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Valsartan, 30 pcs., 80 mg, film-coated tablets

Active specific angiotensin II receptor antagonist, intended for oral administration. Selectively blocks receptors of the AT1 subtype, which are responsible for the effects of angiotensin II. The consequence of AT1 receptor blockade is an increase in the plasma concentration of angiotensin II, which can stimulate unblocked AT2 receptors. Valsartan does not have any pronounced antagonistic activity against AT1 receptors. The affinity of valsartan for receptors of the AT1 subtype is approximately 20,000 times higher than for receptors of the AT2 subtype.

Valsartan does not interact with or block other hormone receptors or ion channels that are important for regulating the function of the cardiovascular system.

The likelihood of coughing when using valsartan is very low, which is due to the lack of influence on the angiotensin converting enzyme (ACE), which is responsible for the degradation of bradykinin.

A comparison of valsartan with an ACE inhibitor showed that the incidence of dry cough was significantly (p < 0.05) lower in patients receiving valsartan than in patients receiving an ACE inhibitor (2.6% versus 7.9%, respectively). In the group of patients who had previously developed a dry cough during treatment with an ACE inhibitor, during treatment with Valsartan this complication was noted in 19.5% of cases, and during treatment with a thiazide diuretic - in 19% of cases, while in the group of patients receiving treatment ACE inhibitor, cough was observed in 68.5% of cases (p < 0.05).

Use for arterial hypertension in patients over 18 years of age

When treating patients with arterial hypertension with valsartan, a decrease in blood pressure (BP) is observed, not accompanied by a change in heart rate (HR).

After taking a single dose of the drug, in most patients, the onset of the antihypertensive effect is noted within 2 hours, and the maximum reduction in blood pressure is achieved within 4-6 hours. After taking the drug, the antihypertensive effect lasts more than 24 hours.

With repeated prescriptions 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 long-term therapy.

When the drug is combined with hydrochlorothiazide, a significant additional reduction in blood pressure is achieved. Abrupt cessation of valsartan is not accompanied by a sharp increase in blood pressure or other undesirable consequences.

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

When using the drug for 2 years in patients who began taking it from 12 hours to 10 days after acute myocardial infarction (complicated by left ventricular failure and/or left ventricular systolic dysfunction), the rates of overall mortality and cardiovascular mortality are reduced and the time until the first hospitalization for exacerbation of CHF, repeated myocardial infarction, sudden cardiac arrest and stroke (without death) increases. The safety profile of valsartan in patients with acute infarction is similar to that in other conditions.

CHF in patients over 18 years of age

The mechanism of action of valsartan in chronic heart failure (CHF) is based on its ability to eliminate the negative consequences of hyperactivation of the renin-angiotensin-aldosterone system (RAAS) and its main effector, angiotensin II, namely vasoconstriction; fluid retention in the body; cell proliferation leading to remodeling of target organs (heart, kidneys, blood vessels); stimulation of excess synthesis of hormones that act synergistically with the RAAS (catecholamines, aldosterone, vasopressin, endothelin, etc.).

With the use of valsartan for CHF, preload decreases, pulmonary capillary wedge pressure (PCWP) and diastolic pressure in the pulmonary artery decrease, and cardiac output increases. Along with hemodynamic effects, valsartan, due to indirect blockade of aldosterone synthesis, reduces sodium and water retention in the body.

It was found that the drug did not have a significant effect on the concentration of total cholesterol, uric acid, and also, when studied on an empty stomach, on the concentration of triglycerides and glucose in the blood plasma.

When using valsartan (in an average daily dose of 254 mg) for 2 years in patients with CHF II (62%), III (36%) and IV (2%) functional class according to the NYHA classification with left ventricular ejection fraction (LV) less than 40% and LV internal diastolic diameter more than 2.9 cm/m2, receiving standard therapy, including ACE inhibitors (93%), diuretics (86%), digoxin (67%) and beta-blockers (36%) there is a significant decrease (by 27.5%) risk of hospitalization due to exacerbation of CHF.

In patients not receiving ACE inhibitors, there was a significant reduction in overall mortality (by 33%), cardiovascular mortality and CHF-related morbidity (time to first cardiovascular event), assessed by the following indicators: death, sudden death with resuscitation, hospitalization for exacerbation of CHF, intravenous administration of inotropic and vasodilator drugs for 4 or more hours without hospitalization (44%). In the group of patients receiving ACE inhibitors (without beta-blockers), during treatment with valsartan there is no reduction in overall mortality, but cardiovascular mortality and morbidity associated with CHF decrease by 18.3%.

