Renitek - instructions for use, reviews, analogs and formulations (5 mg, 10 mg and 20 mg tablets, Co-renitek with a diuretic hydrochlorothiazide) for the treatment of hypertension and pressure reduction in adults, children and in pregnancy

In this article, you can read the instructions for using the drug Renitek. Presented are reviews of visitors to the site - consumers of this medication, as well as opinions of specialists on the use of Renitek in their practice. A big request is to actively add their feedback on the drug: the medicine helped or did not help get rid of the disease, which were observed complications and side effects, possibly not declared by the manufacturer in the annotation. Analogues of Renitek in the presence of existing structural analogs.Use to treat hypertension and reduce blood pressure in adults, children, as well as during pregnancy and lactation.

Renitek - refers to agents that affect the renin-angiotensin system - ACE inhibitors and is a highly specific, long-acting, sulfhydryl-free ACE inhibitor group.

Renitek (the active ingredient of Enalapril Maleate) is a derivative of two amino acids: L-alanine and L-proline. Enalapril is an ACE inhibitor that catalyzes the conversion of angiotensin 1 into an angiotensin prescription substance 2. After absorption, enalapril taken internally is converted by hydrolysis to enalaprilate, which inhibits ACE. Inhibition of ACE leads to a decrease in the concentration of angiotensin 2 in the blood plasma, which leads to an increase in plasma renin activity (due to elimination of reverse negative reaction to changes in renin production) and a decrease in aldosterone secretion.

The ACE is identical to the kinase enzyme 2, so enalapril can also block the destruction of bradykinin, a peptide that has a vasodilating effect.The significance of this effect in the therapeutic effect of enalapril needs clarification. At present, it is believed that the mechanism by which enalapril reduces BP is inhibition of the renin-angiotensin-aldosterone system, which plays an important role in the regulation of blood pressure. Enalapril has antihypertensive effect even in patients with reduced renin concentration. Reduction of blood pressure is accompanied by a decrease in total peripheral vascular resistance, an increase in cardiac output and no changes or slight changes in the heart rate. As a result of enalapril intake, renal blood flow increases, but the level of glomerular filtration remains unchanged. However, in patients with initially reduced glomerular filtration, its level usually rises.

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

Therapy with enalapril is accompanied by a favorable effect on the ratio of lipoprotein fractions and the lack of influence or favorable effect on the concentration of total cholesterol.

The use of enalapril in patients with arterial hypertension leads to a decrease in blood pressure, regardless of the position of the body: both in a standing and lying position without a significant increase in heart rate.

Symptomatic postural hypotension develops rarely. In some patients, achieving an optimal BP reduction may require several weeks of therapy. Interruption of enalapril therapy does not cause a sharp rise in blood pressure.

Effective inhibition of ACE activity usually develops 2-4 hours after a single dose of enalapril inside. The onset of antihypertensive action occurs within 1 hour, the maximum decrease in blood pressure is observed 4-6 hours after taking the drug. The duration of action depends on the dose. However, when using the recommended doses, the antihypertensive effect and hemodynamic effects are maintained for 24 hours.

Renitek reduces the loss of potassium ions caused by the use of hydrochlorothiazide.

Hydrochlorothiazide has a diuretic and antihypertensive effect, increases the activity of renin. Although enalapril itself has antihypertensive effect even in patients with arterial hypertension against a background of low concentrationrenin, the concomitant use of hydrochlorothiazide in such patients leads to a more pronounced decrease in blood pressure.

Composition

Enalapril maleate + excipients.

Enalapril maleate + Hydrochlorothiazide + excipients (Co-renitek).

Pharmacokinetics

After ingestion, Renitek is rapidly absorbed. The degree of absorption of enalapril maleate on ingestion is approximately 60%. Eating does not affect the absorption of enalapril. Enalapril is excreted mainly through the kidneys. The main metabolites detected in the urine are enalaprilat, which is approximately 40% of the dose and unaltered enalapril. There are no data on other metabolites of enalapril.

Indications

• essential hypertension;
• Renovascular hypertension;
• heart failure of any stage.

In patients with the presence of clinical manifestations of heart failure the drug is also indicated for:

• improved patient survival;
• slowing the progression of heart failure;
• decrease in 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, the drug is indicated for:

• slowing the development of clinical manifestations of heart failure;
• decrease in the frequency of hospitalizations for heart failure.

Prevention of Coronary Ischemia

In patients with left ventricular dysfunction, the drug is indicated for:

• decrease the incidence of myocardial infarction;
• decrease in the frequency of hospitalizations for unstable angina.

Forms of release

Tablets 5 mg, 10 mg and 20 mg.

Instructions for use and dosage

Inside, regardless of food intake, as the absorption of tablets depends on the intake of food.

Arterial hypertension

The initial dose is 10-20 mg, depending on the severity of arterial hypertension and is prescribed 1 time per day. With a mild degree of hypertension, the recommended initial dose is 10 mg per day. At other degrees of arterial hypertension, the initial dose is 20 mg per day for a single dose. The maintenance dose is 1 tablet 20 mg once a day. Dosage is selected individually for each patient, but the dose should not exceed 40 mg per day.

Renovascular hypertension

Since in patients in this group, blood pressure and renal function may be particularly sensitive to ACE inhibition, therapy starts with a low initial dose of 5 mg or less. Then the dose is selected according to the patient's needs. Usually effective dose of 20 mg per day with daily intake. Care should be taken when treating patients who have received diuretic treatment shortly before.

Concomitant treatment of arterial hypertension with diuretics

After the first reception of Renitek, hypotension may develop. This effect is most likely in patients who are treated with diuretics. The drug is recommended to be administered with caution. such patients may have a deficiency of fluid or sodium. Treatment with diuretics should be discontinued 2-3 days before treatment Renitek. If this is not possible, the initial dose of Renitech should be reduced (to 5 mg or less) to determine the primary effect of the drug. Then the dosage should be selected taking into account the patient's condition.

Cardiac insufficiency / asymptomatic dysfunction of the left ventricle

The initial dose of Renitek in patients with heart failure or with asymptomatic left ventricular dysfunction is 2.5 mg,while the purpose of the drug should be carried out under careful medical supervision to establish the primary effect of the drug on blood pressure. Renitek can be used for the treatment of heart failure with significant clinical manifestations usually in conjunction with diuretics and, where appropriate, with cardiac glycosides. In the absence of symptomatic hypotension (resulting from treatment Renitec) or after its corresponding correction, the dose should be gradually increased to usual maintenance dose of 20 mg, which is assigned either once or divided in 2 doses, depending on patient tolerability of the drug. The dose can be selected within 2-4 weeks or in shorter periods if there are residual signs and symptoms of heart failure. Such a therapeutic regimen effectively reduces the mortality rates of patients with clinically significant heart failure.

Both before and after starting treatment Renitec should be careful monitoring of blood pressure and renal function in patients with heart failure as a result of taking the drug hypotension followed were about the development of the message (which is observed much less frequently) the occurrence of renal failure.In patients receiving diuretics, the dose of diuretics should be reduced as far as possible before treatment with Renitek. The development of arterial hypotension after taking the first dose of Reniteca does not mean that arterial hypotension will persist with long-term treatment, and does not indicate the need for discontinuation of the drug. When treating Renitek, you should also monitor the potassium level in the serum.

Korenitek

The drug is administered orally, regardless of food intake.

With arterial hypertension, the initial dose is 1 tablet once a day. If necessary, the dose can be increased to 2 tablets once a day.

At the beginning of Co-renitek therapy, symptomatic arterial hypotension may develop, more often in patients with water-electrolyte balance disorders due to previous treatment with diuretics. Therapy with diuretics should be discontinued 2-3 days before the application of Co-Renitech.

