Valz pills 80mg, 28pcs

Composition

1 tablet of 80 mg contains:

Active ingredient: valsartan 80 mg;

Auxiliary substances: lactose monohydrate 42.22 mg, microcrystalline cellulose 36.00 mg, croscarmellose sodium 10.80 mg, povidone K 29-32 7.20 mg, talc 1.8 mg, magnesium stearate 1.26 mg, colloidal silicon dioxide 0.72 mg;

Film shell

Opadray II 85G34643 Pink about 7.20 mg (polyvinyl alcohol 3,168 mg, talc 1,440 mg, titanium dioxide 1,373 mg, macrogol-3350 0.889 mg, iron oxide yellow dye 0.029 mg, iron oxide red dye 0.049 mg, lecithin 0.252 mg).

Pharmacological action

Pharmacotherapeutic group: Angiotensin II receptor antagonist

ATX code: C09CA03

Pharmacological properties

Pharmacodynamics

Valsartan is an active specific angiotensin II receptor antagonist intended for oral use. Selectively blocks AT1 subtype receptorsthat 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 AT1receptors. The affinity of valsartan for the AT_{1 subtype receptors} is approximately 20,000 times higher than for the AT_{2 subtype receptors}.

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 probability of coughing with 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.

When comparing valsartan with an ACE inhibitor, the incidence of dry cough was significantly higher (p In the group of patients who previously developed a dry cough during treatment with an ACE inhibitor, this undesirable phenomenon (AES) was observed in 19.5% of cases when treated with valsartan, and in 19.0% of cases when treated with a thiazide diuretic, while in the group of patients treated with an ACE inhibitor, cough was observed in 68.5% of cases (p

Use in arterial hypertension in patients over 18 years of age

When valsartan is used in patients with arterial hypertension, there is a decrease in blood pressure (BP), which is not accompanied by a change in heart rate.

After oral use of a single dose of the drug in most patients, the onset of antihypertensive action is observed within 2 hours, and the maximum decrease in blood pressure is achieved within 4-6 hours, which persists for more than 24 hours. With repeated use of the drug, the maximum reduction in blood pressure, regardless of the dose taken, is usually achieved within 2-4 weeks and maintained at the achieved level during long-term therapy. In the case of simultaneous use of the drug with hydrochlorothiazide, a significant additional decrease in blood pressure is achieved.

Abrupt discontinuation of valsartan is not accompanied by a significant increase in blood pressure (recoil phenomenon) or other AES. Patients with arterial hypertension, type 2 diabetes mellitus, and nephropathy taking valsartan at a dose of 160-320 mg showed 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 started taking it in the period from 12 hours to 10 days after an acute myocardial infarction (complicated by left ventricular failure and/or left ventricular systolic dysfunction), the overall mortality and cardiovascular mortality rates decrease and the time to first hospitalization for exacerbation of chronic heart failure (CHF), recurrent myocardial infarction, sudden cardiac arrest and stroke (without fatal outcome) increases. The safety profile of valsartan in patients with acute myocardial infarction is similar to that in other conditions.

CHF in patients over 18 years of age

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 excessive synthesis of hormones acting synergistically with RAAS (catecholamines, aldosterone, vasopressin, endothelin). When valsartan is used for CHF, preload decreases, the pressure of jamming in the pulmonary capillaries and diastolic pressure in the pulmonary artery decreases, and cardiac output increases. Along with its hemodynamic effects, valsartan reduces sodium and water retention in the body by indirectly blocking aldosterone synthesis.

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 NYHA functional class of CHF, an increase in the left ventricular ejection fraction, as well as a decrease in the severity of signs and symptoms of heart failure and an improvement in the quality of life compared to placebo.

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

With the use of valsartan and lifestyle changes, there was a statistically significant reduction in the risk of developing diabetes mellitus in this category of patients. Valsartan had no effect on the frequency of deaths due to cardiovascular events, myocardial infarction and non-fatal ischemic attacks, on 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.

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 decrease 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 the achieved level during long-term therapy.

Pharmacokinetics

Suction

After oral use of valsartan_{, its maximum plasma concentration (cmax}) is reached within 2-4 hours. The average absolute bioavailability is 23%. When valsartan is taken with food, the area under the concentration-time curve (AUC) decreases by 48%, although starting from about 8 hours after taking the drug, the plasma concentrations of valsartan are the same both when taken on an empty stomach and when taken with food. The decrease in AUC, however, is not accompanied by a clinically significant decrease in the therapeutic effect, so valsartan can be taken regardless of the meal time.

Distribution

The volume of distribution (vd) of valsartan at steady state after intravenous (iv) use was about 17 liters, which indicates that there is no pronounced distribution of valsartan in tissues. Valsartan is largely bound to serum proteins (94-97%), mainly to albumins.

Metabolism

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

The

pharmacokinetic curve of valsartan has a descending multi-exponential character (the half-life of the initial phase (_T1/2α) is less than 1 hour and the final phase (_T1/2β) is about 9 hours). Valsartan is mainly excreted unchanged through the intestines (about 83%) and kidneys (about 13%). After intravenous use, the plasma clearance of valsartan is about 2 l / h, and its renal clearance is 0.62 l / h (about 30% of the total clearance). The elimination half-life (T_1/2) of valsartan is 6 hours.

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

Pharmacokinetics in selected groups of patients

Patients with CHF

In this category of patients, the time to reach_cmax and T_1/2 are similar to those in healthy volunteers. The increase in AUC and_cmax is directly proportional to the increase in the dose of the drug (from 40 mg to 160 mg 2 times a day). The cumulative factor is on average 1.7. When taken orally, the clearance of valsartan was approximately 4.5 l/h. The age of patients with CHF did not affect the clearance of valsartan.

Elderly patients (over 65 years of age)

In some elderly patients, the systemic bioavailability of valsartan is higher than in young patients, but this has not been shown to have any clinical significance.

Patients with impaired renal function

There was no correlation between renal function and the systemic bioavailability of valsartan.In patients with impaired renal function (creatinine clearance greater than 10 ml/min), no dose adjustment is required. However, valsartan has a high degree of binding to plasma proteins, so its elimination during hemodialysis is unlikely.

Patients with impaired liver function

About 70% of the absorbed dose of valsartan is excreted through the intestine (with bile), mainly in unchanged form. Valsartan does not undergo significant biotransformation. In patients with mild to moderate hepatic impairment, there is a 2-fold increase in the bioavailability (AUC) of valsartan compared to healthy volunteers. However, there is no correlation between valsartan AUC values and the degree of hepatic impairment. The use of the drug in patients with severe hepatic impairment has not been studied.

Patients from 6 to 18 years

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

Indications

Adults

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

Children and teenagers

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

Use during pregnancy and lactation

Like any other drug that affects the RAAS, Valz should not be used in women planning pregnancy. When prescribing any drug that affects the RAAS, the doctor should inform women of childbearing age about the potential dangers of using these drugs during pregnancy.

The use of Valz during pregnancy is contraindicated, since, given the mechanism of action of angiotensin II receptor antagonists, the risk to the fetus cannot be excluded. The effect of ACE inhibitors (drugs that also affect the RAAS) on the fetus, if used in the second and third trimesters of pregnancy, can lead to its damage and death.

According to retrospective data, the use of ACE inhibitors in the first trimester of pregnancy increases the risk of having children with birth defects. There are reports of spontaneous abortions, oligohydramnios (lack of water), and impaired renal function in newborns whose mothers unintentionally received valsartan during pregnancy.

If pregnancy is diagnosed during treatment with Valz, it should be discontinued as soon as possible.

It is not known whether valsartan is excreted in human breast milk, so it is contraindicated to useValz during breastfeeding.

Contraindications

• Hypersensitivity to any of the components of the drug;
• Severe liver dysfunction (more than 9 points on the Child-Pugh scale), biliary cirrhosis and cholestasis;
• Pregnancy, breast-feeding period;
• Age up to 6 years – according to the indication of arterial hypertension, up to 18 years – according to other indications (the effectiveness and safety of use have not been established);
• Concomitant use with aliskiren and drugs containing aliskiren in patients with diabetes mellitus and / or moderate to severe renal impairment (glomerular filtration rate (GFR) less than 60 ml / min/1.73 m2 of body surface area);
• Concomitant use with ACE inhibitors in patients with diabetic nephropathy;
• Lactose intolerance, lactase deficiency, glucose-galactose malabsorption (the drug contains lactose monohydrate).

