Valsacor: what to use and where to buy

Dosage form and composition

The medication is intended for oral administration and is available in the form of yellow film-coated tablets:

Valsacor: contains the active substance valsartan - an antagonist of hormone receptors that provokes an increase in pressure in blood vessels, prevents the development of hypertensive attacks;
Valsacor N80, ND160: a combination drug containing two active ingredients: valsartan and hydrochlorothiazide, has a more pronounced and long-lasting therapeutic effect, reduces blood pressure.

In addition to active compounds, pills contain auxiliary components: MCC, lactose, silicon dioxide, stabilizing and form-building additives.

Mechanism of action of drugs

Valsacor provides a long-term reduction in the resistance of vascular walls, prevents their spasms, improves myocardial contractility, and increases the volume of blood pumped by the heart. As a result, unfavorable symptoms of deficiency disappear:

think in your ears and head;
swelling;
dyspnea;
physical weakness;
dizziness.

Valsacor N maintains normal blood pressure, reduces the likelihood of valsartan side effects, and helps hypertensive patients maintain good health. Hydrochlorothiazide in its composition has a diuretic effect, stimulates the excretion of excess sodium and chlorine.

The medicine quickly dissolves in the stomach after administration and is absorbed into the blood. The effect of one dose of tablets develops over 30–60 minutes, reaches a maximum after 4–5 hours and lasts up to a day. With regular use, Valsacor provides an increasing antihypertensive effect after 3-4 weeks - it prevents the development of high blood pressure.

About 60% of hydrochlorothiazide ingested interacts with blood proteins; in combination with valsartan, it is less bioavailable. The components of the drugs do not accumulate in the body. Metabolism occurs in the liver, then the remaining substances are excreted through the intestinal contents and through the kidneys. Disintegration and release occur approximately 9 hours after the dose of the drug.

Valsacor: use according to instructions

The drug is taken as prescribed by a cardiologist for the following pathologies:

heart failure of non-acute severity: with functional disorders while maintaining a stable physical condition and during periods of remission;
after a heart attack, with persisting dysfunction of the left ventricle of the myocardium;
chronic heart failure without correction of the condition with ACE inhibitors;

Valsacor N and ND are prescribed in cases of hypertension as part of complex treatment.

The treatment regimen depends on the existing health problems:

average daily dosage at the initial stage: 20–40 mg of the drug twice a day;
if necessary, the dose of the drug is increased to 160 mg per day;
The maximum dose of medication per day is 320 mg.

The tablets are taken with a sufficient amount of water, regardless of meal time. There is no need to chew or crush the medicine beforehand. Valsacor is used for long-term correction of physical condition. The general course of its use is at least several months. If side effects are detected, the dose of the drug is reduced or it is recommended to buy a similar antihypertensive drug.

Valsacor 80 mg 90 pcs. film-coated tablets

pharmachologic effect

Angiotensin II receptor antagonist.

Composition and release form Valsacor 80 mg 90 pcs. film-coated tablets

Tablets - 1 tablet:

Active ingredient: valsartan 80.00 mg;
Excipients: lactose monohydrate 30.00 mg, microcrystalline cellulose 41.00 mg, povidone-K25 1.50 mg, croscarmellose sodium 2.00 mg, colloidal silicon dioxide 1.00 mg, magnesium stearate 4.50 mg;
Film shell: hypromellose 6sr 3.00 mg, titanium dioxide (E171) 0.68 mg, red iron oxide dye (E172) 0.02 mg, macrogol-4000 0.30 mg.

7, 10, 14 or 15 tablets in a blister (blister pack) made of combined material PVC/PE/PVDC - aluminum foil.

2, 4, 8, 12, 14 or 20 blisters (blister packs) (7 tablets each), or 2, 3, 6 or 9 blisters (blister packs) (10 tablets), or 1.2 , 4, 6, 7 or 10 blisters (blister packs) (14 tablets each), or 2, 4 or 6 blisters (blister packs) (15 tablets each) together with instructions for use are placed in a cardboard pack.

Description of the dosage form

Round, biconvex tablets with a score on one side, pink film-coated. Fracture view: white rough mass with a pink film shell.

Directions for use and doses

Inside, regardless of meal time.

Patients over 18 years of age

Arterial hypertension. The recommended starting dose of Valsacor® is 80 mg 1 time per day, regardless of the race, age and gender of the patient. The antihypertensive effect develops within 2 weeks and reaches its maximum after 4 weeks. In patients who fail to achieve adequate blood pressure control, the daily dose of valsartan may be gradually increased to a maximum daily dose of 320 mg.

