Lisinopril FT tablets 10mg №10×3

Name:
Lisinopril Release form Tablets. Dosage 10 mg. Pack quantity: 30 pcs. ProducerFarmtekhnologiya ltd. INN Lisinopril. FTGApf blocker.
Description:
Tablets biconvex white or almost white. Composition Each tablet contains 5 mg, 10 mg or 20 mg of lisinopril as active substance (as lisinopril dihydrate). Excipients: corn starch, hypromellose, anhydrous colloidal silicon dioxide, magnesium stearate, anhydrous calcium hydrogen phosphate. Pharmacotherapeutic group Angiotensin-converting enzyme (ACE) inhibitors. ATC code: C09AA03. Pharmacological properties Lisinopril, which is a pharmacologically active substance in the composition of the drug Lisinopril FT, has a depressant effect on the function of the renin-angiotensin-aldosterone system (RAAS), due to its ability to inhibit ACE activity and thereby disrupt the process of converting angiotensin I to angiotensin II, causing vasoconstriction, inducing the formation and release of aldosterone and preventing the destruction of bradykinin and PGE2 (powerful endogenous vasodilating factors). At the same time, the content of angiotensin II and aldosterone decreases in the blood and the level of bradykinin and PGE2 increases, which ensures the development of the hypotensive effect of Lisinopril. The resulting expansion of peripheral vessels is accompanied by an increase in cardiac output without a change in heart rate, a decrease in pressure in the pulmonary capillaries, unloading of the pulmonary circulation and an increase in exercise tolerance. Lisinopril dilates arteries more than veins. Some of its effects are explained by the effect on tissue renin-angiotensin systems. With prolonged use of lisinopril, hypertrophy of the myocardium and walls of resistive arteries decreases, and blood supply to its ischemic areas improves. Course therapy with lisinopril in patients with chronic heart failure leads to a prolongation of their life expectancy, slowing down the progression of left ventricular dysfunction in patients who have had myocardial infarction without clinical manifestations of heart failure. After taking lisinopril, a decrease in blood pressure (BP) appears after 1 hour, reaches a maximum after 6-7 hours and persists throughout the day. Abrupt withdrawal does not lead to a pronounced increase in blood pressure. In addition to lowering blood pressure, lisinopril reduces the degree of proteinuria. In patients with hyperglycemia, it contributes to the normalization of the function of the damaged glomerular endothelium. Lisinopril does not affect the concentration of glucose in the blood in patients with diabetes mellitus and does not lead to an increase in cases of hypoglycemia. Indications for use arterial hypertension (in the form of monotherapy or in combination with other antihypertensive drugs) (see sections “Contraindications”, “Precautions”, “Interaction with other drugs”, “Pharmacological properties”); chronic heart failure (CHF) – as an additional therapy in patients who do not respond to therapy with digitalis and diuretics; acute myocardial infarction (in the first 24 hours in patients with stable hemodynamic parameters increases survival). Patients should receive standard recommended treatments, as needed, such as thrombolytics, aspirin, and beta-blockers; diabetic nephropathy – to reduce albuminuria in type 2 diabetes mellitus complicated by hypertension and initial nephropathy. Dosage and administration For all indications, Lisinopril FT should be taken orally once a day, always at about the same time of day, before or after meals. Hypertension Patients not receiving other antihypertensive agents are started on Lisinopril FT at a dose of 10 mg/day. This dose may be increased to the usual daily maintenance dose of 20 mg. The maximum daily dose should not exceed 40 mg. The full therapeutic effect usually develops after 2-4 weeks from the start of therapy. With insufficient clinical effect, it is possible to combine Lisinopril FT with other antihypertensive drugs (see sections “Contraindications”, “Precautions”, “Interaction with other drugs”, “Pharmacological properties”). If the patient received prior treatment with diuretics, they should be discontinued 2-3 days before the start of Lisinopril. If it is impossible to cancel diuretics, then the initial dose of Lisinopril should not exceed 5 mg / day. In this case, after taking the first dose, medical supervision is recommended for several hours (possibly a pronounced decrease in blood pressure), given that the maximum effect of Lisinopril is reached after about 6 hours. Doses should be adjusted depending on the level of