DR. DOPING

Instructions

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Instructions / Instruction for use: Diovan

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Dosage form: film coated tablets, coated tablets

Active substance: Valsartanum

ATX

C09CA03 Valsartan

Pharmacological group

Angiotensin II receptor antagonist [Angiotensin II receptor antagonists (AT1-subtype)]

Nosological classification (ICD-10)

I10 Essential (primary) hypertension: hypertension; Arterial hypertension; Arterial hypertension crisis course; Essential Hypertension; Essential hypertension; Essential hypertension; Essential hypertension; Essential hypertension; Primary hypertension; Arterial hypertension, complications of diabetes; The sudden increase in blood pressure; Hypertensive disorders of blood circulation; hypertensive condition; hypertensive crises; arterial Hypertension; malignant Hypertension; Hypertonic disease; hypertensive crises; accelerated hypertension; malignant hypertension; The aggravation of hypertensive disease; Transient hypertension; Isolated systolic hypertension

I15 Secondary hypertension: Arterial hypertension, complications of diabetes; hypertension; The sudden increase in blood pressure; Hypertensive disorders of blood circulation; hypertensive condition; hypertensive crises; hypertension; arterial Hypertension; malignant Hypertension; hypertensive crises; accelerated hypertension; malignant hypertension; The aggravation of hypertensive disease; Transient hypertension; hypertension; Arterial hypertension; Arterial hypertension crisis course; renovascular hypertension; Hypertension symptomatic; Renal hypertension; Renovascular hypertension; renovascular hypertension; Symptomatic hypertension

I21.9 Acute myocardial infarction, unspecified: Changes in left ventricle with myocardial infarction; Changes in the left atrium with myocardial infarction; Myocardial infarction; Myocardial infarction without Q wave; Myocardial infarction without signs of chronic heart failure; Myocardial infarction with unstable angina; Pirouette tachycardia with myocardial infarction

I50.0 Congestive heart failure: anasarca heart; Decompensated congestive heart failure; Congestive heart failure; Congestive heart failure with high afterload; Congestive chronic heart failure; Cardiomyopathy with severe chronic heart failure; Compensated chronic heart failure; Swelling with circulatory failure; Edema of cardiac origin; Swelling of the heart; Edematous syndrome in diseases of the heart; Edematous syndrome in congestive heart failure; Edematous syndrome in heart failure; Edematous syndrome in heart failure or liver cirrhosis; right ventricular failure; Congestive Heart Failure; Heart failure stagnant; Heart failure with low cardiac output; Heart failure is a chronic; Cardiac edema; Chronic decompensated heart failure; Chronic Congestive Heart Failure; Chronic heart failure; Change of liver function in heart failure

I50.1 Left ventricular failure: Cardiac asthma; Asymptomatic dysfunction of the left ventricle; Asymptomatic left ventricular heart failure; Diastolic dysfunction of the left ventricle; Left ventricular dysfunction; Changes in the left ventricle with myocardial infarction; Left ventricular heart failure; Violation of the function of the left ventricle; Acute left ventricular failure; Acute cardiac left ventricular failure; Cardiac asthma; Heart failure of left ventricular; Changes in the lungs with left ventricular failure; Precordial abnormal pulsation; Lack of left ventricle

Composition and release form

Tablets, coated with a coating.

Valsartan 40 mg; 80 mg; 160 mg; 320 mg

Auxiliary substances: MCC; Crospovidone; Silicon dioxide colloidal anhydrous; Magnesium stearate; Hypromellose (hydroxypropylmethylcellulose); Macrogol 8000; Titanium dioxide (E171); Iron oxide red (E172); Iron oxide yellow (E172); Iron oxide black (E172) - for tablets coated with a coating, 40, 160 and 320 mg

In blisters for 7 or 14 pcs .; In a pack of cardboard 1, 2, 4, 7, 20 (7 pcs. For a dosage of 320 mg) or 1, 2, 4, 7 (14 pills for 40, 80 and 160 mg doses) of blisters, or 120 × 8 (for a dosage of 80 mg) and 45 × 8 (for a dosage of 160 mg) of blisters; As well as in bottles from GPE for 56, 98 or 280 pcs. (For a dosage of 320 mg).

