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medicalmeds.eu Medicines Angionezina II of receptors antagonist. Atakand of 16 mg

Atakand of 16 mg

Препарат Атаканд 16 мг. AstraZeneca (АстраЗенека) Швеция


Producer: AstraZeneca (Astrazenek) Sweden

Code of automatic telephone exchange: C09CA06

Release form: Firm dosage forms. Tablets.

Indications to use: Chronic heart failure. Arterial hypertension.


General characteristics. Structure:

Active agent
One tablet contains active agent of a kandesartan of a tsileksetil 8 mg or 16 mg.
Excipients
Karmelloza of calcium (a karmelloza calcic salt) 5,6 mg, a hypro rod (hydroxypropyl cellulose) 4,0 mg, dye ferrous oxide red E 172 0,065 mg (for a dosage of 8 mg), 0,26 mg (for a dosage of 16 mg); lactoses monohydrate of 89,4 mg (for a dosage of 8 mg), 81,4 mg (for a dosage of 16 mg), magnesium stearate of 0,4 mg, corn starch of 20,0 mg, a macrogoal of 2,6 mg.
Description
Атаканд® 8 mg: light pink round biconvex tablets, with risky and an engraving of A on one party and 008 on other party.
CG
Атаканд® 16 mg: pink round biconvex tablets, with risky and an engraving of A on one party and 016 on other party.
CH




Pharmacological properties:

Pharmacodynamics. Angiotensin II – the main hormone system renin-angiotensin-aldosteronovoy which plays an important role in a pathogeny of arterial hypertension, heart failure and other cardiovascular diseases. The main physiological effects of angiotensin II are vasoconstriction, stimulation of products of Aldosteronum, regulation of a water and electrolytic homeostasis and stimulation of cellular growth. All these effects are mediated by interaction of angiotensin II with angiotenzinovy receptors of 1 type (AT1 receptors).
Kandesartan is the selection antagonist of receptors of angiotensin II of 1 type (AT1 of receptors). Kandesartan does not inhibit the angiotensin-converting enzyme (ACE) which carries out transformation of angiotensin I into angiotensin II and bradikinin destroys; does not influence APF and does not lead to accumulation of bradikinin or substance P. When comparing a kandesartan with APF inhibitors development of cough occurred at the patients receiving кандесартан tsileksetit less often. Kandesartan does not contact receptors of other hormones and does not block the ion channels participating in
regulation of functions of cardiovascular system. Blocking of AT1 of receptors of angiotensin II is resulted by dozozavisimy increase in level of a renin, angiotensin I, angiotensin II and decrease
concentration of Aldosteronum in a blood plasma.
Arterial hypertension
At arterial hypertension кандесартан causes a dozozavisimy long lowering of arterial pressure (ABP). The anti-hypertensive effect of drug is caused by decrease in the general peripheric resistance of vessels, without change of the heart rate (HR). Cases of the expressed arterial hypotension after reception of the first dose of drug, and also a withdrawal (a syndrome of "ricochet") after the therapy termination were not noted.
The beginning of hypotensive action after reception of the first dose of a kandesartan of a tsileksetil usually develops within 2 hours. Against the background of the continuing therapy by drug in the fixed dose the maximum decrease in the ABP usually is reached within 4 weeks and remains throughout treatment. Kandesartan tsileksetit, appointed once a day, provides effective and smooth decrease in the ABP within 24 hours with insignificant fluctuations of the ABP in intervals between receptions of the next dose of drug. Use of a kandesartan of a tsileksetil together with Hydrochlorthiazidum leads to strengthening of hypotensive effect. Combined use of a kandesartan of a tsileksetil and Hydrochlorthiazidum (or an amlodipina) is well transferred. Efficiency of drug does not depend on age and a sex of patients. Kandesartan tsileksetit increases a renal blood stream and does not change or raises a glomerular filtration rate whereas the renal vascular resistance and filtrational fraction decrease. Reception of a kandesartan of a tsileksetil in a dose of 8-16 mg within 12 weeks does not exert a negative impact on the level of glucose and a lipidic profile at patients with arterial hypertension and a diabetes mellitus 2 types.
Tsileksetit clinical action of a kandesartan on incidence and at reception in a dose of 8-16 mg (an average dose of 12 mg) it was investigated mortality during randomized clinical trial with participation of 4937 elderly patients (age from 70 to 89 years, 21% of patients at the age of 80 years and is more senior) with arterial hypertension of soft and moderate severity receiving therapy kandesartany tsileksetily on average within 3,7 years once a day (the research SCOPE  a research of cognitive functions and the forecast at elderly patients). Patients received кандесартан or placebo, if necessary, in a combination with other anti-hypertensive means. In group of the patients receiving кандесартан the lowering of arterial pressure from 166/90 to 145/80 mm рт.ст and in control group from 167/90 to 149/82 mm hg is noted. Statistically significant distinctions of frequency of cordial vascular complications (a lethality as a result of the cardiovascular diseases, the frequency of a myocardial infarction and stroke which did not bring to deadly and to the course) between two groups of patients were not noted.
In group of the patients receiving кандесартан 26,7 cases were noted
emergence of cardiovascular complications on 1000 patients years in comparison with 30,0 cases on 1000 patients years in control group (a ratio of risks = 0,89, 95% a confidence interval 0,75 - 1,06, p=0,19).
Chronic heart failure
According to results of the research CHARM (Kandesartan at chronic heart failure – Assessment of Decrease in Death rate and Incidence) use of a kandesartan of a tsileksetil led to decrease in frequency of lethal outcomes and need for hospitalization concerning chronic heart failure and to improvement of systolic function of a left ventricle.
Patients with chronic heart failure in addition to the main therapy received кандесартан tsileksetit in a dose 4 - 8 mg a day with increase in a dose to 32 mg a day or to the maximum tolerable therapeutic dose (the average dose of a kandesartan made 24 mg). The median of duration of observation made 37,7 months. In 6 months of therapy of 63% of the patients continuing to accept кандесартан tsileksetit (89%), received a therapeutic dose of 32 mg.
Patients with the reduced fraction of emission of a left ventricle (FELV) <40% which were not receiving APF inhibitor because of intolerance participated in other research CHARM-Alternative a research (n=2028) (generally because of cough of  of 72%); indicators of frequency of lethal outcomes from cardiovascular diseases and the first hospitalization concerning chronic heart failure were much lower in group of the patients receiving кандесартан in comparison with group of placebo (a ratio of risks = 0,77, 95% a confidence interval 0,67 - 0,89, p <0,001). Decrease in relative risk made 23%. Statistically in this research for prevention of one case of a lethal outcome from cardiovascular complications or hospitalization concerning chronic heart failure it was necessary to carry out treatment of 14 patients throughout the entire period of a research. The combined criterion including the frequency of lethal outcomes regardless of their reasons and an indicator of the first hospitalization concerning chronic heart failure, was also much lower in group of the patients receiving кандесартан (a ratio of risks = 0,80, 95% a confidence interval 0,70 - 0,92, p = 0,001). At the same time positive influence of a kandesartan on each of components of this combined criterion – the frequency of lethal outcomes and incidence was noted (an indicator of frequency of hospitalization concerning chronic heart failure). Use of a kandesartan of a tsileksetil led to improvement of a functional class of chronic heart failure on NYHA classification (p = 0,008).
In the research CHARM-Added (n = 2548) at patients from reduced FVLZh <40% receiving APF inhibitors, the combined criterion including a lethality indicator from cardiovascular diseases and the first hospitalization concerning chronic heart failure was much lower in group of the patients receiving кандесартан in comparison with group of placebo (a ratio of risks = 0,85, 95% a confidence interval 0,75 - 0,96, p = 0,011) that corresponded to decrease in relative risk by 15%. In this research for prevention of one case of a lethal outcome from cardiovascular complications or hospitalization concerning chronic heart failure it was necessary to carry out treatment of 23 patients throughout the entire period of a research. Value of the combined criterion of efficiency including assessment of frequency of lethal outcomes regardless of their reasons or frequency of the first hospitalization concerning chronic heart failure was much lower in group of the patients receiving кандесартан (a ratio of risks = 0,87, 95% a confidence interval 0,78 - 0,98, p = 0,021) that also demonstrated positive effect at use of a kandesartan. Use of a kandesartan of a tsileksetil led to improvement of a functional class of chronic heart failure on NYHA classification (p = 0,020).
In the research CHARM-Preserve (n=3023) at patients with the kept systolic function (FVLZh> of 40%) statistically reliable distinctions of value of the combined criterion of efficiency which included the frequency of lethal outcomes and frequency of the first hospitalization concerning chronic heart failure, in groups of a kandesartan and placebo were not revealed (a ratio of risks = 0,89, 95% a confidence interval 0,77 - 1,03, p = 0,118). Small numerical decrease in this criterion was caused by decrease in frequency of hospitalization concerning chronic heart failure. In this research influence of a kandesartan on the frequency of lethal outcomes was not shown.
In the separate analysis of results of 3 researches of the CHARM program reliable distinctions of frequency of lethal outcomes in groups of a kandesartan and placebo were not received. However the frequency of lethal outcomes was estimated in the integrated population of the researches CHARM-Alternative and CHARM-Added and in all 3 researches (a ratio of risks = 0,91, 95% a confidence interval 0,83 - 1,00, p = 0,055). Decrease in frequency of lethal outcomes and frequencies of hospitalization concerning chronic heart failure against the background of therapy of a kandesartan did not depend on age, sex and the accompanying therapy. Kandesartan was also effective at the patients accepting beta adrenoblockers in combination with APF inhibitors, at the same time efficiency of a kandesartan did not depend on whether the patient accepts an optimum dose of APF inhibitor or not.
At patients with chronic heart failure and reduced systolic function of a left ventricle (FVLZh <40%), reception of a kandesartan promoted decrease in the general peripheric vascular resistance and capillary pressure in lungs, to increase in activity of a renin and concentration of angiotensin II in a blood plasma, and also to decrease in level of Aldosteronum.

