Enam pills 10mg №10×2

Product DescriptionEnam. Tablet release forms. MNNEnalapril. FTGApf blocker. Pharmacotherapeutic group Means that affect the renin-angiotensive system. ACE inhibitors. ATX code: C09AA02. Composition Enam 2.5 mg. 1 tablet contains: active ingredient – enalapril maleate 2.5 mg; excipients – anhydrous lactose, maleic acid, zinc stearate. Enam 5 mg 1 tablet contains: active ingredient – enalapril maleate 5 mg; excipients – anhydrous lactose, maleic acid, zinc stearate. Enam 10 mg 1 tablet contains: active ingredient – enalapril maleate 10 mg; excipients – anhydrous lactose, zinc stearate. DescriptionWhite or almost white round tablets with beveled edges, without a shell, on one side the inscription ‘EMT’, on the other side of the risk (the risk is not intended for dividing the tablet) and the inscription “2.5”, “5” or “10” (according to the dosage of the tablet) . Pharmacological properties Pharmacodynamics Enalapril is an antihypertensive drug, the mechanism of action of which is associated with inhibition of the activity of angiotensin-converting enzyme, leading to a decrease in the formation of angiotensin – II. Enalapril refers to “prodrugs”: after its hydrolysis in the body, the active metabolite enalaprilat is formed, which is an ACE inhibitor. The hypotensive effect of Enam is mainly due to the following mechanisms: Inhibition of the conversion of angiotensin-I to angiotensin-II Decreased secretion of aldosterone, vasopressin Decreased inactivation of bradykinin vasodilators and atrial natriuretic factor Inhibition of the activity of the sympathoadrenal system Suppression of arterial smooth muscle hypertrophy, hyperplasia and proliferation of smooth muscle cells, which helps to reduce peripheral resistance In addition to the hypotensive effect, Enam also has the following positive effects: Decreased left ventricular myocardial hypertrophy Decreased excretion of potassium in the urine Increased permeability of cell membranes for glucose, which favorably affects carbohydrate metabolism Increased high-density lipoproteins in the blood frequency of extrasystole, as a result of an increase in the level of potassium in the blood Cardioprotective effect, as a result of a decrease reduction of pre and afterload on the myocardium, reduction of myocardial hypertrophy, increase in coronary blood flow. Improvement of blood circulation in the pulmonary circulation, which contributes to the normalization of breathing. Pharmacokinetics After oral administration, about 60% of enalapril is absorbed, and the peak plasma concentration is reached by the end of the first hour, after which it rapidly decreases. Absorption does not depend on food intake. The drug is metabolized mostly in the liver, forming the active metabolite enalaprilat, the maximum plasma concentration of which is reached 3-4 hours after ingestion. The plasma concentration of enalapril is linearly dependent on the dose taken. A stable level of the drug in the blood is established after 3-4 doses. About 50% of enaprilat binds to plasma proteins. The drug is excreted by the kidneys. The half-life is about 11 hours. The period of elimination of active metabolites is about 30-35 hours. Indications for use Treatment of arterial hypertension as monotherapy and in combination with drugs from other groups. Treatment of symptomatic (with symptoms) heart failure. Prevention of symptomatic heart failure in asymptomatic left ventricular dysfunction (left ventricular ejection fraction < 35%). Method of application and dosage Enam is administered orally, regardless of the time of the meal. Arterial hypertension For patients not receiving diuretics, an initial dose of 5 mg once a day is recommended. Further, the dose is gradually increased depending on the response to the ongoing therapy. A dose of 10 to 40 mg (maximum daily dose) per day in one or two divided doses is usually required. Renovascular hypertension Therapy begins with a dose of 2.5-5 mg, then the dose is gradually increased depending on the patient's response to therapy. Heart failure / asymptomatic left ventricular dysfunction The initial dose of Enam in patients with heart failure (HF) is 2.5 mg, while the drug should be administered under close medical supervision. If well tolerated, the dose should be gradually increased to the usual maintenance daily dose of 10-20 mg in 2 doses under the control of blood pressure and renal function. Complex therapy of myocardial infarction: from 7-14 days after a heart attack at a dose of 5-10 mg per day, depending on the numbers of blood pressure. Nephropathy, diabetes mellitus: with normal pressure, the initial dose is 2.5-5 mg / day, with high blood pressure, dose selection is carried out in the same way as with arterial hypertension. Dosage in renal failure State of renal function Creatinine clearance ml/min Starting dose mg/day Minor impairment of function < 80 >30 ml/min 5-10 mg Moderate impairment of function < 30 > 10 ml/min 2.5-5 mg Severe impairment. Usually such patients are on hemodialysis > 10 ml / min 2.5 mg on dialysis days Use in elderly