Artinova - instructions for use, dose, side effects, contraindications

Excipients: microcrystalline cellulose (Avicel PH 101) - 57 mg, microcrystalline cellulose (Avicel PH 102) - 50 mg, crospovidone 10.5 mg, silicon dioxide colloid 8 mg, talc 2.5 mg, magnesium stearate 6 mg, pregelatinized starch 36 mg.

Shell: opadrai 03052389 yellow 7.5 mg.

Composition of Otradary 03G52389 yellow: hypromellose 6 cp 62.500% mass / mass (4.6875 mg / tab), titanium dioxide 13.545% mass / mass (1.0159 mg / tab), macrogol-400 8,250% mass / mass (0.6188 mg / tab), talc 4.250% w / w (0.3188 mg / tab), macrogol 4000 4000 3.750% w / w (0.2813 mg / tab), iron dye oxide yellow 7.450% w / w (0.5588 mg / tab), iron dye red oxide 0.255% w / w (0.0191 mg / tab).

Each 160 mg tablet contains:

Active substance: atalsartan 160 mg.

Excipients: microcrystalline cellulose (Avicel PH 101) 114 mg, microcrystalline cellulose (Avicel PH 102) 100 mg, crospovidone 21 mg, silicon dioxide colloidal 16 mg, talc 5 mg, magnesium stearate 12 mg, pregelatinized starch 72 mg.

Sheath: fall off 03G54386 pink 15 mg.

Composition Opadray 03G54386 pink: hypromellose 6 cp 62.500% mass / mass (9.3750 mg / tab), titanium dioxide 20.402% weight / weight (3.0603 mg / tab), macrogol-400 8,250% mass / mass (1.2375 mg / tab), talc 4.250% mass / mass (0,6375 mg / tab), macrogol-4000 3,750% weight / weight (0,5625 mg / tab), iron dye oxide red 0.790% w / w (0.1185 mg / tab), iron oxide dye black 0.058% w / w (0.0087 mg / tab).

Description:

Tablets 80 mg. Oval, biconvex tablets, covered with a film shell of orange color, with a dividing risk on both sides, with engraving "V" and "2" on one side.

Tablets 160 mg. Oval, biconvex tablets covered with a pink film shell, with a dividing risk from both sides, with engraving "V" and "1" on one side.

Pharmacotherapeutic group:Angiotensin II receptor antagonist

ATX: & nbsp

C.09.C.A.03 Valsartan

C.09.C.A Angiotensin II antagonists

Pharmacodynamics:

Valsartan is an active specific antagonist of angiotensin II receptors, intended for oral administration. Selectively blocks the receptors of the AT1 subtype, which are responsible for the affects of angiotensin II. The consequence of the blockade AT1-receptors is an increase in plasma concentrations of angiotensin II, which can stimulate unblocked AT2 receptors. Valsartan does not have any expressed agonistic activity in relation to AT1receptors. The affinity of valsartan for the receptors of the subtype AT1 approximately 20,000 times higher than to the AT2 receptor subtype. Valsartan does not interact and does not block the receptors of other hormones or ion channels that are important in regulating the functions of the cardiovascular system.The likelihood of coughing with valsartan is very low, due to the lack of influence on the angiotensin-converting enzyme, which is responsible for the degradation of bradykinin. A comparison of valsartan with an angiotensin converting enzyme inhibitor demonstrates that the incidence of dry cough is significantly (p <0.05) lower in patients taking drug than of patients taking an angiotensin-converting enzyme inhibitor (2.6% vs. 7.9%, respectively). In a group of patients who previously developed a dry cough in the treatment with an angiotensin converting enzyme inhibitor, in valsartan treatment this undesirable phenomenon is noted in 19.5% of cases, and at treatment with thiazide diuretic - in 19.0% of cases, while in the group of patients treated with an inhibitor of the angiotensin-converting enzyme, cough is observed in 68.5% of cases (p < 0,05).

Use in hypertension in patients older than 18 years

In the treatment of valsartan in patients with hypertension, there is a decrease in arterial pressure, not accompanied by a change in the heart rate.

After applying a single dose of the drug in most patients, the onset of antihypertensive action develops within 2 h, and the maximum reduction in blood pressure is achieved within 4-6 h and persists for more than 24 hours. With constant intake of the drug, the maximum reduction in blood pressure, regardless of the dose taken, is usually achieved at within 2-4 weeks and maintained at the achieved level at during prolonged therapy. AT If the drug is simultaneously administered with hydrochlorothiazide, a significant additional reduction in blood pressure is achieved.

A sharp discontinuation of valsartan is not accompanied by a significant increase in blood pressure or other undesirable clinical consequences. Patients from arterial hypertension, diabetes mellitus II type and nephropathy, taking valsartan in a dose of 160-320 mg, there is a decrease in proteinuria (36-44%).

Application after acute myocardial infarction in patients older than 18 years

When application of valsartan in 2 years years in patients who started taking in the period from 12 hours to 10 days after a previous myocardial infarction (complicated by left ventricular failure and / or left ventricular systolic dysfunction),the rates of total mortality, cardiovascular mortality are decreasing and time is increasing before the first hospitalization for exacerbation of chronic heart failure, repeated myocardial infarction, sudden cardiac arrest and stroke (without a lethal outcome). The safety profile of valsartan in patients with acute myocardial infarction is similar to that in other conditions.

Chronic heart failure in patients older than 18 years

When application of valsartan (at mean daily dose of 254 mg) for 2 years in patients with chronic heart failure II (62%), III (36%) and IV (2%) of the functional class by classification NYHA with a left ventricular ejection fraction of less than 40% and internal diastolic diameter of the left ventricle more than 2.9 cm / m², receiving standard therapy, including angiotensin-converting enzyme inhibitors (93%), diuretics (86%), digoxin (67%) and beta-blockers (36%), there is a significant decrease (by 27.5%) of the risk of hospitalization for worsening of chronic heart failure.

In patients who did not receive angiotensin-converting enzyme inhibitors,a significant reduction in the overall mortality rate (by 33%), cardiovascular mortality and incidence associated with chronic heart failure (time before the onset of the first cardiovascular event), which are estimated by the following indicators: death, sudden death with resuscitation, hospitalization for exacerbation of chronic heart failure, intravenous injection of inotropic or vasodilating drugs for 4 or more hours without hospitalization (by 44%). In the group of patients receiving angiotensin-converting enzyme inhibitors (without beta-blockers), there is no reduction in the overall mortality rate with valsartan, but the cardiovascular mortality and morbidity associated with chronic heart failure decrease by 18.3%.

AT In general, the use of valsartan leads to a reduction in the number of hospital admissions by about chronic heart failure, slowing the progression of chronic heart failure, improving the functional class of chronic heart failure by classification NYHA, an increase in the left ventricular ejection fraction, as well as a decrease in the signs and symptoms of heart failure and an improvement in the quality of life compared to from 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 the of this category of patients. Valsartan did not influence the frequency deaths due to cardiovascular events, myocardial infarction and ischemic attacks non-fatal, on the incidence of hospitalizations for heart failure, or unstable angina, arterial revascularization, patients with a tolerance violation to glucose and arterial hypertension, differing in age, sex and race. In patients receiving valsartan, the risk of 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 - 80 mg once at day. If necessary, the dose may be increased to 160 mg.

The use in children and adolescents from 6 to 18 years with hypertension

Children and adolescents from 6 to 18 years valsartan provides a dose-dependent, smooth decrease in blood pressure. When application of valsartan maximum decrease in blood pressure, regardless of from the usual dose is usually achieved within 2 weeks, and is maintained at the achieved level during long-term therapy.

Pharmacokinetics:

Suction

After oral intake of valsartan is rapid, the maximum concentration of valsartan in the blood plasma is reached within 2-4 h. The average bioavailability is 23%. When valsartan is used with food, the area under the "concentration-time" curve decreases by 48%, although starting from about the 8th hour after taking the drug, the concentration of valsartan in the plasma blood as in the case of taking it on an empty stomach, and in the case of reception with food, the same. Reducing the area under the "concentration-time" curve, however, is not accompanied by a clinically significant decrease in the therapeutic effect, so valsartan can be taken regardless of the time of ingestion.