Pharmacokinetics. Absorption and distribution
Kandesartan tsileksetit is pro-medicine for intake. Quickly turns into active agent – кандесартан by means of radio hydrolysis at absorption from a digestive tract, strongly contacts AT1-receptors and slowly dissociates, has no properties of an agonist. Absolute bioavailability of a kandesartan after intake of solution of a kandesartan of a tsileksetil makes about 40%. Relative bioavailability of the tableted drug in comparison with solution for intake makes about 34%. Thus, settlement absolute bioavailability of the tableted form of drug makes 14%. The maximum concentration in blood serum (Cmax) is reached in 3 - 4 hours after reception of the tableted drug form. At increase in a dose of drug within recommended concentration of a kandesartan increases linearly. Pharmacokinetic parameters of a kandesartan do not depend on a sex of the patient. Meal concentration - time" does not exert significant impact on the area under a curve "(AUC), i.e. the concomitant use of food significantly does not influence bioavailability of drug. Kandesartan actively contacts proteins of a blood plasma (> 99%). The volume of distribution of a kandesartan makes 0,1 l/kg.
Metabolism and removal from an organism
Kandesartan, is generally brought from an organism by kidneys and bile in not changed look and only in insignificant degree is metabolized in a liver. The elimination half-life of a kandesartan makes about 9 hours. Cumulation in an organism is not observed.
The general clearance of a kandesartan makes about 0,37 ml/min., at the same time renal clearance – about 0,19 ml/min. Renal excretion of a kandesartan is carried out by glomerular filtering and active canalicular secretion. At intake radioactive меченного a kandesartan of a tsileksetil about 26% of the entered quantity are removed by kidneys in the form of a kandesartan and 7% in the form of an inactive metabolite whereas in Calais 56% of the entered quantity in the form of a kandesartan and 10% in the form of an inactive metabolite are found.
At elderly patients (65 years are more senior) Cmax and AUC of a kandesartan increase by 50% and 80%, respectively, in comparison with young patients. However, the hypotensive effect and frequency of emergence of side effects at use of the drug Atakand® do not depend on age of patients.
At patients with an easy and moderate renal failure of Cmax and AUC of a kandesartan increased by 50% and 70% respectively whereas the elimination half-life of drug does not change in comparison with patients with normal function of kidneys. At patients with a heavy renal failure of Cmax and AUC of a kandesartan increased by 50% and 110% respectively, and the elimination half-life of drug increased twice. At the patients who are on a hemodialysis the same pharmacokinetic parameters of a kandesartan, as at patients with a heavy renal failure were revealed.
At patients with an easy and moderate abnormal liver function increase in AUC of a kandesartan for 23% was noted.


Indications to use:

Arterial hypertension
Chronic heart failure and disturbance of systolic function of a left ventricle (decrease in FVLZh ≤ 40%) as additional therapy to inhibitors of the angiotensin-converting enzyme (ACE) or at intolerance of APF inhibitors (see the section "Pharmacodynamics").


Route of administration and doses:

Атаканд® it is necessary to accept regardless of meal once a day.
Arterial hypertension
The recommended initial and maintenance dose of the drug Atakand® makes 8 mg once a day. Patients who need further decrease in the ABP are recommended to increase a dose to 16 mg once a day. The maximum anti-hypertensive effect is reached within 4 weeks from an initiation of treatment.
If therapy by the drug Atakand® does not lead to decrease in the ABP to optimum level, it is recommended to add thiazide diuretic to therapy.
Patients of advanced age
Patients of advanced age have no need to adjust an initial dose of drug.
Patients with a renal failure
From patients with an easy or moderate renal failure (clearance of  creatinine of 30 ml/min. / 1,73 the body surface area sq.m) does not need change of an initial dose of drug.
Clinical experience of use of drug for patients with a heavy renal failure (clearance of creatinine <30 ml/min. / 1,73 body surface area sq.m) is limited; in this case it is necessary to consider the possibility of an initiation of treatment from a daily dose of 4 mg.
Patients with an abnormal liver function
At patients with an abnormal liver function easy and moderate severity it is recommended to begin treatment with a daily dose of 2 mg once a day. Increase in a dose if necessary is possible. Clinical experience of use for patients with severe damages of a liver is limited.
The accompanying therapy
Use of the drug Atakand® together with diuretics of thiazide type (for example, a hydrochlorothiazide) can strengthen hypotensive effect of the drug Atakand®.
Chronic heart failure
The recommended initial dose of the drug Atakand® makes 4 mg once a day. Increase in a dose to 32 mg or to the most tolerable dose is carried out once a day by its bucketed doubling not less than 2 weeks (see the section "Special Instructions").
Special groups of patients
Patients of advanced age and patients with a renal failure or a liver do not need change of an initial dose of drug.
Use for children and teenagers
Safety and efficiency of use of the drug Atakand® for children and teenagers (aged up to 18 years) are not established.
The accompanying therapy
Атаканд® it is possible to appoint together with other means applied at therapy of chronic heart failure, for example, by APF inhibitors, beta adrenoblockers, diuretics and cardiac glycosides (see the section "Special Instructions", "Pharmacodynamics").


Features of use:

Renal failure
Against the background of therapy by the drug Atakand®, as well as at use of other means oppressing renin-angiotensin-aldosteronovuyu system for some patients renal failures can be noted.
At use of the drug Atakand® for patients with arterial hypertension and the expressed renal failure it is recommended to control periodically potassium concentration and creatinine in blood serum. Clinical experience of use of drug for patients with a heavy renal failure or an end-stage of a renal failure is limited (clearance of creatinine less than 15 ml/min.).
At patients with chronic heart failure it is necessary to control periodically function of kidneys, especially at patients at the age of 75 years and is more senior, and also at patients with a renal failure. At increase in a dose of the drug Atakand® it is also recommended to control potassium concentration and creatinine.
Clinical trials of the drug Atakand® at chronic heart failure did not join patients with concentration of creatinine> 265 µmol/l (> 3 mg/dl).
Combined use with APF inhibitors at chronic heart failure
At use of a kandesartan in a combination with APF inhibitors the risk of development of side effects, especially renal failures and hyperpotassemias can increase (see the section "Side effect"). In these cases careful observation and control of laboratory indicators is necessary.
Renal artery stenosis
With a bilateral renal artery stenosis or a stenosis of an artery of the only kidney the drugs exerting impact on renin-angiotensin-aldosteronovuyu system, in particular APF inhibitors can cause increase in concentration of urea and creatinine in blood serum in patients. Similar effects can be expected at use of antagonists of receptors of angiotensin II.
Renal transplantation
Clinical experience of use of the drug Atakand® for the patients who transferred renal transplantation is limited.
Arterial hypotension
At patients with chronic heart failure against the background of therapy by the drug Atakand® arterial hypotension can develop. As well as at use of other drugs influencing renin-angiotensin-aldosteronovuyu system, reduction of volume of the circulating blood as it is observed at the patients receiving high doses of diuretics can be the cause of development of arterial hypotension in patients with arterial hypertension. Therefore at the beginning of therapy it is necessary to be careful and, if necessary, to carry out correction of a hypovolemia.
General anesthesia and surgery
At the patients receiving antagonists of angiotensin II during the general anesthesia and at surgical interventions arterial hypotension as a result of blockade a system renin-angiotenzinovoy can develop. Very seldom cases of the heavy arterial hypotension demanding intravenous administration of liquid and/or vazopressor can be noted.
Stenosis of the aortal and mitral valve or subaortic hypertrophic stenosis
At purpose of the drug Atakand®, as well as other vazodilatator, patients should be careful with a subaortic hypertrophic stenosis or hemodynamically significant stenosis of the aortal or mitral valve.
Primary hyper aldosteronism
Patients with primary hyper aldosteronism usually rezistentna to therapy by the anti-hypertensive drugs influencing renin-angiotensin-aldosteronovuyu system. In this regard Atakand® such patients are not recommended to appoint.
Hyperpotassemia
Clinical experience of use of other drugs influencing system renin-angiotensin-Aldosteronum shows that co-administration of the drug Atakand® with the kaliysberegayushchy diuretics, drugs of potassium or substitutes of salt containing potassium or other drugs which can increase the content of potassium in blood (for example, heparin) can lead to development of a hyperpotassemia in patients with arterial hypertension.
At patients with chronic heart failure against the background of therapy by the drug Atakand® the hyperpotassemia can develop. At purpose of the drug Atakand® regular control of content of potassium in blood is recommended to patients with chronic heart failure, especially at joint appointment with APF inhibitors and kaliysberegayushchy diuretics.
The general
Patients who have a vascular tone and function of kidneys preferential depend on activity system renin-angiotensin-aldosteronovoy (for example, patients with heavy chronic heart failure or diseases of kidneys, including a renal artery stenosis), are especially sensitive to the drugs operating on renin-angiotensin-aldosteronovuyu system. Purpose of similar means is followed at these patients by sharp arterial hypotension, an azotemia, an oliguria less often – an acute renal failure. The possibility of development of the listed effects cannot be excluded also when using antagonists of receptors of angiotensin II. Sharp decrease in the ABP at patients with coronary heart disease or cerebrovascular diseases of atherosclerotic genesis when using any anti-hypertensive means can lead to development of a myocardial infarction or stroke.
Influence on ability to drive the car or to work with the equipment
Influence on ability to drive the car or to work with the equipment was not studied, but pharmakodinamichesky properties of drug indicate that similar influence is absent.
When driving motor transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions it is necessary to consider that at use of drug dizziness and increased fatigue can be observed.


Side effects:

Arterial hypertension
Side effects during clinical trials had moderate and passing character and were comparable on frequency to group of placebo. The general frequency of emergence of side effects against the background of administration of drug of Atakand® did not depend on a dose of drug, gender and age of the patient. Frequency of cases of the termination of therapy in connection with side effects was similar when using a kandesartan of a tsileksetil (3,1%) and placebo (3,2%).
During the analysis of these conducted researches it was reported about the following side effects, it is frequent (1/100) meeting against the background of reception of a kandesartan of a tsileksetil. The described side effects were observed with a frequency at least 1% more, than in group of placebo.
From the central nervous system: dizziness/weakness, headache;
From a musculoskeletal system, connecting fabric: dorsodynia;
Infections: respiratory infections;
Laboratory indicators: in general at use of the drug Atakand® clinically significant changes of standard laboratory indicators were not noted. As well as at use of other inhibitors system renin-angiotensin-aldosteronovoy, small decrease in concentration of hemoglobin can be observed. Increase in concentration of creatinine, urea or potassium and reduction of concentration of sodium was observed. Increase in activity of alaninaminotranspherase (ALT) was noted slightly more often at use of the drug Atakand® in comparison with placebo (1,3% instead of 0,5%). At drug Atakand® use regular control of laboratory indicators usually is not required. However at patients with a renal failure it is recommended to control periodically potassium concentration and creatinine in blood serum.
Chronic heart failure
The side effects revealed against the background of use of the drug Atakand® for patients with chronic heart failure corresponded to pharmacological properties of drug and depended on a condition of the patient. During clinical trials of CHARM comparison of the drug Atakand® in doses to 32 mg (n=3803) from placebo (n=3796) was carried out, tsileksetit 21% of patients from group of a kandesartan, and 16,1% of patients from group of placebo, stopped treatment because of emergence of side reactions.
The most often found side effects (> 1/100, <1/10):
From cardiovascular system: the expressed decrease in the ABP;
From an urinary system: renal failure;
Laboratory changes: increase in concentration of creatinine, urea and potassium.
It is recommended to control concentration of creatinine and potassium in blood serum.
On the following side effects during post-marketing use of drug it was reported very seldom (1/10000): From circulatory and lymphatic system: leukopenia, neutropenia and agranulocytosis;
The disturbance of metabolism and disease caused by metabolism disturbance: hyperpotassemia, hyponatremia;
From a nervous system: dizziness, weakness, headache;
From respiratory system, bodies of a thorax and a mediastinum: cough;
From digestive tract: nausea;
From a liver and biliary tract: increase in activity of "hepatic" enzymes, abnormal liver function or hepatitis;
Allergic reactions: Quincke's disease, skin rash, small tortoiseshell, skin itch;
From a musculoskeletal system, connecting fabric: dorsodynia, arthralgia, mialgiya;
From an urinary system: a renal failure, including a renal failure at predisposed patients.


Interaction with other medicines:

In pharmacokinetic researches the combined use of the drug Atakand® with a hydrochlorothiazide, warfarin, digoxin, oral contraceptives (ethinylestradiol/levonorgestrel), glibenclamide, nifedipine and enalapril was studied. Clinically significant pharmacokinetic interaction was not revealed.
Kandesartan is metabolized in a liver in insignificant degree (CYP2C9). The conducted researches on interaction did not reveal influence of drug on CYP2C9 and CYP3A4, action on other isoenzymes of system of P450 cytochrome is not studied.
Combined use of the drug Atakand® with other anti-hypertensive means exponentiates hypotensive effect.
Experience of use of other medicines operating on renin-angiotensin-aldosteronovuyu system shows that the accompanying therapy by kaliysberegayushchy diuretics, potassium drugs, substitutes of salt, containing potassium, and other means which can increase potassium concentration in blood serum (for example, heparin) can lead to development of a hyperpotassemia.
At the combined purpose of drugs of lithium with APF inhibitors it was reported about reversible increase in concentration of lithium in blood serum and development of toxic reactions. Similar reactions can meet also at use of antagonists of receptors of angiotensin II in this connection it is recommended to control concentration of lithium in blood serum at the combined use of these drugs.
At combined use of antagonists of receptors of angiotensin II and non-steroidal anti-inflammatory drugs (NPVP), including the selection inhibitors of cyclooxygenase-2, acetylsalicylic acid decrease in hypotensive effect can be noted.
As well as at use of APF inhibitors, combined use of antagonists of receptors of angiotensin II and NPVP can increase risk of a renal failure, including an acute renal failure, increase in potassium concentration in blood serum, especially at patients with reduced function of kidneys. It is necessary to be careful at combined use of these drugs, especially at elderly patients and at patients with the reduced volume of the circulating blood. Patients need to offset loss of liquid and to carefully control function of kidneys after the beginning of a combination therapy and periodically against the background of such therapy.
Bioavailability of a kandesartan does not depend on meal.


Contraindications:

Hypersensitivity to a kandesartan to the tsileksetil or other components which are a part of drug.
Pregnancy and the period of a lactation (see the section "Pregnancy and Period of a Lactation").
The expressed abnormal liver functions and/or cholestasia.
With care: at patients with the expressed renal failure (clearance of creatinine less than 30 ml/min.), a bilateral stenosis of renal arteries or a stenosis of an artery of the only kidney, with hemodynamically significant stenosis of the aortal and mitral valve, after renal transplantation in the anamnesis, at patients with cerebrovascular diseases and the coronary heart disease (CHD), a hyperpotassemia, at patients with a reduced volume of the circulating blood, with primary hyper aldosteronism (there is no enough data on clinical trials), a hypertrophic cardiomyopathy, age up to 18 years (efficiency and safety are not established).
Pregnancy and period of a lactation
Pregnancy
Use of the drug Atakand® during pregnancy is contraindicated (see the section "Contraindications"). The patients accepting the drug Atakand® have to be warned about it before pregnancy planning that they could discuss alternative options of therapy with the attending physician.
In case of pregnancy approach therapy by the drug Atakand® has to be immediately stopped and, if necessary, alternative treatment is appointed.
The drugs having direct effect on renin-angiotensin-aldosteronovuyu system can cause disturbances of fetation or have negative effect on the newborn, up to a lethal outcome, at use of drug during pregnancy. It is known that therapy by antagonists of receptors of angiotensin II can cause disturbances of fetation (a renal failure, олигогидрамнион, delay of ossification of bones of a skull) and development of complications in the newborn (a renal failure, arterial hypotension, a hyperpotassemia).
Lactation period
Now it is not known whether gets кандесартан into breast milk. Due to the possible undesirable action on babies, Atakand® it is not necessary to apply during chest feeding.


Overdose:

Symptoms
The analysis of pharmacological properties of drug allows to assume that clinically expressed decrease in the ABP and dizziness can be the main manifestation of overdose. The separate cases of overdose of drug (to 672 mg of a kandesartan of a tsileksetil) which ended with recovery of patients without serious consequences were described.
Treatment
At development of clinically expressed arterial hypotension it is necessary to carry out a symptomatic treatment and to control a condition of the patient. To lay the patient, to raise the foot end of a bed. If necessary it is necessary to increase the volume of the circulating plasma, for example, by intravenous administration of isotonic solution of sodium chloride. Sympathomimetic drugs can be in case of need appointed. Removal of a kandesartan by means of a hemodialysis is improbable.


Storage conditions:

To store at a temperature below 30 °C, in the place, unavailable to children. Period of validity 3 years. Not to apply after a period of validity.


Issue conditions:

According to the recipe


Packaging:

Tablets on 8 and 16 mg.
On 14 tablets in the blister from PVC/aluminium, on 2 blisters in a cardboard pack with the application instruction.



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