Valaar

General characteristics. Structure:

Active ingredient: 40 mg or 80 mg of a valsartan.

Excipients: cellulose microcrystallic, lactoses monohydrate, sodium carboxymethylstarch (sodium of starch glikolit), povidone, sodium lauryl sulfate, magnesium stearate.

Excipients for a cover:

- for a dosage of 40 mg: Опадрай II [polyvinyl alcohol, macrogoal-3350, talc, titanium dioxide, ferrous oxide yellow, ferrous oxide red, ferrous oxide black];

- for a dosage of 80 mg: Опадрай II [polyvinyl alcohol, a macrogoal-3350, talc, titanium dioxide, an aluminum varnish on the basis of dye charming red, an aluminum varnish on the basis of azoruby dye, an aluminum varnish on the basis of dye a sunset yellow].

Pharmacological properties:

Pharmacodynamics. Valsartan is the active specific antagonist of receptors of angiotensin II. Selectively blocks AT1 subtype receptors which are responsible for effects of angiotensin II. Increase in plasma concentration of angiotensin II which can stimulate the receptors which are not blocked by AT2-is a consequence of blockade of AT1-receptors. Valsartan has no a little expressed agonistic activity concerning AT 1 of receptors. Affinity of a valsartan to receptors of the AT1 subtype is about 20 000 times higher, than to AT2 subtype receptors.

Valsartan does not enter interaction and does not block the receptors of other hormones or ion channels which are important in regulation of functions of cardiovascular system. Probability of developing of cough at use of a valsartan very low that is connected with lack of influence on an angiotensin-converting enzyme (APF) which is responsible for degradation of bradikinin. Comparison of a valsartan with APF inhibitor shows that the frequency of development of dry cough authentically (р <0,05) is lower at the patients accepting валсартан than at the patients accepting APF inhibitor (2,6% against 7,9%, respectively).

In group of patients at whom earlier at treatment by APF inhibitor dry cough developed at treatment valsartany this undesirable reaction is noted in 19,5% of cases, and at treatment by thiazide diuretic - in 19,0% of cases, - while in group of the patients receiving treatment by APF inhibitor, cough is observed in 68,5% of cases (р <0,05).

Use at arterial hypertension for patients is more senior than 18 years. At treatment valsartany patients with arterial hypertension the lowering of arterial pressure (ABP) which is not followed by change of the heart rate (HR) is noted.

After appointment in a single dose of drug at most of patients the beginning of anti-hypertensive action is observed within 2 hours, and the maximum decrease

The ABP is reached within 4-6 hours, remaining more than 24 hours. At repeated use of a valsartan the maximum decrease in the ABP, regardless of the accepted dose, is usually reached within 2-4 weeks, and supported at the reached level during long therapy. In case of simultaneous use of a valsartan with a hydrochlorothiazide reliable additional decrease in the ABP is reached. Sharp phase-out of a valsartan is not followed by substantial increase of the ABP or other undesirable reactions. At patients with arterial hypertension, a diabetes mellitus 2 types and a nephropathy accepting валсартан in a dose of 160-320 mg are noted considerable decrease in a proteinuria (36-44%).

Use after an acute myocardial infarction for patients is more senior than 18 years. At use of a valsartan within 2 years at patients during the period of 12 h up to 10 days after the postponed acute myocardial infarction (complicated by a left ventricular failure and/or systolic dysfunction of a left ventricle) indicators of the general mortality, cardiovascular mortality decrease and time increases to the first hospitalization concerning an aggravation of a course of chronic heart failure, a repeated myocardial infarction, a sudden cardiac standstill and a stroke (without a lethal outcome). The profile of safety of a valsartan at patients with an acute myocardial infarction is similar to that at other states.

The Chronic Heart Failure (CHF) at patients is more senior than 18 years At use of a valsartan (in an average daily dose of 254 mg) within 2 years at patients with XCH II (62%), III (36%) and IV (2%) a functional class on classification of NYHA with fraction of emission of the left ventricle (LV) less than 40% and with an internal diastolic diameter of LZh more than 2.9 cm/sq.m, receiving standard therapy, including APF inhibitors (93%), diuretics (86%), digoxin (67%) and beta adrenoblockers (36%) is noted reliable decrease (for 27,5%) risk of hospitalization concerning an aggravation of a current of HSN.

At the patients who were not receiving APF inhibitors considerable decrease in an indicator of the general mortality (for 33%), the cardiovascular mortality and incidence connected with HSN (time before the first cardiovascular event) which are estimated on the following indicators is noted: death, sudden death with performing resuscitation, hospitalization concerning an aggravation of a current of HSN, intravenous administration of inotropic or vasodilating drugs within 4 or more hours without hospitalization (for 44%). In group of the patients receiving APF inhibitors (without beta adrenoblockers), against the background of treatment valsartany decrease in an indicator of the general mortality is not observed, however indicators of the serdechnoyososudisty mortality and incidence connected with HSN for 18,3% decrease.

In general use of a valsartan leads to reduction of number of hospitalization concerning HSN, to delay of progressing of HSN, improvement of functional class HSN on NYHA classification, increase in fraction of emission of a left ventricle, and also reduction of expressiveness of signs and symptoms of heart failure and improvement of quality of life in comparison with placebo.

Use for patients is more senior than 18 years with arterial hypertension and disturbance of tolerance to glucose. At use of a valsartan and change of a way of life statistically reliable decrease in risk of development of a diabetes mellitus in this category of patients was noted. Valsartan did not exert impact on the frequency of lethal outcomes as a result of serdechnoyososudisty events, a myocardial infarction and the ischemic attacks without lethal outcomes, on hospitalization because of heart failure or unstable stenocardia, arterial revascularization, patients with disturbance have tolerances to glucose and arterial hypertension, differing on age, sex and race. The patients receiving валсартан had a risk of development of a microalbuminuria authentically below, than at the patients who are not receiving this therapy.

Use for children and teenagers aged from 6 up to 18 years at arterial hypertension. At children and teenagers aged from 6 up to 18 years валсартан provides dozozavisimy, smooth decrease in the ABP. At use of a valsartan the maximum decrease in the ABP, regardless of the accepted dose, is usually reached within 2 weeks, and supported at the reached level during long therapy.

Pharmacokinetics. Absorption. After intake absorption of a valsartan happens quickly, the maximum concentration (Cmax) of a valsartan in a blood plasma is reached within 2-4 hours. Average absolute bioavailability of 23%. At use of a valsartan with food the area under a curve "concentration time" (AUC) and Cmax decrease by 40% and 50%, respectively, though, starting with about the 8th h after administration of drug, concentration of a valsartan in a blood plasma both in case of its reception on an empty stomach, and in case of reception with food, identical. AUC reduction, nevertheless, is not followed by clinically significant decrease in therapeutic effect therefore валсартан it is possible to accept irrespective of meal time.

Distribution. The volume of distribution (Vd) of a valsartan in the period of an equilibrium state after intravenous administration made about 17 l that indicates lack of extensive distribution of a valsartan in fabrics. Valsartan substantially contacts serum proteins (94-97%), is preferential with albumine.

Metabolism. Valsartan is not exposed to the expressed metabolism (about 20% of the accepted dose are defined in the form of metabolites). The hydroxylic metabolite is defined in a blood plasma in low concentration (less than 10% of AUC of a valsartan). This metabolite pharmacological is inactive.

Removal. Valsartan is brought dvukhfazno: a α-phase with an elimination half-life (T1/2α) less than 1 h and β-a phase with T 1/2α - about 9 hours. Valsartan is brought generally in not changed look through intestines (about 83%) and kidneys (about 13%). After intravenous administration, the plasma clearance of a valsartan makes about 2 l/h and its renal clearance makes 0,62 l/h (about 30% of the general clearance). T1/2α of a valsartan makes 6 h.

