Arifon retard prolonged action tablets 1.5mg №15×2

Name:
Arifon retard tablet prolong.dey-I from captivity. cover 1.5 mg in kont. cell pack. No. 15×2
Description:
Controlled release tablets, film coated, white, round, biconvex. The main active ingredient indapamide Release form Tablets Dosage 1.5 mg Special instructions Impaired liver function When prescribing thiazide and thiazide-like diuretics in patients with impaired liver function, hepatic encephalopathy may develop, especially in case of electrolyte imbalance. In this case, diuretics should be stopped immediately. Photosensitivity While taking thiazide and thiazide-like diuretics, cases of photosensitivity reactions have been reported. If photosensitivity reactions develop while taking the drug, treatment should be discontinued. If it is necessary to continue diuretic therapy, it is recommended to protect the skin from exposure to sunlight or artificial ultraviolet rays. Water-electrolyte balance the content of sodium ions in the blood plasma: Before starting treatment, it is necessary to determine the content of sodium ions in the blood plasma. Against the background of taking the drug, this indicator should be regularly monitored. It is necessary to constantly monitor the content of sodium ions, because. Initially, a decrease in the concentration of sodium in the blood plasma may be asymptomatic. More frequent monitoring of the content of sodium ions is indicated for patients with cirrhosis of the liver and the elderly. All diuretic drugs can cause hyponatremia, sometimes leading to extremely serious consequences. Hyponatremia and hypovolemia can lead to dehydration and orthostatic hypotension. The concomitant decrease in chloride ions can lead to secondary compensatory metabolic alkalosis: the frequency and severity of this effect are insignificant. the content of potassium ions in the blood plasma: In the treatment of thiazide and thiazide-like diuretics, the main risk is a sharp decrease in the concentration of potassium in the blood plasma and the development of hypokalemia. It is necessary to prevent the risk of developing hypokalemia (<3.4 mmol / l) in patients of the following categories: elderly, debilitated and / or receiving combined drug therapy, patients with liver cirrhosis, peripheral edema and ascites, patients with coronary artery disease, heart failure. Hypokalemia in these patients enhances the toxic effect of cardiac glycosides and increases the risk of arrhythmias. In addition, patients with an increased QT interval, both congenital and drug-induced, are at increased risk. Hypokalemia, as well as bradycardia, is a condition that contributes to the development of severe arrhythmias and, especially, ventricular torsades de pointes, which can be fatal. In all the cases described above, it is necessary to regularly monitor the concentration of potassium in the blood plasma. The first measurement of the concentration of potassium ions in the blood must be carried out within the first week from the start of treatment. If hypokalemia occurs, appropriate treatment should be prescribed. plasma calcium: It should be borne in mind that thiazide and thiazide-like diuretics can reduce the excretion of calcium ions by the kidneys, leading to a slight and temporary increase in the concentration of calcium in the blood plasma. Severe hypercalcemia may be due to previously undiagnosed hyperparathyroidism. It is necessary to stop taking diuretic drugs before examining the function of the parathyroid glands. Plasma glucose It is necessary to monitor blood glucose levels in patients with diabetes mellitus, especially in the presence of hypokalemia. Uric acid In patients with gout, the frequency of attacks may increase or the course of gout may worsen. Diuretics and renal function Thiazide and thiazide-like diuretics are fully effective only in patients with normal or slightly impaired renal function (plasma creatinine in adults is below 25 mg / l or 220 μmol / l). In elderly patients, normal plasma creatinine levels are calculated taking into account age, body weight and sex. It should be borne in mind that at the beginning of treatment, patients may experience a decrease in glomerular filtration rate due to hypovolemia, which, in turn, is caused by the loss of fluid and sodium ions while taking diuretic drugs. As a result, the concentration of urea and creatinine in the blood plasma may increase. If renal function is not impaired, such temporary functional renal failure usually resolves without consequences, but with existing renal failure, the patient's condition may worsen. Athletes Indapamide may give a positive result in doping tests in athletes. Influence on the ability to drive vehicles and control mechanisms The action of the substances that make up the drug Arifon retard does not lead to impaired attention. However, in some people, in response to a decrease in blood pressure, various individual reactions may develop, especially at the beginning of therapy or when other antihypertensive drugs are added to ongoing therapy. In this case, the ability to drive a car or other mechanisms may be reduced. Pharmacological action Mechanism of action Indapamide refers to sulfonamide derivatives containing an indole ring. In terms of pharmacological properties, indapamide is close to thiazide diuretics, the action of which is associated with inhibition of the reverse absorption of sodium ions in the cortical segment of the nephron loop. At the same time, the urinary excretion of sodium, chlorine ions and, to a lesser extent, potassium and magnesium ions increases, which is accompanied by increased diuresis and causes an antihypertensive effect. Pharmacodynamics In phase II and III clinical studies, when using indapamide in monotherapy at doses that do not have a pronounced diuretic effect, a hypotensive effect was demonstrated that persisted for 24 hours. The antihypertensive activity of indapamide is associated with an improvement in the elasticity of large arteries, a decrease in arterial vascular resistance and OPSS. Indapamide helps to reduce left ventricular hypertrophy. Thiazide and thiazide-like diuretics at a certain dose reach a plateau in the therapeutic effect, while the frequency of side effects continues to increase with a further increase in the dose of the drug. Therefore, you should not increase the dose of the drug if the therapeutic effect is not achieved when taking the recommended dose. In short, medium-term and long-term studies involving patients with arterial hypertension, it was shown that indapamide does not affect lipid metabolism (including triglycerides, cholesterol, LDL and HDL) and carbohydrate metabolism (including carbohydrate metabolism). hours in patients with diabetes). Pharmacokinetics Absorption In Arifon retard tablets, the active substance is in a special carrier matrix, which ensures a gradual controlled release of indapamide in the gastrointestinal tract. The released indapamide is rapidly and completely absorbed from the gastrointestinal tract. Eating slightly increases the absorption time of the drug, without affecting the completeness of absorption. Cmax in blood plasma is reached 12 hours after a single oral dose. With repeated doses, fluctuations in the concentration of the drug in the blood plasma in the interval between doses of the drug are smoothed out. There is individual variability in drug absorption rates. Distribution Plasma protein binding is about 79%. Css is achieved after 7 days of regular intake. With repeated administration of the drug, its cumulation is not observed. Metabolism and excretion Indapamide undergoes biotransformation and is excreted in the form of inactive metabolites, mainly with urine - 70% and feces - 22%. T1 / 2 is 14-24 hours (average 18 hours). Pharmacokinetics in special clinical situations In patients with renal insufficiency, the pharmacokinetic parameters of the drug Arifon retard do not change. Indications for use arterial hypertension in adults. Method of application and doses Apply inside 1 tab./day, preferably in the morning. The tablet should be swallowed whole, without chewing, with water. In the treatment of patients with arterial hypertension, an increase in the dose of the drug does not increase the antihypertensive effect, but enhances the diuretic effect. Indapamide is contraindicated in patients with severe renal insufficiency (CC less than 30 ml / min). Thiazide and thiazide-like diuretics are only effective in patients with normal or mildly impaired renal function. The drug is contraindicated in patients with severe hepatic impairment. In elderly patients, plasma creatinine concentration should be monitored taking into account age, body weight and gender. Arifon retard at a dose of 1.5 mg / day (1 tab.) can be prescribed to elderly patients with normal or slightly impaired renal function (see section "Contraindications"). Currently, there are no data on the safety and efficacy of Arifon retard in children and adolescents. Use during pregnancy and lactation Pregnancy At the moment there is not enough data on the use of indapamide during pregnancy (less than 300 cases have been described). Long-term use of thiazide diuretics in the third trimester of pregnancy can cause hypovolemia in the mother and a decrease in uteroplacental blood flow, which leads to fetoplacental ischemia and fetal growth retardation. In animal studies, no direct or indirect effects on pregnancy have been identified. The use of indapamide during pregnancy should be avoided. Breast-feeding period It is not known whether indapamide or its metabolites are excreted in breast milk. In this case, the newborn may develop hypersensitivity to sulfonamide derivatives and hypokalemia. Therefore, a risk to the newborn/infant cannot be excluded. Indapamide is close to thiazide diuretics, the intake of which causes a decrease in the amount of breast milk or even suppression of lactation. Do not use indapamide during breastfeeding. Fertility Preclinical studies have shown no effect on reproductive function in rats of both sexes. Presumably there is no effect on human fertility. Interaction with other drugs Unrecommended combination of drugs With the simultaneous use of indapamide and lithium preparations, as well as with a salt-free diet, 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 used in combination with lithium preparations, while the dose of drugs should be carefully selected, constantly monitoring the content of lithium in the blood plasma. Combinations requiring special attention Drugs that can cause torsades de pointes: class IA antiarrhythmic drugs (quinidine, hydroquinidine, disopyramide); class III antiarrhythmic drugs (amiodarone, sotalol, dofetilide, ibutilide); some antipsychotics: phenothiazines (chlorpromazine, cyamemazine, levomepromazine, thioridazine, trifluoroperazine), benzamides (amisulpride, sulpiride, sultopride, tiapride), butyrophenones (droperidol, haloperidol); others: bepridil, cisapride, diphemanil, erythromycin (iv), halofantrine, mizolastine, pentamidine, sparfloxacin, moxifloxacin, astemizole, vincamine (iv). Hypokalemia increases the risk of developing ventricular arrhythmias, especially torsades de pointes. The concentration of potassium in the blood plasma should be determined and, if necessary, adjusted before starting combination therapy with indapamide and the above drugs. It is necessary to control the patient's clinical condition, control the level of electrolytes in blood plasma, ECG parameters. In patients with hypokalemia, drugs that do not cause torsades de pointes should be used. With simultaneous use with NSAIDs (with systemic administration), including selective COX-2 inhibitors, high doses of acetylsalicylic acid (? 3 g / day), it is possible to reduce the antihypertensive effect of indapamide. There is a risk of developing acute renal failure due to a decrease in glomerular filtration. Patients need to compensate for fluid loss and carefully monitor renal function at the beginning of treatment. The appointment of ACE inhibitors to patients with an initially reduced concentration of sodium ions in the blood (especially patients with renal artery stenosis) is accompanied by a risk of sudden arterial hypotension and / or acute renal failure. Patients with arterial hypertension and a possibly reduced content of sodium ions in the blood plasma due to diuretics should: stop taking diuretics 3 days before starting treatment with ACE inhibitors. In the future, if necessary, resume taking diuretics; or start therapy with ACE inhibitors at low doses, followed by a gradual increase in dose if necessary. In chronic heart failure, treatment should begin with low doses of ACE inhibitors, after lowering the dose of diuretics. In all cases, in the first week of taking ACE inhibitors, it is necessary to monitor kidney function (plasma creatinine). With the simultaneous use of indapamide with other drugs that can cause hypokalemia, incl. with amphotericin B (in / in), gluco- and mineralocorticoids (with systemic administration), tetracosactide, laxatives that stimulate intestinal motility, the risk of developing hypokalemia increases due to an additive effect. It is necessary to constantly monitor the concentration of potassium in the blood plasma and, if necessary, its correction. Particular attention should be paid to patients simultaneously receiving cardiac glycosides. It is recommended to use laxatives that do not stimulate intestinal motility. With the simultaneous use of indapamide with baclofen, an increase in the hypotensive effect is noted. It is necessary to compensate for the loss of fluid and carefully monitor renal function at the beginning of treatment. With simultaneous use with cardiac glycosides, it is possible to increase the toxic effect of the latter due to hypokalemia. It is necessary to monitor the concentration of potassium in the blood plasma and ECG parameters and, if necessary, adjust the therapy. Combinations requiring attention Simultaneous therapy with indapamide and potassium-sparing diuretics (amiloride, spironolactone, triamterene) is reasonable in some patients, but the possibility of developing hypokalemia or hyperkalemia (especially in patients with renal insufficiency or patients with diabetes mellitus) cannot be excluded. It is necessary to monitor the concentration of potassium in the blood plasma, ECG parameters and, if necessary, adjust therapy. Functional renal failure, which can occur against the background of diuretics, especially "loop", while the appointment of metformin increases the risk of developing lactic acidosis. Metformin should not be used in combination with Arifon retard if creatinine levels are more than 15 mg/l (135 µmol/l) in men and 12 mg/l (110 µmol/l) in women. In case of dehydration while taking diuretic drugs, the risk of developing acute renal failure increases, especially when using high doses of iodine-containing contrast agents. Before using iodine-containing contrast agents, patients need to compensate for fluid loss. With the simultaneous use of indapamide and tricyclic antidepressants, antipsychotics (neuroleptics), there is an increase in the hypotensive effect of indapamide and an increased risk of developing orthostatic hypotension (additive effect). With the simultaneous use of thiazide diuretics and calcium salts, hypercalcemia may develop due to a decrease in the excretion of calcium ions in the urine. With the simultaneous use of thiazide diuretics with cyclosporine and tacrolimus, it is possible to increase the content of creatinine in the blood plasma without changing the concentration of circulating cyclosporine, even with a normal content of fluid and sodium ions. With the simultaneous use of thiazide diuretics with corticosteroids, tetracosactide (with systemic administration), a decrease in the hypotensive effect is observed due to the retention of water and sodium ions under the influence of corticosteroids. Contraindications severe renal failure (CC less than 30 ml / min); severe liver failure or