In order to further reduce blood pressure, it is possible to use diuretics (hydrochlorothiazide), as well as the simultaneous use of other antihypertensive drugs.

CHF. The recommended starting dose of Valsacor® is 40 mg 2 times a day. The dose of the drug should be gradually increased over at least 2 weeks to 80 mg 2 times a day, and if well tolerated - up to 160 mg 2 times a day. The maximum daily dose is 320 mg in two doses. This may require a reduction in the dose of concomitantly taken diuretics.

Possible simultaneous use with other drugs intended for the treatment of CHF. However, simultaneous therapy with drugs of three classes: valsartan, ACE inhibitors and beta-blockers is not recommended.

Assessment of patients with CHF should include monitoring of renal function.

Use after acute myocardial infarction. Treatment should begin within 12 hours after the development of acute MI in the presence of stable hemodynamic parameters. After using an initial dose of 20 mg 2 times a day (1/2 tablet 40 mg), the dose of Valsacor® can be gradually increased by titration to: 40, 80 and 160 mg 2 times a day over several weeks. The maximum daily dose is 320 mg in 2 divided doses. It is recommended to increase the dose to 80 mg 2 times a day by the end of the 2nd week, and the maximum target dose of 160 mg 2 times a day can be achieved by the end of the 3rd month of therapy with Valsacor®. Achievement of the target dose depends on the tolerability of valsartan during the dose titration period.

If an excessive decrease in blood pressure develops, accompanied by clinical manifestations, or renal dysfunction, the dose of the drug should be reduced.

Possible simultaneous use with other drugs, incl. thrombolytic agents, acetylsalicylic acid as an antiplatelet agent, beta-blockers and HMG-CoA reductase inhibitors (statins). Concomitant use with ACE inhibitors is not recommended.

Assessment of patients' condition after acute MI should include monitoring of renal function.

Patients from 6 to 18 years old

AG. The recommended initial dose of Valsacor® in children and adolescents from 6 to 18 years of age is 40 mg for children weighing less than 35 kg and 80 mg for children weighing more than 35 kg. Dose adjustment is recommended taking into account the reduction in blood pressure. The maximum recommended daily doses are shown below.

With body weight ≥8 and

The use of higher doses is not recommended.

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

Elderly patients. No dose adjustment is required in patients over 65 years of age.

Renal dysfunction. No dose adjustment is required in patients with creatinine Cl more than 10 ml/min. The simultaneous use of Valsacor® with aliskiren in patients with moderate and severe renal impairment (creatinine Cl less than 60 ml/min) is contraindicated.

Liver dysfunction. In patients with mild or moderate liver dysfunction of non-biliary origin without cholestasis, the drug should be used with caution, the daily dose should not exceed 80 mg.

Patients with diabetes. The simultaneous use of Valsacor® with aliskiren in patients with diabetes is contraindicated.

Pharmacodynamics

Valsartan is a selective angiotensin II receptor antagonist (AT1 type) for oral administration, of a non-protein nature.

Selectively blocks AT1 receptors. The consequence of AT1 receptor blockade is an increase in the plasma concentration of angiotensin II, which can stimulate unblocked AT2 receptors, which balances the vasopressor effects associated with the stimulation of AT1 receptors. Valsartan does not have agonist activity against AT1 receptors. Its affinity for AT1 receptors is approximately 20,000 times higher than for AT2 receptors.

Valsartan does not inhibit 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. The incidence of dry cough is lower in patients receiving angiotensin II receptor antagonists (ARA II) compared to patients receiving an ACE inhibitor. Valsartan does not interact with or block receptors of other hormones or ion channels involved in the regulation of cardiovascular functions.

Use for arterial hypertension in patients over 18 years of age

In the treatment of arterial hypertension (AH), valsartan reduces blood pressure without affecting heart rate.

After oral administration 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 its use. With continuous 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 during long-term therapy. Simultaneous use with hydrochlorothiazide allows achieving a significant additional reduction in blood pressure.

Sudden withdrawal of valsartan is not accompanied by a sharp increase in blood pressure or other undesirable clinical consequences (i.e., withdrawal syndrome does not develop). In patients with hypertension, diabetes mellitus (DM) type 2 and nephropathy, taking valsartan at a dose of 160–320 mg/day, a significant reduction in proteinuria (36–44%) was observed.

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

When using valsartan for 2 years, starting from 12 hours to 10 days after the development of MI (complicated by left ventricular failure and/or left ventricular systolic dysfunction), overall mortality and cardiovascular mortality are reduced and the time to the first hospitalization for an exacerbation is extended. course of CHF, repeated MI, sudden cardiac arrest and stroke (without death).

