Enalapril - instructions for use, dose, side effects, contraindications

1 tablet, contains: active substance: enalapril maleate 5 mg / 10 mg / 20 mg; Excipients: cellulose microcrystalline 73.00 mg / 68 mg / 70 mg, corn pregelatinized starch 30.00 mg / 30 mg / 43 mg, talc 3.00 mg /3.0 mg / 4.10 mg, silicon dioxide colloid 1.00 mg / 1.00 mg / 1.40 mg, magnesium stearate 1.0 mg / 1.00 mg / 1.40 mg, iron oxide red - / 2.00 mg / 0.10 mg.

Description:

Tablets 5 mg: Tablets are round, biconvex in shape from white to white with a yellowish tint of color.

Tablets 10 mg: tablets of round, biconvex form of red-brown color with light and dark impregnations on the surface and on a cross-section.

Tablets of 20 mg: tablets of round, biconvex form from light pink to pink with light and dark impregnations on the surface and on a cross section

Pharmacotherapeutic group:Angiotensin converting enzyme inhibitor.

ATX: & nbsp

C.09.A.A.02 Enalapril

Pharmacodynamics:

Enalapril is an antihypertensive drug whose mechanism of action is associated with the inhibition of the activity of the agiotensive-converting enzyme (ACE), leading to a decrease in the formation of angiotensin II. As a result of the hydrolysis of enalapril, enalaurylate is formed, which inhibits ACE. The mechanism of action is associated with a decrease in the formation of angiotensin II from angiotensin I, a decrease in the concentration of which leads to a direct decrease in the secretion of aldosterone. This reduces the overall peripheral vascular resistance, systolic and diastolic blood pressure (BP), post-and preload on the myocardium. Enalapril expands more arteries than veins, while there is no reflex increase in heart rate. Reduces the degradation of bradykinin, increases the synthesis of prostaglandins. The antihypertensive effect is more pronounced with high renin activity than with normal or reduced activity of renin. Reduction of blood pressure within therapeutic limits does not affect cerebral circulation. Blood flow in the vessels of the brain is maintained at a sufficient level and in the foyer of a lowered blood pressure. Strengthens coronary and renal blood flow.

With prolonged use enalapril reduces hypertrophy of the left ventricle of the myocardium and myocytes of the walls of arteries of the resistive type, prevents the progression of chronic heart failure (CHF), slows the development of left ventricular dysdatics, improves the blood supply of the ischemic myocardium. Has some diuretic effect.Reduces the glomerular hypertension inside, slowing the development of glomerulosclerosis and the risk of chronic renal failure (HG1P).

With prolonged use in patients with a reduced rate of glomerular filtration reduces the symptoms of fluid retention and sodium in the body, and also has a positive effect on the ratio of fractions of lipoproteins. In addition, the use of enalapril is characterized by a lack of influence or a positive effect on the concentration of total cholesterol.

The time of the onset of antihypertensive effect with oral administration is 1 hour, reaches a maximum after 4-6 hours and lasts up to 24 hours. In some patients, to achieve optimal blood pressure therapy is needed for several weeks. With CHF a noticeable clinical effect is observed with long-term treatment - 6 months or more. The duration of the therapeutic effect is dose-dependent.

Pharmacokinetics:

After ingestion, about 60% of enalapril is absorbed. Eating does not affect absorption.

After suction enalapril rapidly hydrolyses to form an active metabolite of enalaprilate, which is a more active inhibitor of LIF than enalapril. The relationship between enalaprilat and plasma proteins is 50-60%.The maximum concentration of enalaprilat in the blood serum is observed after 3-4 hours, enalapril after 1 hour. Stable concentrations in blood serum - after 4 days.

The degree of absorption and hydrolysis of enalapril are the same for different doses within the recommended therapeutic range.

Enalaprilat easily penetrates through gistogematicheskie barriers. excluding the blood-brain barrier, a small amount penetrates through the placenta and into breast milk.

Enalaprilat is excreted mainly by kidneys - 60% (20% in the form of enalapril and 40% in the form of enalaprilat), through the intestine - 33% (6% in the form of enalapril and 27% in the form of enalaprilate). The main metabolites, determined in urine, are enalaprilate, which is approximately 40% of the accepted dose, and unchanged enalapril. There are no data on other metabolites of enalapril. The profile of enalaprilate concentration in the blood plasma has a long final phase, which is apparently due to its binding to AH1F. The half-life of enalaprilat is about 11 hours. It is removed during hemodialysis (rate 62 ml / min) and peritoneal dialysis.

Indications:

- arterial hypertension, (including renovascular hypertension);

- chronic heart failure (as part of combination therapy);

- prevention of the development of clinically significant heart failure in patients with asymptomatic dysfunction of the left ventricle (as part of combination therapy).

Contraindications:

Hypersensitivity to enalapril, other components of the drug, or other ACE inhibitors. angioedema in history, associated with previous use of ACE inhibitors; hereditary or idiopathic angioedema; pregnancy; the period of breastfeeding; age to 18 years; simultaneous use with aliskiren in patients with diabetes mellitus and / or moderate or severe impairment of function kidney (creatinine clearance (CC) less 60 ml / min).

Carefully:

Aortic and / or mitral stenosis (with disturbances in hemodynamics); hypertrophic obstructive cardiomyopathy (GOKMP); cerebrovascular diseases (including cerebral circulatory insufficiency); ischemic heart disease (IHD); autoimmune systemic diseases of connective tissue (including scleroderma, systemic lupus erythematosus); oppression of bone marrow hematopoiesis; condition after kidney transplantation; renal failure (CC less than 80 ml / min),liver failure; aggravated allergic anamnesis or angioedema in history; the use of Negroid race in patients; when performing the procedure of apheresis of low-density lipoproteins (LDL) using dextran sulfate; in patients on dialysis using high-flux membranes (such as AN69); in patients after major surgical interventions or in general anesthesia; Renovascular hypertension; during desensitization with the allergen from the Hymenoptera venom; The patients observing a diet with restriction of consumption of table salt or being on a hemodialysis; hyperkalemia; Conditions, accompanied by a decrease in the volume of circulating blood (BCC), incl. diarrhea, vomiting; elderly age (over 65 years), primary aldosteronism, diabetes mellitus, concomitant use with immunosuppressants and saluristics.

Pregnancy and lactation:

Application of the drug Enalapril when pregnancy is not recommended. At the onset of pregnancy, taking the drug Enalapril should be stopped immediately.

ACE inhibitors can cause disease or fetal or neonatal death if used in II and III trimesters of pregnancy. The use of an ACE inhibitor during this period was accompanied by a negative effect on the fetus and the newborn, including the development of arterial hypotension, renal failure, hyperkalemia and / or hypoplasia of the skull bones in a newborn. Perhaps the development of oligohydramnion, apparently due to a decrease in the function of the kidneys of the fetus. it complication can lead to contracture of the limbs, deformation of the skull bones, including its facial part, lung hypoplasia. When using the drug Enalapril It is necessary to inform the patient about the potential risk for the fetus.

Newborns whose mothers took the drug Enalapril, should be carefully observed in the detection of arterial hypotension, oliguria and hyperkalemia. EnalaPril that penetrates placenta mayt be partially removed from the bloodstream of a newborn with peritoneal dialysis; in theory it can be removed by means of exchange blood transfusion.

Preterm birth delay, intrauterine fetal development, and non-healing of the arterial (Botallova) duct were also reported, but it is unclear whether these cases were associated with the ACE inhibitor. In those rare cases where the use of an ACE inhibitor during pregnancy is considered necessary, periodic ultrasound examinations should be performed to assess the amniotic fluid index. If an oligohydramnion is detected during an ultrasound examination, it is necessary to stop taking the drug, unless its reception is considered vital for the mother. Nevertheless, both the patient and the doctor should know that the oligohydramnion develops with irreversible damage to the fetus. If ACE inhibitors are used during pregnancy and the development of oligohydramnion is observed. then, depending on the week of pregnancy, a stress test, a stress test, or a biophysical profile of the fetus may be necessary to assess the functional state of the fetus.

Enalapril and enalaprilate in trace concentrations are excreted in breast milk.

If it is necessary to use the drug Enalapril During lactation breastfeeding should be discontinued.

Dosing and Administration:

Inside, squeezed a small amount of liquid. Tablets can be taken before. during or after a meal, regularly and at the same time of day.

If the drug is taken Enalapril missed, you should take the missed dose. If several hours are left until the next dose is administered, the dose of the drug Enalapril should not be accepted. The dose should never be doubled.

In case you need to take the drug at a dosage of 2.5 mg, you can use enalapril in tablets of 2.5 mg or / g tablets with a dosage of 5 mg (with a risk - if available).

Arterial hypertension, the initial dose is 5 to 20 mg once a day, depending on the severity of hypertension.

After taking the initial dose, patients should be under medical supervision for 2 hours and an additional 1 hour until BP stabilizes. If there is no therapeutic effect, the dose of the drug Enalapril increase through 1-2 weeks at 5 mg / day.

With mild hypertension, a maintenance dose of 5-10 mg is recommended once a day, with moderate arterial hypertension of 10-20 mg once a day.With more severe arterial hypertension, the recommended maintenance dose is 20 mg once a day.

If necessary, and a fairly good tolerability dose of the drug Enalapril can be increased to 40 mg / day. The maximum daily dose is 40 mg / day.

When Renovascular hypertension the initial dose is 2.5-5 mg / day. After taking the initial dose, patients should be monitored by a doctor. The maximum daily dose is 20 mg / day.

Patients, taking diuretics, it is necessary 2-3 days before the drug is started Enalapril to cancel diuretic therapy. Initial dose for patients who failed to interrupt diuretic therapy before starting treatment with the drug Enalapril, is 2.5 mg once a day.

When hyponatremia (sodium content in the blood serum is less than 130 mmol / l) or serum creatinine concentration greater than 0.14 mmol / l, the initial dose is 2.5 mg once a day.

Chronic heart failure and prevention of the development of clinically significant heart failure in patients with asymptomatic left ventricular dysfunction (as part of combination therapy)

The initial dose is 2.5 mg / day once. Treatment begins under the supervision of a doctor. The dose is gradually increased usually by 2.5-5 mg / day every 3-4 days to a maintenance dose of 20 mg / day.

The dose is selected within 2-4 weeks.

Weeks	Dose
Week 1	Day 1-3: 2.5 mg / day in one session; 4-7 day: 5 mg / day in two divided doses
Week 2	10 mg / day in one or two doses
Week 3 and 4	20 mg / day in one or two doses

The maximum daily dose is -40 mg / day once or in 2 divided doses.

Creatinine clearance	Initial dose
less than 80 ml / min, but more than 30 ml / min	5-10 mg / day
not more than 30 ml / min, but more than K) ml / min	2.5-5 mg / day
not more than 10 ml / min	2.5 mg / day (on dialysis days)

Side effects:

Side effects are classified according to the WHO recommendation in accordance with the frequency of their occurrence: very often - not less than K)%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including individual reports.

From the hemopoietic system and lymphatic system: infrequently, anemia (including aplastic and hemolytic); rarely - neutropenna, reduction of hemoglobin and hematocrit, thrombocytopaia, agranulocytosis, oppression of bone marrow hematopoiesis, pancytopenia, lymphadenopathy, autoimmune diseases.

Disorders from the metabolism and nutrition: infrequently - hypoglycemia.

From the central nervous system: very often - dizziness; often - headache, depression; infrequently - confusion, insomnia, increased excitability, paresthesia, vertigo; rarely - unusual dreams, sleep disturbances.

From the sense organs: infrequently, noise in the ears; rarely - blurred vision.

From the cardiovascular system: often - marked decrease in blood pressure, fainting, chest pain, heart rhythm disturbances, angina pectoris, tachycardia; infrequently, heart palpitations, orthostatic hypotension, myocardial infarction, or cerebrovascular accident (possibly due to a sharp decrease in blood pressure in patients at high risk); rarely - Raynaud's syndrome.

From the respiratory system: very often cough, often shortness of breath, infrequent rhinorrhea, sore throat and hoarseness, bronchospasm / bronchial asthma, rarely infiltrates in the lungs, rhinitis, allergic alveolitis / eosinophilic pneumonia.

From the digestive system: very often - nausea; often - diarrhea, abdominal pain, change in taste; infrequent - intestinal obstruction, pancreatitis, vomiting, dyspepsia, constipation, anorexia,dryness of the oral mucosa, peptic ulcer; rarely - stomatitis / aphthous ulcers, glossitis; very rarely - intestinal angioedema.

From the liver and bile ducts: rarely - hepatic insufficiency, hepatitis (hepatocellular or cholestatic), including hepatic necrosis, cholestasis (including jaundice).

From the skin and subcutaneous tissues: often - reactions increased sensitivity / angionsurotic edema of the face, extremities, lips, tongue, vocal folds and / or larynx, skin rash; infrequently - increased sweating, itching, hives, alopecia; rarely - multiforme exudative erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, pemphigus, erythroderma.

A symptom complex has been reported that may be accompanied by some and / or all of the listed symptoms: fever, delayed, vasculitis, myalgia / myositis. arthralgia / arthritis, increased titer of antinuclear antibodies, increased erythrocyte sedimentation rate, eosinophilia and leukocytosis. Skin rashes, photosensitivity or other skin manifestations may occur.

From the side of the kidneys and urinary tract: infrequently - a violation of the function of the nights, acute renal failure, proteinuria; rarely - oliguria.

From the genitals and the breast: infrequently - impotence: rarely - gynecomastia.

Laboratory indicators: often - hyperkalemia, increased serum creatinine concentration; infrequently - hyponatremia, hyperuricemia; rarely - increased activity of "liver" enzymes, hyperbilirubinemia.

Other: very often - asthenia; often - increased fatigue; infrequently - muscle cramps, flushes of blood to the face, general malaise, fever.

In rare cases with simultaneous use of ACE inhibitors (including enalapril) and intravenous (iv) administration of gold preparations (sodium aurotomy malate) describes a symptomatic complex that includes reddening of the facial skin, nausea, vomiting and arthritic hypotension.

With the use of ACE inhibitors, there have been reports of rare cases of the syndrome of inadequate secretion of antidiuretic hormone.

Adverse events that occurred during the post-marketing application of enalapril (causal relationship not established): urinary tract infection, upper respiratory tract infection, bronchitis, cardiac arrest, atrial fibrillation,herpes zoster, melena, ataxia, pulmonary artery thromboembolism and pulmonary infarction, hemolytic anemia, including hemolysis cases in patients with deficiency of glucose-6-phosphate dehydrohease.

Overdose:

Symptoms: a marked decrease in blood pressure, up to the development of collapse, myocardial infarction, acute impairment of cerebral circulation or thromboembolic complications, disturbance of water-electrolyte balance, renal failure, rapid breathing, tachycardia, palpitations, bradycardia, dizziness, anxiety, fear, cramps, cough, stupor. The concentration of enalaprilate in the blood plasma is 100-200 times higher than after the application of therapeutic doses was observed after ingestion of 300 mg and 440 mg of enalapril, respectively.

Treatment: the patient is transferred to a horizontal position with a low headboard. In mild cases, gastric lavage and ingestion of activated charcoal are shown, in more serious cases, measures aimed at normalizing blood pressure: intravenous injection of 0.9% sodium chloride solution, plasma substitutes, if necessary, intravenous catecholamines, hemodialysis (speed excretion of enalaprilate - 62 ml / min). Patients with a bradycardia that is resistant to therapy are shown staging the pacemaker.

Interaction:

Potassium-sparing diuretics and potassium preparations. Simultaneous use of enalapril and potassium-sparing diuretics (such as spironolactone, eplerenone, triamterep, amiloride), preparations of potassium or potassium-containing substitutes for edible salt, as well as the use of other drugs that increase the potassium content in the blood plasma (for example, heparin) can lead to a significant increase in potassium in the blood plasma. If it is necessary to use enalapril with the drugs listed above, regular monitoring of the potassium content in the blood plasma should be carried out.

