Aldactone pfizer 100mg
2. Qualitative and quantitative composition
Each tablet contains 100 mg spironolactone BP
3. Pharmaceutical form
Aldactone pfizer 100mg are buff, film coated tablets engraved “SEARLE 39” on one side.
4. Clinical particulars
4.1 Therapeutic indications
• Congestive cardiac failure
• Hepatic cirrhosis with ascites and oedema
• Malignant ascites
• Nephrotic syndrome
• Diagnosis and treatment of primary aldosteronism.
Children should only be treated under guidance of a paediatric specialist
4.2 Posology and method of administration
Administration of Aldactone pfizer 50mg once daily with a meal is recommended.
Congestive cardiac failure with oedema
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 50 mg to 200 mg daily. Maintenance dose should be individually determined.
Hepatic cirrhosis with ascites and oedema
If urinary Na+/K+ ratio is greater than 1.0, 100 mg/day. If the ratio is less than 1.0, 200 mg/day to 400 mg/day. Maintenance dosage should be individually determined.
Initial dose usually 100 mg/day to 200 mg/day. In severe cases the dosage may be gradually increased up to 400 mg/day. When oedema is controlled, maintenance dosage should be individually determined.
Usual dose 100 mg/day to 200 mg/day. Spironolactone has not been shown to be anti-inflammatory, nor to affect the basic pathological process. Its use is only advised if glucocorticoids by themselves are insufficiently effective.
Diagnosis and treatment of primary aldosteronism
Aldactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.
Long test: Aldactone pfizer 100mg is administered at a daily dosage of 400 mg for 3 to 4 weeks. Correction of hypokalaemia and hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.
Short test: Aldactone is administered at a daily dosage of 400 mg for 4 days. If serum potassium increases during Aldactone administration but drops when Aldactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.
After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, Aldactone may be administered at doses of 100 mg to 400 mg daily in preparation for surgery. For patients who are considered unsuitable for surgery, Aldactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.
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.
Initial daily dosage should provide 1-3 mg of spironolactone per kilogram body weight given in divided doses. Dosage should be adjusted on the basis of response and tolerance .
Children should only be treated under guidance of a paediatric specialist. There is limited paediatric data available .
Spironolactone is contraindicated in adult and paediatric patients with the following:
• acute renal insufficiency, significant renal compromise, anuria
• Addison’s disease
• hypersensitivity to spironolactone or to any of the excipients listed in section 6.1
• concomitant use of eplerenone or other potassium sparing diuretics.
Spironolactone is contraindicated in paediatric patients with moderate to severe renal impairment.
Aldactone should not be administered concurrently with other potassium conserving diuretics and potassium supplements should not be given routinely with Aldactone as hyperkalaemia may be induced.
4.4 Special warnings and precautions for use
Fluid and electrolyte balance
Fluid and electrolyte status should be regularly monitored particularly in the elderly, in those with significant renal and hepatic impairment.
Hyperkalaemia may occur in patients with impaired renal function or excessive potassium intake and can cause cardiac irregularities which may be fatal. Should hyperkalaemia develop Aldactone pfizer 100mg should be discontinued, and if necessary, active measures taken to reduce the serum potassium to normal (see section 4.3).
Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia has been reported to occur in some patients with decompensated hepatic cirrhosis, even in the presence of normal renal function.
Concomitant use of Aldactone with other potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs, angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin or other drugs or conditions known to cause hyperkalaemia, potassium supplements, a diet rich in potassi