Concor tab p / 10 mg of the film 50 pc

Description

Composition
Active substance:
1 tablet contains: bisoprolol fumarate – 5 mg or 10 mg.
Excipients:
Calcium hydrogen phosphate, anhydrous; corn starch, fine powder; silica, colloidal anhydrous; microcrystalline cellulose; crospovidone; magnesium stearate. film coating: 2910/15 hypromellose, macrogol 400, dimethicone 100, iron oxide yellow dye (E 172), titanium dioxide (E 171).
Description:
Film-coated tablets of 5 mg: Light yellow, heart-shaped, biconvex tablets, film-coated, with the notch on both sides.
Film-coated tablets 10 mg: Light orange, heart-shaped, biconvex tablets, film-coated, with the notch on both sides.
Product form:
Film-coated tablets, 5 and 10 mg.
10 tablets in a blister of aluminum foil and PVC; 3 or 5 blisters together with instructions for use placed in a cardboard box.
30 tablets in a blister of aluminum foil and PVC; 1 blister together with instructions for use placed in a cardboard box.
25 tablets in a blister of aluminum foil and PVC; 2 blister together with instructions for use placed in a cardboard box.
Film-coated tablets, 5 mg.
30 tablets in a blister of aluminum foil and PVC; 3 blisters with instructions for use placed in a cardboard box.
When packaging the drug in the Russian company OOO “Nanolek”
Film-coated tablets, 5 and 10 mg.
30 tablets in a blister of aluminum foil and PVC; 1 blister together with instructions for use placed in a cardboard box.
25 tablets in a blister of aluminum foil and PVC; 2 blister together with instructions for use placed in a cardboard box.
Film-coated tablets, 5 mg.
30 tablets in a blister of aluminum foil and PVC; 3 blisters with instructions for use placed in a cardboard box.
Contraindications
Hypersensitivity to bisoprolol or any of the excipients (see. The section “Composition”), acute heart failure, chronic heart failure decompensation requiring holding inotropic therapy, cardiogenic shock, atrioventricular (AV) block II and III extent without the pacemaker , sick sinus syndrome, sinoatrial block, bradycardia (heart rate less than 60 bpm. / min), marked hypotension (systolic blood pressure less than 100 mm Hg. v.), severe bronchial asthma expressed human peripheral blood circulation or Raynaud’s syndrome, pheochromocytoma (without simultaneous application of alpha-blockers), metabolic acidosis, age 18 years (insufficient data on efficacy and safety in this age group).
Precautions: conducting desensitizing therapy, Prinzmetal angina, hyperthyroidism, diabetes type 1 and diabetes with considerable fluctuations in blood glucose concentration, AV block I degree, expressed renal failure (creatinine clearance less than 20 mL / min) expressed by human liver, psoriasis , restrictive cardiomyopathy, congenital heart disease or heart valve defect with severe hemodynamic disturbances, heart failure with myocardial infarction within the last 3 months, severe chronic obstructive b Handy light, a strict diet.
Dosage
10 mg
Indications
Hypertension ischemic heart disease: stable angina, chronic heart failure.
Interaction with other drugs
On the efficacy and tolerability of the bisoprolol may affect concomitant use of other drugs. Such interaction may also occur in those cases when the two drugs are taken over a short period of time. The doctor should be informed about the acceptance of other drugs, even if they are received without a doctor’s prescription (ie, non-prescription drugs).
Not recommended combinations
Treatment of Chronic Heart Failure: Class I antiarrhythmics (e.g., quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone), while the use of bisoprolol can reduce AV conduction and the contractile ability of the heart.
All indications for Konkor® preparation: blockers “slow” calcium channel (BCCI) verapamil type and to a lesser extent, diltiazem, while the use of bisoprolol can lead to a decrease of myocardial contractility and AV conduction disturbance. In particular, intravenous administration of verapamil in patients receiving beta-blockers may cause severe hypotension and AV blockade. Centrally acting antihypertensives (such as clonidine, methyldopa, moxonidine, rilmenidine) can lead to slowing of the heart rate and reducing cardiac output and vasodilation due to the reduction of the central sympathetic tone. Abrupt withdrawal, particularly before the abolition of beta-blockers may increase the risk of “rebound” hypertension.
Combinations requiring special care
Treatment of hypertension and angina: Class I antiarrhythmics (e.g., quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone), while the use of bisoprolol can reduce AV conduction and contractility of the myocardium.
All indications for use of the drug Konkor®: BCCI dihydropyridine derivatives (e.g. nifedipine, felodipine, amlodipine) while the application of bisoprolol can increase the risk of hypotension. In patients with heart failure can not eliminate the risk of further deterioration of the contractile function of the heart. Class III antiarrhythmics (e.g., amiodarone) may enhance violation AV conduction. The action of beta-blockers for topical (e.g., eye drops for treating glaucoma) may enhance the systemic effects of bisoprolol (decrease in blood pressure, heart rate slowing). Parasympathomimetics while the use of bisoprolol can exacerbate violation of AV conduction and increase the risk of bradycardia. Hypoglycemic effect of insulin or hypoglycemic agents for oral administration may be enhanced. Symptoms of hypoglycaemia – particularly tachycardia – may be masked or suppressed. Such interactions are more likely to occur when using non-selective beta-blockers. Funds for general anesthesia may increase the risk cardiodepressive action, resulting in hypotension (see. Section “Special Instructions”). Cardiac glycosides while the use of bisoprolol can lead to an increase of the pulse time, and thus, to the development of bradycardia. Nonsteroidal anti-inflammatory drugs (NSAIDs) may reduce the hypotensive effect of bisoprolol. Simultaneous application Konkor® preparation with beta-agonists (e.g., isoprenaline, dobutamine) may reduce the effect of both drugs. Bisoprolol combination with agonists affecting the beta- and alpha-adrenergic receptors (such as norepinephrine, epinephrine) may enhance vasoconstrictor effects of these agents arising with alpha adrenergic receptors, resulting in an increase in blood pressure. Such interactions are more likely to occur when using non-selective beta-blockers. Antihypertensives, as well as other means with possible antihypertensive effect (e.g., tricyclic antidepressants, barbiturates, phenothiazines) may enhance the hypotensive effect of bisoprolol. Mefloquine while the use of bisoprolol may increase the risk of bradycardia. MAO inhibitors (MAO inhibitors except for B) can enhance the hypotensive effect of beta-blockers. Concomitant use can also lead to the development of hypertensive crisis.
Overdose
Symptoms. The most common symptoms of overdose: AV block, bradycardia, marked reduction in blood pressure, bronchospasm, acute cardiac insufficiency and hypoglycaemia. Sensitivity to single high dose bisoprolol reception varies greatly among individual patients and probably patients with CHF have a high sensitivity.
Treatment. In the event of an overdose, it is first necessary to stop taking the drug and start supporting symptomatically. In severe bradycardia: intravenous administration of atropine. If the effect is insufficient, you can enter with caution agent with positive chronotropic effect. Sometimes it may require temporary staging an artificial pacemaker. In marked decrease in blood pressure: intravenous plasma-substituting solutions and vasopressor drugs. When AV blockade: patients should be under constant supervision and be treated with beta-agonists such as epinephrine. If necessary – setting an artificial pacemaker. During exacerbation flow CHF: intravenous diuretics, drugs with a positive inotropic effect, and vasodilators. When bronchospasm: the appointment of bronchodilators including beta2-agonists and / or aminophylline. When hypoglycemia: intravenous administration of dextrose (glucose).
pharmachologic effect
Pharmacological group:
Beta1-selective blocker.
Pharmacodynamics:
Selective beta1-adrenergic blocker, without own sympathomimetic activity, has no membrane stabilizing effect. He has only a negligible affinity for the beta2-adrenoceptor bronchial smooth muscle and blood vessels, as well as the beta2-adrenoceptor involved in metabolic regulation. Therefore, bisoprolol generally does not affect the airway resistance and metabolic processes that are involved in the beta2-adrenergic receptors. The selective effect of the drug on beta1-adrenergic receptors is stored outside the therapeutic range. Bisoprolol has no pronounced negative inotropic effect. The maximum effect of the drug is achieved within 3-4 hours after ingestion. Even when assigning 1 bisoprolol once daily its therapeutic effect lasts for 24 hours through 10-12 hour half-life from the blood plasma. Generally, the maximum reduction in blood pressure (BP) reached after 2 weeks of treatment. Bisoprolol reduces the activity simpatoadrenalovoj system (SAS), blocking beta1- cardiac adrenergic receptors. When a single oral administration in patients with coronary heart disease (CHD) without signs of congestive heart failure (CHF), bisoprolol slows the heart rate (HR), cardiac stroke volume decreases and, as a consequence, ejection fraction and reduces myocardial oxygen demand. Prolonged therapy initially increased total peripheral vascular resistance (SVR) is reduced. Reducing the activity of renin in blood plasma is considered as one of the components of the hypotensive effect of beta-blockers.
Pharmacokinetics:
Suction. Bisoprolol almost completely (over 90%) is absorbed from the gastrointestinal tract. Its bioavailability is due to low metabolization “first pass” through the liver (at about 10%) is approximately 90% after oral administration. Eating does not affect the bioavailability. Bisoprolol demonstrates linear kinetics, and its plasma concentration is proportional to the dose in the range of 5 to 20 mg. The maximum plasma concentration is reached after 2-3 hours
Distribution. Bisoprolol is distributed widely enough. The volume of distribution of 3.5 l / kg. Communication plasma protein reaches about 30%.
Metabolism. Metabolized by oxidative way without subsequent conjugation. All metabolites are polar (water soluble) and excreted by the kidneys. The main metabolites found in blood plasma and urine, does not exhibit pharmacological activity. Data obtained from experiments with liver microsomes in vitro human show that bisoprolol is metabolized primarily via isoenzyme CYP3A4 (about 95%) and CYP2D6 isozyme plays only a minor role.
Withdrawal. bisoprolol Clearance determined by the balance between renal excretion in unmodified form (about 50%) and the metabolism in the liver (50%) to metabolites that are also output by the kidneys. The total clearance is 15 l / h. The half – 10-12 hours.
There is no information on the pharmacokinetics of bisoprolol in patients with chronic heart failure and simultaneous impaired liver or kidney function.
Pregnancy and breast-feeding
In pregnancy, the drug Konkor® should be advised to use only if the benefit to the mother outweighs the risk of side effects in the fetus and / or the child. Typically, beta-blockers reduce blood flow to the placenta and can affect fetal development. It is necessary to monitor blood flow in the placenta and uterus, as well as to observe the growth and development of the unborn child and in case of occurrence of adverse events in relation to pregnancy and / or fetus, taking alternative therapies. It is necessary to carefully examine the newborn after delivery. In the first three days of life may have symptoms of hypoglycemia and bradycardia. the allocation of data bisoprolol passes into breast milk is not. Therefore, the drug Konkor® not recommended for women during lactation. If administration during lactation is necessary, breast-feeding should be discontinued.
Conditions of supply of pharmacies
On prescription.
side effects
The frequency of adverse reactions listed below, was determined according to the following: -very often> 1/10; -Frequently> 1/100,
special instructions
Do not interrupt treatment with Konkor® sharply and do not change the recommended dose without first consulting your doctor, as this may lead to temporary impairment of the heart. Treatment should not be interrupted suddenly, especially in patients with CAD. If discontinuation is necessary, the dose should be reduced gradually. In the initial stages of treatment Konkor® patients need constant supervision
The drug should be used with caution in the following cases: Severe COPD and mild form of asthma; Diabetes mellitus with considerable fluctuations in blood glucose concentration: symptoms pronounced decrease of glucose concentrations (hypoglycemia) such as tachycardia, palpitations or sweating may be masked, strict diet, Holding desensitizing therapy, AV block I degree, Prinzmetal angina, disorders of the lung and the peripheral blood circulation moderate (at the start of therapy may be increased symptoms), psoriasis (including history).
Respiratory system: bronchial asthma or COPD shown the simultaneous application of bronchodilatory agents. Patients with asthma may increase airway resistance, which requires higher doses of beta2-agonists. In patients with COPD, bisoprolol, appointed in the complex therapy for the treatment of heart failure, you should start with the lowest possible dose, and the patient carefully observed the appearance of new symptoms (such as shortness of breath, exercise intolerance, cough).
Allergic reactions: beta blockers, including drug Konkor® may increase sensitivity to allergens and severity of anaphylactic reactions due to weakening adrenergic compensatory regulation under their action. Therapy with epinephrine (adrenaline) does not always give the expected therapeutic effect. General anesthesia: general anesthesia, it is necessary to take into account the risk of beta blockade. If you want to stop therapy with Konkor® before surgery, this should be done gradually and completed within 48 hours before the general anesthetic. It is necessary to warn the anesthetist that you are taking the drug Konkor®.
Pheochromocytoma: in patients with adrenal gland tumor (pheochromocytoma) Konkor® drug can only be assigned to treatment with alpha-blockers.
Hyperthyroidism: in the treatment of drug Konkor® symptoms of hyperthyroidism (hyperthyroidism) may be masked.
Effects on ability to drive vehicles and complex mechanisms
Konkor® drug does not affect the ability to drive vehicles according to a study in patients with CAD. However, the ability to drive vehicles or work with technically complicated mechanisms may be compromised due to individual reactions. It should pay particular attention to the beginning of treatment, after a change in dose, as well as the simultaneous use of alcohol.
Storage conditions
Store at a temperature not higher than 30 C.
Keep out of the reach of children.
Dosing and Administration
Konkor® drug tablets should be taken once daily with a little liquid, in the morning before breakfast, during or after it. Tablets should not be chewed or triturate
Hypertension and stable angina
In all cases, the receiving mode and selects the dose the doctor for each patient individually, in particular, taking into account the heart rate and the patient’s condition. Typically, the initial dose is 5 mg drug Konkor® 1 time per day. If necessary, the dose may be increased to 10 mg 1 time per day. In the treatment of hypertension and angina, stable maximum recommended dose is 20mg Konkor® preparation 1 time per day.
Chronic heart failure
Standard treatment of CHF includes the use of angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor antagonists II (in case of intolerance to ACE inhibitors), beta-blockers, diuretics and, optionally, cardiac glycosides. Starting treatment of CHF requires a mandatory drug Konkor® the special titration phase and regular medical supervision. A prerequisite for treatment with Konkor ® is stable chronic heart failure with no signs of aggravation. CHF Konkor® drug treatment is started in accordance with the following scheme titration. This may require individual adaptation depending on how well patients tolerate the prescribed dose, t. E. The dose can be increased only if the previous dose was well tolerated. Для обеспечения соответствующего процесса титрования на начальных этапах лечения рекомендуется применять бисопролол в лекарственной форме: таблетки по 2,5 мг. Рекомендуемая начальная доза составляет 1,25 мг один раз в день. В зависимости от индивидуальной переносимости дозу следует постепенно повышать до 2,5 мг, 3,75 мг, 5 мг, 7,5 мг и 10 мг 1 раз в день. Each subsequent increase in dose should be administered at least two weeks. If an increase in the dose of the drug is poorly tolerated by the patient, may reduce the dose. Максимально рекомендованная доза при лечении ХСН составляет 10 мг препарата Конкор® 1 раз в день. During titration we recommend regular monitoring of blood pressure, heart rate and severity of heart failure symptoms. Worsening symptoms of heart failure may flow from the first day of the drug. Если пациент плохо переносит максимально рекомендованную дозу препарата, следует рассмотреть возможность постепенного снижения дозы. Во время фазы титрования или после нее могут возникнуть временное ухудшение течения ХСН, артериальная гипотензия или брадикардия. In this case it is recommended first of all to carry out correction of drug doses of concomitant therapy. Также может потребоваться временное снижение дозы препарата Конкор® или его отмена. After stabilization of the patient should be a re-titration of the dosage or further treatment.
Продолжительность лечения: при всех показаниях к применению препарата Конкор® Лечение препаратом Конкор® обычно является долговременной терапией.
Special patient groups
Нарушение функции почек или печени:
При нарушении функции печени или почек легкой или умеренной степени обычно не требуется корректировать дозу. При выраженных нарушениях функции почек (КК менее 20 мл/мин. ) и у пациентов с тяжелыми заболеваниями печени максимальная суточная доза составляет 10 мг. Increasing the dose in such patients should be administered with extreme caution.
Elderly patients:
correction dose is not required.
Children:
Так как нет достаточного количества данных по применению препарата Конкор® у детей, не рекомендуется назначать препарат детям до 18 лет
К настоящему времени недостаточно данных относительно применения препарата Конкор® у пациентов с ХСН в сочетании с сахарным диабетом 1 типа, выраженными нарушениями функции почек и/или печени, рестриктивной кардиомиопатией, врожденными пороками сердца или пороком клапана сердца с выраженными гемодинамическими нарушениями. to also still not enough data has been received with respect to patients with chronic heart failure with myocardial infarction within the last 3 months.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist