SPIRETIC

Adults:

Prescribing dose once daily with a meal is recommended Congestive heart failure: Usual dose – 100 mg/day. In difficult or severe cases the dosage may be gradually increased up to 400 mg/day. When oedema is controlled, the usual maintenance level is 25-200 mg/day.

0, 100 mg per day. 0, 200-400 mg/day. Maintenance dosage should be individually determined.

Malignant ascites:

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

Nephrotic syndrome:

Usual dose – 100-200 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:

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

Long tests:

SPIRETIC is administered at a daily dose of 400 mg for three to four weeks. Correction of hypokalaemia and of hypertension provides presumption evidence for the diagnosis of primary hyperaldosteronism.

Short tests:

SPIRETIC is administered at a daily dosage of 400 mg for four days. If serum potassium increases during SPIRETIC administration but drops when SPIRETIC is discontinued a presumptive diagnosis of primary hyperaldosteronism should be considered.

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

Children:

Gynaecomastia may develop in association with the use of spironolactone and appears to be related to both dosage level and duration of therapy. It is normally reversible upon discontinuing spironolactone treatment, on rare occasions some breast enlargement may persist.

Skin rashes may occur. Pruritus or urticaria also may occur. Patients receiving spironolactone therapy should be carefully evaluated for possible disturbances of fluid and electrolyte balance. 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 SPIRETIC should be discontinued, and if necessary active measures taken to reduce the serum potassium to normal. Reversible increase in blood urea has been reported in association with spironolactone therapy, particularly in the presence of impaired renal function.

Dilutional hyponatraemia may be induced, especially when spironolactone is administered in combination with other diuretics.

Other side effects which may occur include:

General: dizziness, headache, mental confusion, drowsiness, lethargy Gastrointestinal: gastrointestinal disturbances, nausea Reproductive system: impotence, menstrual irregularities Urinary system: acute renal failure Liver disorders: hepatotoxicity, abnormal hepatic function: Heamatological: leukopenia, thrombocytopenia Skeletal system: osteomalacia There have been reports of malignant breast tumours in men.

Fluid and electrolyte levels should be monitored, especially in elderly patients and those with significant hepatic or renal impairment. Hepatic coma may be precipitated in susceptible patients. Hyperkalemia may occur in patients with renal impairment or excessive potassium intake (eg supplements).

Spironolactone treatment should be discontinued if hyperkalemia develops. 5). Care should be taken in patients with porphyria. 5) and their dosage should first be reduced by at least 50% when SPIRETIC 100 mg or SPIRETIC 25 mg is added to the treatment regime and then adjusted as necessary.

Carcinogenicity:

Spironolactone has been shown to produce tumours in rats when administered at high doses over a long period of time. The significance of those findings with respect to clinical use is not certain. However the long-term use of spironolactone in young patients requires careful consideration of the benefits and the potential hazards involved.

SPIRETIC is contraindicated in patients with anuria, acute renal insufficiency, rapidly progressing impairment of renal function, hyperkalaemia, hyponatraemia, Addison’s disease and in patients who are hypersensitive to spironolactone.