Description of the drug RENITEC® (RENITEC)

Pharmacological properties of the drug Renitec

Pharmacodynamics. Renitec (enalapril maleate) is a salt of maleic acid and enalapril, a derivative of two amino acids L-alanine and L-proline. When taken orally, enalapril is rapidly absorbed and then hydrolyzed to enalaprilat, a highly specific, long-acting ACE inhibitor that is not a sulfhydryl compound. Mechanism of action. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the pressor substance angiotensin II. After absorption, enalapril is hydrolyzed to enalaprilat, which inhibits ACE. Inhibition of ACE leads to a decrease in the level of angiotensin II in the blood plasma, which leads to an increase in plasma renin activity (by inhibiting the negative feedback between the activity of angiotensin II and the release of renin) and a decrease in aldosterone secretion. Enalapril increases the content of nitric oxide and prostaglandin E. The drug has a natriuretic and uricosuric effect, leads to a slight retention of potassium ions, does not affect the metabolism of glucose and lipoproteins, reduces the level of circulating catecholamines and affects their content in brain tissue. The mechanism of the hypotensive effect of enalapril is directly associated with inhibition of the activity of the renin-angiotensin-aldosterone system; enalapril can cause a hypotensive effect even in patients with low-renin hypertension. The use of Renitec in patients with hypertension (arterial hypertension) has a hypotensive effect in horizontal and vertical positions without a significant increase in heart rate. Symptomatic postural hypotension occurs infrequently. In some patients, optimal blood pressure levels are achieved within a few weeks of starting therapy. The sudden discontinuation of Renitec was not accompanied by a sharp increase in blood pressure. A marked decrease in ACE activity is usually achieved 2–4 hours after oral administration of a single dose of enalapril. The onset of the hypotensive effect is observed after 1 hour, the peak decrease in blood pressure occurs 4-6 hours after taking the drug. The duration of the hypotensive effect depends on the dose of the drug. When taken in recommended doses, the hypotensive and hemodynamic effects persist for 24 hours. The use of Renitec as antihypertensive therapy leads to a significant regression of left ventricular hypertrophy while maintaining its systolic function. In patients with or without diabetes mellitus, with nephropathy and proteinuria, a decrease in albuminuria, urinary IgG excretion and urinary protein levels was observed after the use of enalapril. In patients with essential hypertension, a decrease in blood pressure is usually accompanied by a decrease in peripheral vascular resistance, an increase in cardiac output, and heart rate changes slightly or does not change. Taking Renitec increases renal blood flow and does not affect the glomerular filtration rate. Taking enalapril reduces the incidence of ventricular arrhythmias in patients with heart failure. The cardioprotective effect of Renitec is confirmed by the results of clinical studies. Clinical pharmacology in children The results of clinical studies of the use of the drug in children aged 6–16 years with hypertension (arterial hypertension) revealed that the pharmacokinetics of enalapril when administered orally is similar to that in adult patients. For patients weighing ≤50 kg, enalapril was prescribed at a dose of 0.625 mg/day; 2.5 mg/day or 20 mg/day, patients weighing 50 kg or more - 1.25 mg/day; 5 mg/day or 40 mg/day. When using enalapril once a day, the decrease in diastolic blood pressure occurred depending on the dosage of the drug. The dose dependence of the hypotensive effect of enalapril was observed in all groups of patients (age, Tanner stage of sexual development, gender, race). Pharmacokinetics. When taken orally, enalapril is rapidly absorbed, the maximum concentration in the blood serum is reached within 1 hour. The degree of absorption of enalapril maleate when taken orally is about 60%. Eating does not affect the absorption of enalapril. After absorption, enalapril is rapidly hydrolyzed to form the active substance enalaprilat, a powerful ACE inhibitor. The maximum concentration of enalaprilat in the blood serum is achieved within 3-4 hours after oral administration. The duration of absorption and hydrolysis of enalapril is similar when taken at various recommended therapeutic doses. It is excreted mainly by the kidneys in the form of metabolites, the main of which are enalaprilat, accounting for about 40% of the administered dose, and unchanged enalapril. There are no data on other metabolites of enalapril. The plasma concentration profile of enalaprilat has a long terminal phase, probably due to the release of enalaprilat associated with ACE. In individuals with normal renal function, a stable concentration of enalaprilat is achieved on the 4th day from the start of taking the drug. The half-life of enalapril during a course of use of the drug is 11 hours.

