Enap 10 mg tablets 20
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Active substance: enalapril maleate 10 mg
Excipients: sodium bicarbonate - 5.1 mg, lactose monohydrate - 124.6 mg, corn starch - 21.4 mg, talc - 6 mg, magnesium stearate - 1.7 mg, iron oxide red dye (E172) - 1.2 mg.
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 the decrease Angiotensin II concentrations result in a secondary increase in plasma renin activity due to the elimination of negative feedback during the release of renin and a direct decrease in aldosterone secretion. 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 dysfunction of the left ventricle enalapril reduces the risk of developing major ischemic outcomes (including the incidence 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) may be observed (even a few hours after taking 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 (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 with 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
Assign inside regardless of time Meal.
To ensure the following dosage regimen, it is possible to use the drug Enalapril at a dose of 2.5 mg.
With monotherapy of arterial hypertension - the initial dose of 5 mg 1 time / day. In the absence of a clinical effect, after 1-2 weeks, the dose is increased by 5 mg. After taking the initial dose, patients should be under medical supervision for 2 hours and additionally for 1 hour until blood pressure stabilizes.
If necessary and sufficiently good tolerability, the dose can be increased to 40 mg / day in 2 doses. After 2-3 weeks, they switch to a maintenance dose - 10-40 mg / day, divided into 1-2 doses. With moderate arterial hypertension, the average daily dose is about 10 mg.
The maximum daily dose is 40 mg / day.
In the case of prescribing to patients simultaneously receiving diuretics, treatment with a diuretic should be discontinued 2-3 days before the appointment of the drug Enalapril-FPO. If it's it is impossible, then the initial dose of the drug should be 2.5 mg / day.
For patients with hyponatremia (serum sodium ion concentration less than 130 mmol / l) or serum creatinine concentration of more than 0.14 mmol / l, the initial dose is 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 more often there is a more pronounced hypotensive effect and prolongation of the duration of action of the drug, which is associated with a decrease in the rate of excretion of enalapril, so the recommended initial dose for this category of patients is 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 should be moved to a horizontal position with a low headboard. In mild cases, gastric lavage and ingestion of activated charcoal are indicated; in more serious cases - measures aimed at normalizing blood pressure, intravenous administration of 0.9% sodium chloride solution, plasma substitutes, if necessary - intravenous administration of angiotensin II, hemodialysis (rate of excretion of enalaprilate - 62 ml / min).
From the nervous system: dizziness, headache, feeling tired, increased fatigue; very rarely when used in high doses - sleep disorders, nervousness, depression, imbalance, paresthesia, tinnitus.
From the cardiovascular system: orthostatic hypotension, fainting, palpitations, pain in the heart; very rarely when used in high doses - hot flashes.
From the digestive system: nausea; rarely - dry mouth, abdominal pain, vomiting, diarrhea, constipation, impaired liver function, increased activity of hepatic transaminases, increased concentration of bilirubin in the blood, hepatitis, pancreatitis; very rarely when used in high doses - glossitis.
On the part of the hematopoietic system: rarely - neutropenia; in patients with autoimmune diseases - agranulocytosis.
From the urinary system: rarely - impaired renal function, proteinuria.
From the respiratory system: dry cough.
From the reproductive system: very rarely when used in high doses - impotence.
Dermatological reactions: very rarely when used in high doses - hair loss.
Allergic reactions: rarely - skin rash, angioedema.
Other: rarely - hyperkalemia, muscle cramps.
Keep out of reach of children.Shelf life 3 years.
- Dosage form
- 10 mg
- Number of tablets
- INN Russian
- Russian title