Description of dosage form

The tablets covered with a cover, 40 mg: yellow oval with oblique edges, on one side of risk and squeezed out inscription "DO", on the other side - "NVR".

The film-coated tablets are 80 mg: pale pink, round with bevelled edges, on the one side of the risk and a squeezed out inscription "D / V", on the other hand - "NVR".

The tablets covered with a cover, 160 mg: gray-orange, oval, on the one hand risk and squeezed out inscription «DX / DX», on the other hand - «NVR».

The film-coated tablets are 320 mg: dark gray-violet, oval with beveled edges, on the one side of the risk, and the squeezed out inscription "DXL", on the other hand - "NVR".

Pharmachologic effect

Mode of action - hypotensive.

Pharmacodynamics

The drug Diovan® is an active specific antagonist of angiotensin II receptors, intended for oral administration. Selectively blocks receptors subtype AT1, which are responsible for the effects of angiotensin II. The consequence of the blockade of AT1-receptors is an increase in the plasma concentration of angiotensin II, which can stimulate unblocked AT2 receptors. The preparation Diovan ® does not have any expressed agonist activity against AT1-receptors. The affinity of the drug Diovan® to the receptors of the AT1 subtype is about 20,000 times higher than to the receptors of the AT2 subtype.

The likelihood of coughing with valsartan is very low, which is due to the lack of influence on the ACE, which is responsible for the degradation of bradykinin. Comparison of the preparation Diovan ® with an ACE inhibitor showed that the incidence of dry cough was significantly (p <0.05) lower in patients treated with Diovan ® than in patients receiving an ACE inhibitor (2.6 vs. 7.9%, respectively ). In the group of patients who previously developed a dry cough with treatment with ACE inhibitor, in the treatment with Diovan ® this complication was noted in 19.5% of cases, in 19% of cases, while in the group of patients treated with ACE inhibitor, Cough was observed in 68.5% of cases (p <0.05). Valsartan does not interact and does not block the receptors of other hormones or ion channels, which are important for regulating the functions of the cardiovascular system. When treated with Diovan ® patients with arterial hypertension, there is a decrease in blood pressure, not accompanied by a change in heart rate.

After administration of a single dose of the drug in most patients, the onset of antihypertensive action is noted within 2 hours, and the maximum decrease in blood pressure is achieved within 4-6 hours. After taking the drug, the antihypertensive effect persists for more than 24 hours. For repeated prescriptions of the drug, the maximum decrease in blood pressure, From the accepted dose, is usually achieved within 2-4 weeks and is maintained at the achieved level during long-term therapy. The sudden discontinuation of Diovan® is not accompanied by a sharp increase in blood pressure or other undesirable clinical consequences.

The mechanism of action of the preparation Diovan® in chronic heart failure (CHF) is based on its ability to eliminate the negative effects of chronic hyperactivation of the renin-angiotensin-aldosterone system (RAAS) and its main effector, angiotensin II, vasoconstriction, fluid retention, cell proliferation , Leading to remodeling of target organs (heart, kidneys, vessels), stimulation of excessive synthesis of hormones acting synergistically with RAAS (catecholamines, aldosterone, vasopressin, endothelin and etc.). Against the background of the use of valsartan in CHF, prednagruzka decreases, the wedging pressure in the pulmonary capillaries (DZLK) and DAD in the pulmonary artery decreases, the cardiac output increases. Along with hemodynamic effects, valsartan due to mediated blockade of aldosterone synthesis reduces the retention of sodium and water in the body.

It was found that the drug had no significant effect on the concentration of total cholesterol, uric acid, as well as in the study of fasting - the concentration of triglycerides and glucose in the blood serum.

