Enap tablets 10 mg, 60 pcs (Tsytykolyn Enalapril)

Release form

Tablets.

Packing

60 pcs.

Pharmacological action

Enap - antihypertensive drug, ACE inhibitor. Enalapril is a prodrug: as a result of its hydrolysis, enalaprilat is formed. The mechanism of action is associated with inhibition of ACE activity under the influence of enalaprilat. This leads to a decrease in the formation of angiotensin II from angiotensin I, which causes a direct decrease in aldosterone secretion. As a result, there is a decrease in OPSS, systolic and diastolic blood pressure, post- and preload on the myocardium are reduced.

Expands arteries more than veins, while a reflex increase in heart rate is not observed.

Reduces the degradation of bradykinin, increases the synthesis of prostaglandins.

The antihypertensive effect is more pronounced with a high level of plasma renin than with a normal or reduced level. The decrease in blood pressure in the therapeutic range does not affect cerebral circulation. The blood flow in the vessels of the brain is maintained at a sufficient level and against a background of decreased blood pressure. Enhances coronary and renal blood flow.

With prolonged use, it reduces hypertrophy of the left ventricle of the myocardium and myocytes of the walls of arteries of the resistive type, prevents the progression of heart failure and slows down the development of dilatation of the left ventricle. Improves blood supply to the ischemic myocardium.

Reduces platelet aggregation.

Has some diuretic effect.

When taking the drug inside, the hypotensive effect develops after 1 hour, reaches a maximum after 4-6 hours and lasts up to 24 hours. In some patients, therapy is required for several weeks to achieve the optimal level of blood pressure. With heart failure, a noticeable clinical effect is observed with prolonged use - 6 months or more.

Indications

- arterial hypertension

- chronic heart failure (as part of combination therapy)

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

Contraindications

- history of angioneurotic edema associated with the use of ACE inhibitors

- hereditary Quincke edema or idiopathic angioedema

- porphyria

- pregnancy

early pregnancy (lactation) - early pregnancy (lactation)

- lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome

- increased sensitivity to enalapril and other components of Enap

- increased sensitivity to other ACE inhibitors.

Caution is advised to use the drug in patients with bilateral renal artery stenosis or single kidney artery stenosis, with primary hyperaldosteronism, hyperkalemia, after kidney transplantation, with aortic stenosis and / or mitral stenosis (with impaired hemodynamics), hypertrophic obstructive cardiomyopathy, conditions with reduced BCC, with systemic diseases of the connective tissue (including scleroderma, systemic red) , Ischemic heart disease, with inhibition of bone marrow hematopoiesis, cerebrovascular diseases (including with cerebrovascular insufficiency), with diabetes mellitus, renal failure (proteinuria - more 1 g / day.) Hepatic impairment, in patients on a diet with salt restriction or hemodialysis simultaneously with immunosuppressants and saluretikami in elderly patients (over 65 years).

Special instructions

Arterial hypotension

In case of arterial hypotension, it is necessary to lay the patient on his back with a low headboard and, if necessary, adjust the volume of the bcc by infusion of a solution of 0.9% sodium chloride. Arterial hypotension that occurs after taking the first dose is not a contraindication for further treatment.

Caution is required in patients with coronary heart disease, severe cerebrovascular disease, aortic stenosis or idiopathic hypertrophic obstructive subaortic stenosis, which prevents outflow of blood from the left ventricle, severe atherosclerosis, in elderly patients, as there is a risk of developing arterial hypotension and poor blood supply to the heart, brain, and kidneys.

Potassium-sparing diuretics and potassium preparations

The simultaneous use of EnapВ® and potassium-sparing diuretics, as well as potassium preparations and potassium-containing substitutes for sodium chloride is not recommended.

Hemodialysis

Anaphylactic reactions have been observed in patients receiving ACE inhibitors when hemodialysis using high-flow membranes (e.g. AN69В®). Therefore, it is desirable to use a different type of membrane or to use an antihypertensive drug of another pharmacotherapeutic group.

Aortic and / or mitral valve stenosis / hypertrophic obstructive cardiomyopathy (GOKMP)

EnapВ®, like other ACE inhibitors, it should be used with extreme caution in patients with left ventricular outflow tract obstruction and avoidance in the case of cardiogenic shock and hemodynamically significant left ventricular outflow tract obstruction.

Renal transplantation

There is no experience with the use of EnapВ® in patients who have recently undergone kidney transplantation.

