Irbesartan, 150 mg 28 pcs

Pharmacotherapeutic group

An angiotensin II receptor antagonist

ATX code

C09CA04

Pharmacodynamics:

Irbesartan is a selective angiotensin II antagonist (type AT1). 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 relevant effects of angiotensin II regardless of the source or pathway of its synthesis, including its strong vasoconstrictor and aldosterone-secreting effects through AT1 receptors located on the surface of vascular smooth muscle cells and in the adrenal cortex. It has no agonist activity to AT1 receptors and has much more (more than 8500 times) affinity to AT1 receptors than to AT2 receptors (receptors not related to cardiovascular regulation). 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. Blocking of AT1 receptors by irbesartan interrupts the feedback loop in the renin-angiotensin system, resulting in increased plasma concentrations of renin and angiotensin II. After irbesartan administration in recommended doses, plasma concentration of aldosterone decreases without a significant effect on serum potassium (average increase is <01 mEq/L). Irbesartan has no significant effect on serum concentrations of triglyceride cholesterol and glucose. Irbesartan has no effect on serum uric acid concentrations or uric acid excretion rate by the kidneys.

The antihypertensive effect of irbesartan is already apparent after the first dose and becomes significant within 1-2 weeks of taking it its maximum effect is reached by 4-6 weeks of treatment. In long-term clinical trials, the maintenance of the antihypertensive effect of irbesartan for more than one year has been observed.

In a single daily oral administration of irbesartan in doses up to 900 mg, the antihypertensive effect is dose-dependent. Irbesartan once daily doses of 150-300 mg will lower BP measured at the end of the interdose interval (24 hours after taking a dose of irbesartan, i.e., before taking another dose of irbesartan) by an average of 8-13/5-8 mmHg (systolic/diastolic BP) compared to placebo. Maximum BP reduction is achieved 3-6 h after a single oral dose and persists for at least 24 h.

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

Irbesartan reduces BP in standing and lying position to approximately the same extent. Orthostatic effects are rare, but as with ACE inhibitors, patients with hyponatremia and/or hypovolemia may have excessive BP decreases with clinical manifestations.

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

The efficacy of irbesartan is independent of age or gender. As with other medications that affect RAS, the antihypertensive effect of irbesartan is less pronounced in non-human race patients, but when irbesartan is combined with low-dose hydrochlorothiazide (eg, 125 mg daily) the antihypertensive response in non-human race patients approaches that of Caucasian race patients.

After discontinuation of irbesartan, BP returns to baseline gradually. There is no withdrawal syndrome.

. In a multicenter randomized controlled active substance (amlodipine) and placebo double-blind IDNT clinical trial involving 1715 patients with arterial hypertension and with type 2 diabetes (proteinuria ≥900 mg/day and serum creatinine concentration in the range of 10-30 mg/dL) was shown a 20% (p=0024) reduction (compared with placebo) and a 23% (p=0006) reduction (compared with amlodipine) in the relative risk of first occurrence of any of the following conditions: doubling of serum creatinine concentration development of end-stage renal failure or death from either cause (when comparable BP reduction was 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 (IRMA 2) involving 590 patients with arterial hypertension and type 2 diabetes having microalbuminuria (20-200 mcg/min 30-300 mg/day) and normal renal function (serum creatinine concentration <15 mg/dL in men and <11 mg/dL in women), the effect of long-term treatment (for 2 years) with irbesartan on the progression of clinically significant proteinuria was evaluated. A 300 mg daily dose demonstrated a 70% reduction in the relative risk of developing clinically significant proteinuria (compared with placebo p=00004) and a 150 mg dose demonstrated a 39% reduction in the relative risk of developing clinically significant proteinuria (compared with placebo p=0085). A slowing in the progression of clinically significant proteinuria was noted as early as three months and continued throughout the entire 2-year period of the clinical trial. The decrease in 24-hour creatinine clearance was not significantly different between treatment groups. Regression of microalbuminuria to normal albuminuria (<20 mcg/min; <30 mg/day) was more frequently observed in the irbesartan group at the 300 mg dose (34%) compared with the placebo group (21%).
Pharmacokinetics:

Absorption

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

Distribution.

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

Metabolism.

After oral or intravenous administration of 14C-irbesartan, 80-85% of circulating plasma radioactivity is due to unchanged irbesartan. Irbesartan is metabolized by the liver by oxidation and conjugation to glucuronic acid. The main metabolite in the systemic blood stream is irbesartan glucuronide (approximately 6%). Irbesartan is oxidised mainly by the cytochrome P450 isoenzyme CYP2C9 and CYP3A4 isoenzymes are not significantly involved in the metabolism of irbesartan. Irbesartan is not metabolized by most isoenzymes that are normally involved in drug metabolism (CYP1A1 CYP1A2 CYP2A6 CYP2B6 CYP2D6 or CYP2E1 isoenzymes) and does not cause their inhibition or induction. Irbesartan does not induce or inhibit the CYP3A4 isoenzyme.

