Aldactone medication comes in several different strengths; click on the strength you need to view prices from pharmacies competing to earn your business.
About Aldactone
What Aldactone is used for
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Fluid retention (edema) caused by various conditions, including heart disease, cirrhosis of the liver and nephrotic syndrome;
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High blood pressure;
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Hyperaldosteronism (the body produces too much aldoterone, a naturally occurring hormone);
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Low potassium levels in the blood (hypokalemia).
What Aldactone does
Spironolactone is in a class of medications called aldosterone receptor antagonists. It causes the kidney to eliminate unneeded water and sodium from the body into the urine, but reduces the loss of potassium from the body.
When Aldactone should not be used
You should not use this medicine if you have had an allergic reaction to spironolactone, or if you have certain kidney diseases, high levels of potassium in your blood (hyperkalemia), or if you are pregnant or unable to urinate.
What the medicinal ingredient is
Spironolactone.
What the important nonmedicinal ingredients for Aldactone are
Each ALDACTONE 25 mg and 100 mg tablet contains: calcium sulfate, corn starch, magnesium stearate, peppermint flavouring, povidone, hypromellose, polyethylene glycol 400, carnauba wax, stearic acid, opaspray M-1-2042 (25 mg only) and opaspray M-1-2668 (100 mg only).
What dosage forms Aldactone comes in
ALDACTONE 25 mg:
Each light yellow, round, biconvex, film-coated tablet, debossed “ALDACTONE” and “25” on one face and “SEARLE” and “1001” on the other face and with peppermint odour contains Spironolactone 25 mg.
ALDACTONE 100 mg
Each peach, round, biconvex, scored, film-coated tablet, debossed “ALDACTONE” and “100” on one face and “SEARLE” and “1031” on the other (scored) face and with peppermint odour contains Spironolactone 100 mg.
ALDACTONE tablets are available in strengths of 25 mg and 100 mg in bottles of 100.
Warnings and Precautions
Avoid potassium supplements and foods containing high levels of potassium including salt substitutes.
Before taking ALDACTONE,
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tell your doctor and pharmacist if you are allergic to spironolactone, sulfa drugs, or any other drugs;
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tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially aspirin; lithium; medications for arthritis, diabetes, or high blood pressure; potassium supplements; and vitamins;
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tell your doctor if you have or have ever had diabetes, gout, or kidney or liver disease;
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tell your doctor if you are pregnant, plan to become pregnant, or are breast feeding. If you become pregnant while taking spironolactone, call your doctor immediately;
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if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking spironolactone;
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you should know that this drug may make you drowsy or dizzy. Do not drive a car or operate machinery, or do anything else that could be dangerous if you are not alert until you know how this drug affects you. Remember that alcohol can add to the drowsiness caused by this drug.
Dietary Restrictions
Follow your doctor's directions for a low-salt or low-sodium diet and daily exercise program. Avoid potassium-containing salt substitutes. Limit your intake of potassium-rich foods (eg, bananas, prunes, raisins, and orange juice). Ask your doctor for advice on how much of these foods you may have.
Interactions with Aldactone
Drugs that may interact with ALDACTONE include: aspirin, lithium, digoxin, antipyrine, cholestyramine, and medications for arthritis, diabetes, or high blood pressure.
Proper Use of Aldactone
Usual dose
ALDACTONE comes as a tablet to take by mouth. Take it exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. It usually is taken once a day in the morning with breakfast or twice a day with breakfast and lunch. Carefully follow your doctor's instructions about any special diet.
Missed dose
Take the missed dose as soon as you remember it. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take a double dose to make up for a missed one.