Diuretics (thiazide and "loop"). The use of diuretics in high doses can lead to hypovolemia (due to the reduction of BCC), and the addition to the therapy of enalapril - to a pronounced decrease in blood pressure. The excessive antihypertensive effect of enalapril can be reduced either by the elimination of the diuretic, either by increasing the bcc or drinking common salt, and also with the reduction of the dose of enalapril.

Other antihypertensives. Simultaneous use of enalapril and beta-adrenergic blockers, alpha-blockers,ganglion-blocking agents, methyldonium, nitroglycerin and other nitrates or blockers of "slow" calcium channels can further reduce blood pressure.

Lithium. With the simultaneous use of enalapril with lithium preparations - slowing the excretion of lithium (increased cardiotoxic and neurotoxic action of lithium). If this combination is necessary, the concentration of lithium in the blood plasma should be monitored regularly.

Tricyclic antidepressants, antipsychotics (antipsychotics), drugs for general anesthesia increase the antihypertensive effect and increase the risk of orthostatic hypotension (additive effect).

Non-steroidal anti-inflammatory drugs. Simultaneous use of non-steroidal anti-inflammatory drugs (NSAIDs) (at t.ch. selective inhibitors of cyclooxygenase-2 (COX-2)) can weaken the antihypertensive effect of antihypertensive drugs. Thus, the antihypertensive effect of antagonists of angiotensin II reviewers or ACE inhibitors may be weakened by NSAIDs, including COX-2 inhibitors.

NSAIDs and ACE inhibitors have an additive effect on the increase in potassium in the blood serum, which can lead to impaired renal function,especially in patients with impaired renal function. This effect is reversible. With simultaneous use in patients with impaired renal function, caution should be exercised.

Preparations of gold. With simultaneous use of ACE inhibitors and preparations of gold (sodium aurotomy malate) IV, a symptomatic complex including facial flushing, nausea, vomiting and arterial hypotension is described.

Sympathomimetics can reduce the antihypertensive effect of ACE inhibitors. Hypoglycemic agents for oral administration and insulin. Epidemiological studies suggest that simultaneous use of ACE inhibitors and hypoglycemic agents can lead to hypoglycemia. More often, hypoglycemia develops in the first weeks of therapy in patients with impaired renal function. Long-term and controlled clinical studies of enalapril did not confirm these data and do not limit the use of enalapril in patients with diabetes mellitus. However, such patients should be under regular medical supervision.

Ethanol can enhance the antihypertensive effect of ACE inhibitors. Acetylsalicylic acid, thrombolytics and beta-addresses and bobs. Enalapril can be used simultaneously with acetylsalicylic acid (as an antiaggregant agent), thrombolytic agents and beta-blockers.

Allopurinol, cytostatics and immunosuppressants. Simultaneous use with ACE inhibitors may increase the risk of developing leukopenia.

Cyclosporine. Simultaneous use with ACE inhibitors may increase the risk of developing hyperkalemia.

Antacids can reduce the bioavailability of ACE inhibitors.

Enalapril weakens the effect of medications containing theophylline.

There was no clinically significant pharmacokinetic interaction with hydrochlorothiazide, furosemide, digoxin, timolol, methyldopoy, warfarin. iidometacin, sulindac and cimetidine.

Double blockade of the renin-angiotensin-aldosterone system (RAAS) with the use of angiotensin receptor antagonists II, ACE inhibitors or aliskiren (direct renin inhibitor) is associated with an increased risk of arterial hypotension, syncope, hyperkalemia and renal dysfunction (including acute renal failure) compared with monotherapy.Regular monitoring of blood pressure, kidney function and electrolyte content in the blood in patients taking Enalapril and other drugs that affect RAAS.