Elimination.

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

The final half-life (T1/2) of irbesartan is 11-15 hours. Total clearance of intravenously administered irbesartan is 157-176 mL/min and its renal clearance is 3-35 mL/min. When irbesartan is administered daily once daily, the equilibrium plasma concentration (Css) is reached after 3 days with limited plasma accumulation (less than +20%).

Particular patient groups

The effect of sex on the pharmacokinetics of irbesartan

Women (compared to men) had slightly higher plasma concentrations of irbesartan. However, no gender-related differences in T1/2 and accumulation of irbesartan were detected. No dose adjustment was required for irbesartan in women. No gender-related differences in the effects of irbesartan were observed.

Pharmacokinetics of irbesartan in elderly patients

The AUC (area under the pharmacological concentration-time curve) and Cmax values 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 T1/2 was comparable. No age-related differences in the effects of irbesartan were observed.

Pharmacokinetics of irbesartan in 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 impairment due to cirrhosis, the pharmacokinetic parameters of irbesartan are not significantly altered.

Pharmacokinetics of irbesartan in renal impairment

In patients with renal impairment or patients undergoing hemodialysis, the pharmacokinetics of irbesartan do not change significantly. Irbesartan is not excreted by hemodialysis.

The effect of race on the pharmacokinetics of irbesartan

The AUC and T|/2 of irbesartan were approximately 20-25% higher in the Negro race without arterial hypertension than in the Caucasian race; their Cmax of irbesartan was nearly equal to that of the Caucasian race.

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

Indications

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

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

Active ingredient

Composition

One tablet contains:

the active ingredient: irbesartan – 150.00 mg

excipients: lactose monohydrate – 50.00 mg, povidone – 7.50 mg, microcrystalline cellulose – 27.75 mg, croscarmellose sodium – 6.75 mg, colloidal silicon dioxide – 4.50 mg, sodium stearylfumarate – 6, 50 mg

coating: Sepifilm 003 ready-mix – 4.43 mg, hypromellose – 2.22 mg, macrogoal stearate – 0.44 mg, microcrystalline cellulose – 1.77 mg, Sepispers AP7001 white ready-mix – 0.89 mg: hypromellose – 0.04 mg, propylene glycol – 0.27 mg, titanium dioxide – 0.27 mg, purified water* – 0.31 mg.

How to take, the dosage

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

The usual starting dose of irbesartan is 150 mg once daily. In patients who require additional BP reduction to achieve target values, the dose may be increased to 300 mg once daily.

If BP does not sufficiently decrease with irbesartan monotherapy, diuretics (e.g., hydrochlorothiazide 125 mg daily) or other hypotensive agents (e.g., beta-adrenoblockers or long-acting DMARDs) may be added.

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

Patients with decreased circulating blood volume (CBC) (including diarrhea vomiting) with hyponatremia on treatment with diuretics or diet with restriction of table salt intake or who are on hemodialysis or who are over 75 years old have a recommended dose of irbesartan 75 mg/day.

The use in selected patient groups

Children and adolescents

The safety and effectiveness of the drug in pediatric and adolescent patients has not been established at this time.

Elderly patients

Dose reduction is usually not necessary in elderly patients. In patients who have taken irbesartan in clinical trials, no differences in efficacy and safety have generally been observed between patients aged 65 years or older and patients of younger age. It is recommended that patients over the age of 75 years be started with a dose of 75 mg.

Patients with hepatic impairment

In patients with hepatic impairment (mild to moderate severity), usually no dose reduction is required. There is no experience of using the drug in patients with severe hepatic impairment.

The starting dose of the drug in patients on hemodialysis should be 75 mg/day.

Patients with renal failure

In patients with renal failure (regardless of its severity), usually no dose reduction is required.

Patients with hypovolemia

In patients with significant hypovolemia and/or hyponatremia such as those receiving intensive diuretic therapy or those on hemodialysis, hypovolemia and hyponatremia must be corrected before starting irbesartan.

Interaction

Based on in-vitro studies, no interaction of irbesartan with drugs metabolized by the CYP1 Al isoenzymes CYP1A2 CYP2A6 CYP2B6 CYP2E1 or CYP3A4 is expected. Irbesartan is primarily metabolized by the CYP2C9 isoenzyme and undergoes glucuronidation to a lesser extent. No significant pharmacokinetic and pharmacodynamic interactions have been observed when co-administering irbesartan with warfarin, a drug metabolized by the CYP2C9 isoenzyme. The effects of CYP2C9 isoenzyme inducers such as rifampicin on the pharmacokinetics of irbesartan have not been studied.

