SPIRONOLACTONE TABLETS BP
Dosage form and Strength
Tablets containing spironolactone BP 25 mg (film coated) per tablet.
Spironolactone is a steroid with a structure resembling that of the natural adrenocortical hormone aldosterone.
It acts as a potassium sparing diuretic, increasing sodium and water excretion and reducing potassium excretion.
Spironolactone has a relatively slow onset of action, requiring 2 or 3 days for maximum effect, and similarly slow diminishment of action over 2 or 3 days on discontinuation.
Spironolactone is used for the treatment of oedema and ascites in cirrhosis of the liver, malignant ascites, nephrotic syndrome, congestive heart failure. It is frequently given with the thiazides, furosemide, or similar diuretics.
It is also used for the diagnosis and treatment of primary hyperaldosteronism.
Administer once daily with a meal.
100 mg a day, gradually increased to 400 mg a day, if necessary. When oedema is controlled, the usual maintenance level is 25 mg-200 mg a day.
Presumptive diagnosis: 400mg daily for 3 – 4 weeks.
Pre-operative management: 100 -400 mg daily.
Long-term maintenance therapy in the absence of surgery: lowest effective dosage.
Children: 3mg/kg body weight in divided doses.
PREGNANCY AND BREAST FEEDING
Avoid in pregnancy and breast feeding.
CONTRA-INDICATIONS AND WARNINGS
Do not use in patients with anuria, acute renal insufficiency, rapidly deteriorating or severe impairment of renal function, hyperkalaemia, hyponutreemia, Addison’s disease and in patients who are hypersensitive to spironolactone.
Use with caution in the elderly (reduce done), diabetes mellitus, hepatic impairment, mild renal impairment, and porhyria. Monitor blood urea nitrogen and plasma electrolytes.
Potassium supplements should not be given with spironolactone.
Hyponatraemia maybe induced, especially when administered in combination with other diuretics.
Spironolactone reduces vascular responsiveness to norepinephrine and regional or general anaesthesia should be used with caution.
Spironolactone has been reported to increase serum digoxin concentration and to interfere with certain serum digoxin assays. Concomitant use of spironolactone with other potassium-sparing diuretics, ACE inhibitors, angiotensin II antagonists, aldosterone blockers, potassium supplements, ciclosporin, NSAIDs, a diet rich in potassium, or salt substitutes containing potassium, may lead to severe hyperkalaemia. Should hyperkalaemia develop spironolactone should be discontinued, and if necessary, active measures taken to reduce the serum potassium to normal. In patients receiving spironolactone with NSAIDs or ciclosporin the risk of nephrotoxicity may be increased.
Aspirin has been shown to attenuate the diuretic effect of spironolactone.
Diuretics may reduce lithium excretion and increase the rink of lithium toxicity.
Spironolactone may enhance the effects of other antihypertensive drugs.
Gastro-intestinal disturbances, impotence, gynaecomastia, menstrual irregularities, lethargy, headache, confusion, rashes, hyperkalaemia (discontinue), hyponatraemia, hepatotoxicity, osteomalacia, and blood disorders are reported.
Symptoms: Drowsiness, mental confusion, nausea, vomiting, dizziness or diarrhoea. Hyponatraemia, hyperkalaumia may be induced.
Treatment: No specific antidote. Withdrawal of the drug. General supportive measures including replacement of fluids and electrolytes. For hyperkalaemia, reduce potassium intake, administer potassium-excreting diuretics.
Store in a dry place below 30oC. Protect from light.
Keep out of reach of children.
Jars containing 100/250/500/1000 tablets.
Box containing 10 x 10 strips/blisters or as required.