Valsartan-SZ - instructions for use, dose, side effects, contraindications

auxiliary substances (core): cellulose microcrystalline - 47.5 mg; crospovidone (Kollidon CL) - 9.0 mg; silicon dioxide colloid (aerosil) - 1.0 mg; magnesium stearate - 2.5 mg;

auxiliary substances (shell): Opadrai II 3.0 mg (polyvinyl alcohol, partially hydrolyzed 1.2 mg, titanium dioxide E 171 0.661 mg, talc 0.444 mg macrogol (polyethylene glycol 3350) 0.606 mg iron oxide oxide yellow E 172 - 0.0009 mg, aluminum lacquer based on dye quinoline yellow - 0.0903 mg, aluminum dye-based dye sunset yellow - 0.0021 mg, aluminum dye based on indigo carmine dye - 0.0006 mg);

dosage of 80 mg:

active substance: valsartan - 80 mg;

auxiliary substances (core): cellulose microcrystalline - 95.0 mg; crospovidone (Kollidon CL) - 18.0 mg; silicon dioxide colloid (aerosil) - 2.0 mg; magnesium stearate 5.0 mg;

auxiliary substances (shell): Opadrai II 6.0 mg (polyvinyl alcohol, partially hydrolyzed 2.4 mg, titanium dioxide E 171 1.4268 mg, talc 0.888 mg macrogol (polyethylene glycol 3350) 1.212 mg, aluminum lacquer based on indigo carmine dye - 0.0042 mg, aluminum varnish based on azorubin dye - 0,0384 mg, aluminum varnish based on the dye of the crimson [Ponso 4R0.0306 mg);

dosage of 160 mg:

active substance: valsartan - 160 mg;

auxiliary substances (core): microcrystalline cellulose - 190.0 mg; crospovidone (Kollidon CL) - 36.0 mg; silicon dioxide colloid (aerosil) - 4.0 mg; magnesium stearate - 10.0 mg;

auxiliary substances (shell): Opadrai II - 12.0 mg (polyvinyl alcohol, partially hydrolyzed -4.8 mg, titanium dioxide E 171 - 2.6832 mg, talc - 1.776 mg, macrogol (polyethylene glycol 3350) - 2.424 mg, iron oxide oxide yellow E 172- 0.1716 mg, iron oxide red oxide E 172 - 0.1452 mg).

Description:

The tablets covered with a film cover of yellow color, round, biconcave with risk. On the cross section, the core of the tablet is white or almost white (dosage 40 mg).

The tablets covered with a film cover of pink color, round, biconcave with risk. On the cross section, the core of the tablet is white or almost white (dosage of 80 mg).

Tablets, covered with a film shell of pink-orange color, round, biconcave. On the cross section, the core of the tablet is white or almost white (160 mg).

Pharmacotherapeutic group:Angiotensin II receptor antagonist

ATX: & nbsp

C.09.C.A.03 Valsartan

C.09.C.A Angiotensin II antagonists

Pharmacodynamics:

Valsartan is an active specific antagonist of angiotensin II receptors, intended for oral administration. Selectively blocks AT receptor subtype₁ which are responsible for the effects of angiotensin II. The consequence of the blockade of AT₁ - The receptor is an increase in the plasma concentration of angiotensin II, which can stimulate an unblocked AT₂ receptors. Valsartan does not have any expressed agonistic activity against AT₁ receptors. The affinity of valsartan for AT subtype receptors₁ approximately 20,000 times higher than to the AT subtype receptors₂. 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 probability of occurrence of cough in the application of valsartan is very low, due to the lack of effect on angiotensin converting enzyme (ACE), which is responsible for the degradation of bradykinin. A comparison of valsartan with an ACE inhibitor demonstrates that the incidence of dry cough significantly (p <0.05) lower in patients taking the drug 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 unwanted phenomenon (AE) is noted 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 was observed in 68.5% of cases (p <0.05).

Use in hypertension in patients older than 18 years

In the treatment Valsartan in patients with arterial hypertension, there is a decrease in blood pressure (BP), not accompanied by a change in the heart rate (heart rate).

