Universal reference book for medicines
Product name: VALAAR (VALAAR)

Active substance: valsartan

Type: Angiotensin II receptor antagonist

Manufacturer: ФП ОБОЛЕНСКОЕ (Russia)
Composition, form of production and packaging
The tablets covered with a film membrane of
brownish-yellow color, round, biconcave;
On the cross-section, the inner layer is white or almost white.
1 tab.

valsartan 40 mg

Excipients: microcrystalline cellulose - 29.75 mg, lactose monohydrate 9 mg, carboxymethyl starch sodium (sodium starch glycolate) 7.2 mg, povidone 2.7 mg, sodium lauryl sulfate 0.45 mg, magnesium stearate 0.9 mg.

The composition of the shell: Opadrai II (polyvinyl alcohol 1.2 mg, macrogol 3350-0.606 mg, talc 0.444 mg, titanium dioxide 0.604 mg, iron oxide yellow 0.141 mg, iron oxide red 0.003 mg, iron oxide black 0.002 mg) .

7 pcs.
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14 pcs.
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30 pcs.
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The tablets covered with a film cover of pink color, round, biconcave;
On the cross-section, the inner layer is white or almost white.
1 tab.

valsartan 80 mg

Excipients: microcrystalline cellulose - 59.5 mg, lactose monohydrate - 18 mg, carboxymethyl starch sodium (sodium starch glycolate) - 14.4 mg, povidone 5.4 mg, sodium lauryl sulfate 0.9 mg, magnesium stearate 1.8 mg.

The composition of the shell: Opadrai II (alcohol polyvinyl - 2 mg, macrogol 3350 - 1.01 mg, talc 0.74 mg, titanium dioxide 1.17 mg, aluminum varnish based on the dye charming red 0.029 mg, aluminum varnish based on dye azorubin 0.023 mg, aluminum lacquer based on the dye sunset sunset yellow - 0.028 mg).

7 pcs.
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7 pcs.
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7 pcs.
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10 pieces.
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14 pcs.
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14 pcs.
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14 pcs.
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14 pcs.
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14 pcs.
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14 pcs.
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14 pcs.
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14 pcs.
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15 pcs.
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15 pcs.
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15 pcs.
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15 pcs.
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15 pcs.
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15 pcs.
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15 pcs.
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15 pcs.
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20 pcs.
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20 pcs.
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20 pcs.
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20 pcs.
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20 pcs.
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30 pcs.
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30 pcs.
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30 pcs.
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30 pcs.
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INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2016.

PHARMACHOLOGIC EFFECT

Valsartan is an active specific antagonist of angiotensin II receptors.
Selectively blocks the receptors of the subtype AT 1 , which are responsible for the effects of angiotensin II. The consequence of blockade of AT 1 -receptors is an increase in the plasma concentration of angiotensin II, which can stimulate unblocked AT 2receptors. Valsartan does not have any marked agonistic activity against AT 1 -receptors. The affinity of valsartan for AT 1 subtype receptors is about 20,000 times higher than for AT 2 receptor subtypes. Valsartan does not interact and does not block the receptors of other hormones or ion channels that are important in regulating the functions of the cardiovascular system. The likelihood of coughing with valsartan is very low, which is due to the lack of influence on the ACE, which is responsible for the degradation of bradykinin. A comparison of valsartan with an ACE inhibitor shows that the incidence of dry cough is significantly (p <0.05) lower in patients taking valsartan than in patients taking an ACE inhibitor (2.6% vs. 7.9%, respectively). In the group of patients who previously developed a dry cough with the ACE inhibitor, in valsartan treatment, this undesirable reaction was observed in 19.5% of cases, and in the treatment with thiazide diuretic - in 19.0% of cases, while in the group of patients treated with an ACE inhibitor , cough is observed in 68.5% of cases (p <0.05).
Use in hypertension in patients older than 18 years

In the treatment of valsartan in patients with hypertension, there is a decrease in blood pressure, not accompanied by a change in heart rate.

