Aprovel 300 mg tablets # 28

Author Ольга Кияница

2017-05-11

Amount in a package -
Product form Pills
Manufacturer Sanofi Pharma Bristol-Myers Squibb (France)
Registration certificate UA/8136/02/03
The main medicament Aprovel
morion code 201849

Aprovel (APROVEL) instructions for use

Composition

active ingredient: irbesartan; 1 tablet 75 mg contains 75 mg irbesartan; 1 tablet of 150 mg contains 150 mg of irbesartan; 1 tablet 300 mg contains 300 mg of irbesartan;
auxiliary substances: lactose, corn starch, croscarmellose sodium, poloxamer 188, silicon dioxide hydrated, microcrystalline cellulose, magnesium stearate.

Dosage form

Pills.

Pharmacological group

Angiotensin II receptor antagonists. ATS code C09C A04.

Indications

Essential hypertension.

Arterial hypertension in patients with kidney disease and type II diabetes mellitus in blood pressure.

Contraindications

Hypersensitivity to the components of the drug (see formulation of the drug). Pregnancy. The period of breastfeeding.Age to 18 years. Intolerance to galactose, deficiency of Lappa lactase or malabsorption of glucose-galactose.

Dosing and Administration

The initial and maintenance dose is 150 mg once a day with food or on an empty stomach. Aprovel at a dose of 150 mg once a day usually provides a better 24-hour blood pressure control than a 75 mg dose. However, at the beginning of therapy, a dose of 75 mg can be used, especially for patients on hemodialysis, or for patients older than 75 years.

For patients who do not have enough blood pressure to be regulated at a dose of 150 mg once a day, the dose of Aprovel can be increased to 300 mg once a day or an additional antihypertensive drug can be prescribed additionally. In particular, it has been shown that the addition of a diuretic, such as hydrochlorothiazide, to the therapy with Aprovel has an additional effect.

For patients with hypertension and type 2 diabetes, treatment should begin with a dose of 150 mg irbesartan once a day, then increase to 300 mg once a day, which is the best maintenance dose for treating patients with kidney disease.

The positive nephroprotective effect of the drug Aprovel on the kidneys in patients with hypertension and type II diabetes was shown in studies where irbesartan was used as an adjunct to other antihypertensive agents to achieve the target level of arterial pressure, if necessary.

Renal failure For patients with impaired renal function, dose adjustment is not required. For patients on hemodialysis, a lower initial dose (75 mg) should be used.

Decrease of BCC. Reduced volume of fluid / circulating blood and / or lack of sodium should be adjusted before the use of the drug "Aprovel".

Liver failure. For patients with mild to moderate hepatic insufficiency, dose adjustment is not required. Clinical experience of the drug in patients with severe hepatic insufficiency is absent.

Patients of advanced age. Although treatment of patients older than 75 years should start with a dose of 75 mg, no dose adjustment is usually necessary.

Application in pediatrics. Irbesartan is not recommended for the treatment of children and adolescents due to inadequate data on its safety and efficacy.

Adverse Reactions

The incidence of adverse reactions described below was determined as follows: very common (³1 / 10), common (≥1 / 100, <1/10), uncommon (³1 / 1000, <1/100), rare (³1 / 10000, <1 / 1,000), very rarely (<1/10 000). Within each group, side effects are presented in the direction of decreasing significance.

Arterial hypertension. In placebo-controlled trials in hypertensive patients, the overall incidence of adverse events did not differ between groups receiving irbesartan (56.2%) and placebo (56.5%). Discontinuation of treatment through any clinical or laboratory side effects was less likely in patients receiving irbesartan (3.3%) than those who were administered placebo (4.5%). The frequency of side effects did not depend on the dose (within recommended doses), sex, age, race or duration of treatment. During a placebo-controlled study in which 1965 patients used irbesartan, the following side effects were observed.

From the nervous system. Common: dizziness.

Cardiac disorders. Uncirculated: tachycardia.

Vascular disorders. Uncirculated: congestion.

Respiratory, thoracic mediastinal disorders. Uncirculated: cough.

Gastrointestinal disorders. Common: nausea, vomiting. Unspoken diarrhea, indigestion / heartburn.

Violation of the reproductive system and breast. Uncirculated: sexual dysfunction.

General condition and condition of the injection site. Common tiredness. Unexplained: pain in the chest.

Laboratory research. Common: a significant increase in the level of CK in plasma (in 1.7% of patients who received irbesartan), which was not accompanied by clinical manifestations of the musculoskeletal system.