Side effect

• myocardial infarction;
• stroke;
• chest pain;
• strong palpitations;
• rhythm disturbance;
• angina pectoris;
• Raynaud's syndrome;
• nausea, vomiting;
• diarrhea;
• intestinal obstruction;
• liver failure;
• abdominal pain;
• dyspepsia;
• constipation;
• anorexia;
• stomatitis;
• dry mouth;
• hypoglycemia in patients with diabetes mellitus receiving hypoglycemic agents for ingestion or insulin;
• headache;
• depression;
• confusion of consciousness;
• drowsiness;
• insomnia;
• increased nervousness;
• paresthesia;
• dizziness;
• sleep disorders;
• anxiety;
• dyspnea;
• rhinorrhea;
• a sore throat;
• hoarseness of voice;
• increased sweating;
• itching;
• hives;
• baldness;
• angioedema, swelling of the face, extremities, lips, tongue, glottis and / or larynx;
• impotence;
• redness of facial skin;
• a taste disorder;
• noise in ears;
• glossitis;
• blurred vision;
• fever;
• vasculitis;
• leukocytosis;
• photosensitivity and other skin reactions.

Contraindications

• angioedema in history, associated with the appointment of ACE inhibitors;
• hereditary or idiopathic angioedema;
• age under 18 years (effectiveness and safety not established);
• hypersensitivity to any of the components of the drug.

Application in pregnancy and lactation

Use of the drug during pregnancy is not recommended.At the onset of pregnancy, the reception of Renitec should be stopped immediately. ACE inhibitors can cause the disease or death of a fetus or newborn when administered to pregnant women during the 2nd and 3rd trimesters of pregnancy. The use of ACE inhibitors during these periods was accompanied by a negative impact on the fetus and the newborn, including the development of arterial hypotension, renal failure, hyperkalemia and / or skull hypoplasia in the newborn. Perhaps the development of oligohydramnion, apparently due to a decrease in the function of the kidneys of the fetus. This complication can lead to limb contracture, deformation of the skull, including its facial part, lung hypoplasia. When appointing Renitek, the patient should be informed of the potential risk to the fetus.

These undesirable effects on the embryo and fetus do not appear to be the result of the intrauterine effect of ACE inhibitors during the 3rd trimester of pregnancy.

Newborns whose mothers took Renitek should be carefully monitored in order to detect a decrease in blood pressure, oliguria and hyperkalemia.Enalapril, which penetrates the placenta, can be partially removed from the bloodstream of the newborn by peritoneal dialysis; in theory it can be removed by means of exchange blood transfusion.

Enalapril and enalaprilat are determined in human milk in trace concentrations. In case the use of the drug is necessary, the patient should stop breastfeeding.

Application in elderly patients

With caution in patients older than 65 years.

Use in children

Contraindicated at the age of 18 years (efficacy and safety not established).

special instructions

Renitec should be used with caution in the treatment of patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, with primary hyperaldosteronism, hyperkalemia, a condition after kidney transplantation; aortic stenosis, mitral stenosis (with disturbances in hemodynamics), idiopathic hypertrophic subaortic stenosis; systemic diseases of connective tissue; ischemic heart disease; cerebrovascular diseases; diabetes mellitus; Renal insufficiency (proteinuria - more than 1 g per day); hepatic insufficiency; in patients,observing a diet with restriction of salt or being on hemodialysis; with simultaneous reception with immunosuppressants and diuretics, elderly patients (over 65 years old), oppression of bone marrow hematopoiesis; states, accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting).

Clinically expressed arterial hypotension

Clinically pronounced arterial hypotension is rarely observed in patients with uncomplicated hypertension. In patients with arterial hypertension receiving Renitek, arterial hypotension develops more often against a background of hypovolemia, arising, for example, as a result of diuretic therapy, limiting salt intake, in patients on hemodialysis, as well as suffering from diarrhea or vomiting. Clinically pronounced arterial hypotension was also observed in patients with heart failure, accompanied or not accompanied by renal insufficiency. Arterial hypotension is observed more often in patients with more severe forms of heart failure, who use higher doses of loop diuretics, with hyponatremia or impaired renal function.In such patients Renitek treatment should be started under medical supervision, which should be especially careful when changing the dose of Renitech and / or diuretic. Similarly, patients with coronary heart disease should be monitored, as well as with cerebrovascular diseases, in which a sharp decrease in blood pressure can lead to myocardial infarction or stroke. With the development of arterial hypotension, the patient should be placed and, if necessary, to enter intravenously a physiological solution of sodium chloride.

Transient arterial hypotension with admission Reniteka is not a contraindication to further treatment with the drug, which can be continued after replenishing the volume of fluid and normalizing blood pressure. In some patients with heart failure and with normal or reduced BP, Renitec may cause an additional reduction in blood pressure. Such a reaction to taking the drug can be expected, and it should not be regarded as a reason for discontinuing treatment. In those cases when arterial hypotension assumes a stable character, it is necessary to lower the dose and / or stop treatment with a diuretic and / or Renitek.

Aortic stenosis / hypertrophic cardiomyopathy

Like all vasodilators, patients with obstructed aortic left ventricular aperture ACE inhibitors should be administered with caution.

Impaired renal function

In some patients, arterial hypotension, which develops after the initiation of treatment with ACE inhibitors, can lead to impaired 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. In some patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney, there was an increase in urea in the blood and serum creatinine. Changes were usually reversible and the rates returned to normal after discontinuation of treatment. This type of change is most likely in patients with renal insufficiency. In some patients who did not have renal disease prior to treatment, Renitek, in combination with diuretics, usually caused a slight and transient increase in blood urea and creatinine in the blood serum.In such cases, a dose reduction and / or cancellation of the diuretic and / or Renitec may be required.

Hypersensitivity / Angioedema

In the appointment of ACE inhibitors, including Renitek, rare cases of angioedema of the face, extremities, lips, tongue, glottis and / or larynx that occurred during different periods of treatment were described. In such cases, Renitec should immediately stop treatment and establish constant monitoring of the patient to ensure complete disappearance of the symptoms. Even in cases where there is only difficulty in swallowing without disrupting breathing, patients should be under medical supervision for a long time, since antihistamine and corticosteroid therapy may not be sufficient. Angioneurotic edema of the larynx or tongue can lead to death. In cases where edema is localized in the area of ​​the tongue, glottis or larynx and can cause airway obstruction, appropriate therapy should be started quickly, which may include subcutaneous injection of epinephrine (adrenaline) solution 0.1% (0.3-0.5 ml) and / or urgent measures to ensure airway patency.

Patients who have a history of angioedema, not associated with the use of ACE inhibitors, may have an increased risk of its occurrence and treatment with an ACE inhibitor. In patients of the Negroid race, the frequency of angioedema development with ACE inhibitors is higher than in representatives of other races.

Anaphylactic reactions during hypensensitization by an allergen from Hymenoptera venom

In rare cases, patients receiving ACE inhibitors during an allergen hypensensitivity from Hymenoptera venom develop anaphylactic reactions that threaten the lives of patients. Such reactions can be avoided, if before the beginning of hyposensitization, temporarily stop the use of an ACE inhibitor.

Patients on hemodialysis

Patients on dialysis using high-capacity membranes (eg AN69) and concurrently receiving an ACE inhibitor, in some cases developed anaphylactic reactions. Therefore, for such patients, the use of dialysis membranes of another type or an antihypertensive drug of another group is recommended.

Cough

There are reports of the occurrence of cough in the treatment with ACE inhibitors. Usually the cough is unproductive, permanent and stops after the drug is discontinued. Cough due to treatment with an ACE inhibitor should be taken into account in the differential diagnosis of cough.

Surgery / General Anesthesia

During large surgical operations or during general anesthesia using agents that cause an antihypertensive effect, enalapril blocks the formation of angiotensin 2 secondary to the compensatory release of renin. If this results in a pronounced decrease in blood pressure, explained by such a mechanism, it can be corrected by increasing the volume of the injected fluid.