After the administration of a single dose of the drug in most patients, the onset of antihypertensive action is observed within 2 hours, and the maximum decrease in blood pressure is reached within 4-6 hours, which lasts for more than 24 hours. With repeated use of valsartan, the maximum decrease in blood pressure, regardless of the dose, is achieved within 2-4 weeks, and is maintained at the achieved level during prolonged therapy.
In the case of simultaneous application of valsartan with hydrochlorothiazide, a significant additional decrease in blood pressure is achieved. A sharp discontinuation of valsartan is not accompanied by a significant increase in blood pressure or other undesirable reactions. In patients with arterial hypertension, type 2 diabetes and nephropathy, taking valsartan in a dose of 160-320 mg, there is a significant decrease in proteinuria (36-44%).
Application after acute myocardial infarction in patients older than 18 years

With the use of valsartan for 2 years in patients between 12 hours and 10 days after acute myocardial infarction (complicated by left ventricular failure and / or left ventricular systolic dysfunction), the overall mortality, cardiovascular mortality and the time to the first hospitalization by the exacerbation of chronic heart failure, repeated myocardial infarction, sudden cardiac arrest and stroke (without a lethal outcome).
The safety profile of valsartan in patients with acute myocardial infarction is similar to that in other conditions.
Chronic heart failure (CHF) in patients older than 18 years

Using valsartan (at an average daily dose of 254 mg) for 2 years in patients with CHF II (62%), III (36%) and IV (2%) NYHA with LVEF less than 40 (93%), diuretics (86%), digoxin (67%) and beta-blockers (36%) showed a significant decrease (by 27.5%) and internal diastolic diameter of the left than 2.9 cm / m 2 , receiving standard therapy, including ACE inhibitors %) risk of hospitalization for worsening of the course of CHF.

In patients who did not receive ACE inhibitors, there was a significant reduction in the overall mortality rate (by 33%), cardiovascular mortality and incidence associated with CHF (time to the onset of the first cardiovascular event), which are estimated by the following indicators: death, sudden death with resuscitation, hospitalization for exacerbation of CHF flow, intravenous injection of inotropic or vasodilating drugs for 4 or more hours without hospitalization (by 44%).
In the group of patients receiving ACE inhibitors (without beta-blockers), there is no decrease in the overall mortality rate with valsartan, but the cardiovascular mortality and morbidity associated with CHF decrease by 18.3%.
In general, the use of valsartan reduces the number of hospitalizations for CHF, slows the progression of CHF, improves the NYHA class of CHF, increases the left ventricular ejection fraction, and decreases the signs and symptoms of heart failure and improves quality of life compared with placebo.

Use in patients over 18 years of age with arterial hypertension and impaired glucose tolerance

With the use of valsartan and lifestyle changes, there was a statistically significant reduction in the risk of developing diabetes in this category of patients.
Valsartan had no effect on the incidence of fatal outcomes as a result of cardiovascular events, myocardial infarction and ischemic attacks without lethal outcomes, hospitalization due to heart failure or unstable angina, arterial revascularization, in patients with impaired glucose tolerance and hypertension, age, gender and race. In patients receiving valsartan, the risk of developing microalbuminuria was significantly lower than in patients not receiving this therapy.
Use in children and adolescents aged 6 to 18 years with hypertension

In children and adolescents aged 6 to 18 years, valsartan provides a dose-dependent, smooth decrease in blood pressure.
When valsartan is used, the maximum decrease in blood pressure, regardless of the dose taken, is usually achieved within 2 weeks, and is maintained at the achieved level during prolonged therapy.
PHARMACOKINETICS

Suction

After oral intake of valsartan is rapid, C max valsartan in blood plasma is achieved within 2-4 hours. The average absolute bioavailability is 23%.
When using valsartan with food, AUC and C max decrease by 40% and 50%, respectively, although starting from about the 8th hour after taking the drug, the concentration of valsartan in the blood plasma, both in the case of fasting, and in the case of food intake , the same. The decrease in AUC, however, is not accompanied by a clinically significant decrease in the therapeutic effect, so valsartan can be taken regardless of the time of ingestion.
Distribution

After intravenous administration of V d, valsartan in the equilibrium state was about 17 liters, indicating a lack of extensive distribution of valsartan in the tissues.Valsartan largely binds to serum proteins (94-97%), mainly with albumins.

