Active substanceIndapamideIndapamide
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

    active substance: indapamide 2.5 mg;

    Excipients: pregelatinized starch, microcrystalline cellulose, silicon dioxide colloid (aerosil), magnesium stearate, opadrai II (hypromellose, macrogol, lactose monohydrate and titanium dioxide).

    Description:

    The tablets are biconvex, covered with a film coating of white color. On the cross-section - the inner layer of white or white with a creamy shade of color.

    Pharmacotherapeutic group:Diuretics
    ATX: & nbsp

    C.03.B.A.11   Indapamide

    Pharmacodynamics:

    A hypotensive agent, a thiazide-like diuretic with a moderate in strength and long duration of action, a benzamide derivative. Has moderate saluretic and diuretic effects, which are associated with blockade of reabsorption of sodium, chlorine, hydrogen ions, and to a lesser extent potassium ions in the proximal tubules and cortical segment of the nephron distal tubule. The vasodilator effects and the reduction of the overall peripheral vascular resistance are based on the following mechanisms: a decrease in the reactivity of the vascular wall to norepinephrine and angiotensin II; an increase in the synthesis of prostaglandins with vasodilating activity; oppression of calcium current in the smooth-muscle walls of blood vessels.

    Reduces the tone of the smooth muscles of the arteries, reduces the overall peripheral resistance of the vessels. Helps reduce hypertrophy of the left ventricle of the heart. In therapeutic doses does not affect lipid and carbohydrate metabolism (including in patients with concomitant diabetes mellitus).

    Antihypertensive effect develops at the end of the first / beginning of the second week with a constant intake of the drug and 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 down the speed, but does not affect the completeness of absorption.

    The maximum concentration in the blood is achieved 1-2 hours after ingestion. Equilibrium concentration is achieved after 7 days of regular intake. The preparation binds to blood plasma proteins by 70-80%. Has a high volume of distribution, passes through the histohematological (including placental) barriers, penetrates into breast milk.

    Metabolised in the liver. The half-life of indapamide is on average 14-18 hours. It is excreted from the body by the kidneys (up to 80%) mainly in the form of metabolites, through the intestine - 20%. In patients with renal insufficiency, pharmacokinetics does not change. Do not cumulate.

    Indications:

    Arterial hypertension.

    Contraindications:

    Hypersensitivity to indapamide, other derivatives of the sulfonamide or other components of the drug, cerebrovascular accident, severe renal impairment (creatinine clearance less than 30 mL / min) and / or the liver (including encephalopathy), hypokalemia, simultaneous administration of drugs , extending the interval QT, pregnancy, lactation, age under 18 (efficacy and safety not established).

    The tablet shell contains lactose, therefore, the drug should not be taken by patients with rare hereditary diseases, such as galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

    Carefully:

    With diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis), hyponatremia and other disturbances of water-electrolyte metabolism, moderate hepatic and / or renal insufficiency, ascites, coronary heart disease, chronic heart failure, hyperparathyroidism, in weakened patients and patients with an increased interval QT on an electrocardiogram or receiving a combination therapy with other antiarrhythmic drugs.

    Pregnancy and lactation:

    The drug is not recommended for use during pregnancy, since diuretics can cause fetoplacental ischemia with a risk of fetal malnutrition.

    Indapamide is excreted in breast milk. Given the potential for adverse events in infants, breastfeeding during treatment is not recommended.

    Dosing and Administration:

    Inside, preferably in the morning, regardless of food intake of 2.5 mg (1 tablet) per day, squeezed a sufficient amount of liquid.

    If the desired therapeutic effect is not achieved after 4-8 weeks of treatment, the dose of the drug should not be increased (the risk of side effects increases without increasing the antihypertensive effect). Instead, it is recommended that another antihypertensive drug that is not a diuretic be included in the drug regimen.

    In cases where treatment should start with the taking of two drugs, the dose of Indapamide remains 2.5 mg in the morning once a day.

    Side effects:

    From the side of metabolism: hypokalemia, hyponatremia, hypochloraemic alkalosis, hypercalcemia, increased urea nitrogen in the blood plasma, hypercreatininaemia, glucosuria, hyperuricemia, hyperglycemia.

    From the digestive system: dryness of the oral mucosa, vomiting, gastralgia, anorexia, abdominal discomfort, pancreatitis, constipation or diarrhea, hepatic encephalopathy (against hepatic insufficiency).

    From the central nervous system: asthenia, dizziness, nervousness, headache, drowsiness, fatigue, general weakness, insomnia, depression, tension, irritability, anxiety, lethargy, lethargy, agitation, paresthesia, tingling sensation in the extremities.

    From the sense organs: conjunctivitis, impaired vision.

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

    From the cardiovascular system: Orthostatic hypotension, arrhythmia, palpitation, changes in the electrocardiogram, characteristic of hypokalemia.

