Active substanceIndapamideIndapamide
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  • Dosage form: & nbsptablets of prolonged action, film-coated
    Composition:

    1 tablet contains:

    active substance: indapamide 1.5 mg;

    Excipients: hypromellose (hypromellose 4000) 42-78.4 mg, lactose monohydrate 168.5-132.1 mg, silicon dioxide colloid (aerosil) 1.0 mg, magnesium stearate 2.0 mg;

    sheath: hypromellose (hydroxypropylmethylcellulose) 5.94 mg, macrogol (polyethylene glycol 4000) 1.29 mg, talc 0.462 mg, titanium dioxide 1.29 mg, tropeolin O dye 0.018 mg.

    Description:

    Round, biconvex tablets, covered with a film coating of yellow color. On the cross-section, two layers are visible, the inner layer (core) is white or almost white.

    Pharmacotherapeutic group:Diuretics
    ATX: & nbsp

    C.03.B.A.11   Indapamide

    Pharmacodynamics:

    Hypotensive agent (diuretic, vasodilator). By pharmacological properties is close to thiazide diuretics (disrupts the reabsorption of sodium ions in the cortical segment of the Henle loop). Increases the urinary excretion of sodium, chlorine and, to a lesser extent, potassium and magnesium ions, which is accompanied by increased diuresis.

    Possessing the ability to selectively block "slow" calcium channels, increases the elasticity of the walls of the arteries and reduces the overall peripheral vascular resistance. Helps reduce hypertrophy of the left ventricle of the heart. Does not affect the content of lipids in the blood plasma (triglycerides, low-density lipoproteins, high-density lipoproteins); does not affect carbohydrate metabolism (including in patients with diabetes mellitus). Reduces the sensitivity of the vascular wall to noradrenaline and angiotensin II, stimulates the synthesis of prostaglandin E2 and prostacyclin PGI2, reduces the production of free and stable oxygen radicals.

    Indapamide has an antihypertensive effect in doses that do not have a pronounced diuretic effect. The hypotensive effect develops by the end of the first week, persists for 24 hours against a background of a single dose.

    Pharmacokinetics:

    After oral administration, it is quickly and completely absorbed from the gastrointestinal tract; bioavailability is high (93%). Eating somewhat slows the rate of absorption, but does not affect the amount of absorbed substance.

    The maximum concentration in the blood plasma is reached 12 hours after ingestion. At repeated receptions of fluctuation of concentration of a preparation in a blood plasma in an interval between receptions of two doses decrease. The equilibrium concentration is established after 7 days of regular intake. The half-life is 18 hours, the connection with plasma proteins is about 79%. It also binds to the elastin of the smooth muscles of the vascular wall. Has a high volume of distribution, passes through gistogematicheskie barriers (including placental), penetrates into breast milk.

    Metabolised in the liver. The kidneys excrete 60-80% in the form of metabolites (in unchanged form, about 5% is excreted), through the intestine - 20%.

    In patients with renal insufficiency, pharmacokinetics does not change.

    Do not cumulate.

    Indications:

    Arterial hypertension.

    Contraindications:

    Hypersensitivity to indapamide and other sulfonamide derivatives,severe renal failure (anuria stage), severe hepatic insufficiency (including encephalopathy), hypokalemia; pregnancy, lactation; age under 18 years (effectiveness and safety not established); lactose intolerance, galactosemia, glucose / galactose absorption disorder (the drug contains lactose).

    Carefully:Violation of the liver and / or kidney function, violation of water-electrolyte balance, hyperparathyroidism; interval lengthening QT or simultaneous reception of drugs that extend the interval QT (see "Interaction with other drugs"); diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).
    Pregnancy and lactation:

    Indapamide MB STADA is not recommended during pregnancy. Taking diuretics can cause fetoplacental ischemia and lead to impaired fetal development.

    Due to indapamide excreted in breast milk, the use of the drug during breast-feeding is not recommended. If it is necessary to use Indapamid MB STADA during lactation, breast-feeding should be discontinued.

