Noliprel A Bi-Forte tablets p/o 10mg/2.5mg №30

Name:
Noliprel A Bi-Forte tab. ppl.vol. 10mg 2.5mg per cont. No. 30 in the pack. No. 1
Description:
Noliprel A Bi-forte is a combined antihypertensive drug. The main active ingredient Perindopril + indapamide Release form tablets Dosage 10 mg 2.5 mg . In such cases, regular monitoring of the concentration of electrolytes in the blood plasma is required. If marked arterial hypotension is noted, intravenous administration of a 0.9% sodium chloride solution may be prescribed. Transient arterial hypotension is not a contraindication for further treatment with Noliprel A Bi-forte. With the subsequent normalization of blood pressure and BCC, you can resume the use of the drug at lower doses, or use only one of the active substances. During treatment, cases of severe infectious lesions, sometimes resistant to intensive antibiotic therapy, were recorded. When using perindopril in such patients, it is necessary to periodically monitor the number of leukocytes in the blood. Patients should report any symptoms of an infectious disease (including fever and sore throat) to their doctor. During treatment with Noliprel A Bi-forte, rare cases of angioedema of the tongue, lips, vocal folds and / or larynx, face, limbs have been reported. These complications could occur at any time during therapy. If symptoms of angioedema appear, the drug should be stopped immediately and the patient’s condition should be monitored until the signs of this lesion are completely removed. If the edema has spread to the face and lips, then in most cases the symptoms go away on their own, although antihistamines can also be prescribed if necessary. Angioedema, accompanied by swelling of the larynx, can cause death. Swelling of the vocal folds, tongue, or larynx increases the risk of airway obstruction. With the development of these symptoms, it is recommended to immediately inject epinephrine (adrenaline) subcutaneously at a dilution of 1:1000 (0.3-0.5 ml) or take measures to ensure airway patency. There are reports of a higher risk of angioedema in black patients. In very rare cases, during the period of therapy with ACE inhibitors, the development of angioedema of the intestine was observed, accompanied by abdominal pain (with or without vomiting / nausea); sometimes with a normal concentration of C1-esterase and without the previous appearance of angioedema of the face. The diagnosis of this adverse reaction is established by performing computed tomography (CT) of the abdominal cavity, ultrasound (ultrasound), or during surgery. Symptoms of the lesion are stopped after the abolition of ACE inhibitors. In allergic patients, ACE inhibitors should be used with extreme caution during desensitization. Patients receiving immunotherapy with drugs containing the venom of hymenoptera (including bees and wasps) should avoid the use of ACE inhibitors, as this increases the risk of developing long-term and life-threatening anaphylactic reactions. However, these side effects can be avoided by temporarily stopping ACE inhibitors at least 24 hours before the start of the desensitization procedure. In the presence of arterial hypertension and coronary artery disease during therapy, patients should not stop using beta-blockers. Perindopril, like other ACE inhibitors, demonstrates a weaker antihypertensive effect in patients of the black race when compared with representatives of other races. It is assumed that this difference is due to the often observed low renin activity in patients of this race with arterial hypertension. Against the background of treatment with thiazide diuretics, there have been cases of the appearance of photosensitivity reactions, the development of which requires discontinuation of the drug. If diuretic therapy should be continued, it is recommended to protect the skin from exposure to sunlight and artificial ultraviolet rays. Indapamide can provoke a positive reaction in athletes during doping control. Pharmacological propertiesPharmacodynamics Noliprel A Bi-forte is a combined agent that includes an angiotensin-converting enzyme (ACE) inhibitor and a sulfonamide diuretic. The drug is characterized by pharmacological properties that combine the action of each of its active components. The antihypertensive properties of which are enhanced due to their additive synergism. Perindopril refers to ACE inhibitors, the so-called. kininase II – an exopeptidase involved in the conversion of angiotensin I to the