After applying 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 achieved within 4-6 hours, which lasts for more than 24 hours. With repeated use of the drug, the maximum reduction in blood pressure, regardless of the dose taken, is usually achieved within 2-4 weeks, and is maintained at the achieved level during prolonged therapy. In the case of simultaneous application of the drug 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 AEs. Patients with hypertension, type 2 diabetes and nephropathy receiving 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

When using the drug for 2 years in patients who started taking in the period of 12 hours to 10 days after suffering 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 for exacerbation of the course of chronic heart failure, repeated myocardial infarction, sudden cardiac arrest and stroke (without a lethal outcome) increases. 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%) functional class NYHA with a left ventricular ejection fraction (LV) of less than 40% and an internal diastolic diameter of more than 2.9 cm / m², receiving standard therapy, including ACE inhibitors (93%), diuretics (86%), digoxin (67%) and beta-blockers (36%) there was a significant decrease (by 27.5%) of the 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, 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-adrenoblockers), there is no reduction in the overall mortality rate with valsartan, but the cardiovascular mortality and morbidity associated with CHF are reduced by 18.3%.

In general, the use of valsartan leads to a decrease in the number of hospitalizations for CHF, slowing the progression of CHF, improving the class of CHF according to classification NYHA, an increase in the left ventricular ejection fraction, as well as a decrease in the signs and symptoms of heart failure and an improvement in the 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 did not influence the incidence of fatal outcomes as a result of cardiovascular events, myocardial infarction and ischemic attacks without death, on hospitalization due to heart failure or unstable angina, arterial revascularization, in patients with impaired glucose tolerance and hypertension, differing in age , gender and race.

In patients receiving valsartan, the risk of microalbuminuria was significantly lower than in patients not receiving this therapy. The recommended initial dose of the drug Valsartan in patients with arterial hypertension and violation of glucose tolerance 80 mg once a day.If necessary, the dose may be increased to 160 mg.

The use in children and adolescents from 6 to 18 years with hypertension

Children and adolescents from 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 taking the drug inside the maximum concentration (C_m_Oh) of valsartan in the blood plasma is achieved within 2-4 hours. The average absolute bioavailability is 23%. When valsartan is used with food, the area under the concentration-time curve (AUC) decreases by 48%, although starting from about the 8th hour after taking the drug, the concentration of valsartan in the blood plasma, both in the case of taking it on an empty stomach, and in case of reception with food, are the same. Decrease AUC, nevertheless, is not accompanied by a clinically significant decrease in the therapeutic effect, therefore valsartan can be taken regardless of the time of ingestion.

Distribution

Volume of distribution (Vd) valsartan in the equilibrium period after intravenous administration was about 17 liters, indicating that there was no pronounced distribution of valsartan in the tissues. Valsartan is largely associated with serum proteins (94 - 97%), mainly with albumins.

Metabolism

Valsartan does not undergo significant biotransformation, only about 20% of the dose taken internally is excreted as metabolites. The hydroxyl metabolite is determined in blood plasma at low concentrations (less than 10% of AUC valsartan). This metabolite is pharmacologically inactive.

Excretion

Valsartan is biphasic: α-phase with half-life (T_1/2α) is less than 1 hour and βphase with T_1/2_β - about 9 hours. Valsartan is excreted mainly unchanged through the intestine (about 83%) and kidneys (about 13%). After intravenous administration, plasma clearance Valsartan is about 2 l / h and its renal clearance is 0.62 l / h (about 30% of total clearance). T₁/₂ valsartan is 6 hours. Pharmacokinetics in selected patient groups

Patients with CHF

In this category of patients, the time to reach C_m_Oh and T_1/2 similar to those of healthy volunteers. Increase AUC and C_m_Oh 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 liters / hour.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, the systemic bioavailability of valsartan is higher than that of young patients, however, it has no clinical significance.

Patients with impaired renal function

Correlation between kidney function and systemic bioavailability valsartan is absent. In patients with impaired renal function and a glomerular filtration rate of more than 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 hepatic impairment

In patients with mild and moderate impairment of liver function, there is an increase in bioavailability (AUC) Valsartan is twice as high as healthy volunteers. However, there is no correlation of the values AUC Valsartan with a degree of impaired liver function. The use of the drug in patients with severe impairment of liver function has not been studied.

Patients 6 to 18 years of age

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

Indications:

Adults

- Arterial hypertension.

- Chronic heart failure (II-IV functional class by classification NYHA), in adult patients receiving standard therapy with one or more drugs from the following pharmacotherapeutic groups: diuretics, cardiac glycosides, as well as ACE inhibitors or beta-blockers. The use of each of these drugs is not mandatory. Evaluation of patients with CHF should include assessment of renal function.

- To improve 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 from 6 to 18 years.

Contraindications:

- Hypersensitivity to any of the components of the drug.

- Pregnancy, the period of breastfeeding.

- Severe violations of the liver (more than 9 points on the scale Child-Pugh), biliary cirrhosis and cholestasis.

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

Simultaneous use with aliskiren in patients with type 2 diabetes mellitus.

Carefully:

If you have any of these diseases, consult a doctor before taking the drug.

Special care should be taken when using the drug in patients with hereditary angioedema or with angioedema due to previous therapy with angiotensin II receptor antagonists (APA II) or ACE inhibitors. Take with caution in bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney, primary hyperaldosteronism, while observing a diet with restriction of consumption of table salt; at conditions accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting); in patients with SC less than 10 ml / min, in patients aged 6 to 18 years and CC less than 30 ml / min, including those on hemodialysis, with mild and moderate disorders of liver function of biliary and non-biliary origin without phenomena of cholestasis, patients with chronic heart failure (CHF) III-IV functional class (by NYHA), the function of the kidneys of which depends on the state of RAAS, mitral or aortic stenosis, hypertrophic obstructive cardiomyopathy, as well as in patients after kidney transplantation.

Caution should be exercised simultaneously with the use of ARA II, including Valsartan-SZ, with other agents that inhibit the renin-angiotensin-aldosterone system (RAAS), such as ACE inhibitors or aliskiren.

It is not recommended to use Valsartan-SZ simultaneously with ACE inhibitors, since this combination therapy does not have advantages over monotherapy with valsartan or ACE inhibitor for all-cause mortality rates.

Pregnancy and lactation:

Like any other drug that affects RAAS, Valsartan-SZ should not be used in women who plan pregnancy. When prescribing any drug that affects RAAS, the doctor should inform women of childbearing age of the potential dangers of these drugs during pregnancy.

Like any other drug that directly affects RAAS, the drug Valsartan-SZ should not be used during pregnancy. Given the mechanism of action of ARA II, the risk to the fetus can not be ruled out.The effect of ACE inhibitors (drugs that also affect RAAS) on the fetus, if used in the second and third trimester of pregnancy, can lead to its damage and death. According to the retrospective data, when using ACE inhibitors in the first trimester of pregnancy, the risk of having children with congenital defects increases. There are reports of spontaneous abortions, oligohydramnios and renal dysfunction in newborns, mothers who during pregnancy through negligence took valsartan. If pregnancy is diagnosed during treatment with Valsartan-SZ, treatment should be discontinued as soon as possible.

It is not known whether valsartan with breast milk. Therefore, do not use the drug during breastfeeding.

There are no data on the effect of the drug on human fertility. In animal studies, there were no effects of valsartan on fertility.

Dosing and Administration:

Tablets should be taken orally, without chewing, regardless of the meal, with water.

Adults

Arterial hypertension

The drug can be prescribed in a dose of 40 mg, 80 mg, 160 mg, 320 mg.The recommended initial dose of Valsartan-SZ is 80 mg 1 once a 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 Valsartan-SZ can be gradually increased to a maximum daily dose of 320 mg, or diuretics should be used additionally.

Chronic heart failure

The recommended initial dose of Valsartan-SZ is 40 mg 2 times a day. The dose of the drug should be gradually increased for at least 2 weeks to 80 mg twice a day, and with good tolerability - up to 160 mg 2 times a 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 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 a day.The dose is increased by titration (40 mg, 80 mg, 160 mg twice daily) for several consecutive weeks, until the target dose of 160 mg twice a day is reached.

The maximum daily dose is 320 mg in 2 divided doses. Usually, it is recommended that the dose be increased to 80 mg twice a day by the end of the second week of treatment. Achievement of the maximum target dose of 160 mg 2 times per day is recommended by the end of the third month of therapy with Valsartan-SZ. The increase in dose depends on the tolerability of the drug Valsartan-SZ during the titration period.

In the case of development of arterial hypotension, accompanied by clinical manifestations, or renal dysfunction should be consider lowering the dose.

Assessment of the condition of patients, in the period after a previous myocardial infarction, should include an evaluation of the kidney function.

Children and teens

Arterial hypertension

The recommended initial dose of the drug Valsartan-SZ in children and adolescents from 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 daily doses are shown in the table below. The use of higher doses is not recommended.

Body mass	The maximum recommended daily dose
≥ 8 kg <35 kg	80 mg
≥ 35 kg <80 kg	160 mg
≥ 80 kg <160 kg	320 mg

Chronic heart failure and acute myocardial infarction

Valsartan-SZ is not recommended for the treatment of chronic heart failure and after an acute myocardial infarction in patients under 18 years of age.

Patients over the age of 65 years

In elderly patients, dose adjustment is not required.

Patients with impaired renal function

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 a glomerular filtration rate of less than 10 ml / min.

Patients with hepatic impairment

Patients with mild or moderate impairment of liver function of non-biliary origin without cholestasis should be administered with caution, the daily dose should not exceed 80 mg.

Side effects:

In patients with hypertension in controlled clinical trials, the incidence of adverse events was comparable to placebo. There is no data on the dependence of the frequency of any of the undesirable events on the dose or duration of treatment, as well as sex, age or race.The safety profile of Valsartan-SZ in patients with hypertension aged 6 to 18 years does not differ from the safety profile of valsartan in adult patients.

Below are the undesirable phenomena that were observed during clinical trials, as well as with the use of the drug in clinical practice.

To assess the frequency of adverse events, the following criteria were used: "very often" (≥1 / 10), "often" (≥1 / 100, <1/10), "infrequently" (≥1 / 1000, <1/100), "rarely" (≥1 / 10000, <1/1000), "very rarely" (<1/10000), including individual messages. Within each group allocated according to frequency of occurrence, undesirable phenomena are distributed in order of decreasing importance.

For all the undesirable phenomena found 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

Violations from the blood and lymphatic system: frequency unknown - reduced hemoglobin, hematocrit, neutropenia, thrombocytopenia.

Immune system disorders: frequency is unknown - hypersensitivity reactions, including serum sickness.

Disorders from the metabolism and nutrition: the frequency is unknown - an increase in the potassium content in the serum.

Hearing disorders and labyrinthine disturbances: infrequently - vertigo.

Vascular disorders: frequency is unknown - vasculitis.

Disturbances from the respiratory system, chest and mediastinal organs: infrequently - cough.

Disorders from the gastrointestinal tract: infrequently - pain in the abdomen.

Disorders from the liver and bile ducts: frequency unknown - impaired liver function, including increased bilirubin concentration in blood plasma.

Disturbances from the skin and subcutaneous tissues: very rarely - angioedema, skin rash, itching; frequency unknown - bullous dermatitis.

Disturbances from the musculoskeletal and connective tissue: frequency is unknown - myalgia.

Disorders from the kidneys and urinary tract: frequency unknown - renal dysfunction, increased serum creatinine concentration.

General disorders and disorders at the site of administration: infrequently - increased fatigue.

Also, in the course of clinical studies, the following adverse events were observed in patients with arterial hypertension,the cause-and-effect relationship of which with the administration of the drug is not established: arthralgia, asthenia, back pain, diarrhea, dizziness, insomnia, decreased libido, nausea, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory infections, viral infections.

Patients receiving the drug Valsartan-SZ after suffering acute myocardial infarction and / or with CHF

Violations from the blood and lymphatic system: frequency unknown - thrombocytopenia.

Immune system disorders: frequency is unknown - hypersensitivity reactions, including serum sickness.

Disorders from the metabolism and nutrition: Mr.Often - hyperkalemia; the frequency is unknown - an increase in the potassium content in the serum.

Impaired nervous system: often - dizziness, postural dizziness; infrequently - a syncope, a headache.

Hearing disorders and labyrinthine disturbances: infrequently - vertigo.

Heart Disease: infrequently - increased symptoms of chronic heart failure.

Vascular disorders: often - marked decrease in blood pressure, orthostatic hypotension; frequency is unknown - vasculitis.

Disturbances from the respiratory system and mediastinal organs: infrequently - cough.

Disorders from the gastrointestinal tract: infrequently - nausea, diarrhea.

Disorders from the liver and bile ducts: frequency unknown - impaired liver function.

Disturbances from the skin and subcutaneous tissues: very rarely - angioedema; frequency unknown - skin rash, itching, bullous dermatitis.

Disturbances from the musculoskeletal and connective tissue: rarely - rhabdomyolysis, the frequency is unknown - myalgia.

Disorders from the kidneys and urinary tract: often - renal dysfunction; infrequently - acute renal failure, increased serum creatinine concentration; frequency is unknown - an increase in the urea nitrogen in the blood plasma.

General disorders and disorders at the site of administration: infrequently - asthenia, increased fatigue.

Also in the course of clinical studies, the following adverse events were observed in patients after acute myocardial infarction and / or with CHF, whose cause-and-effect relationship with taking the drug was not established: arthralgia, abdominal pain, back pain, asthenia, insomnia, decreased libido, neutropenia, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

If any of the side effects listed in the manual are aggravated, or you notice any other side effects not listed in the instructions, inform the doctor about it.

Overdose:

Symptoms: when an overdose of the drug Valsartan-SZ the main manifestation is a marked decrease in blood pressure, which can lead to depression, collapse and / or shock.

Treatment: symptomatic, the nature of which depends on time, passed from the time of taking the drug, and on the severity of the symptoms. In case of an accidental overdose, you should induce vomiting (if the drug was taken recently) or to wash the stomach. If there is a marked decrease in blood pressure as a therapy, intravenous injection of 0.9% sodium chloride solution is necessary, the patient should be laid, raising his legs, for a period of time necessary for therapy, to take active measures to maintain the cardiovascular system, including regular monitoring of cardiac activity and the respiratory system, the volume of circulating blood (BCC), and the amount of urine released.

Interaction:

It was found that with monotherapy valsartan there are no clinically significant interactionswith the following medicines: cimetidine, warfarin, furosemide, digoxin, atenolol, indometacin, hydrochlorothiazide, amlodipine, glibenclamide.

Double blockade of RAAS with the use of angiotensin II receptor antagonists, ACE inhibitors or aliskiren

Simultaneous use of angiotensin II receptor antagonists, including Valsartan-SZ preparation, with other agents that affect RAAS is associated with an increased incidence of arterial hypotension, hyperkalemia and changes in kidney function compared to monotherapy. It is recommended to monitor blood pressure, kidney function and electrolyte content in patients taking Valsartan-SZ and other drugs that affect RAAS.

Non-steroidal anti-inflammatory drugs (NSAIDs)

When valsartan is used simultaneously with NSAIDs (including selective inhibitors of cyclooxygenase-2), it is possible to reduce its antihypertensive effect. When angiotensin II receptor antagonists are used concomitantly with NSAIDs, renal function impairment and potassium levels in the blood plasma can be increased.If it is necessary to simultaneously use valsartan and NSAIDs before starting treatment, it is necessary to evaluate the function of the kidneys and correct the violations of the water electrolyte balance.

Protein-carriers

By the results of the study in vitro on liver cultures valsartan is a substrate for the OATP1B1 carrier proteins and MRP2. The simultaneous use of valsartan with inhibitors of the carrier protein OATP1B1 (rifampicin, ciclosporin) and with an inhibitor of carrier protein MRP2 (ritonavir) can increase the systemic exposure of valsartan (C_m_Oh and AUC).

Lithium preparations

With the simultaneous use of lithium preparations with ACE inhibitors and ARA II, a reversible increase in lithium serum levels was observed and, therefore, toxic effects were increased, therefore it is recommended to monitor the lithium content in serum. The risk of toxic effects associated with the use of lithium drugs may be further increased with simultaneous use with the drug Valsartan-SZ and diuretics.

Simultaneous use of potassium-sparing diuretics (including spironolactone, eplerenone, triamterene, amiloride),potassium preparations or salts containing potassium, as well as other drugs that can increase the potassium content (for example, heparin, etc.), can lead to an increase in potassium in the blood serum, and in patients with heart failure to increase the serum creatinine concentration. If such combination treatment is considered necessary, care should be taken.

In children and adolescents, hypertension is often associated with impaired renal function. It is recommended to use caution valsartan simultaneously with other drugs that affect RAAS, in patients in this category, because this may lead to an increase in serum potassium. It should be regularly monitored kidney function and potassium content in the serum of patients in this group.

Special instructions:

Patients with impaired renal function

The simultaneous use of ARA II should be avoided, including Valsartan, or ACE inhibitors with aliskiren in patients with severe renal impairment (GFR <30 mL / min).

Hyperkalemia

With simultaneous application with biologically active additives containing potassium,potassium-sparing diuretics, potassium-containing salt substitutes, or with other drugs that can cause an increase in potassium in the blood (for example, with heparin), care should be taken and regular monitoring of potassium in the blood.

Kidney Transplantation

Data on the safety of Valsartan-SZ in patients who underwent kidney transplantation are not available.

