bisoprolol | Coronal tablets 5 mg, 100 pcs.

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In stock
SKU
BID471359
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Release form

Tablets.
Release form

Tablets.

Packing

Per pack 100 pcs.

Pharmacological action

Selective beta1-blocker. Reduces the activity of plasma renin, reduces the need for myocardium in oxygen, reduces heart rate (at rest and under load). It has antihypertensive, antiarrhythmic and antianginal effects. By blocking 1-adrenoreceptors of the heart in low doses, it reduces the cAMP stimulation of cAMP from ATP, reduces the intracellular calcium ion flow, has a negative chrono-, dromo-, batmo- and inotropic effect (reduces heart rate, inhibits conduction and excitability, reduces myocardial contractility) . With an increase in dose, it has a beta2-adrenergic blocking effect.

OPSS at the beginning of the use of the drug, in the first 24 hours after ingestion, increases (as a result of a reciprocal increase in the activity of -adrenoreceptors and the elimination of stimulation of 2-adrenergic receptors), which after 1-3 days returns to the original, and decreases with prolonged administration.

The antihypertensive effect is associated with a decrease in minute blood volume, sympathetic stimulation of peripheral vessels, a decrease in RAAS activity (more important for patients with initial hypersecretion of renin) and the central nervous system, restoration of the sensitivity of aortic arch baroreceptors (there is no increase in their activity in response to a decrease in blood pressure) and as a result, a decrease in peripheral sympathetic influences. With arterial hypertension, the hypotensive effect develops after 2-5 days, a stable effect - after 1-2 months.

The antianginal effect is due to a decrease in myocardial oxygen demand as a result of decreased heart rate and reduced contractility, longer diastole, improved myocardial perfusion, and reduced myocardial sensitivity to the effects of sympathetic innervation. Reduces the number and severity of angina attacks and increases exercise tolerance. By increasing the final diastolic pressure in the left ventricle and increasing the stretching of the muscle fibers of the ventricles, oxygen demand may increase, especially in patients with chronic heart failure.

Antiarrhythmic effect due to the elimination of arrhythmogenic factors (tachycardia, increased activity of the sympathetic nervous system, increased content of cAMP, arterial hypertension), a decrease in the rate of spontaneous excitation of sinus and ectopic pacemakers and a slowdown in AV conduction (mainly in the antegrade and, to a lesser extent, in retrograde directions through the AV node) and conduction along additional paths.

When used in medium therapeutic doses, unlike non-selective beta-blockers, it has a less pronounced effect on organs containing 2-adrenergic receptors (pancreas, skeletal muscle, smooth muscles of the peripheral arteries, bronchi and uterus) and on carbohydrate metabolism, not causes a delay in sodium ions in the body. When used in high doses (200 mg or more), it has a blocking effect on both subtypes of -Adrenoreceptors, mainly in the bronchi and smooth muscles of blood vessels.

Indications

- arterial hypertension

- IHD: prevention of angina attacks.

Contraindications

- shock (including cardiogenic)

- acute heart failure

- chronic heart failure in the stage of decompensation

- AV block II and III degree (without artificial pacemaker)

- sinoatrial - severe bradycardia

- cardiomegaly (without signs of heart failure)

- arterial hypotension (systolic blood pressure below 100 mm Hg, especially with myocardial infarction)

- bronchial asthma and chronic obstructive pulmonary disease with a history of

- concomitant use of MAO inhibitors (except for type B MAO inhibitors)

- concomitant use of flactaphenin and sulopride

- late stages of peripheral circulatory disease - lactation period

- age up to 18 years (efficacy and safety have not been established)

- hypersensitivity to the drug and other beta-blockers.

With caution, the drug should be prescribed for liver failure, renal failure (CC less than 20 ml / min), metabolic acidosis, pheochromocytoma (with the concomitant use of alpha-adrenergic blockers), diabetes mellitus in the stage of decompensation, grade I AV blockade, Prinzmetal angina, restrictive cardiomyopathy, congenital heart defects or valvular heart defects with severe hemodynamic disturbances, chronic heart failure with myocardial infarction over the past 3 months, psoriasis, depression (including a history), severe allergic reactions in history, during pregnancy, with following a strict diet, carrying out desensitizing immunotherapy with allergens and allergen extracts, as well as elderly patients.

Use during pregnancy and lactation

During pregnancy, Coronal is prescribed only according to strict indications if the intended benefit to the mother outweighs the potential risk to the fetus. 72 hours before the birth, you should stop taking Coronal in connection with the possible development of bradycardia, hypotension, hypoglycemia and respiratory depression in the fetus / newborn.

If Coronal is needed during lactation, breast-feeding should be discontinued.

When taking bisoprolol during pregnancy, the fetus may experience intrauterine growth retardation, hypoglycemia, and bradycardia.

Special instructions

When prescribing Coronal, heart rate and blood pressure should be regularly monitored (at the beginning of treatment daily, then 1 time every 3-4 months), an ECG should be performed, blood glucose levels should be determined in patients with diabetes mellitus (1 time every 4- 5 months). In elderly patients, it is recommended to monitor renal function (1 time in 4-5 months).