In general, the use of valsartan leads to a decrease in the number of hospitalizations for CHF, a slowdown in the progression of CHF, an improvement in the functional class of CHF according to the NYHA classification, an increase in LV ejection fraction, as well as a decrease in the severity of signs and symptoms of heart failure and an improvement in quality of life compared to placebo.

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

When using valsartan and changing lifestyle, there was a statistical reduction in the risk of developing diabetes mellitus in this category of patients. Valsartan had no effect on the incidence of deaths due to cardiovascular events, myocardial infarction and non-fatal ischemic attacks, hospitalizations due to heart failure or unstable angina, arterial revascularization, in patients with impaired glucose tolerance and arterial hypertension, differing in age, gender and race.

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

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

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

Valsartan

Valsartan is an active specific angiotensin II receptor antagonist (ARA II), intended for oral administration.

Selectively blocks receptors of the AT1 subtype, which are responsible for the effects of angiotensin II. The consequence of AT1 receptor blockade is an increase in the plasma concentration of angiotensin II, which can stimulate unblocked AT2 receptors. Valsartan does not have any pronounced agonistic activity against AT1 receptors. The affinity of valsartan for receptors of the AT1 subtype is approximately 20,000 times higher than for receptors of the AT2 subtype. Valsartan does not interact with or block other hormone receptors or ion channels that are important in regulating the functions of the cardiovascular system.

The likelihood of coughing when using valsartan is very low, which is due to the lack of effect on angiotensin-converting enzyme (ACE), which is responsible for the degradation of bradykinin. Accordingly, when using angiotensin II receptor antagonists, ACE inhibition and accumulation of bradykinin or substance P do not occur. In comparative clinical studies of valsartan with an ACE inhibitor, the incidence of dry cough was significantly (p<0.05) lower in patients taking valsartan than in patients taking an ACE inhibitor (2.6% vs. 7.9%, respectively).

Use for arterial hypertension in patients over 18 years of age

When treating patients with arterial hypertension with valsartan, a decrease in blood pressure (BP) is observed, not accompanied by a change in heart rate (HR).

After oral administration of a single dose of valsartan, in most patients, the onset of the antihypertensive effect is observed within 2 hours, and the maximum reduction in blood pressure is achieved within 4-6 hours, lasting more than 24 hours. With repeated use of valsartan, the maximum reduction in blood pressure, regardless of the dose taken, is usually achieved within 2-4 weeks, and is maintained at this level during long-term therapy. Abrupt cessation of valsartan is not accompanied by a significant increase in blood pressure or other adverse events.

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

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

When using valsartan for 2 years in patients who began taking valsartan from 12 hours to 10 days after myocardial infarction (complicated by left ventricular failure and/or left ventricular systolic dysfunction), overall mortality and cardiovascular mortality are reduced and the time until the first hospitalization for exacerbation of chronic heart failure, repeated myocardial infarction, sudden cardiac arrest and stroke (without death) 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 over 18 years of age

The mechanism of action of valsartan in CHF is based on its ability to eliminate the negative consequences of chronic hyperactivation of the renin-angiotensin-aldosterone system (RAAS) and its main effector, angiotensin II, namely: vasoconstriction; fluid retention in the body; cell proliferation leading to remodeling of target organs (heart, kidneys, blood vessels); stimulation of excess synthesis of hormones that act synergistically with the RAAS (catecholamines, aldosterone, vasopressin, endothelin). With the use of valsartan for CHF, preload decreases, wedge pressure in the pulmonary capillaries and diastolic pressure in the pulmonary artery decreases, and cardiac output increases. Along with hemodynamic effects, valsartan, due to indirect blockade of aldosterone synthesis, reduces sodium and water retention in the body.

When using valsartan (in an average daily dose of 254 mg) for 2 years in patients with CHF II (62%), III (36%) and IV (2%) functional class according to the NYHA classification with left ventricular ejection fraction (LV) ) less than 40% and LV intravenous diastolic diameter more than 2.9 cm/m2, receiving standard therapy, including ACE inhibitors (93%), diuretics (86%), digoxin (67%) and beta-blockers (36%), noted significant reduction (by 27.5%) in the risk of hospitalization due to exacerbation of CHF.

In patients not receiving ACE inhibitors, there was a significant reduction in overall mortality (by 33%), cardiovascular mortality and morbidity associated with CHF (time to the onset of the first cardiovascular event), which are assessed by the following indicators: death, sudden death with resuscitation, hospitalization for exacerbation of CHF, intravenous administration of inotropic or vasodilator drugs for 4 or more hours without hospitalization (44%). In the group of patients receiving ACE inhibitors (without beta-blockers), during treatment with valsartan there was no reduction in overall mortality, but cardiovascular mortality and morbidity associated with CHF decreased by 18.3%.

