Enap pills 5mg №10×2

Name:
Enap tabl 5mg in a blister. in pack. No. 10×2
Description:
White round tablets with a flat surface, beveled edges and a notch on one side (for a dosage of 5 mg). The main active ingredient Enalapril Release form 10 tablets are placed in a blister pack of a three-layer film (oriented polyamide/aluminum/polyvinyl chloride) and aluminum foil. 2 blister packs, together with instructions for medical use in the state and Russian languages, are placed in a cardboard pack. Dosage 5 mg Special instructions Arterial hypotension Symptomatic arterial hypotension rarely develops in patients with uncomplicated arterial hypertension. Arterial hypotension with all clinical manifestations can be observed after the first dose of Enap® in patients with hypovolemia, as a result of diuretic therapy, salt-free diet, diarrhea, vomiting or hemodialysis. The development of symptomatic arterial hypotension is more likely in patients with severe heart failure due to the use of high doses of diuretics, hyponatremia, or impaired renal function. In these patients, treatment should be started under the supervision of a physician until the optimal dose adjustment of Enap® and / or diuretic. Similar tactics can be applied to patients with coronary artery disease or cerebrovascular disease, in whom a sharp excessive decrease in blood pressure can lead to the development of myocardial infarction or cerebrovascular accident. In case of severe arterial hypotension, the patient should be given a horizontal position, legs should be raised and, if necessary, 0.9% sodium chloride solution should be injected intravenously. Transient arterial hypotension is not a contraindication to further treatment with Enap® after stabilization of blood pressure and BCC. In some patients with heart failure and normal or low blood pressure, it may be further reduced when taking Enap®. This effect is predictable and is not usually a reason to stop therapy. If arterial hypotension is accompanied by clinical symptoms, the dose should be reduced and / or the diuretic and / or Enap should be discontinued. Aortic or mitral stenosis, HOCM Like all vasodilators, ACE inhibitors should be used cautiously in patients with valvular obstruction and left ventricular outflow tract hypertrophy. It should not be given to patients with cardiogenic shock and hemodynamically significant left ventricular obstruction. Impaired renal function In patients with renal insufficiency (Cl creatinine <80 ml / min (1.33 ml / s), the initial dose of Enap® should be selected primarily taking into account Cl creatinine and then the clinical response to treatment. In such patients, regularly monitor the content of potassium and the concentration of creatinine in the blood serum.In patients with severe heart failure and kidney disease, including renal artery stenosis, renal failure may develop during treatment with Enap®. Changes were usually reversible after discontinuation of the drug Enap®.In some patients with arterial hypertension, in which kidney disease was not detected before the start of treatment, there was a slight and transient increase in the concentration of urea and creatinine in the blood serum when using Enap® simultaneously with a diuretic.In such cases, it may be necessary to reduce the dose of Enap® and / or cancel the diuretic. This situation indicates the possibility th stenosis of the renal artery. Renovascular hypertension In patients with bilateral renal artery stenosis or stenosis of the artery of the only functioning kidney, the risk of arterial hypotension and renal failure is increased when treated with ACE inhibitors. Only minor changes in serum creatinine concentration can indicate a decrease in kidney function. In such patients, treatment should be initiated at low doses under close medical supervision. It is necessary to carefully titrate the dose and monitor renal function. Kidney transplantation There is no experience with the use of Enap® in patients who have recently undergone kidney transplantation. Therefore, the treatment of such patients with Enap® is not recommended. Impaired liver function In rare cases, therapy with ACE inhibitors was accompanied by the development of a syndrome beginning with cholestatic jaundice and hepatitis up to the development of fulminant liver necrosis. The mechanism by which this syndrome develops is unknown. If jaundice occurs or a significant increase in the activity of liver enzymes, treatment with an ACE inhibitor should be stopped immediately, the patient should be carefully monitored and, if necessary, treated. Neutropenia/agranulocytosis Cases of