1 tabl powl. sustained release contains 1.5 mg of indapamide. The preparation contains lactose.
Action:
Diuretic drug with hypotensive effect - a sulphonamide derivative, pharmacologically associated with thiazide diuretic drugs. Inhibits sodium absorption in the renal cortex of the cortex; increases the excretion of sodium and chloride in the urine (thus increasing the amount of urine excreted) and to a lesser extent, the excretion of potassium and Magnesium, increasing the secondary volume of urine produced. In addition, Indapamide acts on blood vessels by reducing arteriovenous and total vascular resistance. Indapamide reduces the hypertrophy of the left ventricle. Indapamide, unlike other diuretics, does not affect the metabolism of lipids: total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol; does not affect carbohydrate metabolism, even in patients with diabetes mellitus and hypertension. Part of indapamide is released quickly and almost completely absorbed from the gastrointestinal tract, Cmax appears after about 12 hours. The drug is approximately 79% bound to plasma proteins. The plasma elimination half-life is 14 to 24 h (average 18 h). The elimination occurs mainly through the kidneys (70% of the dose, the fraction of the unchanged drug is about 5%) and faeces (22%) 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 patients with impaired liver function, indapamide may cause hepatic encephalopathy (especially in the case of water and electrolyte imbalance), in which case the diuretic should be stopped immediately. If a hypersensitivity reaction occurs, it is recommended to discontinue treatment; if re-use is necessary, it is recommended to protect the exposed parts of the body against sunlight and artificial UVA sources. Loss of potassium leading to hypokalemia is a major risk when using indapamide. The higher-risk group includes: elderly, malnourished and / or taking several drugs at the same time, patients with liver cirrhosis with edema and ascites, with coronary heart disease and with heart failure. In these patients, hypokalemia increases the cardiotoxicity of digitalis and the risk of arrhythmia. 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 thiazine diuretics may reduce the excretion of Calcium in the urine, causing a slight and transient increase in plasma calcium. A significant excess of calcium in the blood may be caused by the hyperparathyroidism not diagnosed earlier. Blood Glucose monitoring is particularly important in patients with diabetes mellitus, especially with concomitant hypokalaemia. Patients with hyperuricaemia may be more prone to gout attacks. The drug may exacerbate already existing kidney failure. Indapamide is not recommended in children and adolescents due to the lack of data on the efficacy and safety of its use. Due to the lactose content, the preparation should not be used in patients with galactose intolerance, Lapp lactase deficiency or malabsorption of glucose-galactose.
Pregnancy and lactation:
Avoid using the product in pregnant women (diuretics can cause fetal-placental ischemia that may cause fetal growth disorders) and should never be used to treat physiological pregnancy edema. Breastfeeding during the use of the preparation is not recommended (indapamide is excreted in breast 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 mean drop in potassium was 0.23 mmol / l.In addition, it may occur: often - maculopapular rash (in patients prone to hypersensitivity reactions and asthmatic reactions). Uncommon: vomiting, purpura (in patients prone to hypersensitivity reactions and asthmatic reactions). Rare: dizziness, tiredness, headaches, paresthesia; nausea, constipation, dry mouth. Very rare: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, haemolytic anemia; arrhythmia, hypertension; pancreatitis, renal failure, liver dysfunction, angioneurotic edema, urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, hypercalcemia. Not known: risk of developing hepatic encephalopathy in the course of hepatic failure; the possibility of exacerbating the symptoms of systemic lupus erythematosus; hypersensitivity to light; potassium loss from hypokalemia, particularly severe in selected high-risk groups; Hyponatraemia with hypovolaemia leading to dehydration and orthostatic hypotension, concomitant loss of chloride ions can lead to secondary compensatory metabolic alkalosis (the incidence and severity of this effect are small); increase in uric acid and plasma glucose - the indications for the use of these diuretics should be carefully considered in patients with gout and diabetes.
Dosage:
Orally. Adults: 1 tabl. daily, preferably in the morning. Swallow whole with water. The tablets should not be chewed. Elderly patients may be treated with the preparation only if their renal function is normal or only slightly affected.