Angiakand tablets 16mg, No. 28

? arterial hypertension;

? chronic heart failure and impaired systolic function of the left ventricle (decreased left ventricular ejection fraction less than 40%) as an adjunct therapy to angiotensin-converting enzyme (ACE) inhibitors or in case of intolerance to ACE inhibitors.

Inside, regardless of food intake, 1 time per day.
Arterial hypertension The
recommended initial and maintenance dose is 8 mg once a day. Patients who require a further decrease in blood pressure are advised to increase the dose to 16 mg once a day. The maximum daily dose of the drug is 32 mg once a day.
The maximum antihypertensive effect occurs 4 weeks after the start of treatment.
If therapy with Angiakand does not lead to a decrease in blood pressure to the optimal target level, it is recommended to add a thiazide diuretic to the therapy.
In elderly patients, adjustment of the initial dose is not required.
In patients with mild to moderate renal impairment (CC more than 30 ml / min)no change in the initial dose of the drug is required.
Patients with severe renal impairment (CC less than 30 ml / min) and patients with mild and moderate hepatic impairment: the recommended initial dose is 4 mg once a day (it is possible to use the drug candesartan in another form of release).
Chronic heart failure The
recommended starting dose is 4 mg once a day (it is possible to use the drug candesartan in another form of release).
Increasing the dose to 32 mg 1 time per day or to the maximum tolerated dose is carried out by doubling it with an interval of at least 2 weeks.
Elderly patients and patients with impaired renal and / or liver function do not need to change the initial dose of the drug.
Angiakand can be used in conjunction with other drugs used in the treatment of chronic heart failure, for example, ACE inhibitors, beta-blockers, diuretics, and cardiac glycosides.

1 tablet contains:
active substance:

candesartan cilexetil 16 mg;

Excipients:

pregelatinized corn starch - 23.8 mg,

croscarmellose sodium (primellose) - 5 mg,

lactose monohydrate (milk sugar) - 90 mg,

magnesium stearate - 1 mg,

povidone-K30 - 4.2 mg.

? hypersensitivity to candesartan or other components of the drug;

? lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

? pregnancy;

? lactation period;

? primary hyperaldosteronism (resistance to therapy);

? severe liver dysfunction and / or cholestasis;

? age up to 18 years.

Precautions:
Severe renal failure (creatinine clearance (CC) less than 30 ml / min), bilateral stenosis of the renal arteries, stenosis of the renal artery of a single kidney, after kidney transplant in history, hemodynamically significant stenosis of the aortic and mitral valves, cerebrovascular disease, coronary heart disease , hypertrophic obstructive cardiomyopathy, decreased circulating blood volume (BCC), hyperkalemia.

Trade name: Angiakand

International non-proprietary name: candesartan

Dosage form: tablets

Composition:
Dosage 8 mg
1 tablet contains:
active substance: candesartan cilexetil 8 mg;
excipients: pregelatinized corn starch - 20.3 mg, croscarmellose sodium (primellose) - 3.5 mg, lactose monohydrate (milk sugar) - 64.5 mg, magnesium stearate - 0.7 mg, povidone-K30 - 3 mg.
Dosage 16 mg
1 tablet contains:
active substance: candesartan cilexetil 16 mg;
excipients: pregelatinized corn starch - 23.8 mg, croscarmellose sodium (primellose) - 5 mg, lactose monohydrate (milk sugar) - 90 mg, magnesium stearate - 1 mg, povidone-K30 - 4.2 mg.
Dosage 32 mg
1 tablet contains:
active substance:candesartan cilexetil 32 mg;
excipients: pregelatinized corn starch - 27.5 mg, croscarmellose sodium (primellose) - 7 mg, lactose monohydrate (milk sugar) - 126 mg, magnesium stearate - 1.5 mg, povidone-K30 - 6 mg.

Description:
Tablets are white or almost white, round, biconvex.

Pharmacotherapeutic group:
angiotensin II receptor antagonist.

Pharmacological properties.
Pharmacodynamics:
Candesartan is a selective antagonist of type 1 angiotensin II receptors (AT1 receptors), forms a strong bond with them with subsequent slow dissociation. It has a vasodilating, hypotensive and diuretic effect. Does not exhibit agonist properties (does not inhibit angiotensin-converting enzyme (ACE) and does not lead to the accumulation of bradykinin or substance P, does not bind to receptors of other hormones, does not block ion channels involved in the regulation of the functions of the cardiovascular system). As a result of blocking the AT1 receptors of angiotensin II, there is a compensatory dose-dependent increase in renin activity, the concentration of angiotensin I, angiotensin II and a decrease in the concentration of aldosterone in the blood plasma.
Arterial hypertension
The antihypertensive effect is due to a decrease in total peripheral vascular resistance (OPSR), while there is no effect on the heart rate (HR). There were no cases of severe arterial hypotension after taking the first dose of the drug, as well as a 'withdrawal' syndrome after discontinuation of therapy. The onset of antihypertensive action after the first dose usually develops within 2 hours. Against the background of ongoing therapy with a fixed dose of the drug, the maximum decrease in blood pressure (BP) is usually achieved within 4 weeks and persists throughout the treatment.
Candesartan increases renal blood flow and does not alter or increase the glomerular filtration rate, while renal vascular resistance and filtration fraction are reduced.
Does not affect glucose concentration and lipid profile in patients with arterial hypertension and type 2 diabetes mellitus. Provides a dose-dependent gradual decrease in blood pressure.
Age and gender do not affect the effectiveness of the drug.
Chronic heart failure
In patients with chronic heart failure and a decrease in the left ventricular ejection fraction of less than 40%, taking candesartan contributed to a decrease in the systemic vascular resistance and capillary pressure in the lungs, an increase in renin activity and angiotensin II concentration in the blood plasma, as well as a decrease in the concentration of aldosterone.

Pharmacokinetics:
Candesartan is an oral prodrug. Quickly (via ether hydrolysis) it is converted into the pharmacologically active candesartan. The absolute bioavailability of candesartan after oral administration of candesartan cilexetil solution is about 40%. The relative bioavailability of the tablet formulation compared to oral solution is approximately 34%. Thus, the calculated absolute bioavailability of the tablet form is about 14% and does not depend on the time of the meal. The maximum concentration (Cmax) in the blood serum is reached after 3-4 hours. The concentration in the blood plasma increases linearly with an increase in the dose in the therapeutic range (up to 32 mg). The volume of distribution is 0.13 l / kg. Communication with blood plasma proteins - 99.8%.
It is slightly metabolized in the liver (20-30%) with the participation of the cytochrome P450 isoenzyme CYP2C9 with the formation of an inactive derivative. The final half-life (T1 / 2) is 9 hours. Does not cumulate. The total clearance is 0.37 ml / min / kg, while the renal clearance is about 0.19 ml / min / kg. It is excreted by the kidneys and with bile mainly unchanged, to a small extent - in the form of a metabolite: by the kidneys (by glomerular filtration and active tubular secretion) - 26% in the form of candesartan and 7% - in the form of an inactive metabolite, with bile - 56% and 10%, respectively. After a single oral administration within 72 hours, more than 90% of the dose is excreted.
In elderly patients (over 65 years of age), Cmax and the area under the concentration-time curve (AUC) increase by 50% and 80%, respectively, compared with young patients. However, the antihypertensive effect and the incidence of side effects when using the drug do not depend on the age of the patients.
In patients with mild and moderate renal impairment, Cmax and AUC increase by 50% and 70%, respectively, while the T1 / 2 of the drug does not change compared with patients with normal renal function.
In patients with severely impaired renal function, Cmax and AUC increase by 50% and 110%, respectively, and the T1 / 2 of the drug doubles.
In patients with mild to moderate liver dysfunction, an increase in AUC was observed by 23%.

Indications for use:

? arterial hypertension;

? chronic heart failure and impaired systolic function of the left ventricle (decreased left ventricular ejection fraction less than 40%) as an adjunct therapy to angiotensin-converting enzyme (ACE) inhibitors or in case of intolerance to ACE inhibitors.

Contraindications:

? hypersensitivity to candesartan or other components of the drug;

? lactase deficiency, lactose intolerance, glucose-galactose malabsorption;

? pregnancy;

? lactation period;

? primary hyperaldosteronism (resistance to therapy);

? severe liver dysfunction and / or cholestasis;

? age up to 18 years.

Precautions:
Severe renal failure (creatinine clearance (CC) less than 30 ml / min), bilateral stenosis of the renal arteries, stenosis of the renal artery of a single kidney, after kidney transplant in history, hemodynamically significant stenosis of the aortic and mitral valves, cerebrovascular disease, coronary heart disease , hypertrophic obstructive cardiomyopathy, decreased circulating blood volume (BCC), hyperkalemia.

Use during pregnancy and lactation:
Animal studies have shown kidney damage in the embryonic and neonatal periods with the use of candesartan. It is assumed that the mechanism of damage is due to the pharmacological effect of the drug on the renin-angiotensin-aldosterone system (RAAS).
In the human embryo, the kidney blood supply system, which depends on the development of the RAAS, begins to form in the second trimester of pregnancy. Thus, the risk to the fetus is increased with the use of candesartan in the second and third trimesters of pregnancy. Drugs that have a direct effect on the RAAS can cause fetal developmental disorders or have a negative effect on the newborn, up to death, when using the drug in the second and third trimesters of pregnancy.
Angiakand should not be used during pregnancy. If pregnancy is detected during the period of drug treatment, therapy should be discontinued as soon as possible.
It is not known whether candesartan is excreted in breast milk. Due to the possible undesirable effect on infants, Angiakand should not be used during breastfeeding.

Method of administration and dosage:
Inside, regardless of food intake, 1 time per day.
Arterial hypertension The
recommended initial and maintenance dose is 8 mg once a day. Patients who require a further decrease in blood pressure are advised to increase the dose to 16 mg once a day. The maximum daily dose of the drug is 32 mg once a day.
The maximum antihypertensive effect occurs 4 weeks after the start of treatment.
If therapy with Angiakand does not lead to a decrease in blood pressure to the optimal target level, it is recommended to add a thiazide diuretic to the therapy.
In elderly patients, adjustment of the initial dose is not required.
In patients with mild or moderate renal impairment (CC more than 30 ml / min) , a change in the initial dose of the drug is not required.
Patients with severe renal impairment (CC less than 30 ml / min) and patients with mild and moderate hepatic impairment: the recommended initial dose is 4 mg once a day (it is possible to use the drug candesartan in another form of release).
Chronic heart failure The
recommended starting dose is 4 mg once a day (it is possible to use the drug candesartan in another form of release).
Increasing the dose to 32 mg 1 time per day or to the maximum tolerated dose is carried out by doubling it with an interval of at least 2 weeks.
Elderly patients and patients with impaired renal and / or liver functionno change in the initial dose of the drug is required.
Angiakand can be used in conjunction with other drugs used in the treatment of chronic heart failure, for example, ACE inhibitors, beta-blockers, diuretics, and cardiac glycosides.

Side effect:
Arterial hypertension
Most common side effects (? 1/100, <1/10):
From the central nervous system: dizziness, weakness, headache;
From the musculoskeletal system, connective tissue: back pain;
Others: respiratory infections;
Laboratory indicators: a decrease in hemoglobin, hypercreatininemia, an increase in the concentration of urea in the blood, hyperkalemia, hyponatremia, an increase in the activity of alanine aminotransferase (ALT).
Chronic heart failure
The most common side effects (? 1/100, <1/10):
From the cardiovascular system: a marked decrease in blood pressure;
From the urinary system: impaired renal function;
Laboratory changes: hypercreatininemia, increased blood urea concentration, hyperkalemia.
During the post-marketing use of candesartan, the following side effects were reported (frequency - less than 1/10 000):
From the side of hematopoiesis: leukopenia, neutropenia and agranulocytosis;
Laboratory indicators: hyperkalemia, hyponatremia;
From the side of the central nervous system: dizziness, weakness, headache;
From the digestive system: nausea;
From the liver and biliary tract: increased activity of 'hepatic' transaminases, abnormal liver function or hepatitis;
Allergic reactions: angioedema, skin rash, itching, urticaria;
From the musculoskeletal system, connective tissue: back pain, arthralgia, myalgia;
From the urinary system: impaired renal function, including acute renal failure in predisposed patients.
From the respiratory system: cough.

Overdose:
Symptoms: marked decrease in blood pressure, dizziness, tachycardia.
Treatment: symptomatic, put the patient on his back, raise the lower limbs above the level of the head, if necessary - increase the volume of circulating blood (BCC) by infusion of 0.9% sodium chloride solution, use of sympathomimetics. Hemodialysis is ineffective.

Interaction with other medicinal products:
With the combined use of candesartan with hydrochlorothiazide, warfarin, digoxin, oral contraceptives (ethinylestradiol / levonorgestrel), glibenclamide, nifedipine and enalapril, no clinically significant interactions have been identified.
With the simultaneous use of lithium preparations with ACE inhibitors, a reversible increase in the concentration of lithium in the blood serum and the development of toxic reactions have been reported. Adverse reactions can also occur with the use of angiotensin II receptor antagonists, in connection with which it is recommended to control the level of lithium in the blood serum with the combined use of these drugs.
With the simultaneous use of angiotensin II receptor antagonists and non-steroidal anti-inflammatory drugs (NSAIDs), including selective inhibitors of cyclooxygenase-2 (COX-2) and non-selective NSAIDs, for example, acetylsalicylic acid, more than 3 g / day, the hypotensive effect of candesartan may decrease. As in the case of ACE inhibitors, the simultaneous use of angiotensin II receptor antagonists and NSAIDs increases the risk of decreased renal function, up to the development of renal failure, which leads to hyperkalemia in patients with impaired renal function. This combination should be used with caution, especially in elderly patients. All patients should receive adequate fluid intake. It is necessary to monitor renal function at the beginning of therapy and in the future.
Drugs that affect the RAAS can increase the concentration of urea and creatinine in the blood in patients with bilateral renal artery stenosis or stenosis of a solitary kidney artery.
Diuretics and other antihypertensive drugs increase the risk of arterial hypotension.
Potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, and other drugs that can increase serum potassium (such as heparin) increase the risk of hyperkalemia.
Candesartan is slightly metabolized in the liver (CYP2C9 isoenzyme). Interaction studies have not revealed the effect of candesartan on the isoenzymes CYP2C9 and CYP3A4. The effect on other isozymes of the cytochrome P450 system has not been studied.

Special instructions:
Before and during treatment, it is necessary to control blood pressure, renal function (creatinine in blood plasma), potassium, lithium in serum (with combined use of drugs).
Arterial hypotension
In patients with chronic heart failure during therapy with Angiakand, arterial hypotension may develop. As with the use of other drugs that affect the RAAS, the cause of the development of arterial hypotension in patients with arterial hypertension may be a decrease in the BCC, as is observed in patients receiving large doses of diuretics. Therefore, at the beginning of therapy, care should be taken and, if necessary, correction of hypovolemia should be carried out.
Renal artery stenosis
In patients with bilateral renal artery stenosis or stenosis of an artery of a single kidney, drugs that affect the RAAS, in particular ACE inhibitors, can cause an increase in the concentration of urea and creatinine in the blood serum. Similar effects can be expected with the administration of angiotensin II receptor antagonists.
Kidney transplant There is no
data available on the use of candesartan in patients who have recently undergone a kidney transplant.
Renal dysfunction
During therapy with Angiakand, as well as with the use of other drugs that inhibit the RAAS, some patients may experience renal dysfunction.
When using the drug Angiakand in patients with arterial hypertension and severe renal failure, it is recommended to periodically monitor the content of potassium and creatinine in the blood serum. Clinical experience with the use of candesartan in patients with severe renal impairment or end-stage renal failure (CC less than 15 ml / min) is limited.
In patients with chronic heart failure, it is necessary to periodically monitor renal function, especially in patients aged 75 years and older, as well as in patients with impaired renal function. With an increase in the dose of the drug Angiakand, it is also recommended to control the content of potassium and creatinine in the blood plasma.
Combined use with ACE inhibitors for chronic heart failure
When using the drug Angiakand in combination with ACE inhibitors, the risk of side effects, especially renal dysfunction and hyperkalemia, may increase. In these cases, careful observation and monitoring of laboratory parameters is necessary.
General anesthesia and surgery
In patients receiving angiotensin II receptor antagonists, during general anesthesia and during surgery, arterial hypotension may develop as a result of RAAS blockade. Very rarely, there may be cases of severe arterial hypotension requiring intravenous fluid and / or vasopressors.
Aortic and mitral valve stenosis (hypertrophic obstructive cardiomyopathy)
When using the drug Angiakand, like other vasodilators, patients with hypertrophic obstructive cardiomyopathy or hemodynamically significant stenosis of the aortic and / or mitral valve should be careful.
Primary hyperaldosteronism
Patients with primary hyperaldosteronism are usually resistant to therapy with antihypertensive drugs that affect the activity of the RAAS. In this regard, the drug Angiakand is not recommended for use in such patients.
Hyperkalemia
Clinical experience with other drugs that affect the RAAS shows that the simultaneous use of candesartan with potassium-sparing diuretics, potassium preparations or salt substitutes containing potassium, or other drugs that can increase the potassium content in the blood (for example, heparin), can lead to the development of hyperkalemia in patients with arterial hypertension.
Are common
Patients whose vascular tone and renal function are predominantly dependent on RAAS activity (for example, patients with severe chronic heart failure or kidney disease, including renal artery stenosis) are especially sensitive to drugs acting on the RAAS. The use of such drugs is accompanied in these patients by severe arterial hypotension, azotemia, oliguria, and less often - acute renal failure. The possibility of the development of these effects cannot be excluded when using angiotensin II receptor antagonists. A sharp decrease in blood pressure in patients with ischemic heart disease or cerebrovascular diseases of ischemic origin, with the use of any antihypertensive drugs, can lead to the development of myocardial infarction or stroke.

¬ли¤ние на способность управл¤ть транспортными средствами, механизмами:
¬ период лечени¤ может возникнуть головокружение, слабость, поэтому необходимо соблюдать осторожность при управлении транспортными средствами и зан¤тии другими потенциально опасными видами де¤тельности, требующими повышенной концентрации внимани¤ и быстроты психомоторных реакций.

‘орма выпуска:
“аблетки 8 мг, 16 мг и 32 мг.
ѕо 7, 10, 20, 28 или 30 таблеток в контурную ¤чейковую упаковку из пленки поливинилхлоридной и фольги алюминиевой печатной лакированной.
ѕо 1, 2, 3, 4, 8 контурных ¤чейковых упаковок по 7 таблеток или по 1, 2, 3, 4, 5, 6 контурных ¤чейковых упаковок по 10 таблеток, или по 1, 2, 3 контурных ¤чейковых упаковки по 20 таблеток, или по 1, 2 контурных ¤чейковых упаковки по 28 таблеток, или по 1, 2 контурных ¤чейковых упаковки по 30 таблеток вместе с инструкцией по применению помещают в пачку из картона.

”слови¤ хранени¤:
¬ сухом, защищенном от света месте при температуре не выше 25 —.
’ранить в недоступном дл¤ детей месте.

—рок годности:
2 года.
Ќе примен¤ть по истечении срока годности.

Vacation conditions:
Dispensed by prescription.