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Instructions for use CONCOR® (CONCOR)

The drug is taken orally 1 time/day. The tablets should be taken with a small amount of liquid in the morning before, during or after breakfast. The tablets should not be chewed or crushed into powder.

Arterial hypertension and angina pectoris

The dose is selected individually, primarily taking into account the heart rate and the patient’s condition.

As a rule, the initial dose is 5 mg of Concor® 1 time / day. If necessary, the dose can be increased to 10 mg 1 time / day. For the treatment of arterial hypertension and angina pectoris, the maximum recommended dose is 20 mg of Concor® 1 time per day.

Chronic heart failure

The standard treatment regimen for chronic heart failure includes the use of ACE inhibitors or angiotensin II receptor antagonists (in case of intolerance to ACE inhibitors), beta-blockers, diuretics and, optionally, cardiac glycosides. At the beginning of treatment of chronic heart failure with Concor® or Concor® Cor, a special titration phase is required under regular medical supervision.

The precondition for treatment with Concor® or Concor® Cor is stable chronic heart failure without signs of exacerbation.

Treatment with Concor® or Concor® Cor begins in accordance with the following titration scheme. Individual adaptation may be required depending on how well the patient tolerates the prescribed dose, i.e. the dose can only be increased if the previous dose was well tolerated.

To ensure an appropriate titration process, it is recommended to use bisoprolol in the dosage form of 2.5 mg tablets at the initial stages of treatment.

The recommended starting dose is 1.25 mg 1 time/day. Depending on individual tolerance, the dose should be gradually increased to 2.5 mg, 3.75 mg, 5 mg, 7.5 mg and 10 mg 1 time / day. Each subsequent dose increase should be carried out at least 2 weeks later. If increasing the dose of the drug is poorly tolerated by the patient, then a dose reduction is possible.

The maximum recommended dose for the treatment of chronic heart failure is 10 mg 1 time / day.

During titration, regular monitoring of blood pressure, heart rate and the severity of symptoms of chronic heart failure is recommended. Worsening of the symptoms of chronic heart failure is possible from the first day of using the drug.

If the patient does not tolerate the maximum recommended dose of the drug, then a gradual dose reduction should be considered.

During the titration phase or after it, a temporary worsening of chronic heart failure, arterial hypotension or bradycardia is possible. In this case, it is recommended, first of all, to adjust the doses of concomitant therapy drugs. It may also be necessary to temporarily reduce the dose of the drug or discontinue it. After stabilization of the patient's condition, the dose should be re-titrated or treatment should be continued.

Duration of treatment for all indications

Treatment with Concor® or Concor® Cor is usually long-term.

Special patient groups

Patients with mild or moderate liver or kidney dysfunction

As a rule, no adjustment of the dosage regimen is required.

In case of severe renal dysfunction (creatinine clearance less than 20 ml/min) and in patients with severe liver diseases

the maximum daily dose is 10 mg. Increasing the dose in such patients should be carried out with extreme caution.

Elderly patients

no dose adjustment is required.

Because there is not enough data on the use of Concor® or Concor® Cor in children; it is not recommended to prescribe the drug to children under 18 years of age

To date, there is insufficient data regarding the use of Concor® or Concor® Cor in patients with chronic heart failure in combination with type 1 diabetes mellitus, severe renal and/or liver dysfunction, restrictive cardiomyopathy, congenital heart defects or heart valve disease with severe hemodynamic violations. Also, sufficient data have not yet been obtained regarding patients with chronic heart failure with myocardial infarction within the last 3 months.

Concor®

The effectiveness and tolerability of bisoprolol may be affected by the simultaneous use of other drugs. This interaction can also occur when two drugs are taken within a short period of time. The doctor must be informed about the use of other medications, even if used without a prescription.

Combinations not recommended

Treatment of chronic heart failure

Class I antiarrhythmic drugs (for example, quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone), when used simultaneously with bisoprolol, can reduce AV conduction and cardiac contractility.

All indications for use of the drug Concor®

Blockers of slow calcium channels such as verapamil and, to a lesser extent, diltiazem, when used simultaneously with bisoprolol, can lead to a decrease in myocardial contractility and impaired AV conduction. In particular, intravenous administration of verapamil to patients taking beta-blockers can lead to severe arterial hypotension and AV blockade. Centrally acting antihypertensives (such as clonidine, methyldopa, moxonidine, rilmenidine) can lead to a decrease in heart rate and cardiac output, as well as vasodilation due to a decrease in central sympathetic tone. Abrupt withdrawal, especially before discontinuation of beta-blockers, may increase the risk of developing “rebound” arterial hypertension.

Combinations requiring special caution

Treatment of arterial hypertension and angina pectoris

All indications for use of the drug Concor®

Blockers of slow calcium channels, dihydropyridine derivatives (for example, nifedipine, felodipine, amlodipine), when used simultaneously with bisoprolol, may increase the risk of developing arterial hypotension. In patients with chronic heart failure, the risk of subsequent deterioration of cardiac contractile function cannot be excluded.