Side Effects for Aldactone and What to Do About Them
Although side effects from ALDACTONE are not common, they can occur. Tell your doctor if any of these symptoms do not go away:
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upset stomach
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abdominal pain
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frequent urination
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dryness of mouth, thirst
| Serious Side Effects, How Often They Happen and What to Do About Them |
| Symptom/Effect | Talk with your doctor or pharmacist | Stop taking drug and call your doctor or pharmacist |
| Only if severe | In all cases |
| Vomiting | • | | |
| Diarrhea | • | | |
| Dizziness | • | | |
| Headache | • | | |
| Drowsiness | • | | |
| Fatigue | • | | |
| Fever | • | | |
| Enlarged or painful breasts | | • | |
| Irregular menstrual period | | • | |
| Confusion | | • | |
| Muscle weakness or cramps | | • | |
| Rapid, excessive weight loss | | • | |
| Rapid, slow or irregular heartbeat | | • | |
| Shortness of breath | | • | |
| Unusual bruising or bleeding | | • | |
| Yellowing of the skin or eyes | | • | |
| Skin rash | | | • |
| Vomiting blood | | | • |
This is not a complete list of side effects. If you have any unexpected effects after receiving ALDACTONE, contact your doctor or pharmacist.
Technical InformationDrug Interactions
Food increases the bioavailability of unmetabolized spironolactone (two 100 mg ALDACTONE tablets) by almost 100%. The clinical importance of this finding is not known.
| ALDACTONE Drug Interaction | Effect | Clinical Comment |
| Alcohol, barbiturates or narcotics | Potentiation of orthostatic hypotension may occur. | |
| Antipyrine | Spironolactone enhances the metabolism of antipyrine. | |
| Cholestyramine/ Ammonium Chloride | Hyperchloremic metabolic acidosis, frequently associated with hyperkalemia, has been reported in patients given spironolactone concurrently with ammonium chloride or cholestyramine. | |
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| Corticosteroids, ACTH | Intensified electrolyte depletion, particularly hypokalemia, may occur. | |
| Diuretics and Antihypertensives | Although ALDACTONE may be administered concomitantly with diuretics and antihypertensives, the effect of ALDACTONE is additive.
Hyperkalemia has been associated with the use of angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists and aldosterone blockers in combination with spironolactone. | It is advisable to reduce the dose of these drugs. In particular, the dose of ganglionic blocking agents should be reduced by at least 50% when ALDACTONE is added to the regimen. |
| Lithium | Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity. | Lithium generally should not be given with diuretics. |
| Norepinephrine | ALDACTONE reduces the vascular responsiveness to norepinephrine. | Caution should be exercised in the management of patients subjected to regional or general anaesthesia while being treated with spironolactone. |
| Digoxin | Spironolactone has been shown to increase the half‑life of digoxin. This may result in increased serum digoxin levels and subsequent digitalis toxicity. | It may be necessary to reduce the maintenance dose of digoxin when spironolactone is administered, and the patient should be carefully monitored to avoid over‑ or underdigitalization. |
| Non‑Steroidal Anti‑Inflammatory Drugs | ASA, mefenamic acid, and indomethacin may attenuate the diuretic action of spironolactone due to inhibition of intrarenal synthesis of prostaglandins.
Hyperkalemia has been associated with the use of indomethacin in combination with potassium‑sparing diuretics. | However, it has been shown that ASA does not alter the effect of spironolactone on blood pressure, serum electrolytes, urea nitrogen, or plasma renin activity in hypertensive patients. |
Several reports of possible interference with digoxin radioimmunoassays by spironolactone, or its metabolites, have appeared in the literature. Neither the extent, nor the potential clinical significance of its interference (which may be assay specific) has been fully established.
Spironolactone has been shown to increase the half life of digoxin. This may result in increased serum digoxin levels and subsequent digitalis toxicity (see Drug-Drug Interactions).
Information for the Patient
Aldactone
Dosage and Administration
Diagnosis and Treatment of Primary Hyperaldosteronism: As an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets:
Long Test: Administer ALDACTONE at a daily dosage of 400 mg for 3-4 weeks. Correction of hypokalemia and hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.
Short Test: Administer ALDACTONE at a daily dosage of 400 mg×4 days. If serum potassium increases or urinary potassium decreases during ALDACTONE administration, but reverts when ALDACTONE is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.
After the diagnosis of primary hyperaldosteronism has been established by more definitive testing procedures, ALDACTONE may be administered in doses of 75 mg to 400 mg daily in preparation for surgery. For those unsuitable for surgery, spironolactone may be employed for long term maintenance therapy at the lowest effective dosage determined for the individual.
Edematous Disorders Associated with Congestive Heart Failure, Cirrhosis and the Nephrotic Syndrome: When given as sole agent for diuresis, continue administration for at least 5 days. If an adequate response has been achieved within 5 days, continue dosage at the same level (or in selected patients, at a reduced dosage) in either single or divided daily doses. Some may respond adequately to a dosage of only 75 mg daily. If adequate diuresis is not obtained within 5 days, a second diuretic also should be given for additive effect. Occasionally for severe resistant edema, one may add a potent glucocorticoid to this combined therapy. Normally, an initial daily dosage of 100 mg (but may range from 25-200 mg daily) of ALDACTONE administered in either single or divided doses is recommended.
Dosage in Children: The initial daily dosage should provide approximately 3 mg/kg of body weight administered in either single or divided doses. This dose should be reduced to 1-2 mg/kg for maintenance therapy or combination use with other diuretics.
Essential Hypertension: 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. ALDACTONE has mild to moderate antihypertensive activity.
For adults an initial daily dosage of 50-100 mg (in either single or divided doses) of ALDACTONE is recommended. ALDACTONE may also be given with diuretics that act more proximally in the renal tubule or with other antihypertensive agents. Since a stabilized response may not occur before 2 weeks, continue treatment in either single or divided daily doses for that duration of time. Subsequently, adjust dosage in response to patient's needs. Most patients will respond to doses not exceeding 200 mg/day.
Hypokalemia: ALDACTONE in dosage ranging from 25 mg to 100 mg daily is useful in treating a diuretic induced hypokalemia, when oral potassium supplements or other potassium sparing regimens are inappropriate. See also Table 2 for a summary of dosage recommendations.
Adverse Reactions
renal dysfunction (including acute renal failure).
mental confusion, ataxia, headache, drowsiness, lethargy, dizziness, change in libido.
drug fever, urticaria, maculopapular or erythematous cutaneous eruptions, anaphylactic reactions, vasculitis, pruritus, rash.
leukopenia (including agranulocytosis), thrombocytopenia, anemia.
diarrhea and cramping, gastric bleeding, gastritis, nausea, ulceration, vomiting.
electrolyte disturbances, hyperkalemia.
alopecia, hypertrichosis.
Gynecomastia may develop in association with the use of spironolactone. Development of gynecomastia is related to both dose and duration of therapy. Gynecomastia is usually reversible when spironolactone is discontinued, although in rare instances some breast enlargement may persist.
Adverse reactions are usually reversible upon discontinuation of the drug.
hepatic function disorder. A very few cases of mixed cholestatic/hepatocellular toxicity, with one reported fatality, have been reported with spironolactone administration.
abnormal semen (decreased motility and sperm count), inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, benign breast neoplasm, breast pain.
Carcinoma of the breast has been reported in patients, including male patients, taking spironolactone, but a cause and effect relationship has not been established.
Indications and Clinical Use
ALDACTONE (spironolactone) is indicated for the following:
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Primary Hyperaldosteronism: ALDACTONE (spironolactone) is a useful agent in the diagnosis of primary hyperaldosteronism. In the presence of hypokalemic alkalosis and hypertension, a diagnosis of primary hyperaldosteronism should be considered if both blood pressure (BP) and serum electrolytes return to normal following treatment with ALDACTONE.
ALDACTONE is useful in the pre operative treatment of patients with primary hyperaldosteronism and for the maintenance therapy of such patients who decline surgery, or who are unsuitable for surgery.
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Edematous Conditions:
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Congestive Heart Failure (CHF): ALDACTONE is useful in the management of edema and sodium retention in CHF when the patient is only partially responsive to, or intolerant of, other therapeutic measures. ALDACTONE may be used alone or with thiazides. It is indicated in patients with CHF taking digitalis when other therapies are considered inappropriate.
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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, in combination with bed rest and the restriction of fluid and sodium.
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The Nephrotic Syndrome: ALDACTONE is useful for inducing a diuresis in patients not responsive to glucocorticoid therapy (for the nephrotic syndrome), and not responding to other diuretics. However, ALDACTONE has not been shown to affect the basic pathological process.
