Aldactone 25 mg Tablets

Brand Name

The medication is widely recognized under its trade name, Aldactone, a title synonymous with its therapeutic role in various clinical contexts.

International Nonproprietary Name (INN)

The active ingredient in this drug is known globally as spironolactone, ensuring uniform identification across healthcare systems worldwide.

Form of Release

This medication is primarily available as tablets, designed for oral use with strengths that allow tailored treatment plans. The solid form ensures stability and straightforward storage under typical conditions.

Composition

The primary component is spironolactone, a synthetic steroidal compound targeting specific bodily functions. Inactive ingredients include lactose monohydrate, calcium sulfate dihydrate, corn starch, and magnesium stearate, which support the tablet’s structure and dissolution. A film coating may also be present to improve swallowability and shield the active substance from external factors.

Pharmacologic Properties

Pharmacodynamics

This drug acts as a potassium-sparing diuretic by blocking aldosterone receptors in the distal renal tubules. It inhibits sodium reabsorption while preserving potassium and hydrogen ions, boosting water excretion. By opposing aldosterone’s effects, it reduces fluid buildup in tissues, aiding conditions involving excess fluid. Its influence on electrolyte balance also supports blood pressure control and cardiovascular wellness. The diuretic effect emerges gradually, typically within two to three days, peaking with regular administration.

Pharmacokinetics

When taken orally, the medication absorbs well from the digestive tract, with improved uptake alongside food. Peak plasma levels occur within one to two hours. Spironolactone is extensively metabolized in the liver into active compounds like canrenone, extending its therapeutic duration. These metabolites distribute broadly, binding moderately to plasma proteins. Excretion happens mainly through urine, with some via bile. The parent compound’s half-life is short, around one to two hours, but metabolites like canrenone persist longer, with a half-life of 16 to 20 hours. Kidney function heavily impacts clearance, requiring caution in patients with reduced renal capacity.

Indications for Use

The drug is prescribed for conditions requiring fluid and electrolyte management. It effectively treats edema linked to congestive heart failure, easing swelling through fluid removal. It’s also used for hypertension, especially when other treatments fall short, by countering aldosterone-driven sodium retention. In liver cirrhosis with ascites, it reduces abdominal fluid accumulation. Additionally, it addresses primary hyperaldosteronism, managing excess aldosterone from adrenal issues. Off-label, its anti-androgenic effects may benefit hormonal disorders like polycystic ovary syndrome.

Contraindications

Use of this medication is barred in certain cases to avoid serious risks. Hypersensitivity to spironolactone or tablet components prohibits its use due to potential allergic reactions. Severe renal impairment, such as anuria or acute kidney failure, rules it out, as electrolyte imbalances could worsen. Hyperkalemia, marked by high potassium levels, is another barrier, given the drug’s potassium-sparing nature. Adrenal insufficiency conditions like Addison’s disease also contraindicate it due to aldosterone pathway interference. Combining it with potassium supplements or similar agents is typically avoided unless strictly monitored to prevent dangerous potassium buildup.

Method of Administration and Dosage

How to Take

The medication is taken orally, ideally with food to boost absorption and lessen stomach upset. Tablets should be swallowed whole with water for proper delivery. Taking it at the same time daily maintains steady levels in the system.

Dosage for Adults and Children

Adults with edema often start at 100 mg daily, adjustable from 25 mg to 200 mg based on response. For hypertension, 50 to 100 mg daily in one or two doses is common. In children, dosing is weight-based, typically 1 to 3 mg per kilogram daily, divided to ease system strain. Adjustments depend on condition severity and patient factors.

Dose Adjustment in Specific Conditions

Renal insufficiency calls for reduced doses to prevent accumulation and hyperkalemia, often avoided if creatinine clearance drops below 30 mL/min. Liver impairment also requires lower amounts due to slower metabolism. Regular kidney and liver function checks guide these modifications.

Side Effects

The drug may trigger various adverse effects, though not universally experienced. Gastrointestinal issues like nausea, vomiting, or cramps are common. Electrolyte shifts, especially hyperkalemia, can cause muscle weakness or heart rhythm changes, particularly in vulnerable patients. Hormonal effects, such as gynecomastia in men or menstrual changes in women, arise from its anti-androgenic action, often reversing after stopping. Drowsiness, dizziness, or headaches may occur, typically fading over time. Rare severe skin reactions, like rash or Stevens-Johnson syndrome, demand urgent care. Monitoring symptoms helps manage these risks.

Overdose

Symptoms of Overdose

Taking too much can cause deep drowsiness, confusion, or lethargy due to heightened sedative effects. Hyperkalemia may emerge quickly, leading to muscle paralysis or cardiac irregularities, posing serious threats. Excessive diuresis might trigger nausea, vomiting, dehydration, or low blood pressure, potentially escalating to shock.

First Aid Measures

If overdose occurs, stop the drug and seek immediate medical help. Gastric lavage or induced vomiting may be considered soon after ingestion, under supervision. Activated charcoal can curb absorption. IV fluids and electrolytes, like sodium or calcium, may counter potassium excess. Heart and kidney monitoring are vital until stability returns.

Drug Interactions

Effects on Other Medications

This medication can influence other drugs’ effects. It may amplify antihypertensive agents’ blood pressure-lowering action, needing dose tweaks. With NSAIDs, it might impair kidney function, raising injury risk. Its potassium-sparing trait increases hyperkalemia odds with ACE inhibitors, ARBs, or potassium supplements. It could also alter digoxin clearance, requiring close cardiac oversight.

Compatibility with Alcohol and Food

Alcohol should be limited during use, as it may worsen drowsiness or dehydration, undermining benefits. High-potassium foods like bananas need moderation to avoid elevating potassium levels, though a balanced diet is generally safe.

Special Precautions

Use During Pregnancy and Breastfeeding

The drug isn’t advised in pregnancy unless benefits outweigh risks, as animal data suggest fetal harm from hormonal effects. It enters breast milk, so nursing mothers should consult their doctor, possibly pausing breastfeeding or switching treatments.

Impact on Driving and Machinery Operation

Dizziness or fatigue, especially initially, may hinder driving or machinery use. Patients should gauge their response before such tasks to ensure safety.

Considerations for Elderly and Pediatric Populations

Older adults may need lower doses due to declining kidney and liver function, with extra electrolyte monitoring. In children, precise weight-based dosing and growth checks are key, as long-term developmental impacts remain unclear. Customized care optimizes results.