VEROSPIRON 25MG CPS DUR 100 (SPIRONOLAKTON) –Czech medicine

Directions for use and doses
Mode of application
Orally, after meals, 1 or 2 times a day. Taking the daily dose or the first part of the daily dose of the drug is recommended in the morning.
Adults
Essential hypertension
Additional therapy in the treatment of arterial hypertension in case of insufficient effectiveness of previously used antihypertensive drugs
The initial dose of spironolactone when used simultaneously with other antihypertensive drugs is 25 mg/day. If after 4 weeks the blood pressure does not reach the target values, the dose of the drug can be increased by 2 times. In hypertensive patients receiving medications that may cause hyperkalemia (eg, angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers), serum potassium and creatinine levels should be assessed before initiating spironolactone. Veroshpiron should not be used in patients whose serum potassium content exceeds 5.0 mmol/l and whose serum creatinine concentration exceeds 220 µmol/l. Frequent monitoring of potassium and creatinine levels in the blood is required for 3 months after starting spironolactone.
Congestive heart failure
Edema due to congestive heart failure or nephrotic syndrome
The initial dose is 100 mg and can vary from 25 to 200 mg/day; the drug can be taken in 1-2 doses. When taking higher doses, Veroshpiron can be used in conjunction with a diuretic that acts in the proximal renal tubule. In this case, the dose of spironolactone should be adjusted.
Adjunctive therapy in the treatment of severe heart failure (NYHA class III‒IV and ejection fraction ≤35%)
It has been established that if the potassium content in the blood serum does not exceed 5.0 mmol/l, and the concentration of creatinine in the blood serum does not exceed 220 μmol/l, against the background of basic standard therapy, the dose of spironolactone at the beginning of use should be 25 mg/day. In patients with good tolerance to the drug at a dose of 25 mg/day, according to clinical indications, the dose can be increased to 50 mg/day. For patients with poor tolerance to therapy with Veroshpiron at a dose of 25 mg/day, the dose of the drug can be reduced to 25 mg once every 2 days.
Ascites and edema due to liver cirrhosis
If the ratio of sodium and potassium ions in the urine exceeds 1.0, then the daily dose of the drug should be 100 mg. If the specified ratio is less than 1.0, then the dose of the drug should be in the range from 200 to 400 mg/day.
The maintenance dose should be determined individually for each patient.
Hypokalemia
The drug is prescribed in a dose of 25–100 mg/day if the use of potassium supplements or other potassium-sparing methods is insufficient.
Primary hyperaldosteronism
For diagnostic purposes
1) Long-term test: spironolactone is taken 400 mg/day for 3-4 weeks. When correction of hypokalemia and arterial hypertension is achieved, the presence of primary hyperaldosteronism can be assumed.
2) Short test: spironolactone is taken 400 mg/day for 4 days. If the potassium content in the blood serum increases while taking spironolactone and decreases after its discontinuation, the presence of primary hyperaldosteronism can be assumed.
Treatment
In preparation for surgical treatment, spironolactone is used in doses of 100 to 400 mg/day. If surgery is not indicated, spironolactone can be used for long-term maintenance therapy at the lowest effective dose. In this case, the initial dose of the drug may be reduced every 14 days until the lowest effective dose is reached. To reduce the severity of side effects during long-term use, Veroshpiron is recommended to be used in combination with other diuretics.
Special patient groups
Children and teenagers under 18 years of age
The initial dose of the drug is 1–3 mg/kg body weight per day in 1–4 doses. When conducting maintenance therapy or when used simultaneously with other diuretics, the dose of Veroshpiron should be reduced to 1-2 mg/kg body weight.
When used in children under 3 years of age, a suspension can be used. To prepare a suspension, tablets should be crushed and mixed with liquid or pasty food. The suspension should be used immediately, immediately after preparation.
Elderly patients (over 65 years old)
It is recommended to start treatment with the drug with the lowest dose and gradually increase it until the maximum desired effect is achieved. Caution should be exercised in patients with severe renal or hepatic impairment, which may affect the metabolism and excretion of spironolactone. In addition, when using the drug in elderly patients, the risk of developing hyperkalemia should be taken into account (see section “Special Instructions”).