Enalapril - instructions for use. Sustained result from enalapril in the treatment of hypertension Enalapril dosage 5 mg

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Enalapril - antihypertensive drug, ACE inhibitor. The metabolite of enalapril, enalaprilat, has pharmacological activity. Suppresses the formation of angiotensin 2 and eliminates its vasoconstrictor effect. At the same time, OPSS, systolic and diastolic blood pressure, post- and preload on the myocardium decrease.

It expands the arteries to a greater extent than the veins, while there is no reflex increase in heart rate. It also reduces preload, lowers the pressure in the right atrium in the pulmonary circulation, and reduces left ventricular hypertrophy. Reduces the tone of the efferent arterioles of the renal glomeruli, thereby reducing intraglomerular hemodynamics, and prevents the development of diabetic nephropathy.

Does not affect the metabolism of glucose, lipoproteins and sexual function.

The maximum effect develops 6-8 hours after administration and lasts for 24 hours. The therapeutic effect is achieved after several weeks of treatment.

Composition

Enalapril maleate + excipients.

Pharmacokinetics

After oral administration, about 60% of enalapril is absorbed from the gastrointestinal tract. Food intake does not affect the absorption of the drug. It undergoes hydrolysis with the formation of enalaprilat, which has a pronounced pharmacological activity. It is excreted mainly by the kidneys - 60% (20% - in the form of enalapril and 40% - in the form of enalaprilat), through the intestines - 33% (6% - in the form of enalapril and 27% - in the form of enalaprilat).

Indications

• arterial hypertension;
• chronic heart failure (as part of combination therapy);
• dysfunction of the left ventricle.

Release forms

Tablets 5 mg, 10 mg and 20 mg (Acri, Hexal and others).

Instructions for use and dosage

Assign inside regardless of the time of meal.

For monotherapy of arterial hypertension, the initial dose is 5 mg once a day. If there is no clinical effect after 1-2 weeks, the dose is increased by 5 mg. After taking the initial dose, patients should be under medical supervision for 2 hours and an additional 1 hour until blood pressure stabilizes. If necessary and sufficiently well tolerated, the dose can be increased to 40 mg per day in 2 divided doses. After 2-3 weeks, they switch to a maintenance dose of 10-40 mg per day, divided into 1-2 doses. With moderate arterial hypertension, the average daily dose is about 10 mg.

The maximum daily dose of the drug is 40 mg per day.

In the case of prescribing to patients simultaneously receiving diuretics, diuretic treatment should be discontinued 2-3 days before the appointment of Enalapril. If this is not possible, then the initial dose of the drug should be 2.5 mg per day.

For renovascular hypertension, the initial dose is 2.5-5 mg per day. The maximum daily dose is 20 mg.

In chronic heart failure, the initial dose is 2.5 mg once, then the dose is increased by 2.5 - 5 mg every 3-4 days in accordance with the clinical response to the maximum tolerated doses depending on the blood pressure values, but not higher than 40 mg per day, once or in 2 receptions. In patients with low systolic blood pressure (less than 110 mm Hg), therapy should be started with a dose of 1.25 mg per day. The dose selection should be done within 2-4 weeks or less. The average maintenance dose is 5-20 mg per day for 1-2 doses.

In older people, a more pronounced hypotensive effect and a lengthening of the drug action time are more often observed, which is associated with a decrease in the rate of elimination of enalapril, therefore the recommended initial dose for the elderly is 1.25 mg.

In chronic renal failure, accumulation occurs with a decrease in filtration of less than 10 ml / min. With CC 80-30 ml / min, the dose is usually 5-10 mg per day, with CC up to 30-10 ml / min - 2.5-5 mg per day, with CC less than 10 ml / min - 1.25-2.5 mg per day only on dialysis days.

The duration of treatment depends on the effectiveness of therapy. If the decrease in blood pressure is too pronounced, the dose of the drug is gradually reduced.

The drug is used both in monotherapy and in combination with other antihypertensive drugs.

Side effect

• excessive decrease in blood pressure;
• orthostatic collapse;
• chest pain;
• angina pectoris;
• myocardial infarction (usually associated with a pronounced decrease in blood pressure);
• arrhythmias (atrial brady or tachycardia, atrial fibrillation);
• dizziness;
• headache;
• weakness;
• insomnia;
• anxiety;
• confusion of consciousness;
• increased fatigue;
• drowsiness (2-3%);
• depression;
• violations of the vestibular apparatus;
• noise in ears;
• dry mouth;
• anorexia;
• dyspeptic disorders (nausea, diarrhea or constipation, vomiting, abdominal pain);
• intestinal obstruction;
• unproductive dry cough;
• interstitial pneumonitis;
• bronchospasm;
• dyspnea;
• skin rash;
• hives;
• angioneurotic edema;
• toxic epidermal necrolysis;
• stomatitis;
• glossitis;
• impaired renal function;
• alopecia;
• decreased libido;
• hot flashes.

Contraindications

• a history of angioedema associated with treatment with ACE inhibitors;
• porphyria;
• pregnancy;
• lactation period;
• age up to 18 years (efficacy and safety have not been established);
• hypersensitivity to enalapril and other ACE inhibitors.

special instructions

Care must be taken when prescribing Enalapril to patients with reduced BCC (as a result of diuretic therapy, with restriction of salt intake, hemodialysis, diarrhea and vomiting) - the risk of a sudden and pronounced decrease in blood pressure is increased after using even the initial dose of an ACE inhibitor. Transient arterial hypotension is not a contraindication for continuing treatment with the drug after stabilization of blood pressure. In case of repeated pronounced decrease in blood pressure, the dose should be reduced or the drug should be discontinued.

The use of highly permeable dialysis membranes increases the risk of an anaphylactic reaction. Correction of the dosage regimen on days free from dialysis should be carried out depending on the level of blood pressure.

Before and during treatment with ACE inhibitors, periodic monitoring of blood pressure, blood parameters (hemoglobin, potassium, creatinine, urea, activity of liver enzymes), and protein in the urine is necessary.

Patients with severe heart failure should be closely monitored. ischemic disease heart and cerebrovascular disease, in which a sharp decrease in blood pressure can lead to myocardial infarction, stroke or renal dysfunction.

Abrupt withdrawal of treatment does not lead to withdrawal syndrome (a sharp rise in blood pressure).

For newborns and infants who have been exposed to intrauterine exposure to ACE inhibitors, it is recommended to closely monitor for the timely detection of a pronounced decrease in blood pressure, oliguria, hyperkalemia and neurological disorders possible due to a decrease in renal and cerebral blood flow with a decrease in blood pressure caused by ACE inhibitors. With oliguria, it is necessary to maintain blood pressure and renal perfusion by introducing appropriate fluids and vasoconstrictors. In the presence of renal failure, it is possible to reduce the excretion of the active metabolite, leading to an increase in its concentration in the blood plasma. These patients may require lower doses of the drug.

In patients with arterial hypertension and unilateral or bilateral renal artery stenosis, an increase in serum urea and creatinine is possible.

