Dizziness

Alopecia

Pruritus

Pregnancy & Lactation

Pregnancy

Limited available data did not demonstrate an association of major malformations or other adverse pregnancy outcomes with spironolactone; risks may occur to the mother and fetus associated with heart failure, cirrhosis, and poorly controlled hypertension during pregnancy

Potential risk to the male fetus due to antiandrogenic properties of spironolactone; avoid spironolactone in pregnant women or advise a pregnant woman of the potential risk to a male fetus

Disease-associated maternal and embryo/fetal risks

  • Pregnant women with CHF are at increased risk for preterm birth; stroke volume and heart rate increase during pregnancy, increasing cardiac output, especially during the first trimester; closely monitor pregnant patients with CHF
  • Pregnant women with symptomatic cirrhosis generally have poor outcomes (eg, hepatic failure, variceal hemorrhage, preterm delivery, fetal growth restriction, and maternal death); pregnant women with cirrhosis of the liver should be monitored and managed accordingly
  • Hypertension in pregnancy increases the maternal risk for preeclampsia, gestational diabetes, premature delivery, and delivery complications (eg, need for cesarean delivery, postpartum hemorrhage); hypertension increases the fetal risk for intrauterine growth restriction and death

Lactation

Unknown if distributed in human breast milk

Consider the developmental and health benefits of breastfeeding along with the mother’s clinical need for the drug, and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

(web3)