Irbesartan does not alter the pharmacokinetics of digoxin and simvastatin.

The pharmacokinetics of irbesartan with hydrochlorothiazide or nifedipine are not altered when irbesartan is used together.

With medicinal products containing aliskiren

The concomitant use of irbesartan with medicinal products containing aliskiren is contraindicated in patients with diabetes mellitus or moderate to severe renal impairment (GFR <60 ml/min/173 m2 body surface area) and is not recommended in other patients (seeSee “Contraindications” “Caution” “Special Indications”).

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” “Caution” “Special Precautions”).

With potassium preparations and potassium-saving diuretics heparin

Based on experience with other medications that affect the RAAS, concomitant use of potassium preparations; salt substitutes containing potassium potassium-saving diuretics or other potassium-enhancing medications (heparin) can sometimes significantly increase serum potassium concentrations, requiring close monitoring of plasma potassium levels in patients during treatment.

With NSAIDs including selective COX-2 inhibitors

When angiotensin II receptor antagonists and NSAIDs (including selective COX-2 inhibitors) are used concomitantly. 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 with hypovolemia or with impaired renal function, use of NSAIDs including COX-2 inhibitors concomitantly with angiotensin II receptor antagonists including irbesartan may lead to worsening of renal function including possible acute renal failure. These effects are usually reversible. Patients should restore the blood circulatory capacity and monitor renal function before initiating combination therapy and periodically during the course of combination therapy.

With lithium preparations

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

With diuretics and other hypotensive agents

The simultaneous use of irbesartan and other hypotensive agents may increase the antihypertensive effect. Irbesartan has been used concomitantly with other hypotensive agents, such as long-acting beta-adrenal blockers and thiazide diuretics, without any problems.

Pre-treatment with high-dose diuretics may lead to hypovolemia and increased risk of excessive BP reduction at the start of irbesartan treatment.

Special Instructions

Excessive BP reduction – patients with hypovolemia.

The use of irbesartan has so far rarely been accompanied by excessive BP reduction in patients with arterial hypertension without comorbidities. As with ACE inhibitors, excessive BP lowering accompanied by clinical symptoms may occur in patients with hyponatremia/hypovolemia (e.g., as a result of intensive diuretic therapy with diarrhea or vomiting on a salt restricted diet) and 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, impairment of renal function can be expected in predisposed patients. In patients with renal function dependent on the activity of RAAS (patients with arterial hypertension and renal artery stenosis of one or both kidneys; patients with chronic heart failure of III and IV functional class by [NYHA classification]) treatment with drugs that affect the RAAS has been associated with oliguria and/or progressive azotemia and rarely with acute renal failure and/or death. The possibility of similar effects with angiotensin II receptor antagonists, including irbesartan, cannot be excluded.

Renal failure and renal transplantation

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

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

The benefit of irbesartan in delaying the progression of renal and cardiovascular events varied among patient groups and was less pronounced in female 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 a subgroup of patients at high risk of renal artery stenosis, no patient taking irbesartan experienced an acute early increase in serum creatinine concentration associated with renal artery stenosis.

Double RAAS blockade in combination with ACE inhibitors or aliskiren

Double RAAS blockade in combination with ACE inhibitors or aliskiren is not recommended because compared to monotherapy there is an increased risk of severe BP decrease, hyperkalemia and renal function impairment.

The concomitant use of irbesartan with aliskiren is contraindicated in patients with diabetes mellitus or renal insufficiency with a GFR of <60 ml/min/173 m2 body surface area (see Contraindications, Interactions with Other Drugs) and is not recommended in other patients.

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

Hyperkalemia

As with other drugs affecting the RAAS, treatment with irbesartan may lead to hyperkalemia especially in the presence of renal failure and/or heart disease. In such patients it is recommended to monitor serum potassium content.

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 with hypertrophic obstructive cardiomyopathy.

Primary hyperaldosteronism

Patients with primary hyperaldosteronism usually do not respond to hypotensive drugs acting via RAAS inhibition. Therefore, the use of irbesartan in these cases is not appropriate.

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

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

The effect of irbesartan on the ability to drive vehicles or engage in other potentially dangerous activities requiring 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 (work at height, air traffic controller work with mechanisms, etc.). But in case of dizziness and weakness, a decrease in attention and slower psychomotor reactions are possible. In patients with such adverse reactions the decision regarding the possibility of engaging in any potentially dangerous activities should be made by the physician individually.

Contraindications

Hypersensitivity to irbesartan or any of the excipients of the drug;

Concomitant use with drugs containing aliskiren in patients with diabetes mellitus or with moderate to severe renal impairment (glomerular filtration rate [GFR] <60 ml/min/173 m2 body surface area);

Concomitant use with ACE inhibitors in patients with diabetic nephropathy;

Pregnancy;

Breast-feeding period;

Age less than 18 years (efficacy and safety not established).