Violations of the water-electrolyte balance

Regular monitoring of the serum concentration of electrolytes during the treatment period is necessary to identify possible violations of the water-electrolyte metabolism and timely adoption of necessary measures. Determination of serum concentration of electrolytes is mandatory for patients with prolonged diarrhea, vomiting.

In patients receiving EnapВ®, it is necessary to identify signs of imbalance in water-electrolyte balance, such as dry oral mucosa, thirst, weakness, drowsiness, irritability, myalgia and cramps (mainly calf muscles), decreased blood pressure, tachycardia, oliguria, as well as nausea and vomiting.

Allergic reactions / angioedema

If angioedema of the face occurs, it is usually sufficient to cancel the therapy and prescribe antihistamines to the patient. Angioedema of the tongue, pharynx or larynx may be fatal. With angioedema of the tongue, pharynx or larynx, which can lead to airway obstruction, it is necessary to immediately administer 0.3-0.5 ml of a solution of epinephrine (adrenaline) s / c in a ratio of 1: 1000 and maintain airway patency (intubation or tracheostomy).

Among patients of the Negroid race receiving therapy with an ACE inhibitor, the incidence of angioedema is higher than among patients of a different race.

Patients with a history of angioedema not associated with ACE inhibitors have an increased risk of developing angioedema when taking any ACE inhibitor.

Due to the increased risk of anaphylactic reactions, EnapВ® should not be prescribed to patients undergoing hemodialysis using high-flow polyacrylonitrile membranes (AN 69В®) undergoing LDL apheresis with dextran sulfate and immediately before the hymenopterous venom desensitization procedure.

Surgery / General Anesthesia

Before surgery (including dentistry), the surgeon / anesthetist should be advised of the use of ACE inhibitors.

During surgery or during general anesthesia using hypotensive medications, ACE inhibitors can block the formation of angiotensin II in response to compensatory release of renin. If a marked decrease in blood pressure due to a similar mechanism develops, it can be corrected by an increase in bcc.

Hepatic insufficiency

In rare cases, with the use of ACE inhibitors, cholestatic jaundice occurs, with progression of which fulminant liver necrosis develops, sometimes with a fatal outcome. If jaundice or a significant increase in the activity of hepatic transaminases occurs with the use of ACE inhibitors, the use of EnapВ® should be discontinued.

Neutropenia / agranulocytosis

In patients taking ACE inhibitors, there have been cases of neutropenia / agranulocytosis, thrombocytopenia and anemia. In patients with normal renal function, neutropenia rarely develops in the absence of other complications. EnapВ® must be used with great care in patients with connective tissue diseases (including systemic lupus erythematosus, scleroderma) who are simultaneously receiving immunosuppressive therapy, allopurinol or procainamide, as well as with a combination of these factors, especially with existing renal impairment. Such patients may develop severe infections that are not amenable to intensive antibiotic therapy. If patients nevertheless take EnapВ®, it is recommended to periodically monitor the number of white blood cells in the blood.

Patient should be warned that that in case of any signs of infection, you should immediately consult a doctor.

Patients with diabetes mellitus

When using EnapВ® in patients with diabetes mellitus receiving hypoglycemic agents for oral administration or insulin, it is necessary to regularly monitor blood glucose concentration during the first month of therapy.

Lithium

The simultaneous use of lithium preparations and EnapВ® is not recommended.

Hyperkalemia

Hyperkalemia may develop during treatment with ACE inhibitors, including and enalapril. Risk factors for hyperkalemia are renal failure, old age, diabetes mellitus, some concomitant conditions (a decrease in BCC, acute heart failure in the decompensation stage, metabolic acidosis), simultaneous use of potassium-sparing diuretics (such as spironolactone, eplerenone, triamteren, amiloride), as well as potassium preparations or potassium-containing substitutes for sodium chloride and the use of other drugs that increase the potassium content in blood plasma (for example, heparin). Hyperkalemia can lead to serious cardiac arrhythmias, sometimes fatal. The combined use of the above drugs should be carried out with caution.

Cough

When using the drug EnapВ®, a dry, prolonged cough may occur, which disappears after stopping the use of ACE inhibitors, which must be taken into account in the differential diagnosis of cough with an ACE inhibitor.

Ethnic features

EnapВ®, like other ACE inhibitors, It has a less pronounced antihypertensive effect in patients of the Negroid race compared with representatives of other races.