Arterial hypertension in patients with kidney disease and type II diabetes mellitus. In addition to the side effects described above, orthostatic dizziness and orthostatic hypotension were observed in diabetic patients with hypertension, had microalbuminuria and normal kidney function - in 0.5% of patients (uncommon side effects) - more than in patients receiving placebo.

In patients with diabetes with hypertension, chronic renal failure and severe proteinuria, additional side effects were noted, as indicated below, in> 2% of patients more than in patients receiving placebo.

From the nervous system. Common orthostatic dizziness.

Vascular disorders. Common orthostatic hypotension.

Musculoskeletal disorders, connective tissue and bone disorders. Common musculoskeletal pain.

Laboratory research. Hyperkalemia was more common in diabetic patients who received irbesartan than placebo. In patients with diabetes with hypertension, had microalbuminuria and normal kidney function, hyperkalemia (³ 5.5 mEq / mol) was observed in 29.4% (very common side effects) of patients receiving 300 mg of irbesartan and 22% of patients receiving placebo . In patients with diabetes with hypertension, chronic renal failure and severe proteinuria, hyperkalemia (≥ 5.5 mEq / mol) was observed in 46.3% (very common side effects) of patients receiving irbesartan, and in 26.3% of patients receiving placebo.

A decrease in hemoglobin that was not clinically significant was observed in 1.7% (common side effects) of AH patients and progressive diabetic nephropathy receiving irbesartan.

During the postmarketing period, the following additional side effects were reported. Since these data are obtained from spontaneous messages, it is impossible to determine the frequency of their occurrence.

From the immune system. As in the case of other angiotensin II receptor antagonists, there have been rare reports of hypersensitivity reactions such as rash, hives, angioedema.

Disturbance of metabolism and assimilation of nutrients. Hyperkalemia.

From the nervous system. Headache.

Hearing and vestibular apparatus disorder. Noise in ears.

Gastrointestinal disorders. Dysgeusia (change in taste sensations).

Hepatobiliary system. Hepatitis, a violation of the liver.

Musculoskeletal disorders, connective tissue and bone disorders. Arthralgia, myalgia (in some cases it is associated with an increase in the level of CK in the serum), muscle cramps.

Impaired renal function and urinary system. Violation of kidney function, including kidney failure in patients at high risk (see "Features of the application").

From the skin and subcutaneous tissue. Leukocytoclastic vasculitis.

Application in pediatrics. In a randomized trial, during the 3-week, double-blind phase of 318 children and adolescents aged 6 to 16 years, patients with AH, had the following side effects: headache (7.9%), hypotension (2.2%), dizziness (1.9%), cough (0.9%). During the 26-week open period of the study, deviations from the norm of such laboratory indicators were most often observed: an increase in the level of creatinine (6.5%) and an increase in the level of CK (CK) in 2% of the children of recipients.

Overdose

The experience of using the drug in the treatment of adults at doses up to 900 mg per day for 8 weeks showed no toxicity of the drug. The most likely manifestations of an overdose can be expressed in hypotension and tachycardia;bradycardia may also be a manifestation of an overdose. There is no specific information regarding the treatment of an overdose of the drug "Aprovel". The patient needs to be carefully monitored, the treatment should be symptomatic and supportive. The proposed measures include provocation of vomiting and / or gastric lavage. In the treatment of overdose, it may be useful to use activated carbon. Irbesartan is not excreted during hemodialysis.

Use during pregnancy and lactation

The use of the drug "Aprovel" is contraindicated in the II and III trimesters of pregnancy. In the second and third trimesters of pregnancy, drugs that directly affect the "renin-angiotensin system" can cause kidney failure of the fetus or newborn, hypoplasia of the fetal skull and even his death.

For the purpose of caution is not recommended in the first trimester of pregnancy.

It is necessary to switch to alternative therapy before the planned pregnancy. If pregnancy is diagnosed, the use of irbesartan should be stopped as soon as possible and check the condition of the fetal skull and kidney function with the help of ultrasound, if inattention treatment lasted a long time.

The use of the drug "Aprovel" is contraindicated in the period of breastfeeding. It is not known whether irbesartan is excreted in breast milk. Aprol is excreted in the milk of rats during lactation.

Children

Aprovel was studied in a population of children aged 6 to 16 years, but the data available today is not sufficient to expand its indications for use in children until additional data are obtained.

Application features

Decrease of BCC. Symptomatic arterial hypotension, especially after the first dose, may occur in patients with reduced BCC and / or reduced sodium concentration due to intensive diuretic therapy, diets with limited salt intake, diarrhea, or vomiting. These indicators should be adjusted to the norm before the use of the drug "Aprovel".

Arterial Renovascular Hypertension. When using drugs that affect renin-angiotensin-aldosterone, there is an increased risk of severe arterial hypotension and renal failure in patients with bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney. Although no such cases have been observed with the use of Aprovel, when angiotensin I receptor antagonists are used, such effects can be expected.

Renal failure and kidney transplantation. When using the drug "Aprovel" for the treatment of patients with impaired renal function, it is recommended to conduct regular monitoring of serum potassium and serum creatinine levels. Experience with the drug "Aprovel" for the treatment of patients with recent kidney transplantation does not exist.

Patients with arterial hypertension, kidney disease and type II diabetes mellitus. The effect of irbesartan on the kidney and cardiovascular system was the same in all subgroups that were analyzed in a study of patients with severe kidney disease. In particular, it was less favorable for women and subjects of the non-white race.

Hyperkalemia. As with other drugs that affect renin-angiotensin-aldosterone, hyperkalemia may develop during treatment with Aprovel, especially if there is renal failure, severe proteinuria due to diabetic nephropathy and / or heart failure. It is recommended to closely monitor potassium concentrations in the blood serum of patients at risk.

Lithium. At the same time, lithium and Aprovel are not recommended.

Stenosis of the aortic and mitral valve, obstructive hypertrophic cardiomyopathy. Like other vasodilators, it is necessary to use the preparation with caution in patients with stenosis of the aortic or mitral valve, obstructive hypertrophic cardiomyopathy.

Primary aldosteronism. Patients with primary aldosteronism usually do not respond to antihypertensive drugs acting by inhibiting renin-angiotensin. Therefore, use of Aprovel for the treatment of such patients is not recommended.

General features. Patients whose vascular tone and renal function depend mainly on the activity of renin-angiotensin-aldosterone (eg, in patients with severe congestive heart failure or underlying kidney disease, including renal artery stenosis), treatment with ACE inhibitors or angiotensin II receptor antagonists, which affect this system, was associated with acute hypotension, azotemia, oliguria, and sometimes acute renal failure. As with any antihypertensive agent, excessive reduction in blood pressure in patients with ischemic cardiopathy or ischemic cardiovascular disease can lead to myocardial infarction or stroke. Like angiotensin-converting enzyme inhibitors, irbesartan and other angiotensin antagonists are apparently less effective in lowering arterial blood pressure in members of the black race than in other races, perhaps because among the population of patients of the black race with hypertension, conditions with a low level of renin .

It is contraindicated to use the drug to treat patients with rare hereditary problems - intolerance to galactose, deficiency of lactase Lappa or malabsorption of glucose-galactose.

The ability to influence the reaction rate when driving vehicles or other mechanisms

The impact on the ability to drive and perform work requiring increased attention has not been studied. The pharmacokinetic properties of irbesartan indicate that it is unlikely to affect this ability.

When driving a vehicle or working with machinery, it should be taken into account that dizziness and fatigue may occur during treatment.

Interaction with other drugs and other interactions

Diuretics and other antihypertensive drugs. Other antihypertensive drugs can enhance the antihypertensive effect of irbesartan; Despite this, Aprovel was safely used with other antihypertensive agents, such as beta-blockers, long-acting calcium channel blockers, and thiazide diuretics. Prior treatment with a high dose of diuretics can lead to dehydration of the body and increase the risk of developing arterial hypotension at the beginning of treatment with Aprovel.

Potassium supplements and diuretics that retain potassium. The experience gained with the use of other drugs that affect the system of "renin-angiotensin-aldosterone" shows that the simultaneous use of diuretics that retain potassium, potassium supplements, salt substitute containing potassium, or other drugs that can raise the level of potassium in the serum (eg, heparin), can lead to an increase in potassium levels in the serum. Therefore, it is not recommended to simultaneously use such drugs with the drug "Aprovel".

Lithium. The reverse increase in the concentration of lithium in the blood plasma and its toxicity was noted with simultaneous use of lithium with ACE inhibitors. In rare cases, similar effects were observed with irbesartan. Therefore, this combination is not recommended. If it is necessary, careful monitoring of the level of lithium in the blood plasma is recommended.

Non-steroidal anti-inflammatory drugs. With simultaneous use of angiotensin II antagonists with non-steroidal anti-inflammatory drugs (for example, selective inhibitors of COX-2, acetylsalicylic acid (> 3 g per day) and nonselective NSAIDs), their antihypertensive effect may be weakened.

As with ACE inhibitors, simultaneous use of angiotensin II antagonists and NSAIDs may increase the risk of renal dysfunction, including the likelihood of developing acute renal failure, and lead to an increase in serum potassium, especially in patients with impaired renal function. This combination should be used with caution, especially in elderly patients. It is necessary to conduct appropriate fluid saturation and monitor kidney function at the beginning of the combination therapy and periodically afterwards.

Additional information on the interaction of irbesartan. In clinical studies, hydrochlorothiazide did not affect the pharmacokinetics of irbesartan.Irbesartan is metabolized via CYP2C9 and to a lesser extent - by glucuronidation. There were no significant pharmacokinetic or pharmacodynamic interactions, while the use of irbesartan and warfarin, which is metabolized by CYP2C9. Influence of inducers CYP2C9, such as rifampicin, the pharmacokinetics of irbesartan not studied. The pharmacokinetics of digoxin unchanged while the use of irbesartan.

Pharmacological properties

Pharmacodynamics.Aprovel - a potent, orally active selective antagonist of angiotensin II receptor (type AT 1). It is believed that it blocks all physiologically significant effects of angiotensin II, mediated by AT 1 receptor type, regardless of the source or route of synthesis of angiotensin II. Selective antagonistic action against angiotensin II receptor (AT 1) leads to increased concentrations of renin and angiotensin II in plasma and a decrease in plasma aldosterone concentration. When used in the recommended dosage level of potassium in serum is not significantly changed. Irbesartan does not inhibit ACE (kininazu II) - an enzyme that produces angiotensin II, carries metabolic degradation of bradykinin to inactive metabolites. For the manifestation of their effects Irbesartan does not require metabolic activation.

Clinical efficacy in hypertension. Aprovel lowers blood pressure with minimal changes in heart rate. Lowering blood pressure when administered once a day is dose dependent, with a tendency to reach a plateau at doses of 300 mg. Doses of 150-300 mg when administered once a day reduces blood pressure measured in the supine position or sitting at the end of action (i.e., 24 hours after dosing) by an average of 8-13 / 5-8 mm Hg. Art. (Systolic / diastolic) greater than placebo.

Maximum blood pressure reduction achieved within 3-6 hours after drug administration, the hypotensive effect is maintained for 24 hours.

24 hours after receiving the recommended doses blood pressure reduction is 60-70% compared to the maximum reduction of systolic and diastolic pressure. The drug in a dose of 150 mg once a day has the effect (the actions and the minimum of the average for 24 hours), similar to that achieved in the distribution of the daily dose into two doses.

Antihypertensive drug effect "Aprovel" apparent within 1-2 weeks, and the effect is most pronounced at 4-6 weeks of starting treatment. The antihypertensive effect is maintained with prolonged treatment. After cessation of treatment blood pressure gradually returns to its initial value. Withdrawal symptoms in the form of strengthening of hypertension after the drug was not observed.

Aprovel with thiazide-type diuretics are additive antihypertensive effect. For patients whose irbesartan alone did not provide the desired effect, the simultaneous use of a low dose of hydrochlorothiazide (12.5 mg) irbesartan once daily caused a greater reduction in blood pressure for at least 7-10 / 3-6 mm Hg. Art. (Systolic / diastolic) compared to placebo.

The effectiveness of the drug "Aprovel" does not depend on age or gender. Patients of black race with hypertension had significantly weaker response to irbesartan monotherapy, as well as other drugs that affect the renin-angiotensin system. In the case of simultaneous use of irbesartan with hydrochlorothiazide in a low dose (e.g., 12.5 mg per day), response of patients reached the black race response levels in patients Caucasians. Clinically significant changes in levels of uric acid in serum or excretion of uric acid was observed in the urine.