patients The dose should correspond to the renal function of the elderly patient. Use in children Safety and efficacy in children have not been established. Contraindications Hypersensitivity to enalapril or any other substance that is part of Enam. History of angioedema associated with previous treatment with angiotensin-converting enzyme inhibitors. Hereditary or idiopathic angioedema angioedema. Second and third trimesters of pregnancy (see section “Warnings and special instructions”). – Simultaneous use of angiotensin-converting enzyme inhibitors or ATI receptor blockers with Aliskiren in patients with diabetes mellitus or moderate / severe renal insufficiency (GFR < 60 ml / min / 1.73 m2) (see section “Interaction with other drugs”. “Pharmacological properties ”). Side effect From the side of the central nervous system: headache, dizziness, increased fatigue. On the part of the respiratory system, chest, mediastinum: dry cough, shortness of breath, rhinorrhea, sore throat and hoarseness, bronchospasm/asthma, lung infiltrates, rhinitis, allergic alveolitis/eosinophilic pneumonia may occur. On the part of the digestive system: nausea, diarrhea, constipation, abdominal pain, rarely observed: a violation of taste sensations (metallic taste in the mouth, loss of taste), pancreatitis, hepatitis, liver failure are possible. Sometimes ACE inhibitors are associated with a syndrome of liver damage, which begins with cholestatic jaundice and progresses to acute hepatonecrosis, sometimes leading to death. From the side of the cardiovascular system: arterial hypotension, fainting, rhythm disturbances, angina pectoris are possible. Allergic reactions: skin rashes, itching. Perhaps the development of angioedema of various localization: face, limbs, lips, tongue, larynx and pharynx. A reaction can occur at any time during the course of treatment. From the side of the kidneys and urinary tract: impaired renal function, renal failure, proteinuria, oliguria. Impact on laboratory tests: proteinuria, hyperkalemia, increased bilirubin and liver transaminase activity, leukopenia, neutropenia, anemia, thrombocytopenia. Rare cases of agranulocytosis and suppression of myelopoiesis have been reported in patients with an uncomplicated history taking captopril and other ACE inhibitors, including enalapril. More often, the above conditions occur in patients with renal insufficiency, systemic collagenoses and vasculitis. Very rarely, when used in high doses - insomnia, increased nervous excitability, depression, imbalance, paresthesia, tinnitus, hair loss, decreased potency. Warnings and special instructionsPeculiarities of application Evaluation of renal function Before and during the use of Enam, monitoring of renal function is necessary. Symptomatic hypotension Symptomatic hypotension is rarely observed in patients with uncomplicated arterial hypertension. Among those taking Enam, symptomatic hypotension occurs more often in patients with impaired fluid balance, for example, due to diuretic therapy, a diet with limited salt intake, diarrhea or vomiting. In such patients, it is necessary to determine the levels of electrolytes in the blood serum regularly, at regular intervals. Particular care should be taken in the treatment of patients with ischemic heart disease or cerebrovascular disease, since an excessive decrease in blood pressure can lead to myocardial infarction or stroke. Symptomatic hypotension has been observed in patients with arterial hypertension and heart failure with and without impaired renal function. This condition is more likely to occur in patients with more severe heart failure due to high-dose loop diuretics, hyponatremia, or worsening renal function. In such patients, treatment should be started under the supervision of a physician, and the patient's condition should be closely monitored when changing the dose of Enam and / or diuretic (see section "Method of application and dosage"). Similar actions should be taken in patients with ischemic heart disease or cerebrovascular disease, since an excessive decrease in blood pressure can lead to myocardial infarction or stroke. With the development of arterial hypotension, the patient should be placed on his back and, if necessary, administered intravenously with saline sodium chloride solution. Temporary hypotension is not a contraindication to further use of the drug. If an increase in blood pressure occurs after normalization of the circulating blood volume, therapy can be resumed at the usual doses. In some patients with heart failure and normal or low blood pressure, an additional decrease in blood pressure may occur when using Enam. This effect is predictable and is not a reason to discontinue the drug. If hypotension becomes symptomatic, dose reduction and/or discontinuation of the diuretic and/or Enam may be required. Impaired renal function: The development of renal failure associated with the use of enalapril has been reported, which was observed mainly in patients with severe heart failure or underlying kidney disease, including renal artery stenosis. With