Indapamide MV tablets 1.5mg, No. 30

The tablets are taken orally, without chewing, with a sufficient amount of liquid. The daily dose of the drug is 1.5 mg (1 tab.) 1 time / day (in the morning).

indapamide

• severe renal failure (stage of anuria);

• hypokalemia;

• severe hepatic (including encephalopathy) failure;

• pregnancy;

• lactation period;

• age under 18;

• concomitant use of drugs that prolong the QT interval;

• hypersensitivity to the drug and other sulfonamide derivatives.

• The drug is prescribed with caution in case of impaired liver and / or kidney function, impaired water and electrolyte balance, hyperparathyroidism, patients with an increased QT interval on the ECG or receiving concomitant therapy, diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).

pharmachologic effect

Diuretic. Antihypertensive drug. In terms of pharmacological properties, it is close to thiazide diuretics (the mechanism of action is associated with impaired sodium reabsorption in the cortical segment of Henle's loop). Increases urinary excretion of sodium and chlorine ions, and to a lesser extent - potassium and magnesium ions. Possessing the ability to selectively block slow calcium channels, it increases the elasticity of the arterial walls and reduces the systemic vascular resistance. Helps to reduce left ventricular hypertrophy. Does not affect the content of lipids in blood plasma (TG, LDL, HDL) and carbohydrate metabolism (including in patients with concomitant diabetes mellitus). Reduces the sensitivity of the vascular wall to norepinephrine (norepinephrine) and angiotensin II, stimulates the synthesis of prostaglandin E2, reduces the production of free and stable oxygen radicals.The antihypertensive effect lasts for 24 hours when the drug is taken 1 time / day, the optimal therapeutic effect develops by the end of the first week of administration.

Pharmacokinetics

Suction

After oral administration, it is rapidly and completely absorbed from the gastrointestinal tract; high bioavailability - (93%). Reception with food somewhat slows down the absorption rate, but does not affect its value. Cmax is reached 12 hours after oral administration.

Distribution

With repeated doses, fluctuations in the concentration of the drug in the blood plasma in the interval between doses of two doses are reduced. The equilibrium state is established after 7 days of regular intake. Plasma protein binding - 79%. It also binds to elastin of the smooth muscles of the vascular wall. Does not cumulate. It has a high Vd, penetrates the histohematological barriers (including placental barriers), is excreted in breast milk.

Metabolism and excretion

It is metabolized in the liver. T1 / 2 - 18 hours. It is excreted by the kidneys mainly in the form of metabolites 60-80% (unchanged about 5% is excreted), through the intestines - 20%.

Pharmacokinetics in special clinical situations

In patients with renal insufficiency, the pharmacokinetics does not change.

Side effect

From the digestive system: nausea, anorexia, dry mouth, gastralgia, vomiting, diarrhea, constipation, abdominal pain, hepatic encephalopathy may develop; rarely - pancreatitis. From the side of the central nervous system: asthenia, nervousness, headache, dizziness, drowsiness, vertigo, insomnia, depression; rarely - increased fatigue, general weakness, malaise, muscle spasm, tension, irritability, anxiety. From the respiratory system: cough, pharyngitis, sinusitis; rarely - rhinitis. From the side of the cardiovascular system: orthostatic hypotension, ECG changes (hypokalemia), arrhythmia, palpitations. From the urinary system: frequent infections, nocturia, polyuria. Allergic reactions: rash, urticaria, itching, hemorrhagic vasculitis. On the part of laboratory parameters: hyperuricemia, hyperglycemia, hypokalemia, hypochloremia,hyponatremia, hypercalciuria, increased plasma urea nitrogen, hypercreatininemia, glucosuria. From the hematopoietic system: in isolated cases - thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia and hemolytic anemia. Others: exacerbation of systemic lupus erythematosus.

Application during pregnancy and lactation

The drug is contraindicated for use during pregnancy and lactation.

Application for violations of liver function

The drug is prescribed with caution in case of liver dysfunction.

The use of the drug is contraindicated in severe hepatic insufficiency (including with encephalopathy).

Application for impaired renal function

The drug is prescribed with caution in case of impaired renal function. The use of the drug is contraindicated in severe renal failure (stage of anuria).

special instructions

When prescribing the drug to patients taking cardiac glycosides, laxatives against the background of hyperaldosteronism, as well as to elderly people, regular monitoring of the content of potassium ions and the level of creatinine is shown. While taking indapamide, the concentration of potassium, sodium, and magnesium ions in the blood plasma (electrolyte disturbances may develop), pH, the concentration of glucose, uric acid and residual nitrogen should be systematically monitored. The most careful control is shown in patients with cirrhosis of the liver (especially with edema or ascites due to the risk of metabolic alkalosis, which intensifies the manifestations of hepatic encephalopathy), as well as in coronary artery disease, heart failure and the elderly.The high-risk group also includes patients with an increased QT interval on an ECG (congenital or developed against the background of any pathological process). The first determination of the concentration of potassium ions in the blood should be carried out during the first week of using the drug. Hypercalcemia while taking indapamide may result from previously undiagnosed hyperparathyroidism. In diabetic patients, it is extremely important to control blood glucose levels, especially if hypokalemia is present. Significant dehydration can lead to the development of acute renal failure (decreased glomerular filtration). Patients need to compensate for the loss of water and carefully monitor kidney function at the beginning of treatment. Indapamide can give a positive result during doping control.Patients with arterial hypertension and hyponatremia (due to taking diuretics) need to stop taking diuretics 3 days before starting ACE inhibitors (if necessary, diuretics can be resumed a little later), or ACE inhibitors are prescribed in low initial doses. When prescribing indapamide, it must be borne in mind that sulfonamide derivatives can exacerbate the course of systemic lupus erythematosus. Use in pediatrics The efficacy and safety of the drug in children has not been established.that derivatives of sulfonamides can exacerbate the course of systemic lupus erythematosus. Use in pediatrics The efficacy and safety of the drug in children has not been established.that derivatives of sulfonamides can exacerbate the course of systemic lupus erythematosus. Use in pediatrics The efficacy and safety of the drug in children has not been established.

