Description
Description
Round, biconvex tablets, film-coated white or almost white. In a cross section, the core is white or almost white.
Release form
Long-acting film-coated tablets, 1.5 mg.
10 tablets per blister pack of PVC film and varnished printed aluminum foil.
3 contour cell packs along with instructions for use in a cardboard box.
Packing
30 pcs
Pharmacological action
Antihypertensive drug (diuretic, vasodilator). By pharmacological properties, it is close to thiazide diuretics (it violates the reabsorption of sodium ions in the cortical segment of the Henle loop). Increases urinary excretion of sodium, chlorine and, to a lesser extent, potassium and magnesium ions, which is accompanied by increased urine output. With the ability to selectively block ² Ñslow ² Ñ calcium channels, it increases the elasticity of artery walls and reduces overall peripheral vascular resistance.
Helps reduce left ventricular hypertrophy. Does not affect plasma lipids (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 norepinephrine and angiotensin II, stimulates the synthesis of prostaglandin E2 and prostacyclin PGI2, reduces the production of free and stable oxygen radicals.
Indapamide has a hypotensive effect in doses that do not have a pronounced diuretic effect. The antihypertensive effect develops by the end of the first week, persists for 24 hours against a background of a single dose.
Pharmacokinetics
After oral administration, bioavailability is quickly and completely absorbed from the gastrointestinal tract – high (93%). Eating slightly slows down the absorption rate, but does not affect the amount of absorbed substance. The maximum concentration in blood plasma is reached 12 hours after ingestion. With repeated doses, fluctuations in the concentration of the drug in plasma in the interval between doses of two doses are reduced. The equilibrium concentration is established after 7 days of regular intake. The elimination half-life is 18 hours, the connection with blood plasma proteins is about 79%. It also binds to elastin of the smooth muscles of the vascular wall. It has a high volume of distribution, passes through histohematological barriers (including placental), and passes into breast milk.
Metabolized in the liver. 60-80% in the form of metabolites is excreted by the kidneys (about 5% is excreted unchanged), through the intestines – 20%. In patients with renal failure, the pharmacokinetics do not change. Does not cumulate.
Indications
Arterial hypertension.
Contraindications
Hypersensitivity to indapamide and other sulfonamide derivatives, severe renal failure (stage of anuria), severe liver failure (including encephalopathy), hypokalemia, pregnancy, lactation period under 18 years of age (lactose intolerance and safety not established) , galactosemia, glucose / galactose malabsorption syndrome (the drug contains lactose).
With caution
Impaired liver and / or kidney function, impaired water-electrolyte balance, hyperparathyroidism, prolonged QT interval or the simultaneous use of drugs that extend the QT interval (see ² ÑInteraction with other drugs ² Ñ) diabetes mellitus in the stage of decompensation, hyperuricemia (especially accompanied by gout and urate nephrolithiasis).
If you have one of these diseases, be sure to consult your doctor before taking the drug.
Composition
Active ingredient: indapamide – 1,50 mg.
Excipients: hypromellose (hypromellose 4000) – 42.00-78, 40 mg of lactose monohydrate – 168.50 – 132.10 mg of silicon colloidal dioxide – 1.00 mg of magnesium stearate – 2.00 mg shell: hypromellose – 5.94 mg macrogol (polyethylene glycol 4000) – 1.29 mg talc – 0, 48 mg of titanium dioxide – 1.29 mg.
Dosage and administration
Tablets are taken orally, preferably in the morning, without chewing, drinking plenty of fluids. The daily dose of the drug is 1 tablet of Indapamide MV 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% is very rare – less than 0.01%.
From the cardiovascular system: very rarely – arrhythmia, orthostatic hypotension, palpitations, changes in the electrocardiogram (ECG), characteristic of hypokalemia.
From the hemopoietic organs: very rarely – thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia, bone marrow aplasia.
From the central and peripheral nervous system: rarely – dizziness, headache, paresthesia, irritability, asthenia, drowsiness, vertigo, insomnia, depression, fatigue, malaise, muscle spasm of the limbs, tension, irritability, anxiety. In patients with liver failure, hepatic encephalopathy may develop.
From the digestive system: infrequently – vomiting is rare – nausea, constipation, dryness of the oral mucosa is very rare – pancreatitis, anorexia, abdominal pain, diarrhea.
From the genitourinary system: very rarely – renal failure, nocturia, infection, polyuria.
From the respiratory system: cough, pharyngitis, sinusitis, rhinitis.
Allergic reactions: often – a maculopapular rash infrequently – purpura, very rarely – angioedema and / or urticaria, hemorrhagic vasculitis, toxic epidermal necrolysis, Stevens-Johnson syndrome, pruritus.
Other: individual reports – exacerbation of systemic lupus erythematosus (SLE), photosensitivity reactions.
Laboratory data: a decrease in potassium levels and the development of hypokalemia (especially pronounced in patients at risk). In clinical studies, hypokalemia (plasma potassium content 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 is possible hyponatremia, accompanied by hypovolemia and orthostatic hypotension. Simultaneous loss of chlorine ions can lead to compensatory metabolic alkalosis, however, the frequency of development of metabolic alkalosis and its severity are insignificant hyperuricemia and hyperglycemia (unspecified frequency), increased blood urea nitrogen concentration, hypercreatininemia, glucosuria.
If any of the above side effects worsen or you notice any otherIf any side effects are not listed in the instructions, notify your doctor.
Drug Interaction
If you are taking any other medicines, you should consult your doctor before starting treatment.
