Description
Latin name
Enap
Release form
Tablets.
Packaging
In a blister pack of 10 tablets. In the package 2 blisters.
Pharmacological action
Enalapril is an antihypertensive drug, the mechanism of action of which is associated with inhibition of the activity of angiotensin-converting enzyme, leading to a decrease in the formation of angiotensin-II.
Enalapril is a “prodrug”: as a result of its hydrolysis, enalaprilat is formed, which inhibits ACE. The mechanism of its action is associated with a decrease in the formation of angiotensin II from angiotensin I, a decrease in the content of which leads to a direct decrease in the release of aldosterone. In this case, the general peripheral vascular resistance, systolic and diastolic blood pressure (BP), post- and preload on the myocardium are reduced.
Expands arteries to a greater extent than veins, with no reflex increase in heart rate.
The antihypertensive effect is more pronounced with a high level of plasma renin than with a normal or reduced level of it. A decrease in blood pressure (BP) within the therapeutic range 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. Enhances coronary and renal blood flow.
With prolonged use, hypertrophy of the left ventricle of the myocardium and myocytes of the walls of the 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.
The time of onset of the hypotensive effect when taken orally is 1 hour, reaches a maximum after 4-6 hours and lasts up to 24 hours. In some patients, therapy is needed 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).
– Asymptomatic left ventricular dysfunction (as part of combination therapy).
Contraindications
– Hypersensitivity to enalapril or other components of the drug.
– Hypersensitivity to other ACE inhibitors.
– A history of angioedema, including those associated with the use of ACE inhibitors (an allergic reaction with severe swelling of the lips, face, neck, and possibly hands and feet, accompanied by suffocation and hoarseness).
– Porfiry.
– Pregnancy.
– Lactation (breastfeeding).
– Patients who have ever had angioedema.
– Age under 18 years of age (efficacy and safety not established).
Precautions:
– Bilateral renal artery stenosis.
– Stenosis of a single kidney artery.
– Primary hyperaldosteronism.
– Hyperkalemia.
– Condition after kidney transplantation.
– Aortic stenosis.
– Mitral stenosis (with hemodynamic impairment).
– Idiopathic hypertrophic subaortic stenosis.
– Systemic diseases of the connective tissue.
– Coronary heart disease.
– Inhibition of bone marrow hematopoiesis.
– Cerebrovascular disease.
– Diabetes mellitus.
– Renal failure (proteinuria – more than 1 g / day).
– Liver failure.
– Patients on a salt-restricted diet.
– In patients on hemodialysis.
– Concomitant use with immunosuppressants and saluretics.
– In older people (over 65 years old).
Use during pregnancy and lactation
During pregnancy and during lactation, the drug should not be prescribed. If pregnancy occurs during the treatment with Enap, you should inform your doctor as soon as possible. He will prescribe another antihypertensive treatment.
Composition
1 tablet contains: enalapril maleate 10 mg.
Excipients: lactose monohydrate, hydroxypropyl cellulose, corn starch, sodium bicarbonate, talc, magnesium stearate.
Side effects
Classification of the frequency of development 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 individual 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, increased irritability rarely – unusual dreams, sleep disturbances very rarely – confusion, insomnia. From the sensory organs: often – taste changes 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 function and bile secretion, 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 has been described, which 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 hyperemia of the skin of the face, nausea, vomiting, and arterial hypotension and can develop with the simultaneous use of ACE inhibitors and gold preparations (sodium aurothiomalate) iv. Drug Interaction Patients should refrain from drinking alcohol as ethanol enhances blood pressure (BP) reduction with enalapril. Concomitant use of enalapril and diuretics or other antihypertensive agents increases the effectiveness of these drugs. Interaction with medicines used to treat heart failure (cardiac glycosides) is not clinically relevant. Before surgery, the doctor should be advised that the patient is taking enalapril as there is a risk of arterial hypotension during general anesthesia. Concomitant administration of enalapril and non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid (aspirin), as well as estrogens can reduce the effectiveness of enalapril and increase the risk of renal dysfunction. The concomitant use of some diuretics (spironolactone, amiloride or triamterene) and / or the supplemental administration of potassium-containing tablets may lead to increased serum potassium (hyperkalemia). Bone marrow depressants increase the risk of neutropenia and / or agranulocytosis. Immunosuppressants, allopurinol, cytostatics increase hematotoxicity. Enalapril weakens the action of theophylline-containing agents. Concomitant use of lithium preparations can increase the side effect of lithium. With the simultaneous administration of the drug Enap with cimetidine, the half-life (T 1/2) of Enap increases. If the patient is already taking the above medication or is advised to take any of these drugs, he or she should be advised by the physician that he or she is taking Enap. Overdose If a patient has taken too many tablets for one dose, call a doctor immediately. Symptoms: excessive reduction of blood pressure (BP) up to the development of collapse, myocardial infarction, acute disturbance of cerebral circulation or thromboembolic complications, convulsions, stupor. Treatment: the patient is transferred to a horizontal position with a low head. In mild cases, gastric lavage and intake in saline solution are shown, in more serious cases – measures aimed at stabilization of blood pressure (BP), in / in the introduction of saline, plasma substitutes, if necessary – in / in the introduction of angiotensin II, hemodialysis (speed excretion of enalaprilat – 62 ml / min). Storage conditions Store in a dark place at a temperature not exceeding 25 ° C. Expiration 3 years. Active substance Enalapril Dosage form dosage form tablets KRKA d.d. Novo mesto AO, Slovenia