blood pressure (see “Precautions”). If blood pressure is not controlled with Lisinopril alone, a low dose diuretic may be added – 12.5 mg hydrochlorothiazide has been shown to provide an additive effect. After adding a diuretic, it is possible to reduce the dose of Lisinopril. In renovascular hypertension or other conditions with increased activity of the renin-angiotensin-aldosterone system, the use of Lisinopril should be carried out under the control of blood pressure, kidney function, and plasma potassium concentration. It is advisable to start treatment with small (2.5-5 mg / day) dosages, and the maintenance dose is determined depending on the dynamics of blood pressure. In renal failure, in view of the fact that lisinopril is excreted through the kidneys, the initial dose of the drug should be coordinated with creatinine clearance. With creatinine clearance less than 10 ml / min (including patients on hemodialysis), the recommended initial dose is 2.5 mg / day. For patients with a creatinine clearance of 10-30 ml/min, the first dose is 2.5-5 mg once daily. For patients with creatinine clearance greater than 30 ml / min, the usual dose is 5-10 mg / day. In accordance with the reaction of the body, a maintenance dose is established under the conditions of frequent monitoring of kidney function and plasma levels of potassium and sodium. Chronic heart failure The initial dose of Lisinopril FT at a single dose is 2.5 mg / day. This dose may be increased to the usual maintenance daily dosage of 5 mg to not more than 20 mg. The dose of the concomitant diuretic should be reduced whenever possible to minimize the risk of hypovolemia, which may contribute to hypotension (see “Precautions”, “Interaction with other medicinal products”). Acute myocardial infarction In acute myocardial infarction (as part of combination therapy), 5 mg is prescribed on the first day, then 5 mg every other day, 10 mg after 2 days and then 10 mg 1 time per day. In patients with acute myocardial infarction, Lisinopril FT should be used for at least 6 weeks. At the beginning of treatment or during the first 3 days after acute myocardial infarction in patients with low systolic blood pressure (≤ 120 mm Hg), the drug should be prescribed at a dose of 2.5 mg / day. In the event of a decrease in systolic blood pressure (≤ 100 mm Hg. Art.) while taking Lisinopril, a daily dose of 5 mg can be temporarily reduced to 2.5 mg. In the event of a prolonged marked decrease in systolic blood pressure (≤ 90 mm Hg for more than 1 hour), treatment with Lisinopril should be discontinued. In diabetic nephropathy, Lisinopril FT should be used at a dose of 10 mg / day. If necessary, the dose can be increased to 20 mg per day (once) in order to achieve diastolic blood pressure values below 90 mm Hg. Art. Use in elderly patients In clinical trials, there were no differences in the efficacy and safety of treatment with lisinopril depending on age. Given the decrease in renal function with age, the dose of lisinopril should be adjusted in accordance with that in renal failure (see “Precautions”). In patients after kidney transplantation, treatment with lisinopril is not recommended. Side effects When using Lisinopril FT, as well as other lisinopril-containing drugs, a number of side effects may occur. The most common: dizziness, headache (in 5-6% of patients); weakness, diarrhea, dry cough (1-3%); nausea, vomiting, orthostatic hypotension (including after the first dose), skin rash, chest pain (1-3%). Occurring with a frequency of < 1%: on the part of the immune system: angioedema (face, upper and lower extremities, lips, tongue, larynx or epiglottis (0.1%); on the part of the cardiovascular system: an excessive decrease in blood pressure is possible; on the part respiratory system: malignant tumors of the lungs, hemoptysis, infiltration, embolism and pulmonary infarction, bronchospasm, asthma, pleural effusion, respiratory pain, bronchitis, laryngitis, sinusitis, pharyngitis, rhinitis, epistaxis, runny nose, paroxysmal postural dyspnea; from the side of the central nervous system: increased fatigue, drowsiness, convulsive twitching of the muscles of the limbs and lips, cerebrovascular accident, fainting, ataxia, memory loss; from the hematopoietic system: eosinophilia, leukopenia, neutropenia, anemia, thrombocytopenia, vasculitis; with long-term treatment - a slight decrease in hemoglobin, hematocrit, erythrocytopenia, in isolated cases agranulocytosis and pancytopenia; there are reports of isolated cases of hemolytic anemia in patients with congenital deficiency of glucose-6-phosphate dehydrogenase; from the