Enap, pills 10mg, 60pcs

Composition

>

of 1 tab. contains:

Active ingredients:

enalapril maleate 10 mg.

Auxiliary substances:

sodium bicarbonate-5.1 mg,

lactose monohydrate-124.6 mg,

corn starch-21.4 mg,

talc-6 mg,

magnesium stearate-1.7 mg,

iron oxide red dye (E 172) – 1.2 mg

Pharmacological action

Enap is an antihypertensive drug, an ACE inhibitor. Enalapril is a “prodrug”: as a result of its hydrolysis, enalaprilate 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, OPSS decreases, systolic and diastolic blood pressure decreases, and post – and preload on the myocardium decreases.

Dilates the arteries to a greater extent than the veins, while there is no reflex increase in heart rate.

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

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

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

Reduces platelet aggregation.

It has some diuretic effect.

When taking the drug inside, the hypotensive effect develops in 1 hour, reaches a maximum in 4-6 hours and persists for up to 24 hours. In some patients, therapy for several weeks is necessary to achieve optimal blood pressure levels. 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 clinically significant heart failure in patients with asymptomatic left ventricular dysfunction (as part of combination therapy).

Contraindications

-hereditary angioedema or idiopathic angioedema— – a history of angioedema associated with the use of ACE inhibitors;— porphyria; – pregnancy; – lactation (breastfeeding);- age up to 18 years (efficacy and safety have not been established);— lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome;- hypersensitivity to enalapril and other components of Enap;- hypersensitivity to other ACE inhibitors.

The drug should be used with caution in patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney, with primary hyperaldosteronism, hyperkalemia, after kidney transplantation, with aortic stenosis and/or mitral stenosis (with hemodynamic disorders), hypertrophic obstructive cardiomyopathy, conditions with reduced BCC, with systemic connective tissue diseases (including scleroderma, systemic lupus erythematosus), IHD, with inhibition of bone marrow hematopoiesis, cerebrovascular diseases (including cerebral circulatory insufficiency), with diabetes mellitus, renal failure (proteinuria – more than 1 g/day), liver failure, in patients who follow a salt-restricted diet or are on hemodialysis; simultaneously with immunosuppressants and saluretics; in elderly patients (older than 65 years).

Side effects

WHO classification of side effects: very common (>1/10), common (>>1/100 and >>< 1/10), uncommon (> 1/1000 and < 1/10), uncommon (>< 1/100), rare (> 1/10 000 and < 1/100), rare (>< 1/1000), very rare (

From the hematopoietic 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 gout, hypoglycemia.

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

From the sensory organs: often – changes in taste; infrequently-tinnitus, blurred vision.

From the cardiovascular system: often-a marked decrease in blood pressure, orthostatic hypotension, syncope, chest pain, cardiac arrhythmias (atrial brady or tachycardia, atrial fibrillation), tachycardia, angina pectoris; infrequently-palpitation, myocardial infarction or stroke (due to a pronounced decrease in blood pressure); rarely-pulmonary embolism, Raynaud’s syndrome.

From the respiratory system: very often – cough; often – shortness of breath; infrequently – rhinorrhea, sore throat and hoarseness, bronchospasm; rarely-infiltrates in the lungs, 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 function and bile secretion, hepatitis (hepatocellular or cholestatic), cholestatic jaundice, fulminant necrosis of the liver, stomatitis/aphthous ulcers, glossitis; very rarely – intestinal angioedema.

From the skin: often-skin rash; infrequently-erythema multiforme, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma, heavy sweating, pruritus, urticaria, alopecia, photosensitization.

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

From the reproductive system: infrequently-decreased potency, decreased libido; rarely-gynecomastia. From the musculoskeletal system: often-muscle spasms; infrequently-arthralgia.

From the laboratory parameters: often-hyperkalemia, increased serum creatinine concentration; infrequently-hyperglycemia, hyperuricemia, hypokalemia, hyponagriemia, increased serum urea concentration; rarely-increased activity of hepatic transaminases and bilirubin concentration.

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

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

Interaction

Concomitant use of enalapril and potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), potassium preparations or potassium-containing substitutes for table salt, as well as the use of other drugs that increase the potassium content in blood plasma (for example, heparin) is not recommended.

Tricyclic antidepressants, antipsychotics (neuroleptics) 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 pronounced decrease in blood pressure.

When enalapril is used simultaneously with lithium preparations, the elimination of lithium is slowed down (increased cardiotoxic and neurotoxic effects of lithium). It is necessary to monitor the concentration of lithium in the blood plasma.

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

Concomitant use of other antihypertensive agents with ACE inhibitors may increase the risk of leukopenia.

Concomitant use of other antihypertensive agents with ACE inhibitors may increase the risk of hyperkalemia. Concomitant use of NSAIDs (including selective COX-2 inhibitors) may weaken the antihypertensive effect of ACE inhibitors. NSAIDs and ACE inhibitors have an additive effect on increasing serum potassium, which can lead to deterioration of renal function, especially in patients with impaired renal function. This effect is reversible.

Antacids may reduce 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 may 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 trials of enalapril do not confirm these data and do not limit the use of enalapril in patients with diabetes mellitus. However, such patients should be under regular medical supervision.

With the simultaneous use of ACE inhibitors and gold preparations (sodium aurothiomalate) IV, a symptom complex is described, including hyperemia of the facial skin, 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.

Weakens the effect of drugs containing theophylline.

How to take, course of use and dosage

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, the missed dose should be taken. If there are several hours left before the next dose is applied, then the missed dose of Enap® should not be taken. The dose should never be doubled. Treatment with Enap® requires regular medical examinations, 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

– Arterial hypertension The initial dose is from 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. The usual maintenance dose is 20 mg / day. If necessary and sufficiently well tolerated, the dose of Enap® can be increased to 40 mg / day. The maximum daily dose is 40 mg

. – Renovascular hypertension Since patients in this group may have particularly sensitive blood pressure and renal function to ACE inhibition, therapy begins with an initial dose of 2.5 mg. Then the dose is selected according to the patient’s needs. The maximum daily dose is 20 mg.

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

– Concomitant treatment of arterial hypertension with diuretics

In patients treated with diuretics, a decrease in blood pressure may occur during the first use of Enap®. Enap® should be used with caution due to the possibility of developing a fluid or sodium deficiency. Treatment with diuretics should be discontinued 2-3 days before the start of Enap®use.

– Chronic heart failure and prevention of clinically significant 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 to a maintenance dose of 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 days: dose-2.5 mg / day. in 1 reception,4-7 days: the dose is 5 mg / day. day in 2 doses-Week 2: dose-10 mg in 1-2 doses-Week 3 and 4:dose-20 mg in 1-2 receptions Renal function impairment patients with impaired renal function should increase the intervals between doses and / or reduce the dose of Enap®. Creatinine clearance from 80 ml / min to 30 ml / min: 5 mg-10 mg (initial daily dose)Creatinine clearance from 30 ml / min to 10 ml / min: 2.5-5 mg (initial daily dose)

less than 10 ml / min 2.5 mg on dialysis days

Patients undergoing hemodialysis: on the day of hemodialysis, the recommended dose is 2.5 mg / day; on other days, dose adjustment is necessary in accordance with the blood pressure level. Elderly patients In this category of patients, the dose is set depending on renal function.

Overdose

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

Treatment: the patient should be placed in a horizontal position with a low headboard. In mild cases, gastric lavage and oral use of activated charcoal are indicated; in more serious cases, measures are taken to normalize blood pressure, intravenous use of 0.9% sodium chloride solution, plasma substitutes, if necessary, intravenous use of angiotensin II, hemodialysis (enalaprilate excretion rate is 62 ml / min).

Special instructions

Arterial hypotension

In case of hypotension, the patient should be placed on his back with a low headboard and, if necessary, adjust the volume of BCC by infusion of 0.9% sodium chloride solution. Hypotension that occurs after the first dose is not a contraindication for further treatment.

Caution should be exercised in patients with CHD, severe cerebrovascular diseases, aortic stenosis or idiopathic hypertrophic obstructive subaortic stenosis that interferes with the outflow of blood from the left ventricle, severe atherosclerosis, in elderly patients, because there is a risk of hypotension and deterioration of blood supply to the heart, brain and kidneys.

Potassium-sparing diuretics and potassium supplements

Concomitant use of Enap® and potassium-sparing diuretics, as well as potassium preparations and potassium-containing salt substitutes is not recommended.