Distribution

The volume of distribution of valsartan in the equilibrium period after intravenous administration was about 17 liters, indicating that there was no pronounced distribution in the tissues. Valsartan actively binds to blood serum proteins (94-97%), mainly with albumins.

Metabolism

Valsartan does not undergo significant biotransformation, only about 20% of the dose is excreted as metabolites. The hydroxyl metabolite is determined in blood plasma at low concentrations (less than 10% of the area under the "concentration-time" curve of valsartan). itt metabolite is pharmacologically inactive.

Excretion

Valsartan is biphasic: an α-phase with a half-life of less than 1 hour and β-phase with a half-life of about 9 hours. Displayed at mostly unchanged through the intestine (about 83%) and kidneys (about 13%). After intravenous administration, 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 half-life of valsartan is 6 hours.

Pharmacokinetics in selected patient groups

Patients with chronic heart failure

In this category of patients, the time of reaching the maximum concentration and half-life is similar to that of healthy volunteers. The increase in the area under the concentration-time curve and the maximum concentration is directly proportional to the increase in the dose of the drug (from 40 mg to 160 mg 2 times). The cumulation factor averages 1.7. When ingestion of valsartan clearance was approximately 4.5 l / h. The age of patients with chronic heart failure did not affect the cellandRans Valsairtana.

Patients of advanced age (over 65 years)

Have some patients at over 65 years of age, the systemic bioavailability of valsartan is higher than that of young patients, which is not clinically relevant.

Patients with impaired renal function

Correlation between renal function and systemic bioavailability of valsartan is absent. In patients with impaired renal function and a glomerular filtration rate of more than 10 ml / min, dose adjustment is not required. Currently, there is no data on the use in patients on hemodialysis. Valsartan has a high degree of binding to blood proteins, therefore its excretion in hemodialysis is unlikely.

Patients with hepatic impairment

In patients with mild and moderate impairment of liver function, there is an increase in bioavailability (area under crooked "concentration-time") of valsartan is twice as high as in healthy volunteers. However, there is no correlation of the area under the concentration-time curve of valsartan with the degree of impaired liver function. Application of the drug the patients with severe impairment of liver function have not been studied.

Patients 6 to 18 years of age

The pharmacokinetics of valsartan in children and adolescents 6 to 18 years old do not differ from the pharmacokinetics of valsartan in patients older than 18 years.

Indications:

Adults

- Arterial hypertension.

- Chronic heart failure (II-IV functional class by classification NYHA) in patients receiving standard therapy with one or more of the following farmacotherapeutic groups: diuretics, cordial glycosides, and also inhibitors of angiotensin-converting enzyme or beta-blockers.The use of each of these drugs is not is an compulsory.

Children and teens

- Arterial hypertension in children and adolescents from 6 to 18 years (see "Method of administration and dose").

Contraindications:

- Pincreased sensitivity to any of the components of the drug;

- bPregnancy, the period of breastfeeding;

- tsevere hepatic impairment (more than 9 on the Child-Pugh scale), biliary cirrhosis and cholestasis;

- atozrast to 6 years - according to indications arterial hypertension, up to 18 years - according to other indications;

- aboutthe simultaneous use of angiotensin II receptor antagonists and angiotensin-converting enzyme or aliskiren inhibitors in patients with type 2 diabetes mellitus.

Carefully:

Care should be taken with the use of the drug with hereditary angioedema, or angioedema, on the background of previous therapy with angiotensin receptor antagonists II or angiotensin-converting enzyme inhibitors.