Pharmacokinetics at separate groups of patients Patients with HSN. At this category of patients time of achievement of Cmax and T1/2α  are similar to those at healthy volunteers. Increase in AUC and Cmax in direct ratio to increase in a dose of drug (from 40 mg to 160 mg 2 times). The factor of cumulation averages 1,7. At intake the clearance of a valsartan made about 4,5 l/hour. The age of patients with HSN did not exert impact on clearance of a valsartan.

Patients are aged more senior than 65 years. At some patients 65 years system bioavailability of a valsartan above that at patients of young age are aged more senior (has no clinical value).

Patients with renal failures. Correlation between function of kidneys and system bioavailability of a valsartan is absent. With renal failures and the clearance of creatinine (CC) more than 10 ml/min. of dose adjustment of drug are not required from patients. Now there are no data on use for the patients who are on a hemodialysis. Valsartan has high extent of linkng with proteins of a blood plasma therefore its removal at a hemodialysis is improbable.

Patients with abnormal liver functions. At patients with easy and moderate abnormal liver functions increase in bioavailability (AUC) in a valsartan twice in comparison with healthy volunteers is noted. However correlation of AUC values of a valsartan with degree of an abnormal liver function is not observed.

Use of drug for patients with heavy abnormal liver functions was not studied.

Children and teenagers aged from 6 up to 18 years. Pharmacokinetic properties of a valsartan at children and teenagers aged from 6 up to 18 years do not differ from pharmacokinetic properties of a valsartan at patients 18 years are more senior.

Indications to use:

Adults. Arterial hypertension.

Chronic heart failure (the II-IV functional class on NYHA classification) at the patients receiving standard therapy by one or several drugs from the following pharmakoterapevtichesky groups: diuretics, cardiac glycosides, APF inhibitors or beta adrenoblockers. Use of each of the listed drugs is not obligatory.

For increase in survival of patients after the postponed acute myocardial infarction complicated by a left ventricular failure and/or systolic dysfunction of a left ventricle in the presence of stable indicators of a hemodynamics.

Children and teenagers. Arterial hypertension at children and teenagers aged from 6 up to 18 years.

Route of administration and doses:

Inside, without chewing, irrespective of meal, washing down with enough water.

Adults. Arterial hypertension. The recommended initial dose of drug Valaar makes 80 mg of 1 times a day, regardless of race, age and a sex of the patient. The anti-hypertensive effect is noted in the first 2 weeks of treatment, the maximum effect develops in 4 weeks. To those patients at whom it is not possible to reach the adequate therapeutic answer the daily dose of drug can be gradually increased to the maximum daily dose of 320 mg or it is necessary to apply diuretic means in addition.

Chronic heart failure. The recommended initial dose of drug Valaar makes 40 mg 2 times a day. It is necessary to increase a dose of drug gradually within at least 2 weeks to 80 mg 2 times a day, and at good tolerance - to 160 mg 2 times a day. The maximum daily dose makes 320 mg in 2 receptions. At the same time the dose decline of at the same time accepted diuretics can be required.

For increase in survival of patients after the postponed acute myocardial infarction. Treatment should be begun during 12 h after the postponed myocardial infarction. The initial dose makes 20 mg (1/2 tablets of 40 mg) 2 times a day. Increase in a dose is carried out by a titration method (40 mg, 80 mg, 160 mg 2 times a day) within several next weeks, before achievement of a target dose of 160 mg 2 times a day.

The maximum daily dose makes 320 mg in 2 receptions. As a rule, increase in a dose up to 80 mg 2 times a day by the end 2 weeks of treatment is recommended. Achievement of the maximum target dose on 160 mg 2 times a day is recommended by the end of the third month of therapy by drug Valaar. Increase in a dose depends on portability of drug during titration.

In case of development of the arterial hypotension which is followed by clinical manifestations, or renal failures it is necessary to consider a question of a dose decline.

Assessment of a condition of patients, during the period after the postponed myocardial infarction, has to include assessment of function of kidneys.

Patients are aged more senior than 65 years. At elderly patients 65 years of dose adjustment of drug are more senior it is not required.

Patients with renal failures. At patients with renal failures, dose adjustment of drug is not required. Now there are no data on use of drug for patients with KK less than 10 ml/min.

Patients with abnormal liver functions. Patients with easy or moderate abnormal liver functions of not biliary genesis without the cholestasia phenomena should use drug with care, the daily dose should not exceed 80 mg.

Children and teenagers aged from 6 up to 18 years. Arterial hypertension. The recommended initial dose of drug Valaar at children and teenagers aged from 6 up to 18 years makes 40 mg at the body weight of the child less than 35 kg and 80 mg at the body weight of the child more than 35 kg. It is recommended to adjust a dose taking into account decrease in the ABP.

The maximum recommended doses: at body weight ≥ 8 kg <35 kg the maximum recommended daily dose should not exceed 80 mg; ≥ 35 kg <80 kg - 160 mg, ≥ 80 kg ≤ 160 kg - 320 mg. Use of higher doses not rekoyendovano.

Features of use:

Use at pregnancy and during feeding by a breast. Pregnancy. Considering the mechanism of action of antagonists of receptors of angiotensin II, it is impossible to exclude risk for a fruit. Effect of APF inhibitors (the drugs exerting impact on the renin-angiotensin-aldosteronovuyu system (RAAS) on a fruit in case of their use in the second and third trimesters of pregnancy, can lead to its damage and death. According to retrospective data at use of APF inhibitors in the first trimester of pregnancy the risk of the birth of children with inborn defects increases.

Newborns whose mothers at pregnancy accidentally received валсартан have messages on misbirths, the oligogidramniyena and renal failures. Drug Valaar, as well as any other drug exerting direct impact on RAAS it is not necessary to apply during pregnancy, and also at the women planning pregnancy.

At use of the means influencing RAAS, the doctor should inform women of childbearing age on potential risk of negative influence of these drugs on a fruit at pregnancy. If pregnancy is diagnosed during treatment by drug Valaar, it is necessary to cancel treatment as soon as possible.

Fertility. In preclinical trials at animals effects of impact of a valsargan on fertility were not observed. Data on influence of a valsartan on fertility at the person are absent.

Feeding period breast. It is unknown whether it is allocated валсарган in breast milk. Therefore it is not necessary to use drug during feeding by a breast.

Transplantation of a kidney. Data on safety of use of a valsartan for the patients who transferred transplantation of a kidney no.

Deficit in an organism of sodium and/or decrease in OTsK. At patients with the expressed deficit in an organism of sodium and/or reduced OTsK, for example, of the diuretics receiving high doses, in rare instances in an initiation of treatment drug the arterial hypotension which is followed by clinical manifestations can develop. Before an initiation of treatment drug it is necessary to carry out correction of contents in an organism of sodium and/or to fill OTsK, including by reduction of a dose of diuretic.

Renal artery stenosis. Drug use by a short course at patients with the renovascular hypertensia which developed for the second time owing to a unilateral stenosis of an artery of the only kidney does not lead to a little essential change of indicators of a renal hemodynamics, concentration of creatinine of blood serum or an urea nitrogen of blood. However, considering that other medicines influencing RAAS can cause increase in concentration of urea and creatinine in blood serum in patients with a bilateral stenosis of renal arteries or a stenosis of an artery of the only kidney, as a precautionary measure control of these indicators is recommended.

Primary hyper aldosteronism. Drug is inefficient for treatment of arterial hypertension at patients with primary hyper aldosteronism as at this category of patients activation of RAAS is not noted.

The HSN/period after the postponed myocardial infarction. At patients with HSN or after the postponed myocardial infarction, beginning treatment valsartany, some decrease in the ABP in this connection control of the ABP at the beginning of therapy is recommended is often noted. On condition of observance of recommendations about the dosing mode usually there is no need of drug withdrawal because of arterial hypotension. Assessment of a condition of patients with HSN has to include assessment of function of kidneys.

