Brand Name : ALDACE
Generic Name : Spironolactone
Preparation : 25 mg Tablet
Pharmacological Categories : Potassium Sparing Diuretic, Selective Aldosterone Blocker
Mechanism of Action (MOA)
ALDACE (Spironolactone) inhibits binding of aldosterone with its receptor at Na-K exchange site in the distal renal tubule. Thus, ALDACE inhibits the action of aldosterone and cause kidneys to promote sodium excretion along with water and conserves potassium.
- Absorption : Well absorbed from the gastrointestinal tract
- Onset of Action : 2 to 4 hours
- Time to Peak Effect : 2 to 3 days
- Distribution : Spironolactone or its metabolites may cross the placental barriers and canrenone is distributed into breast milk
- Protein Binding : about 90%
- Metabolism : Liver and Kidney to multiple metabolites, including canrenone, 7α-thiomethylspirolactone and 6-beta-hydroxy-7-alpha-thiomethylspirolactone (active)
- Elimination Half-life : 1.3 to 1.4 hours (Spironolactone), 9 to 23 hours (metabolite- canrenone)
- Excretion : urine and faeces
- Duration of Action after Stoppage : 2 to 3 days
Indications and Dosage
- Edema due to Congestive Heart Failure (CHF), Hepatic Cirrhosis, or Nephrotic Syndrome :
Initially ALDACE 100 mg per day in either single or divided doses for at least 5 days
Range : ALDACE 25 to 200 mg per day
May adjust to optimal therapeutic or maintenance level in single or divided daily doses.
Second diuretic may be added that acts more proximally in the renal tubule if no adequate diuretic response after 5 days is achieved. Do not change spironolactone dose when other diuretic therapy is added.
- Hypertension : ALDACE 50 to 100 mg per day in single or divided doses for at least 2 weeks. Adjust dose according to the response.
- Primary Hyperaldosteronism :
As a Diagnosis Agent :
- Long Test : ALDACE 400 mg per day for 3 to 4 weeks
- Short Test : ALDACE 400 mg per day for 4 days
Short-Term Preoperative Treatment : ALDACE 100 to 400 mg per day
Unsuitable for Surgery/ Long-Term Maintenance : Lowest effective dose individualized for patient
- Acne in women (off-label) : ALDACE 50 to 200 mg once daily or divided every 12 hours
- Hirsutism in women (off-label) : ALDACE 50 to 200 mg once daily or divided every 12 hours
- Severe Heart Failure (in conjunction with standard therapy): Initially one tablet of ALDACE 25 mg per day; if tolerated, may increase to two tablets of ALDACE 25 mg every day as clinically indicated; may reduce to one tablet of ALDACE 25 mg every other day if not tolerated
- Polycystic Ovary Syndrome (Hirsutism and Menstrual Irregularities) : Two to eight tablets of ALDACE 25 mg daily for 3 to 6 months
MAY OCCUR : Headache, drowsiness, gastrointestinal disturbances, cramp, diarrhoea, gynaecomastia, deepening of the voice, menstrual irregularities, impotence, hyponatraemia, hyperkalaemia, breast pain
REPORTED : Ataxia, mental confusion, skin rashes, mild acidosis
Hypersensitivity to spironolactone, lactation, anuria, acute renal insufficiency, hyperkalemia, Addison’s disease, concomitant use with eplerenone
Warnings / Precautions
- Use cautiously in diabetes mellitus, diabetic nephropathy, fluid and electrolyte imbalance, hepatic disease, renal disease, metabolic acidosis, concomitant use with potassium sparing diuretics or ACE inhibitors.
- Risk of potentially fatal hyperkalemia in severe heart failure patients.
- Monitor serum electrolytes; avoid potassium-rich diet or supplements.
- Risk of gynecomastia and male sexual dysfunction.
- Somnolence may occur; caution when operating heavy machinery.
- Not recommended for pregnancy induced hypertension.
- Risk of hyperkalemia if spironolactone is used with potassium supplements or other potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, NSAIDs, ciclosporin, trilostane, aldosterone blockers, heparin, low molecular weight heparin.
- Spironolactone may reduce the excretion of lithium and increase the risk of lithium toxicity.
- Hyponatremia may occur in patients taking a potassium-sparing diuretic with a thiazide.
- Spironolactone may reduce the ulcer-healing properties of carbenoxolone.
- Spironolactone may enhance the effects of other antihypertensive drugs and may reduce vascular responses to noradrenaline.
- Alcohol, barbiturates and narcotics may potentiate orthostatic hypotension.
- With corticosteroids and adrenocorticotropic hormone spironolactone may lead to intensified electrolyte depletion particularly hypokalemia.
- Spironolactone may increase digoxin level.
Pregnancy Category : C
ALDACE 25 mg : A box of 20 blisters, each strip of 10 tablets