Spironolactone USP
Composition : Spironolactone 25mg Tablet
Indication : Spironolactone is indicated in the management of oedema and ascites in hepatic cirrhosis, malignant ascites, nephrotic syndrome, congestive cardiac failure and primary aldosteronism.
Dosage and administration : Administration of Spironolactone once daily with a meal is recommended. Adults: Congestive cardiac faliure: Usual dose 100mg/day. In difficult or severe cases the dosage may gradually increased up to 400mg/day. When oedema is controlled, the usual maintenance level is 75mg-200mg/day. Hepatic cirrhosis with ascites and oedema: If urinary Na+/K+ ratio is greater than 1.0, 100mg/day. If the ratio is less than 1.0, 200- 400mg/day. Maintenance dosage should be individually determined. Malignant ascites: Initial dose usually 100- 200mg/day. In severe cases the dosage may be gradually increased up to 400mg/day. When oedema is controlled, maintenance dosage should be individually determined. Nephrotic syndrome: Usual dose 100- 200mg/day. Spironolactone has not been shown to be anti-inflammatory, nor to affect the basic pathological process. Its use only advised if glucocorticords by themselves are insufficiently effective. Diagnosis and treatment of primary aldosteronism: Spironolactone may employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets. Long test : Spironolactone is administered at a daily dosage of 400mg for three to four weeks. Correction of hypokalamia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism. Short test : Spironolactone is administered at a daily dosage of 400mg for four days. If serum potassium increses during Spironolactone administration but drops when Spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered. Children : Initial daily dosage should provide 3mg of spironolactone per kilogram body weight given in divided doses. Dosage should be adjusted on the basis of response and tolerance. If necessary a suspension may be prepared by crushing Spironolactone tablets.
Packing : Spiretic : 3 x 10'stablets in blister pack.
