The information is intended for specialists and students of medical universities. Do not self-medicate; consult a doctor for qualified help.

Recipe for enalapril (enap) solution in ampoules in Latin

Recipe for enalapril (enap) tablets in Latin

General information:

Active ingredient: Enalapril (INN)

Pharmacological group: ACE inhibitors

Recipe form: N 107-1/у

Use with caution in patients with reduced renal and liver function. Do not take during pregnancy and lactation.

Enalapril - instructions for use, analogues, reviews, price

The drug Enalapril

Release forms

Instructions for use of Enalapril

Indications for use

2. Secondary arterial hypertension in the presence of kidney disease.

3. Chronic heart failure and asymptomatic left ventricular dysfunction (as part of combination treatment).

Contraindications

• Previous presence of angioedema, including due to taking Enalapril and other ACE inhibitors;
• Porphyria;
• Pregnancy;
• Lactation;
• Hypersensitivity to drugs of this class.

Due to the risk of a sharp decrease in pressure, the drug is prescribed with caution for decompensated forms of coronary heart disease, for bilateral narrowing of the renal arteries, stenosis of the artery of a single kidney, cerebrovascular diseases, and for any other diseases that cause an obstruction to the outflow of blood from the left ventricle.

Side effects

There is also evidence of the occurrence of a complex of symptoms: fever, vasculitis, myalgia or myositis.

Treatment with Enalapril

In accordance with the doctor's prescription, the drug is taken 1-2 times a day, regardless of meals. Combined Enalapril preparations containing diuretics are best taken in the morning. Treatment with the drug is long-term and, if well tolerated, throughout life.

For arterial hypertension, they usually start with a dose of 5 mg/day. If the effect is insufficient, the dose is increased to 10 or 20 mg - 1-2 times a day. The maximum dose prescribed is 40 mg 2 times a day.

Interaction of Enalapril with other drugs

Enalapril's analogs

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

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Enalapril

Description current as of 10/25/2014

• Latin name: Enalapril
• ATX code: C09AA02
• Active ingredient: Enalapril
• Manufacturer: Hexal AG (Germany)

Compound

The tablets contain the active ingredient enalapril in doses of 5, 10, 20 mg, as well as excipients: gelatin, lactose monohydrate, magnesium stearate, magnesium carbonate and crospovidone.

Release form

Tablets, 10 pieces in a blister, 2 blisters in a pack.

It is produced by different pharmaceutical companies, as a result of which the name of the company is added to the name of the active substance in the name of the drug, for example: Enalapril-Health.

pharmachologic effect

The medication reduces blood pressure, expands the lumen of blood vessels, and has a cardioprotective and natriuretic effect. The drug belongs to the group of angiotensin-converting enzyme inhibitors.

Pharmacological group: ACE inhibitors.

Pharmacodynamics and pharmacokinetics

According to the abstract, the mechanism of action is the inhibition of angiotensin-converting enzyme (ACE) by Enalapril, from which a decrease in the biosynthesis of angiothepsin II leads to vasodilation, the production of PGE2 and bradykinin, which are powerful vasodilators.

In patients with heart failure, with long-term use (6 months or more), there is an increase in the heart's tolerance to physical activity, a decrease in heart size, and a decrease in the number of deaths. Under the influence of the drug, the pulmonary circulation is unloaded, pressure in the pulmonary capillaries decreases, peripheral resistance decreases, and cardiac output increases (heart rate does not increase).

The absorption of the drug Enalapril reaches 60%, regardless of the intake and presence of food in the gastrointestinal tract. The maximum concentration of the active substance enalaprilat is observed 1 hour after use. In the liver it is biotransformed to enalaprilat. It easily passes through the placenta and histohematic barriers. Excreted by the kidneys. The hypotensive effect is recorded 1 hour after drug administration and lasts for a day. To achieve optimal blood pressure results, several weeks of regular use of Enalapril are required.

Indications for use of Enalapril

What are Enalapril tablets for?

Indications for the use of Enalapril are as follows: hypertension, Raynaud's disease, heart failure, symptomatic arterial hypertension, diabetic nephropathy, scleroderma, secondary hyperaldosteronism. Enalapril is prescribed as part of complex therapy for the treatment of angina pectoris, myocardial infarction, and chronic renal failure. Use tablets for high blood pressure.

Contraindications

Hypersensitivity to ACE inhibitors, renal artery stenosis, azotemia, hyperaldosteronism, hyperkalemia, renal dysfunction, Quincke's edema (hereditary), aortic stenosis, childhood. Enalapril is not prescribed to pregnant women.

Side effects

The drug has the following side effects: increased fatigue, dizziness, headache, convulsions, nervousness, insomnia, glossitis, tinnitus, dry cough, nausea, orthostatic hypotension, palpitations, dyspeptic disorders, proteinuria, impotence, disorders of the liver, kidneys, hyperkalemia, Quincke's edema, neutropenia, increased bilirubin levels in the blood, hair loss, pain in the heart, increased concentrations of liver transaminases.

Enalapril tablets, instructions for use (Method and dosage)

The medicine is taken orally. The initial dosage is 5 mg per day, the drug is taken once a day. In case of pathology of the renal system or taking diuretics, the dose is reduced to 2.5 mg. To achieve an effect, depending on individual characteristics, the dose of the drug can be increased to 1 mg per day (can be divided into 2 doses).

Instructions for use Enalapril Hexal

The drug is used regardless of meals.

For arterial hypertension, you should take 5 mg of enalapril maleate in the morning. The maintenance dose is 10 mg. You should not take more than 40 mg of the drug per day.

For chronic heart failure, take 2.5 mg of the medication in the morning. The maintenance dose is 5-10 mg. You should not take more than 20 mg of the drug per day.

For left ventricular dysfunction, take 2.5 mg twice daily. The maintenance dose is 10 mg twice daily.

How to take if you have kidney problems? In this situation, take 2.5 mg per day. The maintenance dose is usually 5-10 mg. The maximum dose is 20 mg per day.

Instructions for use Enalapril Acri

Anytime. Initially, take 2.5–5 mg once every 24 hours. The maintenance dose is 10–20 mg once every 24 hours. The maximum dose is 40 mg in 1–2 doses.

Instructions for Enalapril FPO

Similar to the dosage method of the previous drug.

Enalapril N dosage regimen

1-2 tablets every 24 hours, regardless of meals.

Overdose

Excessive drop in blood pressure, myocardial infarction, stroke, thromboembolic complications as a consequence of a sharp decrease in blood pressure. Treatment: intravenous administration of NaCl (isotonic solution). There is no specific antidote.

Interaction

Absorption of the drug does not depend on food intake. When taken simultaneously with beta-adrenergic receptor blockers, nitrates, methyldopa, calcium antagonists, Prazosin, hydralazines, Enalapril potentiates the hypotensive effect. Cimetidine increases T1/2 of the drug. NSAIDs increase nephrotoxicity and reduce the effectiveness of Enalapril. Potassium supplements and potassium-sparing diuretics when taken with drugs lead to hyperkalemia. Enalapril reduces the half-life of theophylline and reduces the clearance of lithium. The drug does not interact with cardiac glycosides.

Terms of sale

Storage conditions

At temperatures up to 25 degrees Celsius in a dry place out of reach of children.

