Irbesartan pills 150mg, 28pcs

Composition

One tablet contains:

Active ingredient:  irbesartan-150.00 mg

excipients:  lactose monohydrate – 50,00 mg, povidone – 7,50 mg, microcrystalline cellulose – to 27.75 mg, croscarmellose sodium – of 6.75 mg, silicon dioxide colloid – 4,50 mg, sodium fumarate – 6,50 mg

shell: ready mix “of Sepifilm 003” – 4,43 mg, hypromellose – of 2.22 mg, macrogol stearate – 0,44 mg, microcrystalline cellulose – 1,77 mg, ready mix “Sipispis AR 7001 white” – 0,89 mg: hypromellose – 0.04 mg, propylene glycol and 0.27 mg, titanium dioxide – 0,27 mg purified water* – 0,31 mg.

Pharmacological properties

Pharmacotherapeutic group

Angiotensin II receptor antagonist

ATX code

C09CA04

Pharmacodynamics :

Irbesartan is a selective angiotensin II (AT1 type) antagonist. Irbesartan does not require metabolic activation to acquire pharmacological activity. Angiotensin II is an important component of the renin-angiotensin-aldosterone system (RAAS) and is involved in the pathogenesis of arterial hypertension and sodium homeostasis.

Irbesartan blocks all physiologically significant effects of angiotensin II regardless of the source or route of its synthesis including its pronounced vasoconstrictor and aldosterone-secreting effects realized through AT-1 receptors located on the surface of vascular smooth muscle cells and in the adrenal cortex. It has no agonistic activity to AT1 receptors and has a much greater (more than 8500 times) affinity for AT1 receptors than with AT2 receptors (receptors not related to the regulation of the cardiovascular system). Irbesartan does not inhibit RAAS enzymes (such as renin angiotensin converting enzyme [ACE]) and does not affect other hormone receptors or ion channels involved in the regulation of blood pressure (BP) and sodium homeostasis. Irbesartan blocking of AT1 receptors interrupts the feedback chain in the renin-angiotensin system, which leads to an increase in plasma concentrations of renin and angiotensin II. After taking irbesartan in the recommended doses, the plasma concentration of aldosterone decreases without significantly affecting the content of potassium in the blood serum (the average value of its increase is Irbesartan does not significantly affect the serum concentrations of cholesterol and glucose triglycerides. Irbesartan does not affect the concentration of uric acid in the blood serum or the rate of uric acid excretion by the kidneys.

The antihypertensive effect of irbesartan appears after taking its first dose and becomes significant within 1-2 weeks of taking it, its maximum effect is achieved by 4-6 weeks of treatment. In long-term clinical studies, the antihypertensive effect of irbesartan was observed to persist for more than one year.

With a single oral dose of irbesartan up to 900 mg per day, the antihypertensive effect is dose-dependent. Irbesartan with a single daily dose of 150-300 mg reduces blood pressure measured in the “lying” or “sitting” position at the end of the inter-dose interval (24 hours after taking the dose of irbesartan, i. e. before taking the next dose of irbesartan) by an average of 8-13/5-8 mm Hg (systolic/diastolic blood pressure) compared with placebo. The maximum reduction in blood pressure is achieved 3-6 hours after a single oral dose and persists for at least 24 hours.

The antihypertensive effect of irbesartan before taking the next dose is 60-70% of the maximum values of reducing diastolic and systolic blood pressure. Optimal blood pressure reduction within 24 hours is achieved when taking irbesartan once a day. Taking the drug at a dose of 150 mg once a day leads to a hypotensive effect comparable to twice taking the same dose divided into two doses.

Irbesartan reduces blood pressure approximately equally in the “standing” position and in the “lying” position. Orthostatic effects are rare, but as with ACE inhibitors, patients with hyponatremia and /or hypovolemia may experience an excessive decrease in blood pressure with clinical manifestations.

The antihypertensive effect of irbesartan and thiazide diuretics is additive. In patients with insufficient BP reduction with irbesartan monotherapy, adding low doses of hydrochlorothiazide (125 mg) once a day to irbesartan leads to an additional reduction in blood pressure by 7-10/3-6 mm Hg (systolic/diastolic blood pressure) compared with placebo.

The effectiveness of irbesartan does not depend on age or gender. As with other drugs that affect the RAS, the antihypertensive effect of irbesartan in black patients is noticeably less pronounced, but when irbesartan is used simultaneously with low doses of hydrochlorothiazide (for example,125 mg per day), the antihypertensive response in black patients approaches the effectiveness of that in Caucasian patients.

