Index of drugs

Congestive heart failure. Cirrhosis of the liver with ascites and edema. Ascites in the course of malignancy. Nephrotic syndrome. Diagnostics and treatment of primary hyperaldosteronism. Treatment of hypertension as an add-on to patients not responding adequately to other antihypertensive agents.

1 tabl contains 25 mg of spironolactone. 1 tabl powl. contains 100 mg spironolactone. The preparation contains lactose.

A potassium-sparing diuretic, a competitive aldosterone antagonist. It increases the excretion of sodium with a simultaneous decrease in the excretion of potassium in the distal part of the kidney canal. It shows gradual and prolonged action. Spironolactone good and fast (T._max 2.6 h) is absorbed after oral administration and is metabolized to the active metabolites: metabolites containing sulfur compounds (80%) and partly to canrenone (20%). T_0,5 Spironolactone in the blood is 1.3 hours; active metabolites 2.8-11,2 h. Metabolites are mainly excreted in the urine, but also in the faeces by excretion in the bile. The effects on the kidneys are greatest after 7 h after a single dose and last for at least 24 h.

Hypersensitivity to the active substance or to any of the excipients. acute renal failure, severe renal impairment (GFR <30 ml / min), anuria. Addison's disease or other conditions associated with hyperkalemia. Hyperkalemia. Concomitant use of eplerenone or other potassium-sparing diuretics. Spironolactone should not be used concomitantly with other potassium sparing diuretics and you should not routinely give potassium supplements because hyperkalaemia may occur.

During treatment, the water and electrolyte balance as well as renal function should be monitored regularly. The risk of hyperkalemia is higher in elderly patients, in patients with renal or hepatic failure, in the case of excessive potassium supply, as well as in the combined use of spironolactone and ACE inhibitors or angiotensin II receptor antagonists - in patients should carefully monitor the level of potassium in the blood and renal function. In the event of hyperkalemia, the drug should be discontinued and, if necessary, treatment should be used to reduce the level of potassium in the blood to normal values. Some patients with decompensated cirrhosis have reported reversible hyperchloraemic acidosis, usually with hyperkalemia, even with normal renal function. Transient elevation of urea in the blood associated with the medicine has been reported, particularly in the presence of renal dysfunction. Due to the lactose content, the drug should not be used in patients with galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.Patients with severe heart failure. The concentration of potassium and creatinine in the blood should be monitored once a week after starting or increasing the dose of spironolactone, once a month for the first 3 months, then once a quarter for one year and then every 6 months. Treatment should be discontinued or temporarily discontinued. if the potassium level is> 5 mEq / l or creatinine> 4 mg / dl. Do not use other medicines that increase the level of potassium in your blood (including diuretic). Avoid using oral potassium supplements in patients with a potassium level> 3.5 mEq / l.

Spironolactone or its metabolites can pass through the placental barrier. In rats, feminization of male fetuses associated with the use of spironolactone has been observed. The use of the preparation in pregnant women requires a careful analysis of the balance of expected benefits against possible risks for the woman and the fetus. Spironolactone metabolites have been detected in breast milk. If the preparation is considered necessary, an alternative method of feeding the baby should be used.

You may experience: malaise, mild breast cancer, digestive system disorders, nausea, leukopenia (including agranulocytosis), thrombocytopenia, liver dysfunction, electrolyte disturbances, hyperkalemia, leg muscle cramps, dizziness, confusion, libido changes, menstrual disorders, pain breast, gynecomastia (usually reversible after discontinuation of treatment, in rare cases, slight breast enlargement may persist), Stevens-Johnson syndrome, toxic epidermal necrolysis, drug erosion with eosinophilia and systemic manifestations (DRESS), alopecia, hypertrichosis, pruritus, rash, urticaria, acute renal failure.

Orally.Adults. Congestive heart failure with edema: the usual starting dose is 100 mg per day, given as a single dose or in several divided doses, but the dose range may be 25-200 mg per day. The maintenance dose should be determined individually for each patient.Patients with severe heart failure (NYHA class III-IV): treatment should be initiated with a dose of 25 mg once a day, in combination with standard therapy, if the potassium level in blood is ≤5 mEq / l, and creatinine ≤2.5 mg / dl. If clinically indicated, in patients who tolerate a 25 mg dose once a day, the dose may be increased to 50 mg once a day. For patients who can not tolerate a 25 mg dose once a day, the dose can be reduced to 25 mg every other day.Cirrhosis of the liver with ascites and edema: if the ratio of Na + / K + ions in the urine is> 1.0, a dose of 100 mg per day should be used; if the ratio is <1.0, a dose of 200-400 mg per day is recommended. The maintenance dose should be determined individually for each patient.Ascites in the course of malignancy: the usual starting dose is 100-200 mg per day. In severe cases, the dose may be gradually increased to 400 mg a day. When edema is adequately controlled, the maintenance dose should be determined individually for each patient.Nephrotic syndromeThe usual dose is 100-200 mg per day. Spironolactone has not been shown to have anti-inflammatory or pathological effects. The use of spironolactone is only recommended if glucocorticoid therapy is not sufficiently effective.Diagnostics and treatment of primary hyperaldosteronism: the drug can be used as a preliminary diagnostic procedure to provide indirect evidence of primary hyperaldosteronism at the time when patients use a normal diet.Long-term test400 mg daily for 3-4 weeks; alleviation of hypokalemia and hypertension provides preliminary evidence for the diagnosis of primary hyperaldosteronism.Short-term test400 mg daily for 4 days; if the serum potassium level increases during spironolactone administration and decreases after discontinuation, a preliminary diagnosis of primary aldosteronism should be considered. When the diagnosis of hyperaldosteronism is confirmed by more reliable diagnostic procedures, spironolactone can be used at a daily dose of 100-400 mg as a preparation for surgery. In patients not qualified for surgery, spironolactone can be used as a long-term maintenance treatment at the lowest effective dose, determined individually for each patient.Treatment of hypertension: usually 25-100 mg a day. The full therapeutic effect is usually achieved within approximately 2 weeks, which should be taken into consideration when adjusting the dose. Before starting to use spironolactone in hypertensive patients who are already treated with an ACE inhibitor or angiotensin receptor antagonist, check the potassium and creatinine levels in the blood. Treatment should not be started if the potassium level in blood is> 5.0 mmol / l or creatinine> 2.5 mg / dl. Frequent monitoring of potassium and creatinine in the blood during the first 3 months of treatment is necessary. Combination therapy should be temporarily withheld or discontinued if blood potassium increases> 5.0 mmol / l or creatinine> 2.5 mg / dl.Elderly patients century: it is recommended to start treatment with the lowest dose and then gradually increase it, if necessary, until the maximum benefit is obtained.Children and youth: use an initial dose of 3 mg / kg / day, in divided doses.The dose should be adjusted depending on the response and tolerance.Way of giving. It is recommended to administer the medicine once a day with meals. The 25 mg tablet dividing line only makes it easier to crush it, for easier swallowing and not for equal doses; whereas a 100 mg tablet can be divided into equal doses. If necessary (eg in children), you can break the tablets and prepare the suspension.