Metabolism

Valsartan does not undergo a pronounced metabolism (about 20% of the dose is determined in the form of metabolites).
The hydroxyl metabolite is determined in blood plasma at low concentrations (less than 10% of the valsartan AUC). This metabolite is pharmacologically inactive.
Excretion

Valsartan is biphasic: the β phase with T 1/2 is less than 1 hour and the β phase with T 1/2 is about 9 hours. Valsartan is excreted mainly unchanged through the intestine (about 83%) and kidneys (about 13%) .
After IV introduction, the plasma clearance of valsartan is about 2 l / h and its renal clearance is 0.62 l / h (about 30% of the total clearance). T 1/2 of valsartan is 6 hours.
Pharmacokinetics in special clinical cases

Patients with CHF.
In this category of patients, the time to reach C max and T 1/2 is similar to that of healthy volunteers. The increase in AUC and C max is directly proportional to the increase in the dose of the drug (from 40 mg to 160 mg 2 times). The cumulation factor averages 1.7. When administered, the clearance of valsartan was approximately 4.5 l / h. The age of patients with CHF did not affect the clearance of valsartan.
Patients over the age of 65 years.
In some patients over the age of 65, systemic bioavailability of valsartan is higher than that of young patients (it has no clinical significance).
Patients with impaired renal function.
Correlation between renal function and systemic bioavailability of valsartan is absent. In patients with impaired renal function and KK> 10 ml / min, dose adjustment is not required. Currently, there is no data on the use in patients on hemodialysis. Valsartan has a high degree of binding to blood plasma proteins, so its elimination in hemodialysis is unlikely
Patients with impaired hepatic function.
In patients with mild and moderate impairment of liver function, the bioavailability (AUC) of valsartan is increased by a factor of 2 compared to healthy volunteers. However, there is no correlation between the values ​​of AUC of valsartan and the degree of impaired hepatic function. The use of the drug in patients with severe impairment of liver function has not been studied.
Children and adolescents aged 6 to 18 years

The pharmacokinetic properties of valsartan in children and adolescents aged 6 to 18 years do not differ from the pharmacokinetic properties of valsartan in patients older than 18 years.

INDICATIONS

Adults

- arterial hypertension;

- chronic heart failure (NYHA class II-IV functional class) in patients receiving standard therapy with one or more drugs from the following pharmacotherapeutic groups: diuretics, cardiac glycosides, ACE inhibitors or beta-blockers (each of these drugs is optional) ;

- to improve the survival of patients after acute myocardial infarction complicated by left ventricular failure and / or left ventricular systolic dysfunction, with stable hemodynamic parameters.

Children and teens

- Arterial hypertension in children and adolescents aged 6 to 18 years.

DOSING MODE

Is taken orally, without chewing, regardless of food intake, with plenty of water.

Adults

With arterial hypertension, the recommended initial dose of Valaar is 80 mg 1 time / day, regardless of race, age and sex of the patient.
Antihypertensive effect is observed in the first 2 weeks of treatment, the maximum effect develops after 4 weeks. For those patients who do not achieve an adequate therapeutic response, the daily dose of the drug can be gradually increased to a maximum daily dose of 320 mg or diuretics should be additionally applied.
In chronic heart failure, the recommended initial dose of Valaar is 40 mg 2 times / day.
The dose of the drug should be gradually increased for at least 2 weeks to 80 mg 2 times / day, and with good tolerability - up to 160 mg 2 times / day. The maximum daily dose is 320 mg in 2 divided doses. It may be necessary to reduce the dose of concurrently taken diuretics.
To improve the survival rate of patients after acute myocardial infarction, treatment should be started within 12 hours after myocardial infarction.