neutropenia/agranulocytosis, thrombocytopenia and anemia have been described in patients treated with ACE inhibitors. Neutropenia rarely develops in patients with normal renal function in the absence of other complications. Enap® should be used with great caution in patients with connective tissue diseases (including systemic lupus erythematosus, scleroderma) who are simultaneously receiving immunosuppressive therapy, allopurinol or procainamide, as well as with a combination of these factors, especially with existing impaired renal function . These patients may develop severe infections that are not amenable to intensive antibiotic therapy. If patients still take the drug Enap®, it is recommended to periodically monitor the number of leukocytes in the blood. The patient should be warned that in case of any signs of infection, it is necessary to immediately consult a doctor. Hypersensitivity/angioneurotic edema Angioedema of the face, extremities, lips, vocal cords and/or larynx at any time after initiation of treatment has been reported in patients treated with ACE inhibitors, including enalapril. You should immediately stop the drug Enap® and observe the patient until the symptoms disappear completely. Even in the case of swelling of the tongue only, when there is only difficulty in swallowing without respiratory distress syndrome, patients may require long-term observation, because. the use of antihistamines and corticosteroids may not be sufficient. Angioedema of the larynx or tongue can be fatal in very rare cases. Swelling of the tongue, vocal cords, or larynx can lead to airway obstruction, especially after a history of airway surgery. In the presence of swelling of the tongue, vocal cords or larynx, appropriate therapy is indicated, which may include: s / c injection of a 0.1% solution of epinephrine (adrenaline) (0.3-0.5 ml) and / or measures aimed at recovery airway patency (intubation or tracheostomy). Among black patients receiving therapy with an ACE inhibitor, the incidence of angioedema is higher than among patients of other races. Patients with a history of angioedema unrelated to ACE inhibitors have an increased risk of developing angioedema when taking any ACE inhibitor. Anaphylactoid Reactions During Desensitization with Hymenoptera (Hymenoptera) Venom Rarely, life-threatening anaphylactoid reactions have developed in patients treated with ACE inhibitors during desensitization with hymenoptera venom. To prevent such reactions, it is necessary to temporarily stop taking the ACE inhibitor during desensitization procedures. Anaphylactoid reactions during LDL apheresis Patients taking ACE inhibitors during LDL apheresis with dextran sulfate have rarely developed life-threatening anaphylactoid reactions. It is necessary to temporarily replace the drugs of another group. Hemodialysis Due to the increased risk of anaphylactoid reactions, the drug should not be used in patients on hemodialysis using high-flow polyacrylonitrile membranes (AN69®) undergoing LDL apheresis with dextran sulfate. If it is necessary to carry out hemodialysis, it is advisable to use dialysis membranes of a different type or antihypertensive drugs of another group. Hypoglycemia In diabetic patients receiving oral hypoglycemic agents or insulin, blood glucose levels should be closely monitored during the first month of treatment with an ACE inhibitor. Cough When using the drug Enap®, a dry, unproductive, prolonged cough may occur, which disappears after discontinuation of the use of ACE inhibitors, which must be taken into account in the differential diagnosis of cough against the background of the use of an ACE inhibitor. Surgery / general anesthesia Before surgery (including dental procedures), it is necessary to warn the surgeon / anesthetist about the use of the drug Enap®. During major surgery or general anesthesia with the use of drugs that cause arterial hypotension, ACE inhibitors can block the formation of angiotensin II in response to compensatory renin release. If at the same time a pronounced decrease in blood pressure develops, explained by a similar mechanism, it can be corrected by the introduction of plasma substitutes. Hyperkalemia May develop during treatment with ACE inhibitors, incl. and Enap®. Risk factors for the development of hyperkalemia are renal failure, advanced age (over 70 years), diabetes mellitus, some concomitant conditions (decrease in BCC, acute heart failure in the stage of decompensation, metabolic acidosis), simultaneous use of potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride) , as well as potassium preparations or potassium-containing