Irbetan-N tablets 300 mg/12.5 mg. №30

Description

Irbetan-N Composition
active ingredients: irbesartan, hydrochlorothiazide;

1 tablet contains irbesartan 300 mg and hydrochlorothiazide 12.5 mg;

excipients: lactose, monohydrate; microcrystalline cellulose; croscarmellose sodium; pregelatinized starch; magnesium stearate; anhydrous colloidal silicon dioxide; iron oxide red (E 172); iron oxide yellow (E 172).

Irbetan-N Dosage form
Pills.

Basic physical and chemical properties: tablets of a round shape with a biconvex surface of orange-pink color with white impregnations. Dark dye inclusions are allowed.

Irbetan-N Pharmacotherapeutic group
Combined preparations of angiotensin-II inhibitors.

ATX code С09D A04.

Pharmacodynamics
Irbetan-N is a combination of the angiotensin II receptor antagonist irbesartan and the thiazide diuretic hydrochlorothiazide. Combining these components has an additional antihypertensive effect, in which blood pressure decreases significantly more than when any component is used alone.

Irbesartan is a potent, orally active, selective angiotensin II receptor antagonist (AT1 subtype). It can block all the actions of angiotensin-II, which are provided by the AT1 receptor, regardless of the source or method of synthesis of angiotensin-II. Selective antagonism of angiotensin-II (AT1) receptors causes an increase in renin levels and angiotensin-II levels in blood plasma, as well as a decrease in the concentration of aldosterone in blood plasma. Irbesartan alone, when used in recommended doses in patients who do not have the risk of electrolyte imbalance, does not significantly affect serum potassium levels. Irbesartan does not inhibit ACE (kininase-II), an enzyme that generates angiotensin-II, and also breaks down bradykinin into inactive metabolites. Irbesartan does not require metabolic activation.

Hydrochlorothiazide is a thiazide diuretic. The mechanism of the antihypertensive effect of thiazide diuretics is not fully understood at this time. Thiazides affect the reabsorption of electrolytes in the renal canals, directly enhancing the excretion of sodium and chloride in approximately equal amounts. Due to the diuretic action of hydrochlorothiazide, plasma volume decreases, plasma renin activity, aldosterone secretion increase, as a result of which the loss of potassium and bicarbonate in the urine increases and the concentration of potassium in the blood serum decreases. Probably, due to blocking of the renin-angiotensin-aldosterone system (RAAS) with the simultaneous use of irbesartan, there is a tendency to compensate for the loss of potassium. With hydrochlorothiazide, diuresis begins after 2 hours, and the peak effect occurs at approximately 4 hours, while its effect lasts approximately 6-12 hours.

Indications
Essential hypertension treatment.

This fixed-dose combination is indicated for adult patients whose blood pressure cannot be adequately controlled with irbesartan or hydrochlorothiazide alone.

Contraindications
hypersensitivity to drug components or sulfonamide derivatives (hydrochlorothiazide is a sulfonamide derivative);
severe renal failure (creatinine clearance <30 ml / min);
persistent hypokalemia, hypercalcemia;
severe liver failure, liver cirrhosis and cholestasis;
simultaneous use of the drug Irbetan-N with drugs containing aliskerin in patients with diabetes, and in patients with moderate and severe kidney damage (glomerular filtration rate <60 ml / min / 1.73 m2);
simultaneous use of the drug Irbetan-N with angiotensin converting enzyme (ACE) inhibitors in patients with diabetic nephropathy;
treatment-resistant hypokalemia or hypercalcemia;
refractory hyponatremia;
symptomatic hyperuricemia (gout);
anuria;
the period of pregnancy or lactation;
childhood.