Class III antiarrhythmic drugs (for example, amiodarone), when used simultaneously with bisoprolol, may increase AV conduction disturbances.

The effect of topical beta-blockers (for example, eye drops for the treatment of glaucoma) may enhance the systemic effects of bisoprolol (lowering blood pressure, reducing heart rate).

Parasympathomimetics, when used simultaneously with bisoprolol, may increase AV conduction disturbances and increase the risk of bradycardia.

When used simultaneously with Concor®, the hypoglycemic effect of insulin or oral hypoglycemic agents may be enhanced. Symptoms of hypoglycemia, in particular tachycardia, may be masked or suppressed. Such an interaction is more likely when using non-selective beta-blockers.

General anesthesia agents can increase the risk of cardiodepressive effects, leading to arterial hypotension.

Cardiac glycosides, when used simultaneously with bisoprolol, can lead to an increase in impulse conduction time, and thus to the development of bradycardia.

NSAIDs can reduce the hypotensive effect of bisoprolol.

The simultaneous use of Concor® with beta-agonists (for example, isoprenaline, dobutamine) may lead to a decrease in the effect of both drugs.

The combination of bisoprolol with adrenergic agonists that affect α- and β-adrenergic receptors (for example, norepinephrine, epinephrine) may enhance the vasoconstrictor effects of these drugs due to their action on α-adrenergic receptors, leading to an increase in blood pressure. Such an interaction is more likely when using non-selective beta-blockers.

Antihypertensive drugs, as well as other drugs with a possible antihypertensive effect (for example, tricyclic antidepressants, barbiturates, phenothiazines) can enhance the hypotensive effect of bisoprolol.

Mefloquine, when used simultaneously with bisoprolol, can increase the risk of bradycardia.

MAO inhibitors (except MAO B inhibitors) may enhance the hypotensive effect of beta-blockers. Concomitant use may also lead to the development of a hypertensive crisis.

Concor Cor

Monitoring of patients taking bisoprolol should include monitoring heart rate and blood pressure (at the beginning of treatment - daily, then once every 3-4 months), ECG, blood glucose levels in patients with diabetes (once every 4-5 months). In elderly patients, it is recommended to monitor renal function (once every 4-5 months).

The patient should be taught how to calculate heart rate and instructed about the need for medical consultation if the heart rate is less than 50/min.

Before starting treatment, it is recommended to conduct a study of external respiratory function in patients with a burdened bronchopulmonary history.

In approximately 20% of patients with angina, beta blockers are ineffective. The main causes are severe coronary atherosclerosis with a low ischemic threshold (heart rate less than 100/min) and increased LV EDV, which impairs subendocardial blood flow. In smokers, the effectiveness of beta-blockers is lower.

Patients using contact lenses should take into account that during treatment the production of tear fluid may decrease.

When used in patients with pheochromocytoma, there is a risk of developing paradoxical arterial hypertension (if effective alpha-blockade is not previously achieved).

In case of thyrotoxicosis, bisoprolol can mask certain clinical signs of thyrotoxicosis (for example, tachycardia). Abrupt withdrawal in patients with thyrotoxicosis is contraindicated because it can increase symptoms.

In diabetes mellitus, it can mask tachycardia caused by hypoglycemia. Unlike non-selective beta-blockers, it practically does not enhance insulin-induced hypoglycemia and does not delay the restoration of blood glucose to normal levels.

When taking clonidine concomitantly, it can be discontinued only a few days after bisoprolol is discontinued.

It is possible that the severity of the hypersensitivity reaction may increase and the absence of effect from usual doses of epinephrine against the background of a burdened allergic history.

If planned surgical treatment is necessary, the drug should be discontinued 48 hours before the start of general anesthesia. If the patient took the drug before surgery, he should select a drug for general anesthesia with minimal negative inotropic effect.

Reciprocal activation of the n.vagus can be eliminated by intravenous administration of atropine (1-2 mg).

Drugs that reduce catecholamine reserves (for example, reserpine) can enhance the effect of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision to detect arterial hypotension or bradycardia.

Patients with bronchospastic diseases can be prescribed cardioselective adrenergic blockers in case of intolerance and/or ineffectiveness of other antihypertensive drugs, but the dosage should be strictly monitored. An overdose is dangerous due to the development of bronchospasm.

If elderly patients develop increasing bradycardia (less than 50/min), arterial hypotension (systolic blood pressure below 100 mm Hg), AV block, bronchospasm, ventricular arrhythmias, severe liver and kidney dysfunction, it is necessary to reduce the dose or stop treatment . It is recommended to discontinue therapy if depression caused by taking beta-blockers develops.

Treatment should not be abruptly interrupted due to the risk of developing severe arrhythmias and myocardial infarction. Cancellation is carried out gradually, reducing the dose over 2 weeks or more (reduce the dose by 25% in 3-4 days).

Use during pregnancy and lactation is possible if the benefit to the mother outweighs the risk of side effects in the fetus and child.

Should be discontinued before testing the content of catecholamines, normetanephrine and vanillylmandelic acid in the blood and urine; antinuclear antibody titers.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.