The patient should be trained in the method of calculating heart rate and instructed on the need for medical advice for heart rate less than 50 bpm.

Before starting treatment, it is recommended to study the function of external respiration in patients with a history of bronchopulmonary burden.

It should be borne in mind that in approximately 20% of patients with angina pectoris, beta-blockers are ineffective due to severe coronary atherosclerosis with a low threshold of ischemia (heart rate less than 100 beats / min) and an increased final diastolic volume of the left ventricle, which violates the subendocardial blood flow.

Beta-blockers are less effective in smokers.

Patients using contact lenses should consider that tear fluid production may be reduced during treatment.

When using Coronal in patients with pheochromocytoma, there is a risk of developing paradoxical hypertension (unless effective alpha-adrenoblockade is previously achieved).

Bisoprolol may mask certain clinical signs of thyrotoxicosis (e.g., tachycardia). Abrupt withdrawal of Coronal in patients with thyrotoxicosis is contraindicated, since it can enhance the symptoms of the disease.

In diabetes mellitus, bisoprolol may 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 concentrations to normal levels.

With simultaneous use with clonidine, administration of the latter can be stopped only a few days after the cancellation of the drug Coronal.

It is possible to increase the severity of the hypersensitivity reaction and the lack of effect of the usual doses of epinephrine against the background of a burdened allergic history.

If it is necessary to carry out planned surgical treatment, drug withdrawal is carried out 48 hours before the start of general anesthesia. If the patient took the drug before surgery, he should choose a drug for general anesthesia with minimal negative inotropic effect.

Reciprocal vagus nerve activation can be eliminated iv by administration of atropine (1-2 mg).

Medicines that reduce the reserves of catecholamines (including reserpine) can enhance the effect of beta-blockers, so patients taking such combinations of drugs should be under constant medical supervision to detect a pronounced decrease in blood pressure or bradycardia.

Patients with concomitant bronchospastic diseases can be prescribed cardioselective adrenergic blockers in case of intolerance and / or ineffectiveness of other antihypertensive drugs. An overdose is dangerous for the development of bronchospasm.

In the case of elderly patients with increasing bradycardia (less than 50 beats / min), a pronounced decrease in blood pressure (systolic blood pressure below 100 mm Hg), AV block, it is necessary to reduce the dose or stop treatment.

It is recommended that therapy be discontinued if depression develops.

The drug should be discontinued before conducting a study of blood and urine levels of catecholamines, normetanephrine, vanillinindic acid, and antinuclear antibody titers.

Do not abruptly interrupt treatment because of the danger of developing severe arrhythmias and myocardial infarction. Cancellation is carried out gradually, reducing the dose for 2 weeks or more (the dose is reduced by 25% in 3-4 days).

Use in pediatrics

The use of the drug Coronal in children and adolescents under the age of 18 is contraindicated, because efficacy and safety not established.

Effect on the ability to drive vehicles and control mechanisms

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

Composition

1 tab.: bisoprolol fumarate - 5 mg

Excipients: microcrystalline cellulose - 133 mg, corn starch - 7.5 mg, sodium lauryl sulfate - 1 mg, colloidal silicon dioxide - 2 mg, magnesium stearate - 1.5 mg.

The composition of the film membrane: hypromellose - 6.4 mg, macrogol 400 - 1.28 mg, titanium dioxide (E171) - 2.3 mg, iron oxide yellow oxide (E172) - 20 ?g.

Dosage and administration of

In case of arterial hypertension and coronary heart disease (prevention of attacks of stable angina pectoris), the initial dose is 2.5-5 mg 1 time / day. If necessary, increase the dose to 10 mg 1 time / day. The maximum daily dose is 20 mg.

In patients with impaired renal function with CC <20 ml / min or with severe impaired liver function, the maximum daily dose is 10 mg.

Dose adjustment in elderly patients is not required.

Tablets should be taken orally, in the morning on an empty stomach, without chewing, with a small amount of liquid.

Side effects

The frequency of occurrence of side effects is defined as follows: 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, including individual messages).

From the side of the central nervous system: infrequently - increased fatigue, asthenia, dizziness, headache, drowsiness or insomnia, depression rarely - hallucinations, nightmares, cramps.

From the sensory organs: rarely - impaired vision, decreased secretion of lacrimal fluid, dry and sore eyes, hearing impairment is very rare - conjunctivitis.

From the side of the cardiovascular system: very often - sinus bradycardia often - lowering blood pressure, manifestation of angiospasm (increased impairment of peripheral circulation, cooling of the lower extremities, paresthesia) infrequently - violation of AV conduction, orthostatic hypotension, decompensation of chronic heart failure, peripheral edema.

From the digestive system: often - dry mucous membranes of the oral cavity, nausea, vomiting, diarrhea, constipation rarely - hepatitis, increased activity of hepatic transaminases.

From the respiratory system: infrequently - difficulty breathing when prescribed in high doses (loss of selectivity) and / or in predisposed patients - laryngo- and bronchospasm rarely - nasal congestion, allergic rhinitis.

From the endocrine system: rarely - hyperglycemia (in patients with type 2 diabetes), hypoglycemia (in patients receiving insulin).

Allergic reactions: rarely - skin itching, rash, urticaria.

From the skin: rarely - increased sweating, flushing of the skin is very rare - psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia.

From the musculoskeletal system: infrequently - muscle weakness, cramps in the calf muscles, arthralgia.

From the hemopoietic organs: in some cases - thrombocytopenia, agranulocytosis.

Other: very rare - impaired potency rarely - hypertriglyceridemia, withdrawal syndrome (increased angina attacks, increased blood pressure).

Drug Interactions

Allergens used for immunotherapy or allergen extracts for skin tests increase the risk of severe systemic allergic reactions or anaphylaxis in patients receiving bisoprolol.

When used simultaneously with Coronal, iodine-containing radiopaque drugs for intravenous administration increase the risk of anaphylactic reactions.

With the simultaneous use of phenytoin for iv administration with Coronal, drugs for inhalation general anesthesia (hydrocarbon derivatives) increase the severity of the cardiodepressive effect and the likelihood of a decrease in blood pressure.

With the simultaneous use of coronal changes the effectiveness of insulin and oral hypoglycemic drugs, masks symptoms of developing hypoglycemia (tachycardia, increased blood pressure).

With simultaneous use, Coronal reduces the clearance of lidocaine and xanthines (except diphillin) and increases their concentration in plasma, especially in patients with initially increased clearance of theophylline under the influence of smoking.

NSAIDs (due to the delay of sodium ions and blockade of prostaglandin synthesis by the kidneys), GCS and estrogens (due to the delay of sodium ions) weaken the antihypertensive effect of Coronal.

When used concomitantly with Coronal, cardiac glycosides, methyldopa, reserpine and guanfacine, slow calcium channel blockers (verapamil, diltiazem), amiodarone, and other antiarrhythmic drugs increase the risk of developing or worsening bradycardia, AV blockade, heart failure, and heart failure.

When used concomitantly with Coronal, nifedipine can lead to a significant decrease in blood pressure.

When used concomitantly with Coronal, diuretics, clonidine, sympatholytics, hydralazine and other antihypertensive drugs can lead to an excessive decrease in blood pressure.

Coronal prolongs the action of non-depolarizing muscle relaxants and the anticoagulant effect of coumarins.

When used simultaneously with Coronal, tricyclic and tetracyclic antidepressants, antipsychotic drugs (antipsychotics), ethanol, sedative and hypnotic drugs increase central nervous system depression, can provoke heart rhythm disturbances, bradycardia and orthostatic hypotension.

The simultaneous use of Coronal with MAO inhibitors is not recommended due to a significant increase in the hypotensive effect, a break in treatment between taking MAO inhibitors and Coronal should be at least 14 days.

When used simultaneously with Coronal, non-hydrogenated ergot alkaloids, ergotamine increase the risk of peripheral circulation disorders.

When used concomitantly with Coronal, sulfasalazine increases the plasma concentration of bisoprolol.

When used with Coronal, rifampicin shortens T1 / 2 of bisoprolol.

There is a potential danger of an additive effect with the development of hypotension and / or significant bradycardia when used together with beta-blockers for topical use (eye drops).

There is a decrease in the antihypertensive effect of the drug with the use of adrenaline and norepinephrine.

Probability of violations of automatism, conduction and contractility of the heart increases (mutually) during therapy with quinidine drugs (mefloquine, chloroquine).

In case of shock or arterial hypotension due to flocaphenin, when used together, a decrease in compensatory cardiovascular reactions is possible.

With simultaneous use with baclofen or amifostine, an increase in antihypertensive effect is also noted.

Overdose

Symptoms: arrhythmia, ventricular extrasystole, severe bradycardia, AV blockade, decrease in blood pressure, acute heart failure, acrocyanosis, difficulty breathing, bronchospasm, dizziness, fainting.

Treatment: It is necessary to wash the stomach and appoint adsorbing drugs. Conduct symptomatic therapy: with developed AV blockade - in / in the introduction of 1-2 mg of atropine, epinephrine or staging of a temporary pacemaker for ventricular extrasystole - in / in lidocaine (I class A drugs are not used) with the patient's blood pressure reduction should be in the Trendelenburg position in the absence of symptoms of pulmonary edema - in / in plasma replacement solutions, inefficiency, inefficiency, dobutamine (for maintenance of chrono - and inotropic action and elimination of the expressed decrease in blood pressure) at heart failure - cardiac glycosides, diuretics, glucagon at convulsions - in / in diazepam at a bronchosphere azme - beta2-adrenostimulants inhalation.

Storage Conditions

The product should be stored out of the reach of children at a temperature not exceeding 25 РC.

Shelf life

3 years.

Deystvuyushtee substance

Bisoprolol

Terms and conditions

prescription

dosage form

tablets

Possible product names

Coronal 5mg Tab. p / pl / rev X100 (R)

CORONAL TAB. P / O CAPTURE. 5 MG No. 100

Coronal table. p.p. 5 mg N100 Slovakia

Coronal tablets 5 mg, 100 pcs.

Saneka Pharmaceuticals, Czech Republic

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