In such patients, it is necessary to monitor renal function during the first few weeks of therapy. It may be necessary to reduce the dosage of the drug.

The ratio of risk and potential benefit should be taken into account when prescribing Enalapril to patients with coronary and cerebrovascular insufficiency, due to the danger of increased ischemia with excessive arterial hypotension.

The drug should be administered with caution to patients with diabetes mellitus due to the risk of developing hyperkalemia.

Patients with a history of indications of angioedema may have an increased risk of developing angioedema during treatment with Enalapril.

Patients with severe autoimmune diseases, such as systemic lupus erythematosus or scleroderma, have an increased risk of neutropenia or agranulocytosis while taking Enalapril.

Before exploring functions parathyroid glands the drug should be canceled. Alcohol enhances the hypotensive effect of the drug.

Before surgical intervention (including dentistry), the surgeon / anesthetist should be warned about the use of ACE inhibitors.

Influence on the ability to drive vehicles and use mechanisms

At the beginning of treatment, until the end of the dose selection period, it is necessary to refrain from driving vehicles and practicing potentially dangerous species activities requiring increased concentration of attention and speed of psychomotor reactions, since dizziness is possible, especially after the initial dose of an ACE inhibitor in patients taking diuretics.

Drug interactions

With the simultaneous appointment of Enalapril with non-steroidal anti-inflammatory drugs, a decrease in the hypotensive effect is possible; with potassium-sparing diuretics (spironolactone, triamterene, amiloride) can lead to hyperkalemia; with lithium salts - to slow down the elimination of lithium (control of the concentration of lithium in the blood plasma is shown).

Concomitant use with antipyretic and pain relievers may reduce the effectiveness of enalapril.

Enalapril weakens the effect of drugs containing theophylline.

The hypotensive effect of enalapril is enhanced by diuretics, beta-blockers, methyldopa, nitrates, blockers of slow calcium channels, hydralazine, prazosin.

Immunosuppressants, allopurinol, cytostatics increase hematotoxicity.

Bone marrow suppression drugs increase the risk of neutropenia and / or agranulocytosis.

Analogues of the drug Enalapril

Structural analogues for the active substance:

• Bagopril;
• Berlipril 10;
• Berlipril 20;
• Berlipril 5;
• Vasolapril;
• Vero-Enalapril;
• Invoril;
• Korandil;
• Myopril;
• Renipril;
• Renitek;
• Ednith;
• Enazil 10;
• Enalakor;
• Enalapril HEXAL;
• Enalapril-Ajio;
• Enalapril-AKOS;
• Enalapril-Acri;
• Enalapril-UBF;
• Enalapril-FPO;
• Enalapril maleate;
• Enam;
• Enap;
• Enarenal;
• Enapharm;
• Envas;
• Envipril.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and see the available analogues for the therapeutic effect.

The site provides background information for informational purposes only. Diagnosis and treatment of diseases should be carried out under the supervision of a specialist. All drugs have contraindications. A specialist consultation is required!

Enalapril

Enalapril - an antihypertensive drug belonging to the class of ACE inhibitors. The action of Enalapril is due to its effect on the renin-angiotensin-aldosterone system, which plays an important role in the regulation of blood pressure.

The visible effect of the drug develops after taking it within 2-4 hours, and the initial action within an hour. The maximum pressure decreases after 4-5 hours. When using Enalapril in recommended doses, its hypotensive effect lasts about a day.

The drug is rapidly absorbed in the gastrointestinal tract with a degree of absorption of about 60%. Enalapril is excreted mainly through the kidneys and through the intestines.

Release forms

Enalapril is available in tablets of 5, 10, 20 mg, packaged in blisters of 10 pieces. There are two or three blisters in a carton.

Dutch and English Renitek contains 14 tablets in one package.

Side effects when taking Enalapril are most often reversible. Therefore, if they appear, the drug is immediately stopped.

Enalapril treatment

How to take Enalapril?
In accordance with the doctor's prescription, the drug is taken 1-2 times a day, regardless of food intake. Combined preparations of Enalapril containing diuretics are best taken in the morning. Treatment with the drug is received for a long time, with good tolerance - throughout life.

As a result of the simultaneous administration of Enalapril with preparations of lithium salts, the excretion of lithium may slow down, and its toxic effect increases. Therefore, it is not recommended to prescribe these drugs together.

The combined use of Enalapril with potassium-sparing diuretics can lead to potassium retention and hyperkalemia. Therefore, they can be taken simultaneously only under the control of laboratory tests.

There is evidence that the simultaneous administration of insulin, as well as other hypoglycemic drugs and Enalapril can lead to hypokalemia. Most often this happens at the beginning of treatment in patients with renal disease.

Enalapril weakens the effect of Theophylline.

It is safe to prescribe Enalapril with aspirin in a cardiac dosage, with beta-blockers and thrombolytics.

Enalapril's analogs

Analogs (synonyms) of the drug, which include Enalapril as the main active ingredient, include:

• Enap;
• Vasolapril;
• Invoril;
• Berlipril;
• Ednith;
• Enam;
• Bagopril;
• Myopril;
• Enarenal;
• Renitek;
• Envas;
• Korandil;
• Enalakor and others.

Exist combination drugs, such as Slovenian Enap H and Enap HL, Russian Enapharm H and the like. In addition to Enalapril, these drugs contain the substance Hydrochlorothiazide, which has a diuretic effect, which increases the antihypertensive effect of the drug.

Enalapril analogs with a similar effect, but with a different chemical composition, are the drugs Captopril, Lisinopril, Ramipril, Zofenopril, Perindopril, Trandolapril, Quinapril, Fosinopril.

INN: Enalapril

Manufacturer: Borisov plant medical supplies JSC

Anatomical-therapeutic-chemical classification: Enalapril

Registration number in the RK: No. RK-LS-5 No. 019608

Registration period: 28.01.2013 - 28.01.2018

Instructions

Tradename

Enalapril

International non-proprietary name

Enalapril

Dosage form

5 mg and 10 mg tablets

Composition

One tablet contains

active substance - enalapril maleate 5 mg or 10 mg,

excipients: lactose monohydrate, povidone, potato starch, talc, magnesium stearate.

Description

Tablets are white or white with a yellowish sheen, flat-cylindrical, with a score and a chamfer.

Farmakotherapeutic group

Drugs affecting the renin-angiotensin system. Angiotensin-angiotensin-converting enzyme (ACE). ACE inhibitors. Enalapril.

ATX code С09АА02

Pharmacological properties

Pharmacokinetics

After oral administration, about 60% of the drug is absorbed, food does not affect the absorption of enalapril. After taking in a dose of 10 mg, the time to reach the maximum concentration in the blood plasma is 1 hour, and its level is 200-400 ng / ml. After absorption, it undergoes presystemic metabolism in the liver with the formation of active enalaprilat. Enalaprilat easily passes through the histohematogenous barriers (excluding the blood-brain barrier), crosses the placenta and is found in fetal tissues. The half-life of enalapril is 2 hours. After application in a dose of 20 mg, the maximum concentration of enalaprilat in blood plasma is 70-100 ng / ml and is reached after 3-4 hours. Therapeutic concentration of enalaprilat in blood plasma is 10-100 ng / ml. It binds to plasma proteins by 50%. The half-life of enalaprilat is 8-11 hours. 60% of the dose taken (20% in the form of enalapril and 40% in the form of enalaprilat) is eliminated in the urine and 33% through the intestines (6% in the form of enalapril and 27% in the form of enalaprilat). Within 24 hours, about 90% of the dose taken is eliminated. In severe chronic renal failure (creatine clearance less than 30 ml / min), the elimination of enalaprilat slows down, and its plasma level increases 13 times, drug accumulation occurs when creatine clearance is less than 10 ml / min. It is removed by hemodialysis and peritoneal dialysis.

