Spironolacton-BP (tab)

Spironolactonum

Spironolacton-BP 25 mg tablets: Each tablet contains spironolactone 25 mg. Excipient with known effect: lactose monohydrate.

Spironolacton-BP 50 mg tablets: Each tablet contains spironolactone 50 mg. Excipient with known effect: lactose monohydrate.

Indication: − Short-term pre-operative treatment of primary hyperaldosteronism. If the patient is inoperable or refuses surgery, treatment may be continued long-term. − Secondary hyperaldosteronism associated with oedema; combining spironolactone with other diuretics, salt and fluid restriction, and possibly bed rest, is recommended. − Oedema in heart failure, when the patient no longer responds to treatment with other diuretics and/or to potentiate their effect. − Oedema and/or ascites in patients with hepatic cirrhosis. − Nephrotic syndrome, when treatment of the underlying disease or salt and fluid restriction, as well as the use of other diuretics, prove ineffective. − Hypertension, particularly when associated with hypokalaemia; in this case, combining spironolactone with antihypertensive medication is recommended. − Hypokalaemia, when no other treatment can be used. − Myasthenia gravis (as adjunctive treatment). − Malignant hypertension (as adjunctive treatment).

Hypersensitivity to spironolactone and to any of the excipients − Anuria, acute renal failure, severe chronic renal impairment (creatinine clearance < 10 ml/min) − Hyperkalaemia − Acute or severe hepatic impairment − Concomitant treatment with potassium salts and/or other potassium-sparing diuretics (triamterene, amiloride) − Pregnancy and breast-feeding.

Spironolactone may cause electrolyte disturbances. In patients with renal impairment or those receiving concomitant potassium supplements, hyperkalaemia with significant cardiac rhythm disturbances may occur. Supplementary potassium intake is contraindicated during treatment with spironolactone. In patients with hepatic cirrhosis, hyperkalaemia may be accompanied by reversible hyperchloraemic metabolic acidosis. In patients with diabetes mellitus, hyperglycaemia promotes an increase in kalaemia. An increase in plasma urea has also been reported, particularly in cases of pre-existing renal impairment. As a rule, close monitoring of renal function and electrolyte levels is strongly recommended during treatment with spironolactone. Warning for athletes. Athletes should be warned that this […]