After irbesartan is discontinued, blood pressure gradually returns to its original level. There is no” withdrawal ” syndrome.

In a multicenter, randomized, Active ingredient-controlled (amlodipine) and placebo double-blind IDNT clinical trial involving 1,715 patients with arterial hypertension and type 2 diabetes mellitus (proteinuria ≥ 900 mg/day and serum creatinine concentrations in the range of 10-30 mg/dl), a 20% (p=0024) decrease (compared to placebo) and a 23% (p=0006) decrease (compared to amlodipine) in the relative weight loss of patients with the risk of the first occurrence of any of the following conditions: doubling of serum creatinine concentration, development of end-stage renal failure or death from any of the causes (if a comparable decrease in blood pressure is achieved with irbesartan and amlodipine).

In a multicenter, randomized, placebo-controlled, double-blind clinical trial investigating the effects of irbesartan on microalbuminuria in patients with arterial hypertension and type 2 diabetes mellitus (IRMA 2),590 patients with arterial hypertension and type 2 diabetes mellitus with microalbuminuria (20-200 mcg/min 30-300 mg/day) and normal renal function (serum creatinine <15 mg/dl in men and When taking the drug at a dose of 300 mg per day, there was a 70% reduction in the relative risk of developing clinically significant proteinuria (compared with placebo p=00004) and at a dose of 150 mg, there was a 39% reduction in the relative risk of developing clinically significant proteinuria (compared with placebo p=0085). A slowdown in the progression of clinically significant proteinuria was observed after three months and continued throughout the 2-year period of the clinical study. The decrease in 24-hour creatinine clearance was not significantly different between the treatment groups. Regression of microalbuminuria to normal albuminuria values (<20 mcg / min;

Pharmacokinetics:

Absorption rate

After oral use, irbesartan is rapidly and completely absorbed, with an absolute bioavailability of approximately 60-80%. Simultaneous food intake does not significantly affect the bioavailability of irbesartan. After oral use, the maximum plasma concentration (Cmax) of irbesartan is reached in 15-2 hours.

Distribution.

The binding to plasma proteins is approximately 96%. Binding to the cellular components of the blood is insignificant. The volume of distribution is 53-93 liters.

Metabolism.

After oral or intravenous use of 14C-irbesartan,80-85% of the radioactivity of circulating blood plasma is accounted for by unchanged irbesartan. Irbesartan is metabolized by the liver through oxidation and conjugation with glucuronic acid. The main metabolite found in the systemic circulation is irbesartan glucuronide (approximately 6%). Oxidation of irbesartan is mainly carried out by the cytochrome P450 isoenzyme CYP2C9 the participation of the CYP3A4 isoenzyme in the metabolism of irbesartan is insignificant. Irbesartan is not metabolized by most of the isoenzymes that are normally involved in drug metabolism (isoenzymes CYP1A1 CYP1A2 CYP2A6 CYP2B6 CYP2D6 or CYP2E1) and does not cause their inhibition or induction. Irbesartan does not induce or inhibit the CYP3A4 isoenzyme.

Output.

Irbesartan and its metabolites are eliminated from the body both through the intestines (with bile) and kidneys. After oral or intravenous use of 14C-irbesartan, about 20% of the radioactivity is detected in the urine and the remainder in the feces. Less than 2% of the administered dose is excreted by the kidneys as unchanged irbesartan.

The final half-life (T 1/2) of irbesartan is 11-15 hours. The total clearance of intravenously administered irbesartan is 157-176 ml/min and its renal clearance is 3-35 ml/min. With a single daily intake of irbesartan during the day, the equilibrium plasma concentration (Css) is reached after 3 days, while its limited accumulation in the blood plasma is observed (less than +20%).

Special patient groups

Effect of gender on the pharmacokinetics of irbesartan

Slightly higher plasma concentrations of irbesartan were observed in women (compared to men). However, there were no gender-related differences in T 1/2 and irbesartan accumulation. No dose adjustment of irbesartan is required in women. There were no gender-related differences in the effects of irbesartan.

Pharmacokinetics of irbesartan in elderly patients

The values of AUC (area under the pharmacological curve “concentration – time”) and Cmax of irbesartan in elderly patients (65-80 years) with clinically normal renal and hepatic function were approximately 20-50% higher than in younger patients (18-40 years). The final T 1/2’s are comparable. There were no age-related differences in the effects of irbesartan.