Deficiency in the body of sodium and / or decreased BCC

In patients with severe sodium deficiency and / or reduced bcc, for example, receiving high doses of diuretics, in rare cases, at the beginning of treatment with the drug may develop arterial hypotension accompanied by clinical manifestations. Before starting treatment with Valsartan-SZ, you should correct the sodium content and / or replenish the BCC, including by reducing the dose of the diuretic.

Stenosis of the renal artery

The use of the drug in a short course in patients with reninvascular hypertension, which developed secondary due to unilateral stenosis of the artery of a single kidney, does not lead to any significant change in renal hemodynamics, serum creatinine concentration, or blood urea nitrogen.However, given that other drugs that affect RAAS can cause an increase in serum urea and creatinine levels in patients with bilateral renal artery stenosis or arterial stenosis of a single kidney, it is recommended to monitor these indicators as a precautionary measure.

Primary hyperaldosteronism

The drug is ineffective for the treatment of hypertension in patients with primary hyperaldosteronism, since in this category of patients there is no activation of RAAS.

CHF / period after a previous myocardial infarction

In patients with CHF or after myocardial infarction, starting treatment with Valsartan-SZ, there is often a slight decrease in blood pressure, which is why it is recommended to control blood pressure at the beginning of therapy. Subject to the recommendations on the dosing regimen, there is usually no need to cancel Valsartan-SZ because of hypotension. Evaluation of patients with CHF should include assessment of renal function.

Due to inhibition of RAAS in some patients, renal dysfunction may occur. In patients with CHF III-IV functional class by classification NYHA, whose renal function depends on the state of RAAS, treatment with ACE inhibitors and angiotensin II receptor antagonists may be accompanied by oliguria and / or augmentation of azotemia and, in rare cases, the development of acute renal failure and / or death. Therefore, in these categories of patients before the use of the drug Valsartan-SZ, and also periodically during treatment with the drug, it is necessary to assess the function of the kidneys.

Combination therapy for hypertension

With arterial hypertension, the drug Valsartan-SZ can be used in monotherapy, as well as in conjunction with other antihypertensive drugs, in particular, with diuretics.

Combination therapy in the post-myocardial infarction period

It is possible to use the drug Valsartan-SZ in combination with other drugs used after a myocardial infarction, namely thrombolytics, acetylsalicylic acid as antiplatelet agent, beta-adrenoblockers and inhibitors of HMG-CoA reductase. In this category of patients not It is recommended to use the preparation Valsartan-SZ simultaneously with ACE inhibitors,since this combination therapy has no advantage over monotherapy with valsartan or an ACE inhibitor in terms of overall mortality for any reason.

Combination therapy with CHF

With CHF, Valsartan-SZ can be used both in monotherapy and simultaneously with other agents - diuretics, cardiac glycosides, as well as ACE inhibitors or beta-blockers.

In this category of patients is not recommended the use of triple combination therapy with an ACE inhibitor, a beta-adrenoblocker and a preparation of Valsartan-SZ.

Angioedema, including Quincke's edema

Angioedema, including swelling of the larynx and vocal cords leading to airway obstruction, and / or swelling of the face, lips, pharynx, and / or tongue edema, occurred in patients who received valsartan, some of these patients had angioedema edema earlier when taking other drugs, including ACE inhibitors. Taking Valsartan-SZ in case of angioedema development should be immediately canceled, resumption of Valsartan-SZ preparation is prohibited.

Effect on the ability to drive transp. cf. and fur:

Because of the possible development of such undesirable phenomena as dizziness or fainting on the background of drug therapy, patients taking Valsartan-SZ should be careful in driving vehicles and engaging in potentially hazardous activities.

Form release / dosage:

Tablets, film-coated, 40 mg, 80 mg, 160 mg.

Packaging:

For 10, 14 or 30 tablets per contour cell package.

For 30 tablets in a can of polymer with a lid or a bottle of polymer with a lid.

Each jar or vial, 3, 6 contour cell packs of 10 tablets, 2, 4, 6 contour packs per 14 tablets or 1.2, 3 contour packs of 30 tablets, together with instructions for use are placed in a cardboard box.

Storage conditions:

In a dry, the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-004219

Date of registration:30.03.2017

Expiration Date:30.03.2022

The owner of the registration certificate:NORTH STAR, CJSC NORTH STAR, CJSC Russia

Manufacturer: & nbsp

NORTH STAR, CJSC Russia

Information update date: & nbsp22.04.2017

Illustrated instructions

Instructions

Valsartan-SZ (Valsartan-SZ)