Hyperkalemia

Risk factors for the development of hyperkalemia are renal failure, diabetes mellitus, simultaneous administration of potassium-sparing diuretics (spironolactone, triamterene or amiloride), as well as the use of potassium-containing additives and salts.

The use of potassium supplements, potassium-sparing diuretics or potassium-containing salts, especially in patients with renal insufficiency, can lead to a significant increase in potassium in the serum.Hyperkalemia can cause serious, in some cases fatal, heart rhythm disturbances.

If it is necessary to concomitantly administer the potassium-containing or potassium-raising drugs listed above, caution should be exercised and the serum levels of potassium regularly monitored.

Hypoglycaemia

Patients with diabetes who receive hypoglycemic agents for ingestion or insulin should be informed before starting the use of ACE inhibitors about the need for careful monitoring of blood glucose levels (hypoglycemia), especially during the first month of joint use of these drugs.

Impact on the ability to drive and / or work with machinery

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased concentration and speed of psychomotor reactions (possibly dizziness, especially after taking the initial dose of an ACE inhibitor in patients taking diuretic medicines).

Drug Interactions

When appointing Renitek in combination with other antihypertensive agents, the effect can be summed up.

The concentration of potassium in the serum usually remains within normal limits. In patients with hypertension, treated with Renitek for more than 48 weeks, there is an increase in potassium serum to 0.2 meq / l.

With the combined use of Reniteca with diuretics that cause potassium loss, hypokalemia caused by the action of diuretics is usually weakened by the effect of enalapril.

Risk factors for the development of hyperkalemia are renal failure, diabetes mellitus, simultaneous administration of potassium-sparing diuretics (spironolactone, triamterene or amiloride), as well as the use of potassium-containing additives and salts. The use of potassium supplements, potassium-sparing diuretics or potassium-containing salts, especially in patients with renal insufficiency, can lead to a significant increase in potassium in the serum. If it is necessary to concomitantly administer the potassium-containing or potassium-raising drugs listed above, caution should be exercised and the serum levels of potassium regularly monitored.

The combined use of ACE inhibitors and hypoglycemic agents (insulin, hypoglycemic agents for oral administration) can enhance the hypoglycemic effect of the latter with the risk of developing hypoglycemia. This phenomenon, as a rule, was most often observed during the first weeks of their joint application, as well as in patients with renal insufficiency. In patients with diabetes mellitus receiving hypoglycemic agents for ingestion or insulin, blood glucose levels should be carefully monitored, especially during the first month of joint use with ACE inhibitors.

ACE inhibitors reduce the excretion of lithium by the kidneys, and increase the risk of developing lithium intoxication. If it is necessary to assign lithium salts, it is necessary to control the level of lithium in the blood serum.

NSAIDs, including selective inhibitors of COX-2, can reduce the effect of diuretics and other antihypertensive agents. Thus, the antihypertensive effect of ACE inhibitors can be weakened by NSAIDs, including COX-2 inhibitors.

In some patients with impaired renal function, and taking non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors,The concomitant use of ACE inhibitors can lead to further impairment of kidney function. These changes are usually reversible.

Symptomocomplex, which includes facial flushing, nausea, vomiting and arterial hypotension, is described in rare cases when gold preparations for parenteral use (sodium arothiomalate) and ACE inhibitors (enalapril) are used together.

Analogues of the drug Renitek and Co-Renitek

Structural analogs for the active substance:

• Bagopril;
• Berlipril;
• Vazolapril;
• Vero-Enalapril;
• Involor;
• The Korandil;
• Myopril;
• Renipril;
• Ednit;
• Enazil 10;
• Enalacor;
• Enalapril;
• Enalapril maleate;
• Enam;
• Enap;
• Enarenal;
• Enafarm;
• Envas;
• Envipril.

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