Renitec, pills 10mg, 14pcs

Composition

1 tabetka contains:

Active ingredient:

Enalapril maleate 10 mg.

Auxiliary substances:  

Sodium bicarbonate;

Lactose monohydrate;

Corn starch;

Pre-gelatinized corn starch;

Magnesium stearate;

Iron oxide red (E 172).

Pharmacological action

of the pharmaceutical group:

ACE inhibitor.

Pharmaceutical action:

 Renitec® (enalapril maleate) refers to agents that affect the renin-angiotensin system-ACE inhibitors and is a highly specific, long-acting, non-sulfhydryl group ACE inhibitor.

Renitec® (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 I to the pressor substance angiotensin II. After absorption, oral enalapril is converted by hydrolysis to enalaprilate, which inhibits ACE. ACE inhibition leads to a decrease in the concentration of angiotensin II in blood plasma, which leads to an increase in plasma renin activity (due to the elimination of the reverse negative reaction to changes in renin production) and a decrease in aldosterone secretion.

ACE is identical to the enzyme kininase II, so enalapril can also block the breakdown of bradykinin, a peptide that has a vasodilating effect. The significance of this effect in the therapeutic effect of enalapril requires clarification. Currently, it is believed that the mechanism by which enalapril reduces blood pressure is the suppression of the renin-angiotensin-aldosterone system, which plays an important role in regulating blood pressure.

Enalapril has an antihypertensive effect even in patients with reduced renin concentrations. A decrease in blood pressure is accompanied by a decrease in total peripheral vascular resistance, an increase in cardiac output, and no changes or minor changes in heart rate. As a result of taking enalapril, renal blood flow increases, but the glomerular filtration rate remains unchanged. However, in patients with initially reduced glomerular filtration, its level usually increases.

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

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

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

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

Effective ACE inhibition usually develops 2-4 hours after a single oral dose of enalapril. 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.

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

Indications

• Essential arterial hypertension (mild, moderate and severe forms);
• Renovascular hypertension;
• Chronic heart failure of all functional classes.

In patients with clinical manifestations of heart failure, Renitec is indicated for improving patient survival rates, slowing the progression of heart failure, and reducing the frequency of hospitalizations. In patients with left ventricular dysfunction without clinical symptoms of heart failure, Renitec is indicated for preventing the development of clinically pronounced heart failure, slowing the development of clinical manifestations of heart failure, and reducing the frequency of hospitalizations. In patients with left ventricular dysfunction, Renitec is indicated for the prevention of coronary ischemia, reducing the frequency of myocardial infarction, reducing the frequency of hospitalizations due to unstable angina.

Use during pregnancy and lactation

Use of the drug during pregnancy is not recommended. If pregnancy occurs, Renitek should be discontinued immediately. ACE inhibitors can cause disease or death of the fetus or newborn when administered to pregnant women during the second and third trimesters of pregnancy.

The use of ACE inhibitors during these periods was associated with negative effects on the fetus and newborn, including the development of arterial hypotension, renal failure, hyperkalemia and/or cranial hypoplasia in the newborn. Oligohydramnion may develop, apparently due to a decrease in fetal kidney function. This complication can lead to contracture of the limbs, deformity of the skull, including its facial part, and hypoplasia of the lungs. When prescribing Renitek, the patient should be informed about the potential risk to the fetus.

These adverse effects on the embryo and fetus do not appear to be the result of intrauterine exposure to ACE inhibitors during the first trimester of pregnancy.

Newborns whose mothers have taken Renitec® should be carefully monitored for blood pressure reduction, oliguria, and hyperkalemia. Enalapril, which passes through the placenta, can be partially removed from the newborn’s circulation by peritoneal dialysis; theoretically, it can be removed by an exchange blood transfusion.

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

Contraindications

• Angioedema in the anamnesis associated with the appointment of previously prescribed ACE inhibitors;
• Hereditary or idiopathic angioedema;
• Age up to 18 years (efficacy and safety have not been established);
• Hypersensitivity to any of the components of the drug Renitek.

Side effects

In general, the drug is well tolerated. The total frequency of side effects when using Renitek does not exceed that when prescribing placebo. In most cases, side effects are minor, temporary and do not require discontinuation of therapy. When prescribing the drug Renitek, the following side effects are observed: dizziness and headache are most common. Increased fatigue and asthenia are observed in 2-3% of patients. Other side effects (hypotension, orthostatic hypotension, syncope, nausea, diarrhea, muscle cramps, skin rash, and cough) occur in less than 2% of patients. There are rare reports of impaired renal function, renal failure, oliguria, and proteinuria.

Increased sensitivity/Angioedema

In rare cases, angioedema of the face, limbs, lips, tongue, glottis and/or larynx was observed, and very rarely – intestinal angioedema.

In very rare cases, the following side effects occur: :

From the cardiovascular system: in less than 2% of patients – arterial hypotension, orthostatic hypotension, syncope; in very rare cases – chest pain, palpitations, cardiac arrhythmias, angina pectoris. It is possible to develop acute myocardial infarction or stroke in patients belonging to the risk group.

From the central nervous system and peripheral nervous system:  most often – dizziness, headache; in 2-3% of cases-increased fatigue, asthenia; in very rare cases – depression, confusion, sleep disorders, paresthesia, tinnitus, blurred vision.

From the digestive system: less than 2% of patients, nausea, diarrhea; in very rare cases, intestinal obstruction, pancreatitis, hepatic failure, hepatitis, jaundice, pain in the abdomen, vomiting, dyspepsia, constipation, anorexia, stomatitis, increased activity of hepatic transaminases and bilirubin concentration in plasma (these changes are usually reversible and normalized after discontinuation of Renitek).

Respiratory system disorders: in less than 2% of patients – cough; in very rare cases – pulmonary infiltrates, bronchospasm, shortness of breath, rhinorrhea, pharyngitis, dysphonia (hoarseness of voice).

From the urinary system: in rare cases-impaired renal function, renal failure, oliguria; increased levels of urea, creatinine (these changes are usually reversible and normalize after stopping taking Renitek).

Allergic reactions:  in less than 2% of patients-skin rash; rarely-angioedema of the face, limbs, lips, tongue, glottis and / or larynx; in very rare cases – erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, pruritus, urticaria. A complex symptom complex was reported, including fever, serositis, vasculitis, myalgia/myositis, arthralgia/arthritis, positive antinuclear antibody test, increased ESR, eosinophilia, and leukocytosis.

From the hematopoietic system: in some cases – neutropenia, thrombocytopenia, agranulocytosis.

Dermatological reactions: pruritus, alopecia, hyperemia of the facial skin.

From the side of laboratory parameters:  possible development of hyperkalemia and hyponatremia; decreased hemoglobin and hematocrit levels.

Other services: increased sweating, seizures, impotence, glossitis, changes in taste, tinnitus.

Interaction

When prescribing Renitek in combination with other antihypertensive agents, a summation of the effect can be observed. The concentration of potassium in the blood serum usually remains within the normal range. In patients with arterial hypertension treated with Renitek for more than 48 weeks, an increase in serum potassium up to 0.2 meq/l is observed.

When Renitec is co-administered with diuretics that cause potassium loss, hypokalemia caused by diuretics is usually reduced due to the effect of enalapril.

Risk factors for hyperkalemia include renal failure, diabetes mellitus, concomitant use of potassium-sparing diuretics (spironolactone, triamterene, or amiloride), and the use of potassium-containing supplements 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 serum potassium. If concomitant use of the above-mentioned potassium-containing or potassium-enhancing drugs is necessary, caution should be exercised and the serum potassium content should be regularly monitored.

The combined use of ACE inhibitors and hypoglycemic agents (insulin, hypoglycemic agents for oral use) may increase the hypoglycemic effect of the latter with the risk of hypoglycemia. This phenomenon is usually most often observed during the first weeks of their combined use, as well as in patients with renal insufficiency. In patients with diabetes mellitus receiving oral hypoglycemic agents or insulin, blood glucose levels should be carefully monitored, especially during the first month of co-use with ACE inhibitors.

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

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

In some patients with impaired renal function and taking NSAIDs, including COX-2 inhibitors, concomitant use of ACE inhibitors may lead to further deterioration of renal function. These changes are usually reversible.

A symptom complex that includes facial flushing, nausea, vomiting, and hypotension has been described in rare cases with the combined use of parenteral gold preparations (sodium aurothiomalate) and ACE inhibitors (enalapril).

How to take, course of use and dosage

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

– Arterial hypertension

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

– Renovascular hypertension

Since blood pressure and renal function may be particularly sensitive to ACE inhibition in patients in this group, therapy is initiated with a low initial dose of 5 mg or less. The dose is then adjusted according to the patient’s needs. A dose of 20 mg/day is usually effective. with a daily appointment. Caution should be exercised when treating patients who have recently been treated with diuretics.

– Concomitant treatment of arterial hypertension with diuretics

Hypotension may occur after the first dose of Renitek. This effect is most likely to occur in patients treated with diuretics. The drug is recommended to be prescribed with caution, because such patients may have a lack of fluid or sodium. Treatment with diuretics should be discontinued 2-3 days before the start of treatment with Renitec. If this is not possible, then the initial dose of Renitec should be reduced (to 5 mg or less) to determine the primary effect of the drug. Further, the dosage should be selected taking into account the patient’s condition.

Overdose

Information about overdose is limited.

Symptoms: a marked decrease in blood pressure, starting approximately 6 hours after taking the drug, and stupor. Plasma concentrations of enalaprilate that were 100-200 times higher than those observed at therapeutic doses were observed after taking 300 and 440 mg of enalapril, respectively.

Treatment: intravenous infusion of isotonic sodium chloride solution, if possible – infusion of angiotensin II; provoking vomiting. It is possible to remove enalaprilat by hemodialysis.

Special instructions

Renitek® should be used with caution in the treatment of patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney, with primary hyperaldosteronism, hyperkalemia, condition after kidney transplantation; aortic stenosis, mitral stenosis (with impaired hemodynamic parameters), idiopathic hypertrophic subaortic stenosis; systemic connective tissue diseases; coronary heart disease; cerebrovascular diseases; diabetes mellitus; renal failure (proteinuria – more than 1 g/day); hepatic insufficiency; in patients who follow a diet with salt restriction or are on hemodialysis; when taken simultaneously with immunosuppressants and diuretics, elderly patients (older than 65 years), suppression of bone marrow hematopoiesis; conditions accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting).

Clinically significant arterial hypotension

Clinically significant arterial hypotension is rarely observed in patients with uncomplicated arterial hypertension. In hypertensive patients receiving Renitek®, hypotension develops more often against the background of hypovolemia, which occurs, for example, as a result of diuretic therapy, salt restriction, in patients on hemodialysis, as well as suffering from diarrhea or vomiting. Clinically significant arterial hypotension was also observed in patients with heart failure, accompanied or not accompanied by renal insufficiency.

Hypotension occurs more frequently 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, treatment with Renitec should be initiated under medical supervision, which should be especially careful when changing the dose of Renitec and / or a diuretic. Similarly, patients with coronary heart disease, as well as with diseases of the cerebral vessels, should be monitored in which a sharp decrease in blood pressure can lead to a myocardial infarction or stroke. With the development of arterial hypotension, the patient should be laid down and, if necessary, injected intravenously with saline sodium chloride.

Transient arterial hypotension when taking Renitek is not a contraindication to further treatment with the drug, which can be continued after filling the fluid volume and normalizing blood pressure. In some patients with heart failure and with normal or reduced blood pressure, Renitek® may cause an additional decrease 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 cases where hypotension is stable, the dose should be reduced and/or treatment with diuretics 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 aortic obstruction.

Impaired renal function

In some patients, hypotension that develops after starting treatment with ACE inhibitors can lead to deterioration of renal function. Acute renal failure, usually reversible, has been reported in some cases.

In patients with renal insufficiency, it may be necessary to reduce the dose and / or frequency of taking the drug. Some patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney experienced an increase in blood urea and serum creatinine. The changes were usually reversible and the indicators returned to normal after discontinuation of treatment. This type of change is most likely to occur in patients with renal insufficiency. In some patients who did not develop kidney disease prior to treatment, Renitec® in combination with diuretics usually caused a slight and transient increase in blood urea and serum creatinine. In such cases, it may be necessary to reduce the dose and/or discontinue the diuretic and / or Renitec.

Increased sensitivity/Angioedema

Rare cases of angioedema of the face, extremities, lips, tongue, glottis, and/or larynx that occurred during different periods of treatment have been reported with ACE inhibitors, including Renitec. In such cases, you should immediately stop treatment with Renitec and establish constant monitoring of the patient to make sure that the symptoms completely disappear.Even in cases where there is only difficulty in swallowing without respiratory problems, patients should be kept under medical supervision for a long time, since antihistamines and corticosteroids may not be sufficient.

Angioedema of the larynx or tongue can be fatal. In cases where edema is localized in the tongue, glottis, or larynx and can cause airway obstruction, appropriate therapy should be initiated quickly, which may include subcutaneous use of 0.1% epinephrine (epinephrine) solution(0.3-0.5 ml) and / or urgent measures to ensure airway patency.

Patients who have a history of angioedema that is not associated with the use of ACE inhibitors may also have an increased risk of angioedema when treated with an ACE inhibitor. Patients of the black race are more likely to develop angioedema when taking ACE inhibitors than those of other races.

Anaphylactic reactions during hymenopteran allergen hyposensitization In rare cases, patients receiving ACE inhibitors during hymenopteran allergen hyposensitization have developed life-threatening anaphylactic reactions. Such reactions can be avoided if you temporarily stop taking an ACE inhibitor before starting hyposensitization.

Patients undergoing hemodialysis

Patients undergoing dialysis using high-throughput membranes (for example, AN69®) and receiving an ACE inhibitor at the same time, in some cases developed anaphylactic reactions. Therefore, the use of dialysis membranes of a different type or an antihypertensive agent of a different group is recommended for such patients.

Cough

Cough has been reported during treatment with ACE inhibitors. Usually, the cough is unproductive, permanent and stops after discontinuation of the drug. Cough due to treatment with an ACE inhibitor should be considered in the differential diagnosis of cough.

Surgery/General anesthesia

During major surgical operations or during general anesthesia with antihypertensive agents, enalapril blocks the formation of angiotensin II secondary to the compensatory release of renin. If a marked decrease in blood pressure occurs due to such a mechanism, it can be corrected by increasing the volume of fluid administered.

Hyperkalemia Risk factors for hyperkalemia include renal failure, diabetes mellitus, concomitant use of potassium-sparing diuretics (spironolactone, triamterene, or amiloride), and the use of potassium-containing supplements 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 serum potassium. Hyperkalemia can cause serious, in some cases fatal, cardiac arrhythmias.

If concomitant use of the above-mentioned potassium-containing or potassium-enhancing drugs is necessary, caution should be exercised and the serum potassium content should be regularly monitored.

Hypoglycemia

Patients with diabetes mellitus receiving oral hypoglycemic agents 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 co-use of these drugs.

Use in elderly patients

Clinical studies on the efficacy and tolerability of enalapril were similar in older and younger patients.

Effects on the ability to drive a car and / or work with mechanisms

During treatment, caution should be exercised when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions (dizziness may occur, especially after taking the initial dose of an ACE inhibitor in patients taking diuretic medications).

Form of production

Renitek tablets are pink, interspersed, triangular in shape, with the inscription “MSD 713” on one side and a risk on the other.

Storage conditions

At a temperature not exceeding 25 °C.

Shelf

life is 2.5 years.

Active ingredient

Enalapril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Heart Failure, Hypertension