substitutes and the use of other drugs that increase the content of potassium in the blood plasma (for example, heparin). The use of potassium supplements, potassium-sparing diuretics and salt substitutes containing potassium can lead to a significant increase in serum potassium, especially in patients with impaired renal function. Hyperkalemia can lead to serious heart rhythm disturbances, sometimes fatal. The simultaneous use of the above drugs should be carried out with caution under the control of the content of potassium in the blood serum. Lithium Simultaneous use of lithium salts and Enap® is not recommended. Ethnic features The drug Enap®, like other ACE inhibitors, has a less pronounced antihypertensive effect in patients of the Negroid race compared to representatives of other races. Special information on excipients The drug Enap® contains lactose, so the drug is contraindicated in patients with lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome. Influence on the ability to perform potentially hazardous activities that require special attention and speed of reactions (for example, driving vehicles, working with mechanisms). When using Enap®, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions (dizziness may develop due to a sharp decrease in blood pressure, especially after taking the initial dose of Enap® in patients taking diuretics ). Pharmacological action Pharmacotherapeutic group: Angiotensin-converting enzyme (ACE) inhibitors. ATX code: C09AA02. Pharmacodynamics Enalapril maleate is a salt of maleic acid and enalapril, a derivative of two amino acids (L-alanine and L-proline). After absorption, enalapril undergoes hydrolysis to enalaprilat, which inhibits ACE, which leads to a decrease in the plasma concentration of the angiotensin II pressor compound and, as a result, to an increase in plasma renin activity and a decrease in aldosterone secretion. The drug can also block the breakdown of bradykinin, a powerful vasodepressor (vasodilator) peptide. Although the mechanism by which enalapril exerts its hypotensive effect is primarily through the suppression of the renin-angiotensin-aldosterone system, which plays the most important role in the regulation of blood pressure, the drug also exerts an antihypertensive effect in patients with low renin levels. The use of enalapril in patients with hypertension leads to a decrease in blood pressure in both the supine and standing positions without an increase in heart rate. Symptomatic postural hypotension is rare. In some patients, reaching the level of blood pressure reduction may require several weeks of therapy. Abrupt withdrawal of enalapril is not accompanied by a rapid increase in blood pressure. Effective suppression of ACE activity usually develops within 2-4 hours after ingestion of an individual dose of enalapril. The onset of antihypertensive activity is usually observed within an hour, the maximum reduction in blood pressure is achieved within 4-6 hours after administration. The duration of action depends on the dose. However, in the recommended amounts, the antihypertensive and hemodynamic effects persist for at least 24 hours. In hemodynamic studies in patients with essential hypertension, a decrease in blood pressure was accompanied by a decrease in peripheral resistance in the arteries with an increase in cardiac output and little or no change in heart rate. After the introduction of enalapril, there was an increase in renal blood flow; glomerular filtration rate did not change; no signs of sodium or water retention were observed. However, in patients with reduced glomerular filtration, an increase in this indicator was noted. In short-term clinical studies of patients with kidney disease with or without diabetes mellitus, a decrease in albuminuria and a decrease in urinary excretion of IgG and total protein were observed after taking enalapril. When combined with thiazide-type diuretics, the hypotensive effect is additive. At the same time, enalapril can reduce or prevent the development of hypokalemia caused by taking thiazides. In patients with heart failure during therapy with digitalis and diuretics, enalapril reduces peripheral resistance and blood pressure. Cardiac output increases while heart rate (usually elevated in patients with heart failure) decreases; the wedge pressure in the pulmonary capillaries (DZLK) decreases. Therapy with enalapril normalizes the condition in heart failure and improves exercise tolerance. These effects persist throughout therapy. In patients with mild or moderate heart failure, the drug slows down the progression of heart dilatation and heart failure (decrease in the end diastolic and systolic volume of the left ventricle and improve the ejection fraction (ejection)). In patients with left ventricular dysfunction, enalapril reduces the risk of major cardiovascular events, myocardial infarction and the number of hospitalizations for unstable angina. Pharmacokinetics Absorption Enalapril is rapidly absorbed from the gastrointestinal tract; the maximum concentration in blood serum is reached within one hour. The degree of absorption is about 60%, while eating does not affect absorption. After absorption, enalapril is rapidly and completely hydrolyzed to enalaprilat, an active ACE inhibitor. The peak concentration of enalaprilat in the blood serum is observed 4 hours after taking enalapril inside. The effective half-life for accumulation of enalaprilat after repeated oral administration of enalapril is 11 hours. In patients with normal renal function, a stable serum concentration of enalaprilat is achieved four days after the start of treatment. Distribution In the range of therapeutically significant concentrations, the binding of enalaprilat to serum proteins is 60%. Metabolism With the exception of conversion to enalaprilat, there are no signs of significant metabolism of enalapril. Excretion Enalaprilat is excreted mainly by the kidneys. The main components in the urine are enalaprilat, which accounts for 40% of the dose, and unchanged enalapril (about 20%). Impaired renal function Exposure to enalapril and enalaprilat is increased in patients with renal insufficiency. In patients with mild or moderate renal insufficiency (creatinine clearance 0.6-1 ml / s), after taking the drug 5 mg once a day, the AUC value of enalaprilat is approximately two times higher than in patients with normal renal function; whereas in severe renal insufficiency (creatinine clearance 0.5 ml / s), the AUC value increases by approximately eight times. At this level of renal failure, the effective half-life of enalaprilat is prolonged and the time to steady state is increased. Enalaprilat can be removed from the circulatory system by hemodialysis. Enalaprilat dialysis clearance is 1.03 ml/sec. Children and adolescents Significant differences in pharmacokinetics in children compared with adults have not been established. The data show an increase in AUC (standardized for dose per body weight) with increasing age; however, no increase in AUC was observed when data were standardized for body surface area. At steady state, the mean effective half-life of accumulated enalaprilat was 14 hours. Indications for use Treatment of hypertension. Treatment of symptomatic heart failure. Prevention of symptomatic heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction < 35%). Dosage and administration The dose is selected individually depending on the patient's condition. Hypertension The initial dose is 5 mg - 20 mg depending on the degree of hypertension and the patient's condition. The drug is taken once a day. For moderate hypertension, the recommended starting dose is 5 mg to 10 mg per day. In patients with marked activity of the renin - angiotensin - aldosterone system (for example, renovascular hypertension, loss of water and / or salts, cardiac decompensation or severe hypertension), an excessive drop in blood pressure may occur at the beginning of treatment. In such patients, it is recommended to start treatment under medical supervision with a dose of 5 mg or less. Prior treatment with high doses of diuretics may lead to hypovolemia and the risk of hypotension at the start of treatment. In such patients, the recommended starting dose is 2.5 mg. If possible, 2-3 days before the start of treatment with enalapril, diuretic therapy should be canceled. During treatment, it is necessary to monitor kidney function and potassium levels. The usual maintenance dose is 10-20 mg per day. The maximum maintenance dose is 40 mg per day. Heart failure/asymptomatic left ventricular dysfunction The initial dose of enalapril maleate in patients with symptomatic heart failure or asymptomatic left ventricular dysfunction is 2.5 mg once daily. The initial effect on blood pressure should be carefully monitored. For the treatment of symptomatic heart failure, enalapril maleate is usually used in combination with diuretics and beta-blockers and, if necessary, also with digitalis glycosides. If, after initiation of treatment for heart failure, symptomatic hypotension is absent or effectively eliminated, then the dose should be gradually increased to the usual maintenance dose of 20 mg, taken once or divided into two doses (depending on patient tolerance). Such