Noliprel A Forte tablets p/o 5mg/1.25mg №30

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Noliprel A Forte tab. p / pl.ob. 5mg/1.25mg per col. No. 30 in the pack. No. 1
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Oblong film-coated tablets, white. The main active ingredient perindopril and indapamide Release form tablets Dosage 5 mg / 1.25 mg Special instructions The use of the drug Noliprel® A forte 5 mg + 1.25 mg is not accompanied by a significant decrease in the frequency of side effects, with the exception of hypokalemia, compared with perindopril and indapamide in the lowest doses allowed for use (see section “Side effects”). At the beginning of therapy with two antihypertensive drugs that the patient has not previously received, an increased risk of idiosyncrasy cannot be ruled out. Careful monitoring of the patient minimizes this risk. Impaired renal function Therapy is contraindicated in patients with severe renal insufficiency (CC less than 30 ml / min). In some patients with arterial hypertension without previous obvious impairment of renal function during therapy, laboratory signs of functional renal failure may appear. In this case, treatment should be stopped. In the future, you can resume combination therapy using low doses of drugs, or use drugs in monotherapy. Such patients need regular monitoring of the level of potassium and creatinine in the blood serum – 2 weeks after the start of therapy and then every 2 months. Renal failure occurs more frequently in patients with severe chronic heart failure or underlying renal dysfunction, including renal artery stenosis. Arterial hypotension and disturbance of water and electrolyte balance Hyponatremia is associated with the risk of sudden development of arterial hypotension (especially in patients with stenosis of the artery of a single kidney and bilateral stenosis of the renal arteries). Therefore, during dynamic monitoring of patients, attention should be paid to possible symptoms of dehydration and a decrease in the level of electrolytes in the blood plasma, for example, after diarrhea or vomiting. Such patients require regular monitoring of plasma electrolyte levels. With severe arterial hypotension, intravenous administration of a 0.9% sodium chloride solution may be required. Transient arterial hypotension is not a contraindication for continuing therapy. After restoration of circulating blood volume and blood pressure, therapy can be resumed using low doses of drugs, or drugs can be used in monotherapy. Potassium level The combined use of perindopril and indapamide does not prevent the development of hypokalemia, especially in patients with diabetes mellitus or renal insufficiency. As in the case of the combined use of antihypertensive drugs and a diuretic, regular monitoring of the level of potassium in the blood plasma is necessary. Excipients It should be borne in mind that the excipients of the drug include lactose monohydrate. Do not prescribe Noliprel® A forte to patients with hereditary galactose intolerance, lactase deficiency and glucose-galactose malabsorption. Lithium preparations The simultaneous use of a combination of perindopril and indapamide with lithium preparations is not recommended. Pharmacodynamics Noliprel® A forte is a combined preparation containing perindopril arginine and indapamide. Pharmacological properties of the drug Noliprel® A forte combine the individual properties of each of the components. Mechanism of action The combination of perindopril and indapamide enhances the antihypertensive effect of each. Perindopril Perindopril is an inhibitor of the enzyme that converts angiotensin I to angiotensin II (angiotensin-converting enzyme (ACE) inhibitor). ACE, or kininase II, is an exopeptidase that both converts angiotensin I to the vasoconstrictor angiotensin II and breaks down the vasodilator bradykinin 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 prolonged use, it reduces the total peripheral vascular resistance (OPSS), which is mainly due to the effect on the vessels in the muscles and kidneys. These effects are not accompanied by sodium and fluid retention or the development of reflex tachycardia. Perindopril normalizes myocardial function, reducing preload and afterload. When studying hemodynamic parameters in patients with chronic heart failure (CHF), it was revealed: a decrease in filling pressure in the left and right ventricles of the heart; decrease in OPSS; increase in cardiac output; increased muscle peripheral blood flow. Indapamide Indapamide belongs to the group of sulfonamides and is similar in pharmacological properties 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 the excretion of sodium, chloride ions and, to a lesser extent, potassium and magnesium ions by the kidneys, thereby increasing diuresis and lowering blood pressure (BP). Antihypertensive effect Noliprel® A forte has a dose-dependent antihypertensive effect