Spironolactone

Indications
 Oral
Oedema
Adult: Initially, 100 mg daily, may adjust dose according to response up to 400 mg daily.
Child: Neonates: 1-2 mg/kg daily; 1 mth-12 yr: 1-3 mg/kg daily; 12-18 yr: 50-100 mg daily. To be given in 1-2 divided doses.
Elderly: Initially, 25-50 mg/day in 1-2 divided doses, may increase by 25-50 mg every 5 days when necessary.
CrCl (ml/min)Dosage Recommendation
10-50Recommended dosing interval: Every 12-24 hr.
<10Avoid use.

Oral
Hepatic cirrhosis with ascites and oedema
Adult: Depending on urinary sodium/potassium ratio: If >1: Initially, 100 mg daily and if <1: Initially, 200-400 mg daily.
Child: Neonate: 1-2 mg/kg daily (Max: 7 mg/kg daily in resistant ascites); 1 mth-12 yr: 1-3 mg/kg daily (Max: 9 mg/kg daily in resistant ascites); 12-18 yr: 50-100 mg daily (Max: 400 mg daily in resistant ascites). To be given in 2 divided doses.
Elderly: Dosing adjustment may be required.
CrCl (ml/min)Dosage Recommendation
10-50Recommended dosing interval: Every 12-24 hr.
<10Avoid use.

Oral
Diagnosis of primary hyperaldosteronism
Adult: 400 mg daily for 3-4 wk. Correction of serum potassium levels and hypertension gives the presumptive evidence for the diagnosis of primary aldosteronism.
Elderly: Dosing adjustment may be required.
CrCl (ml/min)Dosage Recommendation
10-50Recommended dosing interval: Every 12-24 hr.
<10Avoid use.

Oral
Preoperative management of hyperaldosteronism
Adult: 100-400 mg daily. Long term maintenance in the absence of surgery: May initiate at 400 mg daily and maintain at 100-300 mg daily; lowest effective dose should be used.
Elderly: Dosing adjustment may be required.
CrCl (ml/min)Dosage Recommendation
10-50Recommended dosing interval: Every 12-24 hr.
<10Avoid use.

Oral
Hypertension
Adult: As monotherapy: Usual dose range: 25-50 mg daily, may increase up to 100 mg daily if needed.
Elderly: Initially, 25-50 mg/day in 1-2 divided doses, may increase by 25-50 mg every 5 days when necessary.
CrCl (ml/min)Dosage Recommendation
10-50Recommended dosing interval: Every 12-24 hr.
<10Avoid use.

Oral
Severe congestive heart failure
Adult: For patients receiving an ACE inhibitor and a loop diuretic with or without a cardiac glycoside: Initially, 12.5-25 mg daily. May increase to 50 mg daily after 8 wk of treatment depending on response.
Child: Neonates: 1-2 mg/kg daily; 1 mth-12 yr: 1-3 mg/kg daily; 12-18 yr: 50-100 mg daily. To be given in 1-2 divided doses.
Elderly: Dosing adjustment may be required.
CrCl (ml/min)Dosage Recommendation
10-50Recommended dosing interval: Every 12-24 hr.
<10Avoid use.

Oral
Diuretic-induced hypokalaemia
Adult: 25-100 mg daily.
Child: Neonates: 1-2 mg/kg daily; 1 mth-12 yr: 1-3 mg/kg daily; 12-18 yr: 50-100 mg daily. To be given in 1-2 divided doses.
Elderly: Dosing adjustment may be required.
CrCl (ml/min)Dosage Recommendation
10-50Recommended dosing interval: Every 12-24 hr.
<10Avoid use.

Oral
Hirsutism
Adult: 50-200 mg daily.
Elderly: Dosing adjustment may be required.
CrCl (ml/min)Dosage Recommendation
10-50Recommended dosing interval: Every 12-24 hr.
<10Avoid use.
Contraindications
 Anuria, hyperkalaemia, acute or progressive renal insufficiency. Addison's disease.
Warnings / Precautions
 Patients at risk of developing hyperkalaemia and acidosis; monitor serum electrolytes; renal and hepatic impairment; DM; elderly; pregnancy.
Adverse Reactions
 Fluid or electrolyte imbalance, gynaecomastia, GI upset, drowsiness, headache, hyponatraemia; tachycardia, hypotension, oliguria, hyperkalaemia; confusion, weakness, paraesthesia, hirsutism, mental disturbances, menstrual irregularities, loss of libido and impotence.
Potentially Fatal: Fatal hyperkalaemia in combination with ACE inhibitors and previous renal impairment; agranulocytosis.
Overdose Reactions
 Acute overdosage may result in drowsiness, mental confusion, maculopapular or erythematous rash, nausea, vomiting, dizziness or diarrhoea. Hyperkalemia may occur, especially in patients with impaired renal function. Induce vomiting or evacuate the stomach by lavage. Supportive treatment to maintain hydration, electrolyte balance and vital functions. For hyperkalaemia, cationic exchange resins such as sodium polystyrene sulfonate may be given orally or rectally. Persistent hyperkalemia may require dialysis.
Drug Interactions
 Sodium excretion effect may be inhibited by aspirin. May reduce ulcer-healing properties of carbenoxolone. Increased risk of nephrotoxicity when used with NSAIDs or ciclosporin. Hyperkalaemia may occur if given with potassium supplements, ACE inhibitors, angiotensin II antagonists, NSAIDs, ciclosporin or trilostane. May increase risk of orthostatic hypotension when used with barbiturates, narcotics or alcohol. May reduce vascular responsiveness to pressor amines. May increase half-life of digoxin.
Potentially Fatal: Increased risk of lithium toxicity when used concurrently.
See Below for More spironolactone Drug Interactions
Lab Interactions
 Interferes with fluorometric measurements of plasma cortisol, immunoassays for serum digoxin, and estimations of 17-ketosteroids and 17-ketogenic steroids.
Food Interactions
 Improved absorption if taken after food.
Mechanism of Actions
 Spironolactone acts on the distal renal tubules as a competitive antagonist of aldosterone. It increases the excretion of sodium chloride and water while conserving potassium and hydrogen ions.
Absorption: Well absorbed from the GI tract after oral admin with a bioavailability of 90%.
Distribution: About 90% bound to plasma proteins.
Metabolism: Extensively metabolised.
Excretion: Mainly excreted in the urine, some in the faeces, as metabolites.
Administration
 Should be taken with food.
Storage Conditions
 Oral: Store <25°C.
ATC Classification
 C03DA01 - spironolactone ; Belongs to the class of aldosterone antagonists. Used as potassium-sparing diuretics.
Storage
 Oral: Store <25°C.
Available As
  • Spironolactone 100 mg
  • Spironolactone 25 mg
  • Spironolactone 50 mg

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