In general, the use of valsartan leads to a decrease in the number of hospitalizations for CHF, a slowdown in the progression of CHF, an improvement in the functional class of CHF according to the NYHA classification, an increase in left ventricular ejection fraction, as well as a decrease in the severity of signs and symptoms of heart failure and an improvement in quality of life compared with placebo.

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

When using valsartan and changing lifestyle, there was a statistically significant reduction in the risk of developing diabetes mellitus in this category of patients. Valsartan had no effect on the incidence of deaths due to cardiovascular events, myocardial infarction and non-fatal ischemic attacks, hospitalizations due to heart failure or unstable angina, arterial revascularization, in patients with impaired glucose tolerance and arterial hypertension, differing in age, gender and race. 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 arterial 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 aged 6 to 18 years with arterial hypertension

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

Valsartan Plus tablets p/o 80mg/12.5mg No. 15x2

Name

Valsartan Plus tablet, coated p/o, 80mg/12.5mg in container pack No. 10x3

Description

Tablets 80 mg/12.5 mg: round, biconvex, white film-coated tablets.

Main active ingredient

Valsartan+hydrochlorothiazide

Release form

Film-coated tablets

Dosage

80mg/12.5mg

pharmachologic effect

The active ingredients of the drug are valsartan and hydrochlorothiazide. Both of these active substances help control high blood pressure (hypertension). Valsartan belongs to a class of medications known as angiotensin II receptor antagonists. Angiotensin II is a substance in the body that causes blood vessels to constrict, thereby increasing blood pressure. Valsartan blocks the action of angiotensin II. As a result, the blood vessels relax (dilate) and blood pressure decreases. Hydrochlorothiazide belongs to the group of so-called thiazide diuretics (diuretics). Hydrochlorothiazide increases urine output, which also lowers blood pressure. Valsartan Plus is used to treat high arterial (blood) pressure, which is not sufficiently controlled by taking one of the components - valsartan or hydrochlorothiazide. High blood pressure increases stress on the heart and arteries. If left unchecked, blood vessels in the brain, heart and kidneys can be damaged and may lead to stroke, heart failure or kidney failure. High arterial (blood) pressure increases the risk of heart attacks. Reducing blood pressure to normal reduces the risk of developing these disorders.

Indications for use

Treatment of essential hypertension in adults. The drug Valsartan Plus is indicated for use in patients whose blood pressure is not sufficiently controlled by monotherapy with valsartan or hydrochlorothiazide. If you have any doubts or questions, consult your doctor.

Directions for use and doses

The tablets are taken orally, without chewing, with a sufficient amount of water, regardless of meals. The recommended dose of Valsartan Plus is 1 tablet per day. Depending on the clinical indicators, a dosage of 80 mg of valsartan and 12.5 mg of hydrochlorothiazide or 160 mg of valsartan and 12.5 mg of hydrochlorothiazide may be prescribed. If necessary, 160 mg of valsartan and 25 mg of hydrochlorothiazide can be prescribed. It is recommended to titrate the dose of individual components. In each specific case, it is necessary to monitor titration with increasing doses of individual components in order to reduce the risk of hypotension and other side effects. When clinically appropriate, direct switching from monotherapy to a fixed-dose combination may be considered in patients whose blood pressure is not adequately controlled on valsartan or hydrochlorothiazide monotherapy, subject to the recommended dosage titration sequence of the individual components. If blood pressure remains uncontrolled upon clinical assessment, the dose may be increased by increasing the maximum dose of either or each active ingredient to 320 mg/25 mg. The antihypertensive effect is achieved within 2 weeks. In most patients, the maximum antihypertensive effect is achieved within 4 weeks. However, for some patients, 4-8 weeks of treatment may be required. This should be taken into account when titrating the dose. Special groups of patients Patients with impaired renal function No dose adjustment is required in patients with mild to moderate renal impairment (GFR >30 ml/min/1.73 m2) no dose adjustment is required. The drug is contraindicated in patients with severe renal impairment (GFR

