1 tabl sustained release contains 1.5 mg of indapamide.
Action:
A diuretic with hypotensive effect - a sulphonamide derivative with pharmacological properties similar to thiazide diuretics. It works in the cortical part of the kidneys, where it inhibits sodium reabsorption. This increases the renal excretion of sodium and chloride, and to a lesser extent, potassium and Magnesium, thus increasing the volume of excreted urine. By reducing the volume of circulating blood, it reduces blood pressure. The hypotensive effect is also associated with a reduction in peripheral resistance. The drug form allows the slow release of indapamide. 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, sulfonamides or other ingredients of the preparation. Severe renal failure. Hepatic encephalopathy or other severe liver problems. Hypokalemia.
Precautions:
The main risk associated with thiazide diuretic therapy is hypokalaemia - it should be prevented, especially in high-risk groups, i.e. malnourished and / or concomitant patients, elderly patients, liver cirrhosis, edema and ascites. , with 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. Caution should be used in patients with hepatic impairment (if symptoms of encephalopathy occur, the drug should be discontinued), hyperparathyroidism (discontinuation of indapamide if hypercalcemia occurs), renal dysfunction (risk of worsening of renal failure), diabetes mellitus, hyperuricaemia (risk of seizure) gout) and in the elderly. The safety and efficacy of the medicine in children and adolescents have not been established - do not use. 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). Do not use the product during breastfeeding (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: diarrheal vertigo, fatigue, headache, paresthesia, nausea, constipation, dry mouth. Very rare: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, haemolytic anemia, arrhythmias, hypotension, pancreatitis, renal failure, liver dysfunction, angioneurotic edema, urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, hypercalcaemia. In addition, hypersensitivity reactions, mainly cutaneous reactions, were observed in patients prone to allergic reactions and asthmatic reactions as well as hypersensitivity reactions to light. Not known: severity of pre-existing systemic lupus erythematosus, potassium loss with severe hypokalaemia especially in patients at risk, hyponatremia with hypovolaemia resulting in dehydration and orthostatic hypotension (concomitant decrease in Cl- can lead to secondary, compensatory metabolic alkalosis, however, the incidence and severity of this effect are small), increased uric acid and blood glucose. In patients with hepatic impairment there is a risk of hepatic encephalopathy.
Dosage:
Orally. Adults: 1 tabl. once a day (preferably in the morning). In elderly patients, adjusting the dose based on blood creatinine should take into account age, weight and sex. The tablets should not be chewed. Drink a glass of water.
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