1 tabl 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, and to a lesser extent, potassium and Magnesium, thus increasing the volume of excreted urine. In addition, the antihypertensive action is to improve the arterial compliance, reduce vascular resistance in the arterioles and reduce total vascular resistance. Thiazide diuretics in higher doses than recommended do not have more antihypertensive effect and increase the frequency of side effects. Indapamide reduces the hypertrophy of the left ventricle. It does not disturb the metabolism of lipids and carbohydrates. It is absorbed quickly and completely from the gastrointestinal tract. The maximum concentration in the blood occurs after 12 hours after administration. It binds to plasma proteins in 79%. 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 any of the excipients. Severe renal failure (creatinine clearance <30 ml / min). Hepatic encephalopathy or 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 (ret. Table), 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. In addition, hypersensitivity reactions (including hypersensitivity to light), exacerbation of pre-existing systemic lupus erythematosus, potassium loss with hypokalaemia of particularly severe course especially in patients at risk, hyponatremia with hypovolaemia causing dehydration and orthostatic hypotension (concurrent- can lead to secondary, compensatory metabolic alkalosis), increased uric acid and blood glucose. In patients with hepatic impairment there is a risk of hepatic encephalopathy. 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:
Orally. 1 tabl daily, preferably in the morning. Table. they should be swallowed whole with water, they should not be chewed. Elderly patients may be treated with the preparation only if their renal function is normal or only slightly affected. It is not recommended for use in children and adolescents, as there is no data on its effectiveness and safety.
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