The initial dose is 20 mg (1/2 tablet 40 mg) 2 times / day.
The dose is increased by titration (40 mg, 80 mg, 160 mg 2 times / day) for the next several weeks, until the target dose of 160 mg 2 times / day is reached.
The maximum daily dose is 320 mg in 2 divided doses.
Usually, it is recommended to increase the dose to 80 mg 2 times / day by the end of 2 weeks of treatment.Achievement of the maximum target dose of 160 mg 2 times / day is recommended by the end of the third month of therapy with the drug Valaar. The increase in dose depends on the tolerability of the drug during the titration period.
In the case of development of arterial hypotension, accompanied by clinical manifestations, or renal dysfunction should consider reducing the dose.

Assessment of the condition of patients in the post-myocardial infarction period includes evaluation of renal function.

In patients older than 65 years, dose adjustment is not required.

In patients with impaired renal function, dose adjustment is not required.
Currently, there is no data on the use of the drug in patients with CC <10 ml / min .
In patients with mild or moderate impairment of non-biliary liver function without the effects of cholestasis, the drug should be used with caution, the daily dose should not exceed 80 mg.

Children and adolescents aged 6 to 18 years

With arterial hypertension, the recommended initial dose of the drug Valaar in children and adolescents aged 6 to 18 years is 40 mg with a body weight of the child less than 35 kg and 80 mg with a body weight of the child more than 35 kg.
The dose is recommended to be adjusted taking into account the decrease in blood pressure. The maximum recommended doses are shown in the table below. The use of the drug in higher doses is not recommended.
Body weight The maximum recommended daily dose

? 8 kg <35 kg 80 mg

? 35 kg <80 kg 160 mg

? 80 kg? 160 kg 320 mg

SIDE EFFECT

Data on the dependence of the frequency of any of the undesirable reactions on the dose or duration of valsartan treatment, as well as sex, age or race, are not available.
The safety profile of valsartan in children and adolescents aged 6 to 18 years with arterial hypertension does not differ from that of valsartan in adult patients.
Below are the undesirable reactions that were observed during clinical trials, as well as with the use of the drug in clinical practice.

The incidence of adverse reactions is given in accordance with the WHO classification: very often (? 1/10 cases), often (> 1/100 and <1/10 cases), infrequently (> 1/1000 and <1/100 cases), rarely (> 1/10000 and <1/1000 cases) and very rarely (<1/10000 cases, including individual messages).
Within each group allocated according to frequency of occurrence, the undesirable reactions are distributed in order of decreasing importance.
For all the undesirable reactions revealed in clinical practice and in the analysis of laboratory indicators (the frequency of development of which can not be established), the gradation "frequency unknown" was used.

Patients with hypertension

On the part of the hematopoiesis system: the frequency is unknown - a decrease in hemoglobin, hematocrit, neutropenia, thrombocytopenia.

From the side of the immune system: the frequency is unknown - reactions of hypersensitivity, including serum sickness.

From the side of metabolism: the frequency is unknown - an increase in the potassium content in the blood serum.

From the side of the organ of hearing and labyrinthine disorders: infrequently - vertigo.

From the cardiovascular system: the frequency is unknown - vasculitis.

From the respiratory system: infrequently - cough.

From the digestive system: infrequently - pain in the abdomen.

From the hepatobiliary system: the frequency is unknown - a violation of the liver, including an increase in the concentration of bilirubin in the blood plasma.

From the skin and subcutaneous tissue: very rarely - angioedema, skin rash, itching.

From the musculoskeletal system: the frequency is unknown - myalgia.

