Spironolactone Teva

/ Teva

Administration of Spironolactone once daily with a meal is recommended.
Children should only be treated under guidance of a pediatric specialist. There is limited pediatric 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.
Pediatric 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 pediatric specialist. There is limited pediatric data available.
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Edema in patients with congestive heart failure, hepatic cirrhosis with edema, essential hypertension, hypokalemia, diagnosis of primary hyperaldosteronism.

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.
Spironolactone should not be administered concurrently with other potassium conserving diuretics and potassium supplements should not be given routinely with Spironolactone as hyperkalaemia may be induced.
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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.
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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.
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