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Spironolakton

Spironolactone

Tablets 25 mg

Tablets 100 mg 

ATC C03D A01

Prescription Only Medicine

Medicines reimbursed by the Health Insurance Fund

POSOLOGY AND METHOD OF ADMINISTRATION


Administration of spironolactone once daily with a meal is recommended.

Adults:

Congestive Cardiac Failure with Oedema

For the 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 to 200 mg daily. The maintenance dose should be individually determined.

Patients with Severe Heart Failure (NYHA Class Ⅲ- Ⅳ)

Based on the Randomized Spironolactone Evaluation Study (RALES), 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

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, 200-400 mg/day. Maintenance dosage should be individually determined.

Malignant Ascites

The initial dose usually 100-200 mg/day. In severe cases, the dosage may be gradually increased up to 400 mg/day. When oedema is controlled, the maintenance dosage should be individually determined.

Nephrotic Syndrome

Usual dose 100-200 mg/day. Spironolactone has not been shown to be anti-inflammatory, nor to affect the basic pathological process. Its use is only advised if glucocorticoids by themselves are insufficiently effective

Diagnosis and Treatment of Primary Aldosteronism

Spironolactone may be employed as an initial diagnostic measure to provide presumptive evidence of primary hyperaldosteronism while patients are on normal diets.

– Long test: Spironolactone is administered at a daily dosage of 400 mg for three to four weeks. Correction of hypokalaemia and of hypertension provides presumptive evidence for the diagnosis of primary hyperaldosteronism.

– Short test: Spironolactone is administered at a daily dosage of 400 mg for four days. If serum potassium increases during spironolactone administration but drops when spironolactone is discontinued, a presumptive diagnosis of primary hyperaldosteronism should be considered. After the diagnosis of hyperaldosteronism has been established by more definitive testing procedures, spironolactone may be administered at doses of 100 mg-400 mg daily in preparation for surgery.

For patients who are considered unsuitable for surgery, spironolactone may be employed for long-term maintenance therapy at the lowest effective dosage determined for the individual patient.

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 3 mg of spironolactone per kilogram body weight given in divided doses. Dosage should be adjusted on the basis of response and tolerance.


Medicine’s information on this web page is only a short description of its characteristics. Do not take them as recommendations for self-treatment of your health condition.

You must inform your physician and pharmacist and follow their recommendations before you use the medicine for treatment. Always read carefully the patient information leaflet.

COMPOSITION

Each tablet contains 25 mg spironolactone, excipients.
Each tablet contains 100 mg spironolactone, excipients.

THERAPEUTIC INDICATIONS

– Congestive cardiac failure.
– Hepatic cirrhosis with ascites and oedema.
– Malignant ascites.
– Nephrotic syndrome.
– Diagnosis and treatment of primary aldosteronism.

CONTRAINDICATIONS

Spironolactone is contraindicated in patients with the following:
– acute renal insufficiency, significant renal compromise, anuria;
– Addison's disease or other conditions associated with hyperkalaemia;
– hypersensitivity to spironolactone or to any of its excipients;
– concomitant use of eplerenone or other potassium-sparing diuretics.
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

PACKAGING

Box of 40 tablets of 25 mg (4 blisters x 10 tablets).
Box of 30 tablets of 100 mg (3 blisters x 10 tablets).