Valsacor, pills 320mg 30pcs

Composition

1 film-coated tablet contains:

Core:

Active ingredient:

Valsartan 320.00 mg

Auxiliary substances:

Lactose monohydrate, microcrystalline cellulose, povidone K-25, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate

Film shell:

Hypromellose, Titanium dioxide (E 171), iron oxide yellow dye (E 172), Iron oxide red dye (E 172), macrogol-4000

Pharmacological action

of angiotensin II receptor antagonist

Clinical Pharmacology

Pharmacodynamics

Valsartan is a selective angiotensin II receptor antagonist (ARA II) for intraprotein use.

Selectively blocks AT_-1receptors. The consequence_ofAT1 receptor blockade is an increase in the plasma concentration of angiotensin II, which, in turn, can stimulate unblocked AT2 subtype receptors, which presumably regulates the effects_ofAT1 receptors. Valsartan has no agonistic activity against AT1receptors. Its affinity for AT1 subtype receptors is approximately 20,000 times greater than for AT2receptors.

Valsartan does not inhibit the angiotensin-converting enzyme (ACE), also known as kininase II, which converts angiotensin I to angiotensin II and destroys bradykinin. Due to the lack of influence on ACE, the effects of bradykinin and substance P are not potentiated, so the development of a dry cough is unlikely when taking AR IIM. Valsartan does not interact with or block the receptors of other hormones or ion channels involved in regulating the functions of the cardiovascular system.

Use in arterial hypertension (AH) in patients over 18 years of age

During treatment, AGvalsartan reduces blood pressure (BP) without affecting the heart rate (HR).

After oral use of a single dose of valsartan, the antihypertensive effect develops within 2 hours, and the maximum reduction in blood pressure is achieved within 4-6 hours. The antihypertensive effect of valsartan persists for 24 hours after taking it. With repeated use of valsartan, the maximum reduction in blood pressure, regardless of the dose, is achieved after 2-4 weeks and is maintained at the achieved level with long-term therapy. Concomitant use with hydrochlorothiazide (HCT) can achieve a significant additional reduction in blood pressure.

Sudden discontinuation of valsartan is not associated with a significant increase in blood pressure or other adverse events (AES).

In patients with hypertension, type 2 diabetes mellitus, and nephropathy taking valsartan at a dose of 160-320 mg, there is a clinically significant decrease in proteinuria (albumin excretion) (36-44%).

Use after acute myocardial infarction in patients over 18 years of age

The use of valsartan in patients from 12 hours to 10 days after the development of acute myocardial infarction complicated by left ventricular failure and/or systolic dysfunction of the left ventricle (LV) for 2 years reduces the overall mortality rate, cardiovascular mortality and extends the time to the first hospitalization for exacerbation of chronic heart failure (CHF), recurrent myocardial infarction, sudden cardiac arrest and stroke (without fatal outcome).

The safety profile of valsartan in patients with acute myocardial infarction is similar to that in other conditions.

CHF in patients over 18 years of age

In the application of valsartan to standard therapy (ACE inhibitors and/or diuretics and/or digoxin and/or beta-blockers) for 2 years in patients with CHF II-IV functional class (FC) NYHA classification with the ejection fraction of the left ventricle (FULI) less than 40% and internal end-diastolic size of the left ventricle (LV KDR) 2.9 cm/m2 noted significant reduction in the risk of first hospitalization for exacerbation of the course of CHF.

In patients who do not receive ACE inhibitors, valsartan treatment significantly reduces overall mortality, cardiovascular mortality, and CHF-related morbidity. When using ACE inhibitors without a beta-blocker, cardiovascular mortality and morbidity associated with CHF are reduced. Valsartan treatment leads to a significant reduction in the NYHA FC of CHF and a reduction in the severity of heart failure symptoms (including shortness of breath, fatigue, edema and “wet” wheezing in the lungs), significantly improves the quality of life (Minnesota Questionnaire for Assessing the Quality of Life of Patients with CHF), increases LVEF and slightly reduces LV CDR.

