Index of drugs

Arterial hypertension.

1 tabl sustained release contains 1.5 mg of Indapamide (and 123.20 mg of lactose).

A diuretic with hypotensive effect - a sulphonamide derivative with pharmacological properties similar to thiazide diuretics acting by inhibiting sodium resorption in the cortical part of the kidney. This results in increased excretion of sodium and chlorides and to a lesser extent of potassium and Magnesium, thus increasing the amount of urine output and inducing antihypertensive effect. The antihypertensive properties of indapamide result from improved arterial compliance, decreased vascular resistance and total peripheral resistance. Indapamide reduces the hypertrophy of the left ventricle. Released from the tablet part of indapamide is quickly and completely absorbed in the gastrointestinal tract. Food slightly accelerates the absorption, but does not affect the amount of absorbed drug. The maximum concentration of the drug in the serum after a single dose occurs after approx. 12 hours, repeated dosing reduces the differences in serum concentrations between the two doses. Indapamide binds to 79% of plasma proteins. T_0,5 in the elimination phase, it is 14-24 h (average 18 h). The saturation condition is reached after 7 days. Repeated dosing does not lead to accumulation of the drug. Indapamide is mainly excreted in the urine (70% of the dose) and faeces (22%) in the form of inactive metabolites.

Hypersensitivity to the active substance, other sulfonamides or to any of the excipients. Severe renal failure. Hepatic encephalopathy or other severe liver problems. Hypokalemia.

In patients with liver failure, diuretic medicines similar to thiazides may cause hepatic encephalopathy, especially in the case of concomitant electrolyte disturbances. The use of diuretics should be stopped immediately if symptoms of hepatic encephalopathy develop. If hypersensitivity reactions occur during treatment, treatment should be discontinued. If it is necessary to re-apply the preparation, protect the skin against direct sunlight or use sunblock with a UVA filter. Due to the risk of hyponatremia, plasma levels should be monitored before starting treatment and then at regular intervals; in elderly patients or with cirrhosis, the control should be much more frequent. Development of hypokalemia (<3.4 mmol / l) should be prevented, especially in patients at greatest risk of developing hypokalaemia, eg in elderly, malnourished and / or multiple drug treatments, in patients with cirrhosis with edema and ascites, with coronary artery disease and heart failure. In this situation, hypokalemia increases the cardiotoxicity of digitalis preparations and the risk of arrhythmias. The risk group includes patients with prolonged QT interval, regardless of whether it is congenital or iatrogenic. Hypokalemia, like bradycardia, contributes to the development of severe cardiac arrhythmias, especially totorsades de pointes. In all of the above-mentioned cases, plasma potassium should be measured more often. The first determination of potassium in plasma should be made within the first week of treatment. If hypokalemia occurs, it must be compensated. If significant hypercalcemia develops during the use of the preparation, it may result from unrecognized hyperparathyroidism - treatment should be discontinued and parathyroid function tests should be performed. In diabetic patients, especially with coexisting hypokalemia, blood Glucose monitoring should be monitored. In patients with hyperuricaemia, an increased incidence of gout attacks may occur. Thiazides and diuretics with similar effects are only fully effective if the renal function is normal or minimally disturbed (in adults, serum creatinine below 25 mg / l, ie 220 mol / l).At the beginning of treatment, hypovolaemia, secondary to fluid and sodium loss, induced by diuretics, leads to decreased glomerular filtration. This can lead to increased levels of urea in the blood and plasma creatinine. This transient functional renal failure does not cause any consequences in patients with normal renal function, but may aggravate already existing renal failure. The product contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.

The use of diuretics in pregnant women should be avoided. They should never be used to treat physiological edema that occurs during pregnancy. Diuretics can cause fetal-placental ischemia and the risk of fetal growth disturbance. Breast-feeding is not recommended (indapamide is excreted in human milk).

In clinical trials, hypokalaemia (plasma potassium <3.4 mmol / l) was observed in 10% of patients, and 4% of patients had a potassium level <3.2 mmol / l after 4-6 weeks of treatment. After 12 weeks of treatment, the mean decrease in potassium plasma concentration was 0.23 mmol / l. Common: maculopapular rashes. Uncommon: vomiting, purpura. Rarely: dizziness, tiredness, headache, paresthesia, nausea, constipation, dry mouth. Very rare: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, haemolytic anemia, arrhythmia, decrease in blood pressure, pancreatitis, renal failure, liver dysfunction, angioneurotic edema and / or urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, hypercalcemia. Not known: there is a possibility of developing hepatic encephalopathy in patients with hepatic impairment; the possibility of exacerbating the symptoms of coexisting systemic lupus erythematosus; potassium loss was observed with hypokalaemia of particularly severe course, especially in patients belonging to high-risk groups; Hyponatraemia with hypovolaemia responsible for dehydration and orthostatic decreases in blood pressure, concomitant loss of chloride ions may lead to secondary, compensated metabolic alkalosis (the frequency and severity of this effect is not significant); increased uric acid and blood glucose during treatment (the advisability to use diuretic products in patients with gout or diabetes should be considered carefully). Cases of hypersensitivity to light have been reported.

Orally. Adults: 1 tabl. every 24 hours. The use of high doses of indapamide does not increase the hypotensive effect of Indapamide, but intensifies its natriuretic effect.Special groups of patients. In elderly patients, plasma creatinine should be adjusted taking into account the age, weight and sex of the patient. Indapamide can be used in elderly patients if they have normal or slightly impaired renal function. In the case of severe renal insufficiency (creatinine clearance <30 ml / min) and severe hepatic insufficiency, the use of the drug is contraindicated. It is not recommended for use in children due to the lack of data on safety and efficacy.Way of giving. The tablet should be swallowed whole with water without chewing, preferably in the morning.