Use during pregnancy and lactation

Pregnancy Angiotensin II receptor antagonists are not recommended during the first trimester of pregnancy and are contraindicated in the second and third trimesters of pregnancy. Epidemiological data have shown an increased risk of teratogenic effects when using ACE inhibitors in the first trimester of pregnancy. A similar risk may also exist when taking angiotensin II receptor antagonists. In patients planning pregnancy, if necessary, alternative antihypertensive treatment should be prescribed that has an established safety profile for use during pregnancy. When pregnancy is detected, treatment with angiotensin II receptor antagonists should be discontinued immediately and, if necessary, alternative treatment should be instituted. Exposure to angiotensin II receptor antagonists in the second and third trimesters is known to cause fetotoxicity (decreased renal function, oligohydramnios, delayed skull ossification) and neonatal toxicity (renal failure, hypotension, hyperkalemia). If a woman took angiotensin II receptor antagonists in the second trimester of pregnancy, ultrasound monitoring of fetal renal and skull function is necessary. Neonates whose mothers took angiotensin II receptor antagonists should be closely monitored due to possible hypotension. There is limited experience with the use of hydrochlorothiazide during pregnancy, especially during the first trimester. Animal studies are insufficient. Hydrochlorothiazide crosses the placenta. Based on the pharmacological mechanism of action of hydrochlorothiazide, its use in the second and third trimester of pregnancy may impair fetoplacental perfusion and lead to consequences for the fetus and newborn, such as jaundice, electrolyte imbalance and thrombocytopenia. Lactation It is not known whether the drug passes into breast milk. Hydrochlorothiazide crosses the placenta and is also excreted in breast milk. Therefore, it is not recommended to take Valsartan Plus for breastfeeding mothers. Children The safety and effectiveness of the drug Valsartan Plus in children have not been established.

Impact on the ability to drive vehicles or potentially dangerous mechanisms

No studies have been conducted to evaluate the effect of the drug Valsartan Plus on the ability to drive a car and operate machinery. When driving or operating machinery, the possibility of dizziness or weakness should be taken into account. As when prescribing other antihypertensive drugs, care must be taken when driving a car and working with moving machinery.

Precautionary measures

Talk to your doctor before starting this medicine if you have had skin cancer or developed unexpected skin lesions during treatment. Hydrochlorothiazide use, especially long-term use at high doses, may increase the risk of developing certain types of skin and lip cancers (non-melanoma skin cancer). If you are taking hydrochlorothiazide, you should protect your skin from exposure to sunlight and ultraviolet rays. Changes in electrolyte balance It is not recommended to co-administer valsartan with potassium preparations, salt substitutes containing potassium, potassium-sparing diuretics or other drugs that can increase the concentration of potassium in the blood serum (heparin, etc.). Cases of hypokalemia have been reported during treatment with thiazide diuretics. It is recommended to monitor serum potassium levels. Treatment with thiazide diuretics is often associated with the occurrence of hyponatremia and hypochloremic alkalosis. Thiazides, including hydrochlorothiazide, increase the excretion of magnesium in the urine, which can lead to the development of hypomagnesemia. Thiazides reduce urinary calcium excretion, which can lead to the development of hypercalcemia. Periodic monitoring of serum electrolyte concentrations is recommended. Patients with sodium deficiency and/or reduced circulating blood volume (BCV) In patients with severe sodium deficiency and/or reduced circulating blood volume (BCV), for example, those receiving high doses of diuretics, in rare cases, symptomatic hypotension may occur at the beginning of treatment with Valsartan Plus. Before starting treatment, the sodium and/or bcc levels in the body should be corrected. Heart failure/Post-infarction state As a consequence of inhibition of the renin-angiotensin-aldosterone system (RAAS), impaired renal function may occur in hypersensitive individuals. In patients with severe heart failure in whom renal function is dependent on the activity of the renin-angiotensin-aldosterone system, treatment with ACE inhibitors or angiotensin receptor antagonists may cause oliguria and/or progressive azotemia, acute renal failure (rarely) and/or death. Evaluation of patients with heart failure or post-infarction should always include monitoring of renal function. Renal artery stenosis The drug Valsartan Plus should not be used for the treatment of arterial hypertension in patients with unilateral or bilateral renal artery stenosis, or stenosis of the artery of a solitary kidney, because there may be an increase in blood urea concentration and serum creatinine concentration in these patients. Primary hyperaldosteronism Patients with primary hyperaldosteronism are not recommended to use Valsartan Plus, since their renin-angiotensin system is not active. Aortic or mitral valve stenosis, obstructive hypertrophic cardiomyopathy As with other vasodilators, special caution should be exercised when using Valsartan Plus in patients with aortic or mitral stenosis or hypertrophic obstructive cardiomyopathy. Impaired renal function In patients with mild or moderate renal impairment (creatinine clearance >30 ml/min), no dose adjustment is required. The drug Valsartan Plus should be taken with caution in patients with severe renal failure (creatinine clearance

