Irbebartan - instructions for use, dose, side effects, contraindications

Excipients: microcrystalline cellulose 16.75 mg / 33.50 mg / 67.00 mg, carmellose calcium 4.50 mg / 9.00 mg / 18.00 mg, povidone K-30 (collidone 30) 1.75 mg / 3.50 mg / 7.00 mg, silicon dioxide colloid 0.50 mg / 1.00 mg / 2.00 mg, calcium stearate 1.50 mg / 3.00 mg / 6.00 mg;

shell: onyad white OY-S-38956 - 2.00 mg / 4.00 mg / 8.00 mg.

Drop off white OY-S-38956: hypromellose (HPMC 2910, E 464) 72.00%, talc (E553b) 14.00%, titanium dioxide (E171) 14.00%.

Description:

Tablets with a dosage of 75 mg.

The capsule-shaped, biconvex tablets covered with a film shell of white or almost white color with engraving stamped, "158" on one side and "H" on the other. On the cross section, the nucleus is white or almost white in color.

Tablets with a dosage of 150 mg.

The capsule-shaped, biconvex tablets covered with a film shell of white or almost white color with an engraving stamped "159" on one side and "H" on the other. On the cross section, the nucleus is white or almost white in color.

Tablets with a dosage of 300 mg.

The capsule-shaped, biconvex tablets covered with a film shell of white or almost white color with an engraving stamped "160" on one side and "H" on the other. On the cross section, the nucleus is white or almost white in color.

Pharmacotherapeutic group:Angiotensin II receptor antagonist

ATX: & nbsp

C.09.C.A.04 Irbesartan

Pharmacodynamics:

Irbesartan is a potent, active when taken orally, a selective antagonist of angiotensin II receptors (type AT₁). It blocks all physiologically significant effects of angiotensin II, which are realized through AT receptors₁ regardless of the source or route of synthesis of angiotensin II. A specific antagonistic action against angiotensin II receptors (AT₁) leads to an increase in plasma concentrations of renin and angiotensin II and a decrease in plasma concentrations of aldosterone.When using the recommended doses of the drug, the content of potassium ions in the blood serum does not change significantly. Irbesartan does not inhibit kininase-H (angiotensin-converting enzyme-ACE), through which the formation of angiotensin II and the destruction of bradykinin to inactive metabolites. For the manifestation of the action of irbesartan, its metabolic activation is not required.

Irbesartan lowers blood pressure (BP) with a minimum change in the heart rate. When taken in doses up to 300 mg once a day, the decrease in blood pressure is dose-dependent, but with a further increase in the dose of irbesartan, the increase in antihypertensive effect is insignificant.

The maximum decrease in blood pressure is achieved in 3-6 hours after taking the drug inside, and the antihypertensive effect persists for at least 24 hours. At 24 hours after taking the recommended doses of irbesartan, blood pressure reduction is 60-70% compared to the maximal antihypertensive response to the drug on the side of diastolic and systolic blood pressure. When administered once a day at a dose of 150-300 mg, the amount of blood pressure reduction at the end of the inter-dose interval (i.e.24 hours after taking the drug) in the patient's "lying" or "sitting" position on average by 8-13 / 5-8 mm Hg. (systolic / diastolic blood pressure) is greater than when receiving a placebo.

Taking the drug at a dose of 150 mg once a day causes the same antihypertensive response (lowering blood pressure before taking the next dose of the drug and an average decrease in blood pressure over 24 hours) as well as taking the drug at a dose of 75 mg, twice a day.

Antihypertensive effect of the drug irbesartan develops within 1-2 weeks, and the maximum therapeutic effect is achieved in 4-6 weeks after the start of treatment. Antihypertensive effect against the background of long-term treatment is preserved. After discontinuation of treatment, blood pressure gradually returns to the initial value. With the withdrawal of the drug, the "cancellation" syndrome is absent.

In studies in which irbesartan was used in addition to other antihypertensive drugs when it was necessary to reach the target blood pressure level, evidence was obtained of the beneficial effect of irbesartan on the kidneys in patients with arterial hypertension and type 2 diabetes.

Effectiveness of the drug irbesartan does not depend on age and sex. Patients of the Negroid race react weakly to motor therapy with a drug irbesartan (as well as on all other drugs that affect the system of renin-angiotensin-aldosterone). Irbesartan does not affect the concentration of uric acid in the serum or the excretion of uric acid by the kidneys.

Pharmacokinetics:

Absorption

After oral administration irbesartan well absorbed and gastrointestinal tract, its absolute bioavailability is approximately 60-80%. Simultaneous food intake does not significantly affect the bioavailability of the drug irbesartan.

Distribution
The connection with plasma proteins is approximately 96%. Binding to the cellular components of blood is negligible. The volume of distribution is 53-93 liters.

Metabolism

After ingestion or intravenous administration¹⁴C-irbesartan 80-85% of the radioactivity circulating in blood plasma accounts for the unchanged irbesartan. Irbesartan metabolized by the liver by oxidation and conjugation with glucuronic acid. Oxidation of the drug irbesartan is mainly carried out with the cytochrome P450 isoenzyme CYP2C9, the participation of the CYP3A4 isoenzyme in the metabolism of the drug irbesartan is insignificant. Irbesartan is not metabolized and does not have the ability to inhibit or induce most isoenzymes that normally participate in the metabolism of drugs (isozymes CYP1A1, CYP1A2, CYP2A6, CYP2B6 CYP2B6 or CYP2E1). Irbesartan Does not induce or inhibit the isoenzyme CYP3A4. The main metabolite in the systemic circulation is irbesartan glucuronide (approximately 6%).

Irbesartan has a linear and proportional dose of pharmacokinetics in the dose range of 10 to 600 mg; at doses in excess of 600 mg (a dose twice the recommended maximum dose of the drug) kinetics of the drug irbesartan becomes nonlinear (decrease in the dose-proportionality of absorption). After ingestion of the drug irbesartan maximum concentrations in blood plasma C_max are achieved after 1.5-2 hours. The total clearance and renal clearance are 157-176 and 3-3.5 ml / min, respectively. The final half-life of the drug irbesartan is 11-15 hours.With a daily single dose of the drug, the equilibrium plasma concentration (Css) is reached after 3 days. With daily intake of the drug irbesartan Once a day, there is a limited accumulation in the blood plasma (less than 20%). In women (compared with men), slightly higher plasma concentrations of irbesartan are noted. However, sex-related differences in the half-life and accumulation of the drug irbesartan is not detected. Dose adjustment irbesartan women are not required. The values of AUC (areas under the pharmacokinetic curve "concentration-time") and C_max (maximum plasma concentration) of the drug irbesartan in elderly patients (≥65 years of age) is slightly higher than in younger patients, but their terminal half-lives are not significantly different. Dose adjustments in elderly patients are not required.

Excretion

Irbesartan and its metabolites are excreted from the body, both through the intestines (with bile) and the kidneys. After ingestion or intravenous administration ¹⁴C-irbesartan about 20% of radioactivity is found in the urine, and the rest - in the stool.Less than 2% of the administered dose is excreted by the kidneys in the form of an unchanged drug irbesartan.

Impaired renal function: In patients with impaired renal function or patients undergoing hemodialysis, the pharmacokinetics of the drug irbesartan substantially do not change. Irbesartan It is not removed from the body during hemodialysis.

Impaired liver function: In patients with mild (functional class A or 5-6 points on the Child-Pugh scale) and moderately expressed (functional class B or 7-9 on the Child-Pugh scale) with hepatic insufficiency, the pharmacokinetic parameters of irbesartan do not change significantly. Pharmacokinetic studies in patients with severe hepatic insufficiency (functional class C or more than 9 points on the Child-Pugh scale) were not performed.

Indications:

Arterial hypertension (in monotherapy and in combination with other antihypertensive drugs, for example, thiazide diuretics, run-adrenoblockers, blockers of "slow" calcium channels (BCCC), long-acting).

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

Contraindications:

- Hypersensitivity to any of the components of the drug.

- Simultaneous use with aliskiren-containing drugs in patients with diabetes mellitus and with moderate and severe degree of renal dysfunction (glomerular filtration rate (GFR) <60 ml / min / 1.73 m² surface area of the body).

- Simultaneous use with ACE inhibitors in patients with diabetic nephropathy.

- Pregnancy.

- The period of breastfeeding.

- Age under 18 years (efficiency and safety not established).

- In severe hepatic insufficiency (functional class C or more than 9 points on the Child-Pyo scale) (lack of clinical experience).

Carefully:

With stenosis of the aortic or mitral valve or hypertrophic obstructive cardiomyopathy.

With hypovolemia, hyponatremia, arising, for example, in intensive treatment with diuretics, hemodialysis, adherence to a diet with restricted intake of table salt, diarrhea, vomiting (the risk of excessive lowering of blood pressure, especially when taking the first dose).

