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  • Aldactone
    / Pfizer


    Active Ingredient

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Coated Tablets

    20 X 25 mg

    full basket chart 9234 1100

    Related information


    Dosage

    Administration of Aldactone once daily with a meal is recommended.
    Children should only be treated under guidance of a paediatric specialist. There is limited paediatric data available.
    Adults:
    Congestive cardiac failure with oedema: For management of oedema an initial daily dose of 100 mg of spironolactone administered in either single or divided doses is recommended, but may range from 25 mg to 200 mg daily. Maintenance dose should be individually determined.
    Severe heart failure (New York Heart Association Class III-IV): Based on the Randomized Aldactone Evaluation Study, treatment in conjunction with standard therapy should be initiated at a dose of spironolactone 25 mg once daily if serum potassium is ≤5.0 mEq/L and serum creatinine is ≤2.5 mg/dL. Patients who tolerate 25 mg once daily may have their dose increased to 50 mg once daily as clinically indicated. Patients who do not tolerate 25 mg once daily may have their dose reduced to 25 mg every other day. See section 4.4 for advice on monitoring serum potassium and serum creatinine.
    Hepatic cirrhosis with ascites and oedema: If urinary Na+/K+ ratio is greater than 1.0, 100 mg/day. If the ratio is less than 1.0, 200 mg/day to 400 mg/day. Maintenance dosage should be individually determined.
    Elderly: It is recommended that treatment is started with the lowest dose and titrated upwards as required to achieve maximum benefit. Care should be taken with severe hepatic and renal impairment which may alter drug metabolism and excretion.
    Paediatric population: Initial daily dosage should provide 3 mg of spironolactone per kilogram body weight given in divided doses. Dosage should be adjusted on the basis of response and tolerance.
    Children should only be treated under guidance of a paediatric specialist. There is limited paediatric data available.


    Indications

    Congestive heart failure
    Cirrhotic ascites


    Contra-Indications

    Spironolactone is contraindicated in adult and paediatric patients with the following:
    • acute renal insufficiency, significant renal compromise, anuria
    • Addison’s disease
    • hyperkalaemia
    • hypersensitivity to spironolactone or to any of the excipients
    • concomitant use of eplerenone or other potassium sparing diuretics
    Spironolactone is contraindicated in paediatric patients with moderate to severe renal impairment.
    Aldactone should not be administered concurrently with other potassium conserving diuretics and potassium supplements should not be given routinely with Aldactone as hyperkalaemia may be induced.


    Special Precautions

    Fluid and electrolyte balance: Fluid and electrolyte status should be regularly monitored particularly in the elderly, in those with significant renal and hepatic impairment.
    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 Aldactone should be discontinued, and if necessary, active measures taken to reduce the serum potassium to normal.
    Reversible hyperchloraemic metabolic acidosis, usually in association with hyperkalaemia has been reported to occur in some patients with decompensated hepatic cirrhosis, even in the presence of normal renal function.
    Concomitant use of Aldactone with other potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, nonsteroidal anti-inflammatory drugs, angiotensin II antagonists, aldosterone blockers, heparin, low molecular weight heparin or other drugs or conditions known to cause hyperkalaemia, potassium supplements, a diet rich in potassium or salt substitutes containing potassium, may lead to severe hyperkalaemia.
    Urea: Reversible increases in blood urea have been reported in association with Aldactone therapy, particularly in the presence of impaired renal function.
    Hyperkalaemia in Patients with Severe Heart Failure: Hyperkalaemia may be fatal. It is critical to monitor and manage serum potassium in patients with severe heart failure receiving spironolactone. Avoid using other potassium-sparing diuretics. Avoid using oral potassium supplements in patients with serum potassium >3.5 mEq/L. The recommended monitoring for potassium and creatinine is 1week after initiation or increase in dose of spironolactone, monthly for the first 3 months, then quarterly for a year, and then every 6 months. Discontinue or interrupt treatment for serum potassium >5 mEq/L or for serum creatinine >4 mg/dL.
    Paediatric population: Potassium-sparing diuretics should be used with caution in hypertensive paediatric patients with mild renal insufficiency because of the risk of hyperkalaemia. (Spironolactone is contraindicated for use in paediatric patients with moderate or severe renal impairment).


    Side Effects

    Very Common ≥ 1/10: Hyperkalaemia.
    Common≥ 1/100 to < 1/10: Confusional state, Dizziness, Nausea, Pruritus, Rash, Muscle spasms, Acute kidney injury, Gynaecomastia, Breast pain (male), Malaise.
    See prescribing information for full details.


    Drug interactions

    Concomitant use of drugs known to cause hyperkalaemia with spironolactone may result in severe hyperkalaemia. In addition, concomitant use of trimethoprim/sulfamethoxazole (co-trimoxazole) with spironolactone may result in clinically relevant hyperkalaemia.
    Spironolactone has been reported to increase serum digoxin concentration and to interfere with certain serum digoxin assays. In patients receiving digoxin and spironolactone the digoxin response should be monitored by means other than serum digoxin concentrations, unless the digoxin assay used has been proven not to be affected by spironolactone therapy. If it proves necessary to adjust the dose of digoxin patients should be carefully monitored for evidence of enhanced or reduced digoxin effect.
    Potentiation of the effect of antihypertensive drugs occurs and their dosage may need to be reduced when Aldactone is added to the treatment regime and then adjusted as necessary. Since ACE inhibitors decrease aldosterone production they should not routinely be used with Aldactone, particularly in patients with marked renal impairment.
    As carbenoxolone may cause sodium retention and thus decrease the effectiveness of Aldactone concurrent use should be avoided.
    Non-steroidal anti-inflammatory drugs such as aspirin, indomethacin, and mefenamic acid may attenuate the natriuretic efficacy of diuretics due to inhibition of intrarenal synthesis of prostaglandins and. have been shown to attenuate the diuretic effect of spironolactone.
    Spironolactone reduces vascular responsiveness to noradrenaline. Caution should be exercised in the management of patients subjected to regional or general anaesthesia while they are being treated with Aldactone.
    In fluorimetric assays, spironolactone may interfere with the estimation of compounds with similar fluorescence characteristics. Spironolactone has been shown to increase the half-life of digoxin.
    Spironolactone enhances the metabolism of antipyrine.
    Spironolactone can interfere with assays for plasma digoxin concentrations.


    Pregnancy and Lactation

    Pregnancy: Spironolactone or its metabolites may cross the placental barrier. With spironolactone, feminisation has been observed in male rat foetuses. The use of Aldactone in pregnant women requires that the anticipated benefit be weighed against the possible hazards to the mother and foetus.
    Lactation: Metabolites of spironolactone have been detected in breast milk. If use of Aldactone is considered essential, an alternative method of infant feeding should be instituted.


    Overdose

    Acute overdosage may be manifested by drowsiness, mental confusion, nausea, vomiting, dizziness or diarrhoea. Hyponatraemia, or hyperkalaemia may be induced, but these effects are unlikely to be associated with acute overdosage. Symptoms of hyperkalaemia may manifest as paraesthesia, weakness, flaccid paralysis or muscle spasm and may be difficult to distinguish clinically from hypokalaemia. Electrocardiographic changes are the earliest specific signs of potassium disturbances. No specific antidote has been identified. Improvement may be expected after withdrawal of the drug. General supportive measures including replacement of fluids and electrolytes may be indicated. For hyperkalaemia, reduce potassium intake, administer potassium-excreting diuretics, intravenous glucose with regular insulin or oral ion-exchange resins.


    Important notes

    Storage: Store below 30°C.


    Manufacturer
    Piramal Healthcare, UK Ltd
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