vasoconstrictor angiotensin II, as well as in the breakdown of bradykinin, which has a vasodilating effect, to the formation of an inactive heptapeptide. This substance provides a decrease in the production of aldosterone, in the blood plasma it contributes to an increase in renin activity according to the principle of negative feedback, with prolonged use it weakens the total peripheral vascular resistance (OPSS), which is associated to a greater extent with the effect on the vessels of the muscles and kidneys. These phenomena do not increase the risk of developing tachycardia and do not lead to fluid and sodium retention. Contributing to the reduction of preload and afterload, perindopril normalizes and maintains the work of the heart muscle. In patients with chronic heart failure (CHF), due to its action (according to hemodynamic parameters), filling pressure in the right and left ventricles of the heart decreases, OPSS decreases, cardiac output and cardiac index increase, and muscle peripheral blood flow increases. Indapamide belongs to the group of sulfonamides and exhibits pharmacological properties similar to those of thiazide diuretics. By inhibiting sodium reabsorption in the cortical segment of the loop of Henle, the substance provides an increase in the excretion of sodium and chloride ions by the kidneys, and to a lesser extent, magnesium and potassium ions, which causes increased diuresis and a decrease in blood pressure. Noliprel A Bi-forte demonstrates a dose-dependent hypotensive effect on diastolic and systolic blood pressure, both in the standing and lying position. The antihypertensive effect of the drug is noted for 24 hours. Less than one month after the start of the course, a stable therapeutic effect is achieved, in which the occurrence of tachyphylaxis is not observed. Completion of therapy does not lead to the appearance of a withdrawal syndrome. The antihypertensive agent helps to reduce the level of left ventricular hypertrophy (GTLH), improve arterial elasticity, reduce peripheral vascular resistance, does not interfere with the metabolism of lipids – triglycerides, total cholesterol, low and high density lipoprotein cholesterol (LDL and HDL). The effect of the combined use of perindopril and indapamide on GTLH when compared with enalapril has been proven. In patients with arterial hypertension and GTTL treated with perindopril erbumine at a dose of 2 mg (corresponding to perindopril arginine at a dose of 2.5 mg) + indapamide at a dose of 0.625 mg / enalapril at a dose of 10 mg 1 time per day, after increasing the dose of perindopril erbumine to 8 mg (corresponding to perindopril arginine in an amount of 10 mg) + indapamide – up to 2.5 mg / enalapril – up to 40 mg, with the same frequency of administration in the perindopril / indapamide group, when compared with the enalapril group, there was a greater decrease in the left ventricular mass index ( LVMI). The most significant effect on LVMI was seen with perindopril erbumine 8 mg + indapamide 2.5 mg. A stronger antihypertensive effect has also been reported with combined treatment with perindopril and indapamide compared with enalapril. The effectiveness of perindopril was noted in the treatment of arterial hypertension of any severity, both with low and normal plasma renin activity. The maximum antihypertensive effect of this substance is observed 4-6 hours after oral administration and persists for more than 24 hours. After this period, there is a high level (about 80%) of residual ACE inhibition. The complex use of thiazide diuretics leads to an increase in the severity of the antihypertensive effect. Also, the combination of an ACE inhibitor and a thiazide diuretic helps to reduce the risk of hypokalemia with concomitant use of diuretics. The combination of an ACE inhibitor and an angiotensin II receptor antagonist (ARA II) dual blockade of the renin-angiotensin-aldosterone system (RAAS) is not recommended for patients with diabetic nephropathy. This conclusion was reached in the course of clinical studies in which patients with a history of cardiovascular or cerebrovascular disease or type 2 diabetes mellitus with confirmed target organ damage took part, as well as patients with type 2 diabetes mellitus. type and diabetic nephropathy. According to the results of studies in patients receiving this combination therapy, there was no significant positive effect on the development of renal and / or cardiovascular events and mortality rates. At the same