Enalapril Hexal 10 mg tablets 20
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Active substance: enalapril maleate 20 mg.
Excipients: lactose (milk sugar), microcrystalline cellulose, silicon dioxide colloidal (aerosil), magnesium stearate, talc.
ACE inhibitor. It is a prodrug from which the active metabolite enalaprilate is formed in the body. It is believed that the mechanism of antihypertensive action is associated with competitive inhibition of ACE activity, which leads to a decrease in the rate of conversion of angiotensin I to angiotensin II (which has a pronounced vasoconstrictor effect and stimulates the secretion of aldosterone in the adrenal cortex).
As a result of a decrease in the concentration of angiotensin II, a secondary increase occurs. plasma renin activity due to the elimination of negative feedback during the release of renin and a direct decrease in the secretion of aldosterone. In addition, enalaprilate appears to have an effect on the kinin-kallikrein system, preventing the breakdown of bradykinin.
Due to the vasodilating effect, it reduces OPSS (afterload), jamming pressure in the pulmonary capillaries (preload) and resistance in the pulmonary vessels; increases the minute volume of the heart and exercise tolerance.
In patients with chronic heart failure with prolonged use, enalapril increases exercise tolerance and reduces the severity of heart failure (assessed according to the NYHA criteria). Enalapril in patients with mild to moderate heart failure slows down its progression, and also slows down the development of left ventricular dilatation. With left ventricular dysfunction, enalapril reduces the risk of developing major ischemic outcomes (including. the frequency of myocardial infarction and the number of hospitalizations for unstable angina).
Indications for use
Arterial hypertension (including renovascular), chronic heart failure (as part of combination therapy).
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 incidence of myocardial infarction and reduce the frequency of hospitalizations for unstable angina.
- hypersensitivity to enalapril or other components of the drug,
- hypersensitivity to other ACE inhibitors,
- angioedema in the anamnesis, including associated with the use of ACE inhibitors (allergic reaction with a sharp swelling of the lips, face, neck and, possibly, hands and feet, accompanied by suffocation and hoarseness of the voice),
- patients who have ever had angioedema.
Use in pregnancy and lactation
During pregnancy and lactation, you can not prescribe the drug.
If pregnancy occurs during the period of treatment with Enap, you should inform your doctor as soon as possible. He will prescribe another antihypertensive treatment.
Arterial hypotension (a sharp decrease in blood pressure) can be observed (even a few hours after taking the first dose) in patients with severe heart failure or severe renal dysfunction, 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 (heart rate) and fainting.
In the 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 subsequent doses of the drug. Arterial hypotension can be avoided by interrupting treatment with diuretics and abandoning a salt-free diet before starting treatment with Enap, if possible.
If there are relapses of arterial hypotension, accompanied by symptoms such as nausea, increased heart rate (HEART rate) and fainting, you should consult a doctor.
Kidney function should be monitored before treatment and during treatment with Enap.
During the period of 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, with the simultaneous appointment of potassium-sparing diuretics (such as spironolactone, amiloride and triamterene) or tablets containing potassium. Therefore, when taking Enap and these drugs at the same time, it is necessary to strictly follow the doctor's instructions. If the patient feels muscle weakness or irregular heartbeats during the period of such treatment, you should immediately inform your doctor.
Allergic reactions can develop due to the use of certain types of filter membranes used in hemodialysis or other types of blood filtration (apheresis). If the doctor plans such treatment, you should warn him about the simultaneous treatment with Enap.
During the treatment of allergies (desensitization) to aspen or bee venom, hypersensitivity reactions may be noted. If the doctor plans such treatment, you should warn him 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 some patients, the drug can cause severe arterial hypotension and dizziness, especially at the beginning of treatment, thus exerting an indirect and transient effect on the ability to drive vehicles and machinery.
Dosage and Administration
For patients with hyponatremia (serum sodium ion concentration less than 130 mmol / l) or creatinine concentration in serum more than 0.14 mmol / l initial dose - 2.5 mg 1 time / day.
With renovascular hypertension, the initial dose is 2.5-5 mg / day. The maximum daily dose is 20 mg.
