Description
Release form
Tablets.
Packing
20 pcs.
Pharmacological action of
Enap is an antihypertensive drug whose mechanism of action is associated with inhibition of the activity of the 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.
Special instructions
Arterial hypotension (a sharp decrease in blood pressure) can occur (even several hours after the first dose) in patients with severe heart failure or severe impaired renal function, as well as in patients with impaired water-electrolyte balance, due to treatment with diuretics, salt-free diet, diarrhea, vomiting, or those on hemodialysis. A pronounced decrease in blood pressure (BP) usually manifests itself in the form of nausea, increased heart rate (HR) and fainting.
In case of arterial hypotension, the patient needs to take a horizontal position, with a low headboard and call a doctor.
Arterial hypotension and its severe consequences are rare and transient. Transient arterial hypotension is not a contraindication to further treatment with the drug. As soon as the blood pressure stabilizes, the patient normally tolerates taking subsequent doses of the drug. Arterial hypotension can be avoided by interrupting treatment with diuretics and refusing a salt-free diet before starting treatment with Enap, if possible.
If relapses in arterial hypotension occur, accompanied by symptoms such as nausea, increased heart rate (HR), and fainting, consult your doctor.
Renal function should be monitored before treatment and during enap treatment. During the treatment with Enap, an increase in the level of potassium in the blood serum is possible, especially in patients with chronic renal failure, diabetes mellitus, while prescribing potassium-sparing diuretics (such as spironolactone, amiloride and triamteren) or tablets containing potassium. Therefore, while taking Enap and these drugs, you must strictly follow the doctor ² ¢s instructions. If the patient feels muscle weakness or irregular heart contractions during such treatment, the doctor should be informed immediately.
Allergic reactions may develop due to the use of certain types of filtering membranes used in hemodialysis or other types of blood filtration (apheresis). If the doctor plans such treatment, he should be warned about the simultaneous treatment with Enap.
During the treatment of allergies (desensitization) to aspen or bee venom, hypersensitivity reactions may occur. If the doctor plans such treatment, he should be warned about the simultaneous treatment with Enap.
The efficacy and safety of the drug in the treatment of children has not been established, so it should not be prescribed to children.
Effect on the ability to drive vehicles and control mechanisms: in certain patients, the drug can cause severe arterial hypotension and dizziness, especially at the beginning of treatment, providing thus, an indirect and transient effect on the ability to drive vehicles and machinery.
Composition
1 tablet contains: enalapril maleate 5 mg.
Excipients: lactose monohydrate, hydroxypropyl cellulose, corn starch, sodium bicarbonate, talc, magnesium stearate.
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 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. 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, heart rhythm disturbances (atrial brady or tachycardia, atrial fibrillation), tachycardia, angina pectoris infrequently – palpitations, myocardial infarction or stroke (due to a pronounced decrease in blood pressure) rarely – thrombosis pulmonary artery, 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 Interactions Patients should refrain from drinking alcohol because ethanol enhances the decrease in blood pressure (BP) with enalapril. The simultaneous use of enalapril and diuretics or other antihypertensive drugs increases the effectiveness of these drugs. Drug Interactions, used to treat heart failure (cardiac glycosides) has no clinical significance. Before surgery, the doctor should be informed that the patient is taking enalapril, since there is a risk of developing hypotension during general anesthesia. The simultaneous use of enalapril and non-steroidal anti-inflammatory drugs (NSAIDs) or acetylsalicylic acid (aspirin), as well as estrogen, can reduce the effectiveness of enalapril and increase the risk of impaired renal function. The simultaneous use of certain diuretics (spironolactone, amiloride, or triamteren) and / or additional prescription of potassium-containing tablets may cause an increase in serum potassium levels (hyperkalemia). Bone marrow depression medications increase the risk of neutropenia and / or agranulocytosis. Immunosuppressants, allopurinol, cytostatics enhance hematotoxicity. Enalapril attenuates the action of theophylline-containing products. Concomitant use of lithium preparations may enhance the side effect of lithium. With the simultaneous administration of Enap with cimetidine, the half-life (T 1/2) of Enap is increased. If the patient is already taking the above drugs or he is advised to take any of them, he should inform the doctor that he is taking Enap. Overdose If a patient has taken too many tablets for one dose, call a doctor immediately. Symptoms: excessive decrease in 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. Shelf life 3 years. Active ingredient Enalapril Terms and conditions prescription dosage form tablets Possible Product Names ENAP 0.005 N20 TABLE Enap 5mg Tab. X20 (R) Enap 5mg No. 20 tab ENAP 5MG. No. 20 TAB. / KRKA / Enap tab 5mg x 20 KRKA d.d. Novo mesto AO, Slovenia
