Enalozid Mono (enalapril, hydrochlorothiazide) tablets 10 mg. №20

Description

Enalozid Mono Storage
active substance: enalapril;

1 tablet contains enalapril maleate in terms of 100% dry matter 5 mg or 10 mg;

Enalozid Mono Excipients: sodium bicarbonate, lactose monohydrate, corn starch, pregelatinized starch, magnesium stearate.

Enalozid Mono Dosage form
Tablets.

Basic physical and chemical properties: tablets of white or almost white color, with a flat surface, a facet and a line.

Pharmacotherapeutic group
Angiotensin-converting enzyme inhibitors, monocomponent. ATX code C09A A02.

Pharmacological properties

Pharmacodynamics.

Enaloside® Mono (enalapril maleate) is a salt of enalapril maleic acid, a derivative of two amino acids, L-alanine and L-proline.

Mechanism of action

Angiotensin converting enzyme (ACE) is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the pressor substance angiotensin II. After absorption, enalapril is hydrolyzed to enalaprilat, which inhibits ACE inhibitors. ACE inhibition causes a decrease in plasma angiotensin II levels, leading to increased plasma renin activity (due to suppression of the negative feedback between angiotensin II activity and renin release) and decreased aldosterone secretion.

ACE is identical to kininase II. Thus, enalapril maleate can also block the cleavage of bradykinin, a strong vasodepressor peptide.

The mechanism by which enalapril maleate lowers blood pressure is primarily associated with inhibition of the activity of the renin-angiotensin-aldosterone system (RAAS); Enalapril maleate may have an antihypertensive effect even in patients with low-renin hypertension.

The use of Enaloside® Mono in the case of hypertension causes a decrease in blood pressure in patients in horizontal and vertical positions without a significant increase in heart rate.

Symptomatic postural hypotension occurs infrequently. In some patients, achieving an optimal reduction in blood pressure may require several weeks of therapy. Abrupt withdrawal of enalapril maleate was not associated with a rapid increase in blood pressure.

Indication
Treatment of arterial hypertension.
Treatment of clinically severe heart failure.
Prevention of clinically severe heart failure in patients with asymptomatic left ventricular dysfunction (ejection fraction ≤ 35%).

Contraindication
Hypersensitivity to enalapril, to any of the excipients or to any other ACE inhibitor.
History of angioneurotic edema associated with ACE inhibitors.
Hereditary or idiopathic angioneurotic edema.
Pregnant women or women planning to become pregnant (see section “Use during pregnancy or breast-feeding”).
Enaloside® Mono should not be used in combination with aliskiren-containing products in patients with diabetes mellitus or renal impairment (GFR <60 ml / min / 1.73 m2).

Do not use the drug in combination with neprilysin inhibitors (eg, sacubitrile). Do not use Enaloside® Mono for 36 hours after switching from / to sacubitril / valsartan, a preparation containing a neprilysin inhibitor (see sections “Interaction with other medicinal products and other forms of interaction” and “Special precautions for use”).