musculoskeletal system: arthritis, arthralgia, myalgia, pain in the neck, back; on the part of laboratory parameters: hyperkalemia, hyponatremia, hyperuricemia, increased concentrations of creatinine, urea, azotemia, hyperbilirubinemia, increased activity of hepatic transaminases (especially if there is a history of kidney disease, diabetes mellitus and renovascular hypertension). Rarely encountered: from the side of the cardiovascular system: palpitations, atrial and ventricular tachycardia, atrial fibrillation, bradycardia, cardiac arrest, myocardial infarction, cerebrovascular stroke in patients with an increased risk of the disease due to a pronounced decrease in blood pressure; from the digestive tract: dry mouth, anorexia, dyspepsia, change in taste, heartburn, diarrhea / constipation, flatulence, gastrointestinal spasms, abdominal pain, gastritis, pancreatitis, hepatocellular or cholestatic jaundice, hepatitis; on the part of the skin: rash, urticaria, increased sweating, pruritus, alopecia, photosensitivity, skin lesions and infections, toxic epidermal necrolysis, Stevens-Johnson syndrome; from the urinary system: impaired renal function, dysuria, oliguria, anuria, uremia, proteinuria, acute renal failure, pyelonephritis, edema; on the part of the immune system: a syndrome that includes accelerated ESR, arthralgia and the appearance of antinuclear antibodies; from the side of the central nervous system: asthenic syndrome, mood lability, confusion, drowsiness, insomnia, peripheral neuropathy, paresthesia, tremor, visual disturbances (diplopia, photophobia, decreased visual acuity), tinnitus; other: fever, weakening of libido, impotence, impaired fetal development. If any side effect occurs or worsens, whether it is described in this section or not, you should contact your doctor immediately. Contraindications hypersensitivity to Lisinopril and other ACE inhibitors; a history of angioedema associated with the use of ACE inhibitors; hereditary angioedema; age up to 18 years (efficacy and safety have not been established); pregnancy; lactation (breastfeeding); simultaneous use of Lisinopril FT with Aliskiren in patients with diabetes mellitus or moderate / severe renal insufficiency (GFR < 60 ml / min / 1.73 m2) (see "Interaction with other drugs", "Pharmacological properties"). Lisinopril FT should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney with progressive azotemia; in the condition after kidney transplantation; with severe renal impairment (severe renal failure: creatinine clearance < 30 ml / min); in patients on hemodialysis; with hyperkalemia; primary hyperaldosteronism; aortic or mitral stenosis and other similar obstructions to blood flow (including hypertrophic obstructive cardiomyopathy) with significant circulatory disorders; with arterial hypotension; cerebrovascular diseases (including cerebrovascular insufficiency); with coronary insufficiency; autoimmune systemic connective tissue diseases (including scleroderma, systemic lupus erythematosus); oppression of bone marrow hematopoiesis; hypovolemic conditions associated with diarrhea and/or vomiting; in patients on a sodium-restricted diet and in elderly patients. Overdose The main symptoms of lisinopril overdose are due to the development of arterial hypotension. If they appear, the patient should take a supine position with raised legs. In mild cases, a saline solution is administered orally to the patient. In more serious cases, in a hospital setting, measures are taken to stabilize blood pressure: intravenous administration of saline or plasma substitutes. In order to remove lisinopril from the body, hemodialysis may be used. Precautions Anaphylactoid and possible related reactions Presumably because angiotensin-converting enzyme inhibitors affect the metabolism of eicosanoids and polypeptides, including endogenous bradykinin, patients receiving ACE inhibitors (including lisinopril) may develop a number of adverse reactions, including serious reactions. Angioedema of the head and neck: There have been reports of swelling of the face, extremities, lips, tongue, glottis and/or larynx in patients receiving ACE inhibitors. This can happen at any time during treatment. A higher incidence of angioedema has been reported with ACE inhibitors in black patients compared to non-black patients. In such cases, the use of the drug should be immediately discontinued, appropriate therapy and monitoring should be provided until the symptoms are completely and sustainably resolved. Even in cases where the observed swelling of the tongue is not accompanied by difficulty in breathing, patients may require long-term observation, since treatment with antihistamines and corticosteroids may not be enough. There are very rare reports of deaths due to swelling of the larynx or tongue. Patients with tongue, glottis, or larynx involvement are likely to experience airway obstruction, especially in cases of previous airway surgery. To ensure the patency of the respiratory tract, measures of appropriate therapy should be taken immediately, for example, subcutaneous administration of adrenaline 1:1000 (0.3 ml to 0.5 ml) (see "Side effect"). Patients with a history of non-ACE inhibitor angioedema may be at an increased risk of developing it when taking ACE inhibitors. Bowel edema has been reported in patients treated with ACE inhibitors. The clinical presentation is abdominal pain with or without nausea or vomiting; in some cases without a history of angioedema of the face and with a normal level of C-1 esterase. Angioedema was diagnosed by procedures such as abdominal computed tomography or ultrasound, or during surgery, and the symptoms resolved after the ACE inhibitor was discontinued. Intestinal angioedema should be included in the differential diagnosis of abdominal pain in patients receiving ACE inhibitors. Anaphylactoid reactions during desensitization: Life-threatening anaphylactoid reactions have been observed in patients undergoing desensitizing treatment against hymenoptera venom and concomitant use of ACE inhibitors. In patients, these reactions can be avoided with temporary discontinuation of ACE inhibitors, but they may reappear after re-appointment. Anaphylactoid reactions during hemodialysis: Sudden and potentially life-threatening anaphylactoid reactions have been reported in some patients using high-flux membranes (eg, AN69®) and concomitant use of ACE inhibitors. In such patients, dialysis should be stopped immediately and active therapy for anaphylactic reactions should be initiated. In these situations, the use of antihistamines does not lead to the disappearance of symptoms. In these patients, consideration should be given to using a different type of dialysis membrane or switching to a different class of antihypertensive drug. Anaphylactoid reactions have also been reported in patients undergoing LDL apheresis (low-density lipoprotein plasmapheresis) using dextran sulfate. Hypotension Excessive hypotension is rarely observed in patients with uncomplicated arterial hypertension receiving lisinopril as monotherapy. In patients with heart failure taking lisinopril, there is usually some decrease in blood pressure with a peak between 6 and 8 hours after a dose. However, discontinuation of therapy due to symptomatic hypotension when the instructions are followed is usually not necessary; care should be taken at the beginning of treatment (see "Method of application and dosage"). The risk of excessive hypotension, sometimes associated with oliguria and / or progressive azotemia, rarely with acute renal failure and / or death, occurs under the following conditions: heart failure with systolic blood pressure below 100 mm Hg. Art., hyponatremia, high doses of diuretics, recent intense diuresis or increase in the dose of a diuretic, dialysis, salt depletion of any etiology. It is advisable to discontinue diuretics (except in patients with heart failure), reduce the diuretic dose, or increase salt intake with caution prior to initiating Lisinopril therapy in patients at risk of excessive hypotension (see "Side effects", "Interaction with other medicinal products"). Treatment with Lisinopril FT should not be started in acute myocardial infarction in patients at risk of further serious haemodynamic deterioration after treatment with vasodilators (eg, systolic blood pressure of 100 mm Hg or below) or cardiogenic shock. In patients at risk of excessive hypotension, therapy should be started under medical supervision and these patients should be closely monitored during the first two weeks of treatment and whenever the dose of Lisinopril and/or diuretic is increased. This also applies to patients with coronary artery disease or cerebrovascular disease, in whom an excessive decrease in blood pressure can lead to myocardial infarction or stroke. If hypotension occurs, the patient should be transferred to a horizontal position and, if necessary, injected intravenously with 0.9% sodium chloride solution. Transient hypotension is not a contraindication for further use of the drug after normalization of blood pressure by increasing blood volume. If symptomatic hypotension develops, dose reduction or discontinuation of treatment with lisinopril or a concomitant diuretic may be