CHF

Hemodynamics and neurohormones. In patients with CHF (II-IV functional class according to the NYHA classification) and DZLK ≥15 mm Hg. Studied hemodynamics and the concentration of neurohormones in the blood serum. In patients permanently receiving ACE inhibitors, valsartan, prescribed against the background of an ACE inhibitor in single and repeated doses, led to an improvement in hemodynamic parameters, incl. To a decrease in DZLK, DAD in the pulmonary artery and SAD. After 28 days of therapy, there was a decrease in the concentrations of aldosterone and norepinephrine in the blood. In patients who did not receive ACE inhibitors for at least 6 months, after 28 days of therapy, valsartan significantly reduced DZLK, systemic vascular resistance, SAD and cardiac output.

Morbidity and mortality. The effect of valsartan, compared with placebo, on incidence and mortality in patients with CHF II (62%), III (36%) and IV (2%) of the NYHA-rated functional class with a left ventricular ejection fraction (LVEF) <40% And internal diastolic diameter of the left ventricle> 2.9 cm / m 2 in conventional therapy, which included ACE inhibitors (93%), diuretics (86%), digoxin (67%) and beta-blockers (36%). . The average duration of the observation period was almost 2 years, the average daily dose of Diovan ® was 254 mg. Two primary efficacy criteria included mortality from all causes (time to death) and incidence of heart failure (time to the first event), which were assessed by the following indicators: death, sudden death with resuscitation, hospitalization for heart failure, IV Introduction of inotropic or vasodilating drugs for 4 hours or more without hospitalization. The death rate from all causes in the valsartan and placebo groups was comparable. Compared with the placebo group, the incidence rate in the group of patients receiving valsartan significantly decreased by 13.2%. The main parameter of effectiveness was a decrease of 27.5% of the time before the first hospitalization for heart failure. This effect was most pronounced in patients who did not receive ACE inhibitors or beta-blockers.

Tolerance to physical activity. In patients with chronic heart failure II-IV functional class according to the NYHA classification with LVEF ≤40%, the effect of valsartan, assigned in addition to traditional CHF treatment, on exercise tolerance using the Modified Naughton Protocol was evaluated. In all therapeutic groups, there was an increase in the time of physical exertion compared to the initial one. Compared to the placebo group, patients who received valsartan had a greater average increase from baseline physical exercise time, although this difference was not significant. The most pronounced improvement in exercise tolerance was observed in a subset of patients who did not receive ACE inhibitors: the mean change in exercise time in the valsartan group was 2 times greater than that in the placebo group. The effect of valsartan on physical activity tolerance, compared with enalapril, was studied in patients with heart failure II-IV functional class according to the NYHA classification with LVEF ≤45% who received the previous (for at least 3 months) therapy ACE inhibitors. Patients were transferred from treatment with an ACE inhibitor to either valsartan or enalapril. Valsartan in doses of 80 to 160 mg once a day was at least as effective as enalapril in doses of 5 to 10 mg twice a day.

NYHA class, symptoms, quality of life, ejection fraction. In patients receiving valsartan, there was a significant improvement in the functional class of CHF in the NYHA classification, as well as in the signs and symptoms of CHF, in comparison with the placebo group. Such as dyspnea, increased fatigue, peripheral edema, wheezing. Compared to the placebo group, a significant increase in the ejection fraction and a significant decrease in LVEF were noted in patients taking valsartan compared to baseline before treatment.

The use of Diovan® reduces the number of hospitalizations for CHF, slows its progression, improves the NYHA functional class, increases the ejection fraction, and decreases the signs and symptoms of heart failure and improves quality of life compared with placebo.

Application after acute myocardial infarction

The VALIANT study included 14,703 patients with acute myocardial infarction complicated by left ventricular failure and / or left ventricular systolic dysfunction.

Randomization was performed 0.5-10 days after acute myocardial infarction, in groups in which, in addition to traditional treatment, treatment was started with either valsartan (4909 patients), or a combination of valsartan and captopril (4,885 patients), or captopril (4909 Patients).

Mortality rates for any reason and mortality from certain causes were similar in all 3 treatment groups. A total of 979 (19.9%) died in the valsartan group, 941 (19.3%) in the combination therapy group and 958 (19.5%) in the captopril group.

The ratio of the risk of death from cardiovascular causes and the risk ratio for the composite indicator, including, in addition to cases of cardiovascular death, serious non-fatal cardiovascular events (repeated myocardial infarction, hospitalization due to heart failure, resuscitation after circulatory arrest and Stroke) were similar for the valsartan group and captopril group, as well as for the combination therapy group and captopril group.

In the combination therapy group, the greatest incidence of adverse events associated with taking medications has been identified. With monotherapy in the valsartan group, hypotension and renal dysfunction were more common, in the captopril group, cough, rash, and taste disorders.

The study proved the effectiveness of valsartan, equal to that of captopril, in reducing overall and cardiovascular mortality. The calculated efficacy of valsartan with respect to the effect on the overall mortality rate is 99.6% of that of captopril. Additional analysis, conducted using the placebo-admission method, showed that valsartan reduces the risk of death by 25%. Valsartan is the same effective drug as captopril in the treatment of patients at high risk of developing cardiovascular complications after myocardial infarction. The addition of valsartan to captopril therapy leads to an increase in the incidence of adverse events, without further improving the survival of patients.

Pharmacokinetics

After taking the drug, suction of valsartan takes place quickly, but the degree of absorption varies widely. The average absolute bioavailability of Diovan® is 23%. T1 / 2 - about 9 hours. In the range of doses studied kinetics of valsartan has a linear character. With repeated use of the drug, no changes in the kinetic parameters were noted. When taking the drug once a day, cumulation is negligible. Plasma concentrations in women and men were similar.

Valsartan is largely (94-97%) bound to serum proteins, mainly albumin. VSS during the equilibrium period is low (about 17 liters). In comparison with the hepatic blood flow (about 30 l / h), the plasma Cl valsartan occurs relatively slowly (about 2 l / h). The amount of valsartan excreted with feces is 70% (of the amount taken internally in the dose). With urine output is about 30%, mostly in unchanged form. With the appointment of Diovan® with food, AUC decreases by 48%, although starting from about the 8th hour after taking the drug, the concentrations of valsartan in the plasma, both in the case of fasting and in the case of food intake, are the same. AUC decrease, however, is not accompanied by a clinically significant decrease in the therapeutic effect, so Diovan® can be taken on an empty stomach and during meals.

Pharmacokinetics in selected groups of patients

Patients of advanced age. In some elderly people, the values of Valsartan AUC were higher than those of young adults, however, no clinical significance of this difference was shown.

Patients with impaired renal function. There was no correlation between renal function and valsartan AUC values. In patients with impaired renal function, dose adjustment is not required. Currently, there is no data available for patients on hemodialysis. Valsartan has a high degree of binding to blood plasma proteins, so its elimination in hemodialysis is unlikely.

Patients with impaired liver function. About 70% of the amount absorbed dose of the drug is excreted with bile, mostly unchanged. Valsartan does not undergo significant biotransformation, valsartan AUC does not correlate with the degree of hepatic impairment. Therefore, in patients with hepatic insufficiency of non-biliary origin and in the absence of cholestasis, dose adjustment of the Diovan® preparation is not required. It has been shown that in patients with biliary liver cirrhosis or obstruction of the bile ducts, the vascartan AUC increases approximately 2-fold.

Indications of the drug Diovan

arterial hypertension;

CHF (II-IV functional class according to NYHA classification) in patients receiving standard therapy, incl. Diuretics, digitalis preparations, as well as ACE inhibitors or beta-blockers (not simultaneously);

Increased survival of patients with acute myocardial infarction complicated by left ventricular failure and / or left ventricular systolic dysfunction, with stable hemodynamic parameters.

Contraindications

Hypersensitivity to any of the components of the preparation Diovan®;

pregnancy;

Period of lactation.