Not recommended combinations
When co-administered with lithium preparations, it is possible to increase the concentration of lithium ions in the blood plasma due to a decrease in its excretion by the kidneys, accompanied by the appearance of signs of overdose (nephrotoxic effect), as well as pr.and adhering to a salt-free diet (reducing the elimination of lithium ions by the kidneys). In the case of co-administration with lithium preparations, careful monitoring of the concentration of lithium in blood plasma and dosage adjustment are required.
Combinations requiring special attention
Drugs, with simultaneous use of which increase the likelihood of arrhythmias in the type of “pirouette” (“torsades de pointes”): antiarrhythmic agents class IA (quinidine, hydroquinidine, disopyramide), antiarrhythmics, III dofetilide, ibutilide, bretilia tosylate), sotalol, some neuroleptics: phenothiazines (chlorpromazine, ciamemazine, levomepromazine, thioridazine, trifluoperazine), benzamides (amisulpride, sulpiride, thiroprodine, butopridide, butopridide, butoprol ridol), others (bepridil, cisapride, diphemanil, erythromycin (intravenous (I / O)), halofantrine, misolastin, pentamidine, sparfloxacin, moxifloxacin, vincamine (in / in), astemizole.
Concomitant use with any of these drugs, especially against hypokalemia, increases the risk of ventricular arrhythmias such as pirouette. The potassium content of blood plasma should be monitored and adjusted if necessary before initiating combination therapy with indapamide and the above drugs. It is recommended to monitor the clinical condition of the patient, as well as the content of electrolytes of blood plasma and ECG. Patients with hypokalemia should use drugs that do not provoke the development of arrhythmias such as “pirouette”.
For the simultaneous administration of non-steroidal anti-inflammatory drugs (NSAIDs) (with systemic use), including selective cyclooxygenase-2 (COX-2) inhibitors, high doses of salicylic acid (3 g / day or more), possibly: reduction of the antihypertensive effect of indapamide, development of acute renal failure in dehydrated patients (due to a decrease in glomerular filtration rate). At the beginning of indapamide therapy, it is necessary to restore the water-electrolyte balance and to control renal function.
Angiotensin converting enzyme (ACE) inhibitors when co-administered 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 decreased plasma diets due to the diuretic content of blood plasma should discontinue diuretics 3 days before treatment with ACE inhibitors. In the future, if necessary, resume diuretics. ACE inhibitor therapy should be started at low doses, followed by a gradual increase in dose if necessary. In chronic heart failure, treatment should be started with low doses of ACE inhibitors, first reducing the dose of diuretics. In all cases, renal function (blood plasma creatinine content) should be monitored during the first week of ACE inhibitors.
Drugs that increase the risk of hypokalemia: amphotericin B (I / O) glucose and mineralocorticosteroids (for systemic use), tetracosactide, laxatives that stimulate bowel motility. The concomitant administration of indapamide with the above drugs increases the risk of hypokalemia (additive effect). If necessary, the content of potassium ions in the blood plasma should be monitored and corrected.
Concurrent therapy with baclofen enhances the antihypertensive effect of indapamide.
Cardiac glycosides: Hypokalemia increases the toxicity of cardiac glycosides (glycosidic intoxication). With the concomitant use of indapamide and cardiac glycosides, the potassium ions in the blood plasma, ECG parameters should be monitored and therapy should be adjusted if necessary.
Combination with potassium-sparing diuretics (amiloride, spironolactone, triamterene) may be effective in some categories of patients, however, the possibility of developing hypo- or hyperkalemia, especially in patients with diabetes mellitus and renal failure, is not completely excluded. In such cases, blood potassium levels, ECG parameters should be monitored, and therapy adjusted if necessary.
With the simultaneous use of diuretics and metformin, lactic acidosis may occur, which appears to be associated with the development of functional renal failure due to the action of diuretics (to a greater extent “loopholes”). It is not recommended to use metformin in combination with indapamide at creatinine levels greater than 15 mg / l (135 μmol / l) in men and 12 mg / l (110 μmol / l) in women.
When using iodine-containing contrast agents, it should be borne in mind that the diuretic effect of indapamide increases the risk of kidney failure. This risk is particularly high when using high-dose iodine-containing contrast media. Patients need to recover fluid loss before using iodine-containing contrast media.
Tricyclic antidepressants and neuroleptics increase the antihypertensive effect and increase the risk of orthostatic hypotension (additive effect).
Drugs containing calcium salts increase the risk of developing hypercalcemia due to decreased renal excretion of calcium ions.
With the simultaneous use of cyclosporine and tacrolimus, an increase in the plasma creatinine content is possible (without changing the concentration of circulating cyclosporine), which is observed even with normal content of water and sodium ions.
Glucorticosteroid drugs, tetracosactide (with systemic use) reduce the antihypertensive effect (delay of sodium and liquid ions).
Reduces the effect of indirect anticoagulants (coumarin or indandione derivatives) due to increased concentration of coagulation factors as a result of decreased circulating blood volume and increased liver production (dose adjustment may be required).
Enhances the blockade of neuromuscular transmission that develops under the action of non-depolarizing muscle relaxants.
overdose
Symptoms: marked decrease in blood pressure, water-electrolyte disorders (hyponatremia, hypokalemia), nausea, vomiting, convulsions, dizziness, drowsiness, retardation, confusion, confusion, confusion Patients with cirrhosis may develop liver coma.
Treatment: gastric lavage, correction of water-electrolyte balance, symptomatic therapy. There is no specific antidote.
Storage conditions
Store in a dry, dark place at a temperature not exceeding 25 ° C.
Keep out of the reach of children.
The Expiration of
is 3 years. Do not use after the expiry date stated on the packaging.
Deystvuyuschee substances
indapamide
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