Indications for use of the drug Renitec

• essential hypertension (arterial hypertension) of any stage;
• renovascular hypertension (arterial hypertension);
• heart failure of any degree.

In patients with clinically significant heart failure, Renitec is used for the following purposes:

• increasing survival;
• slowing the progression of heart failure;
• reducing the frequency of hospitalizations for heart failure.

Prevention of the development of clinically significant heart failure In patients with asymptomatic left ventricular dysfunction, the use of Renitec helps:

• slowing down the development of clinical manifestations of heart failure;
• reducing the frequency of hospitalizations for heart failure.

Prevention of the development of ischemic disorders of the coronary circulation in patients with left ventricular dysfunction in order to:

• reducing the incidence of myocardial infarction;
• reducing the frequency of hospitalization for unstable angina.

Use of the drug Renitec

Since food intake does not affect the absorption of Renitec, the tablets can be taken before, after or during meals. Since the tablet is not divided, if the drug is prescribed in a dose of less than 5 mg, enalapril preparations with the possibility of such dosing are used. Essential hypertension (arterial hypertension). The initial dose of the drug for adults is 10–20 mg 1 time per day, depending on the degree of hypertension. For mild hypertension (arterial hypertension), the recommended initial dose is 10 mg/day. For hypertension (arterial hypertension) of another degree, the initial dose is 20 mg 1 time per day. Maintenance dose - 20 mg (1 tablet) 1 time per day. The dose should be selected individually, but it should not exceed 40 mg/day. Renovascular hypertension (arterial hypertension). In adult patients in this group, therapy should be initiated with a low initial dose, such as 5 mg or lower. Since the tablet is not divided, if the drug is prescribed at a dose of ≤5 mg, enalapril preparations with the possibility of such dosing are used. Then the dose is selected taking into account the patient's condition. It can be expected that the drug will be effective for most people when taking 20 mg (1 tablet) daily. Caution should be exercised when treating patients with Renitec who have recently taken diuretics. Concomitant use of diuretics for hypertension . After taking the initial dose of Renitec, arterial hypotension may develop. This effect is most likely in patients using diuretics. Caution should be exercised in this case, since such patients may have a deficiency of fluid or electrolytes (sodium) in the body. Treatment with diuretics should be stopped 2-3 days before starting treatment with Renitec. If this is not possible, the initial dose of Renitec should be low (5 mg or lower) to determine the primary effect of the drug on blood pressure. Next, the dose should be selected taking into account the patient's condition. Dosing for renal failure. In case of renal failure, the interval between taking enalapril should be increased and/or the dose reduced.

*Cm. SPECIAL INSTRUCTIONS - patients on hemodialysis. **Enalapril is eliminated by hemodialysis. Dosage adjustment on days when hemodialysis is not performed should be carried out depending on the blood pressure level.

Heart failure, asymptomatic left ventricular dysfunction The initial dose of Renitec in patients with heart failure is 2.5 mg, and the use of the drug should be carried out under the strict supervision of a physician in order to establish the initial effect of the drug on blood pressure. Renitec should be used during the treatment of symptomatic heart failure, usually with diuretics and, if necessary, with digitalis preparations. If there is no effect or after appropriate correction of symptomatic hypotension resulting from treatment with Renitec, the dose should be gradually increased to the target dose of 20 mg, which is taken once a day or divided into 2 doses depending on what is better tolerated by the patient. Dose selection can be carried out over 2–4 weeks or shorter periods. This therapeutic regimen was effective in reducing mortality rates in patients with clinically significant heart failure. For the treatment of symptomatic heart failure, Renitec is usually used with diuretics and, if necessary, digitalis. Both before and after starting treatment with Renitec, patients with heart failure should undergo careful monitoring of blood pressure and renal function (see SPECIAL INSTRUCTIONS). The development of arterial hypotension after taking the initial dose of Renitec does not mean that hypotension will persist during long-term treatment and does not indicate the need to stop taking the drug. During treatment with Renitec, serum potassium levels should also be monitored (see INTERACTIONS). Hypertension (arterial hypertension) in children aged 6 to 16 years Renitec is used in children over 6 years of age. Dosage depends on the child's body weight. For patients weighing ≤50 kg, the initial dose of enalapril is 2.5 mg/day, ≥50 kg - 5 mg/day. The maximum clinically studied dose for children is 0.58 mg/kg (up to 40 mg) once a day (see SPECIAL INSTRUCTIONS).

Renitek price, where to buy

This product may have different prices depending on the form of release. Thus, the price of Renitec in 10 mg tablets is approximately 80 rubles. The cost of 20 mg tablets (14 pieces in a cardboard box) is on average 140 rubles. And the price of Renitec in 5 mg tablets is 70 rubles.

• Online pharmacies in RussiaRussia
• Online pharmacies in UkraineUkraine

ZdravCity

• KO-Renitek tablets 20mg+12.5mg 28 pcsMerck Sharp & Dohme BV
  RUB 527 order
• Renitek tab. 10 mg No. 14AO Akrikhin

  70 rub. order

• Renitek tablets 20 mg 14 pcsAO "AKRIKHIN"

  113 RUR order

Pharmacy Dialogue

• Renitek (tab. 10 mg No. 14) Akrikhin JSC

  69 RUR order

• Renitek (tab. 20 mg No. 14) Akrikhin JSC

  101 rub. order

• Renitec (20 mg tablet No. 14) Merck Sharp

  107 RUR order

• Renitek (tab. 20 mg No. 14) Akrikhin JSC

  106 rub. order

• Co-Renitek (tab. 20/12.5 mg No. 28) Merck Sharp

  RUR 534 order

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Pharmacy24

• Tablets Co-Renitek 20/12.5 mg No. 28 Merck Sharp i Dome B.V./Merck Sharp i Dome Limited, Netherlands/Great Britain
  189 UAH order

Side effects of the drug Renitec

When using Renitec, in most cases, side effects were minor, transient in nature and did not require cessation of therapy. When using Renitec, dizziness and headache, increased fatigue and asthenia were noted; other side effects (hypotension, orthostatic hypotension, loss of consciousness, nausea, diarrhea, muscle cramps, rash and cough); Renal dysfunction, renal failure, and oliguria were less frequently reported. Hypersensitivity/angioedema Rarely, when using Renitec, angioedema of the face, extremities, lips, tongue, glottis and/or larynx developed. Angioedema of the intestine has been very rarely reported with concomitant use of ACE inhibitors, including enalapril. During controlled clinical trials or with widespread use of the drug, the following side effects were rarely detected: from the cardiovascular system: myocardial infarction or stroke may be secondary to severe arterial hypotension in patients at risk (see SPECIAL INSTRUCTIONS); chest pain, palpitations, arrhythmias, angina pectoris, Raynaud's phenomenon; from the endocrine system: syndrome of impaired secretion of antidiuretic hormone; from the gastrointestinal tract: intestinal obstruction, pancreatitis, liver failure, hepatitis (hepatocellular or cholestatic), jaundice, abdominal pain, vomiting, dyspepsia, constipation, anorexia, stomatitis; metabolic disorders: cases of hypoglycemia have been reported in patients with diabetes mellitus taking oral hypoglycemic drugs or insulin; symptoms from the central nervous system and mental disorders: depression, confusion, drowsiness, insomnia, nervousness, paresthesia, dizziness, sleep disturbances; from the respiratory system: infiltrates in the lungs, bronchospasm/BA, shortness of breath, rhinorrhea, pharyngitis, dysphonia (hoarseness), dry cough. on the part of the skin: sweating, polymorphic erythema, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, itching, flushing of the facial skin, urticaria, alopecia; other manifestations: impotence, impaired taste perception, tinnitus, glossitis, blurred vision. A complex symptom complex has been reported, including some or all of the following: fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, positive antinuclear antibody (ANA) tests, elevated ESR, eosinophilia and leukocytosis. As adverse reactions, rash, photosensitivity and other dermatological manifestations may occur. Changes in laboratory parameters: Clinically significant changes in standard laboratory parameters are rarely associated with the use of Renitec. Cases of increased blood urea, serum creatinine, liver enzyme activity and/or serum bilirubin have been observed. These changes are usually reversible and normalize after stopping the use of Renitec. Hyperkalemia and hyponatremia are sometimes noted. There are reports of decreased hemoglobin levels and hematocrit values. Since the use of the drug in widespread clinical practice, isolated cases of neutropenia, thrombocytopenia, bone marrow suppression and agranulocytosis have been reported, which are sometimes associated with the use of Renitec. Children The side effect profile in children is no different from that in adults.

Special instructions for the use of Renitec

Clinically significant arterial hypotension. Clinically significant arterial hypotension was rarely detected in patients with uncomplicated hypertension (arterial hypertension). In patients with hypertension (arterial hypertension) receiving Renitec, arterial hypotension develops more often with hypovolemia resulting from diuretic therapy, salt restriction, in patients on hemodialysis, as well as with diarrhea or vomiting (see INTERACTIONS and ADVERSE REACTIONS). EFFECTS). Clinically significant arterial hypotension has been observed in patients with heart failure, with or without renal failure. More often, arterial hypotension develops in patients with severe forms of heart failure who receive higher doses of loop diuretics, with hyponatremia or impaired renal function. In such patients, treatment with Renitec should be started under the supervision of a physician. When changing the dose of Renitec and/or diuretic, monitoring should be especially careful. You should also carefully monitor patients with coronary artery disease and cerebrovascular diseases, in whom a sharp decrease in blood pressure can lead to the development of myocardial infarction or stroke. If arterial hypotension develops, the patient should be laid down and, if necessary, an isotonic sodium chloride solution should be administered intravenously. Transient arterial hypotension when taking Renitec is not a contraindication for treatment with the drug, which can be continued after replenishing the volume of fluid in the body and normalizing blood pressure. In some patients with heart failure and normal or low blood pressure, Renitec may cause an additional decrease in blood pressure. This reaction to the drug can be expected and should not be regarded as a reason to stop taking the drug. If treatment-resistant arterial hypotension develops, the dose should be reduced and/or treatment with a diuretic and/or Renitec should be discontinued. Aortic stenosis/hypertrophic cardiomyopathy : As with all vasodilators, ACE inhibitors should be used with caution in patients with left ventricular outflow tract obstruction. Renal dysfunction . In some patients, arterial hypotension that develops at the beginning of treatment with ACE inhibitors can lead to a further deterioration of renal function. In some cases, the development of acute renal failure, usually reversible, has been reported. In patients with renal insufficiency, it may be necessary to reduce the dose and/or frequency of the drug (see APPLICATION). In some patients with bilateral renal artery stenosis or stenosis of the artery of a solitary kidney, an increase in blood urea and serum creatinine was observed. The changes were usually reversible, and the values ​​returned to normal after cessation of treatment. A similar pattern of changes is most likely in patients with liver failure. In some patients who have not been diagnosed with kidney disease before starting treatment, Renitec, used in combination with diuretics, may lead to a slight transient increase in blood urea and serum creatinine. In such cases, it is necessary to reduce the dose and/or discontinue the use of the diuretic and/or Renitec. Hypersensitivity/angioedema. When treated with ACE inhibitors, including Renitec, isolated cases of the development of angioedema of the face, extremities, lips, tongue, glottis and/or larynx, occurring during different periods of treatment, have been described. In such cases, you should immediately stop treatment with Renitec and establish constant monitoring of the patient to ensure complete disappearance of symptoms. Only after this can observation be stopped. If the swelling is limited to the face and lips, no special treatment is usually required. Angioedema of the larynx can be fatal. In cases where swelling is localized in the area of ​​the tongue, glottis or larynx and can lead to airway obstruction, treatment should be promptly started, including subcutaneous administration of a solution of adrenaline 1:1000 (0.3–0.5 ml) and/or take measures to ensure airway patency. Representatives of the Black race who took ACE inhibitors were more likely to experience angioedema compared with representatives of other races. If the patient's history contains indications of cases of angioedema that are not associated with the use of ACE inhibitors, then such patients have an increased risk of developing it when treated with an ACE inhibitor (see CONTRAINDICATIONS). Anaphylactoid reactions during hyposensitization with an allergen from the venom of Hymenoptera Occasionally, in patients taking ACE inhibitors, during hyposensitization with an allergen from the venom of Hymenoptera, anaphylactoid reactions developed, threatening the lives of the patients. Such reactions can be avoided if you temporarily stop taking the ACE inhibitor before the onset of hyposensitization. Patients on hemodialysis Patients on hemodialysis using high-flow membranes (eg AN69) and concomitantly receiving an ACE inhibitor, in some cases, develop anaphylactoid reactions. Therefore, in such patients, the use of dialysis membranes of a different type or antihypertensive drugs of a different group is recommended. Cough Cough has been reported during treatment with ACE inhibitors. Usually the cough is non-productive, persistent and stops after discontinuation of the drug. Cough due to treatment with an ACE inhibitor must be taken into account in the differentiated diagnosis of cough. Surgery/anesthesia: During large surgical procedures or during anesthesia using drugs that cause hypotension, enalapril blocks the formation of angiotensin II secondary to the compensatory release of renin. If arterial hypotension develops, which can be explained by this interaction mechanism, it is corrected by increasing fluid volume. Serum potassium - see INTERACTIONS. Lactose Since the drug contains lactose, it is contraindicated for use in patients with lactose intolerance. During pregnancy and breastfeeding. The use of Renitec during pregnancy is not recommended. If pregnancy is detected, Renitek's prescription should be discontinued immediately, except in cases where its use is considered vital for the mother. In a published retrospective epidemiological study, infants whose mothers took an ACE inhibitor during the first trimester of pregnancy had a higher risk of congenital malformations compared with those whose mothers did not take an ACE inhibitor during this period. The number of cases of birth defects was small and the results of this study have not yet been replicated. Taking ACE inhibitors in the second and third trimester of pregnancy can cause illness or death of the fetus or newborn. The use of ACE inhibitors during this period is accompanied by negative effects on the fetus and newborn, including hypotension, renal failure and/or cranial hypoplasia. Oligoamnion may develop, probably due to decreased fetal renal function. This complication can lead to contracture of the limbs, deformation of the skull, including its facial part, and hypoplasia of the lungs. When prescribing Renitec, it is necessary to inform the patient about the potential harm to the fetus. In cases where the use of an ACE inhibitor during pregnancy is considered necessary, periodic ultrasound should be performed to assess the condition of the intra-amniotic space. If oligoamnion is detected, Renitec should be discontinued, unless its use is considered vital for the mother. However, the doctor and the patient should be aware that a decrease in the volume of amniotic fluid can occur even after irreversible damage has occurred in the fetus. Newborns whose mothers took Renitec should be carefully monitored for hypotension, oliguria and hyperkalemia. Enalapril, which crosses the placental barrier, can be partially removed from the blood of the newborn using peritoneal dialysis; theoretically, enalapril can also be removed by exchange transfusion. Enalapril passes into breast milk in trace amounts. When prescribing Renitec to women who are breastfeeding, caution should be exercised. Children. Used in children over 6 years of age. Due to the lack of data, Renitec is not recommended for the treatment of children with a glomerular filtration level ≤30 ml/min/1.73 m2. Driving vehicles and working with potentially dangerous mechanisms. Considering the possibility of developing such adverse reactions as dizziness, loss of consciousness, arterial hypotension, muscle cramps, confusion, drowsiness, blurred vision, you should refrain from driving vehicles or operating other mechanisms.

Contraindications

This drug is contraindicated in with a history of angioedema due to the use of ACE inhibitors , as well as hypersensitivity to its components.

In addition, the medicine should not be taken in cases of hereditary or idiopathic angioedema , lactase deficiency , galactosemia and glucose-galactose malabsorption . It is also contraindicated for use in people undergoing hemodialysis using high-permeability membranes, pregnant and lactating women, children under 1 month, and children with a glomerular filtration less than 30 ml/min/1.73 m2. m.

The drug is used with caution before operations, in case of impaired renal function , heart failure , cerebrovascular disorders diuretic therapy , coronary heart disease , hemodialysis , as well as in aortic stenosis , bilateral renal artery stenosis , water-electrolyte imbalance or stenosis of the artery of a single kidney .

Interactions of the drug Renitec

Antihypertensive therapy When Renitec is used in combination with other antihypertensive drugs, an additive effect may be observed. Serum potassium During clinical trials, patients' plasma potassium levels generally remained within the normal range. In patients with hypertension (arterial hypertension) who took Renitec as monotherapy for up to 48 weeks, the average increase in serum potassium was 0.2 mEq/L. When patients received combination therapy with Renitec and a thiazide diuretic, potassium loss caused by the diuretic was usually reduced by the effect of enalapril. If Renitec is used in combination with another diuretic that results in potassium loss, diuretic-induced hypokalemia is reduced. Risk factors for the development of hyperkalemia include renal failure, diabetes mellitus and concomitant use of potassium-sparing diuretics, such as spironolactone, triamterene or amiloride, as well as the use of potassium-containing dietary supplements or salt substitutes containing potassium. The use of potassium-sparing diuretics, dietary supplements or salts containing potassium, especially in the treatment of patients with impaired renal function, can lead to a significant increase in serum potassium levels. If the use of the drugs listed above is considered justified, they should be used with caution and regular monitoring of serum potassium levels. Antidiabetic drugs Epidemiological studies have found that the combined use of ACE inhibitors and antidiabetic drugs (insulin, oral hypoglycemic drugs) can cause a decrease in blood glucose levels with a risk of developing hypoglycemia. This phenomenon is most likely to develop during the first weeks of combined drug use and in patients with renal failure. In patients with diabetes mellitus who are taking oral hypoglycemic agents or insulin, glycemic levels should be carefully monitored, especially during the first month of treatment with an ACE inhibitor. Serum lithium As with other sodium-removing drugs, the clearance of lithium may be reduced when taking Renitec. Therefore, the level of lithium in the blood should be regularly determined if lithium salts are prescribed. NSAIDs, including selective COX-2 inhibitors NSAIDs, including selective COX-2 inhibitors, may reduce the effect of diuretics and other antihypertensive drugs. Therefore, the hypotensive effect of ACE inhibitors may be reduced when taken with drugs of this group. In some patients with impaired renal function (elderly patients or patients with reduced blood volume, including those using diuretics) who are taking NSAIDs, concomitant use of ACE inhibitors may lead to a further deterioration of renal function. Usually these phenomena are reversible. Gold preparations Isolated nitrite reactions (symptoms: facial swelling, nausea, vomiting and hypotension) were observed in patients who simultaneously took injectable gold preparations (sodium aurothiomalate) and ACE inhibitors, including enalapril.

Interaction

Antihypertensive and diuretic drugs, when interacting with Renitec, lead to an increased hypotensive effect. And when combined with potassium-sparing diuretics and medications that contain potassium, the likelihood of hyperkalemia .

Together with lithium preparations, Renitec reduces the excretion of lithium and increases their toxicity. When interacting with non-narcotic analgesics a nephrotoxic increases .

Renitec drug overdose, symptoms and treatment

There is limited clinical data on drug overdose. The main signs according to available data are severe arterial hypotension, which begins approximately 6 hours after dosing and coincides with blockade of the renin-angiotensin system, and stupor. Plasma levels of enalaprilat 100 and 200 times the maximum level achieved at therapeutic doses have been reported following administration of 300 mg and 440 mg of enalapril, respectively. To treat an overdose, intravenous infusions of an isotonic solution are recommended. If necessary, angiotensin II infusion is performed. If the drug has been taken recently, gastric lavage is recommended. Enalaprilat can be removed from the systemic circulation by hemodialysis (see SPECIAL INSTRUCTIONS).

Analogues of Renitek

Level 4 ATC code matches:
Dilaprel

Prenesa

Enap

Diroton

Lipril

Renipril

Parnavel

Fozinap

Tritace

Enam

Zokardis

Fosinopril

Lisinopril

Captopril

Monopril

Hartil

Phosicard

Amprilan

Ramipril

Perindopril

The following analogues of Renitek can be found in the pharmacy chain:

• Berlipril;
• Ena Sandoz;
• Enalapril;
• Enalapril-Astrapharm;
• Enalapril-Darnitsa;
• Enalapril-Health;
• Enalozide Mono;
• Enap;
• Co-Renitek.

The difference between Renitek and Co-Renitec

The key difference between Renitek and Co-Renitec is the composition. In addition to enalapril, the second drug also contains hydrochlorothiazide . Thus, it has both antihypertensive and diuretic effects.