1 tabl sustained release contains 1.5 mg of indapamide. The preparation contains lactose.
Action:
Diuretic with hypotensive effect. It is a non-naturium sulfonamide derivative with a diuretic effect. It inhibits sodium reabsorption in the proximal part of the distal kidney canal. This results in increased urine excretion of sodium and chloride ions, to a lesser extent, potassium and Magnesium ions, thus increasing the amount of urine output. The antihypertensive effect of Indapamide is also associated with improved arterial compliance and reduced peripheral resistance. Indapamide, used for long-term treatment, reduces the hypertrophy of the left ventricle. It does not affect the metabolism of lipids and carbohydrates. The antihypertensive effect of the drug used in monotherapy is maintained for 24 h. The gradually released indapamide is completely absorbed from the gastrointestinal tract after oral administration. Maximum concentration in blood, both after single and repeated administration, the drug reaches after about 8 hours after administration. The drug binds to plasma proteins in 79%. Most of the drug is metabolised to inactive metabolites. Only 5-8% of the dose is excreted in the urine in unchanged form. Most of the administered medicine is excreted in the urine (70% of the administered dose) and faeces (22% of the administered dose) in the form of metabolites. T0,5 in the blood is 14-24 h (average 18 h).
Contraindications:
Hypersensitivity to indapamide, sulfonamides or other ingredients of the preparation. Severe renal failure (creatinine clearance <30 ml / min). Hepatic encephalopathy or other severe liver problems. Hypokalemia.
Precautions:
The main risk associated with diuretic therapy (thiazide or similar treatment) is hypokalaemia - it should be prevented, especially in high-risk groups, i.e. elderly, malnourished, concurrently taking other medications, cirrhosis (with edema) and ascites), coronary artery disease and heart failure. 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 impaired hepatic function (if the symptoms of encephalopathy occur, treatment should be discontinued), with renal impairment (risk of worsening of renal failure), the medicine is only fully effective when normal or slightly impaired renal function, i.e. creatinine is <25 mg / l), with diabetes, with hyperuricaemia (risk of gout) and in the elderly. 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. In case of hypersensitivity reactions to light, it is recommended to discontinue the drug; if it is necessary to resume indapamide therapy, it is recommended to protect the body against sunlight or artificial UV radiation. The safety and efficacy of the medicine in children and adolescents have not been established - do not use. Due to the lactose content, the drug 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 in the treatment of edema in pregnant women. Do not use the product during breastfeeding (indapamide is excreted in human milk).
Side effects:
Common: papular-macular skin rashes. Uncommon: vomiting, purpura. Rarely: dizziness, 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. Not known: risk of developing hepatic encephalopathy in the case of coexistence of liver failure; the possibility of exacerbating the course of previously occurring systemic lupus erythematosus; prolonged QT interval in ECG, tachycardiatorsade de pointes, hypersensitivity reactions (including photosensitivity), loss of potassium with severe hypokalaemia especially in patients at risk, hyponatremia with hypovolaemia causing dehydration and orthostatic hypotension (concomitant decrease in Cl- can lead to secondary, compensatory metabolic alkalosis), increased uric acid and blood glucose. Hypokalaemia (blood potassium <3.4 mmol / l) occurred 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.
Dosage:
Oral: adults 1 tabl. once a day, regardless of the severity of hypertension.
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