Hereditary galactose intolerance lactase deficiency or glucose-galactose malabsorption;

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

Age over 75 years.

In case of aortic or mitral valve stenosis or hypertrophic obstructive cardiomyopathy (HCMP).

In hypovolemic hyponatremia occurring e.g. during intensive diuretic therapy hemodialysis, adherence to a diet with restriction of table salt intake diarrhea (danger of excessive BP reduction).

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

In patients with coronary heart disease and/or clinically significant atherosclerosis of cerebral vessels (with excessive BP reduction there is a risk of increased ischemic disturbances up to the development of acute myocardial infarction and stroke).

In renal failure (requires monitoring of potassium and creatinine concentration in the blood) of recent kidney transplantation (no experience in clinical use).

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

When used in combination with ACE inhibitors or aliskiren, as compared to monotherapy with dual RAAS blockade, there is an increased risk of excessive BP reduction hyperkalemia and impaired renal function (see section “Special Precautions”).

Side effects

The adverse events listed below 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); infrequent (≥1/1000 <1/100); rare (≥1/10000 <1/1000); very rare (<1/10000 including individual reports); unknown frequency (the incidence of the adverse event cannot be determined from available data).

The safety of irbesartan has been studied in approximately 5,000 patients in clinical studies, including 1,300 patients with arterial hypertension who have been taking the drug for more than 6 months and 400 patients who have been taking 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 incidence of adverse events was independent of gender, age, and race.

In placebo-controlled trials in which 1965 patients received irbesartan (averaged over 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 45% of patients taking placebo (differences were statistically significant).

The adverse events observed in placebo-controlled clinical trials of irbesartan in arterial hypertension are probably or possibly related to its administration or have no established relationship with the drug administration.

Nervous system disorders

Often: dizziness headache;

Infrequent: orthostatic dizziness.

Heart disorders

Infrequent: edema tachycardia

Respiratory system disorders of the thorax and mediastinum

Infrequent cough

Gastrointestinal disorders

Often: nausea/vomiting

Infrequent: diarrhea dyspepsia/heartburn

Genital and mammary disorders

Infrequent: sexual dysfunction

General disorders

Often: increased fatigue

Infrequent: Chest pain

Laboratory and instrumental findings

There were no clinically significant changes in laboratory parameters during controlled clinical studies in patients with arterial hypertension. No specific monitoring of laboratory parameters is required for patients with arterial hypertension taking irbesartan.

The adverse events observed in controlled clinical studies of irbesartan in patients with nephropathy in arterial hypertension and type 2 diabetes mellitus (clinical studies IDNT and IRMA2)

The adverse events were similar to those observed in nephropathy patients taking irbesartan. The adverse events were similar to those in patients with arterial hypertension except for orthostatic symptoms (dizziness (102%) (with placebo 6%) orthostatic vertigo (54%) (with placebo 27%) and orthostatic hypotension (54%) (with placebo 32%).

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

Laboratory abnormalities

Hyperkalemia

In the IDNT clinical trial, the percentage of patients with hyperkalemia (>6 mEq/L) was 186% in the irbesartan group compared with 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 discontinuation rate due to hyperkalemia with irbesartan and placebo was 21% and 036%, respectively. In the IRMA clinical trial, the discontinuation rate due to hyperkalemia with irbesartan and placebo was 05% and 0%, respectively.

Indications observed with post-marketing use of irbesartan

Immune system disorders

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

The adverse events listed below have been identified with the use of irbesartan since the market launch of irbesartan.

Blood and lymphatic system disorders

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 blood bilirubin concentrations hepatitis jaundice

Hearing organ disorders

Unknown frequency: tinnitus

Muscular and connective tissue disorders

Unknown frequency: Myalgia

Renal and urinary tract disorders

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

General disorders

Unknown frequency: Asthenia.

Overdose

Experience with the drug in adults at doses up to 900 mg/day for 8 weeks showed no toxicity.

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

The symptoms of overdose – marked decrease in BP tachycardia rarely – bradycardia.

Pregnancy use

Pregnancy

There is no experience with the use of irbesartan in pregnancy. Given that the use of ACE inhibitors by pregnant women in the second and third trimesters of pregnancy has resulted in damage and death of the developing fetus, irbesartan, like any other drug that acts directly on the RAAS, should not be used during pregnancy (I II III trimesters).

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

Breastfeeding

It is not known whether irbesartan or its metabolites are excreted into breast milk. Irbesartan is contraindicated during breastfeeding. Therefore, after weighing the expected benefit to the mother against the potential risk to the infant, either breastfeeding or irbesartan should be stopped.

Similarities