Use in patients over 18 years of age with 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 mellitus in this category of patients. Valsartan had no effect on the frequency of deaths due to cardiovascular events, myocardial infarction and non-fatal ischemic attacks, on the frequency of hospitalizations due to exacerbation of CHF or unstable angina, arterial revascularization in patients with impaired glucose tolerance and hypertension, differing in age, gender and race.

Use in children and adolescents from 6 to 18 years of age with hypertension

In children and adolescents from 6 to 18 years of age, valsartan provides a dose-dependent, smooth decrease in blood pressure. When using valsartan, the maximum reduction in blood pressure, regardless of the dose taken orally, is usually achieved within 2 weeks and maintained at the achieved level during long-term therapy.

Pharmacokinetics

In the range of studied doses, the pharmacokinetics of valsartan are linear. No changes in pharmacokinetic parameters were observed with repeated use of valsartan. When taking valsartan 1 time a day, accumulation is insignificant. Plasma concentrations of valsartan were similar in men and women.

Valsartan is rapidly absorbed after oral use, the maximum concentration (cmax) in blood plasma is reached after 2-4 hours.

The average absolute bioavailability of valsartan is 23%.

When valsartan is taken concomitantly with food, the area under the concentration-time curve (AUC)decreases by 48%, although starting from about 8 hours after taking valsartan, its concentration in blood plasma is the same both when taken on an empty stomach and when taken with food. 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 meal time.

Valsartan is largely bound to serum proteins (94-97%), mainly to albumin. The equilibrium volume of distribution of valsartan is small, about 17 liters. Valsartan does not undergo a pronounced metabolism (about 20% of the dose taken is determined in the form of metabolites). The hydroxyl metabolite is detected in blood plasma at low concentrations (less than 10% of the AUC of valsartan). This metabolite is pharmacologically inactive.

Valsartan is excreted in two phases: alpha-phase with a half-life (_T1/2α) of less than 1 hour and beta-phase with T_1/2-about 9 hours. Valsartan is mainly excreted unchanged in the bile through the intestines (about 83%) and kidneys (about 13%). After intravenous use, 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_1/2of valsartan is 6 hours.

Pharmacokinetics in selected groups of patients

Patients with CHF

In this category of patients, the time to reach C_{of max} and T_1/2is similar to that in healthy volunteers. The increase in AUC and_Cmax is directly proportional to the increase in the dose of valsartan (from 40 mg to 160 mg – 2 times). The cumulative factor is on average 1.7. When taken orally, the clearance of valsartan was approximately 4.5 liters/hour. The age of patients with CHF did not affect the clearance of valsartan.

Elderly patients (over 65 years of age)

In some patients over the age of 65, the systemic bioavailability of valsartan is higher than in young patients, but there is no clinical significance of this fact.

Patients with impaired renal function

There is no correlation between renal function and systemic bioavailability of valsartan. In patients with impaired renal function and creatinine clearance greater than 10 ml/min, no dose adjustment is required. Currently, there are no data on the use of valsartan in patients undergoing hemodialysis. Valsartan has a high degree of binding to plasma proteins, so its elimination during hemodialysis is unlikely.

Patients with impaired liver function

In patients with mild to moderate hepatic impairment, there is a 2-fold increase in the bioavailability (AUC) of valsartan compared to healthy volunteers. However, there is no correlation between valsartan AUC values and the degree of hepatic impairment. The use of valsartan in patients with severe hepatic impairment has not been studied.

Patients from 6 to 18 years

of age The pharmacokinetics of valsartan in children and adolescents from 6 to 18 years of age do not differ from the pharmacokinetics of valsartan in patients over 18 years of age.

Indications

Patients over 18 years of age

• Arterial hypertension.
• Chronic heart failure (NYHA II-IVFC) in patients receiving standard therapy with one or more drugs from the following groups: diuretics, cardiac glycosides, as well as ACE inhibitors or beta-blockers. The use of each of these drugs is not mandatory.
• Improving the survival rate of patients with acute myocardial infarction complicated by left ventricular insufficiency and / or left ventricular systolic dysfunction, in the presence of stable hemodynamic parameters.