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Essential Hypertension: ALDACTONE is indicated, usually in combination with other drugs, for patients who cannot be treated adequately with other agents or for whom other agents are considered inappropriate. ALDACTONE alone has mild to moderate antihypertensive activity.
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Hypokalemia: ALDACTONE is indicated for treatment of hypokalemia, when other measures are considered inappropriate or inadequate. It is also indicated for the prophylaxis of hypokalemia in digitalis therapy when other measures are inadequate or inappropriate.
Overdosage
There have been no reports of fatal overdose in man (except indirectly through hyperkalemia). Nausea and vomiting occurs, and (much more rarely) drowsiness, dizziness, mental confusion, diarrhea, or a maculopapular or erythematous rash. These manifestations disappear promptly on discontinuation of medication. Hyperkalemia may be exacerbated.
No specific antidote. No persistent toxicity has occurred or is expected. Inducing vomiting and evacuating the stomach by lavage could be considered. Spironolactone use should be discontinued and potassium intake (including dietary sources) restricted.
Dosage Forms, Composition and Packaging
Each peach, round, biconvex, scored, film-coated tablet, debossed “ALDACTONE” and “100” on one face and “SEARLE” and “1031” on the other (scored) face and with peppermint odour, contains: spironolactone 100 mg. Nonmedicinal ingredients: calcium sulfate, carnauba wax, cornstarch, hypromellose, magnesium stearate, opaspray M-1-2668, peppermint flavouring, polyethylene glycol 400, povidone and stearic acid. Bottles of 100.
Each light yellow, round, biconvex, film-coated tablet, debossed “ALDACTONE” and “25” on one face and “SEARLE” and “1001” on the other face and with peppermint odour, contains: spironolactone 25 mg. Nonmedicinal ingredients: calcium sulfate, carnauba wax, cornstarch, hypromellose, magnesium stearate, opaspray M-1-2042, peppermint flavouring, polyethylene glycol 400, povidone and stearic acid. Bottles of 100.
Warnings and Precautions
Use ALDACTONE (spironolactone) only for conditions described under Indications and Clinical Use.
ALDACTONE should be used with caution in patients with impaired hepatic function because minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Rare reports of acidosis have been reported with ALDACTONE.
Spironolactone and its metabolites may cross the placental barrier. There are no studies in pregnant women. Therefore, the use of ALDACTONE requires that the potential benefits be weighed against the possible hazard to the mother and fetus.
Spironolactone was devoid of teratogenic effects in mice. Rabbits receiving spironolactone showed reduced conception rate, increased resorption rate, and lower number of live births. No embryotoxic effects were seen in rats administered high dosages, but limited, dose-related hypoprolactinemia and decreased ventral prostate and seminal vesicle weights in males, and increased leutinizing hormone secretion and ovarian and uterine weights in females were reported. Feminization of the external genitalia of male fetuses was reported in another rat study.
Somnolence and dizziness have been reported to occur in some patients. Caution is advised when driving or operating machinery until the response to initial treatment has been determined.
Discontinue spironolactone several days prior to adrenal vein catheterization for measurement of aldosterone concentrations and measurements of plasma renin activity.
Gynecomastia may develop with the use of ALDACTONE and physicians should be advised of its possible occurrence. The development of gynecomastia appears to be related to both dosage and duration of therapy and is normally reversible when the drug is discontinued. If gynecomastia develops, discontinue the drug. In rare instances some breast enlargement may persist.
Reversible hyperchloremic metabolic acidosis, usually in association with hyperkalemia, has been reported to occur in some patients with decompensated hepatic cirrhosis, even when renal function is normal.
Because of the diuretic action of ALDACTONE patients should be carefully evaluated for possible disturbance of fluid and electrolyte balance, due to the possibility of hyperkalemia, hypochloremic alkalosis, hyponatremia and possible BUN elevation, especially the elderly and/or patients with pre-existing impaired renal or hepatic function.
