Valsartan-Nan

General characteristics. Structure:

Active ingredient: 80 mg or 160 mg of a valsartan.

Excipients: cellulose microcrystallic, starch corn prezhelatinizirovanny, croscarmellose sodium, povidone, silicon dioxide colloid anhydrous, magnesium stearate, lactose monohydrate;

Structure of a cover: gidroksipropilmetiltsellyuloza, titanium dioxide (E171), коповидон, polydextrose, polyethyleneglycol, srednetsepochechny triglycerides, iron oxide red (E172).

The cardiological hypotensive drug which is not influencing heart rate.

Pharmacological properties:

Pharmacodynamics. Valsartan has hypotensive effect. A specific blocker of ATi of receptors of angiotensin II (the SCONCE of II), at its reception development of dry cough is improbable. At treatment of arterial hypertension валсартан reduces the arterial pressure (AP), without influencing the heart rate (HR).

The anti-hypertensive effect develops in 2 hours after intake, reaches a maximum within 4-6 hours and more than 24 hours remain. After regular reception the maximum decrease in the ABP is reached in 2-4 weeks.

Use of drug leads to reduction of cases of hospitalization concerning heart failure, to delay of progressing of heart failure, improvement of a functional class on NYHA classification, increase in fraction of emission, and also to reduction of signs and symptoms of heart failure and improvement of quality of life in comparison with placebo.

Indications to use:

- arterial hypertension;

- recently postponed myocardial infarction (treatment of clinically stable patients with clinical displays of heart failure or asymptomatic systolic dysfunction of a left ventricle after postponed (12 hours - 10 days) a myocardial infarction);

- heart failure (treatment of heart failure with clinical symptomatology, at impossibility of use of APF inhibitors or in the form of additional therapy to APF inhibitors at impossibility of use of beta adrenoblockers).

Route of administration and doses:

To take a pill inside, without chewing and washing down with enough water, irrespective of meal.

Arterial hypertension. The recommended dose of drug of Valsartan-Nan makes 80 mg of 1 times a day. The anti-hypertensive effect develops within 2 weeks of treatment; the maximum effect is reached in 4 weeks. If necessary the daily dose of a valsartan can be increased to 160 mg or to the maximum daily dose of 320 mg. The combination with other hypotensive drugs is possible.

Postinfarction state. At patients with a stable state therapy can be begun in 12 hours after a myocardial infarction. The initial dose of drug of Valsartan-Nan makes 20 mg 2 times a day, then it is necessary to increase a dose to 40 mg, 80 mg and 160 mg two times a day for the next several weeks.

This dosage form is not intended for starting therapy in the mode of 20 mg 2 times a day, for this purpose it is necessary to use other medicine which provides achievement of a necessary single dose.

Target maximum daily dose - 160 mg 2 times a day. It is recommended to reach the level of a dose of 80 mg 2 times a day within 2 weeks after an initiation of treatment. The target maximum dose has to be reached within 3 months, proceeding from portability by the patient of a valsartan during titration of a dose. If there is symptomatic hypotension or renal dysfunction, it is necessary to consider a question of a dose decline. Valsartan-Nan can be appointed within a postinfarction combination therapy, for example, in a combination from trombolitika, acetylsalicylic acid, beta adrenoblockers, statines and diuretics. It is not recommended to combine treatment by Valsartan-Nan's drug with APF inhibitors, and also - a concomitant use of APF inhibitor, beta adrenoblocker and Valsartan-Nan's drug. Assessment of a condition of patients after a myocardial infarction always has to include monitoring of function of kidneys. Heart failure

The recommended initial dose of drug of Valsartan-Nan makes 40 mg 2 times a day. Gradual increase in a dose up to 80 mg 2 times a day and then to 160 mg 2 times a day has to be carried out with an interval of, at least, 2 weeks before achievement of the maximum dose transferred by the patient. At co-administration to the patient of diuretic, it is necessary to consider expediency of a possible dose decline of diuretic. The maximum daily dose of drug of Valsartan-Nan - 160 mg 2 times a day.

