Noliprel a-bi-forte pills.po 10mg + 2.5mg N 30
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Active ingredients
Indapamide + Perindopril
Release form
Pills
Composition
Active ingredient: Perindopril arginine + Indapamide (Perindopril arginine + Indapamide) Active ingredient concentration (mg): perindopril arginine 10 mg, indapamide 2. 5 mg
Pharmacological effect
Combined preparation containing perindopril arginine and indapamide. The pharmacological properties of the drug Noliprel A Bi-Forte combine the properties of each of the components. Mechanism of action ACE, or kininase II, is exopeptidase, which carries out both the conversion of angiotensin I into a vasoconstrictor substance angiotensin II, and the destruction of bradykinin, which has a vasodilator, to an inactive heptapeptide. As a result, perindopril reduces the secretion of aldosterone; by the principle of negative feedback increases the activity of renin in the blood plasma; with long-term use reduces the OPSS, which is mainly due to the effect on the vessels in the muscles and kidneys. These effects are not accompanied by the retention of sodium ions and fluids or the development of reflex tachycardia. Perindopril normalizes myocardial work by reducing preload and afterload. OPSS, increased cardiac output, increased muscle peripheral blood flow. Indapamide Indapamide belongs to the sulfonamide group, due to its pharmacological properties ok to thiazide diuretics. Indapamide inhibits the reabsorption of sodium ions in the cortical segment of the loop of Henle, which leads to an increase in kidney excretion of sodium ions, chlorine and to a lesser extent potassium and magnesium ions, thereby increasing diuresis and reducing blood pressure. antihypertensive effect, both on diastolic and systolic blood pressure, both standing and lying. Antihypertensive effect persists for 24 hours.A stable therapeutic effect develops in less than 1 month from the start of therapy and is not accompanied by tachyphylaxis. Discontinuation of treatment does not cause withdrawal. Noliprel A Bi-forte reduces the degree of left ventricular hypertrophy (GTLZH), improves arterial elasticity, reduces PRTS, does not affect lipid metabolism (total cholesterol, HDL cholesterol and LDL cholesterol, triglycerides). The effect of the use of perindopril combination and indapamide on GTLZH in comparison with enalapril. In patients with arterial hypertension and GTLV who received perindopril erbumin 2 mg (equivalent to 2.5 mg perindopril arginine) / indapamide 0.625 mg or enalapril at a dose of 10 mg 1 time / day, and with an increase in perindopril erbumine dose to 8 mg (equivalent to 10 mg perindopril arginine) and indapamide up to 2.5 mg, or enalapril up to 40 mg 1 time / day, there was a more significant decrease in the left ventricular mass index (LVMI) in the perindopril / indapamide group compared with the enalapril group. At the same time, the use of perindopril erbumine 8 mg / indapamide 2.5 mg is the most significant effect on LVMI. Also, a more pronounced antihypertensive effect was observed on the background of combination therapy with perindopril and indapamide compared with enalapril. reaches a maximum after 4-6 hours after a single dose and remains for 24 hours. 24 hours after taking the drug, it is observed clearly e (about 80%) residual inhibition of ACE. Perindopril has an antihypertensive effect in patients with both low and normal renin activity in the blood plasma. Simultaneous administration of thiazide diuretics increases the severity of the antihypertensive effect. In addition, the combination of an ACE inhibitor and a thiazide diuretic also reduces the risk of hypokalemia in patients receiving diuretics. The double blockade of RAACI results from clinical studies of combination therapy with the use of an ACE inhibitor with ARA II (angiotensin II receptor antagonist). Clinical studies were conducted with patients who have history of cardiovascular or cerebrovascular disease, or type 2 diabetes,accompanied by confirmed lesions of the target organ, as well as studies involving patients with type 2 diabetes and diabetic nephropathy. These studies did not reveal a significant positive effect on the occurrence of renal and / or cardiovascular events and death rates in patients receiving combination therapy. While the risk of developing hyperkalemia, acute renal failure and / or arterial hypotension increased compared with patients receiving monotherapy. Taking Attention similar intragroup pharmacodynamic properties of ACE inhibitors and ARA II, these results can be expected for the interaction of any other drugs, representatives of ACE inhibitor classes and ARA II. Therefore, ACE inhibitors and ARA II should not be used simultaneously in patients with diabetic nephropathy. the study of the positive effects of adding aliskiren to standard therapy with an ACE inhibitor or ARA II in patients with type 2 diabetes mellitus and chronic kidney disease or and cardiovascular disease, or having a combination of these diseases. The study was terminated early due to the increased risk of undesirable outcomes. Cardiovascular death and stroke occurred more frequently in the group of patients receiving aliskiren compared with the placebo group. Also, adverse events and serious adverse events of particular interest (hyperkalemia, arterial hypotension and renal dysfunction) were recorded more often in the aliskiren group than in the placebo group. Elastic properties of large arteries, decrease OPS.Indapamid reduces GTZH, does not affect the concentration of lipids in the blood plasma: three glycerides, total cholesterol, LDL, HDL; carbohydrate metabolism (including in patients with concomitant diabetes).