timely diagnosis and appropriate treatment, renal failure associated with the use of enalapril is usually reversible. Enam should not be administered to patients with impaired renal function (creatinine clearance < 80 ml/minute) until enalapril dose titration reaches the dosage in this drug. In some patients with arterial hypertension without signs of existing kidney disease, while using enalapril and a diuretic, an increase in the level of blood urea and creatinine was observed. If such a phenomenon occurs, Enam should be discontinued, and possible renal artery stenosis should be considered. Renovascular hypertension There is an increased risk of hypotension and impaired renal function if a patient with bilateral renal artery stenosis or arterial stenosis of a solitary kidney is treated with an ACE inhibitor. Weakening of kidney function can occur even with mild changes in serum creatinine levels. In such patients, treatment should be started at low doses and under medical supervision, with caution increasing the dose and monitoring renal function. Kidney transplantation There is no experience with the use of enalapril in patients with recent kidney transplantation. For this reason, treatment with enalapril is not recommended. Aortic Stenosis/Hypertrophic Cardiomyopathy As with all other vasodilators, ACE inhibitors should be used with caution in patients with left ventricular valve and outflow tract obstruction. The use of such drugs should be avoided in case of cardiogenic shock and hemodynamically significant obstruction. Liver failure Rarely, the use of ACE inhibitors has been accompanied by a syndrome that begins with cholestatic jaundice or hepatitis and progresses to fulminant necrotizing hepatitis, sometimes fatal. The mechanism of this syndrome is not known. Patients receiving treatment with ACE inhibitors who experience jaundice or marked elevation of liver enzymes should discontinue the ACE inhibitor and establish appropriate medical supervision. Neutropenia/agranulocytosis Neutropenia/agranulocytosis, thrombocytopenia and anemia have been reported in patients receiving ACE inhibitors. Neutropenia occurs rarely in patients with normal renal function and no other complicating factors. Enalapril should be used with extreme caution in patients with collagen vascular disease, in individuals receiving treatment with immunosuppressants, allopurinol or procainamide, or a combination of these complicating factors, especially in the presence of impaired renal function. Some patients have developed serious infections that have not responded to intensive antibiotic therapy. If enalapril is prescribed to such patients, it is recommended to periodically determine the level of leukocytes, and patients should be aware of the need to inform the doctor about the occurrence of any signs of infection. Hypersensitivity/angioneurotic edema Angioedema of the face, extremities, lips, tongue, glottis and/or larynx has been reported in patients taking ACE inhibitors, including enalapril. These reactions can occur at any time during treatment. In such cases, you should immediately stop using Enam and establish appropriate monitoring of the patient's condition to ensure the complete disappearance of symptoms before the patient is discharged. Even in cases where there is only swelling of the tongue without respiratory distress, long-term monitoring of the patient's condition is necessary, since treatment with antihistamines and corticosteroids may not be enough. Very rarely, fatal cases have been reported due to angioedema, which was accompanied by swelling of the larynx and tongue. Patients with swelling of the tongue, glottis, or larynx are more likely to develop airway obstruction, especially in patients with a history of airway surgery. In cases where swelling of the tongue, glottis, or larynx may lead to airway obstruction, appropriate therapy should be initiated immediately, which may include the administration of a 1:1000 solution of epinephrine (0.3-0.5 ml) and/or measures to maintain patency respiratory tract. The development of angioedema was more often reported in patients of the Black race who received ACE inhibitors than in patients of other races. However, it is generally believed that blacks have an increased risk of angioedema. Patients with a history of angioedema that is not associated with the use of ACE inhibitors may have a higher risk of angioedema during the use of an ACE inhibitor (see section “Contraindications”) Anaphylactoid reactions during desensitization with hymenoptera venom In patients who used inhibitors ACE during hymenoptera desensitization, life-threatening anaphylactoid reactions have rarely occurred. The occurrence of such reactions can be avoided by temporarily stopping the use of the ACE inhibitor before starting desensitization. Anaphylactoid Reactions During Low-Density Lipoprotein (LDL) Apheresis Patients treated with ACE inhibitors during LDL apheresis with dextran sulfate have rarely experienced life-threatening anaphylactic reactions. The occurrence of such reactions can be avoided