ENAP PILLS 20MG

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ENAP PILLS 20MG - 1000 tabs

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Adverse 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), the frequency is unknown (cannot be estimated based on available data). In each group, unwanted effects are presented in order of decreasing severity.

Hemic and lymphatic: infrequently - anemia (including aplastic and hemolytic), rarely - neutropenia, decreased hemoglobin and hematocrit, thrombocytopenia, agranulocytosis, bone marrow hematopoietic suppression, pancytopenia, lymphadenopathy, autoimmune diseases.

Metabolism: infrequently - hypoglycemia.

Nervous system: very often dizziness; often - headache, depression; infrequently - confusion, insomnia, drowsiness, paresthesia, irritability, vertigo; rarely - a change in the nature of dreams, sleep disturbances.

From the senses: often - change in taste perception; infrequently - tinnitus; very rarely - blurred vision.

Since the cardiovascular system: often - a pronounced decrease in blood pressure (including orthostatic hypotension), syncope, chest pain, heart rhythm disturbances, angina pectoris; infrequently - a sensation of heartbeat, myocardial infarction or stroke (due to a sharp decrease in blood pressure in high-risk patients); rarely Raynaud's syndrome.

On the part of the respiratory system: very often coughing; infrequently - rhinorrhea, sore throat and hoarseness, bronchospasm / bronchial asthma; rarely - shortness of breath, pulmonary 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, dryness of the oral mucosa, peptic ulcer; rarely, liver dysfunction and biliary excretion, hepatitis (hepatocellular or cholestatic), including liver necrosis, cholestatic jaundice, stomatitis / aphthous ulcers, glossitis; very rarely - angioedema.

From the skin: often - skin rash; infrequently - increased sweating, pruritus, alopecia; rarely, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, erythroderma.

Symptom complex is described, which may include fever, myalgia / myositis, arthralgia / arthritis, serositis, vasculitis, elevated ESR, leukocytosis and eosinophilia, a positive test for antinuclear antibodies. There may be a skin rash, photosensitivity reactions or other skin manifestations.

Urogenital: infrequently - renal failure, proteinuria, renal failure; rarely - oliguria.

From the reproductive system: infrequently - reduction of potency; rarely - gynecomastia.

Musculoskeletal system: infrequently - muscle cramps.

From the laboratory indicators: often - hyperkalemia, increased serum creatinine concentration; infrequently - hyponatremia, increasing the concentration of urea in the blood serum; rarely, increased liver transaminase activity and bilirubin concentration.

Allergic reactions: often - hypersensitivity reactions / angioedema of the face, lips, tongue, pharynx and / or larynx; infrequently - pruritus, urticaria.

Other: frequency is unknown - syndrome of inadequate secretion of ADH.

Adverse events identified during post-marketing use of Enap®However, a causal relationship with the drug is not established: urinary tract infections, upper respiratory tract infections, bronchitis, cardiac arrest, atrial fibrillation, shingles, melena, ataxia, thromboembolism of the branches of the pulmonary artery and pulmonary infarction, hemolytic anemia, including cases of hemolysis in patients with glucose-6-phosphate dehydrogenase.

Contraindications

- angioedema in history, associated with the use of ACE inhibitors;

- hereditary angioedema or idiopathic angioedema;

- simultaneous use with aliskiren in patients with diabetes mellitus or impaired renal function (CC <60 ml / min);

- porphyria;

- pregnancy;

- lactation period (breastfeeding);

- age up to 18 years (efficiency and safety have not been established);

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

- Hypersensitivity to enalapril and other components of the drug;

- hypersensitivity to other ACE inhibitors.

WITH caution the drug should be used in patients with bilateral renal stenosisarteries or stenosis of the artery of a single kidney; with primary hyper aldosteronism; hyperkalemia; after kidney transplantation; with aortic stenosis and / or mitral stenosis (with hemodynamic disturbances); hypertrophic obstructive cardiomyopathy (GOKMP); with reduced BCC (including with diarrhea, vomiting); with systemic connective tissue diseases (including scleroderma, systemic lupus erythematosus); CHD; with oppression of bone marrow hematopoiesis; cerebrovascular diseases (including those with cerebrovascular insufficiency); with diabetes; renal failure (proteinuria - more than 1 g / day); liver failure; in patients on a salt-restricted diet or on hemodialysis; simultaneously with immunosuppressants and diuretics; in older patients (over 65 years).

Use during pregnancy and lactation

Use of the drug Enap®, like other ACE inhibitors, is not recommended in the first trimester of pregnancy. The use of ACE inhibitors, incl. drug Enap®, in the II and III trimesters of pregnancy is contraindicated.