In the 318 children and adolescents aged 6 to 16 years who had hypertension or a risk of occurrence (diabetes, the presence of the family of hypertensive patients) were examined blood pressure reduction after application of titrated doses of irbesartan - 0.5 mg / kg (low), 1.5 mg / kg (medium) and 4.5 mg / kg (high) for three weeks. At the end of the third week minimum systolic blood pressure in the sitting position (SATSP) decreased from baseline in average by 11.7 mmHg. Art. (Low dose), 9.3 mm Hg. Art. (Average dose), 13.2 mm Hg. Art.(High dose). Statistically significant differences were observed between the effects of these doses. Adjusted mean change of minimum diastolic blood pressure in a sitting position (DATSP) was 3.8 mmHg. Art. (Low dose), 3.2 mm Hg. Art. (Average dose), 5.6 mm Hg. Art.(High dose). Two weeks later, the patients were re-randomized to the use of the active drug or a placebo. The patients applied placebo SATSP DATSP and grew by 2.4 and 2.0 mm Hg. v., and in those who used at various doses irbesartan, corresponding changes were 0.1 and 0.3 mm Hg. Art.

Clinical efficacy in patients with hypertension, renal diseases and diabetes mellitus type II. IDNT trial (irbesartan diabetic nephropathy) showed that irbesartan slows the progression of kidney damage in patients with chronic renal failure and severe proteinuria.

IDNT was a double-blind, controlled study that compared the morbidity and mortality among patients treated with Aprovel, amlodipine and placebo. It involved 1715 patients with hypertension and diabetes mellitus type II, in which proteinuria ≥ 900 mg / day and serum creatinine in the range of 1.0-3.0 mg / dL. We explore remote in time (an average of 2.6 years), the implications of the "Aprovel" drug - effect on the progression of renal disease and all-cause mortality. Patients were treated with titrated doses of from 75 mg to 300 mg (maintenance dose) "Aprovel" preparation, from 2.5 mg to 10 mg of amlodipine or placebo, depending on tolerance. In each group, patients are usually prepared 2-4 antihypertensive medications (e.g., diuretics, beta-blockers,alpha blockers) to achieve a predetermined goal - blood pressure at ≤ 135/85 mm Hg. Art.or a decrease in systolic pressure of 10 mm Hg. v. if the parental level is> 160 mm Hg.Art.Target blood pressure levels achieved in 60% of patients in the placebo group, and 76% and 78% in the groups treated with irbesartan and amlodipine, respectively. Irbesartan significantly reduces the relative risk of the primary endpoint, which is combined with the doubling of serum creatinine, end-stage renal disease or total mortality. The primary composite endpoint in the group receiving irbesartan, reached approximately 33% of patients compared with 39% and 41% in the groups treated with placebo or amlodipine [20% decrease in relative risk compared to placebo (p = 0,024), and 23% reduction relative risk compared with amlodipine (p = 0,006)]. When analyzed the individual components of the primary endpoint, it was found that the overall effect on mortality was not,at the same time there was a positive trend to a decrease in the incidence end-stage renal disease and statistically significant reduction in incidence of increase in serum creatinine doubled.

Evaluation of the treatment effect was carried out in the various subgroups allocated by sex, race, age, duration of diabetes, the initial blood pressure, serum creatinine and albumin excretion rate. In the subgroup of women and members of the black race, which accounted for 32% and 26% of the total study population, respectively, there was significant improvement in the state of the kidneys, although the confidence intervals do not exclude it. If we talk about the secondary endpoint - cardiovascular event, which ended (fatal) or completed (non-fatal) death, the differences between the three groups were not in the general population, although the incidence of non-fatal myocardial infarction (MI) was greater in women and less than men from the group treated with irbesartan, compared with the group,placebo. Compared with the group treated with amlodipine, the frequency of occurrence of non-fatal myocardial infarction and stroke in women from the group treated with irbesartan was higher, at the same time, the number of hospitalizations for heart failure in the general population was smaller. No convincing explanation for these results were not found in women.