required. Leukopenia/neutropenia/agranulocytosis In a study with another ACE inhibitor, captopril, its ability to cause agranulocytosis and bone marrow depression was shown, less often in uncomplicated patients, but more often in patients with renal insufficiency, especially in combination with collagenoses. Marketing experience has shown in rare cases the development of leukopenia / neutropenia and bone marrow depression, while a causal relationship with lisinopril cannot be excluded. Periodic monitoring of white blood cell counts in patients with collagenoses and kidney disease should be considered. Liver failure Rarely, ACE inhibitors are associated with a syndrome that begins with cholestatic jaundice or hepatitis and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is unknown. Patients receiving ACE inhibitors who develop jaundice or elevated liver enzymes should stop taking the drug and receive appropriate medical advice. Aortic Stenosis/Hypertrophic Cardiomyopathy: As with all vasodilators, lisinopril should be used with caution in patients with left ventricular outflow obstruction. Renal impairment: Due to inhibition of the RAAS, changes in renal function can be expected in susceptible patients. In patients with severe CHF, where renal function is dependent on RAAS activity, treatment with ACE inhibitors, including lisinopril, may be associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death. In patients with arterial hypertension with unilateral or bilateral stenosis of the renal artery, an increase in blood urea nitrogen and serum creatinine is possible. These changes are usually reversible upon discontinuation of the drug and/or diuretic therapy. In such patients, renal function should be monitored during the first few weeks of therapy. In some patients with arterial hypertension or heart failure without previously diagnosed kidney disease, the increase in blood urea nitrogen and serum creatinine is usually minor and transient, especially when taken with diuretics. Changes are most likely in patients with pre-existing renal insufficiency. Dose adjustment and/or discontinuation of the diuretic and/or lisinopril may be required. In acute myocardial infarction, treatment with lisinopril should be initiated with caution in patients with evidence of impaired renal function (serum creatinine concentration greater than 2 mg/dl). If renal dysfunction develops during treatment (serum creatinine greater than 3 mg/dL or twice the initial value), the physician should consider discontinuing treatment. Evaluation of patients with arterial hypertension, heart failure, myocardial infarction should always include an assessment of kidney function (see "Method of application and doses"). Hyperkalemia: Risk factors for the development of hyperkalemia include renal failure, diabetes mellitus, concomitant use of potassium-sparing diuretics, potassium supplements, and/or potassium-containing salt substitutes. Hyperkalemia can lead to serious, sometimes fatal, arrhythmias. Lisinopril should be used with caution with these substances, frequent monitoring of serum potassium levels is recommended (see "Interaction with other medicinal products"). Cough: By inhibiting the degradation of endogenous bradykinin, with all ACE inhibitors, a persistent non-productive cough is possible, which stops after discontinuation of therapy. Surgery / Anesthesia: In patients undergoing general surgery or anesthesia with drugs that cause hypotension, lisinopril may block the formation of angiotensin II against the background of compensatory secretion of renin. If arterial hypotension due to this mechanism is noted, it is necessary to replenish the volume of fluid. Hypoglycemia: Patients with diabetes mellitus taking oral antidiabetic drugs or insulin should have continuous glycemic control during the first month of therapy with ACE inhibitors. (see "Interaction with other drugs"). Dual blockade of the renin-angiotensin-aldosterone system is associated with an increased risk of hypotension, hyperkalemia, and renal dysfunction (including acute renal failure) compared with monotherapy. Dual blockade of the RAAS with Lisinopril FT, ARB II or Aliskiren cannot be recommended for any patient, especially for patients with diabetic nephropathy (see "Interaction with other drugs", "Pharmacological properties"). In some cases, when the combined use of Lisinopril FT and ARB II is absolutely indicated, careful observation by a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. This refers to the appointment of candesartan or valsartan as adjunctive therapy to lisinopril in patients with CHF. Conducting a double blockade of the RAAS under the close supervision of a specialist and mandatory monitoring of kidney function, water and electrolyte balance and blood pressure is possible in patients with CHF with intolerance to aldosterone antagonists (spironolactone), who have persistent symptoms of CHF, despite other adequate therapy. It should be remembered that patients with CHF in combination with renal failure (or without it) and connective tissue diseases need strict medical supervision in a hospital at the stage of selecting the dose of Lisinopril and diuretics, since it is in such patients, and especially with severe CHF, most often, a pronounced decrease in blood pressure is possible, as a result of the use of diuretics in high doses, hyponatremia, or impaired renal function. In patients with arterial hypertension, lisinopril can cause a sharp decrease in blood pressure, especially after the first dose. Most often, arterial hypotension occurs in patients with a deficiency of electrolytes or fluids, receiving diuretics, following a low-salt diet, after vomiting or diarrhea, or after hemodialysis. In such patients, therapy should be initiated under strict medical supervision, preferably in a hospital, at low doses and the dosage adjusted with caution. At the same time, monitoring of kidney function and serum potassium levels is necessary. If possible, diuretic treatment should be discontinued. Similar rules should be followed when prescribing Lisinopril FT to patients with coronary artery disease and cerebrovascular insufficiency, in whom a sharp drop in blood pressure can lead to myocardial infarction or stroke. In this case, a transient hypotensive reaction is not a contraindication for taking the next dose of the drug. Before you start taking Lisinopril, if possible, you should normalize the concentration of sodium in the blood and / or replenish the lost volume of fluid, carefully monitor the effect of the initial dose on the patient's blood pressure level. In elderly patients, a higher plasma concentration of lisinopril can be created from the same dose of Lisinopril, so special care is required when selecting the dosage of lisinopril in this case, despite the fact that differences in the antihypertensive effect of lisinopril-containing drugs between elderly and young patients not found. For patients over 65 years of age, an initial dose of lisinopril 2.5 mg/day is recommended, as well as monitoring of blood pressure and renal function. When changing laboratory parameters against the background of the use of lisinopril (see the section "Side effects"), they act individually, depending on the severity of these changes and the specific clinical situation. In serious cases, decide on the abolition of lisinopril and the appropriate corrective measures. In all cases, timely monitoring of laboratory parameters is very important. For example, the concentration of electrolytes and creatinine in the blood serum and the indicators of blood cells should be monitored, especially at the beginning of lisinopril therapy, as well as while using it with immunosuppressants, cytostatics, allopurinol and procainamide. In some patients with arterial hypertension without obvious renal dysfunction, with simultaneous therapy with lisinopril and diuretics, there may be an increase in the level of urea and blood creatinine. In such a situation, it may be necessary to reduce the dose of the ACE inhibitor or stop the diuretic. Therapy with lisinopril can lead to an increase in the level of potassium ions in the blood, especially against the background of existing renal or heart failure. Under these conditions, the use of potassium-sparing diuretics or potassium preparations is undesirable. It is also necessary to regularly monitor the level of potassium in the blood. In view of the fact that the potential risk of agranulocytosis and neutropenia cannot be excluded, periodic monitoring of the blood picture is required. After the abolition of ACE inhibitors, agranulocytosis and neutropenia disappear. In patients with reduced renal function or after taking sufficiently high doses of lisinopril, rare cases of proteinuria have been noted. In patients with clinically significant proteinuria (> 1g/day), lisinopril should only be used after careful consideration of the expected benefit and potential risk, and with regular clinical and laboratory monitoring. Some issues of the tactics of using lisinopril in the presence of changes in laboratory parameters are reflected in other sections of the instructions (“Method of application and dose”, “Interaction with other drugs”). Use in children Contraindicated