Pharmacodynamics

Enalapril has a hypotensive, vasodilator and cardioprotective effect.

Enalapril inhibits the activity of the angiotensin-converting enzyme (ACE). As a result, the formation of angiotensin II decreases, the secretion of aldosterone is stimulated. It prevents the breakdown of bradykinin and enhances its vasodilating effect on the B2-type bradykinin receptors.

As a result of the use of enalapril in the blood plasma, the level of vasoconstrictor hormones decreases; the level of bradykinin, prostaglandin E2 and prostacyclin, endothelial relaxing factor and atrial natriuritic peptide increases.

Enalapril causes dilation of arterial vessels and lowers blood pressure. With the introduction of enalapril, the hypotensive effect develops 1 hour after administration, reaches a maximum by 6 hours and lasts for about 24 hours. In overweight individuals, enalapril may need to be taken for several weeks to achieve an optimal stable blood pressure level. Enalapril slows down the development of hypertrophy and fibrosis of the arterial wall. Due to the vasodilating effect, enalapril reduces the total peripheral vascular resistance (afterload on the myocardium), the pressure of wedging in the pulmonary capillaries (preload on the myocardium), resistance in the pulmonary vessels, and increases cardiac output. With prolonged use, it reduces the severity of myocardial hypertrophy, prevents the progression of heart failure and slows down the development of left ventricular dilatation (cardioprotective effect).

Indications for use

Arterial hypertension

Chronic heart failure (as part of combination therapy)

Prevention of symptomatic heart failure in patients with asymptomatic left ventricular dysfunction (left ventricular ejection fraction< 35 %)

Method of administration and dosage

Administered orally, regardless of food intake. Patients with high activity of the renin-angiotensin-aldosterone system (for example, renovascular hypertension, salt deficiency and / or dehydration, cardiac decompensation, or severe hypertension) may experience a sharp decrease in blood pressure after taking the first dose. In this connection, the first dose is better taken at bedtime in the supine position.

With arterial hypertension adults are prescribed an initial dose of 5 mg once a day. If there is no effect after 1-2 weeks, the dose is increased by 5 mg. With good tolerance, the dose can be increased to 20 mg / day in 1 dose. 2-3 weeks after taking enalapril at the maximum dose, they switch to maintenance therapy at a dose of 10-20 mg / day. The maximum daily maintenance dose of enalapril is 40 mg / day (in 2 divided doses).

In the case of diuretic use, diuretic treatment should be discontinued 2-3 days before enalapril is prescribed, or enalapril should be started at a dose of 2.5 mg / day, slowly increasing the dose by 2.5 mg / week until an optimal effect is achieved.

When the concentration of Na + in the blood serum is less than 130 mmol / L or the level of creatinine in the blood serum is more than 0.14 mmol / L, the initial dose of enalapril is 2.5 mg / day.

With renovascular and renal hypertension the initial dose is 2.5-5 mg once a day, the maintenance dose is 10 mg once a day. The maximum daily dose is 20 mg in 2 divided doses.

When chronic heart failure an initial dose of 2.5 mg once with a gradual increase of 2.5-5 mg every 3-4 days up to the maximum tolerable (depending on the blood pressure level), but not more than 20 mg / day. The average maintenance dose is 5-20 mg / day. The next increase in the dose is carried out with a stable maintenance of systolic blood pressure of more than 90 mm Hg. Art. In patients with low systolic pressure (less than 110 mm Hg), as well as in the elderly, treatment begins with a dose of 1.25 mg / day.

For asymptomatic left ventricular dysfunction apply 2.5 mg 2 times a day. The dose is increased by 2.5 mg every week to the optimum tolerated, but not more than 20 mg / day in 2 divided doses.

In patients with impaired renal function the initial dose of enalapril with creatinine clearance (CC) 80-30 ml / min is 5-10 mg / day, with CC 30-10 ml / min - 2.5-5 mg / day, with CC less than 10 ml / min - 1 , 25-2.5 mg / day only on dialysis days. The duration of treatment depends on the severity of the effect of the drug; in case of excessive hypotension, the dose of enalapril must be reduced.

Side effects

Often (≥ 1/10 ):

- visual impairment, in the form of blurred vision

• dizziness

Often (≥ 1/100- < 1/10 ):

hypotension (including orthostatic hypotension), syncope, pain in chest, cardiac arrhythmias, angina pectoris, tachycardia

headache, depression

fatigue

• diarrhea, abdominal pain, change in taste

  skin rash, angioedema of the face, limbs, lips, tongue, glottis and / or larynx

  hyperkalemia, increased creatinine levels

Sometimes (≥ 1/1 000 - < 1/100 ):

orthostatic hypotension, palpitations, myocardial infarction, or cerebral stroke, presumably as a result of an excessive drop in blood pressure in patients with high risk factors

confusion, drowsiness, insomnia, nervousness, dizziness, paresthesia

heartbeat

intestinal obstruction, pancreatitis, vomiting, dyspepsia, constipation, lack of appetite, symptoms of stomach irritation, dry mouth, peptic ulcer

anemia (including aplastic and hemolytic anemia)

rhinorrhea, sore throat and hoarseness, bronchospasm / asthma

sweating, itching, urticaria, alopecia

impaired renal function, renal failure, proteinuria

impotence

muscle cramps, hot flashes, tinnitus, malaise, fever

increased urea levels, hyponatremia, hypoglycemia

Seldom (≥ 1/10 000 - < 1/1000 ):

liver failure, hepatitis, cholestasis, jaundice, increased activity of "hepatic" transaminases, hyperbilirubinemia

neutropenia, decreased hemoglobin and hematocrit, thrombocytopenia, agranulocytosis, bone marrow suppression, pancytopenia, enlarged lymph nodes, autoimmune diseases

changes in the nature of dreams, sleep disturbances

raynaud's syndrome

pulmonary infiltrates, rhinitis, allergic alveolitis / eosinophilic pneumonia

stomatitis / aphthous ulcers, glossitis

liver failure, hepatitis - hepatocellular or cholestatic, including hepatic necrosis, cholestasis (including jaundice)

erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma

oliguria

gynecomastia

increased levels of liver enzymes, increased serum bilirubin levels

Rarely (< 1/10 000 ):

angioedema of the intestine

Frequency unknown:

Parkhon's syndrome (syndrome of inappropriate antidiuretic hormone secretion)

A symptom complex has been reported, which may be accompanied by some or all of the following side effects: fever, serositis, vasculitis, myalgia / myositis, arthralgia / arthritis, increased antinuclear antibody (ANA) titer, increased ESR, eosinophilia and leukocytosis. Skin rash, photosensitivity, or other skin manifestations may occur.