dose titration is recommended to be carried out within 2-4 weeks. The maximum dose is 40 mg per day, and should be divided into two doses. Recommended dose titration of enalapril maleate in patients with heart failure or asymptomatic left ventricular dysfunction Weeks Dose, mg per day Week 1 Days 1-3: 2.5 mg per day* once Days 4-7: 5 mg per day divided into two doses Week 2 10 mg once or divided into two doses Weeks 3 and 4 20 mg once or divided into two doses function, as hypotension and (less commonly) subsequent renal failure have been reported. In patients taking diuretics, the dose should be reduced if possible before starting treatment with enalapril. The appearance of hypotension at the beginning of treatment does not mean that such a reaction will also occur during long-term therapy with enalapril, and does not preclude further use of the drug. During treatment, it is necessary to monitor kidney function and serum potassium levels. Dosage in renal insufficiency In patients with renal insufficiency, the intervals between taking enalapril should be extended and / or the dosage reduced. Creatinine clearance Initial dose, mg per day Creatinine clearance 30-80 ml/min. 5 mg - 10 mg Creatinine clearance 10-30 ml / min. 2.5 mg Creatinine clearance 10 ml/min. or less than 2.5 mg per day of dialysis* * On non-dialysis days, the dose should be adjusted according to blood pressure readings. Use in Elderly Patients The dose should be adjusted according to the patient's renal function. Use in children Clinical experience with the use of enalapril maleate in children with hypertension is limited. For patients who can swallow tablets, the dose should be adjusted individually depending on the patient's condition and response from blood pressure. For patients weighing 20 to 50 kg, the recommended starting dose is 2.5 mg enalapril maleate per day; for patients weighing 50 kg or more - 5 mg of enalapril maleate once a day. The dosage should be selected depending on the needs of the patient. The maximum recommended dose of enalapril maleate for patients weighing 20-50 kg is 20 mg per day; for patients weighing 50 kg or more - 40 mg of enalapril maleate per day. Enalapril maleate is not recommended in neonates and children with a glomerular filtration rate < 0.5 ml/sec/1.73 m2, as no data are available on this. Treatment with Enap is long-term, usually throughout life, unless circumstances arise that require its cancellation. Use during pregnancy and lactation. Pregnancy The use of ACE inhibitors is not recommended during the first trimester of pregnancy. The use of ACE inhibitors is contraindicated during the second and third trimesters of pregnancy. Epidemiological data regarding the risk of teratogenesis due to the use of ACE inhibitors during the first trimester of pregnancy are not conclusive, however, a slight increase in risk cannot be ruled out. Unless continued treatment with ACE inhibitors is deemed necessary, patients planning pregnancy should switch to an alternative antihypertensive treatment that has an established safety profile for use during pregnancy. If pregnancy is established, then ACE inhibitors should be stopped immediately and, if necessary, treatment with alternative means should be started. It is known that the use of ACE inhibitors in women during the second and third trimesters of pregnancy has a fetotoxic effect (decrease in renal function, oligohydramnios, delayed ossification of the skull) and neonatal toxic effect (renal failure, hypotension, hyperkalemia). If the use of ACE inhibitors occurred in the second trimester of pregnancy, it is recommended to conduct ultrasound monitoring of the function of the kidneys and skull. Newborns whose mothers have taken ACE inhibitors should be carefully monitored for hypotension. Lactation period Data on pharmacokinetics indicate a very low concentration in breast milk. Despite the fact that these concentrations are considered clinically insignificant, the use of Enap is not recommended for breastfeeding premature babies and in the first weeks after birth due to the hypothetical risk of effects on the cardiovascular system and kidneys due to the lack of sufficient clinical experience with the use. In a later period, the use of Enap by nursing mothers may be considered in cases where treatment is necessary for the mother, and the child is observed for any side effects. Precautions Symptomatic hypotension Symptomatic hypotension is rare in uncomplicated arterial hypertension. It is most likely to occur in hypertensive patients with hypovolemia, for example, due to diuretic treatment, a salt-depleted