Best before date

No more than 3 years.

special instructions

In the first hours of taking Enalapril can lead to a pronounced decrease in blood pressure. This is especially evident in people taking an antihypertensive drug for the first time, in patients with chronic renal failure, severe heart failure, hypovolemia, and hyponatremia. To prevent a sharp decrease in blood pressure, diuretics and a salt-free diet are discontinued 2-3 days before taking Enalapril. If angioedema develops on the face and neck, it is necessary to stop taking medications and prescribe antihistamines. In severe cases, intubation and tracheotomy are performed. It is not recommended to prescribe potassium-sparing diuretics at the same time. It is necessary to regularly monitor hemostasis. Enalapril is not prescribed to women planning pregnancy.

The medicine is registered by WHO according to the Vidal reference book.

Often used with hydrochlorothiazide as a combination agent.

Recipe in Latin: Tab. Enalaprili 0.01

INN: Enalapril.

Enalapril's analogs

Lisinopril or Enalapril - which is better?

Based on research, lisinopril lowers blood pressure more effectively and also lasts for a longer period of time. Both drugs are tolerated approximately equally.

Enap and Enalapril - what is the difference?

In fact, the drugs are no different, since they have the same active substance. However, the price of Enap is much higher than its analogue.

Enalapril and Enalapril Hexal

The drug is also produced by Hexal, which is why it has the corresponding addition in the name.

Reviews of Enalapril

Reviews from doctors boil down to the fact that this is a very effective, widely used, high-quality drug for blocking ACE. It does reduce blood pressure, however, it has a number of contraindications and side effects, for example, cough.

Reviews about Enalapril Hexal on forums are generally also positive. The drug effectively lowers blood pressure, is inexpensive, but has frequent side effects.

Enalapril price, where to buy

The medicine is sold in rubles.

How much does Enalapril 10 mg cost? About 15 rubles.

The price of Enalapril Hexal is 85 rubles per pack of 20 pieces of 20 mg.

• Online pharmacies in Russia Russia
• Online pharmacies in Ukraine Ukraine
• Online pharmacies in Kazakhstan Kazakhstan

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BIOSPHERE

Education: Graduated from the Bashkir State Medical University with a degree in General Medicine. In 2011, she received a diploma and certificate in Therapy. In 2012, she received 2 certificates and diplomas in “Functional Diagnostics” and “Cardiology”. In 2013, she took courses on “Current issues in otorhinolaryngology in therapy.” In 2014, she completed advanced training courses in the specialty “Clinical Echocardiography” and courses in the specialty “Medical Rehabilitation”.

Work experience: From 2011 to 2014, she worked as a therapist and cardiologist at the Municipal Budgetary Healthcare Institution Polyclinic No. 33 in Ufa. Since 2014, he has been working as a cardiologist and functional diagnostics doctor at the Municipal Budgetary Healthcare Institution Polyclinic No. 33 in Ufa.

When using enalapril, an allergic cough appeared. For a long time I couldn’t understand why. I thought there was something wrong with my lungs. I was examined - my lungs are fine. And the cough just exhausted me. I had fits, coughed so bad that I had to run out of public places so as not to literally scare people. The blessing came when a relative came to visit, and she suggested that there were friends in her circle who had gone through this while taking enalapril. The cough stopped when I switched to another drug

An excellent drug for normalizing blood pressure. Without him, my grandmother is like without hands.

Pohudet.Org: When vodka is infused with something, the percentage of alcohol in it decreases and becomes much worse.

Vladimir: Personally, these pills help me, of course, I get a little sleep on the first night, but the sun goes crazy.

Lera: I was convinced from my own experience that ingavirin works.

Diana: I agree with Nika. When I have congestion, I also always use Aquamaster, it’s great.

All materials presented on the site are for reference and informational purposes only and cannot be considered a treatment method prescribed by a doctor or sufficient advice.

Enalapril

Structural formula

Russian name

Latin name of the substance Enalapril

Chemical name

(S)-1--L-alanyl]-L-proline (and as maleate)

Gross formula

Pharmacological group of the substance Enalapril

Nosological classification (ICD-10)

CAS code

Characteristics of the substance Enalapril

An ACE inhibitor, related to drugs that affect the RAAS. It is a derivative of the amino acids L-alanine and L-proline.

Pharmacology

An antihypertensive drug used for the treatment of essential hypertension (primary arterial hypertension of any severity) and renovascular hypertension, both in monotherapy and in combination with other antihypertensive drugs, in particular diuretics. Enalapril is also used to treat or prevent the development of heart failure.

After oral administration, enalapril is rapidly absorbed and hydrolyzed into enalaprilat, which is a highly specific and long-acting ACE inhibitor that does not contain a sulfhydryl group.

ACE (peptidyl dipeptidase A) catalyzes the conversion of angiotensin I to the vasopressor peptide angiotensin II. ACE inhibition leads to a decrease in the concentration of angiotensin II in the blood plasma, which entails an increase in plasma renin activity (due to the elimination of negative feedback in response to renin release) and a decrease in aldosterone secretion. At the same time, SBP and DBP, OPSS decrease, post- and preload on the myocardium decrease.

Enalapril dilates arteries to a greater extent than veins, and there is no reflex increase in heart rate.

ACE is identical to the enzyme kininase II, so enalapril can also block the destruction of bradykinin, a peptide that has a pronounced vasodilating effect. The significance of this effect in the therapeutic action of enalapril requires clarification. The main mechanism of the antihypertensive effect of enalapril is considered to be the suppression of the activity of the RAAS, which plays an important role in the regulation of blood pressure, but enalapril exhibits an antihypertensive effect even in patients with arterial hypertension and with reduced plasma renin activity. The antihypertensive effect is more pronounced at high renin concentrations than at normal or low levels.

The use of enalapril in patients with arterial hypertension leads to a decrease in blood pressure both in the standing and supine positions without a significant increase in heart rate. Symptomatic orthostatic (postural) hypotension rarely develops during treatment with enalapril.

Effective inhibition of ACE activity usually develops 2–4 hours after a single oral dose of enalapril. The antihypertensive effect develops within 1 hour, the maximum decrease in blood pressure is observed 4-6 hours after taking enalapril. The duration of action depends on the dose. When using recommended doses, the antihypertensive effect and hemodynamic effects persist for 24 hours after administration.

In some patients, achieving optimal blood pressure reduction may require several weeks of therapy. Interruption of enalapril therapy does not cause a sharp rise in blood pressure.

Antihypertensive therapy with enalapril leads to a significant regression of left ventricular hypertrophy and preservation of its systolic function.

In patients with essential hypertension, a decrease in blood pressure is accompanied by a decrease in peripheral vascular resistance and an increase in cardiac output, while heart rate does not change or changes slightly.

After taking enalapril, an increase in renal blood flow is observed. At the same time, GFR does not change, and there are no signs of sodium or fluid retention. However, in patients with initially reduced glomerular filtration rate, its rate usually increases.

Enalapril reduces intraglomerular hypertension, slowing the development of glomerulosclerosis and the risk of developing chronic renal failure.

Long-term use of enalapril in patients with essential hypertension and renal failure may lead to improved renal function, as evidenced by an increase in GFR.

In patients with renal failure and or without diabetes mellitus, there is a decrease in albuminuria, renal excretion of IgG, and a decrease in total protein in the urine after taking enalapril.

With simultaneous use of enalapril and thiazide diuretics, a more pronounced antihypertensive effect is observed. Enalapril reduces or prevents the development of hypokalemia caused by taking thiazide diuretics.

Enalapril therapy is not usually associated with undesirable effects on plasma uric acid concentrations.

Enalapril therapy is accompanied by a beneficial effect on the ratio of lipoprotein fractions in the blood plasma and no effect or a beneficial effect on the concentration of total cholesterol.

In patients with CHF during therapy with cardiac glycosides and diuretics, taking enalapril causes a decrease in peripheral vascular resistance and blood pressure. Cardiac output increases, while heart rate (usually elevated in patients with CHF) decreases. Wedge pressure in the pulmonary capillaries is also reduced. Exercise capacity and severity of heart failure, as assessed by NYHA criteria, improve. These effects are observed with long-term therapy with enalapril.

In patients with mild to moderate heart failure, enalapril slows the progression of cardiac dilatation and heart failure, as evidenced by a decrease in diastolic and systolic volumes and an improvement in left ventricular ejection fraction.

In case of left ventricular dysfunction, enalapril reduces the risk of major ischemic outcomes (including the incidence of myocardial infarction and the number of hospitalizations for unstable angina).

Enalapril reduces the incidence of ventricular arrhythmias in patients with heart failure, although the underlying mechanisms and clinical significance of this effect are unknown.

In CHF, a noticeable clinical effect is observed with long-term treatment for 6 months or more.

Suction. After oral administration, enalapril is rapidly absorbed into the gastrointestinal tract. Cmax of enalapril in blood serum is achieved within 1 hour after oral administration. The degree of absorption when taken orally is approximately 60%. Concomitant food intake does not affect the absorption of enalapril.

After absorption, enalapril is rapidly hydrolyzed to form the active metabolite enalaprilat, a strong ACE inhibitor. Cmax of enalaprilat in the blood serum is observed approximately 4 hours after taking an oral dose of enalapril. The duration of absorption and hydrolysis of enalapril is similar for various recommended therapeutic doses. In healthy volunteers with normal renal function, C ss of enalaprilat in the blood serum is achieved by 4 days from the start of taking enalapril.

Distribution. In the range of therapeutic doses, the binding of enalaprilat to plasma proteins does not exceed 60%.

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

Metabolism. There is no data on other significant metabolic pathways of enalapril other than hydrolysis to enalaprilat. The rate of hydrolysis of enalapril may be reduced in patients with impaired liver function without reducing the therapeutic effect.

Excretion. Excretion of enalaprilat is carried out mainly by the kidneys - 60% (20% - unchanged and 40% - in the form of enalaprilat), through the intestines - 33% (6% - unchanged and 27% - in the form of enalaprilat). The main metabolites detected in urine are enalaprilat, accounting for approximately 40% of the dose taken, and unchanged enalapril. There are no data on other metabolites of enalapril. The plasma concentration profile of enalaprilat has a long terminal phase, apparently due to its binding to ACE. T1/2 of enalaprilat is about 11 hours.

Special patient groups

Renal dysfunction. The AUC of enalapril and enalaprilat is increased in patients with renal impairment.

In patients with mild to moderate renal impairment (creatinine clearance 40–60 ml/min) after taking enalapril 5 mg once daily, the steady-state AUC value of enalaprilat is approximately 2 times higher than in patients with unchanged renal function.

In patients with severe renal failure (Cl creatinine ≤30 ml/min), after repeated use of enalapril, the AUC value of enalaprilat increases approximately 8 times, T 1/2 increases, and the achievement of C ss is delayed.

Enalaprilat can be removed from the general circulation using hemodialysis. Clearance during hemodialysis is 62 ml/min (1.03 ml/s).

Breast-feeding. After a single oral administration of enalapril at a dose of 20 mg in postpartum patients, the average C max of enalapril in breast milk is 1.7 mcg/l (0.54–5.9 mcg/l) 4–6 hours after administration. The average C max of enalaprilat is 1.7 µg/L (1.2–2.3 µg/L) and is observed at various times within 24 hours after dosing. Based on data on maximum concentrations in breast milk, the estimated maximum intake of enalapril for a fully breastfed infant is 0.16% of the maternal body weight dose.

After taking enalapril orally at a dose of 10 mg 1 time per day for 11 months, the C max of enalapril in breast milk is 2 μg/l 4 hours after administration, enalaprilat - 0.75 μg/l approximately 9 hours after administration. The average concentration in breast milk within 24 hours after taking enalapril is 1.44 mcg/l and enalaprilat - 0.63 mcg/l.

Use of the substance Enalapril

Essential hypertension of any severity; renovascular hypertension; heart failure of any severity (in patients with clinical manifestations of heart failure, enalapril is also indicated to increase patient survival, slow the progression of the disease, and reduce the frequency of hospitalizations for heart failure); prevention of the development of clinically significant heart failure (in patients without clinical symptoms of heart failure with left ventricular dysfunction, enalapril is indicated to slow the development of clinical manifestations of the disease and reduce the frequency of hospitalizations for heart failure); prevention of coronary ischemia in patients with left ventricular dysfunction to reduce the incidence of myocardial infarction and reduce the frequency of hospitalizations for unstable angina.

Contraindications

Hypersensitivity to enalapril or other ACE inhibitors; history of angioedema associated with previous use of ACE inhibitors, as well as hereditary or idiopathic angioedema; simultaneous use with aliskiren or aliskiren-containing drugs in patients with diabetes mellitus and/or impaired renal function (GFR<60 мл/мин/1,73 м 2) (см. «Взаимодействие»); возраст до 18 лет (безопасность и эффективность применения не изучены); беременность и период грудного вскармливания; наследственная непереносимость лактозы, дефицит лактазы, синдром глюкозо-галактозной мальабсорбции.

Restrictions on use

Bilateral renal artery stenosis or stenosis of the artery of a single kidney; condition after kidney transplantation; aortic or mitral stenosis (with impaired hemodynamic parameters); hypertrophic obstructive cardiomopathy; IHD; cerebrovascular diseases (including cerebrovascular insufficiency); renal failure (Cl creatinine<80 мл/мин); угнетение костномозгового кроветворения; системные заболевания соединительной ткани (в т.ч. склеродермия, системная красная волчанка), иммуносупрессивная терапия, лечение с применением аллопуринола или прокаинамида или комбинация указанных осложняющих факторов; печеночная недостаточность; сахарный диабет; гиперкалиемия; одновременное применение калийсберегающих диуретиков, препаратов калия, калийсодержащих заменителей поваренной соли и препаратов лития; проведение процедуры афереза ЛПНП с использованием декстрана сульфата; отягощенный аллергологический анамнез или ангионевротический отек в анамнезе; состояния, сопровождающиеся снижением ОЦК (в т.ч. при терапии диуретиками, соблюдении диеты с ограничением поваренной соли, диализе, диарее или рвоте); проведение десенсибилизации аллергеном из яда перепончатокрылых; у пациентов, находящихся на диализе с применением высокопроточных мембран (таких как AN 69 ®); после больших хирургических вмешательств или при проведении общей анестезии; у пациентов негроидной расы; пожилой возраст (>65 years old); primary aldosteronism.

Use during pregnancy and breastfeeding

If pregnancy occurs, enalapril should be discontinued immediately unless it is considered essential for the mother.

Epidemiological data indicate a possible teratogenic effect on the fetus of ACE inhibitors in the first trimester of pregnancy. If ACE inhibitor therapy is not vital, then women planning pregnancy should use other antihypertensive drugs approved during pregnancy that have proven safety.

ACE inhibitors can cause disease or death of the fetus or newborn when used in the second and third trimesters of pregnancy. The use of ACE inhibitors during these periods was accompanied by negative effects on the fetus and newborn, including the development of arterial hypotension, renal failure, hyperkalemia and/or hypoplasia of the skull bones in the newborn. Prematurity, intrauterine growth restriction, and patent ductus arteriosus have also been reported, but it is unclear whether these cases were associated with ACE inhibitors. In cases where the use of an ACE inhibitor during pregnancy is considered necessary, periodic ultrasound should be performed to assess the amniotic fluid index; if oligohydramnios is detected, enalapril should be discontinued unless its use is considered vital for the mother. However, both the patient and the physician should be aware that oligohydramnios occurs when there is irreversible damage to the fetus. If ACE inhibitors are used during pregnancy and the development of oligohydramnios is observed, then, depending on the stage of pregnancy, a stress test, a non-stress test or determination of the biophysical profile of the fetus may be necessary to assess the functional status of the fetus.

It is possible that the development of oligohydramnios occurs due to a decrease in fetal renal function. This complication can lead to contracture of the limbs, deformation of the bones of the skull, including the facial part, and hypoplasia of the lungs. When using enalapril, the patient must be informed of the potential risk to the fetus. Neonates whose mothers took enalapril should be closely monitored for hypotension, oliguria, and hyperkalemia.

Enalapril, which crosses the placenta, can be partially removed from the neonatal circulation by peritoneal dialysis; theoretically it can be removed through exchange transfusion.

Enalapril and enalaprilat are excreted in breast milk in trace concentrations. If it is necessary to use enalapril during lactation, breastfeeding should be discontinued.

Side effects of the substance Enalapril

The frequency of adverse reactions is given in accordance with the WHO classification: very often (>1/10); often (>1/100,<1/10); нечасто (>1/1000, <1/100); редко (>1/10000, <1/1000); очень редко (<1/10000, включая отдельные сообщения); частота неизвестна (определить частоту возникновения по имеющимся данным невозможно).

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

Metabolic and nutritional disorders: uncommon - hypoglycemia (see "Precautions").

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

Hearing and labyrinth disorders: infrequently - tinnitus.

From the side of the organ of vision: rarely - blurred vision.

From the SSS side: often - a pronounced decrease in blood pressure, fainting, chest pain, heart rhythm disturbances, angina pectoris, tachycardia; uncommon - orthostatic hypotension, palpitations, myocardial infarction or stroke (possibly caused by a sharp decrease in blood pressure in high-risk patients) (see "Precautions"); rarely - Raynaud's syndrome.

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

From the digestive system: very often - nausea; often - diarrhea, abdominal pain, taste disturbance; uncommon - intestinal obstruction, pancreatitis, vomiting, dyspepsia, constipation, anorexia, stomach irritation, dry oral mucosa, gastric and duodenal ulcers; rarely - stomatitis/aphthous ulcers, glossitis; very rarely - intestinal edema.

From the liver and biliary tract: rarely - liver failure, hepatitis (hepatocellular or cholestatic), including hepatic necrosis, cholestasis (including jaundice).

For the skin and subcutaneous tissues: often - hypersensitivity reactions/angioedema of the face, limbs, lips, tongue, vocal folds and/or larynx, skin rash; uncommon - increased sweating, itching, urticaria, alopecia; rarely - erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, pemphigus, erythroderma.

The development of a symptom complex has been reported, which may be accompanied by some and/or all of the following symptoms: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, positive antinuclear antibody test, increased ESR, eosinophilia and leukocytosis. Skin rash, photosensitivity, or other skin reactions may also occur.

From the kidneys and urinary tract: uncommon - renal dysfunction, renal failure, proteinuria; rarely - oliguria.

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

From the genital organs and breast: infrequently - erectile dysfunction; rarely - gynecomastia.

Deviations in laboratory and instrumental research data: often - hyperkalemia, increased creatinine concentration in blood serum; uncommon - hyponatremia, increased urea concentration in the blood; rarely - increased activity of liver transaminases, increased concentration of bilirubin in the blood serum.

Common disorders: very often - asthenia; often - increased fatigue; uncommon - muscle cramps, flushing of the face, discomfort, fever.

In rare cases, with the simultaneous use of ACE inhibitors (including enalapril) and intravenous administration of gold preparations (sodium aurothiomalate), a symptom complex has been described, including redness of the facial skin, nausea, vomiting and arterial hypotension.

Adverse events that were observed during post-marketing use of enalapril (a cause-and-effect relationship has not been established): urinary tract infection, upper respiratory tract infection, bronchitis, cardiac arrest, atrial fibrillation, herpes zoster, melena, ataxia, pulmonary embolism and pulmonary infarction, hemolytic anemia, including cases of hemolysis in patients with glucose-6-phosphate dehydrogenase deficiency.

Interaction

Other antihypertensive drugs. With simultaneous use of enalapril and other antihypertensive therapy, an additive effect may be observed.

When enalapril is used concomitantly with other antihypertensive drugs, especially diuretics, an enhanced antihypertensive effect may be observed.

Simultaneous use with beta-blockers, methyldopa or CCB increases the severity of the antihypertensive effect.

Concomitant use with alpha-, beta-blockers and ganglion blockers should be carried out under close medical supervision.

Concomitant use with nitroglycerin, other nitrates or vasodilators enhances the antihypertensive effect.

Serum potassium. In patients with arterial hypertension who took enalapril monotherapy for more than 48 weeks, there was an increase in serum potassium levels by an average of 0.2 mmol/l.

With the simultaneous use of enalapril with diuretics that cause the loss of potassium ions (thiazide or loop diuretics), hypokalemia caused by the action of diuretics is usually weakened due to the effect of enalapril.

Risk factors for the development of hyperkalemia include renal failure, diabetes mellitus, concomitant use of potassium-sparing diuretics (eg spironolactone, eplerenone, triamterene or amiloride), as well as potassium supplements and salts. The use of potassium supplements, potassium-sparing diuretics, or potassium-containing salts, especially in patients with impaired renal function, can lead to a significant increase in serum potassium levels. If necessary, simultaneous use of the above potassium-containing or potassium-increasing drugs should be used with caution and regularly monitor the potassium level in the blood serum.

Hypoglycemic agents. The simultaneous use of ACE inhibitors and hypoglycemic drugs (insulin, hypoglycemic drugs for oral administration) may enhance the hypoglycemic effect of the latter with the risk of developing hypoglycemia. This effect is usually most often observed during the first weeks of combination therapy, as well as in patients with impaired renal function. In patients with diabetes mellitus taking oral hypoglycemic drugs or insulin, blood glucose concentrations should be regularly monitored, especially during the first month of simultaneous use with ACE inhibitors.

Lithium preparations. Like other drugs that affect sodium excretion, ACE inhibitors can reduce the excretion of lithium by the kidneys, therefore, when using lithium preparations and ACE inhibitors simultaneously, it is necessary to regularly monitor the concentration of lithium in the blood serum.

Tricyclic antidepressants/neuroleptics/general anesthesia. The simultaneous use of certain anesthetic drugs, tricyclic antidepressants and antipsychotics with ACE inhibitors can lead to a further decrease in blood pressure (see “Precautions”).

Ethanol. Ethanol enhances the antihypertensive effect of ACE inhibitors.

Acetylsalicylic acid, thrombolytics and beta-blockers. Enalapril can be used simultaneously with acetylsalicylic acid (as an antiplatelet agent), thrombolytics and beta-blockers.

Sympathomimetics. Sympathomimetics may reduce the antihypertensive effect of ACE inhibitors.

NSAIDs. NSAIDs, including selective COX-2 inhibitors, may reduce the effect of diuretics and other antihypertensive drugs. As a result, the antihypertensive effect of ARA II or ACE inhibitors may be weakened when used simultaneously with NSAIDs, incl. with selective COX-2 inhibitors.

In some patients with impaired renal function (for example, in elderly patients or patients with dehydration, including those taking diuretics), receiving therapy with NSAIDs, including selective COX-2 inhibitors, the simultaneous use of ARB II or ACE inhibitors may cause further deterioration of kidney function, including the development of acute renal failure. These effects are usually reversible, so simultaneous use of these drugs should be carried out with caution in patients with impaired renal function.

Double blockade of the RAAS. Dual blockade of the RAAS using ARB II, ACE inhibitors or aliskiren (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, renal function and electrolyte levels in the blood is necessary in patients taking enalapril and other drugs that affect the RAAS at the same time. Enalapril should not be used concomitantly with aliskiren or aliskiren-containing drugs in patients with diabetes mellitus and/or impaired renal function (GFR<60 мл/мин/1,73 м 2).

The simultaneous use of ACE inhibitors with ARA II in patients with diabetic nephropathy is contraindicated.

Gold preparations. In rare cases, with the simultaneous use of gold preparations for parenteral administration (sodium aurothiomalate) and ACE inhibitors, including enalapril, a symptom complex (nitrate-like reactions) is observed, including a rush of blood to the facial skin, nausea, vomiting and arterial hypotension.

mTOR inhibitors. In patients using both an ACE inhibitor and an enzyme inhibitor mTOR (mammalian target of rapamycin- target of rapamycin in mammalian cells) (eg temsirolimus, sirolimus, everolimus), therapy may be accompanied by an increased risk of angioedema.

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

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

Antacids. May reduce the bioavailability of ACE inhibitors.

Theophylline. Enalapril weakens the effect of drugs containing theophylline.

Other medicines. There are no clinically significant pharmacokinetic drug interactions observed between enalapril and the following drugs: hydrochlorothiazide, furosemide, digoxin, timolol, methyldopa, warfarin, indomethacin, sulindac and cimetidine. With the simultaneous use of enalapril and propranolol, the concentration of enalaprilat in the blood serum decreases, but this effect is not clinically significant.

Overdose

Symptoms: pronounced decrease in blood pressure (begins approximately 6 hours after administration), up to the development of collapse, myocardial infarction, acute cerebrovascular accident or thromboembolic complications, water and electrolyte imbalance, renal failure, increased breathing, tachycardia, palpitations, bradycardia, dizziness, anxiety, fear, convulsions, cough, stupor. Enalaprilat plasma concentrations 100–200 times higher than after therapeutic doses were observed after oral administration of 300 and 440 mg of enalapril, respectively.

Treatment: transfer the patient to a horizontal position with a low headboard. In mild cases, gastric lavage and ingestion of activated charcoal are indicated, in more serious cases - measures aimed at normalizing blood pressure (iv administration of 0.9% sodium chloride solution, plasma expanders, if necessary, intravenous administration of catecholamines), hemodialysis (excretion rate enalaprilat - 62 ml/min). In patients with bradycardia that is resistant to therapy, pacemaker placement is indicated.

Routes of administration

Precautions for the substance Enalapril

Symptomatic arterial hypotension. Symptomatic hypotension is rarely observed in patients with uncomplicated hypertension. In patients with arterial hypertension taking enalapril, arterial hypotension develops more often against the background of dehydration, which occurs, for example, as a result of diuretic therapy, restriction of salt intake, in patients on dialysis, as well as in patients with diarrhea or vomiting (see " Side effects", "Interaction"). Symptomatic hypotension is also observed in patients with heart failure with or without renal failure.

Arterial hypotension occurs more frequently in patients with more severe heart failure with hyponatremia or impaired renal function in whom higher doses of loop diuretics are used. In these patients, treatment with enalapril should be started under medical supervision, which should be especially careful when changing the dose of enalapril and/or diuretic. Similarly, patients with coronary artery disease or cerebrovascular disease should be monitored, in whom an excessive decrease in blood pressure may lead to the development of myocardial infarction or stroke.

If arterial hypotension develops, the patient should be laid down and, if necessary, a 0.9% sodium chloride solution should be administered. Transient arterial hypotension when taking enalapril is not a contraindication to further use and increasing the dose; therapy can be continued after fluid volume is replenished and blood pressure is normalized.

In some patients with heart failure and normal or low blood pressure, enalapril may cause an additional decrease in blood pressure. This reaction to taking enalapril is expected and is not a reason to stop treatment. In cases where arterial hypotension becomes stable, the dose should be reduced and/or treatment with a diuretic and/or enalapril should be discontinued.

Aortic or mitral stenosis/hypertrophic obstructive cardiomyopathy. Like all drugs that have a vasodilating effect, ACE inhibitors should be prescribed with caution to patients with left ventricular outflow tract obstruction.

Renal dysfunction. In some patients, hypotension that develops after initiation of treatment with ACE inhibitors may lead to further deterioration of renal function. In some cases, the development of acute renal failure, usually reversible, has been reported.

In patients with renal failure, a reduction in the dose and/or frequency of enalapril may be required. In some patients with bilateral renal artery stenosis or arterial stenosis of a solitary kidney, increases in blood urea and serum creatinine concentrations were observed. The changes were usually reversible, and indicators returned to baseline values ​​after cessation of treatment. This pattern of changes is most likely in patients with renal failure.

In some patients who did not have renal disease before treatment, enalapril in combination with diuretics usually caused a slight and transient increase in blood urea and serum creatinine concentrations. In such cases, it may be necessary to reduce the dose and/or discontinue the diuretic and/or enalapril.

Kidney transplantation. Treatment with enalapril is not recommended in patients after kidney transplantation due to the lack of experience with such use.

Liver failure. The use of ACE inhibitors is rarely associated with the development of a syndrome that begins with cholestatic jaundice or hepatitis and progresses to fulminant liver necrosis, sometimes fatal. The mechanism of this syndrome has not been studied. If jaundice appears or a significant increase in the activity of liver transaminases during the use of ACE inhibitors, enalapril should be discontinued and appropriate auxiliary therapy should be prescribed; the patient should be under appropriate supervision.

Neutropenia/agranulocytosis. Neutropenia/agranulocytosis, thrombocytopenia and anemia are observed in patients taking ACE inhibitors. Neutropenia occurs rarely in patients with normal renal function and no other complicating factors.

Enalapril should be used with extreme caution in patients with systemic connective tissue diseases (systemic lupus erythematosus, scleroderma, etc.) taking immunosuppressive therapy, allopurinol or procainamide, or a combination of these complicating factors, especially if there are pre-existing renal impairments. Some of these patients develop serious infections, which in some cases do not respond to intensive antibiotic therapy. If enalapril is used in such patients, regular monitoring of white blood cell and lymphocyte counts is recommended and patients should be warned to report any signs of infectious disease.

Hypersensitivity reactions/angioedema. When using ACE inhibitors, including enalapril, rare cases of angioedema of the face, extremities, lips, tongue, vocal folds and/or larynx have been observed, occurring at different periods of treatment. In very rare cases, intestinal edema may develop. In such cases, you should immediately stop taking enalapril and carefully monitor the patient's condition in order to monitor and correct clinical symptoms. Even in cases where only swelling of the tongue is observed without the development of respiratory distress syndrome, patients may require long-term observation, since therapy with antihistamines and corticosteroids may not be sufficient.

Very rarely, deaths due to angioedema associated with swelling of the larynx or tongue have been reported. Swelling of the tongue, vocal folds, or larynx can lead to airway obstruction, especially in patients who have undergone respiratory surgery. In cases where swelling is localized to the tongue, vocal folds or larynx and may cause airway obstruction, appropriate treatment should be immediately instituted, which may include subcutaneous injection of 0.1% epinephrine solution (0.3-0.5 ml ) and/or ensure airway patency.

In black patients taking ACE inhibitors, angioedema is observed more often than in patients of other races.

Patients with a history of angioedema not associated with taking ACE inhibitors may be at greater risk of developing angioedema during therapy with ACE inhibitors (see "Contraindications").

Anaphylactoid reactions during desensitization with an allergen from Hymenoptera venom. In rare cases, patients taking ACE inhibitors develop life-threatening anaphylactoid reactions during desensitization with hymenoptera venom allergen. Adverse reactions can be avoided if you temporarily stop taking the ACE inhibitor before starting desensitization.

Anaphylactoid reactions during LDL apheresis. Life-threatening anaphylactoid reactions are rarely observed in patients taking ACE inhibitors during LDL apheresis using dextran sulfate. The development of these reactions can be avoided if the ACE inhibitor is temporarily discontinued before the start of each LDL apheresis procedure.

Hemodialysis. Anaphylactoid reactions have been observed in patients on dialysis using high-flux membranes (such as AN 69®) and concomitantly receiving ACE inhibitor therapy. In these patients, it is necessary to use a different type of dialysis membrane or other classes of antihypertensive drugs.

Cough. Cases of cough occurring during therapy with ACE inhibitors have been observed. As a rule, the cough is non-productive, persistent and stops after discontinuation of therapy. Cough associated with the use of ACE inhibitors should be considered in the differential diagnosis of cough.

Surgical interventions/general anesthesia. During major surgery or general anesthesia with the use of drugs that cause an antihypertensive effect, enalaprilat blocks the formation of angiotensin II caused by the compensatory release of renin. If a pronounced decrease in blood pressure develops, explained by a similar mechanism, it can be corrected by increasing the volume of blood volume.

Hyperkalemia (see "Interactions"). The risk of developing hyperkalemia is observed in renal failure, diabetes mellitus, and also with simultaneous use of potassium-sparing duretics (for example, spironolactone, eplerenone, triamterene or amiloride), potassium supplements or potassium-containing salts.

The use of potassium supplements, potassium-sparing diuretics, or potassium-containing salts, especially in patients with impaired renal function, may lead to a significant increase in serum potassium levels. Hyperkalemia can lead to serious, sometimes fatal arrhythmias.

If necessary, simultaneous use of enalapril and the drugs listed above should be used with caution and regularly monitor the potassium content in the blood serum.

Hypoglycemia. Patients with diabetes mellitus, taking hypoglycemic drugs for oral administration or on insulin therapy, before starting the use of ACE inhibitors, should be informed about the need to regularly monitor the concentration of glucose in the blood (the possibility of hypoglycemia), especially during the first month of simultaneous use of these drugs (see " Interaction").

Double blockade of the RAAS. The development of arterial hypotension, syncope, stroke, hyperkalemia and renal dysfunction (including acute renal failure) has been reported in susceptible patients, especially if combination therapy with drugs that affect the RAAS is used (see “Interactions”). Double blockade of the RAAS by combined use of ACE inhibitors with ARA II or aliskiren is not recommended.

The simultaneous use of enalapril with aliskiren or aliskiren-containing drugs is contraindicated in patients with diabetes mellitus and/or impaired renal function (GFR<60 мл/мин/1,73 м 2) (см. «Противопоказания»).

Elderly patients. The efficacy and safety of enalapril are similar in older and younger patients with hypertension.

Race. As with other ACE inhibitors, enalapril appears to be less effective in lowering blood pressure in black patients than in patients of other races, which may be explained by the higher prevalence of conditions with low plasma renin activity in the black population of patients with arterial hypertension. .

Impact on the ability to drive vehicles and machinery. When using enalapril, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions, due to the possibility of developing dizziness and drowsiness.

Interactions with other active ingredients

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Berlipril, Carlon, Renitek, Ednit, Enalapril, Enalapril-KMP, Enalapril maleate, Enam, Enap, Enarenal, Enat

Recipe

Rp: Tab. Enalaprili 0.01
D.t.d: No. 20 in tab.
S: 1 tablet each. 2 times a day orally

pharmachologic effect

Enalapril is an antihypertensive drug, the mechanism of action of which is associated with inhibition of the activity of angiotensin-convertible enzyme, leading to a decrease in the formation of the vasoconstrictor factor - angiotensin-II and at the same time to activation of the formation of kinins and prostacyclin, which have a vasodilatory effect. Enalanril is a “prodrug”; after its hydrolysis in the body, enalaprilat is formed, which inhibits this enzyme. Enalapril also has some diuretic effect associated with moderate inhibition of aldosterone synthesis. Along with reducing arterial blood pressure, the drug reduces pre- and afterload on the myocardium in heart failure, improves blood circulation in the pulmonary circle and respiratory function, reduces resistance in the vessels of the kidneys, which helps to normalize blood exchange in them. The duration of action of enalapril after a single oral dose is about 24 hours.

Mode of application

Enalapril is prescribed orally regardless of meal time.
When treating hypertension, the initial dose of enalapril for adults is 0.01-0.02 g per day (single dose). Subsequently, the dose is selected individually for each patient (usually a one-time dose of 0.02 g per day). For moderate hypertension, it is enough to prescribe 0.01 g of the drug per day.

The maximum daily dose is 0.04 g.

For renovascular hypertension, enalapril is prescribed in lower doses. The starting dose is usually 5 mg per day. Then the dose is selected individually. The maximum daily dose is 20 mg (once daily)
For heart failure, enalapril is prescribed starting from 0.0025 g, then the dose is gradually increased to 10-20 mg (1-2 times a day).

The duration of treatment depends on the effectiveness of the therapy.
In all cases, if the decrease in blood pressure is too pronounced, the dose of the drug is gradually reduced.
The drug is used both as monotherapy and in combination with other antihypertensive drugs.

Indications

Enalapril is prescribed for various forms of arterial hypertension, including renovascular hypertension, including those with low effectiveness of other antihypertensive drugs.

The drug is also effective for congestive heart failure, coronary heart disease, and bronchospastic conditions.

Contraindications

Enalapril is contraindicated in case of hypersensitivity to angiotensin-converting enzyme inhibitors. The drug is not prescribed to children or during pregnancy.

Side effects

When treated with enalapril, dizziness, headache, orthostatic hypotension, nausea, diarrhea, muscle spasms, allergic skin reactions, and in some cases angioedema are sometimes possible.

Release form

Tablets 0.005; 0.01 and 0.02 g (5; 10 and 20 mg).

ATTENTION!

The information on the page you are viewing is created for informational purposes only and does not in any way promote self-medication. The resource is intended to provide healthcare workers with additional information about certain medications, thereby increasing their level of professionalism. The use of the drug "" necessarily requires consultation with a specialist, as well as his recommendations on the method of use and dosage of the medicine you have chosen.

Source: allmed.pro

Compound

each tablet contains: active substance enalapril maleate – 10.0 mg; auxiliary components: collidon 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 score line on one side and a break line on the other side, inclusions are possible.

pharmachologic effect

ACE inhibitor is an antihypertensive drug. Suppresses the formation of angiotensin II from angiotensin I and eliminates its vasoconstrictor effect. The drug gradually reduces blood pressure without causing changes in heart rate and minute blood volume. Reduces total peripheral vascular resistance, reduces afterload. It also reduces preload, reduces 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 glomeruli of the kidneys, thereby improving intraglomerular hemodynamics, and prevents the development of diabetic nephropathy.

The onset of the hypotensive effect when taken orally is 1 hour, it reaches a maximum after 4-6 hours and lasts up to 24 hours. In some patients, therapy is required for several weeks to achieve an optimal level of blood pressure. 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. Metabolized in the liver to form an active metabolite, enalaprilat. The maximum concentration of enalaprilat in the blood serum is achieved 3-4 hours after administration.

The binding of enalaprilat to plasma proteins is 50-60%. The maximum plasma concentration of enalapril is achieved after 1 hour, enalaprilat - 3-4 hours. Enalaprilat easily passes through histohematic barriers, excluding the BBB, a small amount penetrates the placenta and into breast milk. The half-life of enalaprilat is 11 hours. Excreted primarily 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 (rate
62 ml/min) and peritoneal dialysis.

4 days after starting the drug, the half-life of enalaprilat stabilizes and is 11 hours.

Excreted by the kidneys.

Indications for use

Treatment of arterial hypertension;

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 effectiveness 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 failure (GFR)< 60 мл/мин/1,73 м 2) противопоказано.

With caution: decreased renal and liver function, simultaneously with immunosuppressants, with bilateral stenosis of the renal arteries.

Pregnancy and lactation

Pregnancy

Except in cases where it is not possible to replace an ACEI with another alternative therapy, patients planning pregnancy should be switched to antihypertensive therapy with drugs that have a well-studied safety profile for pregnant women. If pregnancy occurs, the ACE inhibitor should be discontinued immediately and, if necessary, other 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, fetotoxic effects (impaired renal function, oligohydramniosis, delayed ossification of the skull bones) and neonatal toxicity (renal failure, hypotension, hyperkalemia) have been established. If you have been taking an ACE inhibitor since the second trimester of pregnancy, an ultrasound examination of the function of the kidneys and cranial bones is recommended. In newborns whose mothers took ACE inhibitors, blood pressure should be carefully monitored to prevent the possible development of hypotension.

Lactation

Breastfeeding should be stopped during treatment.

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

When feeding an older child, the use of these medications is possible if the 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.

Directions for use and doses

The drug should be taken at the same time of the day (regardless of meals), 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 the dosage form of Enalapril - 5 mg tablets). 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 ranges from 10 – 20 mg, in exceptional cases – up to 40 mg in 1 or 2 doses. If prescribed to patients simultaneously receiving diuretics, treatment with the diuretic should be discontinued 2 to 3 days before enalapril is prescribed. 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. Depending on the patient's condition, dose adjustment is possible. The average maintenance dose is 10 mg 2 times/day.

For chronic heart failure The 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 select 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 arterial hypertension and kidney disease The dosage regimen is set depending on the severity of renal dysfunction or on the values ​​of creatinine clearance. The initial dose of the drug should be gradually increased until a satisfactory clinical effect is achieved. With a creatinine clearance of 80-30 ml/min, the dose is usually 5–10 mg/day, with a creatinine clearance of 30–10 ml/min – 2.5–5 mg/day (in the case of prescribing 2.5 mg, it is recommended to use the dosage form of Enalapril – tablets 2.5 mg).

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

Patients with impaired renal function

Dosage for renal failure

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

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

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

Elderly patients

The dose should be adjusted based on the patient's renal function.

Children with arterial hypertension over 6 years of age

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

For children who can swallow tablets, the dose should be individualized 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 20 to 50 kg (enalapril 2.5 mg tablets are recommended) and 5 mg for patients weighing ≥ 50 kg (enalapril tablets are recommended). 5 mg). Enalapril is taken once a day. Dosage should be adjusted as needed 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 side effects listed below are presented in accordance with the following gradations of frequency of their occurrence: very often (>1/10); often (>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 blood side: 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 ADH secretion.

Metabolic disorders: infrequently - hypoglycemia.

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

From the organs of vision: very often - blurred vision.

From the cardiovascular system: very often - dizziness; often – hypotension (including orthostatic hypotension), syncope, chest pain, arrhythmias, 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, hepatocellular or cholestatic hepatitis, hepatitis, including necrosis, cholestasis (including jaundice).

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

A complex symptom complex has been reported that included some or all of the following: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, positive antinuclear antibody test, increased ESR, eosinophilia and leukocytosis. Side effects may include rash, photosensitivity and other skin reactions.

From the urinary system: uncommon - renal dysfunction, renal failure, proteinuria; rarely - oliguria.

From the reproductive system: infrequently - impotence; rarely - gynecomastia.

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

Changes in laboratory parameters: often – hyperkalemia, increased serum creatinine levels; rarely - increased urea levels in the blood, hyponatremia, increased 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 tablet, simultaneously with blockade of the renin-angiotensin system, and stupor. Symptoms associated with ACE inhibitor overdose may include circulatory shock, electrolyte disturbances, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, restlessness, and cough.

The recommended treatment for overdose is intravenous infusion of saline solution. If hypotension occurs, the patient is placed horizontally with legs elevated. Intravenous infusion of angiotensin II and/or catecholamines should be considered. If the drug has been taken recently, measures should be taken to eliminate enalapril maleate (for example, vomiting, gastric lavage, administration of sorbents and sodium sulfate). Enalapril can be removed from the general circulation using hemodialysis. For treatment-resistant bradycardia, the use of pacemakers is indicated. Vital signs, serum electrolytes and creatinine concentrations should be continuously monitored.

Interaction with other drugs

When administered simultaneously with potassium-sparing diuretics or potassium supplements, hyperkalemia may develop. When used simultaneously with diuretics, beta-blockers, methyldopa, nitrates, calcium channel blockers, hydralazine, prazosin, the hypotensive effect may be enhanced. When used simultaneously with NSAIDs (including acetylsalicylic acid), the effect of enalapril may be reduced and the risk of developing renal dysfunction may be increased. When used simultaneously with ethanol, as well as agents for general anesthesia, the risk of developing arterial hypotension increases. Enalapril weakens the effect of drugs containing theophylline. When used simultaneously with lithium preparations, the excretion of lithium slows down and its effect increases. When used simultaneously with cimetidine, the half-life of enalapril is prolonged.

Dual blockade of the renin-angiotensin-aldosterone system

Based on the available data, dual blockade of the RAAS with ACEI, ARB II, or Aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy.

In patients with diabetes mellitus or moderate/severe renal 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 ACE inhibitors and ARB II is absolutely indicated, careful supervision by a specialist and mandatory monitoring of renal function, water and electrolyte balance, and blood pressure are necessary.

Gold preparations

There have been isolated reports of nitrite 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 concomitant use of ACE inhibitors and antidiabetic drugs (insulin, oral antidiabetic drugs) may lead to a marked decrease in blood sugar levels with a 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 may lead to an additional decrease in blood pressure.

Enalapril. During treatment, the potassium content in the blood serum should also be monitored. 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 treatment with a diuretic and/or enalapril.

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

Upon appointment enalapril, rare cases of angioedema have been described (more often in patients of the Negroid race). In such cases, treatment should be stopped immediately and the patient should be constantly monitored until symptoms disappear completely. Antihistamines have a positive effect. If suffocation develops 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 to hymenoptera allergens or dialysis using high-throughput membranes (for example, AN69) causes severe anaphylactoid reactions. In such patients, the use of a different class of antihypertensive drugs is recommended.

There are reports of the occurrence of reversible nonproductive cough during treatment with ACE inhibitors.

In patients receiving enalapril over 48 weeks, there is an increase in serum potassium levels of 0.02 mEq/L. When treating with enalapril, serum potassium levels should be monitored.

Release form

10 tablets per blister pack. 3 contour packages along with instructions for use are placed in a cardboard pack.