on both diastolic and systolic blood pressure both in the standing and lying positions. The 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 tachycardia. Termination of treatment does not cause a “withdrawal” syndrome. Noliprel® A forte reduces the degree of left ventricular hypertrophy (GTLZH), improves arterial elasticity, reduces peripheral vascular resistance, does not affect lipid metabolism (total cholesterol, high-density lipoprotein cholesterol (HDL) and low-density lipoprotein cholesterol (LDL), triglycerides). The effect of the use of a combination of perindopril and indapamide on GTLH in comparison with enalapril has been proven. In patients with arterial hypertension and LVOT treated with perindopril erbumine 2 mg (equivalent to 2.5 mg perindopril arginine)/indapamide 0.625 mg or enalapril 10 mg once a day, and when the dose of perindopril erbumine is increased to 8 mg (equivalent to 10 mg of perindopril arginine) and indapamide up to 2.5 mg, or enalapril up to 40 mg once a day, there was a more significant decrease in the left ventricular mass index (LVMI) in the perindopril / indapamide group compared to the enalapril group. At the same time, the most significant effect on LVMI is observed with the use of perindopril erbumine 8 mg / indapamide 2.5 mg. A more pronounced antihypertensive effect was also noted in combination therapy with perindopril and indapamide compared with enalapril. In patients with type 2 diabetes mellitus (mean age 66 years, body mass index 28 kg/m2, glycated hemoglobin (HbAlc) 7.5%, BP 145/81 mmHg), the effect of a fixed combination of perindopril/indapamide was studied. for major micro- and macrovascular complications in addition to both standard glycemic control therapy and an intensive glycemic control (IGC) strategy (target HbAlc < 6.5%). 83% of patients had arterial hypertension, 32% and 10% had macro- and microvascular complications, 27% had microalbuminuria. Most of the patients at the time of inclusion in the study received hypoglycemic therapy, 90% of patients - oral hypoglycemic agents (47% of patients - in monotherapy, 46% - therapy with two drugs, 7% - therapy with three drugs). 1% of patients received insulin therapy, 9% - only diet therapy. Sulfonylureas were taken by 72% of patients, metformin - by 61%. As concomitant therapy, 75% of patients received antihypertensive agents, 35% of patients received lipid-lowering agents (mainly HMG-CoA reductase inhibitors (statins) - 28%), acetylsalicylic acid as an antiplatelet agent and other antiplatelet agents (47%). After a 6-week run-in period during which patients received perindopril/indapamide therapy, they were assigned to a standard glycemic control group or an ICS group (Diabeton MB with the option of increasing the dose to a maximum of 120 mg/day or adding another hypoglycemic agent). The IHC group (mean follow-up 4.8 years, mean HbAlc 6.5%) compared with the standard control group (mean HbAlc 7.3%) showed a significant 10% reduction in the relative risk of combined macro- and microvascular complications. The advantage was achieved due to a significant reduction in the relative risk: major microvascular complications by 14%, the onset and progression of nephropathy by 21%, microalbuminuria by 9%, macroalbuminuria by 30% and the development of renal complications by 11%. The benefits of antihypertensive therapy did not depend on the benefits achieved with ICS. Perindopril Perindopril is effective in the treatment of arterial hypertension of any severity. The antihypertensive effect of the drug reaches a maximum after 4-6 hours after a single oral administration and lasts for 24 hours. 24 hours after taking the drug, a pronounced (about 80%) residual ACE inhibition is observed. Perindopril has an antihypertensive effect in patients with both low and normal plasma renin activity. The simultaneous appointment of thiazide diuretics enhances the severity of the antihypertensive effect. In addition, the combination of an ACE inhibitor and a thiazide diuretic also reduces the risk of hypokalemia while taking diuretics. Indapamide The antihypertensive effect is manifested when the drug is used in doses that have a minimal diuretic effect. The antihypertensive effect of indapamide is associated with an improvement in the elastic properties of large arteries, a decrease in peripheral vascular resistance. Indapamide reduces GTLZh, does not affect the concentration of lipids in blood plasma: triglycerides, total cholesterol, LDL, HDL; carbohydrate metabolism (including in patients with concomitant diabetes mellitus). Pharmacokinetics The combination of perindopril and indapamide does not change their pharmacokinetic characteristics compared to taking these drugs separately. Perindopril When taken orally, perindopril is rapidly absorbed. Bioavailability is 65-70%. Approximately 20% of the total absorbed perindopril is converted to perindoprilat, the active metabolite. Taking