CONCOR 5MG 50 TABS - MADE IN GERMANY - FREE SHIPPING

(CONCOR 5MG)
CONCOR 5MG 50 TABS - MADE IN GERMANY - FREE SHIPPING
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MERCK Brand: MERCK

Indications

Ag; ischemic heart disease (angina pectoris); chronic heart failure with left ventricular systolic dysfunction in combination with APF inhibitors, diuretics, and, if necessary, cardiac glycosides.

Application

Concor should be taken without chewing in the morning on an empty stomach or during breakfast, with a small amount of liquid.
AG; Ischemic heart disease (angina pectoris). Treatment should be started gradually with low doses, followed by dose increases. The recommended dose is 5 mg (1 tablet of Concor 5 mg) per day. For mild hypertension (diastolic pressure up to 105 mm Hg), a dose of 2.5 mg is suitable.
If necessary, the daily dose can be increased to 10 mg (1 tablet of 10 mg Concor). Further dose increases are only justified in exceptional cases.
The maximum recommended dose is 20 mg / day.
Dose adjustment is carried out by the doctor individually, depending on the pulse rate and therapeutic benefit.
Chronic heart failure with left ventricular systolic dysfunction in combination with ACE inhibitors, diuretics, and, if necessary, cardiac glycosides. Standard therapy for chronic heart failure: ACE inhibitors (or angiotensin receptor blockers in case of intolerance to ACE inhibitors), β-adrenoreceptor blockers, diuretics and, if necessary, cardiac glycosides.
Concor is prescribed for the treatment of patients with chronic heart failure without signs of exacerbation.
Therapy should be performed by a physician experienced in the management of chronic heart failure.
Treatment of patients with stable chronic heart failure with Concor begins according to the titration scheme presented below and can be adjusted depending on the individual reactions of the body:
  • 1.25 mg * bisoprolol fumarate 1 time per day for 1 week, if well tolerated, increase to
  • 2.5 mg * bisoprolol fumarate 1 time per day for the next 1 week, if well tolerated, increase to
  • 3.75 mg * bisoprolol fumarate 1 time per day for the next 1 week, if well tolerated, increase to
  • 5 mg bisoprolol fumarate once a day for the next 4 weeks, if well tolerated, increase to
  • 7.5 mg bisoprolol fumarate once a day for the next 4 weeks, if well tolerated, increase to
  • 10 mg bisoprolol fumarate 1 time per day as maintenance therapy.
* At the beginning of therapy for chronic heart failure, it is recommended to use Concor Cor film-coated tablets, 2.5 mg each.
The maximum recommended dose of bisoprolol fumarate is 10 mg once a day.
During the titration phase, it is necessary to monitor the following vital signs (blood pressure, heart rate) and symptoms of progression of heart failure. Symptoms can develop from the first day of treatment.
Treatment modification. If the maximum recommended dose is poorly tolerated, a gradual dose reduction is possible. If, during or after the titration phase, there is a gradual worsening of heart failure, arterial hypotension or bradycardia develops, a dose adjustment of the preparation is recommended, which may require a temporary reduction in the dose of bisoprolol or, possibly, suspension of treatment. After stabilization of the condition, the possibility of re-initiating treatment with bisoprolol should always be considered.
You should not stop treatment with the preparation suddenly, especially in patients with coronary artery disease, as this can lead to a worsening of the patient's condition. If necessary, treatment is recommended to be completed slowly, gradually reducing the dose (for example, reducing the dose by half weekly).
Treatment for stable chronic heart failure is usually long-term.
The course of treatment with Concor is long and depends on the nature and severity of the disease.
Patients with hepatic and renal impairment
AG; Ischemic heart disease. For patients with mild to moderate hepatic or renal impairment, dose selection usually should not be done. In patients with severe renal impairment (creatinine clearance 20 ml / min) and with severe hepatic impairment, the dose should not exceed a daily dose of 10 mg Concor. There are limited data on the use of bisoprolol in dialysis patients. There is no need to change the dosage regimen.
Chronic heart failure. There are no data on the pharmacokinetics of bisoprolol in patients with chronic heart failure simultaneously with impaired liver and / or kidney function, therefore, the dose should be increased with caution.
Elderly patients do not need dose adjustment.