    Dosing and Administration:

    Tablets are taken orally, preferably in the morning hours, without chewing, squeezed with enough liquid.

    The daily dose of the drug is 1 tablet of Indapamide MB STADA (1.5 mg) once a day. An increase in the dose of the drug does not lead to an increase in the hypotensive effect.

    Side effects:

    Determination of the frequency of adverse reactions: very often - 10% or more; often - 1% or more, less than 10%; infrequently, 0.1% or more, less than 1%; rarely - 0.01% or more, less than 0.1%; very rarely - less than 0.01%.

    From the cardiovascular system: very rarely - arrhythmia, Orthostatic hypotension, palpitations, changes in the electrocardiogram (ECG), characteristic of hypokalemia.

    From the hematopoiesis: very rarely - thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia, bone marrow aplasia.

    From the central and peripheral nervous system: rarely - dizziness, headache, paresthesia, increased excitability, asthenia, drowsiness, vertigo, insomnia, depression, fatigue, malaise, muscle spasm of the extremities, tension, irritability, anxiety.Patients with hepatic insufficiency may develop hepatic encephalopathy.

    From the digestive system: infrequently - vomiting; rarely - nausea, constipation, dryness of the oral mucosa; very rarely - pancreatitis, anorexia, abdominal pain, diarrhea.

    From the genitourinary system: very rarely - renal failure, nocturia, infections, polyuria.

    From the respiratory system: cough, pharyngitis, sinusitis, rhinitis.

    Allergic reactions: often - maculopapular rash; infrequently - purpura, very rarely - angioedema and / or urticaria, hemorrhagic vasculitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, itching.

    Other: separate messages - exacerbation of systemic lupus erythematosus (SLE), photosensitivity reactions.

    Laboratory data: decrease in the level of potassium and the development of hypokalemia (especially pronounced in patients at risk). In clinical studies, hypokalemia (a potassium content in the blood plasma of less than 3.4 mmol / L) was observed in 10% of patients and 3.2 mmol / L in 4% of patients after 4-6 weeks of treatment. After 12 weeks of therapy, the potassium content in the blood plasma decreased, on average, by 0.23 mmol / l.Very rarely - hypercalcemia; Possible hyponatremia, accompanied by hypovolemia and orthostatic hypotension. Simultaneous loss of chloride ions can lead to compensatory metabolic alkalosis, however the frequency of metabolic alkalosis and its severity is insignificant; hyperuricemia and hyperglycemia (unspecified frequency), increased blood urea nitrogen concentration, hypercreatininaemia, glucosuria.

    If any of the above side effects are aggravated or you notice any other side effects not listed in the instructions, tell your doctor.

    Overdose:

    Symptoms: severe decrease in arterial pressure, water-electrolyte disorders (hyponatremia, hypokalemia), nausea, vomiting, convulsions, dizziness, drowsiness, confusion, confusion, respiratory depression, polyuria or oliguria up to anuria (due to hypovolemia). Patients with cirrhosis may develop hepatic coma.

    Treatment: gastric lavage, correction of water-electrolyte balance, symptomatic therapy. There is no specific antidote.

    Interaction:

    If you are taking any other drugs, you should consult your doctor before starting treatment.

    Unrecommended combinations

    When used simultaneously with lithium preparations it is possible to increase the concentration of lithium ions in the blood plasma due to a decrease in excretion of it from the body by the kidneys, accompanied by the appearance of signs of overdose (nephrotoxic action), as well as when observing a salt-free diet (decrease in excretion of lithium ions by the kidneys). In the case of simultaneous reception with lithium preparations, careful monitoring of the concentration of lithium in blood plasma and correction of dosage are necessary.

    Combinations that require special attention

    Preparations, with simultaneous use with which the probability of occurrence of arrhythmias by the type of "pirouette" ("torsades de pointes"): antiarrhythmics IA class (quinidine, hydroquinidine, disopyramide), antiarrhythmic drugs of III class (amiodarone, dofetilide, ibutilide, brethil tosylate), sotalol, some neuroleptics: phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, sultopride, tiapride), butyrophenones (droperidol, haloperidol), other (bepridil, cisapride, difemanyl, erythromycin (intravenous (iv)), halofantrine, misolastine, pentamidine, sparfloxacin, moxifloxacin, wincamine (w / w), astemizole.

