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Pills
Composition
enalapril maleate 5 mg Auxiliary substances: sodium bicarbonate - 2.6 mg, lactose monohydrate - 129.8 mg, corn starch - 22.4 mg, hyprolosis - 2.5 mg, talc - 6 mg, magnesium stearate - 1.7 mg.
Pharmacological effect
Pharmacological action - hypotensive, vasodilator. Blocks ACE, reduces post-and preload, inhibits the synthesis of aldosterone in the adrenal glands.
Indications
- essential hypertension; - chronic heart failure (as part of combination therapy); - prevention of the development of clinically severe heart failure in patients with asymptomatic left ventricular dysfunction (as part of combination therapy); - prevention of coronary ischemia in patients with left ventricular dysfunction in order to reduce the frequency development of myocardial infarction and reduce the frequency of hospitalizations for unstable angina.
Contraindications
- angioedema edema in history associated with the use of ACE inhibitors; - hereditary angioedema or idiopathic angioedema; - simultaneous use with aliskiren in patients with diabetes or renal dysfunction (CC <60 ml / min); - porphyria; - lactation period (breastfeeding); - age up to 18 years (efficacy and safety have not been established); - lactose intolerance, deficiency of lactase, glucose-galactose malabsorption syndrome; - hypersensitivity to enalapril and other components drug preparations; - hypersensitivity to other ACE inhibitors. With caution, the drug should be used in patients with bilateral renal artery stenosis or arterial stenosis 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).
Precautionary measures
During treatment, psoriasis may worsen. During pheochromocytoma, propranolol can only be used after taking an alpha blocker. After a long course of treatment, propranolol should be discontinued gradually, under the supervision of a physician. during anesthesia, you must stop taking propranolol or find a remedy for anesthesia with minimal negative inotropic effects. The impact on the ability to drive vehicles and control mechanisms of patients whose activities require increased attention, the question of the use of propranolol on an outpatient basis should be addressed only after evaluating the individual response of the patient.
Dosage and administration
The drug is taken orally, regardless of the meal, preferably at the same time of day. Tablets should be taken with a small amount of liquid. Arterial hypertension. The initial dose is 5 to 20 mg 1 time per day, depending on the severity of arterial hypertension. In mild arterial hypertension, the recommended initial dose is 5-10 mg / day. In patients with marked activation of the RAAS (for example, with renovascular hypertension, electrolyte loss and / or dehydration, decompensation of heart failure or severe arterial hypertension), an excessive decrease in blood pressure in start of treatment. In such situations, it is recommended to begin therapy with a low initial dose of 5 mg / day or less, under the supervision of a physician. Prior therapy with high doses of diuretics can lead to dehydration and an increased risk of arterial hypotension at the beginning of Enap therapy; The recommended starting dose is 5 mg / day. Treatment with diuretics should be stopped for 2-3 days before the start of the drug Enap. Care should be taken when using the drug Enap, monitor kidney function and the content of potassium in the blood serum. Usually the maintenance dose is 20 mg 1 time / day. The dose is chosen individually, if necessary, can be increased to a maximum daily dose of 40 mg. Chronic heart failure and dysfunction of the left ventricle. The initial dose is 2.5 mg 1 time / day, and the treatment should be started under the close supervision of a physician. The preparation Enap for the treatment of heart failure can be applied simultaneously on diuretics and / or beta-blockers, if necessary - with cardiac glycosides.In the absence of symptomatic hypotension at the beginning of therapy or after its correction, the dose should be increased gradually (by 2.5-5 mg every 3-4 days) to the usual maintenance dose of 20 mg / day, which is prescribed either once or in 2 doses, in depending on the tolerability of the drug. Dose selection is carried out within 2-4 weeks. The maximum daily dose is 40 mg in 2 divided doses. Considering the risk of hypotension and renal failure (observed much less frequently), the blood pressure and kidney function should be carefully monitored before and after the start of Enap. In patients taking diuretics, the dose of the latter should, if possible, be reduced before starting the administration of Enap. The development of arterial hypotension after taking the first dose does not mean that arterial hypotension will persist with prolonged use, and does not indicate the need to discontinue the use of the drug. Elderly patients In elderly patients more often there is a more pronounced antihypertensive effect and lengthening the time of the drug, which is associated with a decrease in speed enalapril excretion, therefore the recommended initial dose is 1.25 mg. In elderly patients, the dose is adjusted depending on kidney 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), the frequency is unknown (cannot be estimated based on the available data). In each group, undesirable effects are presented in order of decreasing their severity. From the hematopoietic system: infrequently - anemia (including aplastic and hemolytic), rarely - neutropenia, decrease in hemoglobin and hematocrit, thrombocytopenia, agranulocytosis, inhibition of bone marrow hematopoiesis, pancytopenia, chydroma, chystrophytesis, lymphocytosis, chyroid body, chyroid body, lymphocytosis, chystrophytesis, lymphocytosis, chystrophytesis, lymphocytosis, chystrophytesis, lymphocytosis, chystrophytesis, lymphocytosis, chyroid body, chyroid body, lymphocytosis, body building, lymphocytosis, chyroid lesion, lymphocytosis, anemia, lymphocyte, and .In terms of metabolism: infrequently, hypoglycemia. In the 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 sense organs: often - a change in taste perception; infrequently - tinnitus; very seldom - blurred vision. From the side of the cardiovascular system: often - a marked decrease in blood pressure (includingorthostatic 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. From the respiratory system: very often - cough; infrequently - rhinorrhea, sore throat and hoarseness, bronchospasm / bronchial asthma; rarely - shortness of breath, pulmonary infiltrates, rhinitis, allergic alveolitis / eosinophilic pneumonia. On the part of 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 of the intestines. From the skin: often - skin rash; infrequently - increased sweating, pruritus, alopecia; rarely, erythema multiforme, Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis, pemphigus, and erythroderma. Symptom complex is described, which may include fever, myalgia / myositis, arthralgia / arthritis, serositis, vasculitis, elevated erythrocyte syndrome, leukocytosis, and prostatitis. for antinuclear antibodies. Skin rashes, photosensitization reactions or other skin manifestations may occur. On the urinary system: rarely - impaired renal function, proteinuria, renal failure; rarely, oliguria. For the reproductive system: infrequently, a decrease in potency; rarely - gynecomastia. From the musculoskeletal system: infrequently - muscle cramps. From laboratory indicators: often - hyperkalemia, increased serum creatinine concentration; infrequently - hyponatremia, increasing the concentration of urea in the blood serum; rarely, increased activity of hepatic transaminases and bilirubin concentrations. Allergic reactions: often - hypersensitivity reactions / angioedema of the face, lips, tongue, throat and / or larynx; infrequently - pruritus, urticaria. Others: frequency unknown - inadequate secretion syndrome ADH. Adverse events,identified during the post-marketing use of the drug Enap, however, a causal relationship with taking the drug has not been established: urinary tract infection, upper respiratory tract infection, bronchitis, cardiac arrest, atrial fibrillation, shingles, melena, ataxia, pulmonary embolism and pulmonary infarction , hemolytic anemia, including cases of hemolysis in patients with deficiency of glucose-6-phosphate dehydrogenase.
special instructions
NSAIDs and foods high in sodium chloride reduce the effect. Against the background of potassium-sparing diuretics, hyperkalemia is possible. Strengthens action, slows down the excretion of lithium, alcohol.