Storage conditions

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

Keep out of the reach of children.

Best before date

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

Content

Enalapril will help with high blood pressure, circulatory problems, and heart pain - the instructions for use of the drug indicate its effect on blood plasma platelets. Tablets are used for the prevention and treatment of heart and kidney failure in adults. Read their detailed instructions for use to achieve the desired effect during treatment.

Enalapril tablets

According to the pharmacological classification, Enalapril blood pressure tablets belong to the group of ACE inhibitors (angiotensin-converting enzyme). They influence the renin-angiotensin system and have a positive effect in the treatment of cardiovascular diseases. Their active substance is enalapril maleate, which in the body is converted into a metabolite that stimulates the production of hormones and has a vasoconstrictor effect.

Compound

Enalapril is available only in tablet form. The tablets are round in shape, yellow-pink in color, have a line and a break line, inclusions are acceptable. Detailed composition:

Pharmacokinetics of the drug

The drug is considered a prodrug; the body produces the active metabolite enalaprilat. The mechanism of action includes inhibition of ACE activity, which reduces the rate of conversion of the substance to a component that has a pronounced vasoconstrictor effect and stimulates the production of aldosterone in the adrenal cortex. By reducing the concentration of angiotensin, the production of aldosterone is reduced.

This vasodilator reduces afterload, preload (pulmonary capillary pressure), and vascular resistance in the kidneys. Enalapril increases the load capacity. In the presence of chronic heart failure, the drug reduces the degree of its progression, the risk of ischemia and the development of myocardial infarction attacks.

After ingestion, the medicine is absorbed from the stomach. The rate of absorption is not affected by food intake. Metabolism occurs in the liver by hydrolysis and binds to plasma proteins by 55%. The half-life is 11 hours, increases with renal failure. More than half of the dose is excreted by the kidneys, the rest by the intestines. When administered intravenously, 100% of the drug is excreted in the urine.

What are Enalapril tablets for?

Instructions for use of Enalapril tablets indicate the following indications for their use:

• arterial hypertension, including renovascular type;
• chronic heart failure, angina pectoris;
• essential hypertension;
• prevention of the development of severe heart failure;
• prevention of the development of coronary ischemia with left ventricular dysfunction.

How to take Enalapril

According to the instructions, tablets are taken orally or used to prepare an intravenous solution. When taking Enalapril orally, the initial dose is 2.5-5 mg once a day, the average dose is 10-20 mg/day, divided into two doses. For intravenous administration, a dosage of 1.25 mg every 6 hours is practiced. To detect hypotension due to dehydration and sodium deficiency, the dose is 625 mg, repeated after an hour if the response is inadequate.

The maximum daily dose for oral administration is 80 mg of Enalapril. The dosage adjustment is made by the doctor, according to the instructions, and depends on the type of disease:

Disease	Initial dose, mg	Reception regimen, once/day	Average dose, mg	Reception regimen, once/day	Notes
Arterial hypertension			10-20, can reach up to 40		When treating with diuretics, stop treatment with them 2-3 days in advance, the initial dose is reduced to 2.5 mg
Asymptomatic left ventricular dysfunction					Dose adjustments may be made depending on the patient's condition.
Chronic heart failure					The dosage is increased after 2-4 weeks, the maximum maintenance dose is 40 mg, divided into two doses
Arterial hypertension due to kidney disease					Removed during dialysis
Patients weighing 20-50 kg
Patients weighing more than 50 kg

special instructions

The instructions for Enalapril contain special instructions for using the drug that are useful for patients to know:

• With caution, treatment with the drug is allowed in patients with severe aortic stenosis, with loss of fluids and salts; the drug reduces the hypertrophy of cardiomyopathy.
• Long-term therapy requires periodic blood monitoring.
• During operations during treatment with the drug, hypotension may develop, which is corrected by fluid administration.
• When examining the parathyroid glands, drug therapy is discontinued.
• The drug affects the speed of psychomotor reactions and concentration, so caution is required when operating vehicles and machinery.

Enalapril during pregnancy

The instructions say that the use of Enalapril during pregnancy is contraindicated. If it occurs, you should immediately stop taking the drug, unless it is impossible to replace the therapy with an alternative option. When taking the drug in the second and third trimesters, fetotoxic effects and neonatal toxicity were recorded.

If Enalapril cannot be discontinued, an ultrasound scan of the fetus is required. According to reviews from mothers taking the drug while pregnant, newborns' blood pressure is controlled. During lactation, the active substance passes into the milk, so breastfeeding should be stopped. This threatens to have a negative effect on the kidneys and heart.

Drug interactions

The instructions for use indicate Features of drug interactions between Enalapril and other medications:

• immunosuppressants increase the risk of developing leukopenia;
• potassium-sparing diuretics and potassium preparations lead to the development of hyperkalemia;
• opioid analgesics, thiazide and loop diuretics enhance the antihypertensive effect;
• acetylsalicylic acid reduces the antihypertensive effect, and beta-blockers and nitrates enhance it;
• non-steroidal anti-inflammatory drugs reduce the effectiveness of Enalapril;
• simultaneous use of insulin leads to hypoglycemia;
• the medication weakens the effect of Theophylline;
• combination with lithium preparations increases the concentration of lithium in the blood serum, intoxication occurs;
• ethanol increases the risk of arterial hypotension.

Side effects

The instructions for use describe the following: Possible side effects from taking Enalapril:

• dizziness, headaches, feeling tired;
• sleep disorder, depression, tinnitus;
• hypotension, fainting, rapid heartbeat, flushing;
• nausea, dry mouth, vomiting, diarrhea, constipation;
• hepatitis, glossitis, neutropenia;
• dry cough, impotence, hair loss;
• muscle cramps.

Overdose

According to the instructions for use, Symptoms of an overdose of Enalapril are a decrease in blood pressure, the development of collapse, and heart attack. The patient feels tachycardia, dizziness, and a feeling of fear. Therapy includes gastric lavage and the use of activated charcoal. In case of severe poisoning, intravenous administration of saline solution (0.9% sodium chloride) and hemodialysis with high-flow membranes are indicated.

Contraindications

The instructions indicate the following Contraindications for which the use of Enalapril is prohibited:

• history of angioedema;
• bilateral stenosis of the renal blood flow or artery of a single kidney;
• combination with Aliskiren in diabetics;
• renal dysfunction;
• pregnancy, lactation;
• age under 18 years;
• hypersensitivity to components or other ACE inhibitors.

Terms of sale and storage

The medication is dispensed from pharmacies with a prescription, stored in a dry place without access to light and away from children at temperatures up to 25 degrees for three years.

Analogs

Based on the active substance and the pharmacological effect, the following are distinguished: Enalapril analogues in tablets produced by Russian and foreign pharmaceutical factories:

• Enap;
• Renitek;
• Berlipril;
• Lotreal;
• Dinef;
• Enaprene;
• Noprilene;
• Renital;
• Xanef;
• Enaprin;
• Vasotek;
• Reniten;
• Calpiren;
• Ednit;
• Envas.

Enalapril price

You can buy the medicine through pharmacies or the Internet with a prescription in hand. The cost will depend on the number of tablets in the package and the accepted trade markup. Approximate prices for Enalapril in Moscow are as follows:

Variety of tablets	Manufacturer	Internet price, rubles	Pharmacy price, rubles
10 mg 20 pcs.
10 mg 20 pcs.	Switzerland
	Switzerland
20 mg 20 pcs.	Switzerland
10 mg 50 pcs.	Switzerland

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