If you have any of the listed diseases, before taking the drug, be sure to consult a doctor:

- dbilateral stenosis of the renal arteries;

- fromarteritis of the only kidney;

- PPrimary hyperaldosteronism;

- fromObservance of a diet with restriction of consumption of table salt;

- fromConditions, accompanied by a decrease in the volume of circulating blood (including diarrhea, vomiting);

- fromthe glomerular filtration rate is less than 10 ml / min (no clinical data);

- Ppatients from 6 to 18 years with a glomerular filtration rate of less than 30 ml / min, at Tom number of who are on hemodialysis;

- lmild and moderate disorders function liver biliary and non-biliary genesis without the phenomena of cholestasis;

- xheart failure II-IV functional class for NYHA, the renal function of which depends on the state of the renin-angiotensin-aldosterone system;

- mitral or aortic stenosis;

- giptotropic obstructive cardiomyopathy;

- fromstate after kidney transplantation.

It is not recommended to apply valsartan concurrent with angiotensin converting enzyme inhibitors, since this combination therapy has no advantage over monotherapy with valsartan or an angiotensin converting enzyme inhibitor for all-cause mortality rates.

Care should be taken when concomitantly administering angiotensin II receptor antagonists with other renin-enHyotensin-aldosterone system, such as aliskiren.

Pregnancy and lactation:

how and any other drug that affects the renin-angiotensin-aldosterone system, Artinova® should not be used in women planning a pregnancy. When the appointment of any drug that affects the renin-angiotensin-aldosterone system, the doctor should inform women of childbearing age of the potential dangers of using these drugs during pregnancy. Like any other drug that has a direct effect on renin-angiotensin-aldosteronothe Artinov® preparation should not be used during pregnancy. Given the mechanism of action of angiotensin receptor antagonists II, you can not exclude the risk to the fetus. The effect of inhibitors of the angiotensin-converting enzyme (drugs that also affect the renin-angiotazin-aldosterone system) on the fetus, if used in the second and third trimester of pregnancy can result to its damage and death. By retrospective data with the use of angiotensin-converting enzyme inhibitors in the first 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 during pregnancy by recklessly received valsartan. If pregnancy occurs during treatment with valsartan, the drug should be discontinued immediately.

It is not known whether valsartan in breast milk. Therefore, do not use the drug during lactation.

There are no data on the effect of the drug on human fertility. When studies on animals did not observe the effects of valsartan on fertility.

Dosing and Administration:

Tablets are taken orally, without chewing, independently from time of reception of food, washing down with water.

Adults

Arterial hypertension

The recommended initial dose of Artinov® is 80 mg 1 once a day, regardless of race, age and sex of the patient.Hypotensive effect is noted at the first two weeks of treatment; the maximum effect develops through 4 of the week. For those patients who can not achieve an adequate therapeutic effect, the daily dose of Artinov® can be gradually increased to a maximum daily dose of 320 mg or diuretics should be additionally applied.

Chronic heart failure

The recommended initial dose of valsartan is 40 mg twice a day (1/2 tablet 80 mg). The dose of the drug should be gradually increased for at least 2 weeks to 80 mg 2 times at day, and with good tolerability - up to 160 mg 2 times a day. The maximum daily dose is 320 mg in 2 divided doses. It may be necessary to reduce the dose of simultaneously used diuretics.

The maximum daily dose is 320 mg in two divided doses. Usually, it is recommended to increase the dose to 80 mg 3 times at day to end of the second week of treatment. Achieve maximum target dose of 160 mg twice at day is recommended by the end of the third month of therapy with Artinov®. The increase in dose depends on the tolerability of Artinov® during the dose selection period.

In the case of development of arterial hypotension, accompanied by clinical manifestations, or renal dysfunction should consider about dose reduction.

Evaluation of the condition of patients in the period after a previous myocardial infarction should include an evaluation of the function kidney.

Children and teens

Arterial hypertension

The recommended initial dose of valsartan in children and adolescents 6 to 18 years is 40 mg at mass baby's body less 35 kg and 80 mg at body weight of the child more than 35 kg. The dose is recommended to be adjusted taking into account the decrease in blood pressure.

The maximum recommended daily doses are shown in the table below. The use of higher doses is not recommended.