    Simultaneous use with any of these drugs, especially against hypokalemia, increases the risk of ventricular arrhythmias as pirouettes. Before starting the combination therapy with indapamide and the above drugs, you should monitor the potassium content in the blood plasma and, if necessary, adjust it. It is recommended to monitor the clinical state of the patient, as well as the content of plasma electrolytes and ECG. Patients with hypokalemia should use drugs that do not trigger the development of piruet-type arrhythmias.

    With simultaneous appointment nonsteroidal anti-inflammatory drugs (NSAIDs) (with systemic use), including selective inhibitors of cyclooxygenase-2 (COX-2), high doses of salicylic acid (3 g / day or more), possibly reducing the antihypertensive effect of indapamide, the development of acute renal failure in dehydrated patients (due to reduced glomerular rate filtering).At the beginning of therapy with indapamide, it is necessary to restore the water-electrolyte balance and control the function of the kidneys.

    Angiotensin converting enzyme (ACE) inhibitors with concomitant use with indapamide in patients with hyponatremia (especially in patients with renal artery stenosis) increase the risk of sudden arterial hypotension and / or acute renal failure. Patients with arterial hypertension and reduced by the intake of diuretics with the content of sodium ions in the blood plasma need to stop taking diuretics 3 days before the start of treatment with ACE inhibitors. In the future, if necessary, taking diuretics resume. Therapy with ACE inhibitors should start with low doses, followed by a gradual increase in dose if necessary. In chronic heart failure treatment should start with low doses of ACE inhibitors, previously lowering the dose of diuretics. In all cases, in the first week of taking ACE inhibitors, kidney function (creatinine content in the blood plasma) should be monitored.

    Drugs that increase the risk of hypokalemia: amphotericin B (IV); gluco- and mineralocorticosteroids (for systemic administration), tetracosactide, laxatives, stimulating intestinal motility. With the simultaneous administration of the above drugs with indapamide, the risk of developing hypokalemia (additive effect) increases. If necessary, monitor and adjust the content of potassium ions in the blood plasma.

    Simultaneous therapy from baclofen enhances the antihypertensive effect of indapamide.

    Cardiac glycosides: hypokalemia increases the toxic effect of cardiac glycosides (glycoside intoxication). With the simultaneous use of indapamide and cardiac glycosides, the levels of potassium ions in the blood plasma should be monitored, the ECG parameters should be monitored and, if necessary, the therapy should be adjusted.

    Combination from potassium-sparing diuretics (amiloride, spironolactone, triamterene) may be effective in some patients, however, the possibility of hypo- or hyperkalemia, especially in patients with diabetes mellitus and renal insufficiency, is not completely excluded. In such cases, it is necessary to monitor the level of potassium in the blood plasma, the parameters of the ECG and, if necessary, adjust the therapy.

    With the simultaneous use of diuretics and metformin probably the appearance of lactic acidosis, which is associated, apparently, with the development of functional renal failure caused by the action of diuretics (mostly "loop"). It is not recommended to apply metformin in combination with indapamide at a creatinine level of more than 15 mg / L (135 μmol / L) in men and 12 mg / L (110 μmol / L) in women.

    When using iodine-containing radiocontrast preparations, it should be borne in mind that the diuretic effect of indapamide increases the risk of developing renal failure. This risk is especially high when using iodine-containing radiocontrast substances in high doses. Before using iodine-containing radiopaque substances, patients need to restore fluid loss.

    Tricyclic antidepressants and antipsychotics increase the hypotensive effect and increase the risk of development, orthostatic hypotension (additive effect).

    Preparations containing calcium salts, increase the risk of hypercalcemia due to a decrease in excretion of calcium ions by the kidneys.

