Treatment of essential hypertension, alone or in combination with other antihypertensive agents.
Composition:
1 tabl sustained release contains 1.5 mg of indapamide. The tablets contain lactose.
Action:
Diuretic with hypotensive effect. It is a non-azide sulfonamide derivative with pharmacological properties similar to thiazide diuretic drugs that work by inhibiting the reversion of sodium absorption in the proximal distal tubule. 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 of Indapamide is associated with the expansion of peripheral blood vessels, a reduction in total vascular resistance, and a reduction in typical catheterolamines for hypertensive patients with arterial hyperactivity. Indapamide reduces hypertrophy of the left ventricle caused by hypertension. It does not affect the metabolism of lipids and carbohydrates, also in patients with diabetes and hypertension. Following oral administration, indapamide is rapidly and completely absorbed from the gastrointestinal tract. Cmax in the blood occurs after 12 h after administration. It binds to plasma proteins in 76-79%. T0,5 in the blood is 14-24 h. 60-70% of the administered dose is excreted in the urine as metabolites, 5% in the unchanged form. 22% of indapamide is excreted in the faeces.
Contraindications:
Hypersensitivity to Indapamide, sulfonamides or other ingredients of the preparation. Severe renal impairment (creatinine clearance <30 ml / min). Hepatic encephalopathy or other severe liver problems. Hypokalemia.
Precautions:
Treatment with diuretics (thiazides or similar treatment) causes an increased risk of hypokalemia - it should be prevented, especially in high-risk groups, i.e. elderly, malnourished, concurrently taking other medications, cirrhosis, edema and ( or) asbestos, with 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. Blood potassium should be measured regularly and regularly; the first indication should be made in the first week of treatment. If photosensitivity occurs, discontinuation of treatment is recommended. When it is necessary to administer the drug, protect the skin against sunlight and artificial ultraviolet UVA radiation. 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. 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 <2.5 mg / dl), with diabetes (glycemic control should be adequately controlled, especially in cases of hypokalaemia), with hyperuricaemia (risk of gout attack) and in the elderly. The drug may cause slight and transient hypercalcaemia; significant hypercalcemia may be the result of unrecognized hyperparathyroidism; before testing for parathyroid function, indapamide should be discontinued early. Due to the lack of data on the efficacy and safety of use in children and adolescents, the preparation is not recommended in this age group. 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:
Diuretics should be avoided in pregnant women and should never be used to treat physiological pregnancy edema. Diuretics may cause fetal-placental ischemia that may cause fetal growth disorders.The use is not recommended during breastfeeding (indapamide is excreted in breast milk).
Side effects:
Common: maculopapular rash. Uncommon: vomiting, purpura. Rarely: dizziness, fatigue, headache, paresthesia, nausea, constipation, dry mouth. Very rare: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, haemolytic anemia, arrhythmias, hypotension, pancreatitis, liver dysfunction, hypercalcaemia, angioneurotic edema and / or urticaria, toxic epidermal necrolysis, Stevens Johnson syndrome, insufficiency kidney. Not known: the possibility of initiating hepatic encephalopathy in cases of hepatic dysfunction, exacerbation of pre-existing acute generalized lupus erythematosus. In addition, skin hypersensitivity reactions (in patients with predisposition to allergic and asthmatic reactions), photosensitivity, hypokalaemia with particularly severe course in high-risk patients, hyponatremia with hypovolaemia causing dehydration and orthostatic hypotension (concomitant loss of chlorine ion) have been observed. may lead to secondary metabolic alkalosis), increased uric acid levels and blood Glucose (the use of diuretics should be carefully considered in patients with gout or diabetes).
Dosage:
Orally. Adults: 1 tabl. once a day, preferably in the morning. Elderly patients should be measured with plasma creatinine, taking into consideration the age, weight and sex of the patient. Elderly patients may take indapamide as long as their renal function is normal or only slightly affected.