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Hyperkalemia: Hyperkalemia may occur in patients treated with ALDACTONE if the potassium intake is excessive. This can cause cardiac irregularities, some of which may be fatal. Hyperkalemia may also occur even in the absence of potassium supplementation, particularly in patients with impaired renal function, elderly patients, or patients with diabetes. Consequently, no potassium supplementation should ordinarily be given with ALDACTONE. ALDACTONE should not be administered concurrently with other potassium-sparing diuretics. ALDACTONE, when used with angiotensin converting enzyme (ACE) inhibitors Angiotensin II antagonists, other aldosterone blockers or indomethacin, even in the presence of a diuretic, has been associated with severe hyperkalemia (see Drug Interactions). Hyperkalemia can be treated promptly by rapid intravenous administration of glucose (20 to 50%) and regular insulin, using 0.25 to 0.5 units of insulin per gram of glucose. This is a temporary measure to be repeated if required. ALDACTONE should be discontinued and potassium intake (including dietary potassium) restricted.
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Hyponatremia: During the administration of ALDACTONE patients suffering from sodium depletion must be attentively monitored and signs of electrolyte imbalance must be carefully checked.
ALDACTONE may, if administered concomitantly with other diuretics, cause or aggravate hyponatremia, as manifested by dryness of the mouth, thirst, lethargy, and drowsiness.
ALDACTONE therapy may cause transient elevation of BUN, especially in patients with pre existing renal impairment.
Several reports of possible interference with digoxin radioimmunoassays by spironolactone or its metabolites have appeared in the literature. Neither the extent nor the potential clinical significance of this interference (which may be assay specific) has been fully established.
Discontinue spironolactone for at least 4, and preferably 7, days prior to plasma cortisol determinations, if they are to be done by the method of Mattingly, that is, by fluorometric assay. No interference has been demonstrated with the competitive protein binding technique or radioimmunoassay technique.
Lithium generally should not be given with diuretics (see Drug Interactions).
Although high doses of ALDACTONE are required to treat edema and ascites in patients with cirrhosis, the drug dosage may be decreased before diuresis is complete to avoid the possibility of dehydration.
Spironolactone, in chronic toxicity studies, has been shown to be a tumorigen in rats.
The concurrent administration of potassium supplements, a diet rich in potassium, or other K+-sparing diuretics is not recommended as this may induce hyperkalemia.
In a reproduction study in which female rats received dietary doses of 15 and 50 mg/kg/day spironolactone, there were no effects on mating or fertility, but there was a small increase in incidence of stillborn pups at the higher dose. When injected into female rats (100 mg/kg/day, 7 days i.p.) spironolactone was found to increase the length of the estrous cycle by prolonging diestrus during treatment and inducing constant diestrus during a two-week, post-treatment observation period. These effects were associated with retarded ovarian follicle development and a reduction in circulating estrogen levels, which would be expected to impair mating, fertility and fecundity. Spironolactone (100 mg/kg/day i.p.) administered to female mice decreased the number of mated mice that conceived, and decreased the number of implanted embryos in those that became pregnant; at 200 mg/kg/day it also increased the latency period to mating.
Canrenone, a major (and active) metabolite of spironolactone, appears in human breast milk. Because of the unknown potential for adverse events on the breastfeeding infant, a decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.
Storage and Stability
Store at 15 to 25°C.
Action and Clinical Pharmacology
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 loss is minimized.
ALDACTONE acts both as a diuretic and as an antihypertensive drug by this mechanism. It may be given alone or with other diuretic agents which act more proximally in the renal tubule.
| | Mean
Cmax
(ng/mL) | Mean
Tmax
(h) | Mean
Post-Steady State
t½ (h) | Accumulation Factor:
AUC0-24 h, Day 15/AUC0-24 h, Day 1 |
| 7-α-(thiomethyl) spirolactone (TMS) | 391 | 3.2 | 13.8 | 1.25 |
| 6-β-hydroxy-7-α- (thiomethyl) spirolactone (HTMS) | 125 | 5.1 | 15 | 1.5 |
| Canrenone (C) | 181 | 4.3 | 16.5 | 1.41 |
| Spironolactone | 80 | 2.6 | ~1.4 (t½ β) | 1.3 |
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 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.
ContraindicationsAnuria
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Acute renal insufficiency
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Addison’s disease
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Significant impairment of renal function
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Hyperkalemia
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Hypersensitivity to spironolactone or to any ingredient in the formulation. For a complete listing, see Dosage Forms, Composition and Packaging.
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