Indapafon pills p/o 2.5mg №10×3

Name:
Indapaphone tablets 2.5 mg in a cell. pack No. 10×3
Description:
Blue film-coated tablets with a biconvex surface, two layers are visible on the cross section. Composition Each tablet contains: active ingredient: indapamide – 2.5 mg; excipients: lactose monohydrate, starch 1500 (corn starch partially pregelatinized), calcium stearate, hydroxypropyl methylcellulose, opadry II (including partially hydrolyzed polyvinyl alcohol, talc, macrogol 3350, lecithin (soy), coloring pigment of blue color (contains titanium dioxide E 171, iron oxide yellow E 172, indigo carmine E 132)). Pharmacotherapeutic group Diuretics with a low dose ceiling, excluding thiazides. Sulfonamides. ATX code: C03BA11. Pharmacological properties Pharmacodynamics Thiazide-like diuretic with a moderately pronounced long-term effect, a derivative of sulfonamides. It causes a moderate saluretic and diuretic effect associated with inhibition of the reabsorption of sodium, chlorine, hydrogen, and, to a lesser extent, potassium ions in the proximal tubules and in the cortical segment of the distal tubule of the nephron. Indapamide has an antihypertensive effect, which manifests itself only with initially elevated blood pressure. Reduces the tone of the smooth muscles of the arteries, reduces the overall peripheral vascular resistance. The decrease in total peripheral vascular resistance is due to several mechanisms: elimination of excess sodium ions in the vascular wall (due to the high lipophilicity of indapamide), a decrease in the sensitivity of the vascular wall to catecholamines, an increase in the synthesis of prostaglandins E2 and prostacyclins I2, which have a vasodilating effect, inhibition of the influx of calcium ions into smooth muscle cells vascular wall. When using Indapafon in therapeutic doses, the diuretic effect is significantly inferior to its vasodilating effect. Indapafon in therapeutic doses has practically no effect on lipid and carbohydrate metabolism. The antihypertensive effect usually develops 7–10 days after the start of Indapafon intake and reaches a maximum after 3 months of regular intake of the drug. Pharmacokinetics Absorption: After oral administration, indapamide is rapidly absorbed from the gastrointestinal tract. Cmax in plasma is reached 1-2 hours after ingestion. Distribution: Plasma protein binding is 70-79%. With repeated administration, the pharmacokinetic parameters of indapamide do not change, which indicates a minimal risk of cumulation. Indapamide is excreted in breast milk. Metabolism and excretion: the high lipophilicity of indapamide provides a long half-life (average 18 hours). Excreted from the body very slowly, mainly by the kidneys (about 60%), in most cases in the form of metabolites, 5% – unchanged. Indications for use Arterial hypertension. ContraindicationsAcute cerebrovascular accidents, severe liver dysfunction, severe renal dysfunction, diabetes mellitus in the stage of decompensation, gout, anuria, hypokalemia, children and adolescents under 18 years of age, pregnancy, lactation (breastfeeding), hypersensitivity to indapamide and sulfonamide derivatives . This medicinal product should not be administered to patients with rare hereditary problems of lactose intolerance, the lactase deficiency or glucose-galactose malabsorption. Dosage and administration The drug is prescribed at a dose of 2.5 mg 1 time per day in the morning. The tablets should be swallowed whole, without chewing, with water. Application in patients with renal insufficiency In severe renal insufficiency (creatinine clearance below 30 ml / min), the use of the drug is contraindicated. Use in patients with hepatic insufficiency In severe hepatic insufficiency, the use of the drug is contraindicated. Use in Elderly Patients Elderly patients with normal renal function or mild renal impairment do not require dose adjustment. Use in children and adolescents The efficacy and safety of the drug in children and adolescents have not been established, the use of the drug in children and adolescents under 18 years of age is contraindicated. Side effects From the side of the cardiovascular system: rarely – orthostatic hypotension, changes in the electrocardiogram (hypokalemia), arrhythmia, palpitations. From the gastrointestinal tract: nausea, dry mouth, discomfort, epigastric pain, diarrhea, constipation. From the nervous system: asthenia, nervousness, headache, dizziness, drowsiness, vertigo, insomnia, depression; rarely – increased fatigue, general weakness, malaise, muscle spasm, tension, irritability, anxiety. On the part of the organ of vision: conjunctivitis, blurred vision. From the respiratory system: cough, pharyngitis, sinusitis, rarely – rhinitis. From the urinary system: frequent infections, nocturia, polyuria. Allergic reactions: skin rash, urticaria, itching, hemorrhagic vasculitis. From the blood system: thrombocytopenia, leukopenia, agranulocytosis, aplastic anemia, hemolytic anemia. On the part of laboratory parameters: hyponatremia with hypovolemia, hypokalemia, hyperuricemia, hyperglycemia during treatment. Others: flu-like syndrome, chest pain, back pain, infections, impotence, decreased libido, rhinorrhea, sweating, weight loss, tingling in the extremities, pancreatitis, exacerbation of systemic lupus erythematosus. Interactions with other drugs When taken simultaneously with cardiac glycosides, the likelihood of developing digitalis intoxication increases; with Ca2+ preparations – hypercalcemia; with metformin – aggravation of lactic acidosis is possible. Increases the concentration of Li ions in the blood plasma (decreased excretion in the urine), lithium has a nephrotoxic effect. Astemizole, IV erythromycin, pentamidine, sultopride, terfenadine, vincamine, class Ia antiarrhythmic drugs (quinidine, disopyramide) and class III (amiodarone, bretilium, sotalol) can lead to the development of “torsades de pointes” arrhythmia. Non-steroidal anti-inflammatory drugs, glucocorticosteroids, tetracosactide, sympathomimetics reduce the hypotensive