VALSACOR PILLS 160MG

Indications

- arterial hypertension;

- chronic heart failure (NYHA classification II-IV functional class) 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 );

- increase in the survival rate of patients with acute myocardial infarction (12 h-10 days), complicated by left ventricular failure and / or left ventricular systolic dysfunction, in the presence of stable hemodynamic parameters.

Dosage and administration

The drug is prescribed by mouth, regardless of the meal, the multiplicity of reception - 1-2 times / day.

Arterial hypertension

The recommended initial dose is 80 mg 1 time / day, regardless of race, age and sex of the patient. The antihypertensive effect develops within 2 weeks and reaches its maximum after 4 weeks. Patients who fail to achieve optimal control of blood pressure, the daily dose of the drug Valsacor ® may be gradually increased to a maximum daily dose of 320 mg. The simultaneous use of diuretics, such as hydrochlorothiazide, allows to achieve a significant additional reduction in blood pressure.

Chronic heart failure (NYHA class II-IV functional class)

The recommended initial dose is 40 mg 2 times / day. A gradual (up to at least 2 weeks) increase in dose up to 80 mg 2 times / day is possible, with good tolerance up to 160 mg 2 times / day. The maximum daily dose - 320 mg, divided into 2 doses.

At the same time taking diuretics dose is recommended to be reduced. May 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. In patients with heart failure, renal function should always be evaluated.

Increased survival of patients with acute myocardial infarction

In patients with stable hemodynamics, treatment should begin as early as 12 hours after the development of myocardial infarction. After the initial dose of 20 mg is prescribed, 2 times / day, the dose of the drug Valsacor® should be increased by the method of titration to 40 mg, 80 mg 2 times / day for several weeks until reaching the target dose of 160 mg 2 times / day. The maximum daily dose - 320 mg 2 times / day.

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

Drug Valsacor® can be used in patients after myocardial infarction during therapy with other drugs, including thrombolytics, Acetylsalicylic acid as an antiplatelet agent, beta-blockers, HMG-CoA reductase inhibitors (statins) and diuretics. Apply the drug Valsacor® simultaneously with ACE inhibitors is not recommended.

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

For elderly patients (over 65 years) dose adjustment is not required.

Have patients with impaired renal function dose adjustment of the drug is not required.

Have patients with impaired liver function of mild and moderate severity of nonbiliary genesis without cholestasis the maximum daily dose should not exceed 80 mg.

Adverse effects

The incidence of adverse events is comparable to placebo. There are no data on the dependence of the incidence of adverse events on the dose or duration of treatment, as well as on the age, sex or race of patients.

Classification of the incidence of side effects WHO: very often (> 1/10), often (from> 1/100 to <1/10), rarely from (> 1/1000 to <1/100), rarely (from> 1 / 10,000 to <1/1000), very rarely (from <1 / 10,000), the frequency is unknown (cannot be estimated based on available data).

All adverse events in the application of valsartan, identified in clinical practice and in the analysis of laboratory parameters that can not be attributed to any frequency of occurrence, are assigned to the group "frequency unknown".

Arterial hypertension

From the hemopoietic system: frequency is unknown - decrease in hemoglobin, hematocrit, neutropenia, thrombocytopenia.

On the part of the immune system: frequency unknown - hypersensitivity reactions, including serum sickness.

Metabolism: frequency is unknown - an increase in the content of potassium in the blood serum, hyponatremia.

Special senses: infrequently - vertigo.

Cardiovascular: frequency is unknown - vasculitis.

Respiratory: Infrequently - cough.

Gastrointestinal: infrequently - abdominal pain; frequency unknown - abnormal liver function, including an increase in plasma bilirubin concentration.

From the skin of the subcutaneous tissues: very rarely - angioedema, skin rash, pruritus.

Musculoskeletal system: frequency unknown - myalgia.

Urogenital: frequency unknown - impaired renal function, increased serum creatinine concentration.

Other: infrequently - increased fatigue.

Also during clinical studies in patients with arterial hypertension, the following adverse events were observed (a causal relationship with taking the drug was not 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 myocardial infarction and / or heart failure, the safety profile in clinical studies is somewhat different from that in patients with arterial hypertension. This may be due to the disease itself.

Chronic heart failure (NYHA classification II-IV functional class) and increased survival of patients with acute myocardial infarction

Hemic and lymphatic: the frequency is unknown - thrombocytopenia.

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

Metabolism: infrequently - hyperkalemia; frequency is unknown - an increase in the content of potassium in the blood serum, hyponatremia.

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

Special senses: infrequently - vertigo.

Since the cardiovascular system: often - pronounced decrease in blood pressure, orthostatic hypotension; infrequently - increased symptoms of heart failure; frequency is unknown - vasculitis.

On the part of the respiratory system: Infrequently - cough.

Gastrointestinal: infrequently - nausea, diarrhea; frequency unknown - abnormal liver function.

Dermatological: very rarely - angioedema; frequency is unknown - skin rash, skin itch.

