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

    1 tablet contains:

    active substance: indapamide 1.50 mg;

    Excipients: lactose monohydrate 98.60 mg, hypromellose 50.00 mg, povidone-K30 8.00 mg, silicon dioxide colloid 0.40 mg, microcrystalline cellulose 40.00 mg, magnesium stearate 1.50 mg;

    film sheath: Selekoate AQ-02003 (hypnemellosis (55-65%), macrogol 6000 (15-25%), titanium dioxide (15-25%)) 5.00 mg.

    Description:

    Round, biconvex tablets, covered with film shell of white color. On the cross-section the nucleus is white.

    Pharmacotherapeutic group:Diuretics
    ATX: & nbsp

    C.03.B.A.11   Indapamide

    Pharmacodynamics:

    Indapamide is a sulfonamide derivative containing an indole ring pharmacologically related to a group of thiazide diuretics. Disrupts the reabsorption of sodium ions in the cortical segment of the Henle loop. Increases the excretion of urine sodium, chlorine and, to a lesser extent, potassium and magnesium. 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 concentration of lipids in the blood plasma (triglycerides, low-density lipoproteins, high-density lipoproteins); does not affect carbohydrate metabolism (including in patients with concomitant diabetes mellitus). Reduces the sensitivity of the vascular wall to noradrenaline and angiotensin II, stimulates the synthesis of prostaglandin E2 and prostacyclin I2, reduces the production of free and stable oxygen radicals. When used in high doses does not affect the degree of lowering blood pressure, despite an increase in diuresis.

    After repeated administration, the antihypertensive effect is observed after 1-2 weeks, reaches a maximum by 8-12 weeks and lasts up to 8 weeks. After taking a single dose, the maximum effect is observed after 24 hours.

    Pharmacokinetics:

    In tablets Indapamide Sandoz® active substance is in a special matrix-carrier, which provides a delayed release of indapamide in the gastrointestinal tract. The released indapamide quickly and completely absorbed from the gastrointestinal tract; bioavailability is high (93%). Eating somewhat slows the rate of absorption, but does not affect the total amount of absorbed drug. Time to reach the maximum concentration in serum is 12 hours. 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. Relationship with blood plasma proteins - 79%. It also binds to the elastin of the smooth muscles of the vascular wall. Has a high volume of distribution, passes through the blood-brain and placental barriers, is excreted in breast milk.

    Metabolized in the liver.

    Displayed kidneys 60-70% in the form of metabolites (in an unchanged form is about 5-7%), through the intestine - 20-23%. The half-life on average is 18 hours. In patients with renal insufficiency, the pharmacokinetics do not change. With repeated intake of the drug does not cumulate.

    Indications:

    Arterial hypertension.

    Contraindications:

    - Hypersensitivity to indapamide, other sulfonamide derivatives or to any other component of the drug;

    - deficiency of lactase, lactose intolerance, glucose-galactose malabsorption;

    - severe hepatic insufficiency (including with encephalopathy);

    - severe renal failure (creatinine clearance less than 30 ml / min);

    - hypokalemia;

    - lactation period;

    - pregnancy;

    - age to 18 years.

    Carefully:

    In patients with disturbed water electrolyte metabolism; hepatic and / or renal insufficiency; elongation QT interval or with the simultaneous administration of drugs that extend QT interval; hyperuricemia (especially manifested by gout or urate nephrolithiasis); hyperparathyroidism; diabetes mellitus in the stage of decompensation.

    Pregnancy and lactation:

    The drug should not be used during pregnancy, since diuretics can cause fetoplacental ischemia with a risk of impaired fetal development.

    Indapamide is excreted in breast milk. Given the potential for adverse events in infants, breastfeeding during treatment should be discontinued.

    Dosing and Administration:

    Indapamid Sandoz® is used as directed by a doctor.

    Take in 1 tablet whole, in the morning, without chewing, squeezed with enough water.

    With insufficient effectiveness after 4-8 weeks, it is advisable to add to the therapy a drug with a different mechanism of action (increasing the dose is inappropriate - in the absence of a significant increase in the effect, there is an increase in side effects).