With bilateral stenosis of the renal arteries,unilateral stenosis of the artery of a single functioning kidney, chronic cardiac insufficiency of the III-IV functional class (according to the NYHA classification) (in the treatment of such patients with drugs that affect the renin-angiotensin-aldosterone system: arterial hypotension, oliguria and / or progressive azotemia and rarely acute renal failure and / or death, the risk of developing which can not be ruled out when taking irbesartan) (see section "Special instructions").

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

In case of renal insufficiency (control of potassium content and creatinine concentration in the blood is required), recent kidney transplantation (lack of clinical experience).

With the simultaneous use of non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase 2 (COX-2) (increased risk of impaired renal function,including the possibility of developing acute renal failure and increase potassium in the blood serum, especially in patients with already impaired kidney function) (see. section "Interaction with other medicinal products").

When used in combination with ACE inhibitors or aliskiren, as compared to a monotherapy with dual blockade of the RAAS has an increased risk of excessive loss of blood pressure, hyperkalemia, and renal dysfunction (see. The "special instructions").

Pregnancy and lactation:

Pregnancy

Experience with the drug irbesartan when pregnancy is absent. Taking into account the fact that during the reception of ACE inhibitors by pregnant women in the second and third trimester of pregnancy, the developing fetus was damaged and died, irbesartan, like any other drug that acts directly on the renin-angiotensin-aldosterone system, can not be used in pregnancy (I, II, III trimesters).

The transition to appropriate alternative therapy with antihypertensive drugs with established safety profile during pregnancy should be made before the beginning of pregnancy planning.

When diagnosing pregnancy during drug treatment Irbesartan, it should be canceled as soon as possible.

Breastfeeding period

It is not known whether the blood is excreted irbesartan in mother's milk. During lactation, taking the drug irbesartan is contraindicated.

Dosing and Administration:

Inside, regardless of the time of ingestion. The tablet is swallowed whole, washed down with water. Usually recommended for initial intake and maintenance dose is 150 mg 1 time per day, regardless of food intake. Irbesartan at a dose of 150 mg 1 time per day usually provides a better 24-hour BP control than a 75 mg dose.

In patients who have a therapeutic effect when taking the drug irbesartan in a dose of 150 mg once a day is not enough, the dose of the drug irbesartan can be increased to 300 mg, or perhaps additional use of another antihypertensive drug. In particular, it has been shown that an additional intake of a diuretic, such as hydrochlorothiazide, increased the effect of the drug irbesartan (see the section "Interaction with other medicinal products").

Patients with hypertension and Type 2 diabetes treatment should begin with a dose of 150 mg 1 time per day, which should be gradually increased up to 300 mg 1 time per day - dose being preferred maintenance dose for the treatment of nephropathy.

Impaired renal function. Patients with impaired renal function are not required to adjust the dosage regimen. For patients on hemodialysis, the initial dose should be 75 mg (the drug may be used irbesartan in tablets of 75 mg).

Violation of the water-electrolyte balance. Before taking the drug irbesartan should eliminate gopovolemiyu and / or giponagremia or start treatment with a lower dose of irbesartan (possible use of the drug irbesartan in a dose of 75 mg). If there is no reduction in blood pressure to the target values, the dose may be increased.

Violation of the function of the liver. Usually, there is no need to adjust the dosage regimen of the drug irbesartan in patients with impaired liver function of mild or moderate severity (5-6 and 7-9 on the Child-Pugh scale). There is no clinical experience in the use of the drug in patients with severe impairment of liver function.

Patients of advanced age. Although treatment of patients over the age of 75 is recommended to start with a dose of 75 mg (possibly a drug irbesartan in tablets of 75 mg), usually in elderly patients, correction of the dosing regimen is not required. Safety and efficacy of the drug irbesartan in patients under the age of 18 years are not established.

Side effects:

The following side effects are given according to the following grades of frequency: very often (≥ 1/10), often (≥1 / 100, <1/10); infrequently (≥1 / 1000, <1/100); rarely (≥1 / 10000, <1/1000); very rarely (<1/10000) (including individual reports), unknown frequency (it is not possible to determine the incidence of side effects from the available data).

Side effects observed in controlled clinical trials with drug use Irbesartan with arterial hypertension

Disturbances from the nervous system

Often: dizziness, headache.

Infrequent: orthostatic dizziness.

Heart Disease

Infrequently: tachycardia.

Vascular disorders

Infrequently: the "tides" of blood to the skin of the face, swelling.

Disturbances from the respiratory system, chest and mediastinal organs

Infrequently: cough.

Disorders from the gastrointestinal tract

Often: nausea / vomiting.

Infrequent: diarrhea, indigestion / heartburn.

Violations of the genitals and mammary gland Infrequently: sexual dysfunction.

Common violations

Often: increased fatigue.

Infrequent: chest pain.

Violations from laboratory indicators

Often (1,7%): a significant increase in the activity of creatinine phosphokinase plasma in patients who received irbesartan; no such case was accompanied by clinical manifestations of the musculoskeletal system.

Side effects observed in controlled clinical trials of the drug Irbesartan with nephropathy in hypertension and type 2 diabetes mellitus

Side effects were similar to those in patients with hypertension, with the exception of orthostatic symptoms (dizziness, orthostatic dizziness and orthostatic hypotension). In this group of patients, in addition to adverse reactions indicated in patients with hypertension, orthostatic symptoms were more common (see below).

Disturbances from the nervous system

Very often: dizziness (10.2%) (when taking placebo 6%).

Often: orthostatic dizziness (5.4%) (with a placebo 2.7%).

Vascular disorders

Often: orthostatic hypotension (5.4%) (when taking placebo 3.2%).

The percentage of discontinuation due to orthostatic symptoms with irbesartan compared with placebo was 0.3% vs 0.5%, orthostatic dizziness 0.2% vs. 0.0%, and orthostatic hypotension 0.0% vs 0 , 0%, respectively.

Disorders from the musculoskeletal system

Often: pain in muscles and bones.

Violations from laboratory indicators

Hyperkalemia when taking the drug irbesartan patients with arterial hypertension and diabetes were more likely than with placebo. In patients with diabetes mellitus and elevated blood pressure, with microalbuminuria with normal renal function, hyperkalemia (> 5.5% mmol / L) with the intake of 300 mg of the drug irbesartan was observed in 29.4% of patients (very often), and in the placebo group in 22% of patients. In patients with diabetes mellitus and elevated blood pressure, with chronic renal failure and severe proteinuria, hyperkalemia (> 5.5% mmol / L) when taking the drug irbesartan occurred in 46.3% of patients (very often), and in the placebo group - in 26.3% of patients.

In 1.7% of patients with high blood pressure and diabetic nephropathy who received irbesartan, there was a clinically insignificant decrease in hemoglobin (often).

Side effects identified after the release of irbesartan on the market

Immune system disorders

Very rarely: as with all antagonists of angiotensin-P receptors, rare cases of allergic reactions, such as skin rash, hives, angioedema, were noted.

Hearing disorders and labyrinthine disorders Unknown frequency: ringing in the ears.

Disorders from the gastrointestinal tract

Unknown frequency: dysgeusia (distortion of taste).

The following side effects were observed with the use of the drug after its introduction into the market, but a causal relationship with irbesartan was not always established.

Disorders from the metabolism and nutrition:

Unknown frequency: hyperkalemia.

Disturbances from the nervous system

Unknown frequency: Vertigo.

Disturbances from the liver and bile ducts

Unknown frequency: increased activity of "hepatic" enzymes and bilirubin concentration in the blood, a violation of liver function, hepatitis, jaundice.

Disturbances from musculoskeletal and connective tissue

Unknown frequency: myalgia, arthralgia (sometimes in combination with increased activity of creatine phosphokinase), muscle cramps.

Disturbances from the skin and subcutaneous fat:

Unknown frequency: leukocytoclastic vasculitis.

Disorders from the kidneys and urinary tract

Unknown frequency: renal dysfunction, including cases of development of renal failure in patients at risk (see section "Special instructions").

Common violations

Unknown frequency: asthenia.

Overdose:

When using the drug irbesartan in adults, no toxicity was detected in doses up to 900 mg / day for 8 weeks.

Symptoms: the most likely manifestations of an overdose are a marked decrease in blood pressure and tachycardia; the manifestation of an overdose can also be a bradycardia.

Treatment: In case of overdose, it is recommended to induce vomiting and / or gastric lavage; is shown Activated carbon.

It is necessary to establish constant monitoring of the patient's condition and, if necessary, to carry out symptomatic and supportive therapy. There is no specific information regarding the treatment of drug overdose irbesartan. Hemodialysis is ineffective.

Interaction:

Based on in vitro studies, irbesartan is not expected to interact with drugs metabolized with the isoenzymes CYP1A1, CYP1A2, CYP2A6, CYP2B6, CYP2E1 or CYP3A4. Irbesartan, is mainly metabolized by the CYP2C9 isoenzyme and, to a lesser extent, is glucuronidated. No significant pharmacokinetic and pharmacodynamic interactions were observed with the simultaneous use of irbesartan with warfarin, a drug metabolized by the CYP2C9 isoenzyme. Irbesartan does not change the pharmacokinetics of digoxin and simvastatin. With the combined use of irbesartan with hydrochlorothiazide or nifedipine, the pharmacokinetics of irbesartan do not change.

Diuretics and other antihypertensive drugs. With the simultaneous use of irbesartan and other antihypertensive drugs may increase the antihypertensive effect. Irbesartan without any problems applied simultaneously with other antihypertensive drugs, such as beta-blockers, slow-acting calcium channel blockers of prolonged action and thiazide diuretics. The antihypertensive effects of irbesartan and thiazide diuretics are additive. In patients who do not manage to control BP with monotherapy with irbesartan, additional intake of small doses of hydrochlorothiazide (12.5 mg) leads to an additional decrease (in comparison with the placebo effect) of blood pressure by 7-10 / 3-6 mm Hg. Art. (systolic / diastolic blood pressure at the end of the inter-dose period). When taking irbesartan with small doses of hydrochlorothiazide (12.5 mg per day), the antihypertensive effect of this combination in patients of the Negroid race is similar to that in patients of the Caucasian race. Prior treatment with diuretics in high doses can lead to hypovolemia and an increased risk of arterial hypotension at the beginning of treatment with the drug Irbesartan.

Potassium preparations and potassium-sparing diuretics, heparin. Based on experience,obtained with the use of other drugs that affect the system of renin-angiotensin-aldosterone, while using potassium drugs; substitutes for salt containing potassium; potassium-sparing diuretics or others capable of increasing the potassium content of blood preparations (heparin), it is possible to increase the potassium content in the blood serum.

Aliskiren and medications containing aliskiren

Joint use with aliskiren and with aliskiren-containing drugs is contraindicated in patients with diabetes mellitus or with moderate and severe renal failure (glomerular filtration rate (GFR) <60 ml / min / 1.73 m² body surface area) and is not recommended in other patients (see the sections "Contraindications", "With caution", "Special instructions").

ACE Inhibitors

Application of the drug Irbesartan in combination with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients (see the sections "Contraindications", "With caution", "Special instructions").

Non-steroidal anti-inflammatory drugs (NSAIDs). With simultaneous use of angiotensin II receptor antagonists and NSAIDs (for example, selective inhibitors of COX-2 (cyclooxygenase-2),acetylsalicylic acid (more than 3 g / day) and nonselective NSAIDs) it is possible to attenuate the antihypertensive effect. In elderly patients, patients with reduced circulating blood volume or patients with impaired renal function, the use of NSAIDs, including COX-2 inhibitors, concomitantly with angiotensin II receptor antagonists, including irbesartan, as well as simultaneous use of ACE inhibitors and NSAIDs, can lead to impaired renal function, including the possible development of acute renal failure. These effects are usually reversible. In addition, they can increase the potassium content in the blood serum, especially in patients with already impaired function of the nights. It is necessary to use this combination with caution in the above groups of patients. Patients, if necessary, should restore the volume of circulating blood and during the entire combination therapy, as well as periodically after its termination, monitor the kidney function.

With lithium preparations. A reversible increase in serum concentrations of lithium or its toxicity was noted with simultaneous use of lithium preparations with inhibitors of the angiotensin converting enzyme. By now, when taking the drug irbesartan similar effects were observed extremely rarely. If there is a need for this combination, the concentration of lithium in serum should be carefully monitored during treatment.

Additional information on the interaction of irbesartan. When the drug is used together irbesartan with hydrochlorothiazide or nifedipine pharmacokinetics of the drug irbesartan does not change.

Irbesartan is mainly metabolized with the CYP2C9 isoenzyme and is less exposed to glucuronidation. No significant pharmacokinetic or pharmacodynamic interactions were observed with simultaneous application of the drug irbesartan and warfarin, a drug metabolized by the isoenzyme CYP2C9. Studies of the effect of inducers of the activity of the isoenzyme CYP2C9, such as rifampicin, on the pharmacokinetics of the drug irbesartan not carried out. Irbesartan does not change the pharmacokinetics of digoxin and simvastatin.