Influence on the ability to drive vehicles and control mechanisms

When using the drug EnapВ®, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

Composition

1 tab. contains: Active substances: enalapril maleate 10 mg.

Excipients: sodium bicarbonate - 5.1 mg, lactose monohydrate - 124.6 mg, corn starch - 21.4 mg, talc - 6 mg, magnesium stearate - 1.7 mg, iron dye red oxide (E172) - 1.2 mg.

Dosage and administration of

The drug is taken orally, before, during or after meals, regularly, at the same time of day. Tablets should be washed down with a small amount of liquid.

If Enap® is missed, you should take the missed dose. If a few hours remain before applying the next dose schedule, the missed dose of Enap® should not be taken. The dose should never be doubled.

Regular medical examinations are required for treatment with Enap® especially at the beginning of treatment and / or when selecting the optimal dose.

The dose of Enap® should be adjusted depending on the level of blood pressure

- Hypertension

The initial dose is 5 to 10 mg 1 time / day, depending on the degree of arterial hypertension.

After taking the initial dose, patients should be under medical supervision for 2 hours and an additional 1 hour until the blood pressure level stabilizes. In the absence of a therapeutic effect, the dose of Enap® is increased by 5 mg after 1-2 weeks. Typically, the maintenance dose is 20 mg / day. If necessary and with sufficiently good tolerance, the dose of Enap® can be increased to 40 mg / day. The maximum daily dose is 40 mg.

- Renovascular hypertension

Since in patients of this group blood pressure and renal function may be especially sensitive to ACE inhibition, therapy is started with an initial dose of 2.5 mg. Then the dose is selected in accordance with the needs of the patient. The maximum daily dose is 20 mg.

Caution should be exercised when using Enap® in patients who have been treated with diuretics shortly before.

- Concomitant treatment of hypertension with diuretics

In patients who receive treatment with diuretics, a decrease in blood pressure is possible with the first dose of Enap®. Enap® should be used with caution because of the possibility of developing a deficiency of liquid or sodium. Treatment with diuretics must be discontinued 2-3 days before the start of the use of Enap®.

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

The initial dose is 2.5 mg once, then the dose is increased by 2.5-5 mg every 3-4 days until maintenance dose - 20 mg / day. The maximum daily dose is 40 mg / day. once or in 2 divided doses. Dose selection should be carried out within 2-4 weeks.

- Week 1: 1-3 day: dose - 2.5 mg / day. in 1 dose, 4-7 days: dose - 5 mg / day. days in 2 doses

- Week 2: dose - 10 mg in 1-2 doses

- Weeks 3rd and 4th: dose - 20 mg in 1-2 doses

Impaired renal function

In patients with impaired function kidneys should increase the intervals between doses and / or reduce the dose of Enap®.

KK from 80 ml / min to 30 ml / min: 5 mg-10 mg (initial daily dose)

KK from 30 ml / min to 10 ml / min: 2.5-5 mg (initial daily dose)

less than 10 ml / min 2.5 mg on days of

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

Elderly patients

In this category of patients, the dose is set depending on renal function.

Side effects

Classification of the incidence of side effects (WHO): very often {> 1/10), often (> 1/100 and <1/10), infrequently (> 1/1000 and <1/100), rarely ( > 1/10 000 and <1/1000), very rarely (<1/10 000), including single messages.

From the hemopoietic system: rarely - neutropenia, decreased hemoglobin and hematocrit, thrombocytopenia, agranulocytosis, inhibition of bone marrow hematopoiesis, pancytopenia, lymphadenopathy, autoimmune diseases, very rarely - anemia (including aplastic and hemolytic).

From the side of metabolism: infrequently - exacerbation of the course of gout, hypoglycemia.

From the nervous system: very often - dizziness, weakness often - headache, asthenia, depression infrequently - insomnia, drowsiness, paresthesia, irritability rarely - unusual dreams, sleep disturbances very rarely - confusion, insomnia.

On the part of the sensory organs: often - changes in taste infrequently - tinnitus, blurred vision.

From the cardiovascular system: often - a marked decrease in blood pressure, orthostatic hypotension, fainting, chest pain, cardiac arrhythmias (atrial brady or tachycardia, atrial fibrillation), tachycardia, angina pectoris infrequently - palpitations, myocardial infarction or stroke ( marked decrease in blood pressure) rarely - thromboembolism of the pulmonary artery branch, Raynaud's syndrome.

From the respiratory system: very often - cough often - shortness of breath rarely - rhinorrhea, sore throat and hoarseness, rarely bronchospasm - lung infiltrates, rhinitis, allergic alveolitis / eosinophilic pneumonia.