Valsartan-Nan's drug can be used together with other medicines for treatment of heart failure. The concomitant use of APF inhibitor, beta adrenoblocker and Valsartan-Nan's drug is not recommended. Assessment of a condition of patients with heart failure always has to include monitoring of function of kidneys.

Elderly patients. Change of a dose is not required from patients of advanced age.

Patients with a renal failure. Dose adjustment is not required from patients with a slight and moderate renal failure. Monitoring of levels of potassium and creatinine at moderately expressed renal failure is recommended.

Medicine of Valsartan-Nan is contraindicated to patients with a heavy renal failure (a glomerular filtration rate - SKF <30 ml/min. / 1,73 to sq.m) and to the patients who are on dialysis (see the section "Contraindications").

Simultaneous use of medicine of Valsartan-Nan with aliskireny is contraindicated at patients with a moderate / heavy renal failure (SKF <60 ml/min. / 1,73 to sq.m) (see the section "Contraindications").

Patients with abnormal liver functions. Valsartan-Nan is contraindicated to patients with heavy abnormal liver functions, biliary cirrhosis and to patients with a cholestasia. At patients with easy and moderate abnormal liver functions without cholestasia the dose of a valsartan should not exceed 80 mg a day.

At purpose of a valsartan patients with obstruction of biliary tract should observe extra care.

Patients with a diabetes mellitus. Simultaneous use of medicine of Valsartan-Nan with aliskireny is contraindicated to patients with a diabetes mellitus (see the section "Contraindications").

Features of use:

Hyperpotassemia. Co-administration with potassium drugs, the salt substitutes containing potassium, kaliysberegayushchy diuretics or other drugs which can increase potassium concentration in blood serum is not recommended (heparin, etc.). It is recommended to control potassium concentration in blood serum.

Renal failure. Dose adjustment is not required from patients with a slight and moderate renal failure. Monitoring of levels of potassium and creatinine at moderately expressed renal failure is recommended.

Medicine of Valsartan-Nan is contraindicated to patients with a heavy renal failure (the glomerular filtration rate (GFR) <30 ml/min. / 1,73 to sq.m) and to the patients who are on dialysis (see the section "Contraindications").

Simultaneous use of medicine of Valsartan-Nan with aliskireny is contraindicated at patients with a renal failure (SKF <60 ml/min. / 1,73 to sq.m) (see sections of "Contraindication" and "Route of Administration and Doses").

Abnormal liver function. At patients with a liver failure (easy and moderately severe) without Valsartan-Nan's cholestasia it has to be applied with care (see sections of "Contraindication" and "Pharmacokinetics"),

Patients with deficit in an organism of sodium and/or the reduced volume of the circulating blood (OTsK. Patients with the expressed deficit in an organism of sodium and/or reduced OTsK, for example, at those which receive high doses of diuretics in rare instances after an initiation of treatment valsartany can have clinically expressed arterial hypotension. Before an initiation of treatment it is necessary to carry out correction of contents in an organism of sodium and/or OTsK, for example, by reduction of a dose of diuretic.

Double blockade renin-angiotensin-aljdosteronovoy. Hypotonia, a faint, a stroke, a hyperpotassemia, renal failures (including an acute renal failure) were noted at persons with hypersensitivity, especially - at a combination of the medicines influencing RAAS. In this regard double blockade of RAAS at co-administration of an aliskiren with APF or SCONCE II inhibitors is not recommended (including with valsartany).

Patients with a diabetic nephropathy should not appoint IAPF with the SCONCE of II. In some cases, when joint by use of IAPF and SCONCE of II it is absolutely shown, careful observation of the specialist and obligatory monitoring of function of kidneys, water and electrolytic balance, arterial pressure is necessary. It belongs to purpose of a valsartan as additional therapy to APF inhibitors at patients with chronic heart failure. Carrying out double blockade of RAAS under careful observation of the specialist and obligatory monitoring of function of kidneys, water and electrolytic balance and arterial pressure, is possible at patients with chronic heart failure at intolerance of antagonists of Aldosteronum (Spironolactonum) at whom the persistirovaniye of symptoms of chronic heart failure, despite performing other adequate therapy is observed.

