Indications• Congestive cardiac failure• Hepatic cirrhosis with ascites and oedema• Malignant ascites• Nephrotic syndrome• Diagnosis and treatment of primary aldosteronism.Dosage and AdministrationDos
Indications
• Congestive cardiac failure
• Hepatic cirrhosis with ascites and oedema
• Malignant ascites
• Nephrotic syndrome
• Diagnosis and treatment of primary aldosteronism.
Dosage and Administration
Dosage:
Adults
For management of oedema an initial daily dose of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 mg to 200 mg daily. Maintenance dose should be individually determined.
Elderly: It is recommended that treatment is started with the lowest dose and titrated upwards as required to achieve maximum benefit. Care should be taken with severe hepatic and renal impairment which may alter drug metabolism and excretion.
Usage: Administration of Aldactone once daily with a meal is recommended.
Precautions & Warning:
Fluid and electrolyte balance
Fluid and electrolyte status should be regularly monitored particularly in the elderly, in those with significant renal and hepatic impairment.
Urea
Reversible increases in blood urea have been reported in association with Aldactone therapy, particularly in the presence of impaired renal function.
Hyperkalaemia in Patients with Severe Heart Failure
Hyperkalaemia may be fatal. It is critical to monitor and manage serum potassium in patients with severe heart failure receiving spironolactone.
Paediatric population
Potassium-sparing diuretics should be used with caution in hypertensive paediatric patients with mild renal insufficiency because of the risk of hyperkalaemia.
Contraindications:
Spironolactone is contraindicated in adult and paediatric patients with the following:
• acute renal insufficiency, significant renal compromise, anuria
• Addison's disease
• hyperkalaemia
• hypersensitivity to spironolactone or to any of the excipients listed in
• concomitant use of eplerenone or other potassium sparing diuretics.
Spironolactone is contraindicated in paediatric patients with moderate to severe renal impairment.
Adverse Reactions:
Gynaecomastia may develop in association with the use of spironolactone. Development appears to be related to both dosage level and duration of therapy and is normally reversible when the drug is discontinued. In rare instances some breast enlargement may persist.
1.Metabolism and nutrition disorders: Hyperkalaemia, Electrolyte imbalance.
2.Psychiatric disorders: Confusional state
3.Nervous system disorders: Dizziness
4.Gastrointestinal disorders: Nausea
5.Skin and subcutaneous tissue disorders: Pruritus, Rash, Urticaria
6.Musculoskeletal and connective tissue disorders: Muscle spasms
Storage instructions:
Do not store above 30ºC.