    Side effects:

    The incidence of side effects is described in accordance with the following gradation: very frequent - more than 10%, frequent - from 1 to 10%, not frequent - from 0.1% to 1%, rare - from 0.01 to 0.1% very rare - less than 0.01%, unspecified frequency (according to available data, the incidence of side effects was not possible to establish).

    From the side of the cardiovascular system:

    very rare: marked decrease in arterial pressure, arrhythmia; unspecified frequency: arrhythmia of the type "pirouette" (possibly with a fatal outcome), an increase in the interval QT on the ECG.

    From the nervous system:

    rare: dizziness, fatigue, paresthesia, headache;

    unspecified frequency: fainting.

    From the digestive system:

    infrequent: vomiting;

    rare: nausea, constipation, dryness of the oral mucosa; very rare: pancreatitis, impaired liver function;

    unspecified frequency: hepatic encephalopathy, hepatitis.

    From the genitourinary system:

    very rare: renal insufficiency.

    From the skin and its derivatives:

    Frequent: patchy-papular rash;

    infrequent: purpura;

    very rare: angioedema, toxic epidermal

    necrolysis, Stevens-Johnson syndrome;

    unspecified frequency: exacerbation of the systemic lupus erythematosus, photosensitivity reaction.

    From the hematopoiesis:

    very rare: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia.

    Laboratory indicators:

    very rare: hypercalcemia;

    unspecified frequency: hyperuricemia, hypochloraemia, hyponatremia accompanied by hypovolemia, dehydration and orthostatic hypotension (simultaneous loss of chloride ions can lead to compensatory metabolic alkalosis, however, the frequency of development of alkalosis and its severity is negligible), hypokalemia, hyperglycemia, glucosuria, increased activity of "liver" transaminases.

    Overdose:

    Symptoms: nausea, vomiting, weakness, dysfunction of the gastrointestinal tract, disturbance of the water-electrolyte balance, in some cases - excessive reduction in blood pressure, respiratory depression, convulsions, dizziness, drowsiness, confusion, polyuria or oliguria, possibly on the verge of anuria caused by hypovolemia). Patients with cirrhosis may develop hepatic coma.

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

    Interaction:
    With the simultaneous use of indapamide and lithium preparations there may be an increase in the concentration of lithium in the blood plasma due to a decrease in its excretion, accompanied by the appearance of signs of an overdose. If necessary, diuretic drugs can be prescribed in combination with lithium preparations, while carefully choosing the dose of drugs, constantly monitoring the lithium content in blood plasma.

    Increases the risk of kidney dysfunction when used iodine-containing contrast agents in high doses (dehydration of the body). Before using iodine-containing contrast agents, patients need to replenish the volume of circulating blood (BCC).

    Diuretics ("loop", thiazide), cardiac glycosides, gluco- and mineralocorticosteroids, tetracosactide, amphotericin B at intravenous administration, laxatives, stimulating the motility of the gastrointestinal tract, increase the risk of hypokalemia.

    At simultaneous reception from cardiac glycosides the likelihood of developing digitalis intoxication increases; from preparations of calcium - hypercalcemia; with metformin - Possible aggravation of lactic acidosis.

    Antiarrhythmic agents of Ia class (quinidine, hydroquinidine, disopyramide); antiarrhythmic drugs of III class (amiodarone, sotalol, dofetilide and ibutilide); some antipsychotics: phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazinetrifluoperazine), benzamides (amisulpride, sulpiride, sultopride, tiapride), butyrophenones (droperidol, haloperidol); some antihistamines (misolastine); antimalarials (halofantrine); other: bepridil, pentamidine, difemanyl, sparfloxacin, moxifloxacin, cisapride, wincamine and erythromycin for intravenous administration: may lead to the development of piruette-type arrhythmia due to mutual influence (elongation) for the duration of the QT interval.

    Non-steroidal anti-inflammatory drugs (with systemic use, including selective inhibitors of cyclooxygenase-2, high doses of acetylsalicylic acid (more than 3 g / day)), glucocorticoids, tetracosactide, adrenomimetics reduce hypotensive effect, baclofen - strengthens.