From the urinary system: the frequency is unknown - impaired renal function, elevated serum creatinine concentration in the serum.
Other: rarely - fatigue.
Also in the course of clinical studies in hypertensive patients showed the following adverse events, a causal relationship that drug-Off: arthralgia, asthenia, back pain, diarrhea, dizziness, insomnia, decreased libido, nausea, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral infection.
Patients receiving valsartan after acute myocardial infarction and / or CHF
Hematopoietic system: the frequency is unknown - thrombocytopenia.
Immune system: the frequency is unknown - hypersensitivity reactions, including serum sickness.
On the part of metabolism: rarely - hyperkalemia; the frequency is unknown - an increase of potassium in the blood serum.
From the nervous system: often - dizziness, postural dizziness; infrequently - fainting, headache.
On the part of the ear and labyrinth disorders: rare - vertigo.
Cardio-vascular system: often - pronounced decrease in blood pressure, orthostatic hypotension; Infrequent - increased symptoms of chronic heart failure; the frequency is unknown - vasculitis.
The respiratory system: rarely - cough.
From the digestive system: rarely - nausea, diarrhea.
On the part of the hepatobiliary system: the frequency is unknown - abnormal liver function.
Skin and subcutaneous tissue: very rarely - angioedema; the frequency is unknown - skin rash, itching.
On the part of the musculoskeletal system: rarely - rhabdomyolysis; the frequency is unknown - myalgia.
The kidneys: often - renal dysfunction; rarely - acute renal failure, elevated serum creatinine concentration in the serum; frequency is unknown - increase in the content of urea nitrogen in the blood plasma.
General disorders: rarely - fatigue, fatigue.
It is also in clinical trials in patients after acute myocardial infarction and / or heart failure have been observed following adverse events, a causal relationship that drug-Off: arthralgia, abdominal pain, back pain, asthenia, insomnia, decreased libido, neutropenia peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral infection.
If any of the above adverse reactions were aggravated or any other adverse reaction, inform your doctor.
CONTRAINDICATIONS

- increased sensitivity to valsartan or any other component of the formulation;
severe hepatic impairment;

- biliary cirrhosis;
- cholestasis;
- simultaneous application of aliskiren in patients with diabetes or patients with impaired renal function (creatinine clearance <60 mL / min);
- Pregnancy;

- the period of breastfeeding;

- Children under 6 years (as indicated by arterial hypertension);
- child and adolescence to 18 years (except hypertension);
- the drug includes lactose monohydrate, and the drug should not be used with lactose intolerance, lactase deficiency, glucose-galactose malabsorption.
Carefullyuse in patients with bilateral renal artery stenosis, stenosis of the artery to a solitary kidney, primary hyperaldosteronism, with a diet with restriction of salt intake; under conditions involving a decrease in the bcc (including diarrhea, vomiting); adult patients with creatinine clearance <10 mL / min, patients from 6 to 18 years, with creatinine clearance <30 mL / min, including hemodialysis, with mild to moderate hepatic impairment nebiliarnogo genesis without signs of cholestasis in patients with CHF III-IV FC by NYHA, kidney function in which dependent on the RAAS in patients with mitral or aortic stenosis, hypertrophic obstructive cardiomyopathy, and in patients after kidney transplantation; in patients with hereditary angioedema,or angioedema amid prior application of angiotensin II receptor antagonists (ARA II) or ACE inhibitors; simultaneous administration with other agents that inhibit the RAAS, such as ACE inhibitors or aliskiren-containing formulations.
Do not use the drug in conjunction with ACE inhibitors, since this combination therapy has advantages over monotherapy with valsartan or ACE inhibitor in relation to total mortality for any reason.
PREGNANCY AND LACTATION

