Coaprovel tablets 150 + 12.5mg, # 28

Arterial hypertension of moderate or severe severity (treatment of patients for whom combination therapy is indicated).

Inside, regardless of food intake, once a day.

CoaprovelЃ should be used in patients whose blood pressure is insufficiently controlled by irbesartan or hydrochlorothiazide as monotherapy.

CoaprovelЃ 150 / 12.5 mg (tablets containing irbesartan / hydrochlorothiazide 150 / 12.5 mg, respectively)

It can be prescribed to patients whose blood pressure is insufficiently controlled by hydrochlorothiazide (12.5 mg / day) or irbesartan (150 mg / day) in monotherapy.

CoaprovelЃ 300 / 12.5 mg (tablets containing irbesartan / hydrochlorothiazide 300 / 12.5 mg, respectively)

It can be prescribed to patients whose blood pressure is insufficiently controlled by irbesartan (300 mg) or CoaprovelЃ 150 / 12.5 mg.

If necessary, use in patients whose blood pressure is not sufficiently controlled by CoaprovelЃ 300 / 12.5 mg, the doses of drugs in combination can be increased to 300 mg of irbesartan and 25 mg of hydrochlorothiazide per day: Table 2. CoaprovelЃ 150 / 12.5 mg or 1 tab. drug CoaprovelЃ 300/25 mg.

Maximum daily dose: 2 tablets. CoaprovelЃ 150 / 12.5 mg or 1 tab. drug CoaprovelЃ 300/25 mg.

CoaprovelЃ, 300/25 mg (tablets containing irbesartan / hydrochlorothiazide 300/25 mg, respectively)

It can be prescribed to patients who cannot achieve target blood pressure levels while taking CoaprovelЃ 300 / 12.5 mg. CoaprovelЃ 300/25 mg is the maximum daily dose, therefore, the simultaneous use of doses exceeding 300 mg of irbesartan and 25 mg of hydrochlorothiazide 1 time per day is not recommended.

If it is impossible to achieve the target blood pressure level when using CoaprovelЃ 300/25 mg, other antihypertensive drugs (beta-blockers, long-acting CCBs) may be added to it.

Patients with hypovolemia. In patients with hypovolemia and / or hyponatremia, for example, those receiving active diuretic therapy, these disorders should be corrected before starting CoaprovelЃ.

Renal failure Usually, in patients with renal insufficiency (mild to moderate severity - Cl creatinine> 30 ml / min), dose reduction is not required. However, due to the presence of hydrochlorothiazide in the composition of the drug, the use of CoaprovelЃ is not recommended in patients with severe renal failure (Cl creatinine? 30 ml / min) (see 'Special instructions').

Liver failure. In case of mild or moderate hepatic insufficiency (5-6 and 7-9 points according to the Child-Pugh classification), a dose reduction of CoaprovelЃ is not required. Due to the presence of hydrochlorothiazide in the composition of the drug, special care should be taken when using the drug in patients with severe hepatic impairment (more than 9 points on the Child-Pugh scale).

Elderly patients. Elderly patients do not require dose adjustment of CoaprovelЃ. In patients who took CoaprovelЃ in clinical trials, in general, there were no differences in efficacy and safety between patients aged 65 years and older and younger patients.

Children and adolescents. To date, the safety and efficacy of the drug in pediatric and adolescent patients has not been established.

hypersensitivity to the active substances of the drug, any of the excipients of the drug CoaprovelЃ (see 'Composition') or other sulfonamide derivatives (hydrochlorothiazide is a sulfonamide derivative);

hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption syndrome;

simultaneous use with drugs containing aliskiren in patients with diabetes mellitus or with moderate to severe renal failure (glomerular filtration rate (GFR) <60 ml / min / 1.73 m2);

simultaneous use with ACE inhibitors in patients with diabetic nephropathy;

severe renal failure (Cl creatinine? 30 ml / min), anuria (due to the presence of hydrochlorothiazide in the drug);

pregnancy (see 'Application during pregnancy and lactation');

the period of breastfeeding (see 'Application during pregnancy and breastfeeding');

age up to 18 years (efficacy and safety have not been established).

Carefully:

stenosis of the aortic or mitral valve, or hypertrophic obstructive cardiomyopathy (GOKMP);

hypovolemia, hyponatremia, arising, for example, with intensive diuretic therapy, hemodialysis, adherence to a diet with limited salt intake, diarrhea, vomiting (danger of excessive decrease in blood pressure, see 'Special instructions');

patients with renal function dependent on the activity of the RAAS, such as patients with arterial hypertension with bilateral or unilateral renal artery stenosis or chronic heart failure III Ц IV functional class (NYHA classification) (see 'Special instructions');

ischemic heart disease and / or atherosclerotic vascular lesions of the brain (the risk of increased myocardial or cerebral ischemia, up to the development of myocardial infarction or stroke with an excessive decrease in blood pressure);

renal failure of mild to moderate severity (Cl creatinine from 60 to 30 ml / min) (risk of increased azotemia, increased concentration of uric acid in the blood, due to the presence of hydrochlorothiazide in the drug, and the development of hyperkalemia, due to the presence of the drug irbesartan);

condition after kidney transplantation (lack of clinical experience);

liver failure of all degrees of severity or with progressive liver diseases (due to the presence of hydrochlorothiazide in the composition of the drug, since even minor violations of the water-electrolyte balance in such patients can provoke a hepatic coma);

diabetes mellitus (due to the presence of hydrochlorothiazide in the composition of the drug, it is possible to reduce glucose tolerance, increase the need for insulin and oral hypoglycemic agents);

gout (due to the presence of hydrochlorothiazide in the drug, an increase in the concentration of uric acid salts in the blood is possible);

hyperkalemia, concomitant use of potassium-sparing drugs and / or potassium-containing salt substitutes (risk of hyperkalemia);

systemic lupus erythematosus (due to the presence of hydrochlorothiazide in the composition of the drug, since there are reports of exacerbation or aggravation of the course of systemic lupus erythematosus with the use of thiazide diuretics);

concomitant use of other antihypertensive drugs (the possibility of potentiating their antihypertensive action);

sympathectomy (risk of increased antihypertensive effect of hydrochlorothiazide);

use in combination with ACE inhibitors or aliskiren, because compared with monotherapy with double blockade of the RAAS, there is an increased risk of developing an excessive decrease in blood pressure, hyperkalemia and changes in renal function (see 'Special instructions');

a history of allergic reactions to penicillins and sulfonamides, which are risk factors for the development of an idiosyncratic reaction observed when taking sulfonamides or sulfonamide derivatives, manifested in the form of acute angle-closure glaucoma (see 'Special instructions', Acute myopia and secondary acute angle-closure glaucoma).