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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

    For adults, the daily dose may be given in divided doses or as a single daily dose. Administration of Aldactone with a meal is recommended.
    Adults: Congestive Heart failure An initial daily dose of 100 mg of spironolactone administered in either single or divided doses is
    recommended, but may range from 25 to 200 mg daily. Maintenance dose should be individually determined.
    For severe heart failure in conjunction with standard therapy (NYHA Class III-IV): Based on Randomized Aldactone Evaluation Study (RALES), treatment in conjunction with standard therapy should be initiated at a dose of spironolactone 25 mg once daily in
    Patients with a serum potassium: ≤ 5.0 mEq/L and serum creatinine ≤ 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 dosage reduced to 25 mg every other day.  Hepatic cirrhosis with ascites and oedema. If urinary Na+/K+ ratio is greater than 1.0, 100mg/day. If the ratio is less than 1.0, 200-400mg/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.
    Children: Initial daily dosage should provide 3mg of spironolactone per kilogram body weight given in divided doses. Dosage should be adjusted on the basis of response and tolerance. If necessary a suspension may be prepared by pulverizing spironolactone tablets with a few drops of glycerine and adding cherry syrup. Such a suspension is stable for one month when refrigerated.
    For full details see prescribing information.


    Indications

    Primary aldosteronism, hepatic cirrhosis, congestional cardiac failure, nephrotic syndromes.


    Contra-Indications

    – 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.


    Special Precautions

    Potassium supplementation should not ordinarily be given in association with spironolactone. Pregnancy and lactation. Patient’s fluid and electrolyte balance should be carefully evaluated. Hyponatremia may be caused or aggravated, especially when spironolactone is administered in combination with other diuretics.
    For full details see prescribing information.


    Side Effects

    Gynecomastia. A few cases of agranulocytosis have been reported. Gastrointestinal symptoms, drowsiness, lethargy, headache and mental confusion, drug fever, ataxia, maculopapular or erythematous cutaneous eruptions, urticaria, inability to achieve or maintain erection, irregular menses or amenorrhea, postmenopausal bleeding, hirsutism and deepening of the voice, gastric bleeding, ulceration, gastritis and vomiting.
    For full details see prescribing information.


    Drug interactions

    Interactions with other Medicinal Products and other forms of Interaction Concomitant use of drugs known to cause hyperkalemia with spironolactone may result in severe hyperkalemia. Spironolactone has been reported to increase the half-life of digoxin and can interfere with assays for plasma digoxin concentrations. 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. Spironolactone may have an additive effect when given concomitantly with other diuretics and antihypertensive agents. The dose of such drugs may need to be reduced when spironolactone is added to the treatment regimen. Since ACE inhibitors decrease aldosterone production they should not routinely be used with spironolactone, particularly in patients with marked renal impairment. Coadministration of spironolactone with carbenoxolone may result in decreased efficacy of either agent. Non-steroidal anti-inflammatory drugs (Aspirin, indomethacin, and mefenamic acid) have been shown to attenuate the diuretic effect of spironolactone, due toinhibition of intrarenal synthesis of prostaglandins. 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 spironolactone. Spironolactone enhances the metabolism of antipyrine. Hyperkalemic metabolic acidosis has been reported in patients given spironolactone concurrently with ammonium chloride or cholestyramine. In fluorimetric assays, spironolactone may interfere with the estimation of compounds with similar fluorescence characteristics.
    For full details see prescribing information.


    Pregnancy and Lactation

    Spironolactone was devoid of teratogenic effects in mice. Rabbits receiving spironolactone showed reduced conception rate, increased resorption rate, and lower number of live births. No embryotoxic effects were seen in rats administered high dosages, but limited, dosage-related hypoprolactinemia and decreased ventral prostate and seminal vesicle weights in males,and increased luteinizing hormone secretion and ovarian and uterine weights in females were reported. Feminization of the external genitalia of male foetuses was reported in another study in rats. There are no studies in pregnant women. Spironolactone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Canrenone, a major (and active) metabolite of spironolactone, appears in human breast milk. Because many drugs are excreted in human milk and because of the unknown potential for adverse effects on the breastfeeding infant, a decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.


    Overdose

    Acute overdose may be manifested by drowsiness, mental confusion, nausea, vomiting, dizziness, maculopapular or erythematous rash, or diarrhoea. Electrolyte imbalance and dehydration may occur. Hyponatraemia, or hyperkalaemia may be induced, but these effects are unlikely to be associated with acute overdose. Symptoms of hyperkalaemia may manifest as paraesthesia, weakness, flaccid paralysis or muscle spasm and may be difficult to distinguish clinically from hypokalaemia. Electrocardographic changes are the earliest specific signs of potassium disturbances. No specific antidote has been identified. Spironolactone use should be discontinued and potassium intake (including dietary sources) restricted.


    Manufacturer
    Piramal Healthcare, UK Ltd
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