    From the urinary system: nocturia, polyuria, an increase in the incidence of infections.

    On the part of the organs of hematopoiesis: thrombocytopenia, leukopenia, agranulocytosis, bone marrow aplasia, hemolytic anemia.

    Allergic reactions: skin rash, itching, hives, hemorrhagic vasculitis.

    Other: flu-like syndrome, chest pain, malaise, muscle spasm, back pain, decreased libido and potency, rhinorrhea, increased sweating, decreased body weight, exacerbation of systemic lupus erythematosus, cases of photosensitivity reaction are described.

    Overdose:

    Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, water-electrolyte disorders, lowering of arterial pressure, dizziness, drowsiness, confusion, respiratory depression, in patients with impaired hepatic function, the development of hepatic coma is possible.

    Treatment: gastric lavage and / or the appointment of activated charcoal, followed by the restoration of normal water-electrolyte balance, symptomatic therapy. There is no specific antidote.

    Interaction:

    With the simultaneous use of indapamide with lithium preparations, an increase in the concentration of lithium in the blood plasma is possible.

    Astemizole, erythromycin (w / w), pentamidine, sultopride, wincamine, antiarrhythmic drugs IA (quinidine, disopyramide) and III class (amiodarone, brethil tosylate, sotalol) may increase the likelihood of heart rhythm disorders by type torsades de pointes (ventricular tachycardia of the "pirouette" type).

    Non-steroidal anti-inflammatory drugs, glucocorticosteroids, tetracosactide, sympathomimetics reduce hypotensive effect, baclofen - Increases.

    Saluretics, cardiac glycosides, gluco- and mineralocorticosteroids, tetracosactide, amphotericin B (IV), laxatives increase the risk of hypokalemia.

    With simultaneous use with cardiac glycosides, the likelihood of developing digitalis intoxication increases, with calcium preparations - hypercalcemia, with metformin - possibly aggravation of lactic acidosis.

    Combination with potassium-sparing diuretics can be effective in some patients, but the possibility of hypo- or hyperkalemia, in patients with diabetes mellitus and renal insufficiency, is not completely excluded.

    Angiotensin converting enzyme (ACE) inhibitors increase the risk of developing arterial hypotension and / or acute renal failure (especially with existing renal artery stenosis).

    Contrasting iodine-containing drugs in high doses increase the risk of kidney dysfunction (dehydration). Before using contrast iodine-containing drugs, patients need to restore fluid loss.

    Tricyclic antidepressants and antipsychotic drugs increase the hypotensive effect and increase the risk of orthostatic hypotension.

    Cyclosporine increases the risk of hypercreatininaemia.

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

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

    Special instructions:

    With long-term use or when taking indapamide in high doses, electrolyte disorders such as hyponatremia, hypokalemia, hypochloraemic alkalosis can develop. These disorders are more often observed in patients with chronic heart failure (II-IV functional class by classification NYHA), liver disease, with vomiting and diarrhea, as well as in individuals on a salt-free diet.

    The simultaneous use of indapamide with cardiac glycosides and corticosteroids increases the risk of hypokalemia. In addition, magnesium can be increased by the kidneys, which can lead to hypomagnesemia.

    Perhaps the appearance of orthostatic hypotension, which can be provoked by drinking alcohol, barbiturates, narcotic drugs and simultaneous reception of other antihypertensive drugs.

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

    The most thorough control is indicated in patients with cirrhosis of the liver, ischemic heart disease, chronic heart failure.

    To the group of the raised risk also patients with the increased interval QT on an electrocardiogram (congenital or developed against a background of a pathological process).

    The first measurement of the potassium concentration in the blood should be performed during the first week of treatment.

    Hypercalcemia on the background of the use of Indapamide may be a consequence of previously not diagnosed hyperparathyroidism.

    In patients with diabetes, it is extremely important to control the concentration of glucose in the blood, especially when there is hypokalemia.

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

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

    Patients with hypertension and hyponatremia (due diuretics) necessary for 3 days before the reception stop ACE inhibitors diuretics (if necessary diuretics can be resumed later), or apply the initial low dose of ACE inhibitors.

    Derivatives of sulfonamide can aggravate the course of systemic lupus erythematosus (it must be borne in mind when using Indapamide).

    Form release / dosage:

    Tablets, film-coated, 2.5 mg.

    Packaging:

    For 10 tablets in a contour mesh box made of PVC film and foil.

    1, 2, 3, 4 or 5 contour cell packs with instruction in the pack.

    Storage conditions:

    In a dry, the 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 expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001639
    Date of registration:11.03.2011
    Expiration Date:Unlimited
    The owner of the registration certificate:ALSI Pharma, ZAO ALSI Pharma, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspALSI Pharma CJSC ALSI Pharma CJSC Russia
    Information update date: & nbsp03.11.2017
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