Pharmacokinetics
NoliprelA Bi-forteCombined use of perindopril and indapamide does not alter their pharmacokinetic characteristics compared with separate administration of these agents. Perindopril Absorption When ingested, perindopril is rapidly absorbed.Cmax in plasma is achieved 1 hour after ingestion. Perindopril does not possess pharmacological activity. Approximately 27% of the total amount of perindopril ingested enters the bloodstream as an active metabolite of perindoprilat. In addition to perindoprilat, 5 more metabolites are formed that do not possess pharmacological activity. Cmax of perindoprilat in plasma is reached 3-4 h after ingestion. Eating slows down the conversion of perindopril to perindoprilat, thereby affecting bioavailability. Therefore, the drug should be taken 1 time / day, in the morning, before eating. Distribution and elimination There is a linear dependence of the concentration of perindopril in the blood plasma on its dose. Vd of unbound perindoprilat is approximately 0.2 l / kg. The binding of perindopril to plasma proteins, mainly ACE, depends on the concentration of perindopril and is about 20%. T1 / 2 of perindopril is 1 h. Perindoprilat is excreted by the kidneys. The effective T1 / 2 of the unbound fraction is about 17 hours, the equilibrium state is reached within 4 days. Pharmacokinetics in special clinical cases Perinoprilat release is delayed in the elderly, as well as in patients with cardiac and renal failure. In patients with liver cirrhosis, the hepatic clearance of perindopril decreases in 2 times. However, the amount of perindoprilat formed does not decrease, therefore, dose adjustment of the drug is not required (see sections Dosage regimen and Special instructions). The dialysis clearance of perindoprilat is 70 ml / min. Indapamide Absorption and Distribution Indapamide is quickly and completely absorbed from the gastrointestinal tract. Cmax of indapamide in the blood plasma is observed 1 h after oral administration. Plasma protein binding - 79%. Repeated administration of the drug does not lead to its accumulation in the body. Intake T1 / 2 is 14-24 hours (average 18 hours). Excreted mainly by the kidneys (70% of the administered dose) and through the intestine (22%) in the form of inactive metabolites. Pharmacokinetics in special clinical situations. The pharmacokinetics of the drug do not change in patients with renal insufficiency.
Indications
Essential hypertension (patients requiring therapy with perindopril at a dose of 10 mg and indapamide at a dose of 2.5 mg).
Contraindications
Perindopril - hypersensitivity to perindopril and other ACE inhibitors; - angioedema (Quincke edema) in history, associated with taking an ACE inhibitor; - hereditary / idiopathic angioedema; breastfeeding; - age up to 18 years (efficacy and safety have not been established). Indapamide - increased sensitivity to indapamide and other sulfonamides; - severe liver failure (including with encephal phalopathy); - hypokalemia; - simultaneous use with drugs that can cause arrhythmia such as pirouette; - pregnancy; - breastfeeding period; - age up to 18 years (efficacy and safety have not been established). substances that are part of the drug; - severe renal failure (QA less than 60 ml / min); simultaneous intake with potassium-saving diuretics, potassium and lithium preparations and in patients with an increased content of potassium ions in the blood plasma - presence of lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome, lactose intolerance; - simultaneous use of drugs that extend the QT interval; - due to the lack of sufficient clinical experience, Noliprel A Bi-forte should not be used in patients on hemodialysis, as well as in patients with untreated heart failure in the stage of decompensation; - age up to 18 years (efficacy and safety have not been established). With cautionSystem diseases of the connective tissue (including systemic lupus erythematosus, scleroderma), immunosuppressants (risk of neutropenia treatment, agranulocytosis), inhibition of bone marrow hematopoiesis, reduced BCC (diuretics, salt-free diet, vomiting, diarrhea), ischemic heart disease, cerebrovascular disease, renovascular hypertension, diabetes, chronic heart failure ( Functional class IV (NYHA classification), hyperuricemia (especially accompanied by gout and urate nephrolithiasis), blood pressure lability, old age; hemodialysis using high-flow membranes (for example, AN69) or desensitization, LDL apheresis, condition after kidney transplantation, aortic stenosis / hypertrophic cardiomyopathy.
Dosage and administration
The drug is prescribed by mouth, 1 tab.1 time / day, preferably in the morning, before eating. In elderly patients, CC is calculated taking into account age, body weight and sex. Elderly patients with normal renal function are prescribed Noliprel A Bi-Forte, 1 tab. 1 time / day, in this case, the degree of reduction in blood pressure should be monitored. The drug is contraindicated in patients with moderate to severe renal insufficiency (CC less than 60 ml / min). Patients with CC> 60 ml / min need regular monitoring of creatinine and potassium in blood plasma. The drug is contraindicated in patients with severe liver failure. In moderately severe liver failure, dose adjustment is not required. Noliprel A Bi-forte should not be prescribed to children and adolescents under the age of 18 years due to the lack of data on the efficacy and safety of the drug in patients of this age group.