Considering the mechanism of action of angiotensin II receptor antagonists, we can not exclude the risk to the fetus. The action of ACE inhibitors (drugs that affect the RAAS) on the fetus in the case of use in II and III trimester pregnancy, can lead to damage and destruction. According to the historical data with the use of ACE inhibitors in the I trimester of pregnancy increases the risk of having children with birth defects. There have been reports of spontaneous abortion, oligohydramnios and renal function in newborns whose mothers during pregnancy accidentally received valsartan. Valaar, like any other drug, has a direct impact on the RAAS, should not be used during pregnancy and in women planning a pregnancy. In applying means acting on the RAASthe doctor should inform women of childbearing age about the potential risk of the negative impact of these drugs on the fetus during pregnancy. If pregnancy is diagnosed during treatment with Valaar, should be abolished as soon as possible treatment.
In preclinical studies in animals were not observed treatment effects of valsartan on fertility. Data on the effect of valsartan on fertility in humans.
It is not known whether valsartan is excreted in breast milk. Therefore you should not use the drug during lactation.
APPLICATION FOR FUNCTIONS OF THE LIVER

Contra: simultaneous application of aliskiren in patients with diabetes or patients with impaired renal function (creatinine clearance <60 mL / min).
In patients with impaired renal function, the correction dose is not required. Currently there are no data on the use of the drug in patients with creatinine clearance <10 mL / min .
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindications: severe liver dysfunction; biliary cirrhosis; cholestasis.
In patients with mild to moderate hepatic impairment nebiliarnogo genesis without signs of cholestasis drug should be used with caution, the daily dose should not exceed 80 mg.
APPLICATION FOR CHILDREN

Contraindications:

- Children under 6 years (as indicated by arterial hypertension);
- child and adolescence to 18 years (except hypertension);
SPECIAL INSTRUCTIONS

Kidney transplantation
Safety Data application of valsartan in patients undergoing kidney transplantation, no.
The deficit in the body of sodium and / or decrease in CBV
Patients with severe deficiency in the body of sodium and / or reduced BCC, for example, receiving high doses of diuretics, in rare cases, at the beginning of treatment can develop hypotension accompanied by clinical manifestations. Before the start of drug treatment should carry out the correction contents in the body of sodium and / or fill bcc, including by reducing the dose of a diuretic.
Renal artery stenosis
The use of a short course of the drug in patients with renovascular hypertension, which developed secondary to unilateral renal artery stenosis only, does not lead to any significant change in parameters of renal hemodynamics, concentrations of serum creatinine or blood urea nitrogen. However, given that other drugs that affect the RAAS can cause increase in the concentration of urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney, as a precaution we recommend monitoring these indicators.
primary aldosteronism
The drug is not effective for the treatment of hypertension in patients with primary hyperaldosteronism since this category of patients is not marked activation of the RAAS.
CHF / post-myocardial infarction
patients with heart failure or post-myocardial infarction, starting treatment with valsartan, often marked by a decrease in blood pressure, and therefore it is recommended to monitor blood pressure at the beginning of therapy. Subject to the recommendations of the dosage regimen is usually no need discontinuation due to hypotension. Evaluation of patients with CHF condition includes evaluating kidney function.
As a consequence of inhibiting the RAAS, some patients may be impaired renal function. In patients with CHF III-IV functional class NYHA classification, kidney function in which dependent on the RAAS condition, the treatment with ACE inhibitors and angiotensin receptor antagonists II may be accompanied by oliguria and / or increase of azotemia and in rare cases the development of acute renal failure and / or lethal outcome. Therefore, the data categories of patients prior to application of the drug, as well as periodically during the treatment, it is necessary to assess renal function.
Combination therapy in hypertension
When hypertension Valaar product can be used as monotherapy, and together with other antihypertensives, in particular diuretics.
Combination therapy during the post-myocardial infarction
possible to use Valaar drug in combination with other drugs used after myocardial infarction, namely: thrombolytics, aspirin as antiplatelet drugs, beta-blockers and inhibitors of HMG-CoA reductase inhibitors (statins) . In this category of patients is not recommended Valaar drug concurrently with ACE inhibitors, since this combination therapy is not superior to monotherapy with valsartan or inhibitor
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