Epidemiological data on the risk of teratogenic effects of ACE inhibitors during pregnancy do not make it possible to draw final conclusions. However, the likelihood of the development of teratogenic effects cannot be excluded. If necessary, the use of ACE inhibitors, the patient must be transferred to therapy with another antihypertensive drug with a proven safety profile for pregnant women.

When pregnancy is confirmed the drug Enap® need to cancel as soon as possible.

Acceptance of ACE inhibitors in the II and III trimesters of pregnancy can cause fetotoxic effects (renal dysfunction, oligohydramnion, delayed ossification of the skull bones) and neonatal toxic effects (renal failure, arterial hypotension, hyperkalemia).

If the patient took an ACE inhibitor in the II and III trimesters of pregnancy, it is recommended to conduct an ultrasound of the kidneys and bones of the fetal skull.

In those rare cases where the use of an ACE inhibitor during pregnancy is considered necessary, periodic ultrasound scans should be performed to evaluate the amniotic fluid index. If an oligohydramnion is detected during an ultrasound, it is necessary to stop taking the drug. Patients and the physician should be aware that oligohydramnios develops with irreversible damage to the fetus. If ACE inhibitors are used during pregnancy and the development of oligohydramnios is observed, then depending on the duration of pregnancy, a stress test, a non-stress test, or determination of the biophysical profile of the fetus may be required to assess the functional status of the fetus.

Newborns whose mothers took ACE inhibitors during pregnancy should be monitored due to possible arterial hypotension. Enalapril, which crosses the placenta, can be partially removed from the blood circulation of a newborn using peritoneal dialysis; in theory, it can be removed by exchange transfusion.

Enalapril and enaprilat are determined in breast milk in trace concentrations, therefore, if necessary, the use of the drug Enap® during lactation, breastfeeding should be discontinued.

Application for violations of the liver

WITH caution the drug should be used in patients with liver failure.

Application for violations of kidney function

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

QC

Initial daily dose

from 80 ml / min to 30 ml / min

5 mg-10 mg

from 30 ml / min to 10 ml / min

2.5-5 mg

less than 10 ml / min

2.5 mg on dialysis days *

* Enalaprilat is derived from hemodialysis. In the interval between hemodialysis sessions, the dose of the drug should be selected under the control of blood pressure.

WITH caution the drug should be used in patients with bilateral renal artery stenosis or arterial stenosis of a single kidney, after kidney transplantation, renal failure (proteinuria - more than 1 g / day), in patients undergoing hemodialysis.

Hypotension

Symptomatic arterial hypotension rarely develops in patients with uncomplicated arterial hypertension. Hypotension with all clinical manifestations can be observed after the first dose of Enap® in patients with hypovolemia, as a result of diuretic therapy, salt-free diets, diarrhea, vomiting or hemodialysis. The development of symptomatic hypotension is more likely in patients with severe heart failure due to the use of high-dose diuretics, hyponatremia or impaired renal function. In such patients, treatment should begin under the supervision of a physician, up to an optimal dose adjustment of Enap® and / or diuretic. A similar tactic can be applied to patients with coronary artery disease or cerebrovascular diseases in whom a sharp excessive decrease in blood pressure can lead to the development of myocardial infarction or impaired cerebral circulation.

In the case of the development of severe arterial hypotension, it is necessary to transfer the patient to a horizontal position with a low head and, if necessary, inject the 0.9% sodium chloride solution.

Transient arterial hypotension is not a contraindication for further treatment with Enap®. After stabilization of blood pressure and BCC therapy can be continued.

In some patients with heart failure and normal or low blood pressure, it may be further reduced when taking Enap®. This effect is predictable and is not a reason to discontinue therapy. If arterial hypotension is accompanied by clinical symptoms, the dose should be reduced and / or the diuretic and / or Enap abolished.®.

Aortic or mitral stenosis, GOKMP

Like all vasodilators, ACE inhibitors should be used with caution in patients with valvular obstruction and left ventricular outflow tract hypertrophy. Patients with cardiogenic shock and hemodynamically significant obstruction of the left ventricle should not be prescribed.

Renal dysfunction

In patients with renal insufficiency (CC <80 ml / min (1.33 ml / s)), the initial dose of Enap® should be selected, first of all, taking into account QC and, then, the clinical response to treatment. In such patients, potassium levels and serum creatinine levels should be regularly monitored.