Pharmacokinetics of irbesartan in patients with hepatic impairment

In patients with mild (functional class A or Child-Pugh score 5-6) and moderate (functional class B or Child-Pugh score 7-9) hepatic insufficiency due to cirrhosis, the pharmacokinetic parameters of irbesartan do not change significantly.

Pharmacokinetics of irbesartan in patients with impaired renal function

In patients with impaired renal function or patients undergoing hemodialysis, the pharmacokinetics of irbesartan do not change significantly. Irbesartan is not eliminated from the body by hemodialysis.

Effect of race on the pharmacokinetics of irbesartan

The AUC and T|/2 of irbesartan were approximately 20-25% higher in the non-hypertensive black population than in the Caucasian population; the Cmax of irbesartan was almost the same as that of the Caucasian population.

The pharmacokinetic parameters of irbesartan are linear and proportional in the dose range from 10 to 600 mg; at doses above 600 mg (the dose is twice the recommended maximum dose of the drug), the kinetics of irbesartan becomes nonlinear (decrease in absorption).

Indications

-Arterial hypertension (in monotherapy and in combination with other antihypertensive agents such as thiazide diuretics beta-blockers long-acting slow calcium channel blockers BMCC).

– Nephropathy in arterial hypertension and type 2 diabetes mellitus (as part of combined antihypertensive therapy).

Use during pregnancy and lactation

Pregnancy

There is no experience with the use of irbesartan during pregnancy. Given the fact that when taking ACE inhibitors in pregnant women in the second and third trimesters of pregnancy, damage and death of the developing fetus were observed, irbesartan, like any other drug that directly affects the RAAS, should not be used during pregnancy (I II III trimesters).

If pregnancy is diagnosed during treatment with irbesartan, it should be discontinued as soon as possible.

Breast-feeding period

It is not known whether irbesartan or its metabolites are excreted in breast milk. Irbesartan is contraindicated during breastfeeding. Therefore, after evaluating the ratio of the expected benefit of taking the drug for the mother and the potential risk for the child, either breastfeeding or taking irbesartan should be discontinued.

Contraindications

Hypersensitivity to irbesartan or to any of the excipients of the drug;wbr>Concomitant use with medicinal products containing aliskiren in patients with diabetes mellitus or moderate to severe renal insufficiency (glomerular filtration rate [GFR] <60 ml / min/173 m2 of body surface);

Concomitant use with ACE inhibitors in patients with diabetic nephropathy;

Pregnancy;

Breast-feeding period;

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

Hereditary galactose intolerance lactase deficiency or glucose-galactose malabsorption;

In severe hepatic insufficiency (functional class C or more than 9 points on the Child-Pugh scale) (no clinical experience).

With caution:

Age over 75 years.

For aortic or mitral valve stenosis or hypertrophic obstructive cardiomyopathy (HOCMP).

With hypovolemia hyponatremia, for example, with intensive diuretic therapy, hemodialysis, following a diet with limited consumption of table salt, diarrhea, vomiting (risk of excessive lowering of blood pressure).

In patients with renal function dependent on the activity of the RAAS, such as patients with arterial hypertension, bilateral or unilateral renal artery stenosis, or patients with chronic heart failure of functional class III-IV (according to the NYHA classification) (see “Special Instructions”).

With coronary heart disease and / or clinically significant atherosclerosis of the cerebral vessels (with an excessive decrease in blood pressure, there is a risk of increasing ischemic disorders up to the development of acute myocardial infarction and stroke).

In case of renal failure (monitoring of potassium content and blood creatinine concentration is required), recent kidney transplantation (lack of clinical experience).

Concomitant use of nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors (increased risk of renal dysfunction, including the possibility of acute renal failure and increased serum potassium, especially in elderly patients, patients with hypovolemia [including patients taking diuretics] or with impaired renal function (see section “Interaction with other drugs”).

When used in combination with ACE inhibitors or aliskiren, since compared with monotherapy with double RAAS blockade, there is an increased risk of excessive blood pressure reduction, hyperkalemia and impaired renal function (see the section “Special instructions”).

Side effects

The following adverse events are presented according to the following frequency gradations (according to the World Health Organization (WHO) classification): very common (≥1/10); common (≥1/100 <1/10); uncommon (≥1/1000 <1/100); rare (≥1/10000 <1/1000); very rare (

The safety of irbesartan has been studied in clinical trials in approximately 5,000 patients, including 1,300 hypertensive patients who have taken the drug for more than 6 months and 400 patients who have taken the drug for one year or more. Adverse events in patients taking irbesartan were usually moderate and transient and their frequency was not related to the dose taken. The frequency of adverse events did not depend on gender, age, or race.