Carefully:

Bilateral stenosis of the renal arteries, stenosis of the artery of a single kidney;

Adherence to a diet with sodium restriction;

Conditions, accompanied by a decrease in BCC (including diarrhea, vomiting);

Liver failure on the background of bile duct obstruction;

Renal failure (Cl creatinine less than 10 ml / min), incl. Patients who are on hemodialysis (until now no pharmacokinetics studies have been performed in patients on hemodialysis).

Use in children - because controlled studies on the efficacy and safety of valsartan in children and adolescents (under 18 years) have not been carried out, it is not possible to formulate specific recommendations for use in this group of patients.

Application of pregnancy and breastfeeding

Given the mechanism of action of angiotensin II antagonists, the risk to the fetus can not be ruled out. The effect of ACE inhibitors (drugs that affect RAAS) on the fetus, if prescribed in the II and III trimesters of pregnancy, leads to its damage and death. Retrospective data on the use of ACE inhibitors in the I trimester of pregnancy increases the risk of the birth of children with congenital defects. There are reports of spontaneous abortions, oligohydramnios and renal dysfunction in newborns whose mothers received valsartan during pregnancy. The preparation Diovan® as well as any other drug that directly affects RAAS should not be used in pregnancy, as well as in women planning a pregnancy. When prescribing drugs that act on RAAS, the doctor should inform women of childbearing age of the potential risk of adverse effects of these drugs on the fetus during pregnancy. If pregnancy is detected during the period of treatment with Diovan®, the drug should be discontinued as soon as possible.

It is not known whether valsartan (the active ingredient of the Diovan® preparation) penetrates human breast milk, but in experimental models it has been shown that valsartan is excreted in breast milk. Therefore, do not use Diovan® during lactation.

Side effects

The dependence of the frequency of any of the adverse events on the dose or duration of treatment was not shown; Therefore, undesirable phenomena observed with different doses of valsartan were combined. The incidence of adverse events was also not related to gender, age or race. Below are all the undesirable events observed with a frequency of 1% or more in the group of patients receiving the preparation Diovan ®, regardless of their causal relationship with the study drug, as well as postmarketing data obtained in patients with hypertension.

To assess the frequency of adverse events, the following criteria were used: very often (≥1 / 10), often (≥1 / 100, <1/10), sometimes (≥1 / 1000, <1/100), rarely (≥1 / 10000 , <1/1000), very rarely (<1/10000).

Infections and infestations: often - viral infections; Sometimes - infections of the upper respiratory tract, pharyngitis, sinusitis; Very rarely rhinitis.

From the hemopoietic system: often - neutropenia; Very rarely - thrombocytopenia.

From the side of the immune system: very rarely - reactions of hypersensitivity, including serum sickness.

Metabolic disorders: sometimes - hyperkalemia1,2.

From the nervous system: often - postural dizziness; Sometimes - a faint, insomnia, decreased libido; Rarely - dizzy; Very rarely - headache4.

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

From the cardiovascular system: often - orthostatic hypotension2; Sometimes - hypotension1, heart failure1; Very rarely - vasculitis.

From the respiratory system: sometimes - cough.

From the gastrointestinal tract: sometimes - diarrhea, abdominal pain; Very rarely - nausea.

From the skin and subcutaneous tissue: very rarely - angioedema; Rash, itching.

From the musculoskeletal system: sometimes - pain in the back; Very rarely - arthralgia, myalgia.

From the side of the kidneys: very rarely - renal dysfunction3,4, acute renal failure3, renal failure3.

Other: sometimes - a feeling of fatigue, asthenia, swelling.

Changes in laboratory parameters: in rare cases, the use of Diovan® can be accompanied by a decrease in the concentration of hemoglobin and hematocrit. In controlled clinical trials, a significant reduction (> 20%) of hematocrit and hemoglobin, respectively, was noted in 0.8 and 0.4% of patients receiving Diovan®. For comparison, in patients receiving placebo, a decrease in both hematocrit and hemoglobin was noted in 0.1% of cases.

Neutropenia was detected in 1.9% of patients receiving Diovan ® and 1.6% of patients receiving an ACE inhibitor.

A significant increase in the concentration of creatinine, potassium and total bilirubin in serum was observed in 0.8, 4.4 and 6% of patients taking Diovan ®, respectively, and 1.6, 6.4 and 12.9% of patients , Who took an ACE inhibitor. In CHF, an increase in creatinine concentration of more than 50% was noted in 3.9% of patients taking Diovan ®, compared with 0.9% in the placebo group. At the same time, an increase in serum potassium levels by more than 20% was noted in 10% of patients receiving Diovan ® and 5.1% of those receiving placebo.

In the treatment of patients in the period after myocardial infarction, an increase in the serum creatinine concentration in 2 times was observed in 4.2% of patients receiving valsartan, 4.8% of patients receiving valsartan + captopril, and 3.4% of patients receiving captopril.

There have been reports of an increase in hepatic transaminase activity in patients receiving Diovan®.

An increase in serum urea nitrogen concentration by more than 50% was noted in 16.6% of patients treated with valsartan and 6.3% of patients in the placebo group.

Note:

- 1 reported on these adverse events in patients receiving Diovan in the post-myocardial infarction period;

- 2, these adverse events were reported in patients with CHF who received Diovan®;

- 3 reported these adverse events at a frequency sometimes in patients receiving Diovan in the post-myocardial infarction period;

- 4 More often reported on these adverse events in CHF patients receiving Diovan ® (often - dizziness, kidney dysfunction, hypotension, sometimes - headache, nausea).

All patients with CHF received traditional drug therapy for CHF, often - complex therapy, which included diuretics, digitalis preparations, beta-blockers or ACE inhibitors.

With prolonged use of valsartan in patients with CHF, no additional side effects were noted.

Interaction

Clinically significant interactions with other drugs have not been noted so far. Interactions with the following drugs have been studied: cimetidine, warfarin, furosemide, digoxin, atenolol, indomethacin, hydrochlorothiazide, amlodipine and glibenclamide.

Since Diovan® is not subject to significant metabolism, it is unlikely that clinically significant interactions with other drugs - inducers or inhibitors of the cytochrome P450 system. Despite the fact that valsartan is largely bound to blood plasma proteins, no interaction at a given level with a number of molecules having the same high binding to plasma proteins, for example, diclofenac, furosemide and warfarin, has been detected in vitro.

Simultaneous use of potassium-sparing diuretics (including spironolactone, triamterene, amiloride), potassium or potassium-containing salts, can lead to an increase in serum potassium concentration and in patients with heart failure - an increase in the serum creatinine concentration. If such combination treatment is considered necessary, care should be taken.

Dosing and Administration

Inside, not liquid.

Arterial hypertension. The recommended dose is 80 mg once a day daily, regardless of race, age and sex of the patient. Antihypertensive effect observed in the first 2 weeks of treatment, the maximum effect - after 4 weeks. For those patients who cannot achieve an adequate therapeutic response, the daily dose of Diovan® can be increased to 320 mg or additionally prescribed diuretic drugs.

Chronic heart failure. The recommended initial dose is 40 mg 2 times a day daily. The dose of Diovan ® should be gradually increased to 80 mg twice a day, and with good tolerability - up to 160 mg 2 times a day. It may be necessary to reduce the dose of concurrently taken diuretics. The maximum daily intake is 320 mg in 2 divided doses. Assessment of patients with CHF should include assessment of renal function.

The period after the transferred myocardial infarction. Treatment should be started within 12 hours after myocardial infarction. The initial dose is 20 mg (1/2 table 40 mg) twice a day. The dose is increased by titration (40, 80 and 160 mg twice a day) for several weeks, until the target dose is 160 mg twice a day. The maximum daily intake is 320 mg in 2 divided doses. Usually, it is recommended that the dose be reached to 80 mg twice a day by the end of the second week of treatment. Achievement of the maximum target dose of 160 mg 2 times per day is recommended by the end of the third month of therapy with the drug Diovan®. The achievement of the target dose depends on the tolerability of valsartan during the titration period. In the case of development of hypotension, accompanied by clinical manifestations, or renal dysfunction should consider the possibility of dose reduction. Evaluation of the condition of patients in the post-myocardial infarction period should include assessment of renal function.