Patients from 6 to 18 years of age

• Arterial hypertension in children and adolescents from 6 to 18 years.

Use during pregnancy and lactation

Pregnancy

Given the mechanism of action of ARAII, the risk to the fetus cannot be excluded. The drug is contraindicated in the II-III trimesters of pregnancy, since use in the II-III trimesters of pregnancy can cause fetotoxic effects (decreased renal function, lack of water, slowing ossification of the fetal skull bones) and neonatal toxic effects (renal failure, hypotension, hyperkalemia). If the drug was still used in the II-III trimesters of pregnancy, then it is necessary to conduct an ultrasound examination of the kidneys and skull bones of the fetus.

Valsacor®, like any other drug that has a direct effect on the RAAS, should not be used during pregnancy, as well as in women planning pregnancy. When planning pregnancy, it is recommended to transfer the patient to alternative antihypertensive therapy, taking into account the safety profile.

When using drugs that affect the RAAS, it is necessary to inform women of childbearing age about the potential risk of negative effects of these drugs on the fetus during pregnancy. If pregnancy is confirmed, Valsacor should be discontinued as soon as possible.

Breast-feeding period

It is not known whether valsartan is excreted in breast milk. If it is necessary to use Valsacor®during lactation, breastfeeding should be discontinued.

Fertility

The use of valsartan did not have an adverse effect on reproductive function in male and female rats at doses up to 200 mg/kg/day when taken orally. The indicated dose is 6 times higher than the maximum recommended daily dose of a person in terms of mg/m2 of body surface area (calculations were made at the rate of 320 mg / day when taken orally and the patient’s body weight of 60 kg).

Recommendations for use

Take orally at a dose of 80 mg 1 time/day or 40 mg 2 times/day, daily.

In the absence of an adequate effect, the daily dose can be gradually increased.

The maximum daily dose is 320 mg in 2 divided doses.

Contraindications

• Hypersensitivity to valsartan or other components of the drug.
• Pregnancy and breast-feeding period.
• Concomitant use with aliskiren and drugs containing aliskiren in patients with diabetes mellitus and/or moderate to severe renal impairment (glomerular filtration rate (GFR) less than 60 ml/min/1.73 m2 of body surface area).
• Concomitant use with ACE inhibitors in patients with diabetic nephropathy.
• Age up to 6 years – according to the indication of arterial hypertension, up to 18 years – according to other indications.
• Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.
• Liver function disorders, biliary cirrhosis and cholestasis.

Side effects

The incidence of AE is comparable to placebo. There are no data on the dose or duration of treatment associated with the incidence of AE, or on the age, gender, or race of patients. The safety profile of valsartan in patients with hypertension aged 6-18 years does not differ from the safety profile of valsartan in patients with hypertension older than 18 years.

Classification of the frequency of side effects recommended by the World Health Organization (WHO):

very common ≥1/10

common ≥1/100 to <1/10

uncommon ≥1/1000 to <1/100

rare ≥1/10000 to <1/1000

very rare <1/10000

frequency unknown cannot be estimated based on available data.

All valsartan AES detected in clinical practice and in the analysis of laboratory parameters cannot be attributed to any frequency of occurrence, so they are assigned to the “frequency unknown” group.

Arterial hypertension

Disorders of the blood and lymphatic system:

frequency unknown: decreased hemoglobin, hematocrit, neutropenia, thrombocytopenia.

Immune system disorders:

frequency unknown: hypersensitivity reactions, including serum sickness.

Metabolic and nutritional disorders:

frequency unknown: increased serum potassium, hyponatremia.

Hearing disorders and labyrinth disorders:

infrequently: vertigo.

Vascular disorders:

frequency unknown: vasculitis.

Respiratory, thoracic and mediastinal disorders:

infrequently: cough.

Disorders of the gastrointestinal tract:

infrequently: abdominal pain.

Liver and biliary tract disorders:

frequency unknown: impaired liver function, including increased plasma bilirubin concentrations.

