Spiractin 25 mg Tablets

Spironolactone may be used initially in the treatment of patients with oedema and ascites associated with hepatic cirrhosis to avoid depletion of potassium or precipitation of hepatic coma that may follow use of a thiazide diuretic. If more profound diuresis is necessary, or in patients with congestive heart failure and the nephrotic syndrome, a thiazide or other diuretics may be given concomitantly with spironolactone. Spironolactone may be effective in treating patients who do not respond satisfactorily to other diuretic agents but it is most useful when given with another diuretic. Spironolactone is reported to have a hypotensive effect in patients with essential hypertension. The rise in serum potassium levels produced by spironolactone in patients with primary hyperaldosteronism has been used as an aid in the diagnosis of this affliction.

The initial dosage is 100 mg daily in 4 divided doses. After 5 days the effect is evaluated; if the response is satisfactory the medicine is continued, if possible at a lower dose. If the response is not satisfactory, a conventional diuretic may be given concomitantly at usual doses. In certain circumstances the dose of spironolactone may have to be increased to 400 mg daily. On discontinuing the medicine the dose should be gradually decreased.

Spironolactone is contraindicated in patients with acute renal insufficiency, anuria and hyperkalaemia.

Because of the risk of producing hyperkalaemia, spironolactone should be given with caution to patients with impaired renal function. It should only be given under careful supervision in patients with severe hepatic disease as stupor and transient hepatic coma may develop in these patients. Plasma electrolyte determinations must be carried out during treatment to prevent electrolyte imbalance, especially hyponatraemia and hyperkalaemia.

Potassium supplementation in the form of either medication or a potassium-rich diet should not be given. Such supplementation can cause hyperkalaemia. Excipients contains lactose which may have an effect on the glycaemic control of patients with diabetes mellitus. Patients with the rare hereditary conditions of galactose intolerance e.g. galactosaemia, Lapp lactase deficiency, glucose-galactose malabsorption or fructose intolerance should not take SPIRACTIN.

Spironolactone may enhance the effects of other antihypertensive agents, the dose of which may need to be reduced. It should be given with caution with other potassium sparing medicines. Serum electrolytes should be estimated periodically.

Safety in pregnancy has not been established.

Hyperkalaemia and hyponatraemia have been observed in patients treated with spironolactone. Drowsiness, headache, ataxia, coma, maculopapular or erythematous cutaneous eruptions, impotence, gynecomastia, mild androgenic effect including hirsutism, irregular menses and deepening voice may occur occasionally.

The symptoms of overdosage are hyperkalaemia clinically characterised by paralysis or muscle spasm. Treatment is symptomatic with emphasis on potassium excretion.