In placebo-controlled trials in which 1,965 patients took irbesartan (an average of 1-3 months), discontinuation of treatment due to the development of any clinical or laboratory adverse events was required in 33% of patients taking irbesartan and in 45% of patients taking placebo (differences were statistically significant).

Adverse events observed in placebo-controlled clinical trials when using irbesartan for arterial hypertension probably or possibly related to its use or without an established relationship with taking the drug

The frequency of occurrence of the following adverse events when taking irbesartan did not statistically significantly differ from that when taking placebo.

Disorders of the nervous system

Often: dizziness headache;

Infrequently: orthostatic vertigo.

Cardiac disorders

Infrequently: edema tachycardia

Respiratory, thoracic and mediastinal disorders

Infrequently: cough

Gastrointestinal disorders

Common: nausea/vomiting

Infrequently: diarrhea dyspepsia / heartburn

Genital and breast disorders

Infrequently: sexual dysfunction

Common Violations

Often: increased fatigue

Infrequently: chest pain

Laboratory and instrumental data

During controlled clinical trials, no clinically significant changes in laboratory parameters were observed in patients with arterial hypertension. No special monitoring of laboratory parameters is required for patients with arterial hypertension taking irbesartan.

Adverse events observed in controlled clinical trials when using irbesartan in patients with nephropathy in arterial hypertension and type 2 diabetes mellitus (IDNT and IRMA2 clinical trials)

Adverse events were similar to those in patients with hypertension, with the exception of orthostatic symptoms (dizziness (102%) (with placebo 6%) orthostatic vertigo (54%) (with placebo 27%) and orthostatic hypotension (54%) (with placebo 32%).

The percentage of discontinuation due to orthostatic symptoms with irbesartan compared to placebo was 03% vs. 05% for vertigo,02% vs. 00% for orthostatic vertigo, and 00% vs. 00% for orthostatic hypotension, respectively.

Violations of laboratory parameters

Hyperkalemia

In the IDNT clinical trial, the percentage of patients with hyperkalemia (>6 mEq / L) was 186% in the irbesartan group, compared to 6% in the placebo group. In the IRMA 2 clinical trial, the percentage of patients with hyperkalemia (>6 mEq / L) was 10% in the irbesartan group and no hyperkalemia was observed in the placebo group.

In the IDNT clinical trial, the rate of discontinuation due to hyperkalemia with irbesartan and placebo was 21% and 036%, respectively.

In the IRMA clinical trial, the frequency of discontinuation of treatment due to hyperkalemia with irbesartan and placebo was 05% and 0%, respectively.

Adverse events observed with post marketing use of irbesartan

Immune system disorders

Very rarely: As with all angiotensin II receptor antagonists, very rare cases of allergic reactions such as urticaria and angioedema have been reported.

The following adverse events have been identified with the use of irbesartan since the introduction of irbesartan to the market.

Disorders of the blood and lymphatic system

Unknown frequency: thrombocytopenia

Metabolic and nutritional disorders

Unknown frequency: hyperkalemia

Nervous system disorders

Unknown frequency: vertigo

Liver and biliary tract disorders

Unknown frequency: increased activity of “liver” enzymes and bilirubin concentration in the blood hepatitis jaundice

Hearing disorders

Unknown frequency: tinnitus

Musculoskeletal and connective tissue disorders

Unknown frequency: myalgia

Kidney and urinary tract disorders

Unknown frequency: impaired renal function, including cases of renal failure in patients at risk (see section “Special instructions”).

General violations

Unknown frequency: asthenia.

Interaction

Based on the data from initro studies, irbesartan is not expected to interact with drugs metabolized by the isoenzymes CYP1 Al CYP1 A 2 CYP2A6 CYP2B6 CYP2E1 or CYP3A4. Irbesartan is mainly metabolized by the CYP2C9 isoenzyme and undergoes less glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were observed when irbesartan was co-administered with warfarin, a drug metabolized by the CYP2C9 isoenzyme. The effects of inducers of the CYP2C9 isoenzyme such as rifampicin on the pharmacokinetics of irbesartan have not been studied.

Irbesartan does not alter the pharmacokinetics of digoxin and simvastatin.

When irbesartan is co-administered with hydrochlorothiazide or nifedipine, the pharmacokinetics of irbesartan do not change.

With medicinal products containing aliskiren

Concomitant use of irbesartan with medicinal products containing aliskiren is contraindicated in patients with diabetes mellitus or moderate to severe renal insufficiency (GFR

With ACE inhibitors

The use of irbesartan in combination with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients (see sections “Contraindications” “With caution” “Special instructions”).

With potassium supplements and potassium sparing diuretics heparin

Based on the experience gained with the use of other drugs that affect the RAAS with the simultaneous use of potassium preparations; salt substitutes containing potassium; potassium-sparing diuretics or other drugs that can increase the content of potassium in the blood (heparin), it can sometimes significantly increase the serum concentration of potassium, which requires careful monitoring of plasma potassium indicators in patients during treatment.

With NSAIDs including selective COX-2 inhibitors

Concomitant use of angiotensin II receptor antagonists and NSAIDs (including selective COX-2 inhibitors of acetylsalicylic acid (more than 3 g / day) and non-selective NSAIDs) may weaken the antihypertensive effect of irbesartan. This combination should be used with caution, especially in elderly patients and patients with hypovolemia. In elderly patients, patients with hypovolemia or impaired renal function, the use of NSAIDs including COX-2 inhibitors simultaneously with angiotensin II receptor antagonists including irbesartan may lead to deterioration of renal function, including the possible development of acute renal failure. These effects are usually reversible. Patients should restore their BCC before starting combination therapy and monitor their renal function before starting therapy and periodically during combination therapy.

With lithium preparations

An increase in serum lithium concentrations and toxicity has been reported with concomitant use of lithium salts and irbesartan. If it is necessary to use this combination, it is recommended to regularly monitor the concentration of lithium in the blood serum during treatment.

With diuretics and other antihypertensive agents

With the simultaneous use of irbesartan and other antihypertensive agents, the antihypertensive effect may increase. Irbesartan was administered concomitantly with other antihypertensive agents, such as long-acting beta-blockers and thiazide diuretics, without any problems.

Previous treatment with high-dose diuretics may lead to hypovolemia and an increased risk of excessive blood pressure reduction at the beginning of irbesartan treatment.

How to take, course of use and dosage

The drug should be taken orally regardless of the time of food intake. The tablet is swallowed whole with water.

Usually, the initial dose of irbesartan is 150 mg once a day. Patients in whom an additional reduction in blood pressure is required to achieve the target values of blood pressure, the dose can be increased to 300 mg once a day.

If there is insufficient reduction in blood pressure with irbesartan monotherapy, diuretics (for example, hydrochlorothiazide 125 mg per day) or other antihypertensive agents (for example, beta-blockers or long-acting BMCC) can be added to treatment.

In patients with nephropathy, hypertension, and type 2 diabetes, the preferred maintenance dose is 300 mg once daily.

The recommended dose of irbesartan is 75 mg/day for patients with reduced circulating blood volume (CCC) (including diarrhoea, vomiting) and hyponatremia treated with diuretics or a salt-restricted diet, or who are on hemodialysis, or who are over 75 years of age.

Use in selected patient groups

Children and teenagers

Currently, the safety and efficacy of the drug in children and adolescents have not been established.

Elderly patients

Usually, no dose reduction is required in elderly patients. In patients who took irbesartan in clinical trials, there were generally no differences in efficacy and safety between patients aged 65 years and older and younger patients. It is recommended to start treatment of patients over the age of 75 years with a dose of 75 mg.

Patients with hepatic insufficiency

Usually, no dose reduction is required in patients with mild to moderate hepatic impairment. There is no experience of using the drug in patients with severe hepatic insufficiency.

The initial dose of the drug in patients undergoing hemodialysis should be 75 mg / day.

Patients with renal insufficiency

Usually, no dose reduction is required in patients with renal insufficiency (regardless of its severity).

Patients with hypovolemia

In patients with severe hypovolemia and/or hyponatremia, such as patients receiving intensive diuretic therapy or undergoing hemodialysis, hypovolemia and hyponatremia should be corrected before starting irbesartan.

Overdose

Experience with the use of the drug in adults in doses up to 900 mg / day for 8 weeks did not reveal any toxicity.

