Composition, form of production and packaging
Modified-release tablets coated with a white coating , round, biconvex.
indapamide 1.5 mg
[PRING] guar gum (guar gum), lactose, sodium lauryl sulfate, talc purified, magnesium stearate, silicon dioxide colloid, hydroxypropylmethylcellulose, titanium dioxide, polyethylene glycol.
10 pieces. - blisters (1) - packs of cardboard.
10 pieces. - blisters (3) - packs of cardboard.
10 pieces. - blisters (5) - packs of cardboard.
14 pcs. - blisters (2) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2008.
Diuretic. Antihypertensive drug. Refers to sulfonamide derivatives and is close to thiazide diuretics by pharmacological properties. Inhibits the absorption of sodium in the cortical segment of the Henle loop, which leads to an increase in the excretion of sodium ions, chlorine in the urine and leads to increased diuresis. To a lesser extent, increases the excretion of potassium and magnesium ions.
In addition to the diuretic effect, indapamide increases the elasticity of the walls of the arteries and reduces the OPSS.
Has antihypertensive effect in doses that do not cause a pronounced diuretic effect.
At appointment in high doses does not influence a degree of depression of a BP, despite of an increase in a diuresis.
Reduces left ventricular hypertrophy.
Does not affect lipid and carbohydrate metabolism.
Quickly and almost completely absorbed from the digestive tract. Eating somewhat slows absorption, but does not affect the amount of absorbed drug. After ingestion, C max is dosed after 12 hours.
At repeated receptions of fluctuation of concentration of a preparation in plasma in an interval between receptions of two doses decrease. However, there are individual differences in patients.
Binding to plasma proteins - 79%. At repeated admission does not accumulate in the body.
Metabolised in the liver.
T 1/2 - 14-26 hours (an average of 18 hours). 70% of indapamide is excreted by the kidneys in the form of metabolites, in an unchanged form, about 5% is excreted.About 20% is excreted in the form of inactive metabolites.
Pharmacokinetics in special clinical cases
In patients with renal insufficiency, the pharmacokinetics of indapamide does not change significantly.
- arterial hypertension.
The drug is administered orally 1 tablet. 1 time / day, preferably in the morning, squeezed with enough liquid.
From the digestive system: constipation or diarrhea, dyspepsia, nausea, abdominal pain; possibly the development of hepatic encephalopathy; rarely - pancreatitis.
From the side of the central nervous system: headache, dizziness, nervousness, asthenia.
On the part of the respiratory system: cough, pharyngitis, sinusitis.
From the cardiovascular system: orthostatic hypotension, changes in the ECG (hypokalemia), arrhythmia, palpitations.
From the urinary system: frequent infections, nocturia, polyuria.
From the hemopoietic system: rarely - thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, hemolytic anemia.
Allergic reactions: maculopapular rash, hives, itching, hemorrhagic vasculitis .
Laboratory indicators: hyperuricemia, hyperglycemia, hyponatremia, hypochloraemia, hypercalcemia.
Other: possible exacerbation of the systemic lupus erythematosus.
- severe renal failure (anuria stage);
- severe hepatic insufficiency (including with encephalopathy);
- hepatic encephalopathy;
- simultaneous reception of drugs that extend the QT interval;
- children and adolescents under 18 years of age (efficacy and safety not established);
- hypersensitivity to the drug and other sulfonamide derivatives.
With caution , the drug should be prescribed for violations of liver and / or kidney function, violation of water-electrolyte balance, hyperparathyroidism, patients with an increased QT interval on the ECG or receiving combined therapy, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).
PREGNANCY AND LACTATION
Retapres is not recommended for use in pregnancy. the drug can cause fetoplacental ischemia and lead to a slow development of the fetus.
Due to the fact that indapamide is excreted in breast milk, it is also not recommended to prescribe the drug during the period of breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution should prescribe the drug for violations of kidney function.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution should prescribe the drug for violations of liver function.
When prescribing thiazide diuretics, patients with impaired hepatic function may develop hepatic encephalopathy. In such cases, the drug should be discontinued immediately.
Before the start of treatment should determine the content of sodium ions in the blood plasma. In the process of treatment, this indicator should be regularly monitored, since the initial decrease in the concentration of sodium in the blood plasma can be asymptomatic. Especially often such an analysis should be performed in patients with cirrhosis of the liver and in the elderly.
With thiazide diuretics, the main risk is the development of hypokalemia. In a certain category of patients (elderly patients, weakened patients and / or receiving co-therapy, cirrhosis with developed edema or ascites, IHD, chronic heart failure), hypokalemia (<3.4 mmol / l) should be avoided. Hypokalemia in these patients leads to an increase in the toxic effect of cardiac glycosides and increases the risk of arrhythmias. In addition, patients with bradycardia or an increased QT interval on the ECG are at increased risk, but it does not matter if such an increase is due to congenital causes or the presence of a pathological process.