Contraindicated simultaneous use of drug of Valsartan-Nan with aliskireny at patients with a diabetes mellitus or a moderate / heavy renal failure (SKF <60 ml/min. / 1,73м2).

Influence on ability to drive the car and potentially dangerous mechanisms. Researches on impact assessment of drug of Valsartan-Nan on ability to drive the car and to work with mechanisms were not conducted. At control of vehicles or work with mechanisms it is necessary to consider possibility of dizziness or weakness.

During treatment patients need to be careful at control of motor transport and occupation other potentially dangerous types of activity demanding concentration of attention and speed of psychomotor reactions.

Precautionary measures. You need to tell surely your doctor if you suspect that you became pregnant (or could become pregnant). Reception of this medicine is not recommended on early durations of gestation and is contraindicated (should not be accepted) to women with duration of gestation more than 3 months as it can cause serious violations in the child if is accepted in this period (you watch the section of a leaf insert on pregnancy).

Renal artery stenosis. There are no data on safety of use of a valsartan for patients with a bilateral or unilateral renal artery stenosis.

Short-term use of a valsartan for 12 patients with the renovascular hypertensia which is secondary owing to a unilateral renal artery stenosis did not cause any essential changes of hemodynamic parameters of kidneys, changes of concentration of creatinine in blood serum or increase in concentration of an urea nitrogen in blood. However other drugs influencing RAAS can increase concentration of urea in blood and concentration of creatinine in blood serum at patients with a unilateral renal artery stenosis. Proceeding from it, at purpose of a valsartan patients of this group need careful monitoring of function of kidneys. Transplantation of kidneys

Now there are no data on safety of use of a valsartan for the patients who recently underwent an operation on renal transplantation.

Primary giperaljdosteronizm. Purpose of a valsartan as their renin-angiotenzinovaya the system is not active is not recommended to patients with primary hyper aldosteronism.

Stenosis of aortal or mitral valves, subaortic hypertrophic stenosis. As well as for other vazodilatator, at purpose of a valsartan to patients with a stenosis of the aortal or mitral valve or a hypertrophic subaortic stenosis, it is necessary to observe extra care.

/ chronic heart failure the Combination of captopril and a valsartan did not lead an acute myocardial infarction to emergence of additional clinical benefits, however led to increase in risk of development of side reactions in comparison with administration of drugs separately. In this regard the combination of APF inhibitor and a valsartan is not recommended.

It is necessary to be careful at purpose of a valsartan to patients in the early postinfarction period and to the patients with chronic heart failure beginning therapy.

As a result of oppression of RAAS renal failures can be observed. At those persons at whom function of kidneys can depend on activity of RAAS (including at patients with heavy heart failure) at treatment APF inhibitors noted cases of an oliguria and/or the progressing azotemia, an acute renal failure (seldom) and/or a lethal outcome. As валсартан the SCONCE of II is, it is impossible to exclude a possibility of development of renal failures in patients.

Assessment of a condition of patients with heart failure or in a postinfarction state always has to include regular control of function of kidneys.

Purpose of a valsartan to patients during the period after a myocardial infarction and to patients with chronic heart failure leads to an insignificant lowering of arterial pressure, however the termination of therapy in view of symptomatic hypotension, as a rule, is not required if to observe instructions on a drug dosage (see the section "Route of Administration and Doses").

At patients with chronic heart failure triple therapy by APF inhibitor, beta adrenoblocker and valsartany as in the absence of additional clinical benefits this combination increases risk of development of side reactions is not recommended.