Special instructions:

Violation of the water-electrolyte balance. In patients with hypovolemia and / or hyponatraemia (as a result of intensive diuretic therapy, diarrhea or vomiting,observance of a diet with restriction of consumption of table salt, reception of diuretics), and also at the patients who are on a hemodialysis, clinically significant arterial hypotension, especially after reception of the first dose of a preparation can develop. Before starting the preparation Irbesartan it is necessary to correct all violations of water electrolyte balance or start treatment with lower doses.

Renovascular hypertension. Patients with bilateral renal artery stenosis or stenosis of the artery of a single functioning kidney when taking drugs that affect the renin-angiotensin-aldosterone system are at increased risk for developing severe arterial hypotension or kidney failure. Although documented evidence of such effects when taking the drug Irbesartan it is necessary to take into account the possibility of their occurrence when angiotensin II receptor antagonists (such as AT1) are used in these patients.

Due to inhibition of the renin-angiotensin-aldosterone system, impairment of kidney function in predisposing patients can be expected.In patients whose renal function depends on the activity of the renin-angiotensin-aldosterone system (patients with hypertension and renal artery stenosis of one or both kidneys or patients with chronic cardiac insufficiency III and IV functional class [according to NYHA classification]), drug treatment irbesartan was associated with oliguria and / or progressive azotemia and rarely with acute renal failure and / or death.

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

Patients with arterial hypertension and type 2 diabetes mellitus with impaired renal function. Noted for the drug Irbesartan the beneficial effect of slowing the progression of renal and cardiovascular lesions had a different degree of severity in different groups of patients, less pronounced in women and in persons not belonging to the Europoid race.

Double blockade of the renin-angiotensin-aldosterone system (RAAS): double blockade of RAAS (joint use of irbesartan with aliskiren) is not recommended, since there is an increased risk of developing hypotension, hyperkalemia, and changes in kidney function. Application of the drug Irbesartan in combination with aliskiren-containing drugs in patients with diabetes mellitus and with moderate and severe degree of renal dysfunction (glomerular filtration rate (GFR) <60 ml / min / 1.73 m² body surface area) - (see "Contraindications", "Interaction with other medicinal products") and is not recommended in other patients. Application of the drug Irbesartan in combination with ACE inhibitors is contraindicated in patients with diabetic nephropathy (see Sections "Contraindications", "Interaction with other medicinal products") and is not recommended in other patients.

Hyperkalemia. As with the use of other drugs that affect the system of renin-angiotensin-aldosterone, when treated with a drug Irbesartan can develop hyperkalemia, especially if there is kidney failure and / or heart disease.In such patients it is recommended to monitor the potassium content in the blood serum.

Lithium: The combination of lithium and irbesartan is not recommended.

Stenosis of the aortic or mitral valve, hypertrophic obstructive cardiomyopathy. As with the use of other vasodilators, when taking the drug Irbesartan Care should be taken in patients with aortic or mitral stenosis or with hypertrophic obstructive cardiomyopathy.

Primary aldosteronism. Patients with primary aldosteronism usually do not respond to antihypertensive drugs acting through inhibition of the renin-angiotensin-aldosterone system. Therefore, the drug Irbesartan in such cases it is not advisable.

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

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

Effect on the ability to drive transp. cf. and fur:During the treatment period it is recommended to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:Tablets, film-coated 75 mg, 150 mg, 300 mg.

Packaging:

When manufacturing at Hetero Labe Limited, India

For 10 tablets in a blister of Al / PVC-PE-PVDC or Al / PVC-PVDC.

For 1 or 3 blisters together with instructions for use in a cardboard box.

At manufacture, packing and-or packing on Open Company "MAKIZ-PHARMA"

10 tablets in blisters of PVC film / polyvinylidene chloride (PVC / PVDC), aluminum foil, and a printed lacquer. For 3, 6 or 9 contour packs of 10 tablets together with instructions for use in a pack of cardboard.

30, 60, 90 tablets in a jar of high density polyethylene (HDPE), a lid-closed low density polyethylene (LDPE) with a first control opening. Free space, if necessary, is filled with cotton absorbent cotton. A label is attached to the jar.

1 jar along with instructions for use in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

Do not use the product after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-003847

Date of registration:20.09.2016

Expiration Date:20.09.2021

The owner of the registration certificate:Heterose Labs LimitedHeterose Labs Limited India

Manufacturer: & nbsp

MAKIZ-PHARMA, LLC Russia

HETERO LABS, Limited India

Representation: & nbspHeterose Labs LimitedHeterose Labs LimitedIndia

Information update date: & nbsp27.11.2017

Illustrated instructions

Instructions

Irbesartan (Irbesartan)