Treatment of primary hypertension, alone or in combination with other antihypertensive agents.
Composition:
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. The antihypertensive effect is the extension of peripheral blood vessels, reduction of total vascular resistance, and reduction of the over-reactivity typical of hypertensive patients to catecholamines. Thiazide diuretics in higher doses than recommended do not have more antihypertensive effect and increase the frequency of side effects. Indapamide reduces hypertrophy of the left ventricle caused by hypertension. It is absorbed quickly and completely from the gastrointestinal tract. The maximum concentration in the blood occurs after 12 hours after administration. Bioavailability is almost 100%. It binds to plasma proteins in 76-79%. 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 (60-70% 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 kidney problems. Hepatic encephalopathy or other severe liver problems. Hypokalemia.
Precautions:
The risk associated with the treatment of thiazide diuretics is hypokalaemia - it should be prevented, especially in high-risk groups, i.e. malnourished and / or concurrently taking other medicines, elderly patients, liver cirrhosis, edema and ascites, with ischemic heart disease and heart failure. Patients with hypokalemia have an increased risk of digitalis and cardiac arrhythmia. The risk group also includes patients with an extended QT segment. Caution should be exercised in patients with impaired hepatic function (the drug should be discontinued in the event of symptoms of encephalopathy), renal dysfunction and in the elderly. In patients with gout or diabetes, carefully consider treatment. Indapamide is not recommended for use in children and adolescents due to lack of data on efficacy and safety in this age group. The preparation contains lactose - do not use in patients with rare hereditary 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. The use is not recommended during breastfeeding (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 can occur: often - maculopapular rash. Uncommon: purpura. Rarely: dizziness, fatigue, headache, paresthesia; nausea, constipation, dry mouth. Very rare: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, haemolytic anemia; arrhythmia, hypotension; pancreatitis, renal failure, abnormal liver function, hypersensitivity reactions mainly affecting the skin, 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; potassium deficiency with 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 a glass of water. Tablets should not be crushed or crushed. Elderly patients may be treated with the preparation only if their renal function is normal or only slightly affected.