Contraindications

Hypersensitivity to enalapril, drug components or other ACE inhibitors

Hereditary or angioedema that occurs after

the use of angiotensin-converting enzyme inhibitors in

anamnesis

Porphyria

Primary hyperaldosteronism

Hyperkalemia (more than 6 mmol / L)

Aortic stenosis or low-output hypertrophic cardiomyopathy

Leukopenia or thrombocytopenia

Bilateral renal artery stenosis or stenosis of an artery of a solitary kidney

Hereditary fructose intolerance, Lapp-lactase enzyme deficiency, glucose-galactose malabsorption

Pregnancy and lactation

Children and adolescents up to 18 years old

Drug interactions

Food intake does not affect the absorption of enalapril.

With the simultaneous use of enalapril and potassium-sparing diuretics (spironolactone, triamterene, amiloride) or potassium preparations development of hyperkalemia is possible. With the simultaneous use of enalapril with diuretics, beta-blockers, methyldopa, nitrates, calcium channel blockers, hydralazine, prazosin it is possible to increase the hypotensive effect. When used simultaneously with non-steroidal anti-inflammatory drugs (including with acetylsalicylic acid) it is possible to reduce the effect of enalapril and increase the risk of developing renal dysfunction. Enalapril weakens the effect of drugs containing theophylline. With the simultaneous use of enalapril and lithium preparations, the excretion of lithium slows down and its effect is enhanced (control of the concentration of lithium in the blood plasma is shown). With the simultaneous use of enalapril and cimetidine, the half-life of enalapril is lengthened.

The simultaneous use of ACE inhibitors and antidiabetic drugs (insulin, oral hypoglycemic agents) can cause a decrease in blood glucose levels, which is accompanied by the risk of hypoglycemia. This effect is more often observed during the first weeks of combination treatment, as well as in patients with impaired renal function.

Sympathomimetics can weaken the antihypertensive effect of ACE inhibitors. Rarely, the occurrence of nitritoid reactions (facial flushing, nausea, vomiting and arterial hypotension) has been reported in patients who receive treatment with gold injections (sodium aurothiomalate) and at the same time ACE inhibitors, including enalapril.

Concomitant use of other antihypertensive drugs or vasodilators may enhance the hypotensive effect of enalapril.

Alcohol enhances the hypotensive effect of ACE inhibitors.

special instructions

Symptomatic hypotension

Hypotension is rare in uncomplicated arterial hypertension.

With a lack of fluid in the body, for example, as a result of diuretic therapy, depleted diet, dialysis, diarrhea or vomiting in patients suffering from arterial hypertension, symptomatic hypotension develops more often during treatment with Enalapril. Patients with heart failure - with or without renal failure - have symptomatic hypotension. In particular, this may apply to patients with severe heart failure, the severity of which is expressed in high doses of loop diuretics, hyponatremia, or decreased renal function. Treatment of such patients - if a new dose of Enalapril and / or a diuretic is to be selected - must be started and carried out under the supervision of a physician. This is also the case for patients with coronary artery disease or cerebrovascular disease, in whom an excessive drop in blood pressure can lead to myocardial infarction or cerebral stroke.

If hypotension develops, the patient should be laid down in a horizontal position and, if necessary, administered an intravenous infusion of sodium chloride solution. A transient hypotonic reaction is not a contraindication for further treatment, which, as a rule, can be carried out without problems after the normalization (by means of replenishing the circulating blood volume) blood pressure.

In some patients with heart failure, whose blood pressure is normal or low, under the influence of Enalapril, a further decrease in systemic blood pressure may occur. This is by no means an unexpected effect, usually, is not a reason for discontinuation of the drug. If the decrease in blood pressure becomes symptomatic, i.e. will be accompanied by symptoms, it may be necessary to reduce the dose of Enalapril and / or a diuretic and / or discontinue Enalapril.

Aortic or mitral stenosis / hypertrophic cardiomyopathy

As with other vasodilators, it is recommended special care when using an ACE inhibitor in patients who have valve obstruction and obstruction in the outflow tract in the left ventricle. In shock, accompanied by circulatory failure, and hemodynamically obvious obstruction in the outflow tract, the use of these drugs should be avoided.

Renal dysfunction

In patients with decreased renal function (creatinine clearance< 80 мл/мин) начальную дозу эналаприла малеата следует подбирать в зависимости от клиренса креатинина у пациента.

The maintenance dose is selected depending on the patient's response to treatment. In these patients, serum potassium and creatinine control is routine as part of their usual medical supervision.

In particular, renal failure has been reported in association with the use of enalapril maleate in patients with severe heart failure or with underlying renal disease, including renal artery stenosis. With timely diagnosis and appropriate treatment, renal failure during therapy with enalapril maleate is usually reversible.

In some patients with arterial hypertension who do not have kidney disease, the combination of enalapril maleate with a diuretic can lead to an increase in serum urea and creatinine levels. In such cases, it may be necessary to reduce the dose of enalapril maleate and / or withdraw the diuretic. In this case, one must think about the possible stenosis of the renal arteries as the cause of these phenomena.

Renovascular hypertension

In patients with bilateral renal artery stenosis or renal artery stenosis in a single functioning kidney, treatment with an ACE inhibitor poses a particular risk of falling blood pressure or developing renal failure. In this case, loss of renal function may occur, often manifested only by mild changes in serum creatinine levels. Treatment of these patients should be started with low doses and under strict medical supervision, carefully titrating the dose and monitoring renal function.

Kidney transplant

There is no experience with the use of Enalapril in patients who have recently undergone kidney transplantation. Therefore, the treatment of such patients with this drug is not recommended.

Liver failure

In the treatment of ACE inhibitors, a syndrome was occasionally observed, starting with cholestatic jaundice and progressing to fulminant hepatic necrosis (sometimes fatal). The pathogenesis of this syndrome is unclear. In the case of patients who develop jaundice or a clear increase in the level of liver enzymes during the treatment of an ACE inhibitor, the abolition of the ACE inhibitor and appropriate treatment is necessary.

Neutropenia / agranulocytosis

Neutropenia / agranulocytosis, thrombocytopenia and anemia have been reported in patients receiving an ACE inhibitor. In patients with normal renal function and no specific risk factors, neutropenia is rare. Enalapril maleate should be used with extreme caution in patients suffering from collagenoses with involvement of the vascular process, as well as being treated with immunosuppressants, allopurinol, procainamide, or in patients with several of these risk factors, enalapril maleate should be used with extreme caution, especially if there is a decrease in renal function. Some of these patients experienced severe infectious diseases, which in some cases did not respond to intensive antibiotic therapy. If these patients are taking enalapril maleate, then they are recommended to regularly monitor the number of leukocytes, and they should also be obliged to inform their doctor about all signs of any infection.