the drug during meals is accompanied by a decrease in the metabolism of perindopril to perindoprilat (this effect has no significant clinical significance). The maximum concentration of perindoprilat in plasma is reached 3-4 hours after ingestion. Communication with plasma proteins is less than 30% and depends on the concentration of perindopril in the blood. The dissociation of perindoprilat associated with ACE is slowed down. As a result, the "effective" half-life (T1 / 2) is 25 hours. Re-appointment of perindopril does not lead to its cumulation, and T1 / 2 perindoprilat upon repeated administration corresponds to the period of its activity, thus, the equilibrium state is reached after 4 days. Perindoprilat is excreted from the body by the kidneys. T1 / 2 metabolite is 3-5 hours. Removal of perindoprilat is slowed down in the elderly, as well as in patients with heart and kidney failure. The dialysis clearance of perindoprilat is 70 ml/min. The pharmacokinetics of perindopril is changed in patients with cirrhosis of the liver: its hepatic clearance is reduced by 2 times. However, the amount of perindoprilat formed does not decrease, so a change in the dose of the drug is not required. Perindopril crosses the placenta. Indapamide Indapamide is rapidly and completely absorbed from the gastrointestinal tract. The maximum concentration of the drug in blood plasma is observed 1 hour after ingestion. Communication with blood plasma proteins - 79%. T1 / 2 is 14-24 hours (average 19 hours). Repeated administration of the drug does not lead to its accumulation in the body. It is excreted mainly by the kidneys (70% of the administered dose) and through the intestines (22%) in the form of inactive metabolites. The pharmacokinetics of the drug does not change in patients with renal insufficiency. Indications for use Essential hypertension. In patients with arterial hypertension and type 2 diabetes mellitus to reduce the risk of developing microvascular complications (from the kidneys) and macrovascular complications from cardiovascular diseases. Dosage and administration Inside, preferably in the morning, before meals. Essential hypertension 1 tablet Noliprel® A forte 1 time per day. If possible, the drug begins with the selection of doses of single-component drugs. In case of clinical necessity, it is possible to consider the possibility of prescribing combination therapy with Noliprel® A forte immediately after monotherapy. Arterial hypertension and type 2 diabetes The drug is used to reduce the risk of developing microvascular complications (from the kidneys) and macrovascular complications from cardiovascular diseases. It is recommended to start therapy with a combination of perindopril / indapamide at a dose of 2.5 mg / 0.625 mg (Noliprel® A drug) 1 time per day. After 3 months of therapy, subject to good tolerance, it is possible to increase the dose - 1 tablet of Noliprel® A forte 1 time per day. Elderly people Treatment with the drug should be prescribed after monitoring renal function and blood pressure. Renal insufficiency The drug is contraindicated in patients with severe renal insufficiency (CC less than 30 ml / min). For patients with moderately severe renal insufficiency (CC 30-60 ml / min), it is recommended to start therapy with the required doses of drugs (in monotherapy) that are part of Noliprel® A forte. Patients with CC equal to or greater than 60 ml / min do not require dose adjustment. Against the background of therapy, regular monitoring of the concentration of creatinine and potassium in the blood plasma is necessary. Hepatic insufficiency The drug is contraindicated in patients with severe hepatic insufficiency. With moderately severe hepatic insufficiency, dose adjustment is not required. Use during pregnancy and lactation The drug is contraindicated in pregnancy. When planning pregnancy or when it occurs while taking the drug Noliprel® A forte, you should immediately stop taking the drug and prescribe another antihypertensive therapy. Noliprel® A forte should not be used in the first trimester of pregnancy. Appropriate controlled studies on the use of ACE inhibitors in pregnant women have not been conducted. The limited data available on the effects of ACE inhibitors in the first trimester of pregnancy indicate that the use of ACE inhibitors did not lead to fetal malformations associated with fetotoxicity, but a fetotoxic effect of the drug cannot be completely excluded. Noliprel® A forte is contraindicated in the II and III trimester of pregnancy (see section "Contraindications"). It is known that prolonged exposure to ACE inhibitors on the fetus in the II and III trimesters of pregnancy can lead to a violation of its development (decrease in kidney function, oligohydramnios, slowing of the ossification of the skull bones) and the development of complications in the newborn (renal failure, arterial hypotension, hyperkalemia). 