time, the threat of hyperkalemia, arterial hypotension and / or acute renal failure in this case was aggravated when compared with the group of patients receiving monotherapy. The hypotensive effect of indapamide is noted in the treatment of this drug in doses that provide a minimal diuretic effect. This property of the active substance is due to an increase in the elasticity of large arteries and a decrease in OPSS. Indapamide reduces GTLZh, does not affect the level of lipids in the blood (LDL, HDL, total cholesterol, triglycerides) and the metabolism of carbohydrates, even in the presence of diabetes mellitus. Pharmacokinetics The pharmacokinetic characteristics of the active substances of Noliprel A Bi-forte with combined use do not differ from those when using these drugs in monotherapy mode. Indications for use Noliprel A Bi-forte is recommended for the treatment of arterial hypertension in patients who require a combination of perindopril and indapamide at a dose of 10 and 2.5 mg, respectively. Dosage and administration Tablets Noliprel A Bi-forte 10 mg + 2.5 mg are taken orally. The recommended dosage regimen is 1 tablet 1 time per day, preferably in the morning, before meals. Use during pregnancy and lactation Pregnant women, as well as women planning pregnancy, take Noliprel A Bi-forte is contraindicated. Strictly controlled studies of ACE inhibitor therapy in pregnant women have not been conducted. Available data on the effect of the drug in the first trimester of pregnancy indicate the absence of drug-related malformations associated with fetotoxicity. Despite this, a slight increase in the risk of fetal developmental disorders cannot be completely excluded when taking ACE inhibitors. If pregnancy occurs during drug therapy, it is necessary to immediately stop using Noliprel A Bi-forte and prescribe another antihypertensive treatment with drugs approved for use during pregnancy. In the II-III trimesters, with prolonged exposure to ACE inhibitors on the fetus, the risk of developmental disorders, such as oligohydramnios, deterioration of kidney function, and slowing of ossification of the skull bones, may be aggravated. The newborn may experience arterial hypotension, renal failure, hyperkalemia. If a woman received treatment with ACE inhibitors in the II-III trimesters of pregnancy, an ultrasound of the fetus should be performed to assess the activity of the kidneys and the condition of the skull. Newborns whose mothers took these drugs during pregnancy need careful medical supervision for the timely detection and correction of possible arterial hypotension. In the III trimester of pregnancy, long-term therapy with thiazide diuretics can cause hypovolemia in the mother and a decrease in uteroplacental blood flow, causing fetoplacental ischemia and fetal growth retardation. In the treatment of diuretics shortly before delivery, in some cases, thrombocytopenia and hypoglycemia were observed in newborns. The use of Noliprel A Bi-forte during breastfeeding is contraindicated. Whether perindopril passes into breast milk is unknown, but it has been established that indapamide is excreted in breast milk and can lead to the development of hypokalemia, kernicterus and hypersensitivity to sulfonamide derivatives in the newborn. Taking thiazide diuretics can provoke suppression of lactation or a decrease in the amount of mother’s milk. Interaction with other drugs Not recommended combinations of Noliprel A Bi-forte, or its active components with other substances / preparations: lithium preparations: the risk of a reversible increase in the concentration of lithium in the blood plasma and the resulting toxic effects while taking ACE inhibitors increases; additional use of thiazide diuretics may cause a further increase in the plasma level of lithium and aggravate the risk of manifestations of toxicity; if necessary, the implementation of such a combination should regularly monitor the level of lithium in the plasma; estramustine: the threat of an increase in the frequency of undesirable effects, including angioedema, increases when combined with perindopril; potassium preparations, potassium-sparing diuretics (spironolactone, amiloride, triamterene, eplerenone), potassium-containing table salt substitutes: serum potassium levels are within the normal range, hyperkalemia can rarely develop – when combined with ACE inhibitors; the simultaneous use of all these drugs in combination with the drug can cause a significant increase in the