Hypersensitivity / angioedema

Angioneurotic edema has been reported involving the face, limbs, lips, tongue, vocal folds and / or larynx in patients treated with an ACE inhibitor, including Enalapril. During treatment, they can appear at any time. In these cases, Berlipril® must be canceled immediately. To ensure that symptoms have reversed completely before discharge from the hospital, the patient must be closely monitored. Even if angioedema affects only the tongue in the absence of respiratory failure, long-term observation is still necessary, since the administration of antihistamines and corticosteroids may not be enough.

Extremely rare cases of death have been reported against the background of the development of angioedema of the larynx or tongue. Swelling of the tongue, epiglottis, or larynx increases the risk of obstruction respiratory tractespecially in patients who have undergone airway surgery. Angioneurotic edema involving the larynx can be fatal. If the tongue, vocal folds, or larynx are involved and there is a threat of airway obstruction, appropriate treatment should be initiated immediately (eg, subcutaneous administration of 0.3-0.5 ml epinephrine solution [dilution 1: 1,000]) and / or measures should be taken to ensure airway patency ...

In black patients, compared with non-black patients, a higher incidence of angioedema was reported with ACE inhibitors.

Patients with a history of angioedema caused by a non-ACE inhibitor may have an increased risk of developing it when taking an ACE inhibitor.

Anaphylactic reactions during desensitizing therapy against Hymenoptera venom

Occasionally when performing desensitizing therapy against a poison insects, and simultaneous use Anaphylactic reactions that are life-threatening have been observed with ACE inhibitors. If specific immunotherapy (desensitization) directed against the poison is indicated insects, the ACE inhibitor must be temporarily replaced with other agents for the treatment of arterial hypertension or heart failure.

Anaphylactic reactions during LDL apheresis (low density lipoprotein plasmapheresis)

During LDL apheresis with dextran sulfate and concomitant use of an ACE inhibitor, life-threatening anaphylactic reactions have occasionally occurred. If LDL apheresis is indicated, then the ACE inhibitor must be temporarily replaced with other drugs for the treatment of hypertension or heart failure.

Patients undergoing hemodialysis treatment

Anaphylactoid reactions have been reported with the use of high-flux membranes (eg, “AN 69”) during dialysis and concomitant use of an ACE inhibitor. For such patients, the question of using a different type of membrane for dialysis or prescribing an antihypertensive drug of a different class should be considered.

Hypoglycemia

Patients suffering from diabetes mellitus and being treated with oral antidiabetic drugs or insulin, at the beginning of treatment with an ACE inhibitor, should be advised of the need for careful monitoring of blood glucose levels, especially in the first month of concomitant use of these drugs.

Cough

Cough has been reported associated with the use of an ACE inhibitor. The absence of sputum is typical, the cough is persistent and disappears after treatment is discontinued. When differential diagnosis cough should also take into account the cough caused by the ACE inhibitor therapy.

Surgery / Anesthesia

In patients undergoing major surgery or anesthesia with drugs that lower blood pressure, enalapril maleate inhibits the production of angiotensin II in response to compensatory renin secretion. With the development of hypotension on this basis, it can be corrected by replenishing the volume of circulating blood.

Hyperkalemia

In some patients treated with ACE inhibitors, including enalapril, an increase in serum potassium concentration was observed. Risk factors for the development of hyperkalemia are: renal failure, impaired renal function, elderly age (over 70 years of age), diabetes mellitus, intercurrent factors such as dehydration, acute cardiac decompensation, metabolic acidosis and concomitant treatment with potassium-sparing diuretics (e.g. spironolactone, eplerenone, triamterene or amiloride), taking potassium or potassium-containing salt substitutes, and simultaneous treatment with other drugs that can lead to an increase in serum potassium levels (eg, heparin). When using potassium preparations, potassium-sparing diuretics and salt substitutes containing potassium, in patients with impaired renal function, a significant increase in the concentration of potassium in the blood is possible. Hyperkalemia can cause the development of severe arrhythmias, including fatal ones. If the use of the above drugs simultaneously with enalapril is still considered appropriate, then treatment should be carried out with caution, regularly monitoring the concentration of potassium in the blood serum.

Lithium

Double blockade of the renin-angiotensin-aldosterone system (RAAS)

There is evidence that the combined use of ACE inhibitors, angiotensin II receptor blockers or aliskiren increases the risk of arterial hypotension, hyperkalemia and decreased renal function (including acute renal failure). Therefore, carrying out a double blockade of the RAAS with the joint administration of ACE inhibitors, angiotensin II receptor blockers or aliskiren is not recommended.

If dual blockade therapy is absolutely necessary, then it should only be carried out under the supervision of a specialist, as well as with close monitoring of renal function, electrolyte content and blood pressure.

The combined use of ACE inhibitors and angiotensin II receptor blockers is contraindicated in patients with diabetic nephropathy.

Lactose

Enalapril contains lactose. Therefore, patients suffering from rare hereditary galactose intolerance, lactase deficiency in the body or glucose-galactose malabsorption syndrome should not take this drug. The lactose content in one Enalapril tablet does not exceed 200 mg.

Ethnic differences

The severity of the hypotensive effect of enalapril - as in the case of other ACE inhibitors - in black patients, obviously, may be less than in non-black patients; this is presumably due to the fact that black patients with arterial hypertension often have decreased plasma renin levels.

Pregnancy and lactation.

The drug is not prescribed during pregnancy, since ACE inhibitors can cause disease or death of the fetus or newborn, including arterial hypotension, renal failure, hyperkalemia, hypoplasia of the newborn's skull, and oligohydramnios may also develop (contracture of the limbs, deformation of the facial bones of the skull, lung hypoplasia).

The drug in trace concentrations is excreted in breast milk. If necessary, use it during lactation, breast-feeding must stop.

Features of the effect of the drug on the ability to manage vehicle and other potentially dangerous mechanisms.

During the period of using the drug, you should, if possible, refrain from any activity associated with driving a vehicle and potentially dangerous mechanisms, due to the possible development of side effects such as dizziness.

Overdose

Symptoms: arterial hypotension. Taking enalapril at a dose of 300-400 mg leads to the emergence of a drug level in the blood 100-200 times higher than the therapeutic one. Characterized by the development of acute arterial hypotension up to collapse, cerebrovascular accident, myocardial infarction, thromboembolism or angioedema, stupor and seizures may also develop.

Treatment: drug withdrawal, gastric lavage using activated carbon, appointment of saline laxatives, transfer of the patient to a horizontal position with raised legs, replenishment of the circulating blood volume with isotonic sodium chloride solution and plasma-substituting solutions, supportive and symptomatic therapy. In severe cases, hemodialysis is performed.

Enalapril belongs to a group of synthetic drugs designed to lower blood pressure. He has long been known to hypertensive patients and enjoys well-deserved recognition from them.

This medication requires careful use.

Therefore, it should not be taken without consulting a doctor. It is also important to familiarize yourself with the provisions of the instructions for use.

Features of form and composition

Enalapril is produced in the form of tablets with active ingredient enalapril 5, 10 and 20 mg in each tablet.

Auxiliary components are presented:

• lactose monohydrate,
• magnesium carbonate,
• gelatin,
• magnesium stearate,
• crospovidone.

The number of tablets in a blister strip packaging is 20 or 30.

The instructions state that the packaging with the medicine should be stored in conditions protected from moisture and at a temperature of 15 to 25 ° C. Children should not have access to medicine. Its shelf life is three years. After this time, the product cannot be used.

Therapeutic properties

Enalapril has a hypotensive effect (gradually lowers blood pressure).

To others medicinal properties drugs include:

• dilates blood vessels,
• reduces vascular resistance at the periphery,
• reduces the load on the myocardium,
• lowers pressure in the area of \u200b\u200bthe pulmonary circulation,
• increases the ability to withstand physical exercise,
• reduces deformities in the left ventricle,
• improves the picture of glomerular hemodynamics in the kidneys (preventing diabetic nephropathy).

The drug promotes the expansion of arteries more than veins, without a reflex jump in pulse readings. The maximum result is formed after 6-8 hours from the moment of reception and lasts for a day.

Stable therapeutic effect formed after a few weeks of therapy. You can read about the results of treatment in the reviews posted at the end of the text.

About 60% of the amount of the dose taken undergoes rapid absorption from the gastrointestinal tract. Drug metabolism occurs in the liver. It is excreted from the body in the bulk by the kidneys, as well as by the intestines.

Video

For the opinion of doctors about the drug, see the video:

Indications for use

According to the instructions, Enalapril is indicated for:

• arterial hypertension at any stage (including renovascular),
• dysfunction of the left ventricle,
• diabetic nephropathy,
• heart failure in chronic form (as an element of complex treatment).

Contraindications

The range of contraindications for the drug included:

• angioedema due to the use of ACE inhibitors,
• quincke's edema of a hereditary nature,
• porphyria,
• disruption of the kidneys and stenosis of their arteries,
• azotemia,
• hyperkalemia,
• after kidney transplant,
• states of pregnancy and lactation,
• childhood less than 18 years of age (no data on safety and effectiveness),
• hypersensitivity to enalapril and other ACE inhibitors.

Conditions in which increased caution is required:

• systemic diseases connective tissue,
• cerebrovascular diseases,
• renal and hepatic impairment,
• stay on hemodialysis,
• diabetes mellitus (due to possible hyperkalemia),
• adherence to a salt-free diet,
• concurrent treatment with immunosuppressants and saluretics,
• advanced age (from 65 years).

Side effects

The instruction includes the possible negative consequences of taking Enalapril:

• too much lowering of blood pressure,
• chest pain
• orthostatic collapse,
• dizziness with headache,
• insomnia
• confused mind
• weakness,
• anxiety,
• depression,
• excessive fatigue,
• dyspeptic disorders,
• dry cough,
• bronchospasm,
• intestinal obstruction,
• itching and skin rash,
• stomatitis,
• impaired renal function,
• tides,
• decreased libido.

Attention! What not to forget during treatment!

The therapeutic effect of the drug will be maximal if we keep in mind the factors:

1. Before treatment and during admission, it is necessary to resort to periodic monitoring of blood pressure, hemoglobin, urea and other blood parameters, protein in urine.
2. If highly permeable dialysis membranes are used, the risk of anaphylactic reaction increases. On days when dialysis is not performed, dosage adjustments should be made based on pressure.
3. Patients with vascular and cardiac problems require careful monitoring during treatment.
4. With a sudden withdrawal of the drug, the "withdrawal" syndrome is not observed (a sharp jump in pressure).
5. Arterial hypertension in a patient can lead to an increase in creatinine and urea in the blood serum during treatment. These patients require monitoring of kidney function, especially during the first weeks of treatment. Dose reduction is possible.
6. If an examination of the work of the parathyroid glands is to be done, the medicine must be canceled.
7. The hypotensive effect of the drug increases from alcohol.
8. Before any surgery (including in dentistry) you need to warn the doctor about treatment with ACE inhibitors.
9. Before a constant dose of the drug is calculated, at the beginning of the intake, one should refrain from driving vehicles and work that requires concentrated attention and quick reactions. Dizziness may occur during this treatment period.

About the consequences of drug interactions

It is important to know about the combination of Enalapril with other drugs, as indicated by the instruction:

1. The combination with anti-inflammatory nonsteroidal drugs can reduce the hypotensive effect. The same result occurs when eating foods with high amounts of sodium chloride.
2. The addition of potassium-sparing diuretics (amyloid, spironolactone) to treatment is dangerous with hyperkalemia.
3. The combination with lithium salts is fraught with slowing down the elimination of lithium.
4. The effectiveness of the drug can be reduced by the simultaneous use of pain relievers and antipyretic drugs.
5. Enalapril reduces the effect medicines with theophylline.
6. The hypotensive effect of the drug is enhanced by diuretics, nitrates, beta-blockers, prazosin, methyldop, hydralazine.
7. From immunosuppressants, cytostatics, allopurinol, hematotoxicity increases.

Various aspects of practical use

General application scheme

Enalapril is administered orally regardless of food. The primary dose is determined depending on the level of the disease. Usually it is equal to a single dose per day from 2.5 to 5 mg. The initial dose should be taken under medical supervision for 2-3 hours until the pressure stabilizes.

If necessary, a single dose is increased to 20 mg and can be distributed in two divided doses per day. They switch to the usual maintenance dosage after two to three weeks. It is from 10 to 20 mg per day. The maximum amount of the drug is 40 mg per day (with normal tolerance).

Composition

each tablet contains: active substance enalapril maleate - 10.0 mg; auxiliary components: kollidone 25 (povidone), lactose, corn starch, aerosil 200 (colloidal silicon dioxide), magnesium stearate, crimson 4 R (E-124), orange yellow (E-110).

Description

The tablets are round, yellowish-pink in color, with a line on one side and a break line on the other side, inclusions are possible.

pharmachologic effect"type \u003d" checkbox "\u003e

pharmachologic effect

An ACE inhibitor is an antihypertensive agent. Suppresses the formation of angiotensin II from angiotensin I and eliminates its vasoconstrictor effect. The drug gradually lowers blood pressure without causing changes in heart rate and minute blood volume. Reduces the total peripheral vascular resistance, reduces afterload. It also reduces preload, lowers pressure in the right atrium and pulmonary circulation. The drug reduces left ventricular hypertrophy. The drug reduces the tone of the efferent arterioles of the renal glomeruli, thereby improving intraglomerular hemodynamics, and prevents the development of diabetic nephropathy.

The time of the onset of the hypotensive effect when oral administration - 1 hour, it reaches a maximum after 4-6 hours and lasts up to 24 hours. In some patients, to achieve optimal blood pressure levels, therapy is required for several weeks. In chronic heart failure, a noticeable clinical effect is observed with long-term treatment - 6 months or more.

Pharmacokinetics

After oral administration, approximately 60% of enalapril is absorbed from the gastrointestinal tract. It is metabolized in the liver with the formation of an active metabolite - enalaprilat. The maximum concentration of enalaprilat in the blood serum is reached 3-4 hours after administration.

The connection with plasma proteins of enalaprilat is 50-60%. The maximum concentration in blood plasma of enalapril is achieved after 1 hour, enalaprilat - 3-4 hours. Enalaprilat easily passes through the histohematogenous barriers, excluding the BBB, a small amount penetrates the placenta and into breast milk... The half-life of enalaprilat is 11 hours. It is excreted mainly by the kidneys - 60% (20% - in the form of enalapril and 40% - in the form of enalaprilat), through the intestines - 33% (6% - in the form of enalapril and 27% - in the form of enalaprilat). Removed by hemodialysis (speed
62 ml / min) and peritoneal dialysis.

4 days after the start of taking the drug, the half-life of enalaprilat stabilizes at 11 hours.

It is excreted by the kidneys.

Indications for use

Arterial hypertension treatment;

Treatment of clinically significant heart failure;

Prevention of clinically significant heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 35%).

Contraindications

Hypersensitivity to enalapril and other ACE inhibitors, history of angioedema, pregnancy (especially the second and third trimesters of pregnancy) , lactation, children under 18 years of age (safety and efficacy have not been determined).

Renal failure: creatinine clearance less than 10 ml / min (for this dosage form).

Concomitant use of angiotensin-converting enzyme inhibitors or ATP receptor blockers with Aliskiren in patients with diabetes mellitus or moderate / severe renal impairment (GFR< 60 мл/мин/1,73 м 2) противопоказано.

With caution: reduced function of the kidneys, liver, simultaneously with immunosuppressants, with bilateral renal artery stenosis.

Pregnancy and lactation

Pregnancy

Except in cases where it is impossible to replace the ACE inhibitor with another alternative therapy, patients planning a pregnancy should be transferred to antihypertensive therapy with drugs in which the safety profile for pregnant women is well understood. When pregnancy occurs, the ACE inhibitor should be discontinued immediately, and, if necessary, another antihypertensive therapy should be prescribed.

The use of ACE inhibitors is contraindicated in the second and third trimesters of pregnancy.

When using ACE inhibitors in the second and third trimesters of pregnancy, the manifestation of fetotoxic action (impaired renal function, oligohydramnios, delayed ossification of the skull bones) and neonatal toxicity (renal failure, hypotension, hyperkalemia) was established. In the event that an ACE inhibitor was taken from the second trimester of pregnancy, an ultrasound of the function of the kidneys and skull bones is recommended. In newborns whose mothers took ACE inhibitors, blood pressure should be carefully monitored to prevent possible development hypotension.

Lactation

During treatment, breastfeeding should be discontinued.

Enalapril in very low concentrations passes into breast milk. Although the concentrations generated can be considered clinically insignificant, the use of this drug during breastfeeding is not recommended in the case of premature births or in the first few weeks after birth due to the perceived risk of adverse effects on cardiovascular system and kidney, as well as insufficient clinical experience.

When feeding an older child, the use of these drugs is possible if therapy is considered necessary for the mother and the child's condition is monitored from the point of view of the possible development of any adverse reactions.

Method of administration and dosage

The drug should be taken at the same time of the day (regardless of food intake) with a small amount of liquid.

The dosage regimen is set individually, depending on the patient's condition.

In the treatment of arterial hypertension the drug is prescribed at an initial dose of 5 mg / day (in this case, it is recommended to use dosage form Enalapril - tablets 5 mg). After taking the initial dose, patients should be under medical supervision for 2 hours and an additional 1 hour until blood pressure stabilizes. Dose adjustment is carried out depending on the achieved clinical effect. Usually, the maintenance daily dose is from 10 to 20 mg, in exceptional cases - up to 40 mg in 1 or 2 doses. In the case of prescribing to patients simultaneously receiving diuretics, diuretic treatment should be discontinued 2 to 3 days before the appointment of enalapril. The initial dose for patients who received diuretics is 2.5 mg 1 time / day. When the initial dose of the drug is 2.5 mg, it is recommended to use the dosage form of Enalapril - tablets
2.5 mg.

For asymptomatic left ventricular dysfunction the recommended initial dose of the drug is 2.5 mg 2 times / day, in this case it is recommended to use the dosage form of Enalapril - 2.5 mg tablets. Dose adjustment is possible depending on the patient's condition. The average maintenance dose is 10 mg 2 times / day.

With chronic heart failurethe recommended initial dose of the drug is 2.5 mg 1 time / day, in this case it is recommended to use the dosage form of Enalapril - 2.5 mg tablets. The dose of the drug should be increased gradually until the maximum clinical effect is achieved; on average, it takes 2 to 4 weeks to find the optimal dose. The average maintenance dose is 2.5-10 mg 1 time / day, the daily maximum maintenance dose is 40 mg (divided into 2 doses).

In the treatment of hypertension in kidney disease the dosage regimen is set depending on the severity of renal dysfunction or on the values \u200b\u200bof creatinine clearance. The initial dose of the drug should be gradually increased until a satisfactory clinical effect is achieved. When creatinine clearance is 80-30 ml / min, the dose is usually 5-10 mg / day, creatinine clearance is 30-10 ml / min - 2.5-5 mg / day (if 2.5 mg is prescribed, it is recommended to use the dosage form of Enalapril - tablets 2.5 mg).

The duration of treatment depends on the effectiveness of therapy. With a too pronounced decrease in blood pressure, the dose of the drug is gradually reduced.

Patients with impaired renal function

Dosage for renal failure

The interval between enalapril doses should be increased and / or the dose reduced.

Enalapril is removed during dialysis. The dosage on non-dialysis days should be adjusted according to blood pressure.

If you need to take the drug in a dose of 2.5 mg or 5 mg, it is recommended to use the dosage form of Enalapril - 2.5 mg or 5 mg tablets.

Elderly patients

The dose should be adjusted according to the patient's renal function.

Children with arterial hypertension over the age of 6 years

Experience with the clinical use of enalapril in children with hypertension is limited.

For children who can swallow tablets, the dose should be assigned individually, according to the patient's condition, response to treatment and the patient's body weight.

The recommended starting dose is 2.5 mg for patients weighing from 20 to 50 kg (it is recommended to use the dosage form of Enalapril - tablets of 2.5 mg) and 5 mg for patients weighing ≥ 50 kg (it is recommended to use the dosage form of Enalapril - tablets 5 mg). Enalapril is taken 1 time per day. The dosage should be adjusted according to needs, up to a maximum of 20 mg per day for patients weighing 20 to 50 kg and 40 mg for patients weighing ≥ 50 kg.

Side effect

The following side effects are presented in accordance with the following gradations of the frequency of their occurrence: very often (\u003e 1/10); often (\u003e 1/100,<1/10); нечасто (>1/1000, <1/100); редко (>1/10000, <1/1000); очень редко (<1/10000) (включая отдельные сообщения), неизвестная частота (по имеющимся данным определить частоту встречаемости не представляется возможным).

From the side of the blood:rarely - anemia (including aplastic and hemolytic), neutropenia, decreased hemoglobin, decreased hematocrit, thrombocytopenia, agranulocytosis, bone marrow suppression, pancytopenia, lymphadenopathy, autoimmune diseases.

From the endocrine system:unknown - syndrome of impaired secretion of ADH.

Metabolic disorders:infrequently - hypoglycemia.

From the nervous system and psyche:often - depression, headache; rarely - confusion, drowsiness, insomnia, nervousness, paresthesia, vertigo, sleep disorders, abnormal dreams.

On the part of the organs of vision:very often - blurred vision.

On the part of the cardiovascular system:very often - dizziness; often - hypotension (including orthostatic hypotension), syncope, chest pain, rhythm disturbances, angina pectoris, tachycardia; rarely - orthostatic hypotension, tachycardia, myocardial infarction or stroke (possibly as a result of excessive pressure reduction in high-risk patients), Raynaud's phenomenon.

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

From the digestive tract:very often - nausea; often - diarrhea, abdominal pain, change in taste; rarely - intestinal obstruction, pancreatitis, vomiting, dyspepsia, constipation, anorexia, stomach irritation, dry mouth, peptic ulcers, stomatitis / aphthous ulcers, glossitis; very rarely - angioedema of the intestine.

From the digestive system:rarely - liver failure, hepatitis hepatocellular or cholestatic, hepatitis, including necrosis, cholestasis (including jaundice).

On the part of the skin and subcutaneous tissues:often - rash, hypersensitivity / angioedema of the face, limbs, lips, tongue, glottis and / or larynx; infrequently - increased sweating, itching, urticaria, alopecia; rarely - multiple erythema, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma.

The development of a complex symptom complex was reported, which included some or all of such manifestations as: fever, serositis, vasculitis, myalgia / myositis, arthralgia / arthritis, a positive test for antinuclear antibodies, increased ESR, eosinophilia and leukocytosis. Rash, photosensitivity and other skin reactions can occur as side effects.

From the urinary system:infrequently - impaired renal function, renal failure, proteinuria; rarely oliguria.

On the part of the reproductive system:infrequently - impotence; rarely, gynecomastia.

General violations:very often - asthenia; often - fatigue; infrequently - muscle cramps, hot flashes, ringing in the ears, discomfort, fever.

Changes in laboratory parameters:often - hyperkalemia, increased serum creatinine levels; rarely - an increase in the level of urea in the blood, hyponatremia, an increase in liver enzymes, bilirubin in the blood serum.

Overdose

Data on overdose in humans are limited. The most characteristic features of an overdose registered to date are severe arterial hypotension, which begins approximately 6 hours after taking the pill, simultaneously with blockade of the renin-angiotensin system, stupor. Symptoms associated with an ACE inhibitor overdose may include circulatory shock, electrolyte disturbances, kidney failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, restlessness, and coughing.

The recommended treatment for overdose is intravenous saline. If hypotension occurs, the patient is laid horizontally with raised legs. Consideration should be given to intravenous infusion of angiotensin II and / or catecholamines. If the drug has been recently taken, measures should be taken to remove enalapril maleate (eg, vomiting, gastric lavage, administration of sorbents and sodium sulfate). Enalapril can be removed from the general circulation by hemodialysis. With therapy-resistant bradycardia, the use of pacemakers is indicated. You should constantly monitor the basic vital functions, the concentration of serum electrolytes and creatinine.

Interaction with other medicinal products

With simultaneous administration with potassium-sparing diuretics or potassium preparations, hyperkalemia may develop. With simultaneous use with diuretics, beta-blockers, methyldopa, nitrates, calcium channel blockers, hydralazine, prazosin, an increase in the hypotensive effect is possible. With simultaneous use with NSAIDs (including acetylsalicylic acid), it is possible to reduce the effect of enalapril and increase the risk of developing renal dysfunction. With simultaneous use with ethanol, as well as agents for general anesthesia, the risk of developing arterial hypotension increases. Enalapril weakens the effect of drugs containing theophylline. With simultaneous use with lithium preparations, the excretion of lithium slows down and its effect increases. With simultaneous use with cimetidine, the half-life of enalapril is lengthened.

Double blockade of the renin-angiotensin-aldosterone system

Based on the available data, dual blockade of RAAS using an ACE inhibitor, ARB II or Aliskiren cannot be recommended for any patient, especially for patients with diabetic nephropathy.

In patients with diabetes mellitus or moderate / severe renal impairment (GFR<60мл/мин/1,73 м 2) одновременное применение Алискирена с иАПФ или БРА II противопоказано.

In some cases, when the combined use of an ACE inhibitor and ARB II is absolutely indicated, careful supervision of a specialist and mandatory monitoring of renal function, water and electrolyte balance, and blood pressure is necessary.

Gold preparations

There have been sporadic reports of nitritic reactions (symptoms include facial flushing, nausea, vomiting, and hypotension) in patients receiving injectable gold preparations (sodium aurothiomalate) and ACE inhibitors, including enalapril.

Antidiabetic drugs

Epidemiological studies suggest that the simultaneous use of ACE inhibitors and antidiabetic drugs (insulin, oral antidiabetic drugs) can lead to a marked decrease in blood sugar levels with the risk of hypoglycemia. This phenomenon is most likely to occur in patients with kidney damage during the first weeks of combination treatment.

Tricyclic antidepressants / neuroleptics / anesthetics / narcotics

The simultaneous use of certain anesthetics, tricyclic antidepressants and antipsychotics with ACE inhibitors can lead to an additional decrease in blood pressure.

Enalapril. Serum potassium should also be monitored during treatment. Arterial hypotension often develops against the background of hypovolemia, restriction of salt intake, during hemodialysis, against the background of diarrhea or vomiting, during surgery or anesthesia using compounds that cause arterial hypotension.

In cases where hypotension becomes persistent, the dose should be reduced and / or diuretic treatment should be discontinued and / or enalapril.

In patients with bilateral renal artery stenosis or stenosis of a solitary kidney artery, arterial hypotension that develops after starting treatment enalapril, can lead to deterioration of renal function, increased serum urea and creatinine.

Upon appointment enalapril, rare cases of angioedema are described (more often in patients of the Negroid race). In such cases, you should immediately stop treatment and establish constant monitoring of the patient until the symptoms disappear completely. At the same time, antihistamines have a positive effect. With the development of suffocation against the background of edema, a solution of epinephrine (adrenaline) 0.1% (0.3-0.5 ml) should be administered subcutaneously and / or measures should be taken to ensure airway patency.

In rare cases, taking ACE inhibitors against the background of hyposensitization with Hymenoptera allergens or dialysis using high-throughput membranes (for example, AN69) causes severe anaphylactoid reactions. In such patients, the use of antihypertensive drugs of a different class is recommended.

There have been reports of the occurrence of a reversible, unproductive cough during treatment with ACE inhibitors.

In patients who received enalapril within 48 weeks, an increase in serum potassium of 0.02 mEq / L is observed. When treating with enalapril, serum potassium should be monitored.

Release form

10 tablets in a blister strip packaging. 3 contour packages, together with instructions for use, are placed in a cardboard box.

Storage conditions

In a place protected from moisture at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life

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