Enalapril-Teva - instructions for use, dose, side effects, contraindications

1 tablet contains: active substance enalapril maleate 2.50 mg / 5.00 mg / 10.00 mg / 20.00 mg; excipients: lactose monohydrate 64,90 mg / 129,80 mg / 124,60 mg / 117,80 mg, corn starch 11,20 mg / 22,40 mg / 21,40 mg / 13.90 mg,talc 3.00 mg / 6.00 mg / 6.00 mg / 6.00 mg, sodium bicarbonate 1.30 mg / 2.60 mg / 5.10 mg / 10.20 mg, giprolose 1.25 mg / 2 , 50 mg / - / magnesium stearate 0.85 mg / 1.70 mg / 1.70 mg / 1.70 mg, iron dye red oxide E172 - / - / 1.20 mg / 0.10 mg, iron oxide dye yellow E172 - / - / - / 0.30 mg.

Description:

Dosage of 2.5 mg. Round biconvex tablets of white color.

Dosage of 5 mg. Round biconvex tablets are white with a risk.

Dosage of 10 mg. Round biconvex tablets of red-brown color with individual impregnations and with a risk.

Dosage of 20 mg. Round biconvex tablets of light orange color with individual inclusions and with a risk

Pharmacotherapeutic group:angiotensin-converting enzyme inhibitor

ATX: & nbsp

C.09.A.A.02 Enalapril

Pharmacodynamics:

Enalapril - an antihypertensive drug whose mechanism of action is associated with the inhibition of angiotensin-converting enzyme (ACE) activity, leading to a decrease in the formation of angiotensin II. As a result of the hydrolysis of enalapril, enalaprilate, which inhibits ACE. The mechanism of action is associated with a decrease in the formation of angiotensin II from angiotensin I, a decrease in the concentration of which leads to a direct decrease in the secretion of aldosterone.This reduces the overall peripheral vascular resistance, systolic and diastolic blood pressure (BP), post-and preload on the myocardium.

Enalapril dilates arteries more than veins, and there is no reflex increase in heart rate. Reduces the degradation of bradykinin, increases the synthesis of prostaglandins.

The antihypertensive effect is more pronounced with a high concentration of renin than with a normal or low concentration of renin. Reduction of blood pressure within therapeutic limits does not affect cerebral circulation. Blood flow in the vessels of the brain is maintained at a sufficient level and against a background of reduced blood pressure. Strengthens coronary and renal blood flow.

With prolonged use enalapril reduces hypertrophy of the left ventricle of the myocardium and myocytes of the walls of arteries of the resistive type, prevents the progression of chronic heart failure (CHF), slows the development of left ventricular dilatation, improves the blood supply of the ischemic myocardium. Has some diuretic effect. It reduces intra-cerebral hypertension, slowing the development of glomerulosclerosis and the risk of chronic renal failure (CRF).

With prolonged use in patients with a reduced rate of glomerular filtration reduces the symptoms of fluid retention and sodium in the body, and also has a positive effect on the ratio of fractions of lipoproteins. In addition, the use of enalapril is characterized by a lack of influence or a positive effect on the concentration of total cholesterol.

Time of onset of antihypertensive effect when administered orally -1h, reaches a maximum after 4-6 hours and lasts up to 24 hours. In some patients, in order to achieve optimal blood pressure, therapy is needed for several weeks. With CHF, a marked clinical effect is observed with long-term treatment - 6 months or more. The duration of the therapeutic effect is dose-dependent.

Pharmacokinetics:

After ingestion, about 60% of enalapril is absorbed. Eating does not affect absorption.

After suction enalapril rapidly hydrolyses to form an active metabolite of enalaprilate, which is a more active ACE inhibitor than enalapril. The relationship between enalaprilat and plasma proteins is 50-60%. The maximum concentration of enalaprilat in the blood serum is observed after 3-4 hours, enalapril after 1 hour. Stable concentrations in blood serum - after 4 days.

The degree of absorption and hydrolysis of enalapril are the same for different doses within the recommended therapeutic range.

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

Excretion enalapril is performed mainly by the kidneys - 60% (20% - in the form of enalapril and 40% - in the form of enalaprilata), through the intestine - 33% (6% in the form of enalapril and 27% in the form of enalaprilate). The main metabolites, determined in urine, are enalaprilate, which is approximately 40% of the dose taken, and unchanged enalapril. There are no data on other metabolites of enalapril. The enalaprilate concentration profile in the blood plasma has a long final phase, which is apparently due to its binding to the ACE. The half-life of enalaprilat is about 11 hours. It is removed during hemodialysis (rate 62 ml / min) and peritoneal dialysis.

