Concor - selective beta 1 -blocker.
Release form and composition
Concor dosage form - film-coated tablets - biconvex, heart-shaped, with a risk on both sides, light yellow (5 mg tablets) or light orange (10 mg tablets) colors:
- 10 pcs. in blisters, in a cardboard bundle of 3 or 5 blisters;
- 25 pieces in blisters, in a cardboard bundle 2 blisters;
- 30 pieces each in blisters, in a cardboard bundle of 1 or 3 blisters.
The active ingredient of the drug is bisoprolol hemifumarate (bisoprolol fumarate (2: 1)): in 1 tablet 5 or 10 mg.
Auxiliary components: corn starch (fine powder), anhydrous calcium phosphate, crospovidone, microcrystalline cellulose, colloidal anhydrous silicon dioxide, magnesium stearate.
The composition of the film shell:
- Tablets 5 mg: dimethicone 100, macrogol 400, hypromellose 2910/15, titanium dioxide (E171) and iron dye yellow oxide (E172);
- Tablets 10 mg: dimethicone 100, macrogol 400, hypromellose 2910/15, titanium dioxide (E171), iron dyes yellow oxide (E172) and iron red oxide (E172).
Indications for use
- Arterial hypertension;
- Chronic heart failure (CHF);
- Stable angina with coronary heart disease (CHD).
- Sick sinus syndrome;
- AV block II and III degree (without pacemaker);
- Cardiogenic shock;
- A pronounced decrease in blood pressure (BP) (systolic BP <100 mm Hg);
- Sinoatrial blockade;
- Severe bradycardia (heart rate <60 beats per minute);
- Acute heart failure;
- Chronic decompensated heart failure, which requires the use of drugs with a positive inotropic effect;
- Raynaud's disease, pronounced disorders of the peripheral arterial circulation;
- Metabolic acidosis;
- Severe bronchial asthma and a history of chronic obstructive pulmonary disease;
- Pheochromocytoma (without simultaneous use of alpha-blockers);
- Age up to 18 years (due to insufficient data on the effectiveness and safety of use);
- Increased sensitivity to Concor components.
Relative (special caution required):
- Type I diabetes or diabetes mellitus with significant fluctuations in blood glucose;
- Printsmetal angina;
- AV block I degree;
- Restrictive cardiomyopathy;
- Chronic heart failure with myocardial infarction in the last 3 months;
- Congenital heart defects or valvular heart disease with severe hemodynamic disorders;
- Severe renal failure (creatinine clearance <20 ml / min);
- Severe abnormal liver function;
- The period of desensitization therapy;
- Strict diet.
In pregnancy, Concor can only be appointed after a careful assessment of the ratio of the expected benefits for the expectant mother and the possible risks to the fetus.
Whether bisoprolol is excreted in breast milk has not been established, therefore, if it is necessary to conduct a course of treatment, breastfeeding is recommended to stop.
Dosing and Administration
Concor is taken orally, swallowing pills whole, without breaking or chewing, with a small amount of water 1 time per day, in the morning, before meals, during meals or after it.
In case of arterial hypertension and angina pectoris, the dose is selected individually, taking into account the patient’s condition and heart rate (HR).
The initial dose, as a rule, is 5 mg per day, if necessary it is increased to 10 mg. The maximum allowable dose is 20 mg.
The standard treatment regimen for chronic heart failure includes the use of not only beta-blockers, but also diuretics, angiotensin-converting enzyme inhibitors (in case of intolerance, angiotensin II receptor antagonists) and, optionally, cardiac glycosides.
A prerequisite for the appointment of Concor is a stable course of the disease without signs of exacerbation. At the beginning of the drug requires mandatory dose titration under the careful supervision of a physician. This may require individual adaptation depending on the patient's tolerance to bisoprolol, i.e. You can increase the dose only if the previous one is well tolerated.
To ensure an appropriate titration process at the beginning of treatment, bisoprolol is recommended to be used in the form of tablets at a dose of 2.5 mg (Concor Cor).
The initial dose in the treatment of CHF is 1.25 mg 1 time per day. Taking into account the tolerability of the drug, the dose is gradually increased to 2.5-3.75-5-7.5-10 mg once a day. Each subsequent dose increase is carried out at intervals of at least 2 weeks. In the case of poor tolerability, an overdose is reduced.
The maximum daily dose for CHF is 10 mg.
During the titration, it is recommended to regularly monitor blood pressure and heart rate, as well as the severity of CHF, since from the first day of taking Concor there is a possibility of worsening of the course of the disease, the development of bradycardia and hypotension. First of all, in this case, it is necessary to adjust the doses of drugs associated with concomitant therapy, and possibly Concor. In some cases, it may require a temporary cancellation. After stabilization of the condition, repeat dose titration or continue treatment.
The duration of the course of therapy the doctor determines individually. The treatment is usually long.
The maximum daily dose for patients with impaired renal function (with creatinine clearance less than 20 ml per minute) and severe liver disease - 10 mg.