in children and adolescents under 18 years of age. Pregnancy and lactation Pregnancy The use of ACE inhibitors is not recommended during the first trimester of pregnancy and is contraindicated during the second and third trimester of pregnancy (see “Contraindications”). The use of these drugs during the second and third trimesters of pregnancy reduces kidney function and increases morbidity and risk of fetal and neonatal death. As a result of oligohydramnios, pulmonary hypoplasia and skeletal deformities of the fetus are possible. Potential neonatal side effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is established, Lisinopril FT should be discontinued as soon as possible and switched to alternative antihypertensive agents with an established safety profile for use during pregnancy. In the absence of an appropriate alternative to ACE inhibitors for a particular patient, she should be informed of the potential risk to the fetus. It is necessary to conduct serial ultrasound examinations. If oligohydramnios is detected, the drug should be discontinued, unless it is vital for the mother. Patients and doctors should be aware that oligohydramnios can occur when the fetus already has irreversible damage. In the case of the use of ACE inhibitors in the second trimester of pregnancy, it is recommended to monitor kidney function and development of the skull bones using ultrasound. Newborns whose mothers took lisinopril should be carefully monitored for the presence of arterial hypotension, oliguria and hyperkalemia. In animal experiments, no data on the teratogenic effects of lisinopril have been obtained. There are also no data on the negative effects of the drug on the fetus if used during the first trimester of pregnancy. Breast-feeding It is not known whether lisinopril passes into breast milk. Since many drugs are secreted in human milk and because of the risk of severe adverse reactions in infants when using ACE inhibitors, a decision should be made to stop breastfeeding or stop lisinopril, taking into account its importance to the mother. Influence on the ability to drive vehicles and other complex mechanisms Evidence on this problem in the framework of the use of therapeutic dosages of lisinopril-containing drugs is currently absent, however, taking into account the possible occurrence of dizziness, their use (including Lisinopril) in such situations should be exercise with caution. Interaction with other drugs Caution is required when using lisinopril with potassium-sparing diuretics (spironolactone, triamterene, amiloride), potassium, salt substitutes containing potassium, as the risk of developing hyperkalemia increases, especially in the presence of impaired renal function. In this regard, their combined use can only be carried out at the discretion of the attending physician, subject to regular monitoring of the level of potassium in the blood serum and kidney function. Lisinopril should be used with caution along with diuretics, since with the additional administration of a diuretic to a patient treated with Lisinopril, as a rule, an additive antihypertensive effect occurs. With the additional appointment of Lisinopril during diuretic therapy, severe arterial hypotension may occur. Caution must be observed when Lisinopril is combined with other antihypertensive agents (additive effect) and with NSAIDs (especially with indomethacin), estrogens, sympathomimetics – a weakening of the antihypertensive effect. Data from clinical trials have shown that dual blockade of the RAAS by the combined use of an ACE inhibitor, ARB II, or Aliskiren is associated with a higher incidence of side effects such as hypotension, hyperkalemia, and decreased renal function (including acute renal failure) compared with use alone drug (see sections “Contraindications”, “Precautions”, “Pharmacological properties”). Based on the available data, dual blockade of the RAAS with an ACE inhibitor, ARB II, or Aliskiren cannot be recommended for any patient, especially those with diabetic nephropathy. In patients with diabetes mellitus or moderate / severe renal insufficiency (GFR < 60 ml / min / 1.73 m2), the simultaneous use of Lisinopril FT with Aliskiren is contraindicated. In some cases, when the combined use of Lisinopril FT and ARB II is absolutely indicated, careful observation by a specialist and mandatory monitoring of kidney function, water and electrolyte balance, and blood pressure are necessary. Lisinopril, which promotes the excretion of sodium ions from the body, can reduce the excretion of lithium, therefore, when treating with lithium salts, it is necessary to con