Body mass	The maximum recommended dose
≥ 8 kg <35 kg	80 mg
≥ 35 kg <80 kg	160 mg
≥ 80 kg	320 mg

Chronic heart failure and acute myocardial infarction

Valsartan is not recommended for the treatment of chronic heart failure and myocardial infarction in patients younger 18 years.

Patients of advanced age (over 65 years)

In elderly patients, correction doses preparation not it takes.

Patients with impaired renal function

In patients with impaired renal function, dose adjustment is not required. Currently, there is no data on the use of the drug in patients with a glomerular filtration rate of less than 10 ml / min.

Patients with hepatic impairment

Patients with lungs or moderate violations of the liver function of non-biliary origin without the phenomena of cholestasis, the drug should be used with caution, the daily dose should not exceed 80 mg.

Side effects:

Patients from arterial hypertension in controlled clinical trials, the incidence of adverse events was comparable to placebo. There is no data on the frequency dependence of any of the undesirable phenomena from dose or duration of treatment, as well as sex, age or of race. The safety profile of valsartan in patients with arterial hypertension in patients 6 before 18 years does not differ from the safety profile of valsartan in adult patients. Below are the undesirable phenomena that were observed at clinical trials, and at application of the drug at clinical practice.

To assess the frequency of adverse events, the following criteria were used: "very often" (≥1 / 10), "often" (≥1 / 100, <1/10), "infrequently" (≥1 / 1000, <1/100), ((rarely "(≥1 / 10000, <1/1000)," very rare "(<1 /10000), including individual messages.

For all the undesirable phenomena revealed in clinical practice and in the analysis of laboratory indicators (the frequency of development of which can not be established), the gradation "frequency unknown" was used.

Patients with hypertension

On the part of the hematopoiesis and lymphatic system: the frequency is unknown - a decrease in hemoglobin, a decrease in hematocrit, neutropenia, thrombocytopenia.

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

Metabolic disorders: the frequency is unknown - an increase in the potassium content in the serum.

From the side of the hearing and vestibular organs: infrequently - vertigo.

From the cardiovascular system: frequency is unknown - vasculitis.

From the respiratory system: infrequently - cough.

From the gastrointestinal tract: infrequently - pain in the abdomen.

From the hepatobiliary system: frequency unknown - impaired liver function, including increased bilirubin concentration in plasma blood.

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

From the musculoskeletal system: frequency is unknown - myalgia.

From the side of the kidneys: frequency unknown - renal dysfunction, increased serum creatinine concentration.

Other: infrequently - increased fatigue.

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

Patients after acute myocardial infarction and / or chronic heart failure

From the side of hematopoiesis and lymphatic system: frequency unknown - thrombocytopenia.

From the immune system: frequency is unknown - reactions increased sensitivity, including serum sickness.

Metabolic disorders: infrequently hyperkalemia; the frequency is unknown - an increase in the potassium content in the serum.

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

From the side of the hearing and vestibular organs: infrequently - turns.

From the side of the cardiovascular system: often - marked reduction in blood pressure, orthostatic hypotension; infrequently - increased symptoms of chronic heart failure; frequency is unknown - vasculitis.

From the respiratory system: infrequently - cough.

From the gastrointestinal tract: infrequently - nausea, diarrhea.

From the hepatobiliary system: frequency unknown - impaired liver function.

From the skin and subcutaneous tissue: highly rarely - angioedema; frequency unknown - skin rash, itching, bullous dermatitis.

From the musculoskeletal system: rarely - rhabdomyolysis, the frequency is unknown - myalgia.

From the side of the kidneys: often - renal dysfunction; infrequently - acute renal failure, increased serum creatinine concentration; frequency unknown - content increase nitrogen urea in plasma blood.

Common violations: infrequently - asthenia, increased fatigue.

Also, in clinical trials in patients after acute myocardial infarction and / or chronic heart failure, the following adverse events were observed, the cause-effect relationship of which from the administration of the drug is not established: arthralgia, abdominal pain, back pain, asthenia, insomnia, decreased libido, neutropenia, peripheral edema, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

Overdose:

Symptoms: despite the lack of sufficient data, the main expected manifestation of an overdose of the drug will be tachycardia and a marked decrease in blood pressure, which can lead to collapse and / or shock.

Treatment: there is no specific antidote. Treatment is symptomatic, it is recommended to induce vomiting and rinse the stomach, in case the drug has been taken recently. With a marked decrease in blood pressure, 0.9% solution of sodium chloride is injected intravenously. Hemodialysis is ineffective.

Interaction:

Simultaneous use is contraindicated

Simultaneous use of angiotensin II receptor antagonists, including valsartan, or angiotensin-converting enzyme inhibitors with aliskiren is contraindicated in patients with diabetes mellitus and moderate or severe dysfunction of daughters (glomerular filtration rate is less than 60 ml / min).

Simultaneous use is not recommended

Lithium

With the simultaneous use of lithium preparations with angiotensin converting enzyme inhibitors, a reversible increase in lithium content in serum and a consequent increase in toxic effects were observed, therefore it is recommended to control the lithium content in serum. The risk of toxic manifestations associated with the use of lithium drugs may be further increased with simultaneous use with the Artinov® preparation and diuretics.

Potassium-sparing diuretics, potassium preparations, potassium-containing food additives and other medicines that can cause hyperkalemia (eg, heparin)

Simultaneous reception of potassium chloridefleetingx diuretics (spironolactone, eplerenone, triamterene, amiloride),Potassium-containing food supplements can lead to hyperkalemia and in patients from heart failure to increase serum creatinine concentration. If such simultaneous application is considered necessary, care must be taken.

Use with caution at the same time

Non-steroidal anti-inflammatory drugs, including selective inhibitors of cyclooxygenase-2

When simultaneous application of Artinov® with non-steroidal anti-inflammatory drugs (including selective inhibitors of cyclooxygenase-2) may reduce its antihypertensive effect, increase the risk of kidney dysfunction and increase the potassium content at blood plasma. If it is necessary to use Artinov® together with non-steroidal anti-inflammatory drugs, before starting treatment, it is necessary to assess the function of the kidneys and correction of water-electrolyte balance violations.

Protein-carriers

By the results of the study in vitro on liver cultures valsartan is a substrate for carrier proteins of OATP1B1 and MRP2. Simultaneous administration of Artinov® with inhibitors of the carrier protein OATP1B1 (rifampicin, ciclosporin) and with an inhibitor of carrier protein MRP2 (ritonavir) can increase the system exposure of valsartan (maximum concentration and area under the concentration-time curve).

Lack of drug interaction

There were no clinically significant interactions from cimetidine, warfarin, atenolol, indometacin, amlodipine, glibenclamide, furosemide, digoxin, hydrochlorothiazide.

Patients aged 6 to 18 years

Children and adolescents hypertension is often associated with impaired renal function. This category of patients is recommended to take with caution the preparation Artinova® simultaneously with other drugs that affect on renin-angiotensin-aldosterone system, as this may lead to an increase in serum potassium. It should be regularly monitored kidney function and potassium content in the serum of this group of patients.

Special instructions:

Patients with impaired renal function. Avoid simultaneous use of angiotensin II receptor antagonists, including valsartan, or angiotensin-converting enzyme inhibitors with aliskiren in patients with severe renal dysfunction (glomerular filtration rate less than 30 ml / min).

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

Kidney transplantation. There are no data on the safety of valsartan in patients after kidney transplantation.

Deficiency in the body of sodium and / or a decrease in the volume of circulating blood. In patients with severe sodium deficiency in the body and / or a reduced volume of circulating blood, for example, receiving high doses of diuretics, in rare cases, arterial hypotension accompanied by clinical manifestations may develop at the beginning of ARTinova treatment. Before starting treatment with Artinov®, you should correct the sodium content in the body and / or replenish the volume of circulating blood, including by reducing the dose of the diuretic.

