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Generic Spironolactone
Spironolactone is a potassium-sparing diuretic and aldosterone antagonist indicated for the treatment of hypertension (as add-on therapy), edema associated with congestive heart failure, cirrhosis of the liver, and nephrotic syndrome, primary hyperaldosteronism, and hypokalemia. It is also used for the management of heart failure with reduced ejection fraction and for the treatment of acne and hirsutism in women due to its anti-androgenic properties. Spironolactone works by competitively binding to aldosterone receptors in the distal renal tubule, inhibiting sodium reabsorption and reducing potassium excretion, leading to mild diuresis and potassium retention. Unlike loop or thiazide diuretics, spironolactone does not cause significant potassium loss.
Usual adult dose: For hypertension, the usual starting dose is 25 mg taken orally once daily, which may be increased to 50 mg to 100 mg daily, given in single or divided doses. For edema associated with heart failure or cirrhosis, the typical starting dose is 25 mg to 100 mg once daily, titrated based on response and serum potassium levels. For primary hyperaldosteronism, doses up to 400 mg per day may be used under specialist supervision. For heart failure with reduced ejection fraction, the usual dose is 25 mg once daily, increased to 50 mg once daily if tolerated. The 25 mg strength is used for initial therapy and dose titration, while the 100 mg strength is used for higher-dose regimens. Spironolactone should be taken with food to improve absorption and reduce gastrointestinal upset. The maximum dose for most indications is 100 mg per day, except in primary hyperaldosteronism where higher doses may be required. Patients should be monitored for serum potassium, renal function, and blood pressure. If a dose is missed, it should be taken as soon as remembered, but two doses should not be taken on the same day.
Dosage form: Oral tablets: 25 mg (light yellow, round, biconvex, scored) and 100 mg (white, round, biconvex, scored). Available in bottles of 30, 100, or 500 tablets.
Onset of action: The diuretic effect begins within 1 to 2 days of starting therapy, but the antihypertensive effect may take 2 to 4 weeks to become fully evident. Anti-androgenic effects on acne and hirsutism develop gradually over 2 to 6 months of continuous treatment.
Duration of action: The elimination half-life of spironolactone is approximately 1.4 hours, but its active metabolites have half-lives of 10 to 20 hours, allowing for once-daily or twice-daily dosing. The therapeutic effect persists for up to 24 hours, and the drug is typically dosed once daily for hypertension and edema.
Alcohol recommendation: Alcohol should be used with caution during treatment with spironolactone. Alcohol can potentiate the blood-pressure-lowering and central nervous system depressant effects, increasing the risk of dizziness, fainting, and impaired coordination. Patients should limit alcohol intake, especially when first starting therapy or when the dose is increased.
Most common side effects: Hyperkalemia (elevated potassium), gynecomastia (breast enlargement) in men, breast tenderness, menstrual irregularities in women, fatigue, headache, nausea, and dizziness. Hyperkalemia is the most serious risk and can be life-threatening; serum potassium must be monitored regularly, especially in patients with renal impairment, diabetes, or those taking other potassium-sparing medications or potassium supplements. Gynecomastia occurs in up to 10% of men and may be dose-dependent; it is usually reversible upon discontinuation. Spironolactone is contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min), hyperkalemia, Addison's disease, or known hypersensitivity. It should be used with caution in patients with hepatic impairment, as it may precipitate hepatic encephalopathy. Patients should seek immediate medical attention for signs of hyperkalemia, such as muscle weakness, irregular heartbeat, or numbness. Spironolactone is available only by prescription in Canada and must be prescribed and monitored by a healthcare professional.
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