Kandekor - Instructions For Use, Price, Reviews, Analogs Of Tablets

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Kandecor

Kandecor: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Use in childhood
11. In case of impaired renal function
12. For violations of liver function
13. Drug interactions
14. Analogs
15. Terms and conditions of storage
16. Terms of dispensing from pharmacies
17. Reviews
18. Price in pharmacies

Latin name: Candecor

ATX code: C09CA06

Active ingredient: candesartan (Candesartan)

Manufacturer: KRKA, d.d. (KRKA, dd) (Slovenia)

Description and photo update: 2019-12-07

Kandecor is an angiotensin II receptor antagonist (ARA II).

Release form and composition

Dosage form - tablets: light pink, slightly biconvex, round, chamfered and scored (in a cardboard box 2, 4 or 6 blisters containing 15 tablets each, or 1, 2, 4, 6 or 7 blisters containing 14 tablets each, or 2, 4, 8, 12 or 14 blisters containing 7 tablets each, as well as instructions for the use of Kandekor).

Composition of 1 tablet:

active substance: candesartan cilexetil - 8, 16 or 32 mg;
auxiliary components: magnesium stearate, iron dye red oxide (E172), calcium carmellose, macrogol 8000, hyprolose, corn starch, lactose monohydrate.

Pharmacological properties

Pharmacodynamics

Angiotensin II is the main enzyme of the renin-angiotensin-aldosterone system (RAAS). He takes part in the pathogenesis of heart failure, arterial hypertension and other diseases of the cardiovascular system.

Candesartan belongs to the group of selective ARA II, subtype 1 (AT ₁ receptors). The substance does not have agonist properties [does not affect the angiotensin-converting enzyme (ACE)], does not affect the state of the ion channels involved in the regulation of the cardiovascular system, does not bind to receptors of other hormones, and does not lead to the accumulation of substance P or bradykinin.

By blocking the AT ₁ -receptors of angiotensin II, there is a compensatory dose-dependent increase in the concentration of angiotensin I and angiotensin II, renin activity, as well as a decrease in the concentration of aldosterone in the blood plasma.

Arterial hypertension

When the drug is taken orally, by reducing the total peripheral vascular resistance without a reflex increase in the heart rate, a dose-dependent, planned decrease in blood pressure (BP) occurs.

There are no data indicating the occurrence of severe arterial hypotension after taking the first dose or the appearance of a withdrawal syndrome after discontinuation of Candecor.

After taking the first dose of the drug, the onset of the antihypertensive effect is usually noted within 2 hours, and its duration is 24 hours.

The maximum decrease in blood pressure with continued administration of the drug in a fixed dose in most cases is achieved within 28 days and remains throughout the entire course of therapy.

The antihypertensive effect of Candecor is enhanced when the thiazide diuretic hydrochlorothiazide is added to it.

The effectiveness of candesartan does not depend on the age and sex of the patient.

The drug does not change or increase the glomerular filtration rate, increases renal blood flow, while the filtration fraction and renal vascular resistance decrease.

Since in patients of the Negroid race, the activity of renin in the blood plasma is predominantly low, the antihypertensive effect of Candecor in patients of this population is less pronounced.

There are no data indicating the effect of the drug on the progression of diabetic nephropathy. In type 2 diabetes mellitus and arterial hypertension, Kandecor does not have a negative effect on the lipid profile and blood glucose concentration.

Chronic heart failure (CHF)

While taking candesartan, regardless of the gender / age of the patient and concomitant treatment, there is a decrease in the frequency of hospitalization and the mortality rate in CHF. The use of Kandekor leads to a decrease in the functional class of CHF according to the NYHA classification.

The drug is effective in persons receiving concomitant β-blockers with ACE inhibitors. The dose of the latter has no effect on its effectiveness. With reduced systolic function of the left ventricle (left ventricular ejection fraction <40%) and CHF, Kandecor reduces the wedge pressure in the pulmonary capillaries and the total peripheral vascular resistance.

