1 tabl sustained release contains 1.5 mg of indapamide. The preparation contains lactose.
Action:
A diuretic with antihypertensive effect - a sulphonamide derivative with pharmacological properties similar to thiazide diuretics, acting by inhibiting the absorption of sodium in the cortical part of the kidney. This increases the excretion of sodium and chloride, and to a lesser extent, potassium and Magnesium, thus increasing the volume of urine excreted. The antihypertensive properties of Indapamide are associated with improved arterial compliance and reduced vascular resistance and total peripheral resistance. Indapamide reduces the hypertrophy of the left ventricle. The drug form allows the slow release of indapamide. Part of indapamide is released quickly and is completely absorbed from the gastrointestinal tract. The maximum concentration in the blood occurs after 12 hours after administration. Indapamide binds to 79% of plasma proteins. T0,5 in the elimination phase, it is 14-24 h (average 18 h). Steady state is achieved after 7 days of treatment. Indapamide is excreted in the urine (70% of the dose) and faeces (22% of the dose) in the form of inactive metabolites.
Contraindications:
Hypersensitivity to Indapamide, other sulfonamides or other ingredients of the preparation. Severe renal failure. Hepatic encephalopathy or severe liver problems. Hypokalemia.
Precautions:
In the case of liver dysfunction, thiazide-like diuretics can cause hepatic encephalopathy, especially in the case of water and electrolyte disturbances. The use of diuretics should be stopped immediately if symptoms of hepatic encephalopathy develop. If a hypersensitivity reaction occurs, it is recommended to discontinue treatment; if re-use is necessary, it is recommended to protect the skin surface exposed to sunlight or artificial UVA radiation. A serious risk associated with the use of thiazide-type thiazides and thiazide-type diuretics is hypokalaemia - it should be prevented, especially in high-risk groups, i.e. elderly, malnourished and / or multiple-drug-treated patients with cirrhosis, edema and ascites, coronary artery disease and heart failure. In these patients, hypokalemia increases the cardiotoxicity of digitalis and the risk of arrhythmias. The risk group also includes patients with an extended QT segment. Hypokalemia, like bradycardia, is a predisposing factor for the development of severe cardiac arrhythmias, especially to potentially lethaltorsades de pointes. Thiazides and diuretics with a thiazide-like effect may reduce urinary Calcium excretion, resulting in a slight and transient increase in plasma calcium levels. Significant hypercalcemia may be the result of unrecognized hyperparathyroidism. Treatment with these medicines should be stopped before evaluating parathyroid function. In patients with hyperuricaemia, an increased incidence of gout attacks may occur. Carefully used in patients with diabetes. The drug may exacerbate the already existing renal failure. The safety and efficacy of the drug in children and adolescents have not been established - do not use in this age group. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
Pregnancy and lactation:
Precautions should be avoided in pregnant women (diuretics may cause fetal-placental ischaemia with the risk of fetal growth disturbance). Breast-feeding is not recommended (indapamide is excreted in human milk).
Side effects:
Hypokalemia (blood potassium <3.4 mmol / l) observed in 10% of patients; in 4% of patients potassium levels were <3.2 mmol / l after 4-6 weeks of treatment. After 12 weeks of treatment, the average reduction in potassium was 0.23 mmol / l. Common: papular-macular skin rashes. Uncommon: vomiting, purpura.Rare: dizziness, tiredness, headaches, paresthesia; nausea, constipation, dry mouth. Very rare: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, haemolytic anemia; hypercalcemia; cardiac arrhythmia, hypotension, pancreatitis, renal failure, liver dysfunction, angioneurotic edema, urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome. Frequency unknown: potassium loss with hypokalaemia of particularly severe course (especially in high-risk patients); hipolatremia with hypovolaemia causing dehydration and orthostatic hypotension; concomitant loss of chloride ions may lead to secondary, compensatory metabolic alkalosis (the frequency and severity of this effect is not significant); swoon,torsades de pointes, the possibility of developing hepatic encephalopathy in the course of hepatic failure, hepatitis, the possibility of exacerbation of the symptoms of coexisting systemic lupus erythematosus; hypersensitivity to light; increased plasma uric acid and blood Glucose during treatment (consideration should be given to the desirability of using these diuretics in patients with gout or diabetes), prolongation of the QT interval, elevated levels of liver enzymes.
Dosage:
Orally. Adults: 1 tabl. for 24 hours, preferably in the morning. Swallow whole with water. You should not chew. Elderly patients may be treated with the preparation only if their renal function is normal or only slightly affected.