Special instructions:The question of the application of a double blockade of RAAS (for example, by simultaneous application of an ACE inhibitor with an angiotensin receptor antagonist II) It is necessary to solve in each case individually with careful control of kidney function. Caution should be exercised in patients with reduced BCC (including with simultaneous use with diuretics, in conditions of restriction of consumption of table salt, in hemodialysis, diarrhea, vomiting) in which a sudden and pronounced decrease in blood pressure may develop in response to the use of an ACE inhibitor. In patients with CHF of mild degree, CRF or without it, symptomatic arterial hypotension is usually not observed. The development of arterial hypotension is most likely in patients with a more severe degree of CHF due to the use of high doses diuretics, hyponatremia or functional renal failure. Thesex of patients, treatment should be started under the supervision of a physician, up to an optimal dose adjustment Enalapril and / or diuretic. A similar tactic can be applied to patients with IHD and cerebrovascular disease, in whom excessive reduction in blood pressure can lead to myocardial infarction or cerebral circulation impairment. In case of development of severe arterial hypertension, the patient should be placed in a horizontal position and, if necessary, an infusion of 0.9% sodium chloride solution should be started. Transient arterial hypotension is not a contraindication for continuing treatment with the drug

Enalapril after stabilization of blood pressure and replenishment of BCC.

In some patients with CHF with normal or low blood pressure when using the drug Enalapril there may be an additional reduction in blood pressure. Usually this is not a reason for drug withdrawal. 13 In case of development of arterial hypotension, it is necessary to reduce the dose and / or to cancel the diuretic and / or enalapril.

Like all vasodilators, ACE inhibitors should be used with caution in patients with left ventricular hypertrophy and valvular obstruction and refrain from using in cases of cardiogenic shock and hemodynamically significant obstruction.In the case of a violation of kidney function (CC less than 80 ml / min), careful monitoring of the potassium and creatinine content in the blood serum is necessary. In patients with renal insufficiency, it may be necessary to reduce the dose and / or frequency of the drug. In some patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, there is an increase in the concentration of urea and creatinine in the serum. Changes are usually reversible and return to normal after discontinuation of treatment.

In some patients who did not have renal disease before treatment, there was a slight and transient increase in serum urea and creatinine levels when enalapril was used concomitantly with diuretics. In such cases, a dose reduction and / or cancellation of enalaryl and / or diuretic may be required.

In patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney taking ACE inhibitors. there is an increased risk of developing arterial hypotension and kidney failure. To reduce the function of the kidneys can indicate only moderate changes in the concentration of creatinine in the blood plasma.In such patients, treatment should begin with small doses under the supervision of a doctor, gradually selecting an individual dose and controlling the concentration of creatinine in the serum.

The experience of using enalapril in patients who have recently undergone kidney transplantation is missing. Therefore, the use of this drug in such patients is not recommended.

Application of the drug Enalapril in patients with hepatic insufficiency, usually does not require dose adjustment. Rarely, an ACE inhibitor is associated with a syndrome that begins with the development of cholestatic jaundice until the development of fulminant liver necrosis. When symptoms of jaundice appear or the activity of liver enzymes increases in patients taking ACE inhibitors, discontinue drug therapy and conduct an appropriate examination. In patients taking ACE inhibitors, there were cases of development of neutropenia / agranulocytosis, thrombocytopenia and anemia. In patients with normal kidney function and the absence of other complications, neuropathy rarely develops. A drug Enalapril It is necessary to use with very great care in patients with connective tissue diseasestissue (including systemic lupus erythematosus, scleroderma), simultaneously receiving immunosuppressive therapy, allopurinol or procainamide, as well as a combination of these factors, especially with existing violations of kidney function. Such patients can develop severe infections that are not amenable to intensive antibiotic therapy. If, however, patients take the drug Enalapril, it is recommended to periodically monitor the number of white blood cells in the blood. The patient should be warned that if there is any indication of an infection, it is necessary to consult a doctor.

With the use of ACE inhibitors, including enalapril, angionevrotic edema of the face, limbs, tongue, vocal cords and / or larynx has been reported. This can happen at any time during the treatment. In such cases, drug treatment Enalapril should be immediately stopped, and the patient should be under the supervision of a doctor until the complete disappearance of the corresponding symptoms. Even in those cases where there is only difficulty swallowing without difficulty breathing,patients may require long-term medical supervision, because therapy with antihistamines and glucocorticosteroids may not be enough. Angioedema, associated with edema of the larynx and the tongue, in very rare cases can be fatal. In patients with edema, tongue, vocal cords or larynx may develop airway obstruction, especially in patients with a history of surgical intervention on the organs of respiration. In cases of airway obstruction, appropriate therapy should be carried out in the shortest possible time, including subcutaneous injection of epinephrine (0.3-0.5 ml solution of epinephrine (adrenaline) in the ratio 1: 1000) and / or to carry out necessary measures to ensure airway conductance (intubation or tracheostomy).

