Index of drugs

Primary hypertension.

1 tabl sustained release contains 1.5 mg of Indapamide (and 118.86 mg of lactose).

A diuretic with antihypertensive effect - a sulphonamide derivative with pharmacological properties similar to thiazide drugs acting by inhibition of sodium resorption in renal cortex layers. The drug increases the excretion of sodium and chloride in the urine and, to a lesser extent, the excretion of potassium and magnesium. In this way, it increases the amount of urine output and has a hypotensive effect. The antihypertensive effect of indapamide is associated with increased susceptibility of arteries and a decrease in arterial and total vascular resistance. Indapamide reduces the hypertrophy of the left ventricle. The indapamide fraction released from the tablet undergoes rapid and complete absorption in the gastrointestinal tract. C_max in plasma occurs within 12 h after a single dose. Administration of subsequent doses reduces fluctuations in the plasma concentration of substances in the period between successive doses. There is inter-individual variability. Indapamide binds to 79% of plasma proteins. T_0,5 in plasma is 14-24 h (average 18 h). The state of balance is achieved after 7 days. Taking Next doses of the drug does not lead to accumulation. The drug 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 (creatinine clearance below 30 ml / min). Hepatic encephalopathy or other severe liver problems. Hypokalemia.

Thiazide diuretics may cause hepatic encephalopathy in patients with impaired hepatic function, particularly in the presence of electrolyte imbalance. In this situation, the diuretic should be stopped immediately. If hypersensitivity reactions occur, it is recommended to discontinue treatment. When the administration of the drug is necessary, the skin should be protected from sunlight or artificial ultraviolet A (UVA). Plasma sodium should be measured prior to initiation of therapy, followed by repeated testing at regular intervals. In the initial phase of treatment, the decrease in serum sodium concentration may be asymptomatic, therefore it is important to regularly monitor patients. Elderly and cirrhotic patients should be measured more frequently. While using the drug there is a risk of potassium loss and hypokalemia. Hypokalaemia (<3.4 mmol / l) should be avoided in groups of patients at high risk for it, eg elderly patients, malnourished and / or multiple drug users, patients with liver cirrhosis, edema and ascites, patients with coronary artery disease and heart failure. In these groups of patients, hypokalemia increases the cardiotoxic effect of digitalis and the risk of arrhythmias. Patients with congenital or iatrogenic QT prolongation are also at risk for hypokalemia. Hypokalemia, like bradycardia, is a predisposing factor for severe arrhythmias in this group, especiallytorsades de pointesthat can lead to death. In all of the above-mentioned groups of patients, more frequent monitoring of potassium plasma concentrations is required. The first concentration measurement should be performed within 1 week after the start of treatment. When hypokalemia is diagnosed, it is necessary to balance the level of potassium in the blood. Thiazide and thiazide diuretics may reduce urinary Calcium excretion and cause a slight and transient increase in plasma levels. Clinically overt hypercalcemia may be associated with previously unrecognized hyperparathyroidism. The use of the drug should be discontinued before assessing the activity of the parathyroid glands.It is important to monitor blood Glucose in diabetic patients, especially in the case of hypokalaemia. In patients with elevated uric acid levels, an increased incidence of gout attacks may occur. Thiazide and thiazine diuretics are fully effective only when the kidneys are normal or slightly impaired (adults have plasma creatinine below 25 mg / l, ie 220 μmol / l). At the beginning of treatment, hypovolaemia, secondary to the loss of fluid and sodium induced by diuretics, leads to a reduction in glomerular filtration. This may cause an increase in blood urea and serum creatinine. This type of transient impairment of renal function is not of clinical significance in patients with normal renal function, but may increase the already existing renal failure. The product contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.

The use of diuretics in pregnant women should be avoided and never be used in the treatment of physiological pregnancy edema. Diuretics can cause fetal-placental ischaemia with the risk of fetal growth disturbance. Breastfeeding during breast-feeding is not recommended (indapamide is excreted in human milk).

Common: lichenoid rash. Uncommon: vomiting, purpura. Rare: diarrheal vertigo, fatigue, headache, paresthesia, nausea, constipation, dry mouth. Very rare: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, haemolytic anemia, arrhythmia, hypotension, pancreatitis, hepatic dysfunction, angioneurotic edema and / or urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, renal failure, hypercalcemia. Not known: possible encephalopathy in patients with hepatic impairment, possibility of exacerbation of previously existing acute generalized Lupus Erythematosus, cases of hypersensitivity to light, potassium loss causing hypokalaemia with serious consequences in some risk groups, hyponatremia with hypovolaemia causing dehydration and orthostatic hypotension, concomitant ion loss chloride chloride may lead to secondary compensatory metabolic alkalosis (the frequency and severity of this effect are insignificant), increased plasma uric acid and blood glucose (the advisability of using this type of diuretic should be carefully considered in patients with gout and diabetes). During clinical trials, 10% of patients after 4-6 weeks of treatment had hypokalemia (plasma potassium ≤3.4 mmol / l), and 4% had potassium ≤3.2 mmol / l. After 12 weeks of therapy, the mean reduction in potassium was 0.23 mmol / l.

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.