There is no specific information available regarding the treatment of irbesartan overdose. Constant monitoring of the patient’s condition should be established and, if necessary, symptomatic and supportive therapy should be provided. In case of overdose, it is recommended to induce vomiting and / or gastric lavage. Irbesartan is not eliminated from the body by hemodialysis.

Symptoms of overdose-marked decrease in blood pressure tachycardia rarely-bradycardia.

Special instructions

Excessive lowering of blood pressure – patients with hypovolemia.

The use of irbesartan has so far rarely been accompanied by an excessive decrease in blood pressure in patients with arterial hypertension without concomitant diseases. As with the use of ACE inhibitors, an excessive decrease in blood pressure accompanied by clinical symptoms may develop in patients with hyponatremia/hypovolemia (for example, as a result of intensive diuretic therapy for diarrhea or vomiting, adherence to a diet with limited consumption of table salt), as well as in patients on hemodialysis. Hypovolemia and/or hyponatremia should be corrected before starting irbesartan.

Patients with renal function dependent on RAAS activity

As a consequence of RAAS inhibition, deterioration of renal function can be expected in predisposed patients. In patients with renal function dependent on RAAS activity (patients with arterial hypertension and renal artery stenosis of one or both kidneys; patients with chronic heart failure of functional Class III and IV according to [NYHA classification]), treatment with drugs that affect RAAS has been associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death. It is impossible to exclude the possibility of a similar effect when using angiotensin II receptor antagonists, including irbesartan.

Kidney failure and kidney transplant

When using irbesartan in patients with renal insufficiency, periodic monitoring of the potassium content and serum creatinine concentration is recommended. There are no clinical data on the use of irbesartan in patients who have recently undergone a kidney transplant.

Patients with arterial hypertension and type 2 diabetes mellitus with impaired renal function

The beneficial effect of irbesartan on slowing the progression of renal and cardiovascular disorders was different in different groups of patients, it was less pronounced in women and non-Caucasian patients.

In the IDNT clinical trial in patients with arterial hypertension and type 2 diabetes mellitus with proteinuria (>900 mg / day) in the subgroup of patients at high risk of renal artery stenosis, none of the patients taking irbesartan showed an acute early increase in serum creatinine concentration associated with renal artery stenosis.

Double blockade of the RAAS when irbesartan is combined with ACE inhibitors or aliskiren

Double blockade of the RAAS when using a combination of irbesartan with ACE inhibitors or aliskiren is not recommended because compared with monotherapy, there is an increased risk of a sharp decrease in blood pressure, hyperkalemia and impaired renal function.

Concomitant use of irbesartan with aliskiren is contraindicated in patients with diabetes mellitus or renal insufficiency with GFR

Concomitant use of irbesartan in combination with ACE inhibitors is contraindicated in patients with diabetic nephropathy (see sections “Contraindications” and “Interactions with other drugs”) and is not recommended in other patients.

Hyperkalemia

As with other medications that affect the RAAS, hyperkalemia may develop during treatment with irbesartan, especially in the presence of renal failure and / or heart disease. In such patients, it is recommended to monitor the content of potassium in the blood serum.

Aortic or mitral valve stenosis hypertrophic obstructive cardiomyopathy

As with other vasodilators, caution should be exercised when taking irbesartan in patients with aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy.

Primary hyperaldosteronism

Patients with primary hyperaldosteronism usually do not respond to antihypertensive drugs acting through RAAS inhibition. Therefore, the use of irbesartan in such cases is impractical.

Patients with ischemic heart disease and / or clinically significant cerebral vascular atherosclerosis

As with other antihypertensive drugs, a significant reduction in blood pressure in patients with coronary heart disease and / or severe cerebral vascular atherosclerosis may lead to the development of myocardial infarction or stroke. Treatment of such patients should be carried out under strict blood pressure control.

Influence on the ability to drive vehicles and mechanisms:

The effect of irbesartan on the ability to drive vehicles or engage in other potentially dangerous activities that require increased attention and high speed of psychomotor reactions has not been studied. However, based on its pharmacodynamic properties, irbesartan should not affect the ability to drive vehicles and engage in other potentially dangerous activities (working at altitude, working as an air traffic controller, working with mechanisms, etc. ). However, in case of dizziness and weakness, attention may decrease and psychomotor reactions may slow down. In patients with such adverse reactions, the decision on the possibility of engaging in any potentially dangerous activities should be made individually by the doctor.

Storage conditions

In a dry place protected from light at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 3 years.

Do not use the drug after the expiration date indicated on the package.

Active ingredient

Irbesartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets