Coronal, pills 10mg, 100pcs

Composition

1 tablet contains bisoprolol fumarate – 10 mg

auxiliary substances:

microcrystalline cellulose,

corn starch,

sodium lauryl sulfate,

silicon dioxide colloidal anhydrous,

magnesium stearate.  

Pharmacological action

Coronal is a selective beta 1-adrenoblocker without its own sympathomimetic activity. It does not have a membrane stabilizing effect. Reduces plasma renin activity, reduces myocardial oxygen demand, reduces heart rate at rest and during exercise. It has a hypotensive, antiarrhythmic and antianginal effect.

The hypotensive effect is associated with a decrease in minute blood volume, sympathetic stimulation of peripheral vessels, a decrease in the activity of the renin-angiotensin system (more important for patients with initial renin hypersecretion), restoration of sensitivity in response to a decrease in blood pressure and the effect on the central nervous system. With arterial hypertension, the hypotensive effect develops after 2-5 days, the stable effect – after 1-2 months.

The antianginal effect is due to a decrease in the myocardial oxygen demand as a result of a decrease in heart rate and a decrease in contractility, an elongation of the diastole, and an improvement in myocardial perfusion. Due to an increase in the final diastolic pressure in the left ventricle and an increase in the stretching of the ventricular muscle fibers, oxygen demand may increase, especially in patients with chronic heart failure.

The antiarrhythmic effect is due to the elimination of arrhythmogenic factors (tachycardia, increased activity of the sympathetic nervous system, increased cAMP content, arterial hypertension), a decrease in the rate of spontaneous excitation of sinus and ectopic rhythm drivers and a slowdown in AV conduction (mainly in 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 β2-adrenergic receptors (pancreas, skeletal muscles, smooth muscles of peripheral arteries, bronchi and uterus) and on carbohydrate metabolism, does not cause sodium ion retention in the body. When used in high doses (200 mg or more), it has a blocking effect on both subtypes of beta-adrenergic receptors, mainly in the bronchi and vascular smooth muscles.

Indications

• arterial hypertension;
• coronary heart disease: prevention of angina attacks.

Use during pregnancy and lactation

During pregnancy, CORONAL is prescribed only for strict indications if the intended benefit to the mother exceeds the potential risk to the fetus. 72 hours before delivery, CORONAL should be discontinued due to the possible development of bradycardia, arterial hypotension, hypoglycemia and respiratory depression in the fetus / newborn.

If taking CORONAL is necessary during lactation, breastfeeding should be discontinued.

When taking bisoprolol during pregnancy, intrauterine growth retardation, hypoglycemia, and bradycardia are possible in the fetus.

Contraindications

• shock (incl. cardiogenic);
• collapse;
• pulmonary edema;
• acute heart failure;
• chronic heart failure in the decompensation stage;
• AV blockade of II and III degrees;
• sinoatrial blockade;
• SSS;
• pronounced bradycardia;
• angiospastic angina pectoris (Prinzmetal angina pectoris);
• cardiomegaly (without signs of heart failure);
• arterial hypotension (systolic blood pressure below 100 mmHg., especially with myocardial infarction);
• bronchial asthma and chronic obstructive pulmonary disease in anamnesis;
• simultaneous use of MAO inhibitors (except for type B MAO inhibitors);
• late stages of peripheral circulatory disorders;
• Raynaud’s disease;
• pheochromocytoma (without simultaneous use of alpha-blockers);

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• metabolic acidosis;
• age up to 18 years (efficacy and safety have not been established);
• hypersensitivity to the components of the drug and other beta-blockers.

Side effects Actions

The frequency of side effects is determined 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 Central nervous System: infrequently – increased fatigue, asthenia, dizziness, headache, drowsiness or insomnia, depression; rarely – hallucinations, nightmares, convulsions.

From the sensory organs: rarely – visual impairment, decreased secretion of lacrimal fluid, dryness and soreness of the eyes, hearing impairment; very rarely – conjunctivitis.

From the cardiovascular system: very often – sinus bradycardia; often – decrease in blood pressure, manifestation of angiospasm (increased peripheral circulatory disorders, 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 – dryness of the oral mucosa, 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 – laryngeal and bronchospasm; rarely – nasal congestion, allergic rhinitis.

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

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

From the skin: rarely – increased sweating, hyperemia of the skin; very rarely – psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia.

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

From the hematopoietic organs: in some cases – thrombocytopenia, agranulocytosis.

Other: very rarely – violation of potency; rarely – hypertriglyceridemia, “withdrawal” syndrome (increased angina attacks, increased blood pressure).

Interaction

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 use increase the risk of anaphylactic reactions.

When used simultaneously with Coronal phenytoin for intravenous use, medications for inhalation general anesthesia (derivatives of hydrocarbons) increase the severity of cardiodepressive action and the likelihood of a decrease in blood pressure.

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

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

NSAIDs (due to sodium ion retention and blockade of prostaglandin synthesis by the kidneys), GCS and estrogens (due to sodium ion retention) weaken the hypotensive effect of Coronal.

When used simultaneously 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 exacerbating bradycardia, AV blockade, cardiac arrest and heart failure.

When used simultaneously 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 effect of non-depolarizing muscle relaxants and the anticoagulant effect of coumarins.

When used simultaneously with Coronal tricyclic and tetracyclic antidepressants, antipsychotic drugs (neuroleptics), ethanol, sedative and hypnotic drugs increase the depression of the central nervous system.

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

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

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

When used concomitantly with Coronal, rifampicin shortens the half-life of bisoprolol.

How to take, course of use and dosage

The drug is prescribed orally for 2.5-5 mg 1 time / day. If necessary, the dose is increased to 10 mg 1 time / day. The maximum daily dose is 20 mg.

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

Tablets should be taken in the morning on an empty stomach, without chewing.

Overdose

Symptoms: arrhythmia, ventricular extrasystole, severe bradycardia, AV block, decreased blood pressure, heart failure, cyanosis of the fingernails or palms, difficulty breathing, bronchospasm, dizziness, fainting, convulsions.

Treatment: it is necessary to wash the stomach and prescribe adsorbent drugs. Symptomatic therapy is performed: if AV block develops, intravenous use of 1-2 mg of atropine, epinephrine (epinephrine) or setting up a temporary pacemaker; with ventricular extrasystole, intravenous lidocaine (Class I A drugs are not used); with a decrease in blood pressure, the patient should be in the Trendelenburg position; in the absence of symptoms of pulmonary edema, intravenous plasma-substituting solutions, if ineffective – use of epinephrine (epinephrine), dopamine, dobutamine (to maintain chrono – and inotropic effects and eliminate a pronounced decrease in blood pressure); in heart failure – cardiac glycosides, diuretics, glucagon; in convulsions – IV diazepam; in bronchospasm – beta – 2 – adrenomimetics by inhalation.

Special instructions

When prescribing Coronal, you should regularly monitor your heart rate and blood pressure (at the beginning of treatment – daily, then – 1 time in 3-4 months), conduct an ECG, and determine the blood glucose level in patients with diabetes mellitus (1 time in 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 about the need for medical consultation if the heart rate is less than 50 beats/min.

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

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

In smoking patients, the effectiveness of beta-blockers decreases.

Patients who use contact lenses should take into account that during treatment, there may be a decrease in the production of tear fluid.

When using Coronal in patients with pheochromocytoma, there is a risk of developing paradoxical arterial hypertension (if an effective alpha-adrenoblockade is not achieved beforehand).

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

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

When used concomitantly with clonidine, the latter may be discontinued only a few days after discontinuation of Coronal.

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

If elective surgical treatment is necessary, the drug is withdrawn 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 activation of the vagus nerve can be eliminated by intravenous use of atropine (1-2 mg).

Drugs that reduce the supply of catecholamines (including reserpine) can increase the effect of beta-blockers, so patients taking such combinations of drugs should be constantly monitored by a doctor for a pronounced decrease in blood pressure or bradycardia.

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

If elderly patients develop increasing bradycardia (less than 50 beats / min), a marked decrease in blood pressure (systolic blood pressure below 100 mm Hg), AV-blockade, the dose should be reduced or treatment should be discontinued.

It is recommended to stop therapy if depression develops.

The drug should be discontinued before testing the content of catecholamines, normetanephrine, vanillinmindalic acid, and anti-nuclearbody titers in the blood and urine.

Do not abruptly interrupt treatment due to the risk of developing severe arrhythmias and myocardial infarction. Withdrawal 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 Coronal in children and adolescents under 18 years of age is contraindicated, as efficacy and safety have not been established.

Influence on the ability to drive motor vehicles and manage mechanisms

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

Form of production

Film-coated tablets

Active ingredient

Bisoprolol

Conditions of release from pharmacies

By prescription

Dosage form

Tablets