From the digestive system: very often - nausea often - diarrhea, abdominal pain, flatulence infrequently - ileitis, intestinal obstruction, pancreatitis, vomiting, constipation, anorexia, dry oral mucosa, peptic ulcer rarely - impaired liver and biliary function, hepatitis (hepatocellular or cholestatic), cholestatic jaundice, fulminant liver necrosis, stomatitis / aphthous ulcers, glossitis very rarely - intestinal angioedema.

From the skin: often - a skin rash infrequently - exudative erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma, profuse sweating, pruritus, urticaria, alopecia, photosensitivity.

From the urinary system: infrequently - impaired renal function, acute renal failure rarely - oliguria.

From the reproductive system: infrequently - decreased potency, rarely decreased libido - gynecomastia.

From the musculoskeletal system: often - muscle cramps infrequently - arthralgia.

On the part of laboratory indicators: often - hyperkalemia, increased serum creatinine concentration infrequently - hyperglycemia, hyperuricemia, hypokalemia, hyponagraemia, increased serum urea concentration rarely - increased liver transaminase activity and bilirubin concentration.

Allergic reactions: infrequently - Stevens-Johnson syndrome rarely - angioedema of the face, lips, tongue, pharynx, larynx, limbs.

Others: a symptom complex is described that may include fever, myalgia and arthralgia, serositis, vasculitis, increased erythrocyte sedimentation rate, leukocytosis and eosinophilia, skin rash, positive test for antinuclear antibodies. Also, a symptom complex is described, which includes facial skin hyperemia, nausea, vomiting and arterial hypotension and can develop with the simultaneous use of ACE inhibitors and gold preparations (sodium aurothiomalate) iv.

Drug interaction

The simultaneous use of enalapril and potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), potassium preparations or potassium-containing substitutes for sodium chloride, as well as the use of other drugs that increase the level of potassium in the blood (e.g. )

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

The use of diuretics in high doses can lead to hypovolemia (due to a decrease in BCC), and the addition of enalapril to therapy can lead to a marked decrease in blood pressure.

With the simultaneous use of enalapril with lithium preparations, a slowdown in the excretion of lithium (an increase in the cardiotoxic and neurotoxic effects of lithium). It is necessary to control the concentration of lithium in blood plasma.

The simultaneous use of enalapril and beta-blockers, alpha-blockers, ganglion blockers, methyldopa or slow calcium channel blockers can further reduce blood pressure.

The simultaneous use of other antihypertensive drugs with ACE inhibitors may increase the risk of developing leukopenia.

The simultaneous use of other antihypertensive drugs with ACE inhibitors may increase the risk of hyperkalemia.

Concomitant use of NSAIDs (including selective COX-2 inhibitors) can weaken the antihypertensive effect of ACE inhibitors.

NSAIDs and ACE inhibitors have an additive effect on increasing serum potassium, which can lead to impaired renal function, especially in patients with impaired renal function. This effect is reversible.

Antacids may decrease the bioavailability of ACE inhibitors.

Sympathomimetics may reduce the hypotensive effect of ACE inhibitors.

Epidemiological studies suggest that the simultaneous use of ACE inhibitors and hypoglycemic agents can lead to the development of 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 data and do not limit the use of enalapril in patients with diabetes mellitus. Nonetheless, such patients should be under regular medical supervision.

With the simultaneous use of ACE inhibitors and gold preparations (sodium aurothiomalate) iv, a symptom complex has been described, including facial flushing, nausea, vomiting, and arterial hypotension.

Ethanol may enhance the antihypertensive effect of ACE inhibitors.

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

Reduces the effects of theophylline-containing drugs.

Overdose

Symptoms: a marked decrease in blood pressure up to the development of collapse, myocardial infarction, acute disorders of cerebral circulation or thromboembolic complications, convulsions, stupor.

Treatment: The patient should be moved to a horizontal position with a low head. In mild cases, gastric lavage and intake of activated carbon are shown in more serious cases - measures aimed at normalization of blood pressure, in / in the introduction of 0.9% sodium chloride solution, plasma substitutes, if necessary - in / in the introduction of angiotensin II, hemodialysis (excretion rate) - 62 ml / min).

Active ingredient

Enalapril



pharmacy terms of delivery Prescription

Form of Treatment

tablets

KRKA d.d. Novo mesto AO, Slovenia



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