CHF in patients over 18 years of age

When using valsartan (in an average daily dose of 254 mg) for 2 years in patients with CHF II–IV functional class according to the NYHA classification with a left ventricular ejection fraction (LVEF) less than 40% and an internal diastolic diameter of the LV more than 2.9 cm/m2 receiving standard therapy (ACE inhibitors, diuretics, digoxin, beta-blockers), there was a significant reduction in the risk of hospitalization due to exacerbation of CHF, a slowdown in the progression of CHF, an improvement in the functional class of CHF according to the NYHA classification, an increase in LVEF, as well as a decrease in the severity of cardiac symptoms failure and improved quality of life compared to placebo.

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

When using valsartan and changing lifestyle, there was a statistically significant reduction in the risk of developing diabetes in patients with hypertension and impaired glucose tolerance. Valsartan had no effect on the incidence of deaths as a result of cardiovascular events, myocardial infarction and non-fatal transient ischemic attacks, the frequency of hospitalizations due to exacerbation of CHF or unstable angina, or arterial revascularization in this category of patients differing in age, gender and race accessories. In patients receiving valsartan, the risk of developing microalbuminuria was significantly lower than in patients not receiving this therapy.

The recommended starting dose of valsartan in patients with hypertension and impaired glucose tolerance is 80 mg once daily. If necessary, the dose can be increased to 160 mg.

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 gradual decrease in blood pressure. When using valsartan, the maximum reduction in blood pressure, regardless of the dose taken orally, is achieved within 2 weeks and is maintained at the achieved level during long-term therapy.

Pharmacokinetics

Suction. After taking valsartan orally, Cmax in blood plasma is achieved within 2–4 hours. The average absolute bioavailability is 23%. When using valsartan with food, AUC and Cmax in blood plasma are reduced by 40 and 50%, respectively. However, 8 hours after taking the drug, plasma concentrations of valsartan taken on an empty stomach and with food are the same. A decrease in AUC is not accompanied by a clinically significant decrease in the therapeutic effect of valsartan, so Valsacor® can be taken regardless of meal time.

Distribution. Vd of valsartan during the steady-state period after intravenous administration was about 17 l, which indicates the absence of a pronounced distribution of valsartan in tissues. Valsartan actively binds to plasma proteins (94–97%), mainly to albumin.

Metabolism. Valsartan does not undergo significant biotransformation; only about 20% of the dose taken orally is excreted in the form of metabolites. The hydroxyl metabolite is detected in blood plasma in low concentrations (less than 10% of the AUC of valsartan). This metabolite has no pharmacological activity.

Excretion. Valsartan is excreted in two phases: α-phase with T1/2α less than 1 hour and β-phase with T1/2β - about 9 hours. Valsartan is excreted mainly unchanged through the intestines (about 83%) and the kidneys (about 13%) . After intravenous administration, plasma clearance of valsartan is about 2 l/h, renal clearance is 0.62 l/h (about 30% of the total clearance). T1/2 of valsartan is 6 hours.

Pharmacokinetics of special groups of patients

Patients with CHF. In patients with CHF, the time to reach Cmax and T1/2 are similar to those in healthy volunteers. The increase in AUC and Cmax is directly proportional to the increase in the dose of valsartan (from 40 to 160 mg 2 times a day). The cumulation factor is, on average, 1.7. When taken orally, the clearance of valsartan is about 4.5 l/h. The age of patients with CHF did not affect the clearance of valsartan.

Elderly patients (over 65 years old). In some patients over 65 years of age, the bioavailability of valsartan was higher than in younger patients, which is not clinically significant.

Patients with impaired renal function. The renal clearance of valsartan is only 30% of the total clearance, therefore there is no correlation between renal function and systemic bioavailability of valsartan. No dose adjustment is required in patients with impaired renal function (creatinine Cl more than 10 ml/min). The safety of valsartan in patients with creatinine Cl less than 10 ml/min and patients on hemodialysis has not been established, so the drug should be used with caution in such patients. Since the degree of binding of valsartan to plasma proteins is high, its elimination during hemodialysis is unlikely.

Patients with impaired liver function. About 70% of the absorbed dose of valsartan is excreted through the intestines, mainly unchanged. Valsartan is not significantly metabolized. In patients with mild or moderate hepatic impairment, the AUC of valsartan increased by 2 times compared to that in healthy volunteers. However, there is no correlation between valsartan AUC values and the degree of liver dysfunction. The use of valsartan in patients with severe hepatic impairment has not been studied.

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

Indications for use Valsacor 80 mg 90 pcs. film-coated tablets

Patients over 18 years of age

arterial hypertension.
chronic heart failure (II–IV functional class according to the NYHA classification) as part of complex therapy (against the background of standard therapy) in patients not receiving ACE inhibitors;
increasing the survival rate of patients after acute MI complicated by left ventricular failure and/or left ventricular (LV) systolic dysfunction in the presence of stable hemodynamic parameters.

Patients from 6 to 18 years old

arterial hypertension in children and adolescents from 6 to 18 years.

Contraindications

hypersensitivity to valsartan or other components of the drug;
severe liver dysfunction (more than 9 points on the Child-Pugh scale), biliary cirrhosis and cholestasis;
simultaneous use with aliskiren in patients with diabetes mellitus or moderate to severe renal impairment (creatinine clearance less than 60 ml/min);
lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome, since Valsacor® contains lactose;
pregnancy;
breastfeeding period;
age up to 6 years - according to arterial hypertension, up to 18 years - according to other indications.

With caution: hyperkalemia; simultaneous use of potassium-sparing diuretics; potassium preparations; potassium-containing dietary supplements or other drugs that can increase the level of potassium in the blood plasma (for example, heparin); mild and moderate liver dysfunction of non-biliary origin without cholestasis; severe renal dysfunction (creatinine Cl less than 10 ml/min - no clinical data), renal dysfunction in patients from 6 to 18 years (creatinine Cl less than 30 ml/min), incl. those on hemodialysis, hyponatremia, following a diet with limited salt intake, conditions accompanied by a decrease in blood volume (including diarrhea, vomiting); bilateral renal artery stenosis or stenosis of the artery of a single kidney; condition after kidney transplantation; primary hyperaldosteronism, in patients with chronic heart failure of functional class III–IV (according to NYNA); whose kidney function depends on the state of the RAAS; stenosis of the aortic and/or mitral valve; hypertrophic obstructive cardiomyopathy (HOCM), in patients with hereditary angioedema or angioedema during previous therapy with ARB II or ACE inhibitors.

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

Application of Valsacor 80 mg 90 pcs. film-coated tablets during pregnancy and breastfeeding

The use of ARA II in the first trimester of pregnancy is not recommended. The use of ARA II 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, oligohydramnios, delayed ossification of fetal skull bones) and neonatal toxic effects (renal failure, arterial hypotension, hyperkalemia).

If, nevertheless, the drug was used in the II–III trimesters of pregnancy, then it is necessary to conduct an ultrasound of the kidneys and bones of the fetal skull.

When planning pregnancy, it is recommended that the patient be transferred to alternative antihypertensive therapy, taking into account the safety profile. If pregnancy is confirmed, Valsacor® should be discontinued as soon as possible.

Newborns whose mothers received ARA II during pregnancy require medical supervision because there is a risk of developing arterial hypotension. There is no data on the excretion of valsartan into breast milk. Therefore, the issue of stopping breastfeeding or canceling valsartan therapy and switching to alternative antihypertensive therapy should be decided, taking into account the safety profile.

special instructions

Hyperkalemia. Caution should be exercised when using potassium-sparing diuretics (spironolactone, eplerenone, triamterene, amiloride), potassium supplements, potassium-containing salt substitutes or other drugs that can increase plasma potassium levels (for example, heparin). It is necessary to regularly monitor the potassium content in the blood plasma.

Renal dysfunction. In patients with impaired renal function, no dose changes are required. Because There are no data on the use of the drug in severe renal failure (creatinine Cl 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.

The simultaneous use of valsartan with aliskiren in patients with moderate and severe renal impairment (creatinine clearance less than 60 ml/min) is contraindicated.

Liver dysfunction. In patients with mild to moderate liver dysfunction without cholestasis, Valsacor® should be used with caution.

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

Renal artery stenosis. The use of valsartan in a short course in patients with renovascular hypertension, which developed secondary to stenosis of the artery of a single kidney, does not cause significant changes in renal hemodynamics, creatinine concentration or urea nitrogen in the blood serum. However, given that other drugs that affect the RAAS may cause an increase in serum urea and creatinine concentrations in patients with bilateral renal artery stenosis or arterial stenosis of a solitary kidney, it is necessary to regularly monitor the concentrations of creatinine and residual urea nitrogen in the blood serum.

Condition after kidney transplantation. The safety of using Valsacor® in patients who have recently undergone kidney transplantation has not been established.

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

Stenosis of the aortic and/or mitral valves, HOCM. The drug Valsacor® should be used with caution in patients with hemodynamically significant stenosis of the aortic and/or mitral valves or with HOCM.

The period after an MI. Concomitant use with ACE inhibitors is not recommended, because has no additional clinical benefits over monotherapy and increases the risk of adverse events.

The use of valsartan in patients after a myocardial infarction often leads to a slight decrease in blood pressure, but discontinuation of therapy due to arterial hypotension is usually not required if drug dosage recommendations are followed.

Treatment with Valsacor® should be initiated cautiously. Assessment of the condition of patients after acute myocardial infarction should include monitoring of renal function.

Possible simultaneous use in acute MI with other drugs: thrombolytics, acetylsalicylic acid, beta-blockers and HMG-CoA reductase inhibitors (statins).

CHF. In patients with CHF, the simultaneous use of three classes of drugs is not recommended: ACE inhibitors, beta-blockers and valsartan, because this therapy did not provide additional clinical effect, and the risk of adverse events increased. Use in patients with CHF is usually accompanied by a decrease in blood pressure, however, if recommendations for dose selection are followed, treatment rarely requires discontinuation due to arterial hypotension. Treatment with Valsacor® in patients with CHF should be initiated with caution. Due to the suppression of RAAS activity in some patients (for example, in patients with CHF III–IV functional class according to the NYNA classification, whose kidney function depends on the state of the RAAS) during therapy with ACE inhibitors, a change in renal function is possible: the development of oliguria and/or progressive azotemia, and in in rare cases - acute renal failure and/or death. The drug Valsacor® blocks angiotensin II receptors, so patients with CHF require regular monitoring of renal function.

History of angioedema. Among patients with angioedema during therapy with Valsacor®, there were cases of a history of angioedema, incl. and ACE inhibitors. If angioedema develops, the drug should be discontinued immediately and the possibility of repeated use should be excluded.

Special information on excipients

The drug Valsacor® contains lactose, so it should not be used for the following conditions: lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.

Impact on the ability to perform potentially hazardous activities that require special attention and quick reactions (for example, driving, working with moving mechanisms). Due to the possibility of dizziness or weakness while using the drug Valsacor®, care must be taken when driving vehicles and engaging in potentially hazardous activities.

Overdose

Symptoms: the main expected manifestation of a valsartan overdose is a pronounced decrease in blood pressure, which can lead to impaired consciousness, collapse and/or shock.

Treatment: symptomatic, it is recommended to induce vomiting and rinse the stomach. If a pronounced decrease in blood pressure develops, it is necessary to transfer the patient to a supine position with his legs raised up, and administer a 0.9% sodium chloride solution intravenously. Regular monitoring of the activity of the heart and respiratory system, blood volume and the amount of urine excreted is recommended. Hemodialysis is ineffective.

Side effects Valsacor 80 mg 90 pcs. film-coated tablets

Classification of the frequency of side effects of the World Health Organization (WHO): very often - ≥1/10; often - from ≥1/100 to

The safety profile of valsartan in patients with hypertension aged 6 to 18 years does not differ from the safety profile of valsartan in patients with hypertension over 18 years of age.

Arterial hypertension

From the blood and lymphatic system: frequency unknown - decreased hemoglobin, decreased hematocrit, neutropenia, thrombocytopenia.

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

Metabolism and nutrition: frequency unknown - increased potassium levels in the blood serum, hyponatremia.

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

From the side of blood vessels: frequency unknown - vasculitis.

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

From the gastrointestinal tract: infrequently - abdominal pain.

From the liver and biliary tract: frequency unknown - impaired liver function, including increased concentration of bilirubin in the blood plasma.

From the skin and subcutaneous tissues: frequency unknown - angioedema, skin rash, itching, bullous dermatitis.

Musculoskeletal and connective tissue disorders: frequency unknown - myalgia.

From the kidneys and urinary tract: frequency unknown - impaired renal function and renal failure, increased concentration of creatinine in the blood serum.

General disorders and disorders at the injection site: uncommon - increased fatigue.

During clinical studies in patients with hypertension, the following adverse events were observed, the cause-and-effect relationship of which with valsartan was not established: arthralgia, asthenia, back pain, diarrhea, dizziness, insomnia, decreased libido, nausea, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections.

After acute MI and/or chronic heart failure (II–IV functional class according to the NYHA classification)

From the blood and lymphatic system: frequency unknown - thrombocytopenia.

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

From the side of metabolism and nutrition: infrequently - hyperkalemia; frequency unknown - increased potassium content in the blood serum, hyponatremia.

From the nervous system: often - dizziness, postural dizziness; infrequently - fainting, headache.

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

From the heart: infrequently - increased symptoms of CHF.

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

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

From the gastrointestinal tract: infrequently - nausea, diarrhea.

From the liver and biliary tract: frequency unknown - impaired liver function.

From the skin and subcutaneous tissues: infrequently - angioedema; frequency unknown - skin rash, skin itching, bullous dermatitis.

From the musculoskeletal and connective tissue side: rarely - rhabdomyolysis; frequency unknown - myalgia.

From the kidneys and urinary tract: often - impaired renal function and renal failure; uncommon - acute renal failure, increased serum creatinine concentration; frequency unknown - increased urea nitrogen content in the blood plasma.

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

Drug interactions

Concomitant use is contraindicated

Concomitant use of ARB II, including valsartan, or ACE inhibitors with aliskiren is contraindicated in patients with diabetes or moderate to severe renal impairment (creatinine clearance less than 60 ml/min).

Concomitant use is not recommended

Lithium. Simultaneous use with lithium preparations is not recommended, because a reversible increase in the concentration of lithium in the blood plasma and an increase in its toxic effect are possible. The risk of toxic effects associated with the use of lithium preparations may further increase when used simultaneously with Valsacor® and diuretics. If simultaneous 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 supplements, potassium-containing nutritional supplements and other drugs and substances that can cause hyperkalemia (for example, heparin). If simultaneous use with drugs that affect potassium levels is necessary, it is recommended to monitor the potassium content in the blood plasma.

Concomitant use with caution

Double blockade of the RAAS. In some patients, double blockade of the RAAS was accompanied by the development of arterial hypotension, syncope, hyperkalemia and renal dysfunction (including acute renal failure (ARF). Caution is required when using ARB II, including valsartan, with drugs that affect the RAAS, such as inhibitors ACE or aliskiren.

NSAIDs, incl. selective COX-2 inhibitors, acetylsalicylic acid in a dose of more than 3 g/day and non-selective NSAIDs. When used simultaneously with valsartan, it is possible to reduce the antihypertensive effect, increase the risk of developing renal dysfunction and increase the potassium content in the blood plasma. Before starting combination therapy, it is recommended to evaluate renal function, as well as correct water and electrolyte imbalances.

Transport proteins. In vitro studies in liver cultures have shown that valsartan is a substrate for the transporter proteins OATP1B1/OATP1B3 and MRP2. Concomitant use of valsartan with inhibitors of the OATP1B1/OATP1B3 transport protein (rifampicin, cyclosporine) or MRP2 (ritonavir) may increase the systemic exposure of valsartan (Cmax and AUC). Caution must be exercised when starting simultaneous use with the above drugs or after their discontinuation.

No drug interactions

No clinically significant interactions were identified with the following drugs: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine and glibenclamide.

Patients from 6 to 18 years old. In children and adolescents, hypertension is often associated with impaired renal function. The simultaneous use of valsartan with other drugs that affect the RAAS may cause an increase in potassium levels in the blood plasma in such patients. Caution should be exercised when using the above combination simultaneously and regular monitoring of renal function and plasma potassium levels in this group of patients.

Side effects

During treatment with Valsacor, the following are likely:

severe hypotension;
muscle weakness, drowsiness, fatigue;
loss of appetite, nausea, impaired intestinal motility;
back pain;
cough;
insomnia.

In case of overdose, vomiting, disturbances in heart rhythm, coordination of movements, water-salt balance develop, a sharp headache occurs, a feeling of stunnedness, fainting, and toxic shock are possible.

Valsacor Tablets, box, 30 pcs., 80 mg, for oral administration

Side effect

The incidence of adverse events is comparable to placebo. There is no data on the relationship between the incidence of adverse events and the dose or duration of treatment, as well as the age, gender or race of patients. WHO classification of the frequency of side effects: very often (more than 1/10), often (from more than 1/100 to less than 1/10), infrequently from (more than 1/1000 to less than 1/100), rarely (from more than 1/10,000 to less than 1/1000 ), very rare (less than 1/10,000), frequency unknown (cannot be estimated based on available data). All adverse events when using valsartan, identified in clinical practice and in the analysis of laboratory parameters, which cannot be attributed to any frequency of occurrence, are classified as frequency unknown. Arterial hypertension From the hematopoietic system: frequency unknown - decrease in hemoglobin, hematocrit, neutropenia, thrombocytopenia. From the immune system: frequency unknown - hypersensitivity reactions, including serum sickness. From the metabolic side: frequency unknown - increased potassium levels in the blood serum, hyponatremia. From the senses: infrequently - vertigo. From the cardiovascular system: frequency unknown - vasculitis. From the respiratory system: infrequently - cough. From the digestive system: infrequently - abdominal pain; frequency unknown - impaired liver function, including increased concentrations of bilirubin in the blood plasma. From the skin of subcutaneous tissues: very rarely - angioedema, skin rash, itching. From the musculoskeletal system: frequency unknown - myalgia. From the urinary system: frequency unknown - impaired renal function, increased concentration of creatinine in the blood serum. Other: infrequently - increased fatigue. Also, during clinical studies in patients with arterial hypertension, the following adverse events were observed (a cause-and-effect relationship with taking the drug has not been 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 a history of myocardial infarction and/or heart failure, the safety profile in clinical trials is somewhat different from that in patients with arterial hypertension. This may be due to the disease itself. Chronic heart failure (II-IV functional class according to the NYHA classification) and increased survival of patients with acute myocardial infarction From the hematopoietic system: frequency unknown - thrombocytopenia. From the immune system: frequency unknown - hypersensitivity reactions, including serum sickness. From the side of metabolism: infrequently - hyperkalemia; frequency unknown - increased serum potassium, hyponatremia. From the nervous system: often - dizziness, orthostatic (postural) dizziness; infrequently - fainting, headache. From the senses: infrequently - vertigo. From the cardiovascular system: often - marked decrease in blood pressure, orthostatic hypotension; uncommon - increased symptoms of heart failure; frequency unknown - vasculitis. From the respiratory system: infrequently - cough. From the digestive system: infrequently - nausea, diarrhea; frequency unknown - liver dysfunction. From the skin and subcutaneous tissues: very rarely - angioedema; frequency unknown - skin rash, itching. From the musculoskeletal system: very rarely - rhabdomyolysis; frequency unknown - myalgia. From the urinary system: often - impaired renal function; uncommon - acute renal failure, increased serum creatinine concentration; frequency unknown - increased concentration of residual urea nitrogen in the blood serum. Other: infrequently - asthenia, increased fatigue.

Precautions and contraindications

Valsacor requires careful use and constant monitoring of well-being in cases of impaired renal and liver function during treatment after a heart attack. The drug enhances the toxic effect of medications containing acetylsalicylic acid. It is not advisable to take Valsacor simultaneously with cardiac glycosides, anti-gout medications, or potassium-sparing agents.

When combined with barbiturates, adrenergic blockers, vasodilators, the diuretic and hypotensive effect of Valsacor is enhanced. It is important to remember this when choosing dosages.

The medicine affects psychomotor reactions, so during the treatment period caution is required when creating vehicles and operating special equipment.

The drug is incompatible with alcohol and can provoke a sharp drop in blood pressure, hypoxia and vascular collapse.

It is necessary to refuse therapy with Valsacor:

with renal artery stenosis, not on hemodialysis, with severe renal failure;
with cirrhosis, severe hepatosis;
acute dehydration;
during pregnancy and lactation;
in case of individual intolerance to the components.

Caution is required in various forms of cardiomyopathy, stenosis of the mitral valve or aorta.

Instructions for use VALSACOR® H80 (VALSACOR® H80)

Changes in serum electrolytes

The simultaneous use of potassium-containing nutritional supplements, potassium-sparing diuretics, potassium-containing salt substitutes or other substances that can increase the level of potassium in the blood (including heparin) with valsartan is not recommended. Appropriate monitoring of serum potassium levels is necessary.

There are reports of the development of hypokalemia during treatment with thiazide diuretics, including hydrochlorothiazide. Frequent monitoring of serum potassium levels is recommended. Treatment with thiazide diuretics, including hydrochlorothiazide, can cause hyponatremia and hypochloremic alkalosis. Thiazides, including hydrochlorothiazide, increase urinary excretion of magnesium, which can lead to hypomagnesemia. Thiazide diuretics reduce calcium excretion. This can lead to hypercalcemia. During treatment with diuretics, regular periodic monitoring of serum electrolytes should be carried out.

Patients with sodium and/or fluid deficiency

Patients receiving thiazide diuretics, including hydrochlorothiazide, should be monitored for signs of electrolyte and fluid imbalances.

In patients with severe sodium and/or fluid deficiency taking diuretics in high doses, in rare cases, symptomatic arterial hypotension may develop at the beginning of therapy with Valsacor® H80. Before starting treatment with Valsacor® H80, it is necessary to restore the content of electrolytes and fluid in the body.

Patients suffering from severe congestive heart failure or other diseases accompanied by stimulation of the RAAS

In cases where renal function is primarily dependent on the activity of the RAAS (for example, patients suffering from severe heart failure), treatment with ACE inhibitors may be accompanied by the development of oliguria and/or progressive azotemia, and, in rare cases, acute renal failure. The safety of Valsacor® H80 in patients with severe congestive heart failure has not been established. Therefore, we cannot exclude the fact that due to inhibition of the RAAS, the use of Valsacor® H80 may cause renal dysfunction. Such patients should not be prescribed Valsacor® H80.

Renal artery stenosis

Patients with bilateral renal artery stenosis or renal artery stenosis of a solitary kidney should not be prescribed Valsacor® H80 for the treatment of hypertension to avoid increases in blood urea and serum creatinine levels.

Primary hyperaldosteronism

Patients with primary hyperaldosteronism should not be prescribed Valsacor® H80, since in such cases the RAAS is not activated.

Aortic stenosis, mitral stenosis, obstructive hypertrophic cardiomyopathy

As with other vasodilators, special caution should be exercised in patients with aortic stenosis, mitral stenosis, or obstructive hypertrophic cardiomyopathy.

Renal dysfunction

Patients with impaired renal function (creatinine clearance ≥30 ml/min) do not require changes in dosage of the drug. When prescribing Valsacor® H80 to patients suffering from impaired renal function, it is recommended to periodically monitor serum levels of potassium, creatinine and uric acid.

Kidney transplant

Currently, there is no experience with the safe use of Valsacor® H80 in patients who have recently undergone kidney transplantation.

Liver dysfunction

Valsacor® H80 should be prescribed with caution to patients with mild or moderate liver dysfunction without cholestasis. Thiazide diuretics should also be taken with caution in patients with impaired liver function or progressive liver disease, because minor changes in fluid and electrolyte balance may increase the risk of hepatic coma.

Angioedema

Cases of angioedema (including swelling of the larynx and glottis, leading to airway obstruction and/or swelling of the face, lips, pharynx and/or tongue) have been reported in patients receiving valsartan. Some of these patients have a history of angioedema while using other drugs, incl. and when using other angiotensin II receptor antagonists. If angioedema develops, treatment with angiotensin II receptor antagonists should be discontinued immediately. Repeated use of the drug is contraindicated.

Systemic lupus erythematosus

Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics, including hydrochlorothiazide.

Other metabolic disorders

Thiazide diuretics, including hydrochlorothiazide, may alter glucose tolerance and increase serum cholesterol, triglycerides, and uric acid. Patients with diabetes mellitus may require dose adjustments of insulin or oral hypoglycemic agents.

Thiazides may reduce urinary calcium excretion and cause intermittent and mild increases in serum calcium levels in the absence of known disorders of calcium metabolism. Severe hypercalcemia may be a sign of underlying hyperparathyroidism. Thiazides should be discontinued before parathyroid function tests are performed.

Photosensitivity

Cases of photosensitivity reactions have been reported when taking thiazide diuretics. If these reactions occur during treatment, it is recommended to discontinue treatment. If resumption of a diuretic is necessary, it is recommended to protect the exposed areas from the sun or artificial UV rays.

Hypersensitivity reactions

The drug should be prescribed with caution to patients with hypersensitivity to other angiotensin II receptor antagonists. Hypersensitivity reactions to hydrochlorothiazide are most likely in patients suffering from allergies and bronchial asthma.

Acute angle-closure glaucoma

Hydrochlorothiazide has been associated with an idiosyncratic reaction that can lead to acute transient myopia and acute angle-closure glaucoma. There is a sharp decrease in visual acuity or pain in the eyes. These symptoms usually last for several hours a week while using the drug. Untreated glaucoma can lead to permanent vision loss. If intraocular pressure remains uncontrolled, surgical treatment may be required. In such cases, you should immediately stop taking the drug. A risk factor for the development of acute angle-closure glaucoma is an allergic reaction to the use of sulfonamide or penicillin.

Double blockade of the RAAS

When using drugs that affect the RAAS, especially when taken simultaneously, arterial hypotension, syncope, stroke, hyperkalemia, and renal dysfunction (including acute renal failure) have been reported. In patients receiving valsartan and other drugs that affect the RAAS, blood pressure, renal function, and electrolyte levels in the blood should be regularly monitored. In patients with diabetes mellitus and patients with renal failure (GFR <60 ml/min), the simultaneous use of aliskiren and valsartan is contraindicated.

Excipients

Valsacor® H80 contains lactose, therefore the drug is not recommended for patients with lactase deficiency, galactosemia or glucose-galactose malabsorption syndrome.

Impact on the ability to drive vehicles and operate machinery

There is no data on the effect of the drug Valsacor® H80 on the ability to drive vehicles and potentially dangerous mechanisms. When driving or operating machinery, be aware that when taking a combination of valsartan and hydrochlorothiazide, there may be a risk of dizziness or fatigue.