Contraindications

Acute heart failure or heart failure in a state of decompensation requiring inotropic therapy; cardiogenic shock; av-blockade of the ii – iii degree (except for that in patients with an artificial pacemaker); sick sinus syndrome; sinoatrial blockade; symptomatic bradycardia; symptomatic arterial hypotension; severe form of ba; late stages of peripheral circulatory disorders or Raynaud's disease; untreated pheochromocytoma; metabolic acidosis; hypersensitivity to bisoprolol or other components of the preparation.

Side effects

In terms of frequency of occurrence, adverse effects are classified into the following categories: very often (≥1 / 10), often (≥1 / 100 and 1/10), infrequently (≥1 / 1000 and 1/100), rarely (≥1 / 10,000 and 1/1000), very rarely (1/10 000), unknown (frequency not determined).
From the side of the heart: very often - bradycardia (in patients with chronic heart failure); often - signs of worsening heart failure (in patients with chronic heart failure); infrequently - a violation of AV conduction, bradycardia (in patients with hypertension or ischemic heart disease), signs of worsening heart failure (in patients with hypertension or ischemic heart disease).
From the nervous system: often - dizziness *, headache *; rarely syncope.
From the side of the organ of vision: rarely - a decrease in lacrimation (should be considered when wearing contact lenses); very rarely - conjunctivitis.
From the side of the organ of hearing: rarely - hearing impairment.
On the part of the respiratory system: infrequently - bronchospasm in patients with BA or a history of chronic obstructive airway diseases; rarely, allergic rhinitis.
From the digestive tract: often - nausea, vomiting, diarrhea, constipation.
On the part of the skin and connective tissue: rarely - hypersensitivity reactions, including itching, redness, rash; very rarely - alopecia. When treated with β-adrenergic receptor blockers, the condition of patients with psoriasis may worsen in the form of a psoriatic rash.
From the musculoskeletal system: infrequently - muscle weakness, cramps.
From the liver: rarely - hepatitis.
From the side of the vessels: often - a feeling of cold or numbness in the limbs, arterial hypotension (in patients with chronic heart failure); infrequently - orthostatic hypotension (in patients with chronic heart failure), arterial hypotension (in patients with hypertension or coronary artery disease).
From the reproductive system: rarely - violation of potency.
Mental disorders: infrequently - depression, sleep disturbances; rarely - nightmares, hallucinations.
Laboratory indicators: rarely - an increase in the level of triglycerides in the blood, an increase in the activity of hepatic enzymes in the blood plasma (AST, ALAT).
General disorders: often - asthenia (in patients with chronic heart failure), fatigue *; infrequently - asthenia (in patients with hypertension and ischemic heart disease).
* Applies only to patients with hypertension or coronary artery disease. These symptoms usually occur at the beginning of therapy, are mild and disappear within the first 1-2 weeks.
In case of side effects or adverse reactions, you must immediately inform your doctor.

