Evroramipril N (ramipril) 10 tablets 10 mg/12.5 mg. №20

Description

Evroramipril N Storage:

active substances: ramipril and hydrochlorothiazide;

1 tablet contains ramipril 5 mg and hydrochlorothiazide 12.5 mg or ramipril 10 mg and hydrochlorothiazide 12.5 mg;

1 tablet of EuroRamipril H 5 contains excipients: lactose monohydrate, sodium bicarbonate, corn starch, croscarmellose sodium, colloidal hydrophobic silicon dioxide, sodium stearyl fumarate;

1 tablet of EuroRamipril H 10 contains excipients: lactose monohydrate, sodium bicarbonate, corn starch, croscarmellose sodium, colloidal hydrophobic silicon dioxide, sodium stearyl fumarate.

Evroramipril N Dosage form.

Tablets.

Basic physical and chemical properties:

EuroRamipril H 5 – round tablets, flat-cylindrical, beveled, white or almost white.

EuroRamipril H 10 – round tablets, flat-cylindrical, beveled and dashed, white or almost white.

Pharmacotherapeutic group.

Combined drugs of angiotensin-converting enzyme (ACE) inhibitors. ATX code C09B A05.

Evroramipril N Pharmacological properties.

Mechanism of action.

Ramipril. Ramiprilat, the active metabolite of the prodrug-ramipril, is an inhibitor of the enzyme dipeptidylcarboxypeptidase I (also known as angiotensin-converting enzyme, or kinase II). In blood plasma and tissues, this enzyme catalyzes the conversion of angiotensin I to angiotensin II, an active vasoconstrictor, and the cleavage of bradykinin, which is an active vasodilator. Reducing the formation of angiotensin II and inhibiting the breakdown of bradykinin lead to vasodilation.

Because angiotensin II also stimulates the release of aldosterone, ramiprilat causes a decrease in aldosterone secretion. In patients of negroid race (Afro-Caribbean origin) with hypertension (a population characterized by low renin activity), the response to ACE inhibitor monotherapy was on average less pronounced than in patients of other races.

Pharmacodynamics.

Ramipril. The use of ramipril leads to a significant reduction in peripheral arterial resistance. As a rule, significant changes in renal plasma flow or glomerular filtration rate do not occur. In patients with hypertension, the administration of ramipril leads to a decrease in blood pressure in both horizontal and vertical position, which is not accompanied by a compensatory increase in heart rate.

In most patients, the antihypertensive effect occurs approximately 1-2 hours after oral administration of a single dose of the drug. The maximum effect after a single oral dose usually occurs after 3-6 hours. The antihypertensive effect after a single dose usually persists for 24 hours.

With long-term treatment with ramipril, the maximum antihypertensive effect develops in 3-4 weeks. It is proved that with long-term therapy the antihypertensive effect persists for 2 years.

Pharmacokinetics.

Ramipril.

Absorption. After oral administration, ramipril is rapidly absorbed from the gastrointestinal tract. The maximum concentration of ramipril in blood plasma is reached during

1 year. with given the amount of the substance found in the urine, the absorption is at least

56%, and it is not significantly affected by the presence of food in the gastrointestinal tract. The bioavailability of the active metabolite of ramiprilat after oral administration of the drug at a dose of 2.5 mg and 5 mg is 45%.

Treatment of arterial hypertension.
The use of this fixed combination is indicated in patients whose blood pressure is not adequately controlled on ramipril or hydrochlorothiazide monotherapy.

Contraindication.

Hypersensitivity to the active substance of ramipril or to other ACE inhibitors (angiotensin-converting enzyme),