Quincke's disease. It was reported about cases of development of a Quincke's disease, including hypostasis of a throat and glottis that leads to obstruction of respiratory tracts, and/or a face edema, lips, drinks and/or language at the patients accepting валсартан. Some of these patients had in the anamnesis a case of development of a Quincke's disease after reception of other drugs, including APF inhibitors. In case of development of a Quincke's disease in patients administration of drug of Valsartan-Nan should be cancelled, repeated appointment of drug is not allowed.

Special information on excipients. Drug contains lactose therefore patients are not recommended to appoint drug with deficit of lactase, a galactosemia or a syndrome of the broken glucose absorption - galactoses.

In the presence at you one of the listed above diseases or states before administration of drug surely consult with the doctor.

Side effects:

Frequency of emergence of side effects: very often (> 1/10); often (> 1/100, but <1/10); infrequently (> 1/1000, but <1/100); seldom (> 1/10000, but <1/1000), it is very rare (<1/10000). At use of a valsartan the following side effects are possible:

Disturbances from blood and lymphatic system: frequency is unknown - decrease in level of hemoglobin, decrease in a hematocrit, a neutropenia, thrombocytopenia.

Disturbances from immune system: frequency is unknown - hypersensitivity, including a serum disease.

Disturbances from a metabolism: frequency is unknown - the increased potassium concentration in blood serum, a hyponatremia; infrequently - a hyperpotassemia.

Disturbances from a nervous system: often - Dizziness, including postural, вертиго; infrequently - a faint, a headache.

Disturbances from an acoustic organ and labyrinth disturbances: infrequently - вертиго.

Disturbances from cardiovascular system: infrequently - heart failure, it is frequent - hypotension and orthostatic hypotension; frequency is unknown - a vasculitis.

Disturbances from respiratory system, bodies of a thorax and a mediastinum: infrequently - cough.

 

Disturbances from digestive tract: infrequently - an abdominal pain, diarrhea, nausea.

Disturbances from a liver and biliary tract: frequency is unknown - increase in the indicators characterizing function of a liver, including increase in concentration of bilirubin in blood serum.

Disturbances from skin and hypodermic fabrics: frequency is unknown - a Quincke's disease, skin rash, a skin itch; infrequently - a Quincke's disease.

Disturbances from skeletal and muscular and connecting fabric: frequency is unknown - a mialgiya.

Disturbances from kidneys and urinary tract: frequency is unknown - a renal failure, a renal failure, increase in concentration of creatinine in blood serum, increase in concentration of an urea nitrogen in blood; often - a renal failure, a renal failure; infrequently - an acute renal failure, increase in concentration of creatinine in blood serum.

General disturbances: infrequently - an adynamy, increased fatigue.

The following side effects were observed during clinical trials irrespective of their causal relationship with the studied drug: arthralgia, abdominal pain, adynamy, dorsodynia, diarrhea, dizziness, headache, sleeplessness, decrease libido, neutropenia, nausea, hypostases, pharyngitis, rhinitis, sinusitis, upper respiratory tract infections, viral infections.

Note: it was reported at: arterial hypertension; heart failure and/or postinfarction state.

If any of the side effects specified in the instruction are aggravated, or you noticed any other side effects which are not specified in the instruction, report about it to the doctor.

Interaction with other medicines:

Lithium: it was reported about reversible increase in concentration of lithium in blood serum and emergence of toxic effects at co-administration of drugs of lithium with APF inhibitors. In view of lack of experience of purpose of drugs of lithium with valsartany, co-administration is not recommended. If the concomitant use of these drugs is necessary, careful monitoring of concentration of lithium in blood serum is recommended.

Kaliysberegayushchy diuretics, potassium drugs, the salt substitutes containing potassium, and other drugs capable to increase potassium level: combined use with kaliysberegayushchy diuretics (for example, Spironolactonum, Triamterenum, amiloride), the drugs of potassium or substitutes of salt containing potassium can lead to increase in potassium concentration in blood serum, co-administration is not recommended. It is necessary to control potassium concentration in blood serum in case of need of joint administration of the specified drugs.