effect, baclofen enhances. The combination with potassium-sparing diuretics may be effective in some categories of patients, however, the possibility of developing hypo- or hyperkalemia is not completely excluded, especially in patients with diabetes mellitus and renal insufficiency. Angiotensin-converting enzyme inhibitors increase the risk of arterial hypotension and / or acute renal failure (especially with existing renal artery stenosis). Increases the risk of developing renal dysfunction when using iodine-containing contrast agents in high doses (dehydration). Before using iodine-containing contrast agents, patients need to restore fluid loss. Imipramine (tricyclic) antidepressants and antipsychotics increase the hypotensive effect and increase the risk of orthostatic hypotension. Cyclosporine increases the risk of developing hypercreatininemia. Reduces the effect of indirect anticoagulants (coumarin or indandione derivatives) due to an increase in the concentration of coagulation factors as a result of a decrease in circulating blood volume and an increase in their production by the liver (dose adjustment may be required). It enhances the blockade of neuromuscular transmission, which develops under the influence of non-depolarizing muscle relaxants. The simultaneous administration of corticosteroids leads to a decrease in the antihypertensive effect. Precautions When prescribing to patients with liver and kidney diseases, it is necessary to control the level of potassium in the blood. In patients with hyperuricemia, it is recommended to regularly determine the content of uric acid in the blood. It should not be combined with lithium preparations, vincamine, potassium excreting diuretics. In patients who are prescribed Indapafon, the serum sodium concentration should be checked before starting treatment and at regular intervals thereafter. Hyponatremia caused by indapamide can sometimes lead to serious consequences. A decrease in serum sodium levels may be asymptomatic, so regular monitoring is essential, especially in the elderly and patients with cirrhosis. In patients taking cardiac glycosides, laxatives, on the background of hyperaldosteronism, as well as in the elderly, careful monitoring of the content of potassium ions and creatinine is shown. While taking Indapafon, the concentration of potassium, sodium, magnesium ions in plasma should be systematically monitored (electrolyte disturbances may develop), urine pH, concentration of glucose, uric acid and residual nitrogen. The most careful monitoring is indicated in patients with cirrhosis of the liver (especially with edema or ascites – the risk of developing metabolic alkalosis, which increases the manifestations of hepatic encephalopathy), coronary heart disease, chronic heart failure, as well as in the elderly. The high-risk group also includes patients with an increased QT interval on electrocardiography (congenital or developed against the background of any pathological process). The first measurement of the concentration of potassium ions in the blood should be carried out during the first week of treatment. Hypercalcemia while taking Indapafon may be due to previously undiagnosed hyperparathyroidism. In patients with diabetes, it is extremely important to control blood glucose levels, especially in the presence of hypokalemia. Significant dehydration can lead to the development of acute renal failure (reduced glomerular filtration rate). Patients need to compensate for the loss of water and carefully monitor kidney function at the beginning of treatment. Patients with arterial hypertension and hyponatremia (due to taking diuretics) should stop taking diuretics 3 days before starting angiotensin-converting enzyme inhibitors (if necessary, diuretics can be resumed a little later) or they are prescribed initial low doses of angiotensin-converting enzyme inhibitors. May exacerbate systemic lupus erythematosus. Athletes Indapafon may test positive for doping tests. Children Efficacy and safety in children have not been established. Use during pregnancy and lactation As a general rule, the use of diuretics in pregnant women should be avoided. They can not be used to treat physiological edema that occurs during pregnancy. Diuretics can lead to fetoplacental insufficiency and the threat of impaired fetal development. Indapafon can be used during pregnancy only if absolutely necessary, but before prescribing it, the doctor should collect a patient’s history regarding pregnancy or its planning. Indapamide is excreted in breast milk. For this reason, the use of the drug during breastfeeding is not recommended. Influence on the ability to drive a car and other mechanisms In some cases, individual reactions associated with changes in blood pressure are possible, especially at the beginning of treatment and when another antihypertensive agent is added. As a result, the ability to drive a car and work with mechanisms that require increased attention may decrease. Overdose With prolonged use or the use of Indapafon in high doses, hyponatremia, hypokalemia and hypochloremic alkalosis may develop. The risk of overdose increases with severe heart failure (NYHA functional classes III-IV), chronic renal failure, cirrhosis of the liver, diarrhea, as well as in persons on a salt-free diet. Symptoms: possible violations of water and electrolyte balance (hyponatremia, hypokalemia), nausea, vomiting, arterial hypotension. Treatment: carry out symptomatic therapy. Upakovka10 tablets in a blister pack of PVC film and aluminum foil. 3 blister packs, together with a leaflet, are put into a pack of cardboard (packaging No. 10×3). 300 blister packs, together with 10 instructions, are placed in a cardboard box (packaging No. 10×300). Storage conditions In a place protected from light and moisture, at a temperature not exceeding 25 ° C. Keep out of the reach of children. Shelf life 3 years. Do not use the drug after the expiration date. Conditions for dispensing from pharmacies By prescription. Buy Indapafon tablets p / o 2.5 mg No. 10×3