Concor tabs 10mg #50

User manual for Concor

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Concor is a selective beta1-blocker.

Release form and composition

Dosage form Concor - film-coated tablets: light yellow or light orange, have a biconvex heart-shaped shape and a dividing line on both sides (5 mg or 10 mg in blisters: 10 pcs., In cartons 3 or 5 blisters; 25 pcs., in cardboard packs 2 blisters; 30 pcs., in a cardboard box 1 blister; 5 mg, 30 pcs. in a blister, in a cardboard box 3 blisters).
The active ingredient is bisoprolol hemifumarate (bisoprolol fumarate (2: 1)):
    1 light yellow tablet - 5 mg;
    1 light orange tablet - 10 mg.
Auxiliary components: corn starch, anhydrous calcium hydrogen phosphate, anhydrous colloidal silicon dioxide, crospovidone, microcrystalline cellulose, magnesium stearate.
The composition of the film shell: titanium dioxide (E171), hypromellose 2910/15, dimethicone 100, macrogol 400, dye iron oxide yellow (E172).
Additionally, in the composition of the light orange film sheath - iron oxide red dye (E172).

Pharmacodynamics

Concor is a selective beta1-blocker that does not have its own sympathomimetic activity and membrane stabilizing effect. Has a slight affinity for beta2-adrenergic receptors of smooth muscles of blood vessels, bronchi and for beta2-adrenergic receptors, which are involved in the regulation of metabolism. The drug has no effect on airway resistance, as well as on metabolic processes that occur with the participation of beta2-adrenergic receptors.
The selective effect of bisoprolol on beta2-adrenergic receptors is also observed outside the therapeutic range.
Bisoprolol has no pronounced negative inotropic effect. After oral administration, the maximum effect is achieved after 3-4 hours. The half-life is 10-12 hours. When using the drug once a day, the therapeutic effect lasts for 24 hours. Most often, the maximum decrease in blood pressure is achieved 2 weeks after the start of therapy.
Bisoprolol blocks beta2-adrenergic receptors of the heart and reduces the activity of the sympathoadrenal system.
In ischemic heart disease and in the absence of chronic heart failure, a single oral administration of bisoprolol decreases the heart rate and decreases the stroke volume of the heart, which leads to a decrease in the ejection fraction and a decrease in myocardial demand for incoming oxygen.
With long-term treatment, there is a decrease in the initially increased total peripheral vascular resistance, and the activity of renin in the blood plasma also decreases (this effect is considered one of the components of the hypotensive effect of beta-blockers).

Pharmacokinetics

    absorption: bisoprolol is absorbed from the gastrointestinal tract almost completely (over 90%). Oral bioavailability is about 90%, there is a slight "first pass" effect through the liver, in which about 10% is metabolized. Food intake does not affect bioavailability. The drug demonstrates linear kinetics, its concentration in blood plasma is proportional to the dose of bisoprolol taken in the range of 5–20 mg. The time to reach the maximum concentration in blood plasma is about 2-3 hours;
    distribution: bisoprolol is distributed widely enough. The volume of distribution is 3.5 l / kg, the connection with plasma proteins is about 30%;
    metabolism: bisoprolol is metabolized by the oxidative pathway without conjugation. Bisoprolol metabolites are polar (water-soluble), excreted by the kidneys. The main metabolites found in urine and blood plasma lack pharmacological activity. The results of studies of human liver microsomes showed that in vitro bisoprolol is primarily metabolized using the CYP3A4 isoenzyme (approximately 95%), and the role of the CYP2D6 isoenzyme is insignificant;
    excretion: clearance of bisoprolol is due to the balance between excretion unchanged by the kidneys (about half of the dose) and its metabolism in the liver (about half of the dose) to metabolites excreted by the kidneys. The total clearance is 15 l / h, the half-life is 10-12 hours.
There are no data on the pharmacokinetics of Concor in patients with impaired renal or hepatic function and concurrent coronary heart disease.

Indications for use

    Chronic heart failure;
    Arterial hypertension;
    Stable angina pectoris with coronary heart disease.

