ALDACTONE TABLET 25 mg

4.1 Therapeutic indications

Spironolactone is indicated for the following:

• Congestive cardiac failure.
• Hepatic cirrhosis with ascites and edema.
• Malignant ascites.
• Nephrotic syndrome.
• Diagnosis and treatment of primary hyperaldosteronism.

4.3 Contraindications

Spironolactone is contraindicated in patients with the following:

• acute renal insufficiency, significant renal compromise, anuria;
• Addison’s disease;
• hyperkalemia;
• hypersensitivity to spironolactone;
• concomitant use of eplerenone.

4.2 Posology and method of administration

Administration of spironolactone once daily with a meal is recommended.

Adults

Congestive cardiac failure

The usual dosage is 100 mg/day. In difficult or severe cases, the dosage may be gradually increased up to 400 mg/day. When edema is controlled, the usual maintenance level is 75 mg/day to 200 mg/day.

Hepatic cirrhosis with ascites and edema

If urinary Na+/K+ ratio is greater than 1.0, the usual adult dose is 100 mg/day. If the ratio is less than 1.0, the usual adult dose is 200 mg/day to 400 mg/day. Maintenance dosage should be individually determined.

Malignant ascites

Initial dose is usually 100 mg/day to 200 mg/day. In severe cases the dosage may be gradually increased up to 400 mg/day. When edema is controlled, maintenance dosage should be individually determined.

Nephrotic syndrome

The usual adult dose is 100 mg/day to 200 mg/day. Spironolactone has not been shown to be anti-inflammatory, or to affect the basic pathological process. Its use is only advised if glucocorticoids by themselves are insufficiently effective.

Diagnosis and treatment of primary hyperaldosteronism

Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.

Long test: Daily adult dose of 400 mg for 3 to 4 weeks. Correction of hypokalemia and hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.

Short test: Daily dosage of 400 mg for 4 days. If serum potassium increases during spironolactone administration, but drops when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered.

Short-term preoperative treatment of primary hyperaldosteronism

After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered at doses of 100 mg to 400 mg daily in preparation of surgery. For patients who are considered unsuitable candidates for surgery, Aldactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.

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.

Children

Initial dosage is 3 mg/kg body weight daily in divided doses. Dosage should be adjusted on the basis of response and tolerance. If necessary a suspension may be prepared by pulverizing spironolactone tablets with a few drops of glycerine and adding cherry syrup. Such a suspension is stable for one month when refrigerated at 2°C to 8°C.