ALDACTONE (SPIRONOLACTONE)

Aldactone is a brand name for a generic medication called Spironolactone. It is a prescription drug that got FDA approval for use in reducing edema (fluid retention) in patients suffering from liver cirrhosis, congestive heart failure, or kidney disorders called nephrotic syndrome. Doctors even give it to treat hypertension (high blood pressure), hypokalemia (low potassium in the blood), primary hyperaldosteronism, or heart failure with reduced ejection fraction.

Aldactone tablets contain Spironolactone as the active ingredient and the following inactive ingredients corn starch, calcium sulfate, flavor, iron oxide, hypromellose, magnesium stearate, povidone, polyethylene glycol, and titanium dioxide. Spironolactone is an aldosterone antagonist, practically insoluble in water, and is chemically designated as 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate.

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Aldactone belongs to the pharmacological class of Aldosterone receptor antagonists; Potassium-sparing diuretics. Aldosterone receptor antagonists are a class of medications, also known as diuretics (water pills) that inhibit the effects of aldosterone. Aldosterone is a mineralocorticoid hormone produced by the adrenal gland. Its role is to cause water and sodium retention in the blood, thereby increasing blood volume and blood pressure.

Aldosterone receptor antagonists block the activity of aldosterone, causing sodium reabsorption by the kidneys and other glands. This promotes the loss of extra water from the blood and the subsequent lowering of blood pressure and fluid reduction around the heart. Moreover, this drug class reduces myocardial collagen formation, improves endothelial function, normalizes heart rate, and increases the bioactivity of basal nitric oxide.

Potassium-sparing diuretics are a class of medications that cause the flushing out of water and sodium (salts) through urine without losing potassium. They work to increase urination (diuresis). Aldactone is a weak diuretic that works as an aldosterone receptor antagonist.

Aldactone tablets come in three strengths: 25mg, 50mg, and 100mg.

• 25mg: This strength tablet is light yellow, round, and film-coated with debossing of “1001” on the one side and “ALDACTONE 25” on the other side.
• 50mg: This strength tablet is light yellow, round, scored, and film-coated with debossing of “SEARLE” and “1041” on one side and “ALDACTONE” and “50” on the other side.
• 100mg: This strength tablet is peach-colored, round, scored, and film-coated with debossing of “SEARLE” and “1031” on the scored side and “ALDACTONE” and “100” on the other side.

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Aldactone is given by doctors for the treatment of the following medical conditions:

• Heart failure: Aldactone is usually given in adjunct with other therapies for heart failure. This medicine can help increase life expectancy, reduce the requirement of hospitalization, and manage edema in patients suffering from NYHA class III-IV heart failure with reduced ejection fraction.
• Hypertension: Aldactone is given as an add-on therapy to hypertensive patients who fail to adequately control their blood pressure with other antihypertensive drugs. If the cause of blood pressure is increased blood volume due to water and salt retention, Aldactone is the best medication for treating hypertension.
• Edema associated with Nephrotic Syndrome or Hepatic Cirrhosis: Aldactone helps manage edema in liver cirrhosis and nephrotic syndrome patients when restriction of fluids and sodium intake does not help and other diuretics produce an inappropriate response.
• Primary Hyperaldosteronism: Aldactone is effective in reducing aldosterone hormone levels in the body, thereby regulating water and salt balance in the body. Therefore, it is given as short-term pre-operative therapy for patients suffering from primary hyperaldosteronism. It can also be given as long-term maintenance therapy for patients with idiopathic hyperaldosteronism or discrete aldosterone-producing adrenal adenomas, who are not candidates for surgical intervention.
• Hypokalemia: Aldactone helps increase serum potassium so it can be effective in treating hypokalemia (reduced potassium level in the blood) in cases where other diuretics have caused hypokalemia.

• The suggested dose of Aldactone for Edema is 25 to 200 mg daily in single or divided doses. If Aldactone is taken as a sole diuretic, take the initial dose for at least 5 days and thereafter dose adjustment may be made to an optimal maintenance dose.
• The suggested dose of Aldactone for hypertension is 50 to 100 mg daily in single or divided doses. Take Aldactone for at least two weeks to get a maximum drug response and subsequently adjust the dose as per response.
• The initial suggested dose of Aldactone for congestive heart failure is 25 mg orally once a day. This is as per the assumption that the patient’s serum creatinine is less than or equal to 2.5 mg/dL and serum potassium is less than or equal to 5 mEq/L.
• The usual diagnostic dose for primary hyperaldosteronism for short tests is 400 mg daily for 4 days and for long tests is 400 mg daily for 3 to 4 weeks. A maintenance dose is 100 to 400 mg daily until the surgery.
• The suggested dose for hypokalemia is 25 to 100 mg daily.

Aldactone tablets are meant for oral administration. Take Aldactone with or without food, but in the same way as taken each time. This allows it to be absorbed through the digestive system and then absorbed into the bloodstream. This ensures the medication is metabolized effectively and achieves the desired therapeutic effects.

The commonly reported side effects of taking Aldactone are:

• Headache
• Skin rash
• Nausea
• Vomiting
• Dizziness
• Gas or Bloating.
• Stomach pain
• Breast swelling or tenderness.

Some of the serious unwanted effects of taking Aldactone are:

• Little to no urination.
• Muscle spasms
• Light-headedness
• Bloody or Tarry stools.
• Signs of high potassium like weakness, chest pain, irregular heartbeats, tingly feeling, and others.
• Signs of other electrolyte imbalances like slurred speech, loss of coordination, unsteadiness feeling, severe weakness, numbness, confusion, increased thirst or urination, muscle weakness/pain, and others.

This is not an exhaustive list of side effects. Talk to your doctor for medical advice if experiencing any side effects from taking Aldactone.

Some of the drugs known to interact with Aldactone include:

• Digoxin
• Colchicine
• Loperamide
• Lithium
• Trimethoprim
• Medicines to prevent blood clot.
• Heart or blood pressure medications (especially other diuretics).
• Non-steroidal anti-inflammatory drugs (NSAIDs).

Aldactone is not safe for use by:

• Anyone having known hypersensitivity to any of the ingredients of the Aldactone tablet.
• Patients suffering from hyperkalemia, Addison’s disease, kidney disease, liver disease, heart disease, or inability to urinate.
• Patients who have an electrolyte imbalance such as low levels of sodium, calcium, or magnesium.
• Patients already taking eplerenone.
• Women who are pregnant or intend to get pregnant.
• Breastfeeding women.
• Children under the age of 18 years.

When taking Aldactone, it is important to watch for the following:

• Before starting to take Aldactone, inform the doctor of any existing allergies or medical conditions, current intake of medications/supplements, whether pregnant or breastfeeding, and other significant health-related facts.
• Do not make up for missed doses by doubling the dose.
• Do not take Aldactone if it is out of date, the tablets show signs of deterioration, or the package is torn.
• Avoid alcohol intake as it can cause certain unwanted effects.
• Avoid taking any potassium supplements or salt substitutes, unless a doctor prescribes.
• Do not take a sodium-rich diet as excess salt may cause the body to retain excess water and can make Aldactone less effective.
• Avoid driving, abruptly changing positions, or performing any hazardous activity until you are aware of how Aldactone affects you.

• Store Aldactone tablets in their blistered pack at room temperature, preferably 15-30°C.
• Keep it away from light, moisture, heat, and small children.
• Keep it away from pets.

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