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 rare cases, while taking diuretics shortly before delivery, newborns develop hypoglycemia and thrombocytopenia. If the patient received the drug Noliprel® A forte during the II or III trimester of pregnancy, it is recommended to conduct an ultrasound examination of the newborn to assess the condition of the skull and kidney function. In newborns whose mothers received therapy with ACE inhibitors, arterial hypotension may be observed, and therefore, newborns should be under close medical supervision. Lactation Noliprel® A forte is contraindicated during lactation. It is not known whether perindopril is excreted in breast milk. Indapamide is excreted in breast milk. Taking thiazide diuretics causes a decrease in the amount of breast milk or suppression of lactation. At the same time, the newborn may develop hypersensitivity to sulfonamide derivatives, hypokalemia and "nuclear" jaundice. Since the use of perindopril and indapamide during lactation can cause severe complications in an infant, it is necessary to evaluate the significance of therapy for the mother and decide whether to stop breastfeeding or stop taking the drug. Interaction with other drugs Combinations not recommended for use Lithium preparations: with the simultaneous use of lithium preparations and ACE inhibitors, a reversible increase in the concentration of lithium in the blood plasma and associated toxic effects may occur. The additional appointment of thiazide diuretics may further increase the concentration of lithium and increase the risk of toxicity. The simultaneous use of a combination of perindopril and indapamide with lithium preparations is not recommended. If necessary, such therapy should constantly monitor the content of lithium in the blood plasma (see section "Special Instructions"). Drugs, the combination with which requires special attention Baclofen: may increase the hypotensive effect. Blood pressure and renal function should be monitored, if necessary, dose adjustment of antihypertensive drugs is required. Non-steroidal anti-inflammatory drugs (NSAIDs), including high doses of acetylsalicylic acid (more than 3 g / day): the appointment of NSAIDs may lead to a decrease in diuretic, natriuretic and antihypertensive effects. With a significant loss of fluid, acute renal failure may develop (due to a decrease in the glomerular filtration rate). Before starting treatment with the drug, it is necessary to replenish fluid loss and regularly monitor kidney function at the beginning of treatment. Combinations requiring attention Tricyclic antidepressants, antipsychotics (neuroleptics): These classes of drugs increase the antihypertensive effect and increase the risk of orthostatic hypotension (additive effect). Corticosteroids, tetracosactide: decrease in antihypertensive effect (fluid retention and sodium ions as a result of the action of corticosteroids). Other antihypertensive drugs: may increase the antihypertensive effect. Contraindications Contraindications Perindopril hypersensitivity to perindopril and other ACE inhibitors; angioedema (Quincke's edema) in history while taking other ACE inhibitors (see section "Special Instructions"); hereditary/idiopathic angioedema; pregnancy; breastfeeding period; simultaneous use with aliskiren and drugs containing aliskiren in patients with diabetes mellitus and / or moderate or severe impaired renal function (glomerular filtration rate (GFR) less than 60 ml / min / 1.73 m2 of body surface area) (see section "Medicinal interaction"); simultaneous use with angiotensin II receptor antagonists (ARA II) in patients with diabetic nephropathy; age up to 18 years (efficacy and safety have not been established). Contraindications Indapamide hypersensitivity to indapamide and other sulfonamides; severe renal failure (CC less than 30 ml / min); hepatic encephalopathy; hypokalemia; severe liver failure; simultaneous use with non-antiarrhythmic drugs that can cause polymorphic ventricular tachycardia of the "pirouette" type; breastfeeding period; age up to 18 years (efficacy and safety have not been established). Noliprel® A forte hypersensitivity to the excipients that make up the drug (see section "Dosage regimen"); due to the lack of sufficient clinical experience, the drug Noliprel® A forte should not be used in patients on hemodialysis, as well as in patients with untreated decompensated heart failure; age up to 18 years (efficacy and safety have not been established); the presence of lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome (the drug contains lactose). Composition 1 tablet contains: active substances: perindopril arginine 5 mg, which corresponds to 3.395 mg of perindopril and indapamide 1.25 mg; excipients: lactose monohydrate 71.33 mg, magnesium stearate 0.45 mg, maltodextrin 9 mg, colloidal anhydrous silicon dioxide 0.27 mg, sodium carboxymethyl starch (type A) 2.7 mg; film shell: macrogol-6000 0.087 mg, premix for white film shell SEPIFILM 37781 RBC (glycerol 4.5%, hypromellose 74.8%, macrogol-6000 1.8%, magnesium stearate 4.5%, titanium dioxide (E 171) 14.4%) 2.913 mg. Overdose Symptoms The most likely symptom of an overdose is a pronounced decrease in blood pressure, sometimes in combination with nausea, vomiting, convulsions, dizziness, drowsiness, confusion and oliguria, which can turn into anuria (as a result of hypovolemia). Electrolyte disturbances (hyponatremia, hypokalemia) may also occur. Treatment Emergency measures are reduced to the removal of the drug from the body: gastric lavage and / or the appointment of activated charcoal, followed by restoration of water and electrolyte balance. With a significant decrease in blood pressure, the patient should be transferred to the "lying" position with raised legs. If necessary, correct hypovolemia (for example, intravenous infusion of 0.9% sodium chloride solution). Perindoprilat, the active metabolite of perindopril, can be removed from the body by dialysis. Side effect Perindopril has an inhibitory effect on the renin-angiotensin-aldosterone system (RAAS) and reduces the excretion of potassium ions by the kidneys while taking indapamide. In 4% of patients, while using the drug Noliprel® A forte, hypokalemia develops (potassium level less than 3.4 mmol / l). On the part of the circulatory and lymphatic system Very rarely: thrombocytopenia, leukopenia / neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia. Anemia: In certain clinical situations (patients after kidney transplantation, patients on hemodialysis), ACE inhibitors can cause anemia. From the side of the central nervous system Often: paresthesia, headache, dizziness, asthenia, vertigo. Infrequently; sleep disturbance, mood lability. Very rare: confusion. Unspecified frequency: syncope. On the part of the organ of vision Often: blurred vision. On the part of the organ of hearing Often: tinnitus. Since the cardiovascular system Often: a pronounced decrease in blood pressure, including orthostatic hypotension. Very rarely: cardiac arrhythmias, including bradycardia, ventricular tachycardia, atrial fibrillation, as well as angina pectoris and myocardial infarction, possibly due to an excessive decrease in blood pressure in high-risk patients (see section "Special Instructions"). Unspecified frequency: pirouette-type arrhythmias (possibly fatal) (see section "Interaction with other medicinal products"). On the part of the respiratory system Often: against the background of the use of ACE inhibitors, a dry cough may occur, which persists for a long time while taking this group of drugs and disappears after their withdrawal. Dyspnea. Uncommon: bronchospasm. Very rare: eosinophilic pneumonia, rhinitis. From the digestive system Often: dryness of the oral mucosa, nausea, vomiting, abdominal pain, epigastric pain, taste disturbance, loss of appetite, dyspepsia, constipation, diarrhea. Very rarely: angioedema of the intestine, cholestatic jaundice, pancreatitis. Unspecified frequency: hepatic encephalopathy in patients with hepatic insufficiency (see sections "Contraindications" and "Special Instructions"), hepatitis. On the part of the skin and subcutaneous fat Often: skin rash, itching, maculopapular rash. Infrequently: angioedema of the face, lips, extremities, mucous membrane of the tongue, vocal folds and / or larynx; urticaria (see section "Special Instructions"); hypersensitivity reactions in patients predisposed to broncho-obstructive and allergic reactions; purpura. In patients with acute systemic lupus erythematosus, the course of the disease may worsen. Very rare: erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome. There have been cases of photosensitivity reactions (see section "Special Instructions"). From the musculoskeletal system and connective tissue Often: muscle spasms. From the urinary system Infrequently: renal failure. Very rare: acute renal failure. Laboratory indicators hyperkalemia, often transient; a slight increase in the concentration of creatinine in the urine and in the blood plasma, passing after discontinuation of therapy, more often in patients with renal artery stenosis, in the treatment of arterial hypertension with diuretics and in case of renal failure. Rare: hypercalcemia. Unspecified frequency: an increase in the QT interval on the ECG; increase in the concentration of uric acid and glucose in the blood; increased activity of "liver" enzymes; hypokalemia, especially significant for patients at risk (see section "Special Instructions"); hyponatremia and hypovolemia leading to dehydration and orthostatic hypotension. Simultaneous hypochloremia can lead to metabolic alkalosis of a compensatory nature (the probability and severity of this effect is low). Storage conditions The drug should be stored at a temperature not exceeding 30 ° C. 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