ALDACTONE 25MG TABLETS 20`S

Therapeutic indications Oedema associated with congestive heart failure Severe heart failure, (NYHA III-IV) As an adjuvant in treatment of resistant hypertension Nephrotic syndrome Liver cirrhosis with ascites and oedema Diagnosis and treatment of primary hyperaldosteronism (Conn?s syndrome) ? Posology and method of administration Posology Adults The dosage should be determined individually depending on the condition and the degree of diuresis required. Dosage up to100 mg daily may be administered as a single dose or in divided doses. Oedema associated with congestive heart failure 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 to 200 mg daily. Maintenance dose should be individually determined. Severe heart failure (NYHA Class III-IV) Treatment in conjunction with standard therapy should be initiated at a dose of spironolactone 25 mg once daily if serum potassium is ? 5.0 mEq/L and serum creatinine is ? 2.5 mg/dL (221 ?mol/L). Patients who tolerate 25 mg once daily may have their dose increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once daily may have their dose reduced to 25 mg every other day. Resistant Hypertension The starting dose for spironolactone should be 25mg daily in a single dose; the lowest effective dose should be found, very gradually titrating upwards to a dose of 100mg daily or more. Nephrotic syndrome Usual dose is 100-200mg/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. Hepatic cirrhosis with ascites and oedema The starting dose is 100-200 mg per day, e.g. based on Na+/K+ ratio. If the response to 200 mg spironolactone within the first two weeks is not sufficient, furosemide is added and if necessary, the spironolactone dose is increased stepwise up to 400 mg per day. Maintenance dosage should be individually determined. Diagnosis and treatment of primary aldosteronism If primary hyperaldosteronism is suspected, spironolactone is given at a dose of 100 ? 150 mg, or up to 400 mg daily. In the event of rapid onset of a strong diuretic and antihypertensive effect, this is a clear indication of elevated aldosterone production. In this case, 100 ? 150 mg daily is administered for 3 ? 5 weeks prior to surgery. If surgery is not an option, this dose is often sufficient to maintain blood pressure and potassium concentration at normal levels. In exceptional cases, higher doses are necessary, but the lowest possible dosage should be found. Paediatric population 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. The Elderly It is recommended that treatment is started at the lowest possible dose, then titrated with higher doses until the optimum effect is achieved. Caution is required, in particular in renal dysfunction. Method of administration The tablets should be taken with meals. Daily dosages in excess of 100 mg should be given in several divided doses.