    Combination from potassium-sparing diuretics It may be effective in some categories of patients, but it is not completely excluded the possibility of developing hypo- or hyperkalemia, especially in patients with diabetes and renal failure.

    Angiotensin converting enzyme inhibitors (ACE) increase the risk of developing arterial hypotension and / or acute renal failure (especially with existing renal artery stenosis). Before using the drug with ACE inhibitors, it is necessary to reduce the initial dose of an ACE inhibitor or interrupt indapamide therapy for 3 days.

    Tricyclic antidepressants and antipsychotic drugs (antipsychotics) intensify the hypotensive effect and increase the risk of orthostatic hypotension.

    Cyclosporin, tacrolimus increase the risk of hypercreatininaemia.

    Special instructions:
    With prolonged use or when taking the drug Indapamide Sandoz® in high doses may develop electrolyte disturbances such as hyponatremia, hypokalemia, alkalosis gipohloremichesky. These disorders are more common in patients with chronic heart failure (II-IV functional class NYHA classification), liver disease, with vomiting and diarrhea, as well as in those on a low-salt diet.

    With prolonged intake of the drug Indapamide Sandoz® is recommended to regularly monitor the content of potassium, sodium, magnesium in the blood plasma (electrolyte disorders may develop), acid-base state, glucose concentration, uric acid and residual nitrogen.

    The most thorough control is shown in patients with cirrhosis of the liver (especially with edema or ascites - the risk of metabolic alkalosis, which increases manifestations of hepatic encephalopathy), coronary heart disease, chronic heart failure, and also in the elderly. The high-risk group also includes patients with increased QT interval on the ECG (congenital or developed against a background of a pathological process).

    The first measurement of the potassium content in the blood should be performed within 1 week of treatment.

    Hypercalcemia on the background of taking indapamide may be a consequence of previously undiagnosed hyperparathyroidism. It is necessary to cancel the drug before examining the function of parathyroid glands.

    Significant dehydration can lead to the development of acute renal failure (reduced glomerular filtration).Patients should complete the BCC and at the beginning of the treatment carefully monitor the kidney function.

    Indapamide can give a positive result in doping control.

    With the use of thiazide and thiazide-like diuretics, cases of photosensitization reactions have been described. When a photosensitization reaction occurs, treatment is recommended to be discontinued. If it is necessary to re-appoint a diuretic, it is recommended to protect the exposed areas of the body from the sun or artificial ultraviolet irradiation.

    In patients with diabetes, monitoring of blood glucose is important, especially with hypokalemia.

    In patients with hyperuricemia, the likelihood of developing seizures or exacerbation of the gout current may increase.

    Patients with arterial hypertension and hyponatremia (due to taking diuretics) need to stop taking diuretics 3 days before the start of taking ACE inhibitors (if necessary, diuretics can be taken a little later) or they are given initial low doses of ACE inhibitors.

    It can aggravate the course of systemic lupus erythematosus.

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

    Data on the adverse effects of the drug Indapamide Sandoz® in recommended doses for the ability to drive vehicles or work with mechanisms there. However, taking into account individual reactions, especially at the beginning of treatment (possibly the development of arterial hypotension), care should be taken when engaging in activities requiring concentration of attention.

    Form release / dosage:

    Tablets of prolonged film-coated effects, 1.5 mg

    Packaging:

    10 tablets per blister from Al / Al.

    For 3, 6 or 9 blisters are placed together with instructions for medical use in a cardboard box.

    Storage conditions:

    In the original packaging in a dry place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use the drug after the expiry date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002232
    Date of registration:17.09.2013 / 09.09.2015
    Expiration Date:17.09.2018
    Date of cancellation:2017-02-09
    The owner of the registration certificate:Sandoz d.Sandoz d. Slovenia
    Manufacturer: & nbsp
    LEK d.d. Slovenia
    Representation: & nbspSANDOZ SANDOZ Switzerland
    Information update date: & nbsp02.11.2017
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