ALDACTONE 25 Tablets

What is ALDACTONE 25

ALDACTONE 25 is an oral medication containing 25 mg of spironolactone, a potassium-sparing diuretic and aldosterone antagonist. It is used to treat various medical conditions related to fluid retention, high blood pressure, and hormonal imbalances.

• Drug Classification: Potassium-sparing diuretic; aldosterone receptor antagonist.
• Mechanism: Blocks aldosterone receptors in the kidneys, promoting sodium and water excretion while conserving potassium.
• Indications:
  • Edema associated with heart failure, liver cirrhosis, or nephrotic syndrome
  • Essential hypertension
  • Primary hyperaldosteronism (diagnosis and treatment)
  • Heart failure with reduced ejection fraction (HFrEF)
  • Polycystic ovary syndrome (PCOS) and hirsutism (off-label)
• Tablet Strength and Packaging: Each tablet contains 25 mg spironolactone; the 100-count pack is suitable for long-term management of chronic conditions.
• Benefits: Helps manage fluid overload and reduce blood pressure while preserving potassium levels—an advantage over loop or thiazide diuretics.
• Special Considerations: Often used in combination with other antihypertensives or diuretics in resistant cases.

How to use ALDACTONE 25

Proper administration of ALDACTONE 25 is essential to ensure safety and therapeutic success. The dosage depends on the medical indication, patient response, and coexisting health conditions.

• Route of Administration: Oral (by mouth)
• Timing: Can be taken with or without food. Taking it with food may reduce gastrointestinal discomfort.
• Dosage Frequency: Usually once or twice daily depending on the dose.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it's near the next dose, skip the missed one. Never double up doses.
• Monitoring Requirements:
  • Serum potassium and sodium
  • Renal function tests (e.g., serum creatinine, eGFR)
  • Blood pressure
• Long-Term Use Tips:
  • Ensure regular follow-up with your healthcare provider.
  • Stay hydrated and avoid potassium-rich foods or supplements unless advised.
• Precautions:
  • Use caution in the elderly or patients with kidney impairment.
  • Do not abruptly discontinue without consulting a physician.

Mode of Action ALDACTONE 25

Spironolactone, the active ingredient in ALDACTONE 25, exerts its pharmacologic effects by antagonizing aldosterone—a hormone that promotes sodium retention and potassium excretion.

• Renal Effects:
  • Inhibits aldosterone at the distal renal tubules.
  • Promotes excretion of sodium and water.
  • Reduces potassium and hydrogen ion excretion—preventing hypokalemia.
• Cardiovascular Benefits:
  • Reduces preload and afterload via diuresis.
  • Lowers blood pressure in hypertensive patients.
  • Prevents cardiac remodeling in heart failure by blocking aldosterone-mediated fibrosis.
• Endocrine Effects:
  • Anti-androgenic activity by blocking androgen receptors and inhibiting testosterone synthesis.
  • Useful in conditions like PCOS, acne, and hirsutism in women.
• Onset of Action: Diuretic effect begins within a few days; full antihypertensive effect may take 2–4 weeks.
• Half-life: Spironolactone has an approximate half-life of 1.5 hours, but its active metabolites (e.g., canrenone) prolong its effect.

ALDACTONE 25 Interactions ALDACTONE 25

Spironolactone may interact with a wide range of medications and supplements, requiring close monitoring and dose adjustments.

• Drugs Increasing Potassium:
  • ACE inhibitors (e.g., enalapril, lisinopril)
  • ARBs (e.g., losartan)
  • Potassium supplements
  • NSAIDs
  • Trimethoprim-sulfamethoxazole (may lead to severe hyperkalemia)
• Diuretics:
  • Loop and thiazide diuretics may enhance diuretic efficacy but increase risk of electrolyte imbalance.
• Lithium: Risk of lithium toxicity increases due to reduced clearance.
• Digoxin: Levels may increase; monitor for digoxin toxicity symptoms.
• Anticoagulants: Spironolactone may interfere with warfarin metabolism, requiring INR monitoring.
• Alcohol: Enhances the blood pressure-lowering effect and dizziness—limit alcohol intake.

Dosage of ALDACTONE 25

ALDACTONE 25 is used in individualized doses depending on the specific condition. Below is a dosing guide based on standard practices:

• Hypertension: 25–100 mg daily, usually started at 25 mg once daily.
• Edema (CHF, liver cirrhosis, nephrotic syndrome): 25–200 mg/day in divided doses depending on severity.
• Heart Failure (HFrEF): 25 mg daily; may be increased to 50 mg if tolerated.
• Primary Hyperaldosteronism: Diagnostic: 100–400 mg/day; Maintenance: lowest effective dose, typically 50–100 mg.
• Hirsutism/PCOS (off-label): 50–100 mg twice daily.
• Geriatric Dosing: Start low (12.5–25 mg) and adjust based on renal function and potassium levels.
• Renal Impairment: Avoid use in severe renal dysfunction; monitor potassium and creatinine closely.

Possible side effects of ALDACTONE 25

While generally well tolerated at 25 mg, spironolactone may cause side effects that range from mild to serious. Monitoring is important during long-term use.

• Common Side Effects:
  • Nausea, vomiting
  • Dizziness, headache
  • Muscle cramps
  • Menstrual irregularities
• Endocrine-Related Effects:
  • Gynecomastia in males (dose-dependent, reversible on discontinuation)
  • Breast tenderness
  • Impotence or libido changes
• Electrolyte Imbalance:
  • Hyperkalemia (potentially life-threatening)
  • Hyponatremia
• Rare But Serious Reactions:
  • Agranulocytosis
  • Hepatotoxicity
  • Stevens-Johnson syndrome

ALDACTONE 25 Contraindications ALDACTONE 25

ALDACTONE 25 should not be used in specific medical conditions where its pharmacological effects can worsen the patient’s state or pose serious risks.

• Absolute Contraindications:
  • Hyperkalemia (serum K+ >5.5 mEq/L)
  • Anuria
  • Acute renal insufficiency
  • Known hypersensitivity to spironolactone
• Relative Contraindications (Use with Caution):
  • Chronic kidney disease (especially eGFR <30 mL/min)
  • Liver dysfunction
  • Pregnancy—risk of feminization of male fetus
  • Lactation—excreted in breast milk
• Drug Interactions Worsening Risk: Concurrent use with potassium supplements or ACE inhibitors increases hyperkalemia risk.

Storage of ALDACTONE 25

Proper storage ensures the stability, safety, and effectiveness of the medication throughout its shelf life.

• Temperature: Store at 20°C to 25°C (68°F to 77°F). Brief excursions permitted between 15°C and 30°C.
• Humidity: Store in a dry place away from moisture and humidity. Do not store in bathrooms.
• Light Protection: Keep in original packaging to protect from light exposure.
• Child Safety: Store out of the reach of children and pets. Use child-resistant packaging.
• Disposal: Do not flush down the toilet. Dispose of unused tablets via pharmacy take-back programs or as directed by local regulations.