Hypokalemia, as well as bradycardia, is a condition conducive to the development of severe cardiac arrhythmias, especially of the pirouette type. In all the cases described above it is necessary to determine the content of potassium ions in the blood plasma more often. The first measurement of the concentration of potassium ions in the blood should be carried out within the first week after the start of treatment.
With the development of hypokalemia, its correction is required.
When prescribing Retapres, patients with diabetes mellitus are important to control the level of glucose, especially when hypokalemia is present.
Patients with elevated uric acid levels tend to increase the number of gout attacks.
Thiazide diuretics are effective only in the absence of impairment or with moderate impairment of kidney function (creatinine content in the blood is less than 2.5 mg / dL or 220 Ојmol / L).
In elderly patients, the normal level of creatinine in the blood plasma is calculated taking into account age, body weight and sex.
It should be borne in mind that at the beginning of treatment in patients can be observed a decrease in glomerular filtration caused by hypovolemia, which is caused by the loss of water and sodium ions on the background of taking diuretics. As a consequence, the blood plasma can increase the concentration of urea and creatinine.If the kidney function is not broken, such temporary renal failure, as a rule, passes without consequences. However, with the existing renal failure, the patient's condition may worsen.
Against the background of taking indapamide, a positive result is possible during the doping control of athletes.
Impact on the ability to drive vehicles and manage mechanisms
In some cases, with lowering blood pressure, individual reactions may occur (especially at the onset of therapy or with the combination of several antihypertensive drugs). In this case, the ability to engage in activities that require increased attention and speed of psychomotor reactions, can be reduced.
Symptoms: water-electrolyte balance disorders (hyponatremia, hypokalemia), nausea, vomiting, depression of blood pressure, convulsions, dizziness, drowsiness, inhibition, polyuria or oliguria, resulting in anuria (due to hypovolemia) are possible.
Treatment: urgent measures aimed at removing the drug from the body: washing the gastrointestinal tract and / or the appointment of activated carbon with the subsequent restoration of the normal water-electrolyte balance . Symptomatic therapy is indicated. There is no specific antidote.
With the simultaneous use of indapamide and lithium preparations, an increase in the concentration of lithium in the blood plasma is possible, accompanied by the appearance of signs of an overdose (due to a decrease in the excretion of lithium in the urine). If necessary, this combination should monitor the concentration of lithium in the blood plasma and, if necessary, adjust its dose.
With the simultaneous use of indapamide with astemizole, bepridilom, erythromycin (for intravenous administration), halofantrine, pentamidine, sultopride, terfenadine, vincamine, antiarrhythmic drugs of class IA (including quinidine, hydroquinidine, disopyramide, amiodarone, brethilia, sotalol) the likelihood of arrhythmias of the "pirouette" type increases. This condition can contribute to hypokalemia, bradycardia or prolongation of the QT interval.
With simultaneous use with NSAIDs (for systemic administration), salicylates in high doses, it is possible to develop acute renal failure in dehydrated patients (due to a sharp decrease in glomerular filtration rate). If it is necessary to prescribe NSAIDs against the background of Retapresome therapy, you should compensate for the loss of fluid and carefully monitor the kidney function.
With the simultaneous use of indapamide with amphotericin B (for intravenous administration), gluco- and mineralocorticoids (for systemic administration), tetracosactide, laxatives, stimulating intestinal motility, cardiac glycosides, the risk of hypokalemia (additive effect) increases. It is necessary to monitor the level of potassium in the blood plasma and ECG parameters, if necessary, the appropriate treatment is indicated.
With the simultaneous use of indapamide with baclofen, there is an increase in the hypotensive effect.
With the simultaneous use of indapamide and cyclosporine, an increase in creatinine in the blood plasma with an unchanged concentration of cyclosporine is possible.
With the simultaneous use of indapamide and tricyclic antidepressants, neuroleptics noted increased hypotensive effect and increased risk of orthostatic hypotension (additive effect).
With the simultaneous use of indapamide and calcium salts, the development of hypercalcemia is possible due to a decrease in the excretion of calcium ions in the urine.
With the simultaneous administration of indapamide with ACE inhibitors, the risk of developing arterial hypotension increases.
When a combination of indapamide with potassium-sparing diuretics (amiloride, spironolactone, triamterene) increases the risk of hypo- or hyperkalemia, especially in patients with diabetes mellitus and in patients with impaired renal function.
With the simultaneous administration of indapamide with iodine-containing contrast agents in high doses, it is possible to develop dehydration of the body and increase the risk of developing acute renal failure. Before using iodine-containing contrast agents, patients should compensate for fluid loss.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected light, out of reach of children at a temperature of no higher than 25 В° C. Shelf life - 2 years.