    With simultaneous application cyclosporine and tacrolimus it is possible to increase the creatinine content in the blood plasma (without changing the concentration of circulating cyclosporine), which is observed even with normal water content and sodium ions.

    Glucorticosteroid preparations, tetracosactide (with systemic application) reduce the hypotensive effect (retention of sodium and liquid ions).

    Reduces the effect indirect anticoagulants (coumarin or indanedione derivatives) due to an increase in the concentration of coagulation factors as a result of a decrease in the volume of circulating blood and increase in their production by the liver (dose adjustment may be required).

    Strengthens the blockade of neuromuscular transmission, which develops under the action of Nondepolarizing muscle relaxants.

    Special instructions:

    With insufficient effectiveness after 4-8 weeks, it is advisable to add an antihypertensive drug to the therapy with a different mechanism of action. Do not increase the dose of the drug (in the absence of a significant increase in the hypotensive effect, the risk of side effects increases).

    In patients taking cardiac glycosides, laxatives, against hyperaldosteronism, as well as in the elderly, regular monitoring of the content of potassium and creatinine ions is shown.

    Against the background of taking indapamide, the concentration of potassium, sodium, magnesium ions in the blood plasma should be systematically monitored (electrolyte disturbances may develop), pH, glucose concentration, uric acid and residual nitrogen. Determination of the content of sodium ions in blood plasma is recommended to be performed before the start of treatment. The first measurement of the concentration of potassium ions in the blood plasma should be carried out within the first week after the start of treatment. The most thorough control is indicated in patients with coronary heart disease, heart failure, cirrhosis of the liver (especially with edema or ascites - the risk of metabolic alkalosis, increasing manifestations of hepatic encephalopathy), weakened patients or who receive combined medication. To the group of the raised risk also patients with the increased interval QT on an electrocardiogram (congenital or developed against a background of any pathological process) and patients taking, along with indapamide, drugs that extend the interval QT (see "Interaction with other drugs").Thiazide diuretics can reduce the excretion of calcium ions in the urine, which leads to minor and temporary hypercalcemia. Expressed hypercalcemia on the background of taking indapamide may be a consequence of previously undiagnosed hyperparathyroidism. It is necessary to cancel the use of diuretic drugs before the study of parathyroid function.

    In the appointment of thiazide diuretics, patients with hepatic insufficiency may develop hepatic encephalopathy. In such cases, the drug should be discontinued immediately.

    In patients with diabetes, it is extremely important to monitor blood glucose levels, especially when hypokalemia is present.

    Significant dehydration can lead to the development of acute renal failure (reduced glomerular filtration). Patients must compensate for the loss of water and at the beginning of treatment carefully monitor the kidney function.

    Indapamide can give a positive result in the conduct of doping control.

    In patients with a high level of uric acid in blood plasma against the background of indapamide therapy, the incidence of gout attacks may increase.

    Derivatives of sulfonamides can exacerbate the course of systemic lupus erythematosus (should be borne in mind when administering indapamide).

    Effect on the ability to drive transp. cf. and fur:

    Some patients, mainly at the beginning of treatment or with the addition of another antihypertensive agent, may experience drowsiness, dizziness, and other side effects from the nervous system. When they occur, the patient must observe special precautions when driving a vehicle and working with complex mechanisms.

    Form release / dosage:

    Tablets of prolonged action, film-coated, 1.5 mg.

    Packaging:

    For 10 tablets in a contour mesh package made of a polyvinyl chloride film and aluminum foil printed lacquered.

    By 3 contour squares with instructions for use in a cardboard pack.

    Storage conditions:

    Store in a dry, dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-000610
    Date of registration:09.06.2010 / 10.12.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:Nizhny Novgorod Chemical and Pharmaceutical Plant, OJSCNizhny Novgorod Chemical and Pharmaceutical Plant, OJSC
    Manufacturer: & nbsp
    Representation: & nbspNizhpharm, JSCNizhpharm, JSCRussia
    Information update date: & nbsp31.10.2017
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