1 tabl sustained release contains 1.5 mg of indapamide.
Action:
A diuretic with hypotensive effect - a sulphonamide derivative, pharmacologically associated with thiazide diuretics. It increases the excretion of sodium and chlorides in the urine and, to a lesser extent, the excretion of potassium and Magnesium, increasing the secondary volume of urine produced. The hypotensive effect is related to the improvement of the susceptibility of the arterial walls and the decrease in the total peripheral resistance and resistance in arterioles. Indapamide inhibits left ventricular hypertrophy. The released fraction of indapamide undergoes immediate and complete absorption through the gastrointestinal tract, Cmax appears after about 12 hours. The drug is approximately 79% bound to plasma proteins. The plasma elimination half-life is 14 to 24 h (average 18 h). Elimination occurs primarily through the kidneys (70% of the dose) and faeces (22%) in the form of inactive metabolites.
Contraindications:
Hypersensitivity to indapamide or to any of the excipients. Hypersensitivity to sulfonamides. Hepatic encephalopathy or other severe liver problems. Severe renal failure. Hypokalemia.
Precautions:
In patients with hepatic impairment indapamide may cause hepatic encephalopathy, in which case the diuretic should be stopped immediately. If a hypersensitivity reaction occurs, it is recommended to discontinue treatment; if re-use is necessary, it is recommended to protect the exposed parts of the body against sunlight and artificial UVA sources. Loss of potassium leading to hypokalemia is a major risk when using indapamide. The higher-risk group includes the elderly, malnourished and / or polypharmacy, patients with liver cirrhosis with edema and ascites, with ischemic heart disease and with heart failure. In these states, hypokalemia increases the cardiac side effects of digitalis preparations and the risk of arrhythmias. The risk group also includes patients with an extended QT segment. Hypokalemia, like bradycardia, is a predisposing factor for the development of severe cardiac arrhythmias, especially to potentially lethaltorsades de pointes. Thiazide and thiazide diuretics may reduce urinary Calcium excretion by causing a slight and transient increase in plasma calcium. Significant hypercracia may occur in the case of previously unrecognized hyperparathyroidism; treatment should be discontinued until the parathyroid function is clear. Monitoring blood Glucose is especially important in patients with diabetes, especially with concomitant hypokalaemia. Patients with hyperuricaemia may be more prone to gout attacks. The drug may exacerbate already existing kidney failure. Indapamide is not recommended for use in children and adolescents due to lack of data on efficacy and safety in this age group. 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:
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. It should not be used during breastfeeding (indapamide is excreted in breast milk).
Side effects:
Very common: hypokalemia. Common: maculopapular rashes. Uncommon: vomiting; purpura. Rarely: dizziness, fatigue, headache, paresthesia; nausea, constipation, dryness of the oral mucosa. Very rare: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, haemolytic anemia; inflammation of the pancreas; arrhythmia, hypotension; renal failure; liver dysfunction; angioneurotic edema and / or urticaria, toxic necrotic decay of the epidermis, Stevens-Johnson syndrome; hypercalcemia.Frequency unknown: fainting; ventricular tachycardiatorsade de pointes (potentially fatal); the possibility of developing hepatic encephalopathy in the course of hepatic failure; the possibility of exacerbating the symptoms of existing systemic lupus erythematosus; prolongation of the QT interval on the electrocardiogram; increased uric acid and blood glucose (the desirability of using this type of diuretic in patients with gout or diabetes should be considered with caution); increase in liver enzymes; Hyponatraemia with hypovolaemia, hypochloremia (which may lead to secondary, compensatory metabolic alkalosis - the frequency and severity of this effect are not significant). Cases of hypersensitivity to light have been reported.
Dosage:
Orally. Adults: 1 tabl. daily, preferably in the morning. Swallow whole with a glass of water. The tablets should not be chewed. Elderly patients may be treated with the preparation only if their renal function is normal or only slightly affected.