- In essential hypertension (as a part of combination therapy);
- in oedema syndrome in chronic heart failure (can be used in monotherapy and as a part of combination therapy);
- in conditions in which secondary hyperaldosteronism can be detected, including liver cirrhosis, accompanied by ascites and/or oedema, nephrotic syndrome, and other conditions accompanied by oedema;
- in hypokalemia/hypomagnesemia (as an aid to its preventive therapy during treatment with diuretics and in case of inability to use other methods of potassium value correction);
- in primary hyperaldosteronism (Conn's syndrome) — for a short preoperative course of treatment;
- for the diagnosis of primary hyperaldosteronism;
- in severe chronic heart failure (III-IV functional class according to NYHA classification) in the course of standard therapy.
To be administered by mouth with food.
- In essential hypertension: The single daily adult dose is usually 50−100 mg and can be increased to 200 mg, the dose to be increased gradually, once in the term of 2 weeks. To achieve an adequate response to therapy, the drug must be taken at least for 2 weeks. If necessary, dosage moderation is to be carried out;
- In idiopathic hyperaldosteronism: assigned dosage is 100−400 mg per day;
- In pronounced hyperaldosteronism and hypokalemia: The daily dose is 300 mg per day (maximum 400 mg) for 2−3 intakes. When the condition is improving, the dosage is reduced to 25 mg/day;
- In hypokalemia and/or hypomagnesemia caused by diuretic therapy: the drug is prescribed in a dosage of 25−100 mg per day, as a single dose or for several intakes. The maximum daily dose is 400 mg, potassium preparations for oral administration or other methods of filling its deficiency are ineffective;
- In primary hyperaldosteronism diagnosis and treatment: as a diagnostic tool for a short diagnostic test: the drug is prescribed to be taken for 4 days at 400 mg/day, distributing the daily dose for several intakes per day. If blood plasma potassium value increases during the administration of the drug and decreases after its withdrawal, primary hyperaldosteronism can be assumed;
- As a diagnostic tool for
long-termdiagnostic test: the drug is prescribed in the same dose to be taken for 3−4 weeks. If correction of hypokalemia and arterial hypertension is achieved, primary hyperaldosteronism can be assumed;
- As a short course of preoperative treatment of primary hyperaldosteronism: After the diagnosis of hyperaldosteronism is established using more accurate diagnostic methods, the drug should be taken in the dosage of 100−400 mg per day, divided into 1−4 intakes per day during the entire period of surgery preparation. If the operation is not indicated, the drug is to be taken
as long-termmaintenance therapy, and the lowest effective dose is applied, adjusted individually for each patient;
- In oedema associated with nephrotic syndrome: the usual daily adult dose is 100−200 mg/day. No effect of spironolactone on the main pathological process has been identified, and therefore the use of this drug is recommended only in cases where other types of therapy are ineffective.
- In oedema syndrome associated with chronic heart failure: The drug is to be administered daily, for 5 days at the dosage of 100−200 mg per day in 2−3 intakes, in combination with a «loop» or thiazide diuretic. Depending on the effect (see the section «Pharmacokinetics in certain groups of patients»), the daily dose may be reduced to 25 mg. Maintenance dose is adjusted individually. The maximum dose is 200 mg per day;
- In oedema associated with liver cirrhosis: if the ratio of sodium and potassium ions (Na + / K +) in the urine exceeds 1.0, then the usual daily adult dose amounts to 100 mg. If the ratio is less than 1.0, the usual daily adult dose amounts to 200−400 mg. Maintenance dose is adjusted individually.
- In oedema in children: the initial dose in over 3-year-old children is 1−3.3 mg per kg of the body weight or 30−90 mg per m2 per day divided into 1−4 intakes. After 5 days, the dose is adjusted and, if necessary, increased by 3 times compared to the original.
- In elderly patients: it is recommended to begin treatment with a minimum dose and titrate it until the maximum necessary dose is achieved with a constant control of liver/kidney function.
- In severe chronic heart failure (III-IV functional class according to the NYHA classification) in the course of standard therapy: treatment starts with 25 mg once per day if serum potassium is less than 5.0 mg eq / l and creatinine is less than 2.5 mg / l. For the patients who tolerate a dose of 25 mg once a day dosage can be increased to 50 mg once a day. The treatment is carried out under control of potassium and creatinine value in blood in one week after the start of therapy or after an increase in dose, then monthly for the first 3 months, then quarterly for a year, and then every 6 months.
3 years. Prohibited to use after the expiry date.
Store in a dry and dark place at a temperature below +25°С. Keep out of reach of children.
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