In patients with severe heart failure and kidney disease, including renal artery stenosis, when treated with Enap® possible development of renal failure. Changes were usually reversible after discontinuation of Enap®..

Renovascular hypertension

In patients with bilateral renal artery stenosis or arterial stenosis of the only functioning kidney with treatment with ACE inhibitors, the risk of arterial hypotension and renal failure is increased. Only insignificant changes in serum creatinine may indicate a decrease in kidney function. In these patients, treatment should begin with small doses under the close supervision of a physician. It is necessary to carefully titrate the dose and monitor kidney function.

Kidney transplantation

Experience with Enap® in patients who have recently undergone kidney transplantation, is absent. Therefore, the treatment of such patients with Enap® Not recommended.

Liver dysfunction

In rare cases, therapy with ACE inhibitors has been accompanied by the development of a syndrome starting with cholestatic jaundice and hepatitis, up to the development of fulminant necrosis of the liver. The mechanism of development of this syndrome is unknown. If jaundice appears or a significant increase in liver enzyme activity, immediately discontinue treatment with an ACE inhibitor, carefully monitor the patient's condition and, if necessary, treat it.

Neutropenia / Agranulocytosis

Patients who used ACE inhibitors described cases of neutropenia / agranulocytosis, thrombocytopenia, and anemia.In patients with normal renal function in the absence of other complications, neutropenia rarely develops. Drug Enap® It should be used with great caution 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 for existing disorders of renal function. Such patients may develop severe infections that are not susceptible to intensive antibiotic therapy. If patients still take the drug Enap®It is recommended to periodically monitor the number of leukocytes in the blood. The patient should be warned that in the event of any signs of infection, you should immediately consult a doctor.

Hypersensitivity / angioedema

In patients receiving ACE inhibitors, including the drug Enap®, reports of the development of angioedema of the face, extremities, lips, vocal folds and / or larynx at any time after the start of treatment. It should immediately cancel the drug Enap® and observe the patient until symptoms disappear. Even in the presence of edema of the tongue, when there is only difficulty in swallowing without respiratory distress syndrome, patients may need long-term observation, since use of antihistamines and corticosteroids may be insufficient.

Angioedema of the larynx or tongue can be very rarely fatal. Swelling of the tongue, vocal cords or larynx can lead to airway obstruction, especially after a history of airway surgery. In the presence of edema of the tongue, vocal folds or larynx, appropriate therapy is indicated, which may include: subcutaneous injection of a 0.1% solution of epinephrine (adrenaline) (0.3 ml-0.5 ml) and / or measures aimed at restoring the airway patency (intubation or tracheostomy).

The incidence of angioedema is higher among patients of the Negroid race who receive treatment with an ACE inhibitor, than among patients of a different race.

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

Anaphylactoid reactions in desensitization by hymenoptera venom (Hymenopter)

Patients taking ACE inhibitors during desensitization with hymenoptera poison rarely developed life-threatening anaphylactoid reactions. To prevent such reactions, it is necessary to temporarily stop taking the ACE inhibitor during desensitization procedures.

Anaphylactoid reactions during LDL apheresis

Patients who took ACE inhibitors during apheresis of LDL using dextran sulfate, in rare cases, have developed life-threatening anaphylactoid reactions. The drug should be temporarily replaced by drugs of another group.

Hemodialysis

Due to the increased risk of anaphylactoid reactions, the drug should not be used in patients on hemodialysis using high-flow polyacrylonitrile membranes (AN69®). If hemodialysis is necessary, it is advisable to use dialysis membranes of another type or antihypertensive drugs of another group.

Hypoglycemia

In patients with diabetes mellitus receiving hypoglycemic drugs for oral administration or insulin, the concentration of blood glucose should be carefully monitored during the first month of treatment with an ACE inhibitor.

Cough

When using the drug Enap® a dry, unproductive, long-lasting cough may occur, which disappears after discontinuation of the use of ACE inhibitors, which must be taken into account in the differential diagnosis of cough while using an ACE inhibitor.

Surgical intervention / general anesthesia

Before surgery (including dental procedures) it is necessary to warn the surgeon / anesthesiologist about the use of Enap®. With extensive surgery or general anesthesia using agents that cause arterial hypotension, ACE inhibitors can block the formation of angiotensin II in response to compensatory renin release. If this develops a pronounced decrease in blood pressure, explained by a similar mechanism, it can be adjusted by the introduction of plasma substitutes.

