CONCOR COR 2.5MG 30 TABS - MADE IN GERMANY - FREE SHIPPING

(CONCOR COR 2.5MG)
CONCOR COR 2.5MG 30 TABS - MADE IN GERMANY - FREE SHIPPING
Availability: In Stock
MERCK Brand: MERCK

Indications

Treatment of chronic heart failure with left ventricular systolic dysfunction in combination with APF inhibitors, diuretics, and, if necessary, cardiac glycosides.

Application

Concor Cor should be taken without chewing in the morning on an empty stomach or during breakfast with a small amount of liquid.

Standard therapy for chronic heart failure: ACE inhibitors or angiotensin II antagonists, β-adrenergic receptor blockers, diuretics and, if necessary, cardiac glycosides.

At the beginning of treatment with bisoprolol, the patient should not show signs of exacerbation. Possible transient worsening of heart failure, arterial hypotension or bradycardia during the titration period and after it.

Dose titration period. Treatment of chronic heart failure with bisoprolol begins in accordance with the following titration scheme 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 once a 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.

The maximum recommended dose of bisoprolol hemifumarate is 10 mg once a day.

During the titration phase, careful monitoring of vital signs (blood pressure, heart rate) and symptoms of progression of heart failure is necessary. Symptoms can occur from the first day after starting treatment.

Treatment modification. If during the titration phase or after it worsens heart failure, arterial hypotension or bradycardia develop, it is recommended to adjust the dose of the preparation, which may require a temporary reduction in the dose of bisoprolol or suspension of treatment. After stabilization of the patient's condition, preparation treatment is continued.

The course of treatment with the preparation Concor Cor is long.

You should not stop treatment suddenly and change the recommended dose without consulting your doctor, as this may worsen the patient's condition. If necessary, treatment with the preparation should be completed slowly, gradually reducing the dose.

Patients with hepatic and renal impairment. 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 extreme caution.

Elderly patients. No dose adjustment required.

Contraindications

Acute heart failure or heart failure in a state of decompensation, which requires intravenous inotropic therapy; cardiogenic shock; av-blockade ii and iii degrees; sick sinus syndrome; pronounced sinoatrial blockade; symptomatic bradycardia; symptomatic arterial hypotension; severe form of ba; severe form of obliterating peripheral arterial disease 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).

From the side of the cardiovascular system: very often - bradycardia; often - signs of worsening heart failure, a feeling of cold or numbness in the limbs, arterial hypotension, especially in patients with heart failure; infrequently - violation of AV conduction, orthostatic hypotension.

From the side of 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 a history of asthma and chronic obstructive airway diseases; rarely, allergic rhinitis.

From the digestive tract: often - nausea, vomiting, diarrhea, constipation.

On the part of the skin: rarely - hypersensitivity reactions (itching, redness, rash); very rarely - during treatment with β-adrenergic receptor blockers, the condition of patients with psoriasis may deteriorate in the form of psoriatic rash, alopecia.

From the musculoskeletal system: infrequently - muscle weakness, cramps.

From the liver: rarely - hepatitis.

From the reproductive system: rarely - violation of potency.

Mental disorders: infrequently - depression, sleep disturbances; rarely - nightmares, hallucinations.

The body as a whole: often - asthenia, fatigue.

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 I diabetes mellitus (insulin-dependent), severe renal dysfunction, severe liver dysfunction, restrictive cardiomyopathy, congenital heart defects, hemodynamically significant acquired valvular heart disease , myocardial infarction within the last 3 months.

The preparation should be used with caution in patients with the following conditions:

  • bronchospasm (with asthma or COPD);
  • diabetes mellitus with sharp fluctuations in blood glucose levels; hypoglycemic symptoms may be hidden;
  • strict diet;
  • during desensitizing therapy. Like other blockers of β-adrenergic receptors, bisoprolol may 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.

It is imperative to warn the anesthesiologist about taking β-adrenergic receptor blockers. 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 postoperative period. It was recommended to continue the use of β-adrenergic receptor blockers during the perioperative period. The anesthesiologist should consider potential preparation interactions that can lead to bradyarrhythmias, reflex tachycardia, and a decreased ability of the reflex mechanism to compensate for blood loss. If bisoprolol is canceled 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-adrenoreceptor (β1) blockers have less effect on lung function compared to non-selective β-adrenergic blockers, their use, like all β-adrenergic blockers, should be avoided in obstructive airway diseases unless there are compelling reasons. for therapy. If necessary, the preparation Concor Cor should be used with caution. In patients with obstructive airway diseases, 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 a careful study of the benefit / risk ratio.

Patients with pheochromocytoma are prescribed bisoprolol only after administration of therapy with α-adrenergic receptor blockers. Symptoms of thyrotoxicosis can be masked while taking the preparation.

Application during pregnancy or lactation. During pregnancy, the preparation is used only when the expected benefit to the mother outweighs the potential risk to the fetus. Typically, blockers of α-adrenergic receptors reduce blood flow in the placenta and can affect the development of the fetus. It is necessary to control the uteroplacental blood flow.

After delivery, the newborn should be closely monitored. The development of symptoms of hypoglycemia and bradycardia can be expected within the first 3 days.

There are no data on the excretion of bisoprolol into breast milk or the safety of exposure to infants, therefore it is not recommended to use Concor Cor 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 some cases, the preparation can 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 effects on myocardial contractile function and AV conduction. IV administration of verapamil can lead to severe arterial hypotension and AV blockade.

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). Abrupt withdrawal of the preparation, especially if it is preceded by the 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) may 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 Cor may lead to a decrease in the therapeutic effect of both preparations. Higher doses of epinephrine may be required to treat allergic reactions.

Sympathomimetics that activate α- and β-adrenergic receptors (for example, 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, there are several cases of overdose 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, treatment with the preparation is stopped and supportive and symptomatic therapy is carried out. 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.

For bronchospasm: bronchodilators (eg isoprenaline), β2-adrenergic agonists and / or aminophylline.

With hypoglycemia: intravenous administration of glucose.

Storage conditions

At a temperature not exceeding 25 ° c.

Tags: CONCOR

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