content of potassium in the blood serum, up to a lethal outcome; with confirmed hypokalemia, caution is required and regular monitoring of plasma potassium concentration and ECG parameters is required. Possible interaction reactions that require special attention and caution when using Noliprel A Bi-forte or its active ingredients with the following drugs / substances: baclofen: antihypertensive effect is enhanced, blood pressure and kidney function must be monitored, if necessary, dose adjustment of antihypertensive drugs should be carried out ; NSAIDs (including acetylsalicylic acid in doses exceeding 3000 mg per day, non-selective NSAIDs and COX-2 inhibitors): it is possible to reduce the antihypertensive effect when combined with ACE inhibitors; there is an increased risk of deterioration in kidney function, including the appearance of acute renal failure, and an increase in the level of potassium in the blood serum, mainly in patients with initially reduced kidney function; patients should restore fluid balance and regularly monitor renal function at the beginning of joint treatment and during its implementation; hypoglycemic oral agents, sulfonylurea derivatives: the hypoglycemic effect of these agents and insulin increases in diabetic patients while taking ACE inhibitors; extremely rare occurrence of hypoglycemia due to an increase in glucose tolerance and a decrease in the need for insulin; it is required to carry out regular monitoring of glucose levels in blood plasma during the first month of this combination; class IA antiarrhythmics (quinidine, disopyramide, hydroquinidine) and class III (bretylium tosylate, dofetilide, amiodarone, ibutilide), sotalol, benzamides (sultopride, amisulpride, tiapride, sulpiride); neuroleptics (levomepromazine, chlorpromazine, cyamemazine, trifluoperazine, thioridazine); butyrophenones (droperidol, haloperidol); pimozide, diphemanil methyl sulfate, sparfloxacin, bepridil, halofantrine, cisapride, moxifloxacin, erythromycin (i.v.), pentamidine, mizolastine, vincamine (i.v.), terfenadine, astemizole, methadone (agents that can trigger torsades de pointes arrhythmias): increased risk the occurrence of hypokalemia while taking indapamide; it is required to control the QT interval, plasma potassium, and, if necessary, correct hypokalemia; gluco- and mineralocorticoids (having a systemic effect), amphotericin B (iv), tetracosactide; laxatives that activate intestinal motility (agents that can provoke hypokalemia): due to the additive effect, when combined with indapamide, the risk of hypokalemia increases; it is required to control the concentration of potassium in the plasma, and if necessary, also its correction; patients receiving cardiac glycosides require careful monitoring; it is recommended to use laxatives that do not stimulate peristalsis; cardiac glycosides: the toxic effect of these agents is enhanced by hypokalemia, as a result, when combined with indapamide, plasma potassium and ECG indicators should be monitored; therapy may need to be adjusted. Interaction reactions that require attention with the combined use of Noliprel A Bi-forte or its active ingredients with the following drugs / substances: tetracosactide, corticosteroids: the antihypertensive effect is weakened due to fluid retention and sodium ions due to the influence of corticosteroids; antipsychotics (neuroleptics), tricyclic antidepressants: the antihypertensive effect increases and the threat of orthostatic hypotension is aggravated (additive effect); other antihypertensive drugs; vasodilators: possibly increased hypotensive effect; ARA II inhibitors, aliskiren: while taking these drugs with an ACE inhibitor, the incidence of undesirable effects, such as hyperkalemia, arterial hypotension, and functional disorders of the kidneys (including acute renal failure), increases when compared with the use of a single drug that affects on the RAAS; therefore, dual blockade of the RAAS by the combined use of an ACE inhibitor with ARA II or aliskiren is not recommended; if this combination is necessary, drugs should be taken under strict medical supervision, with regular monitoring of plasma potassium concentration, renal function and blood pressure; thiazide and loop diuretics (in high doses): hypovolemia may develop; when these drugs are added to the treatment with perindopril, the risk of arterial hypotension increases; cytostatic and immunosuppressive drugs, allopurinol, corticosteroids (with systemic use), procainamide: the threat of leukopenia increases when taken with ACE inhibitors; preparations for general anesthesia: the antihypertensive effect is enhanced when combined with perindopril; it is recommended, if possible, to stop taking Noliprel A Bi-forte 24 hours before surgery using general anesthesia; gliptins (sitagliptin, saxagliptin, linagliptin, vildagliptin): the risk of angioedema increases when combined with ACE inhibitors due to inhibition of dipeptidyl peptidase-4 activity by gliptin; sympathomimetics: reduced antihypertensive effect; gold preparations (in / in), including sodium aurothiomalate: against the background of the use of ACE inhibitors, nitrate-like reactions may develop, such as nausea, vomiting, arterial hypotension, flushing of the skin of the face; iodine-containing contrast agents (especially in high doses): the risk of developing acute renal failure increases as a result of dehydration of the body while taking diuretic drugs; before carrying out this combination, it is necessary to restore the water balance; metformin: increased risk of lactic acidosis due to functional renal failure associated with the use of diuretics (especially loop diuretics); with a plasma level of creatinine in men – 15 mg / l (135 μmol / l), and in women – 12 mg / l (110 μmol / l), metformin should not be used; calcium salts: hypercalcemia may develop as a result of a decrease in the excretion of calcium ions by the kidneys; cyclosporine: plasma creatinine concentration increases in the absence of a change in its level, even with normal levels of water and sodium ions. Contraindications Absolute contraindications for perindopril: the presence of one functioning kidney or bilateral stenosis of the renal arteries (since, against the background of the initial hyponatremia, there is a possibility of sudden onset of arterial hypotension); hereditary/idiopathic angioedema; indications in the anamnesis of angioedema (Quincke’s edema), caused by taking an ACE inhibitor; combined use with aliskiren-containing drugs in patients with diabetes mellitus or impaired renal function, glomerular filtration rate (GFR) less than 60 ml / min / 1.73 m? body surface area; due to the increased risk of hyperkalemia, deterioration of kidney function, cardiovascular morbidity and mortality; hypersensitivity to perindopril and other ACE inhibitors. Absolute contraindications for indapamide: hypokalemia; severe liver failure (including with the development of encephalopathy); moderate and severe renal failure; creatinine clearance (CC) less than 60 ml / min; combined use with drugs that can lead to torsades de pointes arrhythmia; hypersensitivity to indapamide and other sulfonamides. Absolute contraindications for Noliprel A Bi-forte: lactase deficiency, glucose-galactose malabsorption syndrome or galactosemia, lactose intolerance; simultaneous use with potassium and lithium preparations, potassium-sparing diuretics, drugs that prolong the QT interval; the presence in the blood plasma of an increased content of potassium ions; the presence of untreated heart failure in the stage of decompensation, hemodialysis therapy (due to the lack of sufficient clinical experience with the use of Noliprel A Bi-forte); pregnancy and breastfeeding period; age up to 18 years; hypersensitivity to additional ingredients included in the medicinal product. Noliprel A Bi-forte should be taken with caution in the following conditions / diseases: systemic lesions of the connective tissue (including systemic lupus erythematosus, scleroderma); therapy with immunosuppressants (the threat of neutropenia, agranulocytosis is aggravated); cerebrovascular diseases, coronary heart disease (CHD), CHF IV functional class according to the NYHA classification (it is recommended to start therapy with the lowest effective doses); aortic valve stenosis/hypertrophic obstructive cardiomyopathy; oppression of bone marrow hematopoiesis; blood pressure lability, renovascular hypertension; violations of the liver and / or kidneys; condition after kidney transplantation; reduced BCC (diarrhea, vomiting, diuretic therapy, salt-free diet); hyperuricemia (especially flowing with gout and urate nephrolithiasis); performing hemodialysis using high-flow membranes (such as AN69) or desensitization, LDL apheresis; diabetes; upcoming anesthesia; belonging to the Negroid race; elderly age; combined use with non-steroidal anti-inflammatory drugs (NSAIDs), gold, lithium, corticosteroids, baclofen, drugs that can provoke