Pharmacokinetics

absorption and distribution: after oral administration, the absolute bioavailability of candesartan is approximately 40%, the relative bioavailability is 34%, the maximum concentration in the blood serum is reached after 3-4 hours. When the dose is increased in the therapeutic interval (up to 32 mg), the concentration of the substance in the plasma increases linearly blood. Candesartan is characterized by a high binding to blood proteins (> 99%), and its volume of distribution is 0.1 L per kg;
metabolism: candesartan is metabolized by 20-30% in the liver with the participation of the isoenzyme CYP2C9 with the formation of an inactive derivative. Its half-life is approximately 9 hours. The substance does not cumulate. The total clearance is approximately 0.37 ml per minute per 1 kg, while the renal clearance is equal to 0.19 ml per minute per 1 kg;
Excretion: after oral administration of ¹⁴ C-labeled candesartan cilexetil, 56% of the dose in the form of candesartan and 10% in the form of an inactive metabolite are excreted in the intestine with bile, 26% of the dose in the form of candesartan and 7% in the form of an inactive metabolite are excreted by the kidneys. After a single application within 72 hours,> 90% of the dose is eliminated.

Pharmacokinetics in special patient groups:

elderly patients: in patients over 65 years of age, the area under the concentration-time curve and the maximum concentration of candesartan in serum increase in comparison with these indicators in young patients by approximately 80 and 50%, respectively. In this case, the development of possible side effects or reactions from blood pressure during drug therapy does not depend on the age of the patients;
patients with impaired renal function: with mild to moderate renal impairment, the area under the concentration-time curve and the maximum concentration of candesartan in serum increase by approximately 70% and 50%, respectively. In this case, the half-life of the substance does not change in comparison with patients with normal renal function. In cases of severe renal dysfunction, the first two indicators increase by 110 and 50%, respectively, and the third - 2 times;
patients with impaired liver function: with mild to moderate impairment of liver function, the area under the concentration-time curve of candesartan increases by 23%.

Indications for use

arterial hypertension;
CHF and impaired systolic function of the left ventricle (left ventricular ejection fraction ≤ 40%) - as an additional treatment to ACE inhibitors or in case of their intolerance in patients with symptomatic heart failure, despite optimal therapy, as well as intolerance of mineralocorticoid receptor antagonists.

Contraindications

Absolute:

cholestasis and / or severe liver dysfunction;
syndrome of glucose-galactose malabsorption, lactase deficiency, lactose intolerance;
combined treatment with aliskiren or drugs that include it in patients with diabetes mellitus, moderate / severe renal impairment (glomerular filtration rate <60 ml per minute per 1.73 m ² body surface area);
combined therapy with ACE inhibitors for diabetic nephropathy;
pregnancy;
period of breastfeeding;
age under 18;
individual intolerance to the components of the drug.

Relative (Kandekor is appointed under medical supervision):

impaired renal function;
hemodynamically significant stenosis of the mitral and / or aortic valve;
stenosis of an artery of a single kidney or bilateral stenosis of the renal arteries;
being on hemodialysis;
condition after kidney transplantation;
hyperkalemia;
hypertrophic obstructive cardiomyopathy;
ischemic heart disease and cerebrovascular disorders of ischemic origin;
reduced volume of circulating blood;
primary hyperaldosteronism;
recent general anesthesia and surgery;
the combined use of potassium preparations, potassium-sparing diuretics, aliskiren;
belonging to the Negroid race.

Kandecor, instructions for use: method and dosage

Kandecor tablets are taken orally, regardless of food, 1 time per day.

Arterial hypertension

For patients with arterial hypertension, Kandecor is prescribed at an initial dose of 8 mg once a day. The dose, if necessary, can be doubled. During 28 days of therapy, the maximum antihypertensive effect is achieved.

The maximum dose is 32 mg once a day. If, when taking it, adequate control of blood pressure cannot be achieved, a thiazide diuretic is added to therapy.

In the presence of the following disorders / risks, the initial dose of Kandecor is 4 mg per day (half a tablet of 8 mg):

mild or moderate renal impairment (creatinine clearance> 30 ml per minute per 1.73 m ² body surface area);
dysfunction of the liver of mild to moderate severity;
the risk of arterial hypertension.