With caution

Bilateral renal artery stenosis; stenosis of the artery of a single kidney; primary hyperaldosteronism, adherence to a diet with limited consumption of table salt; in conditions accompanied by a decrease in the volume of circulating blood (BCC) (including diarrhea and vomiting); severe renal failure (creatinine clearance less than 10 ml/min), since there are no clinical data; in patients aged 6 to 18 years and creatinine clearance less than 30 ml/min, including those on hemodialysis; lungs and moderate hepatic impairment of non-biliary origin without cholestasis, CHF of functional class II-IV (NYHA), mitral or aortic stenosis, hypertrophic obstructive cardiomyopathy, patients after kidney transplantation; concomitant use of drugs that block RAAS (ACE inhibitors, aliskiren).

Side effects

In controlled clinical trials of valsartan in adult hypertensive patients, the incidence of AE was comparable to placebo.

There are no data on the dose-or duration-of-treatment dependence of the frequency of any of the AES, as well as on gender, age, or race. The safety profile of Valz in patients with arterial hypertension aged 6-18 years does not differ from the safety profile of valsartan in adult patients.

The following are AES that were observed during clinical trials, as well as when using the drug in clinical practice.

The frequency of side effects: very often (>10%); often (>1% and <10%); uncommon (>0.1% and <1%); rarely (>0.01% and <Is 0.1%); very rare (<0,01%), including individual messages; frequency unknown (frequency of development according to the available data it is impossible to determine).

Within each group, identified by frequency of occurrence, AES are distributed in order of decreasing importance.

Patients with arterial hypertension

Hematopoietic and lymphatic system disorders: frequency unknown-decreased hemoglobin, hematocrit, neutropenia, thrombocytopenia.

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

From the side of metabolism and nutrition: frequency unknown-increased serum potassium, hyponatremia.

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

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

Respiratory, thoracic and mediastinal disorders: infrequently-cough.

From the gastrointestinal tract: infrequently-abdominal pain.

Liver and biliary tract disorders: frequency unknown-impaired liver function, including increased plasma bilirubin concentrations.

From the skin and subcutaneous tissues: very rarely – angioedema, skin rash, pruritus; frequency unknown-bullous dermatitis.

Musculoskeletal and connective tissue disorders: frequency unknown-myalgia.

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

General disorders and disorders at the injection site: infrequently – increased fatigue.

Also, in clinical studies of valsartan in patients with arterial hypertension, the following AES were observed, the causal relationship of which with its use 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.

Patients receiving valsartan after acute myocardial infarction and / or CHF

Hematopoietic and lymphatic system disorders: 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 serum potassium, hyponatremia.

Nervous system disorders: often – dizziness, postural vertigo; infrequently-fainting, headache.

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

From the heart: infrequently-increased symptoms of CHF.

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

Respiratory, thoracic and mediastinal disorders: infrequently-cough.

From the gastrointestinal tract: infrequently – nausea, vomiting.

Liver and biliary tract disorders: frequency unknown – impaired liver function.

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

Musculoskeletal and connective tissue disorders: rare-rhabdomyolysis; frequency unknown-myalgia.

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

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

Also, in clinical studies of valsartan in patients after acute myocardial infarction and / or CHF, the following AES were observed, the causal relationship of which with its use has not been established: arthralgia, abdominal pain, back pain, asthenia, insomnia, decreased libido, neutropenia, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

Interaction

Dual blockade of RAAS with angiotensin receptor antagonists, ACE inhibitors or aliskiren:

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

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

Joint admission is not recommended

Lithium preparations

When lithium preparations are co-administered with ACE inhibitors and angiotensin II receptor antagonists, there is a reversible increase in the content of lithium in the blood serum and an increase in its toxic effect in this regard. Due to the lack of experience in using valsartan with lithium, their simultaneous use is not recommended. If the combined use of valsartan and lithium preparations is necessary, it is necessary to monitor the lithium content in the blood serum.

Medications that may lead to an increase in the potassium content in the blood plasma

If it is necessary to use concomitantly with dietary supplements, potassium-containing salt substitutes, or other medications that may cause an increase in the potassium content in the blood, regular monitoring of the potassium content in the blood plasma should be carried out.

Combinations that require caution when using

Nonsteroidal anti-inflammatory drugs (NSAIDs)

Concomitant use of valsartan with NSAIDs (including selective cyclooxygenase-2 inhibitors) may reduce its antihypertensive effect. When using angiotensin II receptor antagonists simultaneously with NSAIDs, renal function may worsen and the potassium content in blood plasma may increase. If the combined use of valsartan and NSAIDs is necessary, renal function assessment and correction of water-electrolyte balance disorders should be performed before starting treatment.

Carrier proteins

According to the results of an in vitro study on liver cultures, valsartan is a substrate for OATP1V1 and MRP2 transporter proteins. Concomitant use of valsartan with OATP1-In-1 transporter protein inhibitors (rifampicin, cyclosporine) and MRP2 transporter protein inhibitor (ritonavir) may increase the systemic exposure of valsartan (_cmax and AUC).

Other drug groups

Valsartan monotherapy was found to have no clinically significant interactions with other drugs (cimetidine, warfarin, furosemide, digoxin, atenolol, Indometacin, hydrochlorothiazide, amlodipine, glibenclamide).

Children and teenagers under 18 years of age

In children and adolescents, hypertension is often associated with impaired renal function. This category of patients is recommended to take valsartan with caution at the same time as other drugs that affect the RAAS, as this may lead to an increase in serum potassium. Regular monitoring of renal function and serum potassium should be performed in this group of patients.

How to take, course of use and dosage

Inside, without chewing, regardless of the meal time, with water.

Adults

Arterial hypertension

The drug can be prescribed in a dose of 80 mg,160 mg,320 mg.

The recommended starting dose of Valz is 80 mg once a day, regardless of the patient’s race, age, or gender. The antihypertensive effect is noted in the first 2 weeks of treatment; the maximum effect develops after 4 weeks. For those patients who fail to achieve an adequate therapeutic response, the daily dose of Valz can be increased to 160 mg, as well as to a maximum daily dose of 320 mg, diuretics can be additionally prescribed.

Chronic heart failure

The drug can be prescribed in a dose of 40 mg,80 mg,160 mg.

The recommended starting dose of Valz is 40 mg twice daily. The dose of the drug should be gradually increased for at least 2 weeks to 80 mg 2 times a day, and with good tolerability – to 160 mg 2 times a day. The maximum daily dose is 320 mg in 2 divided doses. In this case, it may be necessary to reduce the dose of concomitantly used diuretics.

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

To improve the survival rate of patients after myocardial infarction

The drug can be prescribed in a dose of 40 mg,80 mg,160 mg.

Treatment begins within 12 hours after a previous myocardial infarction with an initial dose of 20 mg (1/2 tablet of 40 mg) 2 times a day, followed by an increase in the dose (40 mg,80 mg,160 mg 2 times a day) for several subsequent weeks, until the target dose of 160 mg 2 times a day is reached.

Reaching a dose of up to 80 mg 2 times a day is recommended by the end of the 2nd week of treatment. Achieving the maximum target dose of 160 mg twice daily is recommended by the end of the 3rd month of Valz therapy. The increase in the dose depends on the tolerability of the drug during the dose selection period.

In the event of hypotension, accompanied by clinical manifestations, or impaired renal function, a dose reduction should be considered.

Assessment of patients ‘ condition after a previous myocardial infarction should include an assessment of renal function.

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

Use in elderly patients (over 65 years of age)

No dose adjustment is required in elderly patients.

Use in patients with impaired renal function

In patients with impaired renal function with creatinine clearance greater than 10 ml/min, no dose adjustment is required. Concomitant use of valsartan with aliskiren is contraindicated in patients with moderate or severe renal impairment (GFR less than 60 ml / min/1.73 m2 of body surface area). Currently, there are no data on the use of the drug in patients with a creatinine clearance rate of less than 10 ml / min.

Use in patients with impaired liver function

In patients with mild to moderate hepatic impairment of non-biliary origin without cholestasis, the drug should be used with caution, the daily dose should not exceed 80 mg. In patients with severe hepatic impairment (more than 9 points on the Child-Pugh scale), biliary cirrhosis and cholestasis, the use of Valz is contraindicated.

Children and teenagers

Arterial hypertension

The recommended initial dose of Valz in children and adolescents from 6 to 18 years of age is 40 mg once a day for a child’s body weight of less than 35 kg and 80 mg once a day for a child’s body weight of more than 35 kg. It is recommended to adjust the dose taking into account the decrease in blood pressure.

The maximum recommended daily doses are shown in the table below. Higher doses are not recommended.

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

CHF and previous acute myocardial infarction

Valz is not recommended for the treatment of CHF and after acute myocardial infarction in patients under 18 years of age.

Use in patients from 6 to 18 years of age with impaired renal function

In patients from 6 to 18 years of age with impaired renal function in CC No dose adjustment is required in patients aged 6-18 years with creatinine clearance greater than 30 ml / min. Renal function and serum potassium levels should be carefully monitored while taking Valz.

Use in patients from 6 to 18 years of age with impaired liver function

As with adult patients, Valz is contraindicated in patients aged 6 to 18 years with severe hepatic impairment, biliary cirrhosis, and cholestasis. Experience with valsartan in patients with mild to moderate hepatic impairment is limited. Do not exceed the dose of 80 mg in this group of patients.

Overdose

Symptoms: a marked decrease in blood pressure, which can lead to depression of consciousness, collapse and / or shock. Treatment: symptomatic, the nature of which depends on the time that has elapsed since taking the drug, and on the severity of symptoms. In case of accidental overdose, you should induce vomiting (if the drug was taken recently) or perform gastric lavage.In case of a marked decrease in blood pressure, intravenous use of 0.9% sodium chloride solution is necessary as therapy, the patient should be placed with his legs raised for the necessary period of time for therapy, taking active measures to maintain the activity of the cardiovascular system, including regular monitoring of the activity of the heart and respiratory system, BCC and the amount of urine released. Valsartan is not eliminated by hemodialysis.

Description

round biconvex tablets of pink color, film-coated, with a risk on both sides, side risks and marking “V” on one side.

Special instructions

Hyperkalemia

When used concomitantly with dietary supplements containing potassium, potassium-sparing diuretics, potassium-containing salt substitutes, or with other drugs that may cause an increase in blood potassium (for example, with heparin), care should be taken and regular monitoring of blood potassium levels should be carried out.

Impaired renal function

There is no experience of safe use in patients with creatinine clearance less than 10 ml/min and in patients undergoing hemodialysis, so valsartan should be used with caution in such patients. In patients with creatinine clearance greater than 10 ml/min, no dose adjustment is required.

Liver function disorders

Valsartan should be used with caution in patients with mild or moderate hepatic insufficiency without cholestasis.

Lack of sodium in the body and / or a decrease in BCC

In patients with severe sodium deficiency in the body and / or reduced BCC, for example, receiving high doses of diuretics, in rare cases after starting therapy with valsartan, hypotension may develop, accompanied by clinical manifestations. Before starting treatment with Valz, it is necessary to adjust the sodium content in the body and / or replenish the BCC, including by reducing the dose of a diuretic.

Renal artery stenosis

The use of the drug in a short course in patients with renovascular hypertension, which developed a second time due to unilateral stenosis of the artery of a single kidney, does not lead to any significant changes in renal hemodynamics, serum creatinine concentration or blood urea nitrogen. 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 stenosis of the artery of a single kidney, monitoring of these indicators is recommended as a precautionary measure.

Kidney transplantation

There are no data on the safety of Valz in patients undergoing kidney transplantation.

Primary hyperaldosteronism

The drug is not effective for the treatment of arterial hypertension in patients with primary hyperaldosteronism, since RAAS activation is not observed in this category of patients.

Aortic and mitral stenosis, obstructive hypertrophic cardiomyopathy

As with other vasodilating agents, caution should be exercised when taking Valz in patients with aortic or mitral stenosis and obstructive hypertrophic cardiomyopathy.

Pregnancy

Angiotensin II receptor antagonist therapy is contraindicated during pregnancy. Patients planning pregnancy should be treated with alternative medications that have a proven safety profile when used during pregnancy. If pregnancy is diagnosed during treatment with Valz, it should be discontinued as soon as possible and alternative treatment should be prescribed (see sectionsContraindications andUse during pregnancy and lactation).

