Coronal, 10 mg 100 pcs

Coronal is a selective beta1-adrenoblocker without sympathomimetic activity of its own. It has no membrane stabilizing effect. It reduces plasma renin activity, decreases myocardial oxygen demand, decreases HR at rest and under load. It has hypotensive, antiarrhythmic and antianginal action.

Hypotensive effect is associated with a decrease in the minute blood volume, sympathetic stimulation of peripheral vessels, reduction of the activity of renin-angiotensin system (of greater importance for patients with initial hypersecretion of renin), restoration of sensitivity in response to BP reduction and the effect on the CNS. In arterial hypertension hypotensive effect develops in 2-5 days, stable effect – in 1-2 months.

The antianginal action is caused by decrease of myocardial oxygen demand as the result of heart rate reduction and decrease of contractility, prolongation of diastole, improvement of myocardial perfusion. By increasing left ventricular end-diastolic pressure and increasing ventricular muscle fiber stretch, oxygen demand may increase, particularly in patients with chronic heart failure.

. Antiarrhythmic action is caused by the removal of arrhythmogenic factors (tachycardia, increased activity of the sympathetic nervous system, increased content of CAMF, arterial hypertension), the decrease of spontaneous excitation rate of sinus and ectopic pacemakers and slowing of AV conduction (mainly in antegrade and, to a lesser degree, in retrograde direction through the AV node) and conduction through additional pathways.

In medium therapeutic doses, in contrast to non-selective beta-adrenoblockers, it has less pronounced effect on the organs containing β2-adrenoreceptors (pancreas, skeletal muscles, smooth muscle of peripheral arteries, bronchi and uterus) and carbohydrate metabolism, does not cause delay of sodium ions in the body. When used in high doses (200 mg and more) it has a blocking effect on both subtypes of β-adrenoreceptors, mainly in bronchi and vascular smooth muscle.

Indications

Active ingredient

Composition

1 tablet contains bisoprolol fumarate – 10 mg

Supplementary substances:

Microcrystalline cellulose,

Corn starch,

sodium lauryl sulfate,

colloidal anhydrous silica,

magnesium stearate.

How to take, the dosage

The drug is administered orally at 2.5-5 mg once daily. If necessary, the dose is increased to 10 mg once daily. Maximum daily dose is 20 mg.

In patients with impaired renal function at a CKR of < 20 ml/min or with significant hepatic impairment, the maximum daily dose is 10 mg.

The tablets should be taken in the morning on an empty stomach without chewing.

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.

In concomitant use with Coronal, iodine-containing intravenous radiopaque drugs increase the risk of anaphylactic reactions.

Concomitant use of IV phenytoin, drugs for inhalation general anesthesia (hydrocarbon derivatives) increases the severity of cardiodepressive effects and the likelihood of BP reduction with Coronal.

In concomitant use, Coronal alters the effectiveness of insulin and oral hypoglycemic drugs and masks the symptoms of developing hypoglycemia (tachycardia, increased BP).

Concomitant use of Coronal decreases clearance of lidocaine and xanthines (except diphylline) and increases their plasma concentrations, especially in patients with initially increased clearance of theophylline under the influence of smoking.

The NSAIDs (due to retention of sodium ions and blockade of prostaglandin synthesis by the kidneys), GCS and estrogens (due to retention of sodium ions) weaken the hypotensive 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 may lead to a significant decrease in BP.

Diuretics, clonidine, sympatholytics, hydralazine and other hypotensive drugs may cause excessive BP reduction when used concomitantly with Coronal.

Coronal prolongs the effects of nondepolarizing myorelaxants and the anticoagulant effect of coumarins.

When used concomitantly with Coronal, tricyclic and tetracyclic antidepressants, antipsychotic drugs (neuroleptics), ethanol, sedatives and hypnotics increase CNS depression.

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

When used concomitantly with Coronal, nonhydrogenated ergot alkaloids, ergotamine increase the risk of peripheral circulatory disorders.

Sulfasalazine increases the plasma concentration of bisoprolol when used concomitantly with Coronal.

In concomitant use with Coronal, rifampicin shortens the half-life of bisoprolol.

Special Instructions

When prescribing Coronal, HR and BP should be monitored regularly (daily at the beginning of treatment, then once every 3-4 months), ECG should be performed, blood glucose levels should be determined in diabetic patients (once every 4-5 months). In elderly patients it is recommended to control kidney function (once every 4-5 months).

The patient should be trained on how to calculate heart rate and instructed to consult a physician if the heart rate is less than 50 bpm.

Physicians with a history of bronchopulmonary problems should have an external respiratory function study before starting treatment.

It should be considered that beta-adrenoblockers are ineffective in approximately 20% of angina patients because of severe coronary atherosclerosis with low ischemic threshold (HR less than 100 bpm) and increased left ventricular end-diastolic volume, which impairs subendocardial blood flow.

In patients who smoke, the effectiveness of beta-adrenoblockers is reduced.

Patients who wear contact lenses should be aware that the treatment may decrease tear fluid production.