Among patients of the Negroid race receiving ACE inhibitor therapy, 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 angioedema mri reception of any ACE inhibitor.

There are reports of the development of life-threatening anaphylactic reactions in patients taking ACE inhibitors. during the procedure of desensitization by the venom of Hymenoptera. Such reactions can be avoided, if before the beginning of desensitization temporarily stop taking ACE inhibitors. The use of ACE inhibitors in patients receiving immunotherapy with bee venom should be avoided.

In rare cases, life-threatening anaphylactoid reactions have been observed in patients taking ACE inhibitors during apheresis of LDL with dextrin sulfate. If LDL-AFS cuts are used, AIIF inhibitors should be temporarily replaced with other medications to treat hypertension and heart failure.

Anaphylactoid reactions have been reported in patients on hemodialysis using high-density polyacrylonitrile membranes (AN69). In these cases it is recommended to use a membrane of another type for dialysis or to use an antihypertensive drug of another pharmacotherapeutic group.

When using the drug Enalapril in patients with diabetes mellitus,receiving hypoglycemic agents for ingestion or insulin, during the first month of therapy it is necessary to regularly monitor the concentration of glucose in the blood. It was reported the occurrence of cough with the use of ACE inhibitors. Usually, cough has an unproductive, persistent character and stops after the withdrawal of ACE inhibitors. With a differential diagnosis of cough, one should also consider a cough caused by the use of ACE inhibitors.

In patients undergoing surgical interventions, or in general anesthesia with agents that cause arterial hypotension, ACE inhibitors can block the formation of angiotensin II in response to compensatory release of renin. Before surgery (including dental procedures), an anesthesiologist should be alerted to application of the drug Enalapril.

Hyperkalemia can develop on the background of therapy with ACE inhibitors, including enalapril. Risk factors for hyperkalemia are renal failure, | elderly age (over 65 years), diabetes mellitus, some concomitant conditions (decreased BCC.acute heart failure in the stage of decompensation, metabolic acidosis), simultaneous reception of potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), as well as preparations of potassium or potassium-containing substitutes for edible salt and the use of other drugs that increase the level of potassium in the blood plasma (for example, heparin). The use of potassium, potassium-sparing diuretics or potassium-containing substitutes for edible salt, especially in patients with renal insufficiency, can lead to a significant increase in potassium levels in the blood plasma. Hyperkalemia can lead to serious heart rhythm disturbances, sometimes with a fatal outcome. Simultaneous use of Enalairil with any of the above drugs should be done with caution and should be accompanied by regular monitoring of the potassium content in the blood plasma. Simultaneous use of lithium and drug preparations Enalapril usually not recommended.

A drug Enalapril, like other ACE inhibitors, has a less pronounced antihypertensive effect in patients of the Negroid race compared with representatives of other races.probably due to the low activity of renin in patients with hypertension in this population.

The sudden discontinuation of enalapril does not lead to the development of the "withdrawal" syndrome.

Effect on the ability to drive transp. cf. and fur:

When using the drug Enalapril care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions, due to the possibility of developing dizziness and drowsiness.

Form release / dosage:

Tablets 5 mg, 10 mg, 20 mg.

Packaging:

10 per each in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

For 1, 2, 3, 5 or 10 contour cell packs, along with instructions for medical use are placed in a cardboard box.

Storage conditions:

In a dark place at a temperature not above. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003016

Date of registration:02.06.2015

The owner of the registration certificate:IZVARINO PHARMA, LLC IZVARINO PHARMA, LLC Russia

Manufacturer: & nbsp

IZVARINO PHARMA, LLC Russia

Information update date: & nbsp19.10.2015

Illustrated instructions

Instructions

Enalapril (Enalapril)