Special instructions

Treatment of stable chronic heart failure with bisoprolol should begin with the titration phase.
Patients with coronary artery disease should not be stopped suddenly unnecessarily, as this can lead to a transient worsening of the condition. Initiation and termination of treatment with bisoprolol requires regular monitoring.
Currently, there is not enough therapeutic experience in the treatment of heart failure in patients with the following diseases and pathological conditions: type 1 diabetes mellitus (insulin-dependent), severe renal dysfunction, severe liver dysfunction, restrictive cardiomyopathy, congenital heart defects, hemodynamically significant acquired valvular heart defects, myocardial infarction within the last 3 months.
The preparation should be used with caution in patients with conditions such as:
·         bronchospasm (with asthma, obstructive respiratory diseases);
·         diabetes mellitus with significant fluctuations in blood glucose levels, while the symptoms of hypoglycemia (tachycardia, palpitations, increased sweating) may be hidden;
·         strict diet;
·         desensitization. Like other blockers of β-adrenergic receptors, bisoprolol can increase sensitivity to allergens and increase the severity of anaphylactic reactions. In such cases, epinephrine treatment does not always give a positive therapeutic effect;
·         AV block I degree;
·         Prinzmetal's angina;
·         obliterating diseases of peripheral arteries (at the beginning of therapy, complaints may increase);
·         general anesthesia.
In patients undergoing general anesthesia, the use of β-adrenergic receptor blockers reduces the risk of arrhythmia and myocardial ischemia during induction of anesthesia, intubation and the postoperative period. It was recommended to continue the use of β-adrenergic receptor blockers during the perioperative period. It is imperative to warn the anesthesiologist about taking β-adrenergic receptor blockers, since the doctor must take into account the potential interaction with other preparations, which can lead to bradyarrhythmias, reflex tachycardia and a decrease in the ability of the reflex mechanism to compensate for blood loss. In the case of discontinuation of bisoprolol before surgery, the dose should be gradually reduced and the preparation should be discontinued 48 hours before general anesthesia.
Combinations of bisoprolol with calcium antagonists of the verapamil or diltiazem group, with class I antiarrhythmic preparations and with centrally acting antihypertensive preparations are not recommended (see INTERACTIONS).
Despite the fact that cardioselective β-adrenergic receptor blockers (β1) have less effect on lung function compared to non-selective β-adrenergic receptor blockers, their use, like all β-adrenergic receptor blockers, should be avoided in obstructive airway diseases unless there are compelling reasons for therapy. If necessary, the preparation Concor should be used with caution. In patients with obstructive airways disease, treatment with bisoprolol should be started with the lowest possible dose and the patient's condition should be monitored for the onset of new symptoms (such as shortness of breath, exercise intolerance, cough).
In asthma or other COPD that can cause symptoms, concomitant therapy with bronchodilators is indicated. In some cases, while taking the preparation, patients with asthma due to increased airway resistance may require the use of higher doses of β2-sympathomimetics.
Patients with psoriasis (including a history) are prescribed β-adrenergic receptor blockers (eg bisoprolol) after careful study of the benefit / risk ratio.
Patients with pheochromocytoma are prescribed Concor only after the appointment of therapy with α-adrenergic receptor blockers. Symptoms of thyrotoxicosis can be masked while taking the preparation. When using the preparation Concor, a positive result may be observed during doping control.
Use during pregnancy and lactation. Pregnancy. Bisoprolol has pharmacological properties that can have harmful effects on pregnancy and / or fetal / newborn development. Typically, β-adrenoreceptor blockers reduce placental blood flow, which can cause intrauterine growth retardation, intrauterine death, spontaneous abortion, or premature birth. Side effects in the fetus and newborn (eg hypoglycemia, bradycardia) may develop. If treatment with β-adrenergic receptor blockers is necessary, it is desirable that it be a selective β1-adrenergic blocker.
During pregnancy, the preparation is used only when the expected benefit to the mother outweighs the potential risk to the fetus. It is necessary to control the uteroplacental blood flow and fetal growth. In case of harmful effects on the course of pregnancy or the fetus, alternative treatment should be considered.
After delivery, the newborn should be closely monitored. Symptoms of hypoglycemia and bradycardia can be expected within the first 3 days.
Breastfeeding period. There is no data on the excretion of bisoprolol into breast milk, therefore it is not recommended to use the preparation Concor during breastfeeding.
Children. There are no clinical data on the efficacy and safety of the preparation in children; therefore, the preparation should not be used in patients of this category.
The ability to influence the reaction rate when driving or operating other mechanisms. In the course of studies involving patients with coronary artery disease, the preparation did not affect the ability to drive vehicles. However, in individual cases, the preparation may affect the ability to drive vehicles or operate machinery. Particular attention must be paid at the beginning of treatment, when changing the dose of the preparation or when interacting with alcohol.

