Treatment of arterial hypertension; treatment of clinically expressed heart failure; prevention of clinically expressed heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 35 %).
Enalapril-TEVA 10 mg. Composition
active substance: enalapril maleate;
1 tablet contains 2.5 mg or 5 mg or 10 mg or 20 mg of enalapril maleate;
Enalapril-TEVA 10 mg. Excipients:
2.5 mg and 5 mg tablets: lactose, corn starch, talc, sodium bicarbonate, hydroxypropyl cellulose, magnesium stearate
tablets of 10 mg and 20 mg: lactose, corn starch, talc, sodium bicarbonate, magnesium stearate, iron oxide red, iron oxide yellow (for tablets of 20 mg).
Enalapril-TEVA 10 mg. 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%).
Hypersensitivity to enalapril, to any excipient of the drug or other ACE inhibitors.
A history of angioedema associated with previous treatment with ACE inhibitors.
Pregnancy or planning pregnancy (see section “Use during pregnancy or lactation”).
Hereditary or idiopathic angioedema.
Simultaneous use of enalapril with drugs containing aliskiren in patients with diabetes mellitus or with impaired renal function (glomerular filtration rate <60 ml / min / 1.73 m2).
Method of administration and dosage.
Food intake does not affect the absorption of Enalapril-Teva tablets.
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). Enalapril-Teva is taken once a day. For mild arterial hypertension, the recommended starting dose is 5-10 mg per day.
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 2.5 mg to 5 mg is recommended before starting treatment – under medical supervision.
Pretreatment with high doses of diuretics can lead to fluid deficiency and the development of arterial hypotension at the beginning of therapy with enalapril. For these patients, an initial dose of 2.5 mg to 5 mg is recommended. If possible, diuretic treatment should be discontinued 2-3 days before starting treatment with Enalapril-Teva. Renal function and serum potassium levels should be monitored.
The usual maintenance dose is 20 mg once a day. The maximum maintenance dose is 40 mg once a day.
Heart failure / asymptomatic left ventricular dysfunction
For the treatment of clinically severe heart failure, Enalapril-Teva is used together with diuretics and, if necessary, with digitalis drugs or beta-blockers. The initial dose of the drug Enalapril-Teva for patients with clinically expressed heart failure or asymptomatic left ventricular dysfunction is 2.5 mg, while the use of the drug must be carried out under the supervision of a physician in order to establish the primary effect of the drug on blood pressure. In the absence of effect or after appropriate correction of symptomatic hypotension that occurred at the beginning of treatment with Enalapril-Teva for heart failure, 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. This therapeutic regimen is effective in reducing mortality rates in patients with clinically significant heart failure. The maximum dose is 40 mg per day in 2 divided doses.
Applied to children aged 6 years and over.
Enalapril is not recommended for newborns and children with a glomerular filtration rate <30 ml / min / 1.73 m2 due to lack of data.