by temporarily stopping the use of the ACE inhibitor before each session of apheresis. Hypoglycemia Patients with diabetes mellitus treated with oral antidiabetic drugs or insulin should be carefully monitored for hypoglycemia when prescribing an ACE inhibitor, especially during the first month of combination therapy (see section “Interaction with other medicinal products”) Cough Cough has been reported with use of ACE inhibitors. As a rule, the cough is unproductive, persistent and disappears after cessation of therapy. Cough that occurs as a result of the use of ACE inhibitors should be considered in the differential diagnosis of cough. Surgery / Anesthesia Enalapril blocks the formation of angiotensin II and therefore reduces the compensatory abilities of patients associated with the renin-angiotensin system during major surgery or anesthesia using drugs that lead to arterial hypotension. If arterial hypertension occurs, which is explained by a similar mechanism, it can be corrected by increasing the volume of circulating blood. Hyperkalemia Elevated serum potassium levels have been observed in some patients treated with ACE inhibitors, including enalapril. Risk factors for hyperkalemia include impaired renal function, impaired renal function, age (> 70 years), diabetes mellitus, intercurrent conditions such as dehydration, acute cardiac decompensation, metabolic acidosis, and concomitant use of potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene or amiloride), potassium supplements or salt substitutes containing potassium, as well as the use of other drugs associated with an increase in serum potassium levels (for example, heparin). The use of potassium supplements, potassium-sparing diuretics or salt substitutes containing potassium, in particular in patients with impaired renal function, can lead to a significant increase in serum potassium levels. Hyperkalemia can cause serious, sometimes fatal, arrhythmias. If the simultaneous use of enalapril and any of the above drugs is necessary, these drugs should be used with caution and frequently monitor the level of potassium in the blood serum (see section “Interaction with other drugs”). Lithium As a rule, it is not recommended to use lithium in combination with enalapril and diuretics (see the section “Interaction with other drugs”). Use in children The safety and efficacy of the drug in children have not been established (see section “Method of application and dosage”). Ethnic differences As with other ACE inhibitors, enalapril is less effective in lowering blood pressure in patients of the black race, compared with patients of other races. This may be due to the higher prevalence of the low-active renin system among black patients with hypertension. Lactose Enalapril contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not use this medicine. Double blockade of the renin-angiotensin-aldosterone system Double 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 RAAS blockade with an ACE inhibitor, ARB II, or Aliskiren cannot be recommended for any patient, especially those with diabetic nephropathy. In some cases, when the combined use of an ACE inhibitor 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 use of candesartan or valsartan as add-on therapy to ACE inhibitors in patients with chronic heart failure. 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 chronic heart failure with intolerance to aldosterone antagonists (spironolactone), who have persistent symptoms of chronic heart failure, despite other adequate therapy (see section “Interaction with other drugs”, “Pharmacological properties”). Use in pregnant and lactating women If pregnancy is detected, stop taking Enam immediately. Enalapril maleate is not recommended for use in the first trimester of pregnancy; in the 2nd and 3rd trimesters of pregnancy, the drug is contraindicated. If long-term therapy with enalapril is necessary, patients planning pregnancy should switch to alternative treatment with antihypertensive drugs that have a proven safety profile during pregnancy. If pregnancy is diagnosed, then enalapril maleate should be stopped immediately and, if necessary, treatment with alternative means should be started. Epidemiological data regarding the risk of teratogenesis due to the use of enalapril maleate in the first trimester of pregnancy are not conclusive, but a slight increase in risk is not excluded. Long-term use of enalapril maleate in the 2nd and 3rd trimester causes toxic effects on the fetus (deterioration of renal function, oligohydramnia (oligohydramnios), slowing of the ossification of the skull bones) and in newborns (renal failure, hypotension, hyperkalemia). If enalapril maleate was taken in the 2nd or 3rd trimester, an ultrasound examination is recommended to check renal function and the skull. Children whose mothers have taken enalapril maleate should be closely monitored for hypotension, oliguria, and hyperkalemia. Enalapril maleate crosses the placenta. However, it can be successfully removed from the neonatal circulation in clinically significant