Study "Effect of irbesartan for microalbuminuria in patients with diabetes of type II diabetes, and hypertension with" (IRMA 2) showed that irbesartan 300 mg in patients with slow progression of microalbuminuria to the appearance of overt proteinuria. IRMA 2 - double-blind, placebo-controlled study, wherein the estimated 590 deaths among patients with diabetes mellitus type II with microalbuminuria (30-300 mg per day) and normal renal function (serum creatinine ≤ 1,5 mg / dl in men and <1 , 1 mg / dL in women). The study examined distant in time (2 years) implications of the "Aprovel" preparation - influence on the progression of the appearance of symptomatic (explicit) proteinuria (albumin excretion rate in urine (SHEAS)> 300 mg per day and increased SHEAS at least 30% from baseline).Predetermined target was the blood pressure level ≤135 / 85 mmHg. Art.To help achieve this goal with additional necessary administered antihypertensive agents (other than ACE inhibitors, angiotensin II receptor antagonists and dihydropyridine calcium channel blockers). In all treatment groups blood pressure level, which is reached, patients were similar, but in the group receiving 300 mg irbesartan minimal number of subjects (5.2%) than those that received placebo (14.9%) or 150 mg irbesartan per day (9.7%) reached endpoint - overt proteinuria. This indicates a relative risk reduction of 70% after application of high doses compared to placebo (p = 0,0004). Simultaneously increasing the glomerular filtration rate (GFR) for the first three months of treatment was not observed.slowing the progression of the appearance of clinical proteinuria was evident within three months, and this effect lasted train the 2-year period. Regression to normoalbuminuria (<30 mg per day) was more common in the group receiving Aprovel 300 mg (34%) than in the placebo group (21%).

Pharmacokinetics.After oral administration, irbesartan is well absorbed: studies have shown that bioavailability is approximately 60-80%. Simultaneous food intake does not significantly influence the bioavailability of irbesartan. Plasma protein binding is approximately 96%, while binding to blood cells is negligible. The volume of distribution - 53-93 liters. Upon receiving administration or 14 C 80-85% irbesartan circulating plasma radiolabel falls on unmodified irbesartan. Irbesartan is metabolized in the liver by conjugation to glucuronide and oxidation. The main blood circulating metabolite is irbesartan-glucuronide (approximately 6%). Studies in vitro data suggest that irbesartan is oxidized mainly by the enzyme CYP2C9 cytochrome P450; CYP3A4 isozyme it has almost no effect.

Pharmacokinetics of irbesartan in a dosage range from 10 to 600 mg is linear and proportional to the dose. Less than proportional increase in oral absorption is observed at doses of 600 mg (twice the maximum recommended dose) the mechanism of this is unknown. The peak plasma concentration is reached after 1.5-2 hours after oral administration of the drug. Overall renal clearance and make 157-176 and 3-3.5 ml / min, respectively. Terminal half-life of irbesartan - 11-15 hours. Equilibrium plasma concentrations are established in 3 days after the onset of the drug once a day. When applied once daily accumulation of irbesartan in plasma is low (<20%). In one study, women with hypertension were observed somewhat higher plasma concentrations of irbesartan.However, differences in half-life and accumulation of irbesartan were not in time. For women to change the dose. In the elderly (³65 years) values of AUC (area under the drug concentration curve) and C max for irbesartan were slightly higher than in younger patients (18-40 years). However, the terminal half-life is not significantly changed. For elderly patients the dose of the drug need correction.

Irbesartan and its metabolites are excreted through the bile and kidneys. Upon receiving or administration of 14 C irbesartan about 20% of the radioactivity found in urine, and the rest - the faeces. Less than 2% of irbesartan received the dose excreted in the urine in an unmodified form.

One study investigated the pharmacokinetics of irbesartan in 23 hypertensive children after administration at a dose of 2 mg irbesartan / kg once and several times per day to a maximum daily dose of 150 mg for 4 weeks. To compare the pharmacokinetics to that of adults selected 21 children from the 23 (twelve children - under the age of 12 years, nine - aged 6-12 years). The results showed that the C max, AUC, and clearance in children were comparable with those of adult patients receiving 150 mg irbesartan daily. Upon receipt dose once daily accumulation of irbesartan in plasma is small (18%).

Impaired renal function.In patients with renal impairment or in patients undergoing hemodialysis, the pharmacokinetic parameters of irbesartan are not significantly altered. Irbesartan is not removed from the body during hemodialysis.

Abnormal liver function irbesartan pharmacokinetic parameters do not change significantly in patients with liver cirrhosis mild or moderate severity.

In patients with severe liver failure, studies have not been conducted.

Basic physical and chemical properties

Tablets 75 mg: white or almost white, oval, biconvex tablets engraved with a heart on one side and the number "2771" - on the other

Tablets 150 mg: White or almost white oval biconvex tablets with an engraving in a heart on one side and the number "2772" - to another

Tablets 300 mg: white or almost white, oval, biconvex tablets engraved with a heart on one side and the number "2773" - on the other

Shelf life

3 years.

Storage conditions

Keep out of the reach of children in the original container at temperatures below 30 ° C.

Packaging

№ 14: 14 tablets in a blister, 1 blister in a cardboard box.

Category of leave

On prescription.


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