Indapamide retard
Indapamide retard: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Use in the elderly
- 14. Drug interactions
- 15. Analogs
- 16. Terms and conditions of storage
- 17. Terms of dispensing from pharmacies
- 18. Reviews
- 19. Price in pharmacies
Latin name: Indapamide retard
ATX code: C03BA11
Active ingredient: Indapamide (Indapamide)
Producer: ZAO ALSI Pharma (Russia), OOO OZON (Russia), OAO Tatkhimfarmpreparaty (Russia), ZAO Kanonfarma Production (Russia), OOO Izvarino Pharma (Russia)
Description and photo update: 2018-25-10
Prices in pharmacies: from 49 rubles.
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Indapamide retard is an antihypertensive drug, diuretic, vasodilator.
Release form and composition
Dosage forms of Indapamide retard:
- sustained-release film-coated tablets / film-coated tablets: round, biconvex; the core in the cross section is white or almost white; depending on the manufacturer, the casing can be white or white with a grayish or light brown tint (in a contoured cell package 10, 15, 20 or 30 pcs., in a cardboard box 1–6, 8 or 10 packages - depending on the manufacturer; in polymer container 10, 20, 30, 40, 50 or 100 pcs., 1 container in a cardboard box);
- controlled release film-coated tablets: round, biconvex, almost white or white (in a contoured cell package 10 pcs., in a cardboard box 2-9 packs; in a contour cell package 15 pcs., in a cardboard box 2, 4 or 6 packs).
Composition of 1 tablet of prolonged action, film-coated / film-coated:
- active substance: indapamide - 1.5 mg;
- auxiliary components in the core (depending on the manufacturer): hypromellose, colloidal silicon dioxide (aerosil), lactose monohydrate (milk sugar), magnesium stearate (ALSI Pharma), or hypromellose, magnesium stearate, microcrystalline cellulose, polyvinylpyrrolidone (OZON), or (hydroxypropyl methylcellulose), lactose monohydrate (milk sugar), magnesium stearate, povidone (low molecular weight polyvinylpyrrolidone), colloidal silicon dioxide (Tatchimpharmaceuticals), or hypromellose (hydroxypropyl methylcellulose), copovidone, sugar lactose monohydrate (microcrystalline cellulose monohydrate) colloidal anhydrous silicon dioxide, polyvinyl acetate, sodium lauryl sulfate), magnesium stearate, anhydrous colloidal silicon dioxide (Canonpharm Production);
- shell (depending on the manufacturer): hypromellose, lactose monohydrate, polyethylene glycol, titanium dioxide (ALSI Pharma), or titanium dioxide, macrogol-4000, hypromellose, talc (OZONE), or macrogol 4000, polyvinyl alcohol, titanium dioxide, talc (Tatkhimfarmpreprep, Canonpharm Production).
Composition of 1 controlled release film-coated tablet:
- active substance: indapamide - 1.5 mg;
- auxiliary components (core): hypromellose, mannitol, povidone K-90, colloidal silicon dioxide, magnesium stearate;
- shell: opadry II white (hypromellose, titanium dioxide, lactose monohydrate, macrogol, triacetin).
Pharmacological properties
Pharmacodynamics
The active substance of the drug, indapamide, is a thiazide-like diuretic with a long-lasting and moderate hypotensive effect. It has saluretic and diuretic effects associated with inhibition of active reabsorption of sodium, chlorine, hydrogen ions in the cortical segment of the ascending part of Henle's loop and in the proximal tubules, which is accompanied by an increase in the amount of urine excreted and increased excretion of sodium, chlorine, potassium and magnesium ions by the kidneys.
Indapamide improves the elasticity of the walls of large arteries, reduces the tone of the smooth muscles of the arteries and reduces the total peripheral vascular resistance (OPSR) due to a decrease in the reactivity of the vascular wall to angiotensin II and norepinephrine, an increase in the synthesis of prostaglandins with vasodilating activity, inhibition of the flow of calcium ions into the smooth muscle vascular walls. The drug helps to reduce left ventricular hypertrophy.
When using indapamide in therapeutic doses, it does not affect the concentration of lipids in the blood plasma (high density lipoproteins, low density lipoproteins, triglycerides), does not affect carbohydrate metabolism (including with concomitant diabetes mellitus).
After a single dose of indapamide, the antihypertensive effect persists for 24 hours, while a moderately pronounced diuretic effect is observed. With regular use of the drug, a stable hypotensive effect develops at the end of the first or beginning of the second week of therapy.
Pharmacokinetics
- absorption: after oral administration, indapamide is rapidly and completely absorbed in the gastrointestinal tract; bioavailability - 93%. Food intake slightly slows down the rate of absorption, but does not affect the completeness of absorption. The maximum concentration in blood plasma (C max) is achieved 12 hours after oral administration of a single dose. With subsequent doses, fluctuations in the plasma concentration of the substance in the intervals between doses decrease;
- distribution: widely distributed in the body; 79% binds to blood plasma proteins; tends to pass through the blood-brain barrier and the placenta, enters breast milk. Equilibrium concentration (C ss) is achieved after one week of regular administration of the drug. When re-taking the cumulation of the substance is not observed;
- metabolism and excretion: indapamide is metabolized in the liver; half-life (T 1/2) - from 14 to 24 hours (average 18 hours); excreted mainly in the form of inactive metabolites: with urine - up to 80%, with feces - about 20%. 5% is displayed unchanged.
In patients with renal insufficiency, pharmacokinetic parameters do not change.
Indications for use
According to the instructions, Indapamide retard is indicated for use in arterial hypertension.
Contraindications
Absolute:
- severe forms of renal dysfunction (creatinine clearance below 30 ml / min);
- hypokalemia;
- lactose intolerance, lactase deficiency, glucose-galactose malabsorption;
- severe liver dysfunction (including hepatic encephalopathy);
- simultaneous use with drugs that prolong the QT interval (electric systole of the heart);
- acute disorder of cerebral circulation;
- pregnancy, breastfeeding period;
- age up to 18 years;
- increased individual sensitivity to indapamide, other sulfonamide derivatives or auxiliary components of the drug.
Relative (diseases / conditions in which the use of Indapamide retard requires caution):
- impaired renal and / or liver function of moderate severity;
- hyperparathyroidism;
- hyponatremia and other disorders of water and electrolyte balance;
- increased QT interval on the electrocardiogram;
- diabetes mellitus in the stage of decompensation;
- hyperuricemia (especially accompanied by urate nephrolithiasis and gout).
Instructions for the use of Indapamide retard: method and dosage
The tablets are taken orally, swallowing whole, with a sufficient amount of liquid, mainly in the morning, regardless of the meal.
The recommended dose of Indapamide retard is 1.5 mg (1 tablet) per day.
If the desired hypotensive effect is not achieved after 4–8 weeks of therapy, the dose of the drug should not be increased (because of the risk of increasing the frequency of adverse reactions without increasing the therapeutic effect). In this case, it is recommended to use another antihypertensive agent that is not a diuretic.
If it is necessary to start therapy with two different drugs, Indapamide retard should be taken in the same dose - 1 tablet in the morning 1 time per day.
Side effects
Most of the adverse reactions (clinical and laboratory parameters) are dose-dependent.
The incidence of side effects from systems and organs in accordance with a special scale (> 0.1 - very often; 0.01-0.1 - often; 0.001-0.01 - infrequently; 0.0001-0.001 - rarely; < 0.0001 - extremely rare; with an indefinite frequency - if it is impossible to calculate the frequency using the available data):
- central nervous system: rarely - headache, dizziness, paresthesia, fatigue;
- circulatory and lymphatic systems: very rarely - agranulocytosis, leukopenia, thrombocytopenia, hemolytic anemia, aplastic anemia;
- cardiovascular system: very rarely - lowering blood pressure, arrhythmia;
- digestive system: infrequently - vomiting; rarely - constipation, nausea, dry mouth; very rarely - pancreatitis;
- urinary system: very rarely - renal failure;
- liver and biliary tract: very rarely - liver dysfunction; with an uncertain frequency - the development of hepatic encephalopathy in the case of liver failure;
- skin: often - maculopapular rash; infrequently - hemorrhagic vasculitis; very rarely - urticaria and / or angioedema, Stevens-Johnson syndrome, toxic epidermal necrolysis; with an indefinite frequency - worsening of the course of the disease in the acute form of disseminated lupus erythematosus; cases of photosensitive reactions have been reported;
- laboratory parameters: very rarely - hypercalcemia; with an indefinite frequency - hyponatremia, hypokalemia, hyperglycemia, hyperuricemia, hypochloremia, glucosuria, hypercreatininemia, increased plasma urea nitrogen concentration, increased QT interval on the electrocardiogram.
Overdose
In case of an overdose of Indapamide retard, the following symptoms may develop: nausea / vomiting, dizziness, confusion, drowsiness, convulsions, excessive decrease in blood pressure, respiratory depression, oliguria up to anuria, polyuria, the development of hepatic coma (in patients with impaired liver function).
There is no specific antidote for indapamide. Initial treatment is gastric lavage and / or activated charcoal. Then symptomatic therapy and restoration of the body's water and electrolyte balance are recommended.
special instructions
During the period of treatment with Indapamide retard, it is necessary to systematically monitor the concentration of sodium, potassium and magnesium ions in the blood plasma due to the possible occurrence of disorders of the water and electrolyte balance, check the pH level, the concentration of uric acid, glucose and residual nitrogen.
Those taking laxatives, cardiac glycosides, elderly patients, as well as patients with aldosteronism syndrome are shown regular monitoring of the concentration of potassium and creatinine ions.
The first measurement of the content of potassium ions in the blood must be carried out within 7 days from the start of treatment.
In patients with impaired liver function, the use of thiazide-like diuretics increases the risk of developing hepatic encephalopathy, especially with disorders of the water-salt balance. In this case, you should immediately stop taking Indapamide retard.
The most careful monitoring of the potassium content in the blood is necessary in patients with heart failure, coronary artery disease (coronary artery disease), liver cirrhosis (especially with ascites or edema - due to the risk of metabolic alkalosis). Patients with an increased QT interval on the electrocardiogram are also at increased risk. Hypokalemia is a predisposing factor for the development of severe arrhythmias, especially pirouette-type arrhythmias, which can be fatal.
An increase in plasma calcium concentration during the use of Indapamide retard can be observed due to previously undiagnosed hyperparathyroidism.
In diabetes mellitus, it is important to carefully monitor blood glucose levels, especially in hypokalemia.
At the initial stage of treatment, kidney function should be checked. Patients with impaired renal function need to replenish the BCC (circulating blood volume). Significant dehydration can lead to acute renal failure.
In patients with gout, while taking indapamide, the frequency of attacks may increase and / or the course of gout may worsen.
If it is necessary to use ACE (angiotensin-converting enzyme) inhibitors in patients with arterial hypertension and hyponatremia, indapamide should be discontinued 3 days before starting ACE inhibitors (with the possibility of subsequent resumption of diuretic use) or initially low doses of ACE inhibitors should be prescribed.
Before conducting a study of the function of the parathyroid glands, you should stop taking the drug.
Indapamide retard can give a positive result during doping control in athletes.
With the development of photosensitivity reactions against the background of the use of thiazide-like diuretics, drug therapy should be discontinued. If treatment is necessary to continue, it is recommended to cover the skin from the sun or artificial ultraviolet rays.
Influence on the ability to drive vehicles and complex mechanisms
The substances that make up Indapamide retard do not cause disorders of psychomotor reactions. But due to the development of individual reactions in some patients to a decrease in blood pressure (especially at the initial stage of treatment or with concomitant therapy with other antihypertensive drugs), care must be taken when driving and performing all types of work associated with an increased risk of accidents.
Application during pregnancy and lactation
Since Indapamide retard can cause fetoplacental ischemia and the development of fetal malnutrition, its use during pregnancy is contraindicated. It is prohibited to use the drug for the treatment of physiological edema in pregnant women.
It is not recommended to take indapamide while breastfeeding, as the substance passes into breast milk. If necessary, drug treatment during lactation, breastfeeding should be discontinued.
Pediatric use
The safety and effectiveness of the use of Indapamide retard in pediatrics have not been established, therefore, it is prohibited to prescribe the drug to children and adolescents under 18 years of age.
With impaired renal function
Indapamide retard is contraindicated for severe renal impairment (creatinine clearance below 30 ml / min).
With normal kidney function during the period of use of thiazide-like diuretics, temporary renal failure, observed at the beginning of treatment, usually goes away without consequences. Patients with kidney problems may get worse.
Indapamide retard is fully effective only with normal or slightly reduced (in adults, the concentration of creatinine in the blood plasma below 220 μmol / L or 25 mg / L) renal function. A pronounced decrease in circulating blood volume can cause an increase in the concentration of urea and creatinine in the blood (due to a decrease in the glomerular filtration rate), which can lead to the development of acute renal failure.
For violations of liver function
Indapamide retard is contraindicated in patients with severely impaired liver function (including hepatic encephalopathy).
With hepatic failure during therapy with thiazide-like diuretics, hepatic encephalopathy may develop, especially with disorders of water-salt balance. In this case, the diuretic should be canceled.
Use in the elderly
Indapamide retard can be taken by elderly patients with normal or slightly abnormal kidney function. It is necessary to control the concentration of creatinine in the blood plasma in such patients, taking into account age, sex and body weight.
Drug interactions
The use of Indapamide retard simultaneously with some drugs can lead to the development of the following effects:
- lithium preparations: an increase in the concentration of lithium in the blood plasma (with signs of an overdose) due to a decrease in its excretion. If it is necessary to use it simultaneously with indapamide, it is important to control the level of plasma lithium content;
- thiazide diuretics, pyrethanide, furosemide, bumetanide, xypamide and other diuretics that can cause hypokalemia: it is not recommended to combine with indapamide;
- antiarrhythmic drugs of subgroup IA (disopyramide, hydroquinidine, quinidine); class III antiarrhythmics (ibutilide, dofetilide, amiodarone) and sotalol; some antipsychotics (phenothiazines - trifluoperazine, thioridazine, levomepromazine, cyamemazine, chlorpromazine; benzamides - tiapride, sultopride, sulpiride, amisulpride; butyrophenones - haloperidol, droperidol); erythromycin for intravenous use, cisapride, bepridil, sparfloxacin, pentamidine, mizolastine, halofantrine, astemizole, vincamine for intravenous use, moxifloxacin: increased risk of developing polymorphic ventricular tachycardia of the pirouette type (risk factor - hypokalemia). Serum potassium levels need to be adjusted prior to commencing combination therapy. Also, in the process of combination therapy, clinical monitoring should be carried out,electrocardiographic analysis and monitor the level of electrolytes in the blood;
- non-steroidal anti-inflammatory drugs of systemic action (including selective inhibitors of cyclooxygenase 2), high doses of acetylsalicylic acid (more than 3 g per day): a decrease in the hypotensive effect of indapamide, an increased risk of developing acute renal failure in patients with dehydration. It is necessary at the beginning of treatment with indapamide to compensate for the lack of fluid in the body and regularly check the functioning of the kidneys during the entire course of therapy;
- ACE inhibitors: against the background of sodium deficiency (especially in patients with renal artery stenosis), a sharp decrease in blood pressure and / or an increase in the likelihood of developing acute renal failure is possible;
- drugs that cause hypokalemia (mineralocorticosteroids for systemic use, glucocorticosteroids, amphotericin B for intravenous use, tetracosactide, stimulating intestinal motility laxatives): increased risk of hypokalemia (due to additive action);
- baclofen: increased hypotensive effect of indapamide;
- cardiac glycosides: an increase in the likelihood of developing hypokalemia, predisposing to the manifestation of the toxic effects of cardiac glycosides;
- potassium-sparing diuretics (triamterene, spironolactone, amiloride): increased risk of hypokalemia or hyperkalemia (especially in patients with renal failure and / or diabetes mellitus);
- metformin: increased likelihood of metformin-induced lactic acidosis. Disorders of kidney function associated with the use of diuretics may be a predisposing factor;
- iodine-containing contrast agents (in high doses): an increased risk of acute renal failure (against the background of diuretic-induced dehydration). It is necessary to rehydrate before using iodine-containing substances;
- tricyclic antidepressants and neuroleptics: an increase in the hypotensive effect of indapamide and an increase in the likelihood of orthostatic hypotension (due to an additive effect);
- calcium salts: an increased risk of hypercalcemia due to a decrease in calcium excretion by the kidneys;
- cyclosporine and tacrolimus: an increase in the concentration of creatinine in the blood plasma with constant indicators of the content of cyclosporine in the circulating blood, even without a deficiency in the body of sodium and / or fluid;
- corticosteroids (mineral and glucocorticosteroids) and tetracosactide (for systemic administration): a decrease in the hypotensive effect of indapamide due to fluid and sodium retention in the body caused by corticosteroids.
Analogs
Analogs of Indapamide retard are: Acripamide, Arifon, Vero-Indapamide, Indap, Indapamid, Indapamide Canon, Indapamide retard-Teva, Indapamid-Teva, Ipres long and others.
Terms and conditions of storage
Store in a dark, dry place at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
Shelf life is 3 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Indapamide retard
Judging by the reviews about Indapamide retard, a stable effect from the use of the drug (with regular use) does not appear immediately, but after a fairly long time - 4-8 weeks from the start of treatment. The drug is not suitable for a rapid decrease in blood pressure.
Price for Indapamide retard in pharmacies
The average price for Indapamide retard 1.5 mg is approximately 110 rubles per pack of 30 tablets.
Indapamide retard: prices in online pharmacies
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Drug name Price Pharmacy |
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Indapamide retard 1.5 mg film-coated tablets of prolonged action 30 pcs. RUB 49 Buy |
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Indapamide retard 1.5 mg film-coated tablets with controlled release 30 pcs. RUB 61 Buy |
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Indapamide retard 1.5 mg film-coated tablets of prolonged action 30 pcs. RUB 66 Buy |
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Indapamide retard 1.5 mg film-coated tablets of prolonged action 30 pcs. 73 rbl. Buy |
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Indapamide retard 1.5 mg film-coated tablets of prolonged action 30 pcs. 77 RUB Buy |
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Indapamide Retard tablets p.o. prolonged action 1.5mg 30 pcs. 89 RUB Buy |
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Indapamide Retard tablets p.o. prolonged action 1.5mg 30 pcs. 125 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