Hemodialysis

Anaphylactodic reactions have been reported in patients receiving ACE inhibitors during hemodialysis using high-flow membranes (for example, AN69®). Therefore, it is advisable to use a different type of membrane or use an antihypertensive drug of a different pharmacotherapeutic group.

Aortic and/or mitral valve stenosis/hypertrophic obstructive cardiomyopathy (HOCMP)Enap®, like other ACE inhibitors, should be used with extreme caution in patients with left ventricular outflow tract obstruction and avoid use in cases of cardiogenic shock and hemodynamically significant left ventricular outflow tract obstruction.

Kidney transplantation

There is no experience of using Enap® in patients who have recently undergone kidney transplantation.

Violations of the water-electrolyte balance

It is necessary to regularly monitor the serum concentration of electrolytes during treatment to identify possible violations of water-electrolyte metabolism and timely take the necessary measures. Determination of serum electrolyte concentrations is mandatory for patients with prolonged diarrhea and vomiting.

In patients receiving Enap®, it is necessary to detect signs of impaired water-electrolyte balance, such as dry oral mucosa, thirst, weakness, drowsiness, increased excitability, myalgia and convulsions (mainly of the 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 therapy and prescribe antihistamines to the patient. Angioedema of the tongue, pharynx, or larynx can be fatal. In case of angioedema of the tongue, pharynx or larynx, which can lead to airway obstruction, it is necessary to immediately introduce 0.3-0.5 ml of epinephrine (epinephrine) solution subcutaneously in a ratio of 1:1000 and maintain airway patency (intubation or tracheostomy).

Among black patients receiving ACE inhibitor therapy, the incidence of angioedema is higher than among patients of other races.

Patients with a history of angioedema that is 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, Enap® should not be prescribed to patients undergoing hemodialysis using high-flow polyacrylonitrile membranes (AN 69®), undergoing LDL apheresis with dextran sulfate and immediately before the hymenoptera venom desensitization procedure.

Surgical intervention/General anesthesia

Before surgical intervention (including in dentistry), it is necessary to warn the surgeon/anesthesiologist about the use of ACE inhibitors. During surgical procedures or during general anesthesia using agents that cause arterial hypotension, ACE inhibitors can block the formation of angiotensin II in response to the compensatory release of renin. If a marked decrease in blood pressure develops due to this mechanism, it can be corrected by increasing the BCC.

Liver failure

In rare cases, against the background of the use of ACE inhibitors, cholestatic jaundice occurs, with the 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 during the use of ACE inhibitors, the use of Enap® should be discontinued.

Neutropenia/agranulocytosis

Neutropenia/agranulocytosis, thrombocytopenia, and anemia have been reported in patients treated with ACE inhibitors. Neutropenia is rare in patients with normal renal function in the absence of other complications. Enap® should be used with great caution in patients with connective tissue diseases (including systemic lupus erythematosus, scleroderma), simultaneously receiving immunosuppressive therapy, allopurinol or procainamide, as well as with a combination of these factors, especially with existing renal dysfunction. These patients may develop severe infections that do not respond to intensive antibiotic therapy. If patients still take Enap®, it is recommended to periodically monitor the number of white blood cells in the blood.The patient should be warned that if any signs of infection appear, it is necessary to immediately consult a doctor.

Patients with diabetes mellitus

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

Lithium

Concomitant use of lithium and Enap is not recommended.

Hyperkalemia

Hyperkalemia may develop during treatment with ACE inhibitors, including enalapril. Risk factors for hyperkalemia include renal failure, advanced age, diabetes mellitus, certain concomitant conditions (decreased BCC, acute heart failure in the decompensation stage, metabolic acidosis), concomitant use of potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), as well as potassium preparations or potassium-containing substitutes for table salt, and the use of other drugs that contribute to an increase in the content of potassium 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 Enap®, a dry, prolonged cough may occur, which disappears after discontinuation of ACE inhibitors, which should be taken into account in the differential diagnosis of cough against the background of the use of an ACE inhibitor.

Ethnic features

Enap®, like other ACE inhibitors, has a less pronounced antihypertensive effect in patients of the black race compared to representatives of other races.

Influence on the ability to drive motor vehicles and manage mechanisms

When using Enap®, care should be taken when driving vehicles and engaging in other potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Pills.

Active ingredient

Enalapril

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Hypertension, Heart Failure