Skin and subcutaneous tissue disorders:

very rare: angioedema, skin rash, pruritus;

frequency unknown: bullous dermatitis.

Musculoskeletal and connective tissue disorders:

frequency unknown: myalgia.

Kidney and urinary tract disorders:

frequency unknown: impaired renal function, increased serum creatinine.

General disorders and disorders at the injection site:

infrequently: increased fatigue.

The following AES were also observed in patients with hypertension in clinical trials (no causal relationship with the drug was established):: arthralgia, asthenia, back pain, diarrhea, dizziness, insomnia, decreased libido, nausea, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

In adult patients with acute myocardial infarction and / or CHF, the safety profile in clinical trials differs slightly from that in patients with hypertension. This may be due to the disease itself.

CHF (NYHA FC II-IV)andincreased survival in patients with acute myocardial infarction

Disorders of the blood and lymphatic system:

frequency unknown: thrombocytopenia.

Immune system disorders:

frequency unknown: hypersensitivity reactions, including serum sickness.

Metabolic and nutritional disorders:

infrequently: hyperkalemia;

frequency unknown: increased serum potassium, hyponatremia.

Nervous system disorders:

common: dizziness, orthostatic (postural) vertigo;

uncommon: fainting, headache.

Hearing disorders and labyrinth disorders:

infrequently: vertigo.

Cardiac disorders:

infrequently: increased symptoms of CHF.

Vascular disorders:

common: marked decrease in blood pressure, orthostatic hypotension;

frequency unknown: vasculitis.

Respiratory, thoracic and mediastinal disorders:

infrequently: cough.

Disorders of the gastrointestinal tract:

infrequently: nausea, diarrhea.

Liver and biliary tract disorders:

frequency unknown: impaired liver function, increased activity of “hepatic” transaminases in blood plasma.

Skin and subcutaneous tissue disorders:

very rare: angioedema;

frequency unknown: skin rash, pruritus, bullous dermatitis, urticaria.

Musculoskeletal and connective tissue disorders:

rare: rhabdomyolysis;

frequency unknown: myalgia.

Kidney and urinary tract disorders:

frequently: impaired renal function;

infrequently: acute renal failure( acute renal failure), increased serum creatinine;

frequency unknown:increased serum residual urea nitrogen.

General disorders and disorders at the injection site:

infrequently: asthenia, increased fatigue.

The following AES were also observed in clinical trials in patients after acute myocardial infarction and/or CHF (a causal relationship with valsartan has not been established): arthralgia, abdominal pain, back pain, asthenia, insomnia, decreased libido, neutropenia, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

Interaction

Double blockade of the RAAS

In some patients, double blockade of the RAAS was accompanied by the development of hypotension, syncope, hyperkalemia, and impaired renal function, including acute renal failure.

Caution should be exercised when concomitant use of ARA II, including valsartan, with drugs that affect the RAAS, such as ACE inhibitors or aliskiren.

Concomitant use of ARA II, including valsartan, with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or moderate to severe renal impairment (GFR less than 60 ml/min / 1.73 m2 of body surface area) and is not recommended in other patients.

Concomitant use of ARA II with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.

Lithium

Concomitant use with lithium preparations is not recommended, since a reversible increase in the concentration of lithium in blood plasma and the development of intoxication is possible. Concomitant use of valsartan with diuretics and lithium preparations may contribute to an additional increase in lithium concentrations and increase the risk of intoxication. If concomitant use with lithium preparations is necessary, the concentration of lithium in the blood plasma should be carefully monitored.

Potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride), potassium preparations, potassium-containing food additives, and other drugs and substances that may increase the potassium content in the blood serum (for example, heparin)

If it is necessary to use concomitantly with drugs that affect the potassium content, it is recommended to monitor the potassium content in the blood plasma.

Non-steroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors, acetylsalicylic acid at a dose of more than 3 g / day, and non-selective NSAIDs

When used concomitantly, the antihypertensive effect may be weakened, the risk of developing impaired renal function may increase, and the potassium content in blood plasma may increase. At the beginning of therapy, it is recommended to assess kidney function, as well as correct violations of the water-electrolyte balance.

Carrier protein inhibitors

In vitro studies on liver cultures have shown that valsartan is a substrate for OATP1B1/OATP1B3 and MRP2 transporter proteins. The clinical significance of this fact is unknown. Concomitant use of OATP1B1/OATP1B3 transporter protein inhibitors (e. g. rifampicin, cyclosporine) and MRP2 (e. g. ritonavir) may increase the systemic exposure of valsartan (_cmax and AUC). This should be taken into account both at the beginning of combined therapy with these drugs, and at the end of it.

There were no clinically significant interactions with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, Indometacin, HCTZ, amlodipine and glibenclamide.

How to take, course of use and dosage

Inside, regardless of the meal time, without chewing, once a day.

Patients over 18 years of age

Arterial hypertension

Use of the drug Valsacor ® is possible in a dose of 40 mg,80 mg,160 mg,320 mg.

The recommended starting dose is 80 mg once a day, regardless of the patient’s race, age, or gender. The antihypertensive effect develops during 2 weeks of therapy and reaches its maximum after 4 weeks. In patients who are unable to achieve optimal blood pressure control, the daily dose of Valsacor® can be gradually increased to a maximum daily dose of 320 mg. Concomitant use of diuretics, such as HCT, can achieve a significant additional reduction in blood pressure.

Chronic heart failure (NYHA FC II-IV)

The recommended starting dose of Valsacor is 40 mg twice daily. The dose of the drug should be increased gradually for at least 2 weeks to 80 mg 2 times a day, and with good tolerability – to 160 mg 2 times a day. The maximum daily dose is 320 mg in 2 divided doses. In this case, it may be necessary to reduce the dose of simultaneously taken diuretics. It can be used simultaneously with other drugs intended for the treatment of CHF. However, the combination of an ACE inhibitor, beta-blocker and valsartan is not recommended. Renal function should always be evaluated in patients with CHF.

Improving the survival rate of patients with acute myocardial infarction

In patients with stable hemodynamics, treatment should begin as early as 12 hours after a myocardial infarction. The initial dose is 20 mg (1/2 tablet of 40 mg of Valsacor®) 2 times a day, then the dose is increased by titration to 40 mg,80 mg 2 times a day for several weeks, until the target dose of 160 mg 2 times a day is reached. The dose increase depends on the tolerability of valsartan during the titration period. The maximum daily dose is 320 mg in 2 divided doses.

As a rule, taking into account the tolerability of therapy, it is recommended to increase the dose to 80 mg 2 times a day by the end of the 2nd week of treatment and to the maximum target dose of 160 mg 2 times a day by the end of the 3rd month of therapy. In case of symptomatic hypotension or impaired renal function, it is advisable to consider reducing the dose.

Valsacor® can be used in patients after a myocardial infarction during therapy with other drugs, including thrombolytics, acetylsalicylic acid as an antiplatelet agent, beta-blockers, HMG-CoA reductase inhibitors (statins) and diuretics. It is not recommended to use Valsacor concomitantly with ACE inhibitors and other drugs that inhibit RAAS.

In patients with myocardial infarction, renal function should always be evaluated.

Special patient groups

Elderly patients (over 65 years of age)

For elderly patients, no dose adjustment is required.

Impaired renal function

In patients with impaired renal function with creatinine clearance greater than 10 ml/min, no dose adjustment of valsartan is required. Currently, there are no data on the use of valsartan in patients with GFR less than 10 ml/min.

Impaired liver function

In patients with impaired liver function, biliary cirrhosis and cholestasis, Valsacor ® in a dosage of 320 mg is contraindicated, since the maximum daily dose should not exceed 80 mg.

Patients from 6 to 18 years of age

Arterial hypertension

The recommended starting dose of Valsacor®in children and adolescents from 6 to 18 years of age is 40 mg with a child’s body weight of less than 35 kg and 80 mg with a child’s body weight of more than 35 kg. It is recommended to adjust the dose to reduce blood pressure. The maximum recommended daily doses are shown in the table below. Higher doses are not recommended.

