1 tabl sustained release contains 1.5 mg of Indapamide (and 97.58 mg of lactose).
Action:
Diuretic drug 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 results in increased excretion of sodium and chlorides and to a lesser extent of potassium and Magnesium, thus increasing the amount of urine output and inducing antihypertensive effect. The antihypertensive properties of indapamide are associated with increased susceptibility of arteries and a decrease in arterial and total peripheral resistance. Indapamide reduces the hypertrophy of the left ventricle. Released from the tablet part of indapamide is quickly and almost completely absorbed in the gastrointestinal tract. The food slightly affects the absorption rate slightly, but does not affect the amount of absorbed drug. Maximum serum concentration after a single dose occurs after about 12 hours. After reaching steady state, the difference in serum concentration between doses is reduced. Indapamide binds to 79% of plasma proteins. T0,5 is 14-24 h (average 18 h). Steady state is reached after 7 days. Repeated dosing does not lead to accumulation of the drug. Indapamide is mainly excreted in the urine (70% of the dose) and faeces (22%) in the form of inactive metabolites.
Contraindications:
Hypersensitivity to the active substance, other sulfonamides or to any of the excipients. Severe renal failure. Hepatic encephalopathy or severe liver problems. Hypokalemia.
Precautions:
In patients with impaired hepatic function, thiazide diuretics may cause hepatic encephalopathy, particularly in the presence of fluid and electrolyte imbalance - in this case, the diuretic should be stopped immediately. Before starting treatment, plasma levels should be checked and regularly monitored; in older patients and with cirrhosis the control should be more frequent. Hypokalemia is the main risk when using indapamide. Hypokalemia (<3.5 mmol / l) should be prevented in high-risk groups, including: malnourished and / or multiple-antipsychotic patients, elderly, cirrhotic patients, edema and ascites, and patients with disease coronary insufficiency and heart failure. In these patients, hypokalemia increases the cardiotoxicity of digitalis and the risk of arrhythmia. The risk group also includes patients with prolonged QT interval, regardless of whether it is a congenital or drug-induced disorder. Hypokalemia (as well as bradycardia) is a predisposing factor for severe cardiac arrhythmias, in particular ventricular tachycardiatorsades de pointesthat can lead to death. Serum potassium should be monitored more frequently in these patients. The first determination of potassium in the plasma should be made in the first week of treatment. If the potassium concentration is low, it should be leveled. Thiazide and thiazide diuretics may reduce urinary Calcium excretion by causing a slight and transient increase in plasma calcium. Significant hypercalcemia may occur in the case of previously unrecognized hyperparathyroidism; before the planned examination of parathyroid function, the diuretic should be discontinued. Patients with diabetes should be monitored for blood Glucose, especially if they have hypokalaemia. In patients with hyperuricaemia, an increased incidence of gout attacks may occur. The drug may exacerbate the already existing renal failure. If a hypersensitivity reaction occurs, it is recommended to discontinue treatment; if re-application is necessary, it is recommended to protect the skin surface exposed to sun or artificial UVA radiation.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:
Precautions should be avoided in pregnant women (diuretic agents may cause fetal placental ischaemia and risk of fetal developmental distress) and should never be used to treat physiological edema occurring during pregnancy. The product is not recommended during breastfeeding (indapamide is excreted in breast milk and will probably affect the fed baby).
Side effects:
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. Common: maculopapular rashes. Uncommon: vomiting, purpura. Rarely: pain and dizziness, fatigue, paresthesia, nausea, constipation, dry mouth. Very rare: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, haemolytic anemia, arrhythmia, hypotension; pancreatitis, renal failure, abnormal liver function, angioneurotic edema, urticaria, toxic epidermal necrolysis, Stevens-Johnson syndrome, hypercalcemia. Frequency unknown: fainting,torsades de pointes (potentially fatal), possibility of developing hepatic encephalopathy in the course of hepatic failure, hepatitis, possibility of worsening of systemic lupus erythematosus, photosensitivity, QT prolongation visible on the ECG, increase in liver enzymes, potassium loss from hypokalemia, particularly severe in high groups risk, hyponatremia 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 Glucose in the blood - the desirability of using these diuretics in patients with gout or diabetes should be considered particularly carefully.
Dosage:
Orally. Adults: 1 tabl. every 24 hours. The use of high doses of indapamide does not increase the hypotensive effect of Indapamide, but intensifies its natriuretic effect.Special groups of patients. In elderly patients, plasma creatinine should be adjusted taking into account the age, weight and sex of the patient. Indapamide can be used in elderly patients if they have normal or slightly impaired renal function. In the case of severe renal insufficiency (creatinine clearance <30 ml / min) and severe hepatic insufficiency, the use of the drug is contraindicated.Way of giving. The tablet should be swallowed whole with water without chewing, preferably in the morning.