Hyperkalemia

May develop during treatment with ACE inhibitors, incl. Enap®. Risk factors for the development of hyperkalemia are renal failure, advanced age (older than 70 years), diabetes mellitus, some concomitant states (decreased BCC, acute heart failure in the decompensation stage, metabolic acidosis), simultaneous use of potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride), as well as preparations of potassium or potassium-containing substitutes and the use of other drugs that increase the content of potassium in the blood plasma (for example, heparin).

The use of potassium preparations, potassium-sparing diuretics, and potassium-containing food salt substitutes may lead to a significant increase in the serum potassium content, especially in patients with impaired renal function. Hyperkalemia can lead to serious heart rhythm disturbances, sometimes fatal. The simultaneous use of the above preparations should be carried out with caution under the control of the content of potassium in the blood serum.

Lithium

The simultaneous use of lithium salts and the drug Enap® Not recommended.

Ethnic features

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

Special information on excipients

Drug Enap® contains lactose, so the drug is contraindicated in patients with lactase deficiency, lactose intolerance, and glucose-galactose malabsorption syndrome.

Influence on ability to drive motor transport and control mechanisms

When using the drug Enap® Care must be taken when driving and performing other potentially dangerous types of work that require increased concentration and psychomotor speed (dizziness may develop as a result of a sharp decrease in blood pressure, especially after taking the initial dose of Enap® in patients taking diuretics).

Overdose

Symptoms: approximately 6 hours after ingestion, a pronounced decrease in blood pressure up to the development of collapse, impaired water and electrolyte balance, renal failure, hyperventilation, tachycardia, palpitations, bradycardia, dizziness, anxiety, cough, cramps, stupor. After oral administration of enalapril at a dose of 300 and 440 mg, serum plasma concentrations of enalaprilat were normal therapeutic concentrations of 100 and 200 times, respectively.

Treatment: the patient should be placed in a horizontal position with a low head. In mild cases, gastric lavage and ingestion of Activated carbon are shown; in more serious cases, intravenous infusion of 0.9% sodium chloride solution, plasma substitutes, and, if necessary, intravenous catecholamine administration.Perhaps the elimination of enalaprilat by hemodialysis, the elimination rate is 62 ml / min. Patients with bradycardia resistant to therapy are shown to set a pacemaker. The serum electrolyte and serum creatinine levels should be carefully monitored.

Drug interaction

The risk of arterial hypotension, hyperkalemia and renal dysfunction (including acute renal failure) is higher in the case of a double blockade of the RAAS, i.e. with the simultaneous use of antagonists of angiotensin II receptors, ACE inhibitors or aliskiren, compared with the use of the drug of one of these groups. If necessary, the simultaneous use of drugs recommended to monitor blood pressure, kidney function and water and electrolyte balance.

The simultaneous use of enalapril with aliskiren in patients with diabetes mellitus or impaired renal function (CC <60 ml / min) is contraindicated.

ACE inhibitors reduce the loss of potassium by diuretics. The simultaneous use of enalapril and potassium-sparing diuretics (such as spironolactone, eplerenone, triamterene, amiloride), potassium preparations or potassium-containing salt substitutes, as well as the use of other drugs that increase the plasma potassium (eg heparin) can lead to hyperkalemia. If necessary, the simultaneous use of caution and regularly monitor the serum potassium content.

Prior diuretic therapy in high doses may lead to a decrease in BCC and an increase in the risk of arterial hypotension during the initiation of enalapril therapy. Excessive antihypertensive effect can be reduced by discontinuing the diuretic, increasing the consumption of water or salt, as well as under the condition that treatment with enalapril is started in a low dose.

The use of beta-blockers, alpha-blockers, ganglion-blocking agents, methyldopa, slow Calcium channel blockers, Nitroglycerin or other nitrates simultaneously with enalapril can further reduce blood pressure.

With the simultaneous use of ACE inhibitors with lithium preparations, a transient increase in the serum lithium concentration and the development of lithium intoxication were observed. The use of thiazide diuretics can lead to an additional increase in the serum concentration of lithium and the risk of lithium intoxication, while the use of ACE inhibitors. The simultaneous use of enalapril with lithium is not recommended. If necessary, the use of such a combination should be carefully monitored serum concentrations of lithium.

The simultaneous use of certain anesthetics, tricyclic antidepressants and antipsychotics (neuroleptics) with ACE inhibitors can lead to an additional decrease in blood pressure.

Simultaneous use of NSAIDs (including selective COX-2 inhibitors) may weaken the antihypertensive effect of ACE inhibitors or angiotensin II receptor antagonists.NSAIDs and ACE inhibitors have an additive effect on increasing serum potassium, which can lead to a reversible deterioration of kidney function, especially in patients with

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