amounts by peritoneal dialysis. Theoretically, it can also be removed by exchange transfusion (see section “Contraindications”) Lactation Enalapril maleate passes into mother’s milk, therefore, enalapril maleate is not recommended for the treatment of nursing mothers. Influence on the ability to drive vehicles and work with mechanisms As a result of treatment with enalapril, individual reactions may develop that may impair the patient’s ability to actively participate in road traffic, which should also be borne in mind when servicing machines and when working with devices that require increased attention . These phenomena increase with increasing doses and with alcohol intake. Interactions with other drugs Simultaneous use with antihypertensive drugs of other groups (β-blockers, calcium channel blockers, diuretics, methyldopa, α-blockers, etc.), as well as nitrates, enhances the hypotensive effect of the drug. When taken simultaneously with diuretics, severe hypotension may develop at the beginning of therapy. Co-administration with NSAIDs, including selective inhibitors of cyclooxygenase-2 (COX-2), may weaken the effect of diuretics and other antihypertensive drugs. For this reason, the antihypertensive effect of angiotensin II receptor antagonists, ACE inhibitors or diuretics may be weakened by the use of NSAIDs, including selective COX-2 inhibitors. The simultaneous use of NSAIDs (including COX-2 inhibitors) and angiotensin II receptor antagonists or ACE inhibitors has an additional effect on increasing the level of potassium in the blood serum and may lead to impaired renal function. These effects are usually reversible. Rarely, renal failure may develop, particularly in patients with impaired renal function (eg, elderly or dehydrated patients, including those treated with diuretics). Therefore, this combination of drugs should be used with caution in patients with impaired renal function. If potassium-sparing diuretics and potassium preparations are indicated (with hypokalemia), care should be taken to constantly monitor the concentration of potassium in the plasma, since enalapril reduces the excretion of potassium from the body. It is advisable to avoid the appointment of potassium-containing drugs and potassium-sparing diuretics in patients with renal insufficiency receiving enalapril due to the possibility of increasing the content of potassium in the blood. When taken with lithium salts – slowing down the excretion of lithium (control of the concentration of lithium in the blood plasma is shown). Cases of lithium intoxication have been described while taking lithium with drugs (including enalapril) that enhance sodium excretion. When combined with allopurinol, procainamide, glucocorticosteroids, cytostatics, the risk of violations of the blood formula (leukopenia, neutropenia) increases. Due to the influence of Enam on the absorption of glucose in tissues, when Enam is used together with oral hypoglycemic drugs or insulin preparations, dose adjustment of hypoglycemic drugs may be required. Cimetidine prolongs the action of Enam. The use of Enam together with anesthetic agents may enhance the hypotensive effect. Eating does not affect the absorption of enalapril. During the period of treatment with Enam, it is forbidden to drink alcohol, because. alcohol enhances the hypotensive effect of the drug. Dual blockade of the renin-angiotensin-aldosterone system Based on available data, dual blockade of the RAAS with an ACE inhibitor, ARB II, or Aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy. In patients with diabetes mellitus or moderate/severe renal insufficiency (GFR < 60 ml/min/1.73 m2), the concomitant use of Aliskiren with an ACE inhibitor or ARB II is contraindicated. In some cases, when the combined use of an ACE inhibitor and ARB II is absolutely indicated, careful observation of a specialist and mandatory monitoring of kidney function, water and electrolyte balance, blood pressure are necessary (see the section “Interaction with other drugs”, “Pharmacological properties”, “Contraindications ”). Overdose The most common symptom of an overdose is hypotension, may also be observed: circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, bradycardia, dizziness, anxiety, cough. In most cases, overdose symptoms develop 6 hours after taking the drug, simultaneously with blockade of the renin-angiotensin system and stupor. Treatment: the patient should be laid with the legs elevated. In mild cases, water-salt solutions are administered orally. In severe cases, in a hospital, measures are taken to stabilize blood pressure: infusion of water-salt solutions, plasma substitutes. Perhaps the use of hemodialysis. Storage conditionsStore in a dry, dark place at temperatures up to 25°C. Keep out of the reach of children. Shelf life 3 years. Release form 10 tablets in an aluminum foil strip or aluminum-aluminum blister, 2 strips or blisters are packed in a cardboard box with instructions for use. Conditions of release Released by prescription. Buy Enam tablets 10mg No. 10x2 Price for Enam tablets 10mg No. 10x2