Influence on the ability to drive vehicles and use mechanisms

In some cases, individual reactions associated with changes in blood pressure are possible, especially at the beginning of treatment and with the addition of another antihypertensive agent. As a result, the ability to perform work requiring increased attention may be reduced.

Overdose

Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, disturbances in water and electrolyte balance, in some cases - an excessive decrease in blood pressure, respiratory depression. In patients with cirrhosis of the liver, hepatic coma may develop. Treatment: gastric lavage, correction of water and electrolyte balance; if necessary, symptomatic therapy is carried out. There is no specific antidote. Drug interactions

When used together with indapamide, saluretics, cardiac glycosides, gluco- and mineralocorticoids, tetracosactide, amphotericin B (for intravenous administration), laxatives increase the risk of hypokalemia. When taken simultaneously with cardiac glycosides, the likelihood of developing digitalis intoxication increases; with calcium preparations - hypercalcemia; with metformin - aggravation of lactic acidosis is possible. When combined with indapamide, the concentration of lithium ions in the blood plasma increases (due to a decrease in excretion in the urine); lithium has a nephrotoxic effect. When used together with indapamide, it should be borne in mind that astemizole, erythromycin IV, pentamidine, sultopride, terfenadine, vincamine, class Ia antiarrhythmic drugs (quinidine, disopyramide) and class III (amiodarone, bretilium,sotalol) can lead to the development of arrhythmias of the 'pirouette' type. With the combined use of NSAIDs, GCS, tetracosactide, sympathomimetics reduce the hypotensive effect of indapamide, baclofen enhances. The combination with potassium-sparing diuretics may be effective in a certain category of patients, but this does not completely exclude the possibility of hypo- or hyperkalemia, especially in patients with diabetes mellitus and renal failure. When used together with indapamide, ACE inhibitors increase the risk of arterial hypotension and / or acute hepatic failure (especially with existing renal artery stenosis). Indapamide increases the risk of developing renal dysfunction when using iodine-containing contrast media in high doses (due to dehydration).Before using iodine-containing contrast agents, patients need to restore fluid loss. Tricyclic antidepressants and antipsychotics increase the hypotensive effect and increase the risk of orthostatic hypotension. When used together, cyclosporine increases the risk of developing hypercreatininemia. Indapamide reduces the effect of indirect anticoagulants (coumarin or indandione derivatives) due to an increase in the concentration of coagulation factors as a result of a decrease in BCC and an increase in their production by the liver (dose adjustment may be required). Indapamide enhances the blockade of neuromuscular transmission, which develops under the influence of non-depolarizing muscle relaxants.Tricyclic antidepressants and antipsychotics increase the hypotensive effect and increase the risk of orthostatic hypotension. When used together, cyclosporine increases the risk of developing hypercreatininemia. Indapamide reduces the effect of indirect anticoagulants (coumarin or indandione derivatives) due to an increase in the concentration of coagulation factors as a result of a decrease in BCC and an increase in their production by the liver (dose adjustment may be required). Indapamide enhances the blockade of neuromuscular transmission, which develops under the influence of non-depolarizing muscle relaxants.Tricyclic antidepressants and antipsychotics increase the hypotensive effect and increase the risk of orthostatic hypotension. When used together, cyclosporine increases the risk of developing hypercreatininemia. Indapamide reduces the effect of indirect anticoagulants (coumarin or indandione derivatives) due to an increase in the concentration of coagulation factors as a result of a decrease in BCC and an increase in their production by the liver (dose adjustment may be required). Indapamide enhances the blockade of neuromuscular transmission, which develops under the influence of non-depolarizing muscle relaxants.Indapamide reduces the effect of indirect anticoagulants (coumarin or indandione derivatives) due to an increase in the concentration of coagulation factors as a result of a decrease in BCC and an increase in their production by the liver (dose adjustment may be required). Indapamide enhances the blockade of neuromuscular transmission, which develops under the influence of non-depolarizing muscle relaxants.Indapamide reduces the effect of indirect anticoagulants (coumarin or indandione derivatives) due to an increase in the concentration of coagulation factors as a result of a decrease in BCC and an increase in their production by the liver (dose adjustment may be required). Indapamide enhances the blockade of neuromuscular transmission, which develops under the influence of non-depolarizing muscle relaxants.