Non-steroidal anti-inflammatory drugs (NPVS), including the selection inhibitors of cyclooxygenase-2 (TsOG-2), acetylsalicylic acid (more than 3 g/days) and other non-selective NPVS: at co-administration weakening of anti-hypertensive action, and also increase in risk of deterioration in function of kidneys and increase in potassium concentration in blood serum is possible. In case of need uses of a similar combination should be provided adequate hydration of patients and monitoring of function of kidneys from an initiation of treatment.

Conveyors: these in vitro show what валсартан is substrate of OATP1B1/OATR1VZ and MRP2 conveyors. Clinical value of these data is not established. Joint appointment with inhibitors of the OATP1B1/OATR1VZ conveyor (Rifampinum, cyclosporine) or the efflyuksny MRP2 conveyor (ритонавир) can strengthen action of a valsartan. Special precautionary measures have to be undertaken at the beginning or at the end of joint therapy by the specified medicines.

Double blockade system renin-angiotensin-aldosteronovoy (SRAA) of the SCONCE II, APF inhibitors or aliskireny: simultaneous use of the SCONCE of II (including валсартан) with other medicines blocking RAAS - i.e. with APF inhibitors or with aliskireny, is associated with the increased risk of development of hypotonia, a hyperpotassemia and a renal failure (including development of an acute renal failure) in comparison with monotherapy. Regular control of the ABP, function of kidneys and content of electrolytes in blood at the patients accepting at the same time Valsartan-Nan and other means influencing RAAS is necessary. Contraindicated simultaneous use of the SCONCE And, including Valsartan-Nan, or APF inhibitors with aliskireny at patients with a diabetes mellitus or a moderate / heavy renal failure (a glomerular filtration rate <60 ml/min. / 1,73м2).

Others: clinically significant interactions with such medicines as Cimetidinum, warfarin, furosemide, digoxin, атенолол, indometacin, a hydrochlorothiazide, амлодипин and Glibenclamidum are not revealed.

Your attending physician has to be informed on all medicine which you take. Before reception of any medicine during treatment by Valsartan-Nan's drug consult with the attending physician.

Contraindications:

- hypersensitivity to a valsartan or to any other component of drug;

- heavy abnormal liver functions, biliary cirrhosis, cholestasia;

- pregnancy, feeding by a breast;

- children's and teenage age up to 18 years (safety and efficiency of use for children aged up to 18 years are not established);

- simultaneous use of the SCONCE of II, including Valsartan-Nan, or APF inhibitors with aliskireny at patients with a diabetes mellitus or a moderate / heavy renal failure (SKF <60 ml/min. / 1,73м2);

- a heavy renal failure (SKF <30 ml/min. / 1,73 sq.m) and the patients who are on dialysis.

Overdose:

At reception bigger, than it is registered by the doctor, doses of medicine it is necessary to address immediately specialists for rendering timely medical care!

Symptoms: the overdose of a valsartan can be followed by the expressed arterial hypotension which can lead to consciousness oppression, a collapse and/or shock. Treatment: set of therapeutic measures depends on time of reception of an excess dose of drug and weight of observed symptoms, the major measure is stabilization of work of cardiovascular system. If drug was accepted recently, then it is necessary to cause vomiting. At development of arterial hypotension it is necessary to give to the patient lying situation and to take measures for adjustment of volume of the circulating blood. Removal of a valsartan by means of a hemodialysis is improbable.

Storage conditions:

In the place protected from light and moisture, at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years.

Issue conditions:

According to the recipe

Packaging:

Tablets, coated, 80 mg. On 10 or 15 tablets in a blister strip packaging. 3 blister strip packagings on 10 tablets or 2 blister strip packagings on 15 tablets with the instruction on a medical use place in a cardboard pack.

Tablets, coated, 160 mg. On 10, 14 or 15 tablets in a blister strip packaging. 3 blister strip packagings on 10 tablets or 2 blister strip packagings on 14 or 15 tablets with the instruction on a medical use place in a cardboard pack.