Enalapril (enalapril) coated tablets 0.02 g. №20

Description

Enalapril tablets Composition
active substance: 1 tablet contains enalapril maleate 20 mg

Enalapril tablets excipients: lactose, microcrystalline cellulose, croscarmellose sodium, copolyvidone, calcium stearate.

Enalapril tablets Indications.
Treatment of arterial hypertension.
Treatment of clinically significant heart failure.
Prevention of clinically significant heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 35%).

Contraindications
Hypersensitivity to the components of the drug or to any other ACE inhibitor.
A history of angioedema associated with the use of ACE inhibitors.
Hereditary or idiopathic angioedema.
Pregnant women or women planning to become pregnant (see section “Use during pregnancy or lactation”).
Enalapril should not be used with drugs containing aliskiren in patients with diabetes mellitus or with impaired renal function (GFR <60 ml / min / 1.73 m2).

Method of administration and dosage.
Food intake does not affect the absorption of the tablets. Since the tablet is not divided, in the case of prescribing a drug in a dose of less than 5 mg, use enalapril preparations with the possibility of such dosage.

The dosage should be selected individually in accordance with the condition of each patient and the response of blood pressure in response.

Arterial hypertension. The dose of the drug ranges from an initial 5 mg to a maximum of 20 mg, depending on the degree of arterial hypertension and the patient’s condition (see below). The drug is taken 1 time per day. For mild arterial hypertension, the recommended starting dose is 5-10 mg.

In patients with a very activated renin-angiotensin-aldosterone system (for example, with renovascular hypertension, impaired salt and / or fluid balance, decompensation of cardiac function, or severe arterial hypertension), an excessive decrease in blood pressure after taking the initial dose is possible. For such patients, an initial dose of 5 mg or less is recommended, and the initiation of treatment should be under the supervision of a physician.

Pretreatment with high doses of diuretics can lead to fluid deficiency and the risk of arterial hypotension at the beginning of therapy with enalapril. For these patients, an initial dose of 5 mg or less is recommended. If possible, treatment with diuretics should be discontinued 2-3 days before starting treatment with the drug. Renal function and serum potassium levels should be monitored.

The usual maintenance dose is 20 mg once daily. The maximum maintenance dose is 40 mg per day.

Heart failure / asymptomatic left ventricular dysfunction. For the treatment of clinically severe heart failure, the drug should be used with diuretics and, if necessary, digitalis drugs or beta-blockers. The initial dose for patients with clinically severe heart failure or asymptomatic left ventricular dysfunction is 2.5 mg, while the use of the drug must be carried out under close medical supervision in order to establish the primary effect of the drug on blood pressure. If there is no effect or after appropriate correction of symptomatic hypotension that occurs at the beginning of treatment of heart failure with the drug, the dose should be gradually increased to the usual maintenance dose of 20 mg, administered once or divided into 2 doses, depending on what is better tolerated by the patient. It is recommended to select the dose within 2-4 weeks. Such a therapeutic regimen effectively reduces mortality rates in patients with clinically significant heart failure. The maximum dose is 40 mg per day in 2 divided doses.

Children.
For use in children over 6 years of age.

The drug is not recommended for newborns and children with a glomerular filtration rate <30 ml / min / 1.73 m2 due to lack of data.