diet, dialysis, diarrhea, or vomiting. Symptomatic hypotension may also occur in patients with heart failure with or without concomitant renal failure. More likely to occur in patients with more severe heart failure due to high doses of loop diuretics, hyponatremia, or kidney damage. In such patients, treatment should be started under medical supervision, with strict adherence to selected doses of enalapril and / or diuretic. A similar principle can be applied to patients with ischemic heart disease or cerebrovascular disease, in whom a sudden drop in blood pressure can lead to myocardial infarction or stroke. If hypotension develops, the patient should be placed in the supine position and, if necessary, intravenous infusion of 0.9% sodium chloride solution should be given to replenish plasma volume. Transient hypotension is not a contraindication for enalapril treatment. After adjusting blood pressure and plasma volume, patients subsequently generally tolerate treatment well. In some patients with heart failure with normal or low blood pressure, enalapril may cause an additional decrease in blood pressure. This effect is predictable and is usually not a reason to stop treatment. If hypotension becomes symptomatic, dose reduction and/or discontinuation of the diuretic and/or enalapril is required. Double blockade of the renin-angiotensin-aldosterone system (RAAS) The simultaneous use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of hypotension, hyperkalemia, impaired renal function (including acute renal failure). Due to the dual blockade of the RAAS, the combined use of ACE inhibitors, angiotensin II receptor blockers, or aliskiren is not recommended. The appointment of therapy for dual blockade of the RAAS, due to its absolute necessity, should occur only under the supervision of a specialist and subject to frequent close monitoring of renal function, electrolytes and blood pressure. Co-administration of ACE inhibitors and angiotensin II blockers is not recommended in patients with diabetic nephropathy. Aortic or mitral valve stenosis/hypertrophic cardiomyopathy As with all vasodilators, ACE inhibitors should be used with extreme caution in patients with left ventricular outflow tract obstruction. In cases of cardiogenic shock and severe hemodynamic obstruction of the outflow tract of the left ventricle, the use of these drugs should be avoided. Impaired renal function In patients with impaired renal function (creatinine clearance < 1.33 ml / s), the initial dose should be adjusted according to creatinine clearance. Maintenance doses are prescribed according to the patient's response to treatment. At the same time, the levels of creatinine and potassium in the blood serum should be monitored regularly. In patients with severe heart failure or underlying kidney disease, including renal artery stenosis, renal failure may occur during treatment with enalapril. With timely diagnosis and appropriate treatment, this disease is usually reversible. Some patients with overt pre-existing kidney disease have developed minimal and transient increases in serum urea and creatinine levels when enalapril was given concomitantly with a diuretic. In such cases, it may be necessary to reduce the dosage of ACE inhibitors and / or cancel diuretics. This situation should increase the likelihood of predisposing renal artery stenosis. Renovascular hypertension There is an increased risk of hypotension and renal failure in patients with bilateral renal artery stenosis or stenosis of the artery to one functioning kidney and treated with ACE inhibitors. In this case, a decrease in kidney function can be manifested only by minor changes in the level of creatinine in the blood serum. In such patients, treatment should begin at low doses and under medical supervision; during treatment, careful titration and monitoring of renal function is necessary. Kidney transplantation Due to lack of experience with enalapril, treatment with enalapril is not recommended in patients with a recent kidney transplant. Liver failure During treatment with ACE inhibitors, in rare cases, a syndrome may occur that begins with cholestatic jaundice and progresses to fulminant hepatic necrosis and (sometimes) death. The mechanism of this syndrome is unknown. If jaundice or a marked increase in liver enzymes develop during treatment with ACE inhibitors, treatment should be discontinued immediately and the patient should be closely monitored and treated if necessary. Neutropenia/agranulocytosis Neutropenia/agranulocytosis, thrombocytopenia and anemia have been reported in patients receiving ACE inhibitors. Neutropenia rarely