- Laboratory indicators: rarely - increased levels of liver enzymes in the blood;
- Allergic reactions: rarely - hyperemia of the skin, pruritus, rash, allergic rhinitis;
- Cardiovascular system: very often - bradycardia (with CHF); often - exacerbation of symptoms of CHF (in patients with CHF), marked reduction in blood pressure (especially in patients with CHF), feeling of numbness or coldness in the limbs; infrequently, orthostatic hypotension, exacerbation of symptoms of chronic heart failure and bradycardia (in patients with angina pectoris and arterial hypertension), impaired AV – conduction;
- Digestive system: often - diarrhea or constipation, nausea and / or vomiting; rarely, hepatitis;
- Respiratory system: infrequently - bronchospasm (in patients with obstructive respiratory diseases or bronchial asthma in history);
- Sense organs: rarely - hearing impairment, reduction of tearing (this should be taken into account by people wearing contact lenses); very rarely - conjunctivitis;
- Skin: very rarely - alopecia, psoriasis-like rash or exacerbation of the course of psoriasis;
- Musculoskeletal system: infrequently - muscular weakness and cramps;
- Reproductive system: rarely - violations of potency;
- Mind: infrequently - insomnia, depression; rarely, nightmares, hallucinations;
- Central nervous system: often - increased fatigue, dizziness and headache (in patients with angina and arterial hypertension, these symptoms especially often appear at the beginning of treatment, are mild and usually disappear within 1-2 weeks); rarely - loss of consciousness;
- Other: often - asthenia in patients with CHF, infrequently - asthenia in patients with angina and arterial hypertension.
At the beginning of the drug requires constant medical supervision.
The patient should be warned that it is impossible to abruptly interrupt the treatment or independently change the dose, because This can lead to a temporary deterioration of the heart. If there is a need to stop therapy, the dose of Concor should be gradually reduced.
For COPD or bronchial asthma, the simultaneous use of bronchodilating agents is indicated. In bronchial asthma, there is a chance of increasing the resistance of the respiratory tract, therefore, a higher dose of beta 2 -adrenomimetica may be required.
Like all beta-blockers, Concor may increase the patient's sensitivity to allergens and increase the severity of anaphylactic reactions. It is important to know that epinephrine (adrenaline) does not always give the expected effect.
If necessary, general anesthesia should take into account the risk of blockade of β-adrenergic receptors. If before surgery it is necessary to cancel bisoprolol, then do it gradually, and complete the reception 48 hours before surgery. The anesthesiologist must be warned that the patient was taking Concor.
With pheochromocytoma, bisoprolol can be prescribed only if alpha-blockers are used.
Concor may mask the symptoms of hyperthyroidism.
Bisoprolol does not affect the ability to concentrate and the speed of reactions; however, at the beginning of treatment and with each dose change, individual reactions of the body are possible, therefore caution should be exercised when driving vehicles and performing potentially dangerous types of work.
The tolerability and effectiveness of bisoprolol can be affected by any drugs taken at the same time (even after a short period of time), therefore the physician should be warned about the use of other medicines, including those taken without prescription.
Not recommended combinations:
- With all indications for use of Concor: blockers of slow calcium channels such as verapamil and diltiazem can reduce myocardial contractility and disrupt AV conductivity. When intravenous verapamil may develop severe arterial hypotension and AV-blockade. Central antihypertensive drugs (moxonidine, methyldopa, rilmenidine, clonidine) can lead to a decrease in cardiac output, a decrease in heart rate, vasodilation. With a sharp cessation of their use, especially until Concor is canceled, the risk of ricochet hypertension increases;
- In the treatment of chronic heart failure: Class I antiarrhythmic drugs (such as lidocaine, disopyramide, propafenone, phenytoin, quinidine, flecainide), while used with bisoprolol, can reduce cardiac contractility and AV conductivity.
Combinations requiring special care in the treatment of angina and arterial hypertension: Class I antiarrhythmic drugs.
Combinations that require special care, regardless of the indications for use of Concor, in connection with possible undesirable reactions of interaction:
- Slow calcium channel blockers derived from dihydropyridine (for example, felodipine, nifedipine, amlodipine) - the risk of developing arterial hypertension, in CHF - worsening of the contractile function of the heart;
- Class III antiarrhythmic drugs (for example, amiodarone) - increased AV-conduction disturbance;
- Nonsteroidal anti-inflammatory drugs - reducing the hypotensive effect of bisoprolol;
- Beta-blockers for local use (for example, eye drops for the treatment of glaucoma) - increased systemic effects of bisoprolol (decrease in heart rate, decrease in blood pressure);
- Parasympathomimetics - increased AV conduction disturbances, increased risk of developing bradycardia;
- Insulin and oral hypoglycemic agents - enhancing their hypoglycemic action (with the symptoms of hypoglycemia can be suppressed or masked);
- Agents for general anesthesia - the risk of a cardiodepressive action leading to arterial hypotension;
- Cardiac glycosides - an increase in impulse time and the development of bradycardia;
- Beta adrenomimetics (for example, isoprenaline, dobutamine) - reducing the effectiveness of both drugs;
- Adrenomimetics affecting α- and β-adrenergic receptors (for example, epinephrine and norepinephrine) increase their vasoconstrictor effect, leading to an increase in blood pressure;
- Antihypertensive drugs and drugs with a possible antihypertensive effect (for example, barbiturates, tricyclic antidepressants, phenothiazines) - enhancing the hypotensive effect of bisoprolol;
- Meflokhin - the risk of developing bradycardia;
- Monoamine oxidase inhibitors (with the exception of type B) - enhancing the hypotensive effect of bisoprolol, the development of hypertensive crisis.
Terms and conditions of storage
Store at temperatures up to 30 ºС out of the reach of children.
Shelf life - 5 years.