1 tabl powl. sustained release contains 1.5 mg of indapamide. The preparation contains lactose.
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, to a lesser extent, potassium and Magnesium, thus increasing the volume of urine excreted. By reducing the volume of circulating blood, it reduces blood pressure. Indapamide reduces the hypertrophy of the left ventricle. It does not affect the metabolism of lipids and carbohydrates (also in patients with diabetes). The antihypertensive properties of indapamide are associated with improved susceptibility of the arteries and reduction of vascular resistance and total peripheral resistance. The maximum concentration in the blood occurs after 12 hours after administration. Indapamide binds to 79% of plasma proteins. Steady state is achieved after 7 days of treatment. Indapamide is excreted in the urine (70%) and faeces (22%) in the form of inactive metabolites. T0,5 is 14-24 h (average 18 h).
Contraindications:
Hypersensitivity to Indapamide, other sulfonamides or other ingredients of the preparation. Severe renal failure. Hepatic encephalopathy or other severe liver problems. Hypokalemia.
Precautions:
Especially cautiously use in patients at high risk of hypokalemia, i.e. elderly, malnourished, multiple drug treatment, liver cirrhosis with edema and ascites, coronary artery disease and heart failure, and patients with prolonged QT interval. The drug may cause slight and transient hypercalcaemia; significant hypercalcemia may result from unrecognized hyperparathyroidism - in this case, treatment with indapamide should be discontinued and parathyroid function tests should be performed. Particular attention should be paid to the desirability of indapamide in patients with gout or diabetes. Use with caution in patients with renal insufficiency. In patients with hyperuricaemia, an increased incidence of gout attacks was observed. The drug is only fully effective in patients with normal or slightly impaired renal function. Before starting treatment and then at regular intervals, blood sodium should be measured; in the elderly and patients with liver cirrhosis this control should be more frequent. Blood potassium should be measured, especially in high-risk hypokalemia (the first sign should be done in the first week of treatment). Monitoring blood Glucose is important in patients with diabetes, especially if they have hypokalaemia. In the case of photosensitivity, sun protection is recommended. The preparation should not be used in children and adolescents due to unsteady efficacy and safety of 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:
It is recommended to avoid using indapamide during pregnancy. Prolonged exposure to thiazide during the third trimester of pregnancy may reduce maternal plasma volume and uterine-placental flow, which may cause placental and fetal ischemia and growth retardation. You should not use indapamide during breast-feeding. Indapamide is similar to thiazide diuretics, the use of which during breastfeeding was associated with a reduction or even suppression of milk production. Hypersensitivity to sulphonamide derivatives and hypokalaemia may occur.
Side effects:
Common: hypersensitivity reactions (mainly related to the skin, allergy prone and asthmatic reactions), maculopapular rashes. Uncommon: vomiting, purpura. Rarely: pain and dizziness, fatigue, paresthesia, fainting, 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. Frequency unknown: myopia, blurred vision, blurred vision, disturbancestorsade de pointes, prolonged QT interval in ECG, hepatic encephalopathy in the course of hepatic failure (drug should be discontinued), hepatitis, increased liver enzymes, exacerbation of coexisting systemic lupus erythematosus, hypersensitivity to light (drug should be discontinued), potassium loss with hypokalaemia (particularly severe the course of high-risk patients), hyponatremia, increased blood glucose and uric acid levels.
Dosage:
Orally. Adults: 1 tabl. once a day (preferably in the morning). In elderly patients, serum creatinine must be corrected by age, weight and sex. Elderly patients may be treated with the preparation only if their renal function is normal or only slightly affected. Swallow whole with water. The tablets should not be chewed.
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