LDACTONE® 25 TABLETS
(and dosage form):
ALDACTONE® 25 TABLETS
ALDACTONE 25: Each tablet contains 25 mg spironolactone
ALDACTONE promotes diuresis in patients with oedema or ascites. ALDACTONE acts in the distal portion of the renal tubule by competitive inhibition of aldosterone, a sodium-retaining, potassium-excreting hormone.
Congestive cardiac failure, hepatic cirrhosis with ascites and oedema, the nephrotic syndrome, idiopathic oedema including premenstrual oedema, malignant ascites, essential hypertension, pre-operative management of primary aldosteronism, long-term treatment of primary aldosteronism where the patient is unable or unwilling to undergo surgery, as an aid to the diagnosis of mineralocorticoid excess, including primary aldosteronism.
ALDACTONE should not be given in acute renal insufficiency, rapidly progressing impairment of renal function, anuria or hyperkalaemia.
Administration is not recommended in the presence of a raised serum potassium and the concomitant use of triamterene or amiloride should be avoided as hyperkalaemia may be induced. The use of potassium supplements is also not recommended for the same reason except in cases of initial potassium depletion.
DOSAGE AND DIRECTIONS FOR USE:
Adults:- Congestive heart failure, hepatic cirrhosis with ascites and oedema, idiopathic oedema including premenstrual oedema, the nephrotic syndrome, malignant ascites. The usual dosage is 100 - 200 mg/day, (usually in association with a conventional diuretic).
Essential hypertension, the usual dosage is 100 mg/day. A higher dosage may be used it necessary. Primary aldosteronism and other forms of hypertension associated with low plasma renin.
a) Pre-operative management
100 - 400 mg/day for 3 - 5 weeks before operation.
b) Long-term management
Where operative correction of primary aldosteronism is not desirable, or possible, 200 - 400 mg/day frequently normalises blood pressure and electrolyte abnormalities. The smallest dose which achieves the desired effect should be used.
c) Screening for mineralocorticoid excess including primary aldosteronism.
Mineralocorticoid excess may be detected by using 300 - 400 mg daily in divided doses in conjunction with in-vivo faecal dialysis, or rectal electrical potential measurements. Tests based on changes in serum potassium, and serum and urinary potassium have also been described.
Children:- The recommended dosage is 3 mg/kg body weight daily.
ALDACTONE is insoluble in water but the tablets may be crushed and given in suspension if necessary.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Gastro-intestinal intolerance, drowsiness and mental confusion have been observed. Reversible unilateral or bilateral gynaecomastia may occur. A maculopapular or erythematous cutaneous eruption has been reported. There have been rare reports of mild androgenicity, hirsutism and menstrual irregularity.
Hyponatraemia may occur, especially with intense treatment in combination with conventional diuretics.
Potentiation of the action of other anti-hypertensive drugs occurs.
Caution should be observed in the presence of liver disease as hepatic coma may be precipitated in susceptible subjects. As with all diuretic therapy, periodic estimation of serum electrolytes may be desirable.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
True toxic effects have not been reported in overdosage. Hyperkalaemia may be manifested clinically by paraesthesia, weakness, flaccid paralysis or muscle spasm, and may be difficult to distinguish clinically from hypokalaemia.
Electrocardiographic changes give the earliest indications of pathologically disturbed serum potassium levels. In the event of hyperkalaemia, discontinue the drug, reduce potassium intake and administer potassium-excreting diuretics and intravenous glucose with insulin or an oral ion-exchange resin as appropriate.
ALDACTONE 25mg: Containing 60 tablets.
Store in a dry place below 25°C. Keep out of reach of children.