torsades de pointes arrhythmia. Active ingredients: perindopril arginine – 10 mg (equivalent to perindopril in the amount of 6.79 mg); indapamide – 2.5 mg; additional components: anhydrous colloidal silicon dioxide, magnesium stearate, lactose monohydrate, maltodextrin, sodium carboxymethyl starch (type A); film shell: magnesium stearate, macrogol 6000, titanium dioxide (E171), hypromellose, glycerol. Overdose The most common symptom of an overdose of Noliprel A Bi-Forte is a pronounced decrease in blood pressure, against which dizziness, drowsiness, nausea, vomiting, confusion, convulsions and oliguria can sometimes be observed (in combination with hypovolemia, it can turn into anuria). It is also possible the appearance of electrolyte disturbances, including hyponatremia and hypokalemia. If an overdose is suspected, activated charcoal and / or gastric lavage are prescribed, followed by measures to restore water and electrolyte balance. If necessary, with a pronounced decrease in blood pressure, the patient is transferred to the supine position with raised legs, and hypovolemia is corrected by intravenous (iv) infusion of a 0.9% sodium chloride solution. Perindoprilat can be removed from the body by dialysis. Side effects of the nervous system: often – headache, vertigo, dizziness, paresthesia; infrequently – mood lability, sleep disturbance; extremely rarely – confusion; with an unknown frequency – fainting; sensory organs: often – tinnitus, blurred vision; lymphatic and circulatory systems: extremely rarely – leukopenia / neutropenia, hemolytic / aplastic anemia, thrombocytopenia, agranulocytosis; respiratory system, organs of the chest and mediastinum: often – shortness of breath (when using ACE inhibitors, a dry cough is possible, which persists for a long time during therapy with drugs of this group and passes after its completion); infrequently – bronchospasm; extremely rarely – eosinophilic pneumonia, rhinitis; cardiovascular system: often – a significant decrease in blood pressure, including orthostatic hypotension; extremely rarely – heart rhythm disturbances (atrial fibrillation, ventricular tachycardia, bradycardia), angina pectoris and myocardial infarction, presumably as a result of an excessive decrease in blood pressure in patients at high risk; with an unknown frequency – arrhythmia of the pirouette type, in some cases with a fatal outcome; musculoskeletal system and connective tissue: often – muscle spasms; digestive system: often – dry mouth, loss of appetite, epigastric / abdominal pain, vomiting, nausea, taste disturbance, diarrhea, dyspepsia, constipation; extremely rarely – cholestatic jaundice, pancreatitis, cytolytic / cholestatic hepatitis, angioedema of the intestine; with an unknown frequency – hepatic encephalopathy against the background of liver failure; urinary system: infrequently – renal failure; extremely rarely – acute renal failure; reproductive system: infrequently – impotence; skin and subcutaneous fat: often – skin rashes, rash, itching, maculopapular rash; infrequently – hypersensitivity reactions in the presence of a predisposition to allergic and broncho-obstructive responses; urticaria, angioedema of the extremities, lips, face, mucous membrane of the tongue, larynx and / or vocal folds, hemorrhagic vasculitis; worsening of the course of systemic lupus erythematosus in patients with an acute form of the disease; extremely rarely – toxic epidermal necrolysis, erythema multiforme, Stevens-Johnson syndrome, photosensitivity reactions; general disorders and symptoms: often – asthenia; infrequently – increased sweating; laboratory parameters: rarely – hypercalcemia; with an unknown frequency – an increase in the QT interval on the electrocardiogram (ECG); increased levels of glucose and uric acid in the blood, increased activity of liver enzymes; a slight increase in the level of creatinine in blood plasma and urine, which disappears when therapy is discontinued and occurs mainly in patients with renal artery stenosis, during the treatment of arterial hypertension with diuretics and in renal failure; hyperkalemia (usually transient), hypokalemia, especially significant for patients at risk, hypovolemia and hyponatremia, causing dehydration and orthostatic hypotension. Storage conditions Store at a temperature not exceeding 30 ° C, out of the reach of children. Buy Noliprel A Bi-Forte tablets p / o 10mg / 2.5 mg No. 30 №30 Instructions for use for Noliprel A Bi-Forte tablets p/o 10mg/2.5mg №30