Contraindications

    Acute form of heart failure;
    Decompensated chronic heart failure;
    Cardiogenic shock;
    Atrioventricular (AV) block II and III degree (in the absence of a pacemaker);
    Sick sinus syndrome;
    Severe bradycardia (heart rate (HR) less than 60 beats per minute);
    A pronounced decrease in blood pressure (BP) (systolic blood pressure below 100 mm Hg);
    Sinoatrial blockade;
    Severe bronchial asthma and chronic obstructive pulmonary disease (COPD), indicated in history;
    Raynaud's disease, severe peripheral arterial circulation disorders;
    Metabolic acidosis;
    Pheochromocytoma (without a combination with alpha-blockers);
    Age under 18;
    Breastfeeding period;
    Hypersensitivity to the components of the drug.
Concor should be prescribed with caution in patients with severely impaired liver function, Prinzmetal angina pectoris, type 1 diabetes mellitus and diabetes mellitus with significant fluctuations in blood glucose, hyperthyroidism, grade I AV block, psoriasis, severe renal failure (creatinine clearance less than 20 ml / min), congenital heart disease or heart valve disease with severe hemodynamic disorders, restrictive cardiomyopathy, chronic heart failure on the background of myocardial infarction within the next 3 months, during the period of desensitizing therapy, as well as patients on a strict diet.
The use of Concor during pregnancy is possible if, according to the doctor's definition, the expected therapeutic effect for the mother outweighs the potential risk to the fetus (bisoprolol hemifumarate reduces blood flow in the placenta).

Instructions for the use of Concor: method and dosage

Concor tablets are taken orally, without chewing, with a sufficient amount of liquid. The drug should be taken once a day, in the morning, regardless of food intake.
The doctor prescribes dosage individually, taking into account the patient's condition and clinical indications.
In the treatment of angina pectoris and arterial hypertension, the dose is selected, taking into account the patient's heart rate. It should start with 5 mg per day. If necessary, the dose can be increased to 10 mg; it is not recommended to exceed 20 mg.
Treatment of chronic heart failure is carried out according to the standard scheme, which includes combination therapy, which includes angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor antagonists (with intolerance to ACE inhibitors), diuretics, beta-blockers, cardiac glycosides.
Concor is indicated only for stable chronic heart failure without exacerbation symptoms. Special titration phases must be completed according to a specific schedule.
The recommended starting dosage for the treatment of chronic heart failure is 1.25 mg. Further dose adjustment depends on the individual tolerance of bisoprolol and is carried out after a certain adaptation to the previous one.
The dose is increased gradually, once every 2 weeks by 1.25 mg, the maximum dose is 10 mg. The selection of the dose of Concor is carried out under the supervision of a doctor and control of heart rate, blood pressure, in case of an exacerbation of the condition against the background of the last titration, the dose should be reduced to the previous one.
A temporary exacerbation of the symptoms of the course of the disease, the appearance of arterial hypotension or bradycardia is possible from the first days of using the drug, during titration and treatment. In this case, it is necessary to simultaneously adjust the doses of concomitant therapy and bisoprolol, and in critical situations, cancel it until the patient's condition stabilizes. You can then continue treatment or start re-titration of the dose.
The use of Concor for all indications is long-term.
Patients with mild or moderate hepatic or renal dysfunction and elderly patients usually do not need dosage adjustment.
In severely impaired renal and liver function, the recommended daily dose should not exceed 10 mg, and increasing the dose in this category of patients is carried out with extreme caution.

Side effects

Against the background of the use of Concor, the following side effects may occur:
    From the side of the cardiovascular system: very often - bradycardia (with chronic heart failure); often - exacerbation of symptoms of chronic heart failure (with chronic heart failure), feeling of numbness or coldness in the extremities, a strong decrease in blood pressure (more often in patients with chronic heart failure); infrequently - bradycardia (with angina pectoris or arterial hypertension), impaired AV conduction, orthostatic hypotension, increased signs of chronic heart failure (with angina pectoris or arterial hypertension);
    From the digestive system: often - vomiting, nausea, diarrhea or constipation; rarely - hepatitis;
    From the nervous system: often - dizziness and headache (more often at the beginning of treatment for arterial hypertension or angina pectoris, is mild and disappears after 1-2 weeks of therapy); rarely - loss of consciousness;
    From the senses: rarely - hearing impairment, decreased lacrimation; very rarely - conjunctivitis;
    From the side of the psyche: infrequently - insomnia, depression; rarely - terrible dreams, hallucinations;
    Reproductive system disorders: rarely - potency disorders;
    From the respiratory system: infrequently - bronchospasm against the background of bronchial asthma or obstructive airway diseases in history;
    From the musculoskeletal system: infrequently - muscle cramps, muscle weakness;
    From the side of the skin: very rarely - alopecia; in patients with psoriasis, an exacerbation of the disease or the appearance of a psoriasis-like rash;
    Allergic reactions: rarely - itching, skin rash, flushing, allergic rhinitis;
    On the part of laboratory parameters: rarely - an increase in the level of concentration of liver enzymes (alanine aminotransferase and aspartate aminotransferase) in the blood;
    Others: often - asthenia (with chronic heart failure), increased fatigue (more often at the beginning of treatment for arterial hypertension or angina pectoris, is mild and disappears after 1-2 weeks of therapy); infrequently - asthenia (with arterial hypertension or angina pectoris).

Overdose

The most common symptoms: AV block, marked decrease in blood pressure, severe bradycardia, acute heart failure, hypoglycemia, bronchospasm.
With a single dose of a high dose of bisoprolol, sensitivity varies greatly in individual patients. Sensitivity is probably increased for patients with chronic heart failure.
In case of an overdose, you should stop taking Concor and resort to supportive symptomatic therapy.
With severe bradycardia, intravenous atropine is recommended. If these measures are not enough, a drug with a positive chronotropic effect can be administered with caution. In some cases, an artificial pacemaker is temporarily installed.
In the case of a pronounced decrease in blood pressure, intravenous administration of vasopressor drugs and plasma-substituting solutions is recommended.
In case of AV blockade, constant monitoring of the patient should be ensured and therapy with beta-adrenergic agonists (for example, epinephrine) should be prescribed. In some cases, temporary placement of an artificial pacemaker is advisable.
In case of exacerbation of chronic heart failure, intravenous administration of diuretics, vasodilators and drugs with a positive inotropic effect is recommended.
For bronchospasm, bronchodilators are prescribed, including beta2-adrenomimetics and / or aminophylline.
In hypoglycemia, intravenous glucose (dextrose) is recommended.

Special instructions

You can not abruptly stop therapy, especially for patients with coronary heart disease, the cancellation of the drug should take place by gradually reducing the dose. Dosage adjustments are made under supervision and on the recommendation of a physician.
For patients with bronchial asthma or COPD, the administration of the drug is indicated only while taking bronchodilators. With an increase in airway resistance, it is recommended to increase the dose of beta2-adrenomimetics for patients with bronchial asthma.
Against the background of the drug, an increase in sensitivity to allergens and the severity of anaphylactic reactions is possible, while treatment with adrenaline (epinephrine) may not have a sufficient therapeutic effect.
Before a planned surgical operation using general anesthesia, it is necessary to gradually reduce the dose of the drug and stop taking it 48 hours before the start of the operation. The anesthesiologist should be informed about taking bisoprolol.
With pheochromocytoma, the use of the drug is possible only against the background of alpha-blockers.
The drug can mask the symptoms of hyperthyroidism.
Although Concor does not affect the patient's ability to drive vehicles and mechanisms, given the different individual tolerability of the drug and the possible violation of the condition when changing the dose, it is recommended to be careful, especially at the beginning of treatment and in the case of simultaneous alcohol consumption.

Application during pregnancy and lactation

According to the instructions, the drug is allowed to be used during pregnancy only in cases where the potential risk to the fetus is lower than the intended benefit to the mother.
Under the influence of beta-blockers, blood flow in the placenta decreases, which can affect the development of the fetus. Shows the control of blood flow in the uterus and placenta, as well as monitoring the development of the fetus. In case of diagnostics of adverse events, it is recommended to turn to alternative methods of treatment. The newborn should be examined carefully after delivery. In the first three days of life, symptoms of hypoglycemia and bradycardia may appear.
There are no data on the excretion of bisoprolol in breast milk, therefore, it is not recommended to take Concor during breastfeeding. If the use of the drug is necessary, then breastfeeding should be discontinued.

Childhood use

It is contraindicated to use Concor for the treatment of patients under the age of 18 years.

With impaired renal function

With severe renal failure (CC up to 20 ml / min) the drug should be used with caution. With mild to moderate renal impairment, there is no need to adjust the dose.

For violations of liver function

In case of severe violations of liver function, Concor should be used with caution. The maximum dose in such patients should not exceed 10 mg. With mild to moderate impairment of liver function, there is no need to adjust the dose.

Use in the elderly

When treating elderly patients, dose adjustment is not required.

Drug interactions

When prescribing Concor, the patient must inform the doctor about all the medications he is taking. This information will allow the doctor to take into account the possible interaction of drugs and give the patient the necessary recommendations on the rules and sequence of their use.
In the treatment of chronic heart failure, the simultaneous administration of quinidine, lidocaine, disopyramide, phenytoin, propafenone, flecainide and other class I antiarrhythmics is not recommended.
Undesirable combinations for the simultaneous use of Concor:
    Diltiazem, verapamil and other slow calcium channel blockers can cause a decrease in myocardial contractility and a violation of AV conduction;
    Clonidine, moxonidine, methyldopa, rilmenidine and other antihypertensive drugs of central action can cause a decrease in cardiac output and heart rate and lead to vasodilation against the background of a decrease in central sympathetic tone. The likelihood of rebound arterial hypertension increases with abrupt withdrawal of the drug before the withdrawal of beta-blockers.
Special care should be taken when treating angina pectoris and hypertension in combination with lidocaine, quinidine, disopyramide, flecainide, phenytoin, propafenone (class I antiarrhythmics), this combination with bisoprolol can reduce myocardial contractility and AV conduction.
Drugs, in combination with which the appointment of Concor requires special care:
    Felodipine, nifedipine, amlodipine and other dihydropyridine derivatives - increase the risk of arterial hypotension; in chronic heart failure, subsequent deterioration of the contractile function of the heart is possible;
    Non-steroidal anti-inflammatory drugs - reduce the hypotensive effect of bisoprolol;
    Amiodarone and other class III antiarrhythmic drugs - can exacerbate the violation of AV conduction;
    Beta-blockers for topical use, including eye drops for the treatment of glaucoma - increase the systemic effect of bisoprolol;
    Parasympathomimetics - may increase the risk of developing bradycardia and impaired AV conduction;
    Oral hypoglycemic agents and insulin - increase their clinical effect, symptoms of hypoglycemia (tachycardia) can be suppressed or masked;
    Drugs for general anesthesia - increase the likelihood of a cardiodepressant effect, which can lead to arterial hypotension;
    Cardiac glycosides - can increase the duration of the impulse and lead to the development of bradycardia;
    Tricyclic antidepressants, phenothiazines, barbiturates and other drugs with an antihypertensive effect - can increase the antihypertensive effect of Concor;
    Mefloquine - increases the likelihood of developing bradycardia;
    Monoamine oxidase (MAO) inhibitors (except MAO B inhibitors) - potentiate the hypotensive effect of the drug and can cause the development of a hypertensive crisis.
The combination of Concor with isoprenaline, dobutamine and other beta-adrenergic agonists leads to a decrease in the clinical effect of both drugs.
Simultaneous reception with bisoprolol adrenergic agonists that affect alpha and beta adrenergic receptors (norepinephrine, epinephrine), leads to an increase in blood pressure.

Terms and conditions of storage

Store at temperatures up to 30 ° C. Keep out of the reach of children.
The shelf life is 5 years.

Reviews about Concor

Reviews of Concor indicate that this drug effectively lowers blood pressure and reduces heart rate. The main disadvantages of Concor, according to users, are the frequent development of side effects, withdrawal symptoms and the relatively high cost.

Terms of sell

You don't need a prescription to buy Concor.