CHF/post-myocardial infarction period

In patients with CHF or after a previous myocardial infarction, starting treatment with valsartan, there is often a slight decrease in blood pressure, and therefore it is recommended to monitor blood pressure at the beginning of therapy. If the recommendations for changing the dosage regimen are followed, it is usually not necessary to cancel the drug due to arterial hypotension. Assessment of patients with CHF should include an assessment of renal function.

Due to RAAS inhibition, some patients may have impaired renal function. In patients with NYHA functional class II-IV CHF, treatment with ACE inhibitors and angiotensin II receptor antagonists may be accompanied by oliguria and/or increased azotemia and, in rare cases, acute renal failure and / or death. Therefore, in these categories of patients, before using Valz, as well as periodically during treatment, it is necessary to evaluate renal function.

Combination therapy for arterial hypertension

In case of arterial hypertension, Valz can be used in monotherapy, as well as in combination with other antihypertensive agents, in particular, with diuretics.

Combination therapy in the period after myocardial infarction

It is possible to use Valz in combination with other medications used after a myocardial infarction, namely: thrombolytics, acetylsalicylic acid as an antiplatelet agent, beta-blockers, HMG-CoA reductase inhibitors and diuretics. In this category of patients, it is not recommended to use Valz concomitantly with ACE inhibitors, since this combination therapy does not have advantages over monotherapy with valsartan or an ACE inhibitor in terms of overall mortality for any reason.

Combination therapy for CHF

In patients with CHF, Valz can be used both in monotherapy and simultaneously with other drugs – diuretics, cardiac glycosides, as well as ACE inhibitors or beta-blockers.

Triple combination therapy with ACE inhibitor, beta-blocker and Valz is not recommended in this category of patients.

Angioedema (angioedema)

Angioedema associated with laryngeal and vocal cord edema, leading to airway obstruction, and/or swelling of the face, lips, pharynx, and/or tongue have been reported during treatment with valsartan. Some patients in this group have previously experienced angioedema while taking other medications, including ACE inhibitors. If angioedema develops, Valz should be discontinued immediately, and then valsartan-containing medications should not be taken in the future.

Double blockade of the RAAS

Severe BP reduction, syncope, stroke, hyperkalemia, and changes in renal function (including acute renal failure) have been reported in sensitive patients treated with drugs that affect the RAAS, especially when combined with them.

Caution should be exercised when combining angiotensin II receptor antagonists, including valsartan, with other drugs that block RAAS, such as ACE inhibitors or aliskiren.

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

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

Other conditions of RAAS stimulation (320 mg dose only)

In patients whose renal function may depend on the activity of the RAAS (for example, patients with severe congenital heart failure), treatment with ACE inhibitors is associated with the appearance of oliguria and/or progressive azotemia, and in rare cases with acute renal failure and/or death. Since valsartan is an angiotensin II receptor antagonist, it cannot be excluded that its use may be associated with impaired renal function.

Children and teenagers under 18 years of age

Impaired renal function

In patients from 6 to 18 years of age with impaired renal function in CC No dose adjustment is required in patients aged 6-18 years with creatinine clearance greater than 30 ml / min. Renal function and serum potassium levels should be carefully monitored while taking Valz. In particular, these precautions should be observed when taking Valz against a background of elevated temperature or with a reduced BCC, since in this case it is possible to develop impaired renal function.

Impaired liver function

As with adult patients, Valz is contraindicated in patients aged 6 to 18 years with severe hepatic impairment, biliary cirrhosis, and cholestasis. Experience with valsartan in patients with mild to moderate hepatic impairment is limited. Do not exceed the dose of 80 mg in this group of patients.

Influence on the ability to drive vehicles and mechanisms

Since AES such as dizziness or fainting may occur during therapy with the drug, patients taking Valz should be careful when driving vehicles and engaging in other potentially dangerous activities.

Form of production

Film-coated tablets 40 mg,80 mg,160 mg. 7,10 or 14 tablets in a PVC/PE/PVDC blister/Aluminum foil.2 or 4 blisters of 7 tablets; 1,2, or 3 blisters of 10 tablets,4 or 7 blisters of 14 tablets together with the instructions for use in a cardboard pack with the control of the first opening.

Storage conditions

Store at a temperature not exceeding 30 C. Keep out of reach of children!

Shelf

life is 3 years. Do not use after the expiration date indicated on the package.

Active ingredient

Valsartan

Conditions of release from pharmacies

By prescription

Dosage form

Tablets