hepatic encephalopathy; hypokalemia; hypersensitivity to the active substance, other sulfonamide derivatives or to any of the excipients (see section "Composition and form of release). Due to the fact that the drug contains lactose, Arifon retard is not recommended for patients with lactose intolerance, galactosemia, glucose - galactose malabsorption.With caution: impaired liver and kidney function, disturbances in water and electrolyte balance, debilitated patients or patients receiving combination therapy with other antiarrhythmic drugs, diabetes mellitus, elevated uric acid levels, hyperparathyroidism, patients with a prolonged QT interval. due to the lack of sufficient clinical data, the drug is not recommended for use in children and adolescents under the age of 18. Composition Excipients: lactose monohydrate - 124.5 mg, hypromellose - 64 mg, magnesium stearate - 1 mg, povidone - 8.6 mg, colloidal anhydrous silicon dioxide - 0.4 mg The composition of the film shell: glycerol - 0.219 mg, gi Promellose - 3.642 mg, Macrogol 6000 - 0.219 mg, Magnesium stearate - 0.219 mg, Titanium dioxide - 0.701 mg. 15 pcs. - blisters (2) - packs of cardboard, with control of the first opening (if necessary). 30 pcs. - blisters (1) - packs of cardboard, with control of the first opening (if necessary). OverdoseSymptoms Indapamide, even at very high concentrations (up to 40 mg, i.e. 27 times more than the therapeutic dose), does not have a toxic effect. Signs of acute drug poisoning are primarily associated with a violation of the water and electrolyte balance (hyponatremia, hypokalemia). Nausea, vomiting, decreased blood pressure, convulsions, vertigo, drowsiness, confusion, polyuria or oliguria leading to anuria (due to hypovolemia) may also be noted. Treatment Emergency measures aimed at removing the drug from the body: gastric lavage and / or administration of activated charcoal, followed by restoration of water and electrolyte balance. Side effects The most frequently reported adverse reactions were hypersensitivity reactions, mainly dermatological, in patients with a predisposition to allergic and asthmatic reactions, as well as maculopapular rash. In clinical studies, hypokalemia (potassium concentration less than 3.4 mmol / l) was observed in 10% of patients, and potassium concentration less than 3.2 mmol / l was observed in 4% of patients 4-6 weeks after the start of therapy. After 12 weeks of therapy, the mean decrease in plasma potassium concentration was 0.23 mmol/L. Most adverse reactions (laboratory and clinical parameters) are dose-dependent. The frequency of adverse reactions that were noted during therapy with indapamide is given as the following gradation: very often (≥1/10); often (?1/100, <1/10); infrequently (?1/1000, <1/100); rarely (?1/10,000, <1/1000); very rarely (<1/10,000); unspecified frequency (frequency cannot be calculated from the available data). On the part of the blood and lymphatic system: very rarely - agranulocytosis, aplastic anemia, hemolytic anemia, leukopenia, thrombocytopenia. From the side of metabolism and nutrition: very rarely - hypercalcemia; the frequency is unknown - a decrease in the concentration of potassium and the development of hypokalemia, especially significant for patients at risk (see section "Special Instructions"). From the nervous system: rarely - increased fatigue, vertigo, headache, paresthesia; frequency unknown - fainting. On the part of the organ of vision: the frequency is unknown - myopia, blurred vision, visual impairment. From the side of the heart: very rarely - arrhythmia; the frequency is unknown - pirouette-type tachycardia (potentially fatal) (see sections "Special Instructions" and "Drug Interactions"). From the side of the vessels: very rarely - a decrease in blood pressure. From the gastrointestinal tract: infrequently - vomiting; rarely - nausea, constipation, dry mouth; very rarely - pancreatitis. From the side of the liver and biliary tract: very rarely - impaired liver function; the frequency is unknown - it is possible to develop hepatic encephalopathy in case of liver failure, hepatitis (see sections "Contraindications" and "Special Instructions"). From the skin and subcutaneous tissues: often - hypersensitivity reactions, maculo-papular rash; infrequently - purpura; very rarely - angioedema, urticaria, toxic epidermal necrolysis, Steven-Johnson syndrome; the frequency is unknown - an exacerbation of an existing acute systemic lupus erythematosus, photosensitivity is possible (see section "Special Instructions"). From the side of the kidneys and urinary tract: very rarely - renal failure. On the part of laboratory parameters and instrumental studies: the frequency is unknown - prolongation of the QT interval on the ECG (see sections "Special Instructions" and "Drug Interactions"), an increase in the concentration of glucose in the blood (see the section "Special Instructions"), an increase in the concentration of uric acid (see section "Special Instructions"), increased activity of liver enzymes. Storage conditions The drug should be stored out of the reach of children at a temperature not exceeding 30°C. Shelf life - 2 years. Do not use after the expiration date indicated on the package. Buy Arifon retard tablets of prolonged action 1.5 mg No. 15x2 Price for Arifon retard tablets of prolonged action 1.5 mg No. 15x2