occurs in patients with normal renal function and no other complications. Enalapril should be used with extreme caution in patients with vascular collagenosis (eg, systemic lupus erythematosus, scleroderma), as well as in patients treated with immunosuppressive drugs, allopurinol or procainamide, or in patients with a combination of these factors, especially with pre-existing impaired renal function. Some of these patients may develop serious infections, in some cases not responding to intensive antibiotic therapy. If enalapril is used in such patients, then periodic monitoring of the number of leukocytes is recommended. Patients should be instructed to report any signs of infection. Hypersensitivity / angioedema During treatment with ACE inhibitors, including enalapril, angioedema of the face, extremities, lips, tongue, pharynx and / or larynx may develop in rare cases at any stage of treatment. In such cases, enalapril should be discontinued immediately. Appropriate monitoring should be carried out to ensure that all symptoms have disappeared before the patient is discharged from the hospital. Angioedema of the face and lips usually does not require treatment; antihistamines may be used to relieve symptoms. Angioedema of the larynx can be fatal. In case of angioedema of the tongue, pharynx or larynx, which can cause airway obstruction, it is necessary to immediately prescribe epinephrine (0.3-0.5 ml subcutaneous adrenaline solution in a ratio of 1:1000) and ensure free airway patency. Patients with a history of angioedema unrelated to treatment with ACE inhibitors have an increased risk of developing angioedema while receiving ACE inhibitors. Anaphylactoid reaction during desensitization Rarely, life-threatening anaphylactoid (allergic-type) reactions may occur in patients taking ACE inhibitors during desensitization against wasp or bee venom. These reactions can be avoided by temporarily stopping treatment with ACE inhibitors before each desensitization. Anaphylactoid reactions during LDL apheresis In patients receiving ACE inhibitors, during low-density lipoprotein (LDL) apheresis with dextran sulfate, life-threatening anaphylactoid (allergic-type) reactions can occur in rare cases. These reactions can be avoided by temporarily stopping treatment with ACE inhibitors before each apheresis. Patients on hemodialysis There have been reports of hypersensitivity reactions and allergic-type reactions (anaphylactoid reactions) in patients undergoing dialysis using high flux density membranes (eg AN 69) and concomitantly treated with ACE inhibitors. If hemodialysis is necessary, the patient should be transferred to another class of drugs, or another type of membrane should be used for dialysis. Patients with diabetes In patients with diabetes treated with oral antidiabetic drugs or insulin, blood glucose levels should be carefully monitored during the first few months of concomitant treatment with ACE inhibitors. Cough During treatment with ACE inhibitors, a persistent, dry, non-productive cough may occur, which stops after treatment is discontinued. This should be included in the differential diagnosis. Surgery / Anesthesia In patients undergoing major surgery or during anesthesia with drugs that cause hypotension, enalapril may block the formation of angiotensin II secondary to compensatory renin release. Hypotension associated with this mechanism can be corrected by increasing blood volume. Hyperkalemia During treatment with ACE inhibitors, including enalapril, the level of potassium in the blood may increase in some patients. The risk of developing hyperkalemia is higher in patients with renal insufficiency, diabetes mellitus, who are simultaneously taking potassium-sparing diuretics, potassium supplements, or other drugs that can cause hyperkalemia (eg, heparin). In cases where the simultaneous use of the above-mentioned agents is considered appropriate, it is recommended to regularly monitor the level of potassium in the blood serum. Lithium The combination of lithium and enalapril is not usually recommended. Use in children There is limited, effective and safe experience in children over 6 years of age with hypertension. There is no experience with other indications. Limited pharmacokinetic data are available for children over 2 months of age. Enalapril is recommended for use in children only for the treatment of hypertension. Enalapril is not recommended in neonates and children with a glomerular filtration rate of less than 30 ml/min/1.73 m2, as no data are available on this. Ethnicity Like other ACE inhibitors, enalapril is less effective in lowering blood p