In chronic heart failure, the initial dose is - 2.5 mg 1 time / day, then the dose is increased by 2.5-5 mg every 3-4 days in accordance with the clinical response to the maximum tolerated doses, depending on the value of blood pressure, but not higher than 40 mg / day once or in 2 doses. In patients with low systolic blood pressure (less than 110 mm Hg), therapy should begin with a dose of 1.25 mg. Dose selection should be carried out within 2-4 weeks or at a shorter time. The average maintenance dose is 5-20 mg / day for 1-2 doses.
In elderly patients, a more pronounced hypotensive effect and an extension of the duration of action of the drug are more often observed, which is associated with a decrease in the rate of excretion of enalapril, so the recommended initial dose for this category patients - 1.25 mg.
In chronic renal failure, cumulation occurs with a decrease in filtration of less than 10 ml / min. With QC of 80-30 ml / min, the dose is usually 5-10 mg / day, with QC up to 30-10 ml / min - 2.5-5 mg / day, with QC less than 10 ml / min - 1.25-2.5 mg / day only on dialysis days.
The duration of treatment depends on the effectiveness of therapy. With too pronounced a decrease in blood pressure, the dose of the drug is gradually reduced.
The drug is used both as monotherapy and in combination with other antihypertensive drugs.
Symptoms: a pronounced decrease in blood pressure up to the development of collapse, myocardial infarction, acute cerebral circulation disorders or thromboembolic complications, convulsions, stupor.
Treatment: The patient is transferred to a horizontal position with a low headboard. In mild cases, gastric lavage and ingestion of saline are indicated, in more severe cases - measures, aimed at stabilizing blood pressure: intravenous administration of saline, plasma substitutes, if necessary - the introduction of angiotensin II, hemodialysis (rate of excretion of enalaprilate - 62 ml / min).
Enalapril is generally well tolerated and in most cases does not cause adverse reactions that require discontinuation of the drug.
From the cardiovascular system: excessive decrease in blood pressure, orthostatic collapse; rarely - chest pain, angina pectoris, myocardial infarction or stroke (usually associated with a pronounced decrease in blood pressure); extremely rarely - arrhythmias (atrial brady- or tachycardia, atrial fibrillation), palpitations, thromboembolism of the branches of the pulmonary artery, Raynaud's syndrome.
From the nervous system: dizziness, headache, weakness, insomnia, anxiety, confusion, increased fatigue, drowsiness (2-3%); very rarely when used in high doses - nervousness, depression, paresthesia.
From the senses: disorders of the vestibular apparatus, hearing and visual impairment, tinnitus.
From the digestive system: dry mouth, anorexia, dyspeptic disorders (nausea, diarrhea or constipation, vomiting, abdominal pain), intestinal obstruction, pancreatitis, impaired liver function and biliary excretion, hepatitis (hepatocellular or cholestatic), jaundice.
From the respiratory system: unproductive dry cough, sore throat, hoarseness of the voice, pulmonary infiltrates, interstitial pneumonitis, bronchospasm, shortness of breath, rhinorrhea, pharyngitis.
Allergic reactions: skin rash, itching, urticaria, angioedema; extremely rarely - dysphonia, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, pemphigus, photosensitization, serositis, vasculitis, myositis, arthralgia, arthritis, stomatitis, glossitis, intestinal edema (very rarely).
On the part of laboratory indicators: hypercreatininemia, increased urea content, increased activity of liver enzymes, hyperbilirubinemia, hyperkalemia, hyponatremia, hypoglycemia in patients suffering from diabetes mellitus receiving hypoglycemic agents for oral administration or insulin. In some cases, there is a decrease in the concentration of hemoglobin and hematocrit, an increase in ESR, thrombocytopenia, neutropenia, agranulocytosis (in patients with autoimmune diseases), eosinophilia.
From the urinary system: impaired renal function; rarely - proteinuria.Other: alopecia, decreased libido, impotence, hot flashes
The drug should be stored out of the reach of children, dry, protected from light, at a temperature not exceeding 25 ° C.Shelf life - 3 years.
- Dosage form
- 10 mg
- Number of tablets
- INN Russian