Owing to RAAS inhibition at some patients renal failures are possible. At patients with HSN III-IV of a functional class on NYHA classifications, function of kidneys at which depends on a condition of RAAS, treatment by APF inhibitors and antagonists of receptors of angiotensin II can be followed by an oliguria and/or increase of an azotemia and in rare instances development of an acute renal failure and/or a lethal outcome. Therefore at these categories of patients before drug use, and also periodically during treatment, it is necessary to carry out assessment of function of kidneys.

Combination therapy at arterial hypertension. At arterial hypertension drug Valaar can be used in monotherapy, and also along with other antihypertensives, in particular, with diuretics.

Combination therapy during the period after the postponed myocardial infarction
Drug use Valaar in a combination with other medicines applied after the postponed myocardial infarction is possible namely: trombolitikam, acetylsalicylic acid as antiagregantny means, beta adrenoblockers and inhibitors of GMG-KOA-reduktazy (statines). At this category of patients Valaar along with APF inhibitors as this combination therapy has no advantages before monotherapy valsartany or APF inhibitor concerning indicators of the general mortality for any reason is not recommended to use drug.

Combination therapy at HSN. At HSN drug Valaar can be used both in monotherapy, and along with other means - diuretics, cardiac glycosides, and also APF inhibitors or beta adrenoblockers. At this category of patients use of a triple combination therapy by APF inhibitor, beta adrenoblocker and valsartany is not recommended.

Quincke's disease. The Quincke's disease, including the hypostasis of a throat and phonatory bands leading to obstruction of respiratory tracts and/or a face edema, lips, drinks and/or a paraglossa, occurred at the patients receiving валсартан, some of these patients had a Quincke's disease against the background of reception of other drugs, including APF inhibitors earlier. Administration of drug Valaar in case of development of a Quincke's disease has to be immediately cancelled, resuming of drug is forbidden.

Influence on ability to manage vehicles and to be engaged in other types of activity. As against the background of therapy by drug Valaar development of such undesirable reactions as dizziness or a faint is possible, the patients accepting drug should be careful during the driving and occupation potentially dangerous types of activity.

Side effects:

The frequencies given about dependence any of undesirable reaction from a dose or duration of treatment valsartany, and also a sex, age or race, no. The profile of safety of a valsartan at children and teenagers aged from 6 up to 18 years with arterial hypertension does not differ from a profile of safety of a valsartan at adult patients.

Undesirable reactions which were observed during clinical trials, and also at use of drug in clinical practice are included below.

Frequency of development of undesirable reactions is specified according to the WHO classification: very often (≥1/10 cases), it is frequent (≥1/100 and <1/10 cases), infrequently (≥1/1000 and <1/100 cases), is rare (≥1/10000 and <1/1000 cases) and is very rare (<1/10000 cases, including separate messages). Within each group allocated on occurrence frequency, undesirable reactions are distributed as reduction of their importance.

For all undesirable reactions revealed in clinical practice and in the analysis of laboratory indicators (which frequency of development cannot be established) the gradation "was used frequency is unknown".

Patients with arterial hypertension:

From system of a hemopoiesis and lymphatic system: frequency is unknown - decrease in hemoglobin, a hematocrit, a neutropenia, thrombocytopenia.

From immune system: frequency is unknown - hypersensitivity reactions, including a serum disease.

Metabolism disturbances: frequency is unknown - increase in content of potassium in blood serum.

From an acoustic organ and labyrinth frustration: infrequently - вертиго.

From cardiovascular system: frequency is unknown - a vasculitis.

From respiratory system: infrequently - cough.

From digestive tract: infrequently - abdominal pains.

From gepatobiliarny system: frequency is unknown - an abnormal liver function, including increase in concentration of bilirubin in a blood plasma.

From skin and hypodermic cellulose: very seldom - a Quincke's disease, skin rash, an itch.

From a musculoskeletal system: frequency is unknown - a mialgiya.

From kidneys: frequency is unknown - renal failures, increase in concentration of creatinine in blood serum.

Others: infrequently - increased fatigue.

Also during clinical trials at patients with arterial hypertension the following undesirable phenomena which relationship of cause and effect with were observed

by administration of drug it is not established: arthralgia, adynamy, dorsodynia, diarrhea, dizziness, sleeplessness, decrease libido, nausea, peripheral hypostases, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

The patients receiving валсартан after the postponed acute myocardial infarction and/or at HSN:

From system of a hemopoiesis and lymphatic system: frequency is unknown - thrombocytopenia.

From immune system: frequency is unknown - hypersensitivity reactions, including a serum disease.

Metabolism disturbances: infrequently - a hyperpotassemia; frequency is unknown - increase in content of potassium in blood serum.

From a nervous system: often - dizziness, postural dizziness; infrequently - a faint, a headache.

From an acoustic organ and labyrinth frustration: infrequently - вертиго.

From cardiovascular system: often - the expressed decrease in the ABP, orthostatic hypotension; infrequently - strengthening of symptoms of chronic heart failure; frequency is unknown - a vasculitis.

From respiratory system: infrequently - cough.

From digestive tract: infrequently - nausea, diarrhea.

From gepatobiliarny system: frequency is unknown - an abnormal liver function. From skin and hypodermic cellulose: very seldom - a Quincke's disease; frequency is unknown - skin rash, an itch.

From a musculoskeletal system: seldom - рабдомиолиз, frequency is unknown - a mialgiya.

From kidneys: often - a renal failure; infrequently - an acute renal failure, increase in concentration of creatinine in blood serum; frequency is unknown - increase in maintenance of an urea nitrogen in a blood plasma.

General disturbances: infrequently - an adynamy, increased fatigue.

Also during clinical trials at patients after the postponed acute myocardial infarction and/or HSN the following undesirable phenomena which relationship of cause and effect is not established with administration of drug were observed: arthralgia, abdominal pains, dorsodynia, adynamy, sleeplessness, decrease libido, neutropenia, peripheral hypostases, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

If any of the undesirable reactions specified in the instruction are aggravated, or you noticed other undesirable reactions which are not specified in the instruction, report about it to the doctor.

Interaction with other medicines:

It is established that at monotherapy valsartany there are no clinically significant interactions with the following medicines: Cimetidinum, warfarin, furosemide, digoxin, atenololy, indometacin, hydrochlorothiazide, amlodipiny, Glibenclamidum.

Double blockade of RAAS at use of antagonists of receptors of angiotensin II, APF inhibitors or an aliskirena. Simultaneous use of antagonists of receptors of angiotensin II, including валсартан, with other means exerting impact on RAAS is connected with the increased frequency of development of arterial hypotension, a hyperpotassemia and changes of function of kidneys in comparison with monotherapy. It is recommended to carry out monitoring of arterial pressure, function of kidneys and content of electrolytes at the patients accepting валсартан and other medicines exerting impact on RAAS.

Non-steroidal anti-inflammatory drugs (NPVP), including the selection inhibitors of cyclooxygenase-2. At use of a valsartan along with NPVP, including the selection inhibitors of cyclooxygenase-2, reduction of its anti-hypertensive action is possible. At use of antagonists of receptors of angiotensin II along with NPVP deterioration in function of kidneys and increase in content of potassium in a blood plasma is possible. In need of simultaneous use of a valsartan and NPVP prior to treatment it is necessary to carry out assessment of function of kidneys and correction of disturbances of vodnoyoelektrolitny balance.
 
Proteins carriers. By results of the research in vitro on cultures of a liver валсартан is substrate for proteins of carriers of OATP1B1 and MRP2. Co-administration of a valsartan with inhibitors of protein carrier OATP1B1 (rifampicin, cyclosporine) and with inhibitors of protein carrier MRP2 (ритонавир) can increase system exposure of a valsartan (Cmax and AUC).
 
Lithium drugs. At use of APF inhibitors along with drugs of lithium increase in content of lithium in a blood plasma and strengthening of its toxic action is noted. It is not recommended to apply валсартан along with lithium drugs (experience of use is limited). In need of use of a valsartan along with drugs of lithium it is necessary to provide control of content of lithium in a blood plasma.

At simultaneous use of a valsartan with the dietary supplements containing potassium, kaliysberegayushchy Diuretinums (including Spironolactonum, эплеренон, Triamterenum, amiloride), kaliysoderzhashchy substitutes of salt or with other drugs which can cause increase in content of potassium in blood (for example, with heparin) it is necessary to be careful and carry out regular control of content of potassium to blood.

At children and teenagers arterial hypertension is often connected with a renal failure. It is recommended to this category of patients to take with caution валсартан along with other drugs influencing renin-angiotensin-aldosteronovuyu system as it can lead to increase in potassium concentration in blood serum. It is necessary to carry out regular control of function of kidneys and potassium concentration in blood serum at this group of patients.

Contraindications:

Hypersensitivity to a valsartan or any other component of drug.

Pregnancy and period of feeding by a breast.

Heavy abnormal liver functions, biliary cirrhosis and cholestasia.

Simultaneous use with aliskireny for patients with a diabetes mellitus or patients with a renal failure (clearance of creatinine less than 60 ml/min.).

Age up to 6 years - according to the indication arterial hypertension, up to 18 years - according to other indications.

Monohydrate therefore drug should not be used at a lactose intolerance, deficit of lactase, glyukozo-galaktozny malabsorption is a part of drug lactoses.

With care. Drug Valaar needs to be used with care at a bilateral stenosis of renal arteries, a stenosis of an artery of the only kidney, primary hyper aldosteronism, at observance of a diet with restriction of consumption of table salt; at the states which are followed by decrease in volume of the circulating blood (including diarrhea, vomiting); adult patients with KK have less than 10 ml/min., patients have from 6 to 18 years with KK less than 30 ml/min. including which are on a hemodialysis with easy and moderate abnormal liver functions of not biliary genesis without the cholestasia phenomena, at patients with HSN III-IV of a functional class on NYHA, function of kidneys at which depends from the system renin-angiotensin-aldosteronovoy (SRAA), at patients with a mitral or aortal stenosis, a hypertrophic subaortic stenosis, and also at patients is after transplantation of a kidney.

Drug Valaar should be used with care at patients with a hereditary Quincke's disease, or a Quincke's disease against the background of the previous use of antagonists of receptors of angiotensin II (the MACAW of II) or APF inhibitors. It is necessary to be careful at co-administration of drug with other means the inhibiting RAAS, such as APF inhibitors or the aliskiren-containing drugs.

It is not recommended to use drug along with APF inhibitors as this combination therapy has no advantages before monotherapy valsartany or APF inhibitor concerning indicators of the general mortality for any reason.

Overdose:

Symptoms. At overdose of a valsartan the main manifestation is the expressed decrease in the ABP which can lead to consciousness oppression, a collapse and/or shock.

Treatment. A symptomatic treatment which character depends on time which passed from the moment of administration of drug and on severity of symptoms.

At accidental overdose it is necessary to cause vomiting (if drug was accepted recently) or to carry out a gastric lavage. In case of the expressed decrease in the ABP as therapy intravenous administration of 0,9% of solution of sodium of chloride is necessary, the patient should be laid, having raised legs, for a span, necessary for therapy, to take active measures for maintenance of activity of cardiovascular system, including regular control of action of the heart and respiratory system, the volume of the circulating blood (VCB) and amount of the emitted urine.

Storage conditions:

In the dry place protected from light at a temperature not above 25 °C. To store in the place, unavailable to children. A period of validity - 2 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets, film coated, 40 mg and 80 mg. On 7, 10, 14, 15, 20, 30 tablets in a blister strip packaging from a film of the polyvinyl chloride and printing aluminum foil varnished. On 1, 2, 3, 4, 5, 6, 7, 8, 20, 50, 70, 80 or 100 blister strip packagings together with the application instruction in a pack from a cardboard.