Indications:

- Arterial hypertension (including renovascular hypertension);

- chronic heart failure (as part of combination therapy);

- prevention of the development of clinically significant heart failure in patients with asymptomatic dysfunction of the left ventricle (as part of combination therapy).

Contraindications:

Hypersensitivity to enalapril, other components of the drug or other ACE inhibitors, history of angioedema, associated with previous use of ACE inhibitors; hereditary or idiopathic angioedema; pregnancy; the period of breastfeeding; lactose intolerance, lactase deficiency, glucose-galactose malabsorption; age under 18 years of age (safety and efficacy not studied); simultaneous use with aliskiren in patients with diabetes mellitus and patients with renal insufficiency (creatinine clearance (CK) less than 60 ml / min).

Carefully:

Aortic and / or mitral stenosis (with disturbances in hemodynamics); hypertrophic obstructive cardiomyopathy (GOKMP); cerebrovascular diseases (including cerebral circulatory insufficiency); ischemic heart disease (IHD); autoimmune systemic diseases of connective tissue (including scleroderma, systemic lupus erythematosus); oppression of bone marrow hematopoiesis; condition after kidney transplantation; bilateral stenosis of the renal arteries; stenosis of the artery of a single kidney; renal failure (CC less than 80 ml / min), liver failure; Patients,Observing a diet with restriction of consumption of table salt or being on hemodialysis; hyperkalemia; conditions, accompanied by a decrease in the volume of circulating blood (BCC), including diarrhea, vomiting; elderly age (over 65 years), primary aldosteronism, diabetes mellitus, concurrent use with immunosuppressants and saluretic drugs.

Pregnancy and lactation:

The use of Enalapril-Teva during pregnancy is not recommended. At the onset of pregnancy, the drug Enalapril-Teva should be discontinued immediately.

ACE inhibitors can cause disease or death of the fetus or newborn when used in the II and III trimesters of pregnancy. The use of ACE inhibitors during this period was accompanied by a negative impact on the fetus and newborn, including the development of arterial hypotension, renal failure, hyperkalemia and / or hypoplasia of the skull bones in a 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 bones of the skull, including its facial part, and lung hypoplasia.When using Enalapril-Teva, the patient should be informed of the potential risk to the fetus. Newborns whose mothers took the drug Enalapril-Teva should be carefully monitored for the detection of arterial hypotension, 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 enalaprilate in trace concentrations are excreted in breast milk. If you need to use the drug Enalapril-Teva during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Inside, squeezed a small amount of liquid. Tablets can be taken before, during or after a meal, regularly and at the same time of day.

If ingestion of Enalapril-Teva is missed, the missed dose should be taken. In the event that several hours are left until the next dose is administered, the missed dose of Enalapril-Teva should not be taken. The dose should never be doubled.

Arterial hypertension

The initial dose is 5 to 20 mg once a day, depending on the severity of hypertension

After taking the initial dose, patients should be under medical supervision for 2 hours and an additional 1 hour until BP stabilizes.

In the absence of a therapeutic effect, the dose of Enalapril-Teva is increased in 1 to 2 weeks by 5 mg / day.

With mild hypertension, a maintenance dose of 5-10 mg is recommended once a day, with moderate arterial hypertension of 10-20 mg once a day. With more severe hypertension, the recommended maintenance dose is 20 mg 1 time per day.

If necessary and fairly well tolerated, the dose of Enalapril-Teva can be increased to 40 mg / day. The maximum daily dose is 40 mg / day.

When Renovascular hypertension the initial dose is 2.5-5 mg / day. After taking the initial dose, patients should be under the supervision of a doctor. The maximum daily dose is 20 mg / day.

Patients taking diuretics, it is necessary to abolish diuretic therapy 2-3 days before the Enalapril-Teva drug is used.The initial dose for patients who were unable to interrupt diuretic therapy before initiating Enalapril-Teva treatment is 2.5 mg once daily.

When hyponatremia (sodium content in the blood serum is less than 130 mmol / l) or serum creatinine concentration more than 0.14 mmol / l, the initial dose is 2.5 mg once a day.

Chronic heart failure and prevention of the development of clinically significant heart failure in patients with asymptomatic left ventricular dysfunction (as part of combination therapy)

The initial dose is 2.5 mg / day once. Treatment begins under the supervision of a doctor. The dose is gradually increased usually by 2.5-5 mg / day every 3-4 days to a maintenance dose of 20 mg / day.