Interactions

Combinations not recommended for use
Treatment of chronic heart failure. Class I antiarrhythmics (for example, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone): potentiation of the effect with respect to AV conduction and an increase in the severity of the negative inotropic effect is possible.
All indications. Calcium antagonists such as verapamil, to a lesser extent diltiazem: negative effect on myocardial contractile function and AV conduction. IV administration of verapamil can lead to severe arterial hypotension and AV block.
Antihypertensive preparations with a central mechanism of action (clonidine, methyldopa, moxonidine, rilmenidine): may worsen the course of heart failure due to a decrease in central sympathetic tone (decreased heart rate and cardiac output, vasodilation). Sudden preparation withdrawal, especially if it is preceded by withdrawal of β-adrenergic receptor blockers, may increase the risk of rebound hypertension.
Combinations to be used with caution
Treatment of hypertension or ischemic heart disease (angina pectoris). Class I antiarrhythmics (for example, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone): potentiation of the effect with respect to AV conduction and an increase in the severity of the negative inotropic effect is possible.
All indications. Calcium antagonists such as dihydropyridine (eg nifedipine, felodipine, amlodipine) may increase the risk of arterial hypotension. The possibility of increasing the negative effect on the inotropic function of the myocardium in patients with heart failure is not excluded.
Class III antiarrhythmic preparations (eg amiodarone) can increase the negative effect on AV conduction.
Local β-adrenergic receptor blockers (for example, contained in eye drops for the treatment of glaucoma): an increase in the severity of the systemic effects of bisoprolol is possible.
Parasympathomimetics: AV conduction time may increase and the risk of bradycardia may increase.
Insulin and oral hypoglycemic agents: increased hypoglycemic action. Blockade of β-adrenergic receptors can mask the symptoms of hypoglycemia.
Anesthetics: the risk of myocardial function depression and arterial hypotension increases (see SPECIAL INSTRUCTIONS).
Cardiac glycosides: decreased heart rate, increased AV conduction time.
NSAIDs can weaken the hypotensive effect of bisoprolol.
β-Sympathomimetics (for example, orciprenaline, isoprenaline, dobutamine): use in combination with Concor can lead to a decrease in the therapeutic effect of both preparations. Higher doses of epinephrine may be needed to treat allergic reactions.
Sympathomimetics that activate α- and β-adrenergic receptors (eg epinephrine, norepinephrine): a vasoconstrictor effect mediated through α-adrenergic receptors is possible, which leads to an increase in blood pressure and an increase in intermittent claudication. Such an interaction is more likely with the use of non-selective β-adrenergic receptor blockers.
When combined with antihypertensive preparations and preparations that exhibit hypotensive effects (for example, tricyclic antidepressants, barbiturates, phenothiazine), the risk of arterial hypotension may increase.
Possible combinations
Mefloquine may increase the risk of developing bradycardia.
MAO inhibitors (with the exception of MAO type B inhibitors) increase the hypotensive effect of β-adrenergic receptor blockers, but there is a risk of developing a hypertensive crisis.

Overdose

Symptoms in case of an overdose (for example, a daily dose of 15 mg instead of 7.5 mg), cases of the development of grade III av blockade, bradycardia and dizziness were recorded. frequent signs of an overdose of β-adrenergic receptor blockers are bradycardia, arterial hypotension, acute heart failure, hypoglycemia and bronchospasm. currently, several cases of overdose are known in patients with ag and / or ischemic heart disease (the maximum dose is 2000 mg of bisoprolol). bradycardia and / or arterial hypotension were noted. all patients recovered. There is wide variability in individual sensitivity to a single high dose of bisoprolol; patients with heart failure may be more sensitive to the preparation. therefore, treatment should be started with a gradual increase in dose (see application).
Treatment. In case of an overdose, discontinue treatment with the preparation and conduct supportive and symptomatic therapy. There is limited evidence that bisoprolol is difficult to dialysis. If an overdose is suspected in accordance with the expected pharmacological action and based on the recommendations for other β-adrenergic receptor blockers, the following general measures should be considered.
With bradycardia: intravenous administration of atropine. If there is no reaction, isoprenaline or another preparation with a positive chronotropic effect is administered with caution. In exceptional cases, transvenous administration of an artificial pacemaker may be required.
With arterial hypotension: intravenous administration of fluid and vasoconstrictor preparations. IV glucagon can be helpful.
For AV block II and III degrees: careful observation and infusion of isoprenaline or transvenous administration of a pacemaker.
With exacerbation of chronic heart failure: the introduction of diuretics, inotropic preparations, vasodilators.
With bronchospasm: bronchodilators (for example isoprenaline), β2-adrenergic agonists and / or aminophylline.
With hypoglycemia: intravenous glucose.

Storage conditions

At a temperature not higher than 30 ° C.

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