Interaction with other drugs

Always tell your doctor what medications you are taking or have recently taken, even if they are over-the-counter medications. Interactions related to valsartan and hydrochlorothiazide Concomitant use is not recommended Lithium: Reversible increases in serum lithium concentrations and increased toxicity have been reported when used concomitantly with ACE inhibitors, angiotensin II receptor antagonists and thiazides. Experience with the simultaneous use of valsartan and lithium drugs is limited, so it is not recommended to combine these drugs. If concomitant use of these drugs is necessary, careful monitoring of serum lithium concentration is recommended. Concomitant use requiring caution Other antihypertensive drugs: Valsartan Plus may enhance the effect of other antihypertensive drugs (guanethidine, methyldopa, vasodilators, ACE inhibitors, beta-blockers, calcium channel blockers). Sympathomimetics (adrenaline, norepinephrine): the therapeutic response to sympathomimetics may be weakened. Nonsteroidal anti-inflammatory drugs (NSAIDs), including selective cyclooxygenase-2 (COX-2) inhibitors, acetylsalicylic acid (more than 3 g/day) and other non-selective NSAIDs: when administered concomitantly, the antihypertensive effect may be weakened. In addition, in patients who are elderly, malnourished (including those on diuretic therapy), or with compromised renal function, concomitant use of angiotensin II antagonists and NSAIDs may result in an increased risk of deterioration of renal function. Therefore, monitoring of renal function is recommended when initiating or making changes to valsartan therapy in patients taking NSAIDs concomitantly. Interactions that occur during treatment with individual active components of a drug may also occur during treatment with this drug. Interactions related to valsartan Dual blockade of the renin-angiotensin-aldosterone system (RAAS) by ARB II, ACE inhibitors or aliskiren: simultaneous use of angiotensin receptor antagonists, including valsartan, with other substances acting on the RAAS is associated with an increased incidence of hypotension, hyperkalemia, and changes in renal function compared with monotherapy. It is recommended to monitor blood pressure, renal function and electrolyte levels in patients using Valsartan Plus and other substances that affect the RAAS. Based on the available data, dual blockade of the RAAS using ACE inhibitors, angiotensin receptor antagonists, or aliskiren cannot be recommended in any patient, especially in patients with diabetic nephropathy. Concomitant use of II ARBs, including valsartan, or ACE inhibitors with aliskiren is contraindicated in patients with diabetes mellitus or moderate/severe renal impairment (GFR).

Contraindications

Hypersensitivity to valsartan, hydrochlorothiazide, sulfonamides or any other component of the drug;
pregnancy and breastfeeding;
severe liver dysfunction, biliary cirrhosis and cholestasis;
anuria, severe renal failure (GFR
refractory hypokalemia, hyponatremia, hypercalcemia and symptomatic hyperuricemia;
simultaneous use of ARB II (angiotensin II receptor antagonists), including valsartan, or ACE inhibitors with aliskiren in patients with diabetes mellitus or moderate/severe renal impairment (GFR)

Compound

One tablet of the drug Valsartan Plus 80 mg/12.5 mg contains: active substances: valsartan - 80 mg, hydrochlorothiazide - 12.5 mg; excipients: sodium starch glycolate (type A), sodium stearyl fumarate, crospovidone (type B), colloidal anhydrous silicon dioxide, microcrystalline cellulose, calcium hydrogen phosphate dihydrate; shell composition: opadry II white (partially hydrolyzed polyvinyl alcohol, titanium dioxide, macrogol 4000 / PEG, talc).

Overdose

Symptoms: An overdose of valsartan can cause severe hypotension, which, in turn, can lead to impaired consciousness, circulatory collapse and/or shock. An overdose of hydrochlorothiazide may cause nausea, drowsiness, hypovolemia, and electrolyte imbalance, accompanied by cardiac arrhythmias and muscle spasms. Treatment: Therapeutic measures depend on how long the overdose has been taken, as well as the type and severity of symptoms, with stabilization of the cardiovascular system being the first priority. In case of overdose, depending on the time elapsed after taking the drug, measures taken should include inducing vomiting, gastric lavage and/or taking activated charcoal. In case of hypotension, the patient should be placed in a horizontal position and the water-salt balance should be immediately restored by administering an isotonic saline solution. Valsartan is not eliminated by hemodialysis due to its strong binding to plasma proteins, however, hemodialysis is effective for removing hydrochlorothiazide from the body.

Side effect

Listed below are side effects that have been found to have a possible association with the use of valsartan in combination with hydrochlorothiazide. Classification of the frequency of side effects: very often? 1/10, often from? 1/100 to

Storage conditions

In a place protected from moisture and light at a temperature not exceeding 25 ° C. Keep out of the reach of children.