Currently, the clinical experience of using Kandekor is limited in severe renal dysfunction (creatinine clearance <30 ml per minute per 1.73 m ² body surface area), and in cholestasis or severe liver dysfunction, it is completely absent.

CHF

The initial dose of the drug is 4 mg once a day. It is possible to increase the dose to the maximum daily dose (32 mg) or the maximum tolerated dose by doubling the dose with an interval of at least 14 days.

Kandecor can be used simultaneously with other drugs for the treatment of CHF, including cardiac glycosides, diuretics, β-blockers and ACE inhibitors, or with a combination of these drugs.

Against the background of symptomatic heart failure, which developed despite the optimal standard treatment of CHF, if the patient has an intolerance to mineralocorticoid receptor antagonists, the drug can be used in combination with ACE inhibitors.

Combination therapy with Kandecor, a potassium-sparing diuretic and an ACE inhibitor is not recommended and can only be carried out after a careful assessment of the possible risks and potential benefits.

Correction of the dosage regimen in elderly patients with CHF is not carried out.

Side effects

Arterial hypertension

In the course of controlled clinical trials, the side effects observed while taking Kandecor were moderate and transient.

The dosage of the drug, the age and sex of the patients did not affect the overall incidence of adverse events. Discontinuation rates due to side effects were similar with Candecor (3.1%) and placebo (3.2%).

A generalized analysis of the data from clinical studies showed that when using candesartan cilexetil in patients with arterial hypertension, the incidence of adverse reactions was 1% higher than in the placebo group.

The most common side effects were respiratory infections, headache, vertigo / dizziness.

Possible side effects of Candecor registered in clinical trials and with post-marketing use (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare; frequency unknown - it is impossible to establish the frequency of occurrence of adverse reactions based on the available data):

infectious and parasitic infections: often - respiratory infections;
blood and lymphatic system: very rarely - agranulocytosis, neutropenia and leukopenia;
metabolism and nutrition: very rarely - hyponatremia, hyperkalemia;
nervous system: often - headache, vertigo, dizziness;
respiratory system, chest and mediastinal organs: very rarely - cough;
gastrointestinal tract: very rarely - nausea; frequency unknown - diarrhea;
liver and biliary tract: very rarely - hepatitis, liver dysfunction, increased activity of liver enzymes;
skin and subcutaneous tissues: very rarely - itching / rash, urticaria, angioedema;
musculoskeletal and connective tissue: very rarely - myalgia, arthralgia, back pain;
kidneys and urinary tract: often - impaired renal function, including renal failure in patients with a predisposition to the development of the disease;
laboratory tests: there were no clinically significant changes in standard laboratory parameters. As with therapy with other drugs that affect the RAAS, a slight decrease in hemoglobin was observed. The use of the drug in most cases does not require regular monitoring of laboratory parameters, however, in case of impaired renal function, the concentration of creatinine and potassium in the blood serum should be periodically monitored.

CHF

The undesirable reactions revealed when using candesartan cilexetil in adult patients with CHF depended on the patient's condition and corresponded to the pharmacological properties of the substance.

The ongoing clinical studies of the use of the drug at a dose of up to 32 mg (n = 3803) and placebo (n = 3796) revealed the development of side effects in 21% of participants in the group receiving the drug and in 16.1% of participants in the placebo group.

The most common adverse reactions were renal impairment, hypotension, and hyperkalemia. These phenomena were most often observed in patients over the age of 70 with diabetes mellitus, or in patients taking other drugs that affect the RAAS (including spironolactone) and / or ACE inhibitors.

Possible adverse reactions registered in clinical trials and with post-marketing use (> 10% - very common;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare; frequency unknown - it is impossible to establish the frequency of occurrence of adverse reactions based on the available data):

blood and lymphatic system: very rarely - agranulocytosis, neutropenia, leukopenia;
metabolism and nutrition: often - hyperkalemia; very rarely - hyponatremia;
nervous system: very rarely - headache, dizziness;
vessels: often - arterial hypotension;
gastrointestinal tract: very rarely - nausea; frequency unknown - diarrhea;
liver and biliary tract: very rarely - hepatitis, liver dysfunction, increased activity of liver enzymes;
skin and subcutaneous tissues: very rarely - skin rash / itching, urticaria, angioedema;
connective and musculoskeletal tissue: very rarely - myalgia, arthralgia, back pain;
kidneys and urinary tract: often - impaired renal function, including renal failure in patients with a predisposition to the development of pathology.

Overdose

The main symptoms: tachycardia, dizziness, marked decrease in blood pressure. There have been reports of overdose cases of candesartan (up to 0.672 g of candesartan cilexetil), which ended in the patient's recovery without serious consequences.

Therapy: the patient is placed in a supine position with his legs raised up, measures are taken to increase the volume of circulating blood (0.9% sodium chloride solution is injected intravenously), symptomatic treatment under the control of vital body functions. Hemodialysis is ineffective.

special instructions

Kandecor in patients of the Negroid race has a less pronounced antihypertensive effect compared to patients of other races, which may require an increase in its doses or combined use with other antihypertensive drugs.

The experience of using Kandecor in severe renal failure or end-stage renal failure (creatinine clearance <15 ml per minute) is limited. In such cases, a strict selection of its doses and careful monitoring of blood pressure are required.

In patients with CHF, especially those over the age of 75, as well as with impaired renal function, kidney function should be monitored periodically. It is important to monitor the level of potassium and the concentration of creatinine in the blood serum during the period of selection of doses of the drug.

Combined treatment with Kandecor and an ACE inhibitor can lead to an increase in the likelihood of side effects, in particular a decrease in renal function (including acute renal failure), hyperkalemia and arterial hypotension.

Also, therapy with a three-way combination of candesartan, a mineralocorticoid receptor antagonist and an ACE inhibitor is not recommended. In such cases, patients should be under close medical supervision, it is important for them to monitor blood pressure, electrolyte levels and renal function.

During hemodialysis, blood pressure can be especially sensitive to the blockade of AT ₁ -receptors due to activation of the RAAS and a decrease in circulating blood volume. In this regard, in patients on hemodialysis, blood pressure is monitored, the dose of the drug is selected for them on an individual basis.

Reception of ACE inhibitors, as well as other drugs affecting the RAAS, can cause an increase in the concentration of urea and creatinine in stenosis of an artery of a single kidney or bilateral stenosis of the renal arteries. ARA II therapy can lead to the development of a similar effect.

Clinical experience with the use of Candecor in patients after recent kidney transplantation is absent.

Reception of Kandekor with CHF may be accompanied by the occurrence of arterial hypotension. Its development is also possible with a reduced volume of circulating blood, for example, against the background of the use of high doses of diuretics. It is recommended to start treatment with caution; if necessary, the volume of circulating blood should be compensated.

Due to the blockade of the RAAS in patients receiving ARA II, arterial hypotension may occur during general anesthesia and surgical interventions. In rare cases, it can be severe and require intravenous administration of vasopressors and / or fluids.

Kandecor with caution, under medical supervision, should be prescribed for hypertrophic obstructive cardiomyopathy or hemodynamically significant stenosis of the mitral and / or aortic valve.

Since patients with primary hyperaldosteronism are resistant to antihypertensive drugs that affect the RAAS, the use of the drug in such cases is not recommended.

Against the background of arterial hypertension, combined treatment with Kandecor and potassium preparations, salt substitutes containing potassium, potassium-sparing diuretics, or other agents that can increase the serum potassium content (for example, heparin) can lead to the development of hyperkalemia. It can also appear in patients with CHF receiving Kandecor. The use of the drug for CHF should be accompanied by periodic monitoring of the potassium content in the blood serum, especially with the combined use of potassium-sparing diuretics (eplerenone, amiloride, triamterene, spironolactone) and ACE inhibitors.

In patients whose renal function and vascular tone predominantly depend on the activity of the RAAS (for example, severe CHF or renal pathology, including renal artery stenosis), treatment with other drugs that affect through the RAAS may be accompanied by the occurrence of oliguria, azotemia, arterial hypotension and, less commonly, acute renal failure. When taking ARA II, the likelihood of such undesirable effects cannot be excluded.

A pronounced decrease in blood pressure in cerebrovascular pathologies of atherosclerotic origin or coronary heart disease can cause the development of a stroke or myocardial infarction.

Under the influence of other drugs that can lower blood pressure, the antihypertensive effect of candesartan may increase when used as an antihypertensive agent or for other indications.

It has been proven that combined treatment with aliskiren, ARA II or ACE inhibitors increases the likelihood of decreased renal function (including acute renal failure), hyperkalemia and arterial hypotension. If necessary, such therapy is carried out under close medical supervision with regular monitoring of blood pressure, electrolyte content and renal function.

Patients with moderate or severe renal insufficiency and / or diabetes mellitus are contraindicated in simultaneous therapy with ARA II with drugs containing aliskiren. This combination is not recommended for other patients.

For patients with diabetic nephropathy, combined administration of ARA II with ACE inhibitors is contraindicated, such therapy is not recommended for other patients.

Influence on the ability to drive vehicles and complex mechanisms

Patients during the period of taking Kandecor should be careful when driving and engaging in potentially hazardous activities.

Application during pregnancy and lactation

Candecor is not prescribed during pregnancy / lactation. If pregnancy is diagnosed during drug therapy, it should be discontinued as soon as possible. In cases of planning pregnancy, it is recommended to transfer the patient to an adequate alternative treatment.

Newborns whose mothers received the drug during pregnancy should be under close medical supervision due to the possible occurrence of arterial hypotension.

Pediatric use

Patients under 18 years of age Kandecor is not prescribed, since the safety and effectiveness of its use in patients of this age group have not been established.

With impaired renal function

Kandecor is used with caution against the background of impaired renal function, stenosis of the artery of a single kidney, bilateral stenosis of the renal arteries and after kidney transplantation.

For violations of liver function

Patients with severely impaired liver function are not prescribed Kandecor.

Drug interactions

There was no clinically significant pharmacokinetic interaction between candesartan and enalapril, nifedipine, glibenclamide, oral contraceptives (levonorgestrel / ethinyl estradiol), digoxin, warfarin, or hydrochlorothiazide.

To a small extent, candesartan is metabolized in the liver by means of the CYP2C9 isoenzyme. No effect on CYP2C9 and CYP3A4 isoenzymes has been identified, and the effect on other isoenzymes of the cytochrome P _{450 system has} not been studied.

Possible interactions of candesartan with other drugs / substances:

antihypertensive drugs: potentiate its antihypertensive effect;
potassium-sparing diuretics, potassium preparations, salt substitutes containing potassium, other drugs that increase the serum potassium content (for example, heparin): hyperkalemia may develop;
lithium preparations: it is possible to increase the concentration of lithium in the blood serum and the occurrence of toxic reactions. It is required to periodically monitor the serum lithium content;
non-steroidal anti-inflammatory drugs, including selective inhibitors of cyclooxygenase-2 and non-selective non-steroidal anti-inflammatory drugs (for example, acetylsalicylic acid at a dose of> 3 g per day): can reduce its antihypertensive effect;
nonsteroidal anti-inflammatory drugs: the likelihood of a decrease in renal function increases, up to renal failure, which, in the presence of renal dysfunction, leads to hyperkalemia. Such treatment should be carried out with caution, especially in elderly patients, and accompanied by regular monitoring of renal function after starting the drug and during the period of therapy. It is important that patients drink enough fluids.

Analogs

Analogues of Kandekor are: Ordiss, Angiakand, Xarten, Atakand, Kandesartan-SZ, Hyposart.

Terms and conditions of storage

Store in a place protected from light and moisture at temperatures up to 25 ° C. Keep out of the reach of children.

Shelf life is 2 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Kandekor

According to reviews, Kandekor in most cases is a safe and effective drug, the intake of which allows you to keep blood pressure within normal limits. In some cases, the use of the drug was accompanied by the appearance of heaviness and pain in the chest, cramps in the legs at night.

The price of Kandecor in pharmacies

The approximate price for Kandecor (in a package of 28 tablets): dosage 8 mg - 631 rubles, dosage 16 mg - 888 rubles.

Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!