Stenosis of the renal artery. The use of the drug in a short course in patients with reninvascular hypertension, which developed secondarily as a result of unilateral stenosis of the renal artery of a single kidney, does not lead to any significant change in renal hemodynamics, serum creatinine or blood urea concentration. However, given that other drugs that affect the renin-angiotensin-aldosterone system can cause an increase in urea and creatinine concentrations, in the serum of patients with bilateral renal artery stenosis or stenosis of the artery of a single kidney, it is recommended to monitor these indicators as a precautionary measure .

Primary hyperaldosteronism. The drug is ineffective for the treatment of hypertension in patients with primary hyperaldosteronism, since this category of patients does not have activation of the renin-angiotensin-aldosterone system.

Chronic heart failure. In patients with chronic heart failure who begin ARTinova treatment, there is often a slight decrease in blood pressure, and therefore it is recommended that blood pressure control at the beginning of therapy.Subject to the recommendations on the dosing regimen, there is usually no need to discontinue Artinov® because of hypotension. An assessment of the condition of patients with chronic heart failure should include an assessment of renal function.

Due to inhibition of the renin-angiotensin-aldosterone system, some patients may have impaired renal function. In patients with chronic heart failure III-IV functional class by classification NYHA, whose kidney function depends from the state of the renin-angiotensin-aldosterone system, treatment with angiotensin-converting enzyme inhibitors and antagonists of angiotensin receptors II may be accompanied by oliguria and / or increased azotemia and, in rare cases, the development of acute renal failure and / or death. Therefore, in this category of patients before the use of Artinov®, and also periodically in time of treatment, it is necessary to assess the function of the kidneys.

Combination therapy in the post-myocardial infarction period. It is possible to use Artinov® in combination with other medications,used after a myocardial infarction, namely thrombolytics, acetylsalicylic acid as antiplatelet agent, beta-adrenoblockers and inhibitors of hydroxymethylglutaryl-CoA reductase (statins). In this category of patients, it is not recommended to use Artinov® simultaneously with angiotensin-converting enzyme inhibitors, since this combination therapy has no advantages over valsartan ionotherapy or an angiotensin-converting enzyme inhibitor for all-cause mortality rates.

Combination therapy for chronic heart failure. In chronic heart failure, Artinov® can be used both in monotherapy and simultaneously with other agents - diuretics, cardiac glycosides, as well as inhibitors of angiotensin-converting enzyme or beta-blockers.

In this category of patients, the use of triple combination therapy with an angiotensin converting enzyme inhibitor, beta-blockers and Artinov® is not recommended.

Angioedema (including Quincke's edema), including laryngeal edema and vocal cords leading to obstruction of the upper respiratory tract and / or swelling of the face, lips, pharynx, and / or tongue edema occurred in patients who received valsartan, some patients had angioedema earlier with other drugs, including angiotensin-converting enzyme inhibitors. The administration of Artinov® in the case of angioedema development should be immediately canceled, the resumption of the Artinov® drug is prohibited.

Effect on the ability to drive transp. cf. and fur:

As against the background of Artinov® therapy, it is possible to develop such undesirable phenomena as dizziness or fainting, patients taking the Artinov® preparation should be careful in managing motor vehicles and engaging in potentially hazardous activities.

Form release / dosage:

Film-coated tablets, 80 mg and 160 mg.

Packaging:

7 tablets per blister of aluminum foil, PVC film and polyamide. By 2, 4 or 8 blisters together with instructions by application in a cardboard bundle.

7 tablets in a blister pack of aluminum foil and PVC / ACLAR films. By 2, 4 or 8 blisters together with instructions for use in a cardboard pack.

Storage conditions:

When temperature not more than 25 FROM.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-003054

Date of registration:23.06.2015 / 19.04.2016

Expiration Date:23.06.2020

The owner of the registration certificate:Ranbaxy Laboratories LimitedRanbaxy Laboratories Limited India

Manufacturer: & nbsp

RANBAXY LABORATORIES, Ltd. India

Representation: & nbspRABBAYS LABORATORY LIMITEDRABBAYS LABORATORY LIMITED

Information update date: & nbsp25.09.2017

Illustrated instructions

Instructions

Artinova (Artinova)