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

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

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

If used concomitantly with clonidine, the latter can be discontinued only after several days of withdrawal of Coronal.

The severity of hypersensitivity reactions and lack of effect of usual doses of epinephrine with a history of allergy may increase.

If planned surgical treatment is necessary, the drug should be withdrawn 48 hours before the start of general anesthesia. If the patient has taken the drug prior to surgery, the drug for general anesthesia should be selected with minimal negative inotropic effect.

The reciprocal activation of the vagus nerve can be eliminated by IV administration of atropine (1-2 mg).

Drugs that reduce catecholamine stores (including reserpine) can potentiate the effects of beta-adrenoblockers, so patients taking these combinations of drugs should be under constant medical supervision for signs of marked lowering of BP or bradycardia.

Patients with concomitant bronchospastic disorders may be prescribed cardioselective adrenoblockers if other hypotensive medications are intolerant and/or ineffective. Overdose is dangerous with the development of bronchospasm.

In case of increasing bradycardia (less than 50 bpm), marked BP decrease (systolic BP below 100 mmHg), AV-blockade in elderly patients the dose should be reduced or the treatment should be stopped.

It is recommended that therapy be discontinued if depression develops.

The drug should be discontinued before blood and urine catecholamine, normetanephrine, vanillylindalic acid, and antinuclear antibody titers are investigated.

The treatment should not be abruptly interrupted because of the risk of severe arrhythmias and myocardial infarction. Withdrawal is done gradually, reducing the dose over 2 weeks or more (the dose is reduced by 25% every 3 to 4 days).

Pediatric use

The use of Coronal in children and adolescents less than 18 years of age is contraindicated because efficacy and safety have not been established.

Impact on driving and operating machinery

When using the drug, caution must be exercised while driving vehicles and engaging in other potentially dangerous activities requiring increased concentration and quick psychomotor reactions.

Contraindications

Side effects

The incidence of side effects is defined as follows: very frequently (≥1/10), frequently (≥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 reports).

CNS disorders: infrequent – increased fatigue, asthenia, dizziness, headache, drowsiness or insomnia, depression; rare – hallucinations, nightmares, seizures.

Sensory organs: rare – visual disturbances, decreased tear fluid secretion, dry and painful eyes, hearing disorders; very rare – conjunctivitis.

Cardiovascular system: very common – sinus bradycardia; common – decrease of BP, angiospasm manifestation (increase of peripheral circulation disturbance, coldness of lower extremities, paresthesia); infrequent – AV conduction disturbance, orthostatic hypotension, decompensation of chronic heart failure, peripheral edema.

Digestive system disorders: frequently – dry mouth, nausea, vomiting, diarrhea, constipation; rarely – hepatitis, increased liver transaminase activity.

Respiratory system disorders: infrequent – difficulty in breathing when prescribed in high doses (loss of selectivity) and/or in susceptible patients – laryngo- and bronchospasm; rare – nasal congestion, allergic rhinitis.

Endocrine system: rarely – hyperglycemia (in patients with type 2 diabetes), hypoglycemia (in patients receiving insulin).

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

Skin disorders: rare – increased sweating, skin hyperemia; very rare – psoriasis-like skin reactions, exacerbation of psoriasis symptoms, alopecia.

Muscular system disorders: infrequent – muscle weakness, cramps of the calves, arthralgia.

Hematopoietic system: in rare cases – thrombocytopenia, agranulocytosis.

Others: very rarely – potency disorder, rarely – hypertriglyceridemia, withdrawal syndrome (increased angina pectoris attacks, increased BP).

Overdose

Symptoms: arrhythmia, ventricular extrasystole, marked bradycardia, AV-blockade, decreased BP, heart failure, cyanosis of finger nails or palms, difficulty breathing, bronchospasm, dizziness, fainting, seizures.

Treatment: it is necessary to flush the stomach and prescribe adsorptive drugs. Symptomatic therapy is carried out: in developed AV-blockade – IV injection of 1-2 mg of atropine, epinephrine (adrenaline) or placement of a temporary pacemaker; in ventricular extrasystole – IV lidocaine (Class I A drugs are not used); if BP decreases, the patient should be in Trendelenburg position; In the absence of symptoms of pulmonary edema – IV plasma substitute solutions, if ineffective – injection of epinephrine (adrenaline), dopamine, dobutamine (to maintain chrono- and inotropic action and eliminate marked BP decrease); in heart failure – cardiac glycosides, diuretics, glucagon; in convulsions – IV diazepam; in bronchospasm – beta2-adrenomimetics by inhalation.

Pregnancy use

In pregnancy, CORONAL is prescribed only under strict indications if the expected benefits to the mother exceed the potential risk to the fetus. 72 hours before delivery the use of CORONAL should be stopped due to the possible development of bradycardia, arterial hypotension, hypoglycemia and respiratory depression in the fetus/newborn.

If the use of CORONAL is necessary during lactation, breastfeeding should be stopped.

Bisoprolol administration during pregnancy may cause fetal growth retardation, hypoglycemia, and bradycardia.

Similarities