Note for all indications

It is not necessary to correct the dosage regimen for patients with impaired renal function and patients with hepatic insufficiency of non-biliary genesis without the phenomena of cholestasis.

Overdose

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

Treatment: if the drug has been taken recently, you should induce vomiting; With a pronounced decrease in blood pressure the usual method of therapy is intravenous injection of 0.9% sodium chloride solution. It is unlikely that valsartan can be removed from the body by hemodialysis.

Special instructions

During treatment with Diovan®, patients with essential hypertension do not need regular monitoring of laboratory parameters.

Deficiency in the body of sodium and / or reduced BCC. In patients with a marked deficit in the body of sodium and / or BCC, for example receiving high doses of diuretics, in rare cases at the beginning of treatment with the drug Diovan ® hypotension may occur, accompanied by clinical manifestations. Before starting treatment with Diovan®, you should correct the sodium and / or BCC content, including by reducing the dose of the diuretic.

In case of hypotension, the patient should be laid, legs lifted. If necessary, an intravenous infusion of 0.9% solution of sodium chloride. After the BP stabilizes, the treatment can be continued.

Stenosis of the renal artery. The use of the short course Diovan® preparation in 12 patients with reninvascular hypertension, which developed secondary due to unilateral stenosis of the renal artery, did not lead to any significant changes in renal hemodynamics, serum creatinine concentration, or blood urea nitrogen. However, given that other drugs that affect RAAS can cause an increase in serum urea and creatinine levels in patients with bilateral or unilateral stenosis of the renal artery, it is recommended to monitor these indicators as a precautionary measure.

Impaired renal function. Patients with impaired renal function do not need a dose adjustment. However, with severe disturbances (when Cl creatinine is less than 10 ml / min), caution is advisable.

Violation of the function of the liver. Patients with hepatic insufficiency do not need a dose adjustment, except for cases of cholestasis. Valsartan is excreted mainly unchanged with bile, and it has been shown that in patients with bile duct obstruction Cl, valsartan is reduced. When appointing valsartan, these patients should be especially careful.

CHF / period after a previous myocardial infarction. In patients with CHF or after myocardial infarction, beginning treatment with the drug Diovan®, there is often a slight decrease in blood pressure, and therefore it is recommended to monitor BP at the beginning of therapy. Subject to the recommendations on the dosing regimen, there is usually no need to discontinue Diovan® because of hypotension. Due to inhibition of RAAS in sensitive patients, changes in kidney function are possible. In patients with severe CHF, treatment with ACE inhibitors and angiotensin receptor antagonists may be accompanied by oliguria and / or augmentation of azotemia and (rarely) acute renal failure and / or fatal. Therefore, it is necessary to evaluate the kidney function in patients with heart failure and patients who underwent acute myocardial infarction.

Combined therapy. In patients with CHF, caution should be exercised when using a combination of an ACE inhibitor, a beta-blocker and a valsartan.

With arterial hypertension, Diovan® can be administered both as a monotherapy and together with other antihypertensive agents, in particular with diuretics.

With CHF, Diovan® can be prescribed both as monotherapy and together with other agents - diuretics, digitalis preparations, as well as ACE inhibitors or beta-blockers.

It is possible to use Diovan ® in combination with other drugs prescribed after a myocardial infarction, namely thrombolytics, acetylsalicylic acid, beta-adrenoblockers and statins.

Influence on the ability to drive a car and work with mechanisms. Patients taking the drug Diovan® should be careful when driving a car and controlling the mechanisms.

Conditions of supply of pharmacies

On prescription.

Storage conditions of the drug Diovan

At a temperature of no higher than 30 ° C, in the original packaging.

Keep out of the reach of children.

The shelf life of the drug Diovan

3 years.

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

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