Musculoskeletal system: very rarely - rhabdomyolysis; frequency unknown - myalgia.

Urogenital: often - impaired renal function; infrequently - acute renal failure, increased serum creatinine concentration; unknown frequency - increase in the concentration of residual nitrogen in the serum of urea.

Other: infrequently - asthenia, fatigue.

Contraindications

- hypersensitivity to valsartan or to other components of the drug;

- abnormal liver function, biliary cirrhosis and cholestasis;

- dysfunction of the liver of mild and moderate severity (for a dose of 320 mg);

- simultaneous use with aliskiren in patients with diabetes mellitus or impaired renal function (CC <60 ml / min);

- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;

- pregnancy;

- lactation period (breastfeeding);

- children and adolescents up to 18 years (the effectiveness and safety of the use of valsartan in children has not been proven).

WITH caution: severe renal impairment (CC <10 ml / min); stenosis of the aortic and / or mitral valve; hypertrophic obstructive cardiomyopathy (GOKMP); chronic heart failure (NYHA class III-IV functional class); condition after kidney transplantation; hemodialysis; hyponatremia; diet restriction of salt intake; bilateral renal artery stenosis or arterial stenosis of a single kidney; hyperkalemia; primary hyper aldosteronism; conditions accompanied by a decrease in the bcc (includingdiarrhea, vomiting); hereditary angioedema, or edema in the background of previous therapy with angiotensin II receptor antagonists or ACE inhibitors.

Use during pregnancy and lactation

Given the mechanism of action of angiotensin II receptor antagonists, the risk to the fetus cannot be excluded. The drug is contraindicated in the II and III trimesters of pregnancy, because its use during this period can cause fetotoksicheskie effects (decreased renal function, oligohydramnios, delayed ossification of the fetal bones) and neonatal toxic effects (renal failure, arterial hypotension, hyperkalemia). In the case of the drug in the II and III trimesters of pregnancy, an ultrasound scan of the kidneys and bones of the fetal skull is necessary.

Valsacor®As with any other drug that has a direct effect on the RAAS, it should not be used during pregnancy, as well as in women planning pregnancy. When planning a 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 a negative effect of these drugs on the fetus during pregnancy. When confirming pregnancy drug Valsacor® need to cancel as soon as possible.

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

The use of valsartan did not adversely affect reproductive function in males and females of rats in doses up to 200 mg / kg / day when taken orally. The indicated dose is 6 times the maximum recommended daily dose of a person in terms of mg / m2 (calculations were made at the rate of 320 mg / day with the ingestion and patient body weight of 60 kg).

Application for violations of the liver

The use of the drug is contraindicated in disorders of the liver, biliary cirrhosis and cholestasis (disorders of mild to moderate severity - for a dose of 320 mg).

Application for violations of kidney function

Carefully the drug should be used for severe impaired renal function (CC <10 ml / min), condition after kidney transplantation, in patients on hemodialysis, bilateral stenosis of the renal arteries or stenosis of the artery of a single kidney.

Concurrent use with aliskiren in patients with impaired renal function (QC <60 ml / min) is contraindicated.

Use in children

Contraindicated: age up to 18 years (efficacy and safety of valsartan use in children has not been proven).

Use in elderly patients

For elderly patients (over 65 years) dose adjustment is not required.

special instructions

When using the drug Valsacor® patients with arterial hypertension do not require regular monitoring of laboratory parameters.

Hyponatremia and / or dehydration

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

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

Hyperkalemia

The simultaneous use of potassium-sparing diuretics, potassium preparations, potassium-containing food additives or other drugs that can increase the content of potassium in the blood serum (eg, heparin) is not recommended. It is necessary to control the content of potassium in the blood plasma.

Renal artery stenosis

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

Condition after kidney transplantation

The safety of the drug 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, such patients use Valsacor® Not recommended.

Aortic and / or mitral valve stenosis, hypertrophic obstructive cardiomyopathy

Drug Valsacor® It should be used with caution in patients with hemodynamically significant stenosis of the aortic and / or mitral valves or with hypertrophic obstructive cardiomyopathy.

Renal dysfunction

Patients with impaired renal function do not need to change doses of the drug. Since there are no data on the use of the drug in severe renal failure (CC <10 ml / min or 0.167 ml / s) and in patients on hemodialysis, in such cases it is recommended to use the drug with caution.

The simultaneous use of angiotensin II receptor antagonists, including valsartan, or ACE inhibitors with aliskiren is contraindicated in patients with impaired renal function (CC <60 ml / min).

Liver dysfunction

Patients with impaired liver function of mild to moderate severity of nonbiliary genesis without cholestasis; Valsacor® at a dosage of 320 mg is contraindicated, because the maximum daily dose should not exceed 80 mg.

Angioedema in history

Among patients with angioedema (swelling of the larynx and vocal cords, causing obstruction of the airways and / or swelling of the face, lips, pharynx and / or tongue) during therapy with Valsacor®, there have been cases of angioedema in history, including and ACE inhibitors. With the development of angioedema should immediately discontinue the drug and exclude the possibility of re-use.

Arterial hypertension

When hypertension drug Valsacor® it can be used as monotherapy or simultaneously with other antihypertensive drugs, in particular with diuretics.

CHF / improved survival of patients with acute myocardial infarction

Perhaps the use of the drug Valsacor® in combination with other drugs used in acute myocardial infarction (thrombolytics, acetylsalicylic acid as an antiplatelet agent, beta-blockers and inhibitors of MMC-CoA reductase (statins)). Simultaneous use of the drug Valsacor® and ACE inhibitors in this category of patients is not recommended, because This combination therapy does not lead to an additional clinical effect and is accompanied by an increase in the risk of the development of adverse events as compared with therapy with two drugs separately.

In patients with chronic heart failure, triple combination therapy: with Valsacor®, an ACE inhibitor and beta-blocker is not recommended, because does not lead to an additional clinical effect and is accompanied by an increased risk of adverse events.

Use of the drug Valsacor® in patients with CHF or myocardial infarction often leads to a small decrease in blood pressure, as a rule, without discontinuation of the drug when you follow the instructions for dosing.

In patients whose renal function may depend on the activity of the RAAS (for example, in severe chronic heart failure), therapy with ACE inhibitors is accompanied by oliguria and / or an increase in azotemia, and in rare cases, acute renal failure and / or death. Since valsartan is an antagonist of angiotensin II receptors, the possibility of impaired renal function in its use cannot be ruled out. Patients with CHF or myocardial infarction should be started carefully. When examining patients, renal function should always be evaluated.

Special information on excipients

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

Influence on ability to drive motor transport and control mechanisms

Care must be taken when driving and occupations of potentially hazardous activities that require increased concentration and psychomotor speed, becausemay develop dizziness or weakness on the background of arterial hypotension.

Overdose

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

Treatment: symptomatic, the nature of which depends on the time elapsed since the moment of taking the drug, and on the severity of the symptoms. In case of accidental overdose, it is necessary to induce vomiting (if the drug has been taken recently) or to perform a gastric lavage. With a pronounced decrease in blood pressure, it is necessary to transfer the patient to a horizontal position with a low head, then you should take measures aimed at maintaining the functions of the cardiovascular and respiratory systems, BCC (introduction of 0.9% sodium chloride solution in / in) and control of daily diuresis. Hemodialysis is ineffective.

Drug interaction

Simultaneous use is contraindicated

The simultaneous use of angiotensin II receptor antagonists, including valsartan, or ACE inhibitors with aliskiren is contraindicated in patients with diabetes mellitus and renal dysfunction (CC <60 ml / min).

Simultaneous use is not recommended.

Simultaneous use with lithium preparations is not recommended, since perhaps a reversible increase in the concentration of lithium in the blood plasma and the development of intoxication. The simultaneous use of valsartan with diuretics and lithium preparations may further increase the concentration of lithium and increase the risk of intoxication.If necessary, the simultaneous use of lithium preparations should be carefully monitored for the concentration of lithium in the blood plasma.

When used simultaneously with potassium-sparing diuretics, potassium preparations, potassium-containing food additives and other drugs and substances that can increase the content of potassium in the blood serum (eg, heparin), it is recommended to monitor the content of potassium in the blood plasma.

Simultaneous use with caution

In some patients, double blockade of the RAAS was accompanied by the development of arterial hypotension, fainting, hyperkalemia and impaired renal function (including acute renal failure). Care must be taken with the simultaneous use of angiotensin II receptor antagonists, including valsartan, with drugs that affect the RAAS, such as ACE inhibitors or aliskiren.

When used simultaneously with NSAIDs, incl. selective inhibitors of COX-2, acetylsalicylic acid in a dose of more than 3 g / day and non-selective NSAIDs may weaken the hypotensive effect, increase the risk of developing renal dysfunction and increase the potassium content in blood plasma. At the beginning of therapy, it is recommended to evaluate the function of the kidneys, as well as correct the water and electrolyte balance disorders.

According to the results of an in vitro study, valsartan is a substrate for OATP1B1 / OATP1BZ liver transporter proteins and MRP2 efflux transporter.The clinical significance of this fact is unknown. The simultaneous use of OATP1B1 / OATP1BZ transporter protein inhibitors (for example, rifampicin, cyclosporine) and the efflux MRP2 transporter (for example, ritonavir) can increase the systemic exposure of valsartan (Cmax and AUC). This should be considered at the beginning and at the end of concurrent therapy.

Lack of drug interaction

There were no clinically significant interactions with the following drugs: cimetidine, Warfarin, Furosemide, Digoxin, Atenolol, Indomethacin, hydrochlorothiazide, Amlodipine, and glibenclamide.

Terms and conditions of storage

The drug should be stored out of reach of children, in its original packaging, at a temperature not higher than 30 ° C.