Body weight	Maximum recommended daily dose
≥ 8 kg < 35 kg	80 mg
≥ 35 kg < 80 kg	160 mg
≥ 80 kg ≤ 160 kg	320 mg

CHF and previous acute myocardial infarction

Valsacor® is not recommended for the treatment of CHF and previous acute myocardial infarction in patients under 18 years of age.

Special patient groups

Impaired renal function

The safety of valsartan in hemodialysis patients aged 6-18 years or with creatinine clearance less than 30 ml / min has not been studied. Therefore, the use of Valsacor® in such patients is not recommended. Children aged 6 to 18 years with creatinine clearance greater than 30 ml / min do not need to adjust the dose of Valsacor®. Renal function and serum potassium levels should be carefully monitored.

Impaired liver function

Valsacor® is contraindicated in children from 6 to 18 years of age with impaired liver function, biliary cirrhosis and cholestasis, since the maximum daily dose of valsartan in such patients should not exceed 80 mg.

Overdose

Symptoms: a marked decrease in blood pressure, which can lead to impaired consciousness, collapse and / or shock.

Treatment: symptomatic, the nature of which depends on the time that has elapsed since taking the drug, and on the severity of symptoms. In case of accidental overdose, you should induce vomiting (if the drug was taken recently) or perform gastric lavage.

With a marked decrease in blood pressure, it is necessary to transfer the patient to the “lying on his back” position with his legs raised up, then measures should be taken to maintain the functions of the cardiovascular and respiratory systems, replenish the BCC (use of 0.9% sodium chloride solution intravenously) and control daily diuresis.

Hemodialysis is ineffective.

Description

Oval, biconvex tablets with a risk on one side, covered with a film-coated light brown color.

Functional features

After oral use, valsartan is rapidly absorbed from the gastrointestinal tract, the degree of absorption is characterized by individual differences. Absolute bioavailability averages 23%. The pharmacokinetic curve of valsartan has a multi-exponential character (T_1/2 in the α-phase < 1 h and T_1/2 in the β-phase-about 9 h), the kinetics is linear.

No changes in pharmacokinetic parameters were observed during the course of application.

When valsartan is taken with food, the AUC decreases by 48%, and approximately 8 hours after use, the plasma concentrations of valsartan are the same in patients who took it with food and on an empty stomach. A decrease in AUC is not accompanied by a clinically significant decrease in the therapeutic effect.

When taking valsartan 1 time/day, the accumulation is expressed insignificantly. Plasma concentrations of valsartan were similar in women and men.

Binding to plasma proteins, mainly albumins, is 94-97%. V_d at equilibrium is about 17 liters.

The plasma clearance of valsartan is about 2 l/h. It is excreted in the feces – 70% and in the urine-30%, mainly in unchanged form.

In patients with biliary cirrhosis or biliary tract obstruction, the AUC of valsartan increases approximately 2-fold.

Special instructions

Severe renal impairment in patients over 18 years of age (creatinine clearance less than 10 ml/min) (no clinical data available), renal impairment in patients 6 to 18 years of age (creatinine clearance less than 30 ml/min), including those on hemodialysis, aortic and/or mitral valve stenosis, hypertrophic obstructive cardiomyopathy (HOCMP), CHF (NYHA II-IV PCI), post-kidney transplant status, hemodialysis, hyponatremia, diet with hyperkalemia, primary hyperaldosteronism, conditions associated with reduced circulating blood volume (BCC) (including diarrhea, vomiting, treatment with high doses of diuretics), in patients with hereditary angioedema, or edema on the background of previous therapy with ARA II or ACE inhibitors, concomitant use of ARA II with other drugs that inhibit the development of angioedema. the renin-angiotensin-aldosterone system (RAAS), such as ACE inhibitors and drugs containing aliskiren.

It is not recommended to use ARA II, including valsartan, simultaneously with ACE inhibitors, since their simultaneous use does not have advantages over monotherapy with valsartan or an ACE inhibitor in terms of overall mortality.

Contraindicated in children under 6 years of age-for indications of arterial hypertension, under 18 years of age-for other indications.

Patients from 6 to 18 years of age

Arterial hypertension

The recommended starting dose of Valsacor® in children and adolescents from 6 to 18 years of age is 40 mg with a child’s body weight of less than 35 kg and 80 mg with a child’s body weight of more than 35 kg. It is recommended to adjust the dose to reduce blood pressure. The maximum recommended daily doses are shown in the table below. Higher doses are not recommended.

Body weight	Maximum recommended daily dose
≥ 8 kg < 35 kg	80 mg
≥ 35 kg < 80 kg	160 mg
≥ 80 kg ≤ 160 kg	320 mg

CHF and previous acute myocardial infarction

Valsacor® is not recommended for the treatment of CHF and previous acute myocardial infarction in patients under 18 years of age.

Special patient groups

Impaired renal function

The safety of valsartan in hemodialysis patients aged 6-18 years or with creatinine clearance less than 30 ml / min has not been studied. Therefore, the use of Valsacor® in such patients is not recommended. Children aged 6 to 18 years with creatinine clearance greater than 30 ml / min do not need to adjust the dose of Valsacor®. Renal function and serum potassium levels should be carefully monitored.

Impaired liver function

Valsacor® is contraindicated in children from 6 to 18 years of age with impaired liver function, biliary cirrhosis and cholestasis, since the maximum daily dose of valsartan in such patients should not exceed 80 mg.

Elderly patients (over 65 years of age)

For elderly patients, no dose adjustment is required.

Impaired renal function

In patients with impaired renal function with creatinine clearance greater than 10 ml/min, no dose adjustment of valsartan is required. Currently, there are no data on the use of valsartan in patients with GFR less than 10 ml/min.

Impaired liver function

In patients with impaired liver function, biliary cirrhosis and cholestasis, Valsacor ® in a dosage of 320 mg is contraindicated, since the maximum daily dose should not exceed 80 mg.

When using Valsacor® in patients with hypertension, regular monitoring of laboratory parameters is not required.

Double blockade of the RAAS

In some patients, double blockade of the RAAS was accompanied by the development of severe hypotension, syncope, stroke, hyperkalemia, and impaired renal function (including acute renal failure).

Concomitant use of ARA II, including valsartan, with drugs that affect the RAAS, such as ACE inhibitors or aliskiren, is not recommended; if necessary, such therapy should carefully monitor blood pressure, renal function, and plasma electrolyte levels.

Concomitant use of ARA II, including valsartan, with drugs containing aliskiren is contraindicated in patients with diabetes mellitus and/or moderate to severe renal impairment (GFR less than 60 ml/min / 1.73 m2 of body surface area) and is not recommended in other patients.

Concomitant use of ARA II with ACE inhibitors is contraindicated in patients with diabetic nephropathy and is not recommended in other patients.

Hyponatremia and / or dehydration

In patients with severe hyponatremia and / or dehydration, for example, due to taking high doses of diuretics, in rare cases, hypotension with clinical manifestations may develop at the beginning of therapy with Valsacor®. Before starting treatment, it is recommended to restore the sodium content and / or replenish the BCC, in particular, by reducing the doses of diuretics.

With the development of arterial hypotension with clinical manifestations, the patient should be given a horizontal position and, if necessary, inject 0.9% sodium chloride solution intravenously. Therapy with Valsacor® can be continued only after stabilization of hemodynamic parameters.

Hyperkalemia

Concomitant use of potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride), potassium preparations, potassium-containing dietary supplements, or other drugs that can increase the content of potassium in the blood serum (for example, heparin) is not recommended. It is necessary to monitor the content of potassium in the blood plasma.

Renal artery stenosis

Short-term use of valsartan in patients with second-time renovascular hypertension due to unilateral stenosis of the artery of a single kidney was not accompanied by significant changes in renal hemodynamics, serum creatinine or urea nitrogen concentrations. Since other drugs that affect the RAAS can increase serum urea and creatinine concentrations in patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney, it is recommended to constantly monitor these indicators as a precautionary measure.

Condition after undergoing a kidney transplant

The safety of Valsacor® in patients who have recently undergone a kidney transplant has not been established.

Primary hyperaldosteronism

Patients with primary hyperaldosteronism are resistant to antihypertensive drugs that affect the RAAS, so the use of Valsacor® is not recommended for such patients.

Aortic and/or mitral valve stenosis, HOCMP

Valsacor® should be used with caution in patients with hemodynamically significant aortic and/or mitral valve stenosis or with HOCMP.

Impaired renal function

In patients with impaired renal function, no dose changes are required, since there are no data on the use of Valsacor in severe renal insufficiency (creatinine clearance less than 10 ml/min or 0.167 ml/s) and in patients on hemodialysis, in such cases, the drug is recommended to be used with caution.

Concomitant use of ARA II, including valsartan, or ACE inhibitors with aliskiren is contraindicated in patients with impaired renal function (GFR less than 60 ml / min/1.73 m2 of body surface area).

Impaired liver function

In patients with impaired liver function, biliary cirrhosis and cholestasis, Valsacor ® in a dosage of 320 mg is contraindicated, since the maximum daily dose should not exceed 80 mg.

History of angioedema

Patients with angioedema (laryngeal and vocal cord edema that causes airway obstruction and/or swelling of the face, lips, pharynx, and / or tongue) have experienced a history of angioedema during Valsacor therapy, including when taking ACE inhibitors. If angioedema develops, the drug should be discontinued immediately and the possibility of repeated use should be excluded.

Arterial hypertension

In patients with hypertension, Valsacor® can be used in monotherapy or simultaneously with other antihypertensive agents, in particular, with diuretics.

CHF / improved survival in patients with acute myocardial infarction

It is possible to use Valsacor® in combination with other medications used in acute myocardial infarction (thrombolytics, acetylsalicylic acid as an antiplatelet agent, beta-blockers and HMG-CoA reductase inhibitors (statins)). Concomitant use of Valsacor® and ACE inhibitors in this category of patients is not recommended, since this combination therapy does not lead to an additional clinical effect and is accompanied by an increased risk of developing AE compared to therapy with two drugs separately.

In patients with CHF, triple combination therapy (Valsacor®, an ACE inhibitor, and a beta-blocker) is not recommended, since it does not lead to an additional clinical effect and is accompanied by an increased risk of developing AE.

The use of Valsacor in patients with CHF or acute myocardial infarction often leads to a slight decrease in blood pressure. As a rule, it is not necessary to cancel the drug when following the dosage instructions.

In patients whose renal function may depend on the activity of RAAS (for example, in patients with CHF II-IV FC according to NYHA classification), therapy with ACE inhibitors and ARA II is accompanied by oliguria and/or increased azotemia, and in rare cases – acute renal failure and/or death. Since valsartan is ARA II, the possibility of deterioration of renal function with its use cannot be excluded.

Start therapy in patients with CHF or acute myocardial infarction with caution. Renal function should always be evaluated when examining patients.

Special information on excipients

Valsacor ® contains lactose, so the drug is contraindicated in patients with lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome.

Caution should be exercised when driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions, as dizziness or weakness may develop against the background of arterial hypotension.

Form of production

Film-coated tablets,320 mg.

10,14 or 15 tablets in a blister made of a combined PVC/PE / PVDC material-aluminum foil.

2,3 or 14 blisters (10 tablets each), or 1,2,4,7 or 10 blisters (14 tablets each), or 2 blisters (15 tablets each) together with the instructions for use are placed in a cardboard pack.

For hospitals:

20,50 or 56 blisters (10 tablets each), or 40 blisters (14 tablets each) together with the instructions for use are placed in a cardboard pack.

Storage conditions

At a temperature not exceeding 25 ° C, in the original packaging.

Keep out of reach of children.

Shelf

life is 5 years.

Do not use the drug after the expiration date.

Active ingredient

Valsartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Heart Failure, Myocardial Infarction, Hypertension