The dose is selected within 2-4 weeks.

A week	Dose
Week 1	Day 1-3: 2.5 mg / day in one session; 4-7 day: 5 mg / day in two divided doses
Week 2	10 mg / day in one or two doses
Week 3 and 4	20 mg / day in one or two doses

The maximum daily dose is 40 mg / day once or in 2 divided doses.

In patients with renal insufficiency it is necessary to increase the intervals between the use of Enalapril-Teva.

Creatinine clearance	Initial dose
less than 80 ml / min, but more than 30 ml / min	5-10 mg / day
not more than 30 ml / min, but more than 10 ml / min	2.5-5 mg / day
not more than 10 ml / min	2.5 mg / day (on dialysis days)

Patients on hemodialysis: On the day of hemodialysis, the recommended dose is 2.5 mg / day; in the remaining days, dose adjustment is necessary in accordance with blood pressure. Elderly patients

In connection with a more pronounced antihypertensive effect in elderly patients, the initial dose of Enalapril-Teva is 2.5 mg / day. The maintenance daily dose should be selected depending on the status of kidney function

Side effects:

Side effects are classified according to the frequency of their occurrence: very often - not less than 10%; often - not less than 1%, but less than 10%; infrequently - not less than 0,1%, but less than 1%; rarely - not less than 0.01%, but less than 0.1%; very rarely - less than 0.01%, including individual reports.

From the hemopoietic system and lymphatic system: infrequently, anemia (including aplastic and hemolytic); rarely - neutropenia, a decrease in hemoglobin and hematocrit, thrombocytopenia, agranulocytosis, oppression of bone marrow hematopoiesis, pancytopenia, lymphadenopathy, autoimmune diseases.

Disorders from the metabolism and nutrition: infrequently - hypoglycemia.

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

From the sense organs: infrequently, noise in the ears; rarely - blurred vision.

From the cardiovascular system: often - marked decrease in blood pressure, orthostatic hypotension, fainting, chest pain, heart rhythm disturbances, angina pectoris, tachycardia; infrequent - palpitation, myocardial infarction or cerebral circulation (possibly due to a sharp decrease in blood pressure in patients at high risk); rarely - Raynaud's syndrome.

From the respiratory system: very often - cough; often shortness of breath; infrequently -

rhinorrhea, role in the throat and hoarseness, oronchospasm / oronchial asthma; rarely infiltrates in the lungs, rhinitis, allergic alveolitis / eosinophilic pneumonia.

From the gastrointestinal tract: very often - nausea; often - diarrhea, abdominal pain, change in taste; infrequent - intestinal obstruction, pancreatitis, vomiting, indigestion, constipation, anorexia, dryness of the oral mucosa, peptic ulcer; rarely - stomatitis / aphthous ulcers, glossitis; very rarely - intestinal angioedema.

From the liver and bile ducts: rarely - hepatic insufficiency, hepatitis (hepatocellular or cholestatic), including hepatic necrosis, cholestasis (including jaundice).

From the skin and subcutaneous tissues: often - reactions increased sensitivity / angioedema, facial edema, extremities, lips, tongue, vocal cords and / or larynx, skin rash; infrequently - increased sweating, itching, hives, alopecia; rarely - multiforme exudative erythema, Stevens-Johnson syndrome, toxic epidermal necrolysis, exfoliative dermatitis, pemphigus, erythroderma.

A symptom complex has been reported that may be accompanied by some and / or all of the following symptoms: fever, serositis, vasculitis, myalgia / myositis, arthralgia / arthritis, increased titer of antinuclear antibodies, increased erythrocyte sedimentation rate, eosinophilia and leukocytosis. There may be a skin rash, photosensitivity or other skin manifestations.

From the side of the kidneys and urinary tract: infrequently - a violation of kidney function, acute renal failure, proteinuria; rarely - oliguria.

From the genitals and the breast: infrequently - impotence; rarely - gynecomastia.

Laboratory indicators: often - hyperkalemia, increased serum creatinine concentration; infrequently - hyponatremia, hyperuricemia; rarely - increased activity of "liver" enzymes, hyperbilirubinemia.

Other: very often - asthenia; often - increased fatigue; infrequently - muscle cramps, flushes of blood to the face, general malaise, fever.

In rare cases with simultaneous use of ACE inhibitors (including enalapril) and intravenous (iv) administration of gold preparations (sodium aurotomy malate) describes a symptom complex that includes reddening of the facial skin, nausea, vomiting and arterial hypotension.

With the use of ACE inhibitors, rare cases of the syndrome inadequate secretion antidiuretic mountainsmona

Overdose:

Symptoms: a marked decrease in blood pressure, up to the development of collapse, myocardial infarction, acute impairment of cerebral circulation or thromboembolic complications, disturbance of water-electrolyte balance, renal failure, rapid breathing, tachycardia, palpitations, bradycardia, dizziness, anxiety, fear, cramps, cough, stupor.The concentration of enalaprilate in the blood plasma is 100-200 times higher than after the application of therapeutic doses was observed after oral intake of 300 mg and 440 mg of enalapril, respectively.

Treatment: the patient is transferred to a horizontal position with a low headboard.

In mild cases, gastric lavage and ingestion of activated charcoal are shown, in more serious cases, measures aimed at normalizing blood pressure: intravenous injection of 0.9% sodium chloride solution, plasma substitutes, if necessary, intravenous catecholamines, hemodialysis (speed excretion of enalaprilate - 62 ml / min). Patients with a bradycardia that is resistant to therapy are shown staging the pacemaker

Interaction:

Potassium-sparing diuretics and potassium preparations. Simultaneous use of enalapril and potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), potassium or potassium-containing substitutes for table salt, and the use of other drugs that increase potassium levels in the blood plasma (eg heparin) can lead to a significant increase in potassium in the plasma.If it is necessary to use enalapril with the drugs listed above, regular monitoring of the potassium content in the blood plasma should be carried out.

Diuretics (thiazide and "loop"). Use of diuretics in high doses can lead to hypovolemia (by reducing CBV), and adding to enalapril therapy - a pronounced decrease in BP. Excessive hypotensive effect of enalapril can be reduced either by canceling a diuretic, either by increasing or bcc use of salt and also provided a dose reduction enalapril.

Other antihypertensives. The simultaneous use of enalapril and beta-blockers, alpha-blockers, ganglioblokiruyuschih agents, methyldopa, nitroglycerine and other nitrate or blockers "slow" calcium channel may further reduce blood pressure.

Lithium. With the simultaneous use of enalapril with lithium preparations - slowing the excretion of lithium (increased cardiotoxic and neurotoxic action of lithium). If this combination is necessary, the concentration of lithium in the blood plasma should be monitored regularly.

Tricyclic antidepressants, antipsychotics (antipsychotics, drugs for anesthesia) increase the antihypertensive effect and increase the risk of orthostatic hypotension (additive effect).

Non-steroidal anti-inflammatory drugs. The simultaneous use of non-steroidal anti-inflammatory drugs (NSAIDs) (including selective inhibitors of cyclooxygenase-2 (COX-2)) can weaken the antihypertensive effect of antihypertensive drugs. Thus, the antihypertensive effect of angiotensin II receptor antagonists or ACE inhibitors may be weakened by NSAIDs, including COX-2 inhibitors.

NSAIDs and ACE inhibitors have an additive effect on potassium levels in the blood serum, which can lead to impaired renal function, especially in patients with impaired renal function. This effect is reversible. With simultaneous use in patients with impaired renal function, caution should be exercised.

Preparations of gold. With simultaneous use of ACE inhibitors and preparations of gold (sodium aurotomy malate) IV, a symptom complex including facial flushing, nausea, vomiting and arterial hypotension is described.

Sympathomimetics can reduce the antihypertensive effect of ACE inhibitors. Hypoglycemic agents for oral administration and insulin. Epidemiological studies suggest that simultaneous use of ACE inhibitors and hypoglycemic agents can lead to hypoglycemia. More often, hypoglycemia develops in the first weeks of therapy in patients with impaired renal function. Long-term and controlled clinical studies of enalapril do not confirm these findings and do not limit the use of enalapril in patients with diabetes mellitus. However, such patients should be under regular medical supervision.

Ethanol can enhance the antihypertensive effect of ACE inhibitors. Acetylsalicylic acid, thrombolytics and beta-blockers. Enalapril can be used simultaneously with acetylsalicylic acid (as an antiplatelet agent), thrombolytic agents and beta-blockers.

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

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

Antacids can reduce the bioavailability of ACE inhibitors.

Enalapril weakens the effect of medications containing theophylline.

With simultaneous use with aliskiren, the risk of a double blockade of the renin-angiotensin-aldosterone system increases, so this combination of drugs is contraindicated (see the section "Contraindications").

Special instructions:

Caution should be exercised in patients with reduced BCC (including with simultaneous use with diuretics, in conditions of restriction of consumption of table salt, in hemodialysis, diarrhea, vomiting) in which a sudden and pronounced decrease in blood pressure may develop in response to the use of an ACE inhibitor. In patients with CHF of mild degree, CRF or without it, symptomatic arterial hypotension is usually not observed. The development of arterial hypotension is most likely in patients with a more severe degree of CHF due to the use of high doses of diuretics, hyponatremia or functional renal failure. In these patients, treatment should be started under the supervision of a physician, up to an optimal dose adjustment of Enalapril-Teva and / or a diuretic.A similar tactic can be applied to patients with IHD and cerebrovascular disease, in whom excessive reduction in blood pressure can lead to myocardial infarction or cerebral circulation impairment. In case of development of severe arterial hypertension, the patient should be placed in a horizontal position and, if necessary, an infusion of 0.9% sodium chloride solution should be started. Transient hypotension is not a contraindication for the continuation of treatment with Enalapril-Teva after stabilization of blood pressure after replenishment of BCC.

In some patients with CHF with normal or low blood pressure, an additional BP reduction may occur with Enalapril-Teva. Usually this is not a reason for drug withdrawal. In the case of development of arterial hypotension, it is necessary to reduce the dose and / or to cancel the diuretic and / or enalapril.

Like all vasodilators, ACE inhibitors should be used with caution in patients with left ventricular hypertrophy and valvular obstruction and refrain from using in cases of cardiogenic shock and hemodynamically significant obstruction.

In the case of a violation of kidney function (KK less than 80 ml / min), careful monitoring of the concentration of potassium and creatinine in the blood serum is necessary. 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 is an increase in the concentration of urea and creatinine in the blood serum, the changes are mainly oorasyma and return to normal after the treatment is discontinued.

In some patients who did not have renal disease before treatment, there was a slight and transient increase in serum urea and creatinine levels when enalapril was used concomitantly with diuretics. In such cases, dose reduction and / or elimination of enalapril and / or diuretic may be required.

In patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney taking ACE inhibitors, there is an increased risk of developing arterial hypotension and renal failure. To reduce the function of the kidneys can indicate only moderate changes in the concentration of creatinine in the blood plasma.In such patients, treatment should begin with small doses under the supervision of a doctor, gradually selecting an individual dose and controlling the concentration of creatinine in the serum.

The experience with enalapril in patients who have recently undergone kidney transplantation is lacking. Therefore, the use of this drug in such patients is not recommended.

The use of Enalapril-Teva in patients with hepatic insufficiency usually does not require dose adjustment. Rarely, an ACE inhibitor is associated with a syndrome that begins with the development of cholestatic jaundice until the development of fulminant liver necrosis. When symptoms of jaundice appear or the activity of liver enzymes increases in patients taking ACE inhibitors, discontinue drug therapy and conduct an appropriate examination.

In patients who took ACE inhibitors, there were cases of development of neutropenia / agranulocytosis, thrombocytopenia and anemia. In patients with normal renal function and the absence of other complications, neutropenia develops rarely. The drug Enalapril-Teva should be used with great care in patients with connective diseasestissue (including systemic lupus erythematosus, scleroderma), simultaneously receiving immunosuppressive therapy, allopurinol or procainamide, as well as a combination of these factors, especially with existing violations of kidney function. Such patients can develop severe infections that are not amenable to intensive antibiotic therapy. If, however, patients take the drug Enalapril-Teva, it is recommended to periodically monitor the number of white blood cells in the blood. The patient should be warned that if there is any indication of an infection, it is necessary to consult a doctor.

With the use of ACE inhibitors, including enalapril, angionevrotic edema of the face, limbs, tongue, vocal cords and / or larynx has been reported. This can happen at any time during the treatment. In such cases, treatment with Enalapril-Teva should be stopped immediately, and the patient should be under medical supervision until the symptoms disappear completely. Even in those cases where there is only difficulty swallowing without difficulty breathing,patients may require long-term medical supervision, because therapy with antihistamines and glucocorticosteroids may not be enough. Angioedema, associated with edema of the larynx and the tongue, in very rare cases can be fatal. In patients with edema of the tongue, vocal cords or larynx, airway obstruction may develop, especially in patients who have a history of surgical procedures on the respiratory tract. In cases of airway obstruction, appropriate therapy should be carried out in the shortest possible time, including subcutaneous injection of epinephrine (0.3-0.5 ml of epinephrine (adrenaline) solution in a ratio of 1: 1000) and / or take the necessary measures to ensure airway conduction intubation or tracheostomy).

Among patients of the Negroid race receiving ACE inhibitor therapy, the incidence of angioedema is higher than among patients of other races. Patients with a history of angioedema not associated with the use of ACE inhibitors have an increased risk of developing angioedema due to the administration of any ACE inhibitor.

There have been reports of the development of life-threatening anaphylactic reactions in patients taking ACE inhibitors during the procedure for desensitization by Hymenoptera. Such reactions can be avoided, if before the beginning of desensitization temporarily stop taking ACE inhibitors. The use of ACE inhibitors in patients receiving immunotherapy with bee venom should be avoided.

In rare cases, life-threatening anaphylactoid reactions have been observed in patients taking ACE inhibitors during low-density lipoprotein (LDL) apheresis with dextran sulfate. If LDL-apheresis is used, ACE inhibitors should be temporarily replaced with other medications to treat hypertension and heart failure.

Anaphylactoid reactions have been reported in patients on hemodialysis using high-density polyacrylonitrile membranes (AN69®). In these cases it is recommended to use a membrane of another type for dialysis or to use an antihypertensive drug of another pharmacotherapeutic group.

When using Enalapril-Teva in patients with diabetes mellitus,receiving hypoglycemic agents for ingestion or insulin, during the first month of therapy it is necessary to regularly monitor the concentration of glucose in the blood.

It was reported the occurrence of cough with the use of ACE inhibitors. Usually, cough has an unproductive, persistent character and stops after the withdrawal of ACE inhibitors. With a differential diagnosis of cough, one should also consider a cough caused by the use of ACE inhibitors.

In patients undergoing surgical interventions, or in general anesthesia with agents that cause arterial hypotension, ACE inhibitors can block the formation of angiotensin II in response to compensatory release of renin. Before surgery (including dental procedures), an anesthesiologist should be alerted to the use of Enalapril Teva.

Hyperkalemia can develop on the background of therapy with ACE inhibitors, including enalapril. Risk factors for hyperkalemia is renal failure, advanced age (over 65 years), diabetes mellitus, some comorbid conditions (reduction of BCC, acute heart failure decompensation,metabolic acidosis), simultaneous administration of potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), as well as potassium or potassium-containing substitutes for common salt and the use of other drugs that increase the potassium content in the blood plasma (for example, heparin). The use of potassium, potassium-sparing diuretics or potassium-containing substitutes for common salt, especially in patients with renal insufficiency, can lead to a significant increase in potassium levels in the blood plasma. Hyperkalemia can lead to serious heart rhythm disturbances, sometimes with a fatal outcome. The simultaneous use of the drug Enalapril-Teva with any of the above drugs should be done with caution and should be accompanied by regular monitoring of potassium content in the blood plasma.

Simultaneous use of lithium preparations and Enalapril-Teva is usually not recommended.

The composition of Enalapril-Teva contains lactose monohydrate. Do not use the drug in patients with lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

The drug Enalapril-Teva, like other ACE inhibitors, has a less pronounced antihypertensive effect in patients of the Negroid race compared with representatives of other races, possibly due to low renin activity in patients with hypertension in this population.

The sudden discontinuation of enalapril does not lead to the development of the "withdrawal" syndrome.

Effect on the ability to drive transp. cf. and fur:

When using Enalapril-Teva, care should be taken when driving vehicles and engaging in other potentially hazardous activities requiring increased attention and speed of psychomotor reactions, due to the possibility of developing dizziness and drowsiness.

Form release / dosage:

Tablets 2.5 mg, 5 mg, 10 mg, 20 mg.

Packaging:

For 10 tablets in a blister of Aluminum / Aluminum foil. For 1, 2, 3, 5, 10 blisters together with instructions for use in a cardboard box.

Storage conditions:

Store at a temperature not exceeding 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years. Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002314

Date of registration:25.11.2013

The owner of the registration certificate:Teva Pharmaceutical Enterprises Co., Ltd.Teva Pharmaceutical Enterprises Co., Ltd. Israel

Manufacturer: & nbsp

MERCKLE, GmbH Germany

